GSK3739937 First-Time-In-Human (FTIH) Study in Healthy Vo... | NCT04493684 | Trialant
NCT04493684
Sponsor
ViiV Healthcare
Status
Completed
Last Update Posted
Jul 16, 2025Actual
Enrollment
91Actual
Phase
Phase 1
Conditions
HIV Infections
Interventions
GSK3739937 (PIB)
Placebo
GSK3739937 (Tablet)
Countries
United States
Protocol Section
Identification Module
NCT ID
Results Section
Participant Flow Module
Pre-assignment Details
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Derived Section
Miscellaneous Info Module
Version Holder
NCT04493684
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
212548
Secondary IDs
Not provided
Brief Title
GSK3739937 First-Time-In-Human (FTIH) Study in Healthy Volunteers
Official Title
A Double-Blind (Sponsor Unblinded), Randomized, Placebo-Controlled, Single and Repeated Dose Escalation Study to Investigate the Safety, Tolerability and Pharmacokinetics of GSK3739937 in Healthy Participants
Acronym
Not provided
Organization
ViiV HealthcareINDUSTRY
Status Module
Record Verification Date
Jul 2025
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Jul 31, 2020Actual
Primary Completion Date
Aug 30, 2021Actual
Completion Date
Aug 30, 2021Actual
First Submitted Date
Jul 20, 2020
First Submission Date that Met QC Criteria
Jul 29, 2020
First Posted Date
Jul 30, 2020Actual
Results Waived
Not provided
Results First Submitted Date
Aug 29, 2022
Results First Submitted that Met QC Criteria
Aug 20, 2023
Results First Posted Date
Aug 23, 2023Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Jul 7, 2025
Last Update Posted Date
Jul 16, 2025Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
ViiV HealthcareINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This study is a Phase 1, double-blind (sponsor-unblinded), randomized, placebo-controlled, single- and repeat-dose escalation study including a weekly oral dose (MAD) cohort and a relative bioavailability (RBA) and food effect (FE) cohort to investigate the safety, tolerability and PK of VH3739937 in healthy participants. This is a three part study. Part 1 and Part 2 is designed to gain information on the safety, tolerability, and pharmacokinetic (PK) properties of GSK3739937 when administered as powder-in-a-bottle (PiB). Part 3 will evaluate the RBA of the GSK3739937 PiB and GSK3739937 Tablet and the safety, tolerability and PK parameters of the tablet formulation when administered under fasting and fed conditions.
Detailed Description
Not provided
Conditions Module
Conditions
HIV Infections
Keywords
Acquired Immunodeficiency Syndrome
First-time-in-human
Pharmacokinetics
Safety
Tolerability
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
91Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Part 1: Cohort 1: Participants receiving GSK3739937
Experimental
Part 1 cohort 1 may contain up to 4 escalating doses (Period 1- 10 milligram [mg], Period 2- 80 mg, and Period 3- 320 mg, Period 4- 800 mg) of GSK3739937.
Drug: GSK3739937 (PIB)
Part 1: Cohort 1: Participants receiving Placebo
Placebo Comparator
In this cohort, participants will be randomized to receive placebo.
Drug: Placebo
Part 1: Cohort 2: Participants receiving GSK3739937
Experimental
Part 1 cohort 2 may contain up to 3 escalating doses ( Period 1- 30 mg, Period 2- 160 mg, and Period 3- 640 mg) of GSK3739937.
Drug: GSK3739937 (PIB)
Part 1: Cohort 2: Participants receiving Placebo
Placebo Comparator
In this cohort, participants will be randomized to receive placebo.
Drug: Placebo
Part 2: Cohort 3: Participants receiving GSK3739937
Experimental
Eligible participants in part 2 cohort 3, will consist of approximately 10 participants out of 7 participants will be randomized to receive a once-daily dose of 25 mg GSK3739937 for 14 days.
Interventions
Name
Type
Description
Arm Group Labels
Other Names
GSK3739937 (PIB)
Drug
GSK3739937 will be administered as oral suspension.
Part 1: Cohort 1: Participants receiving GSK3739937
Part 1: Cohort 2: Participants receiving GSK3739937
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Part 1 - Number of Any Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; is a congenital anomaly/birth defect and important medical events may jeopardize the participant or may require medical or surgical intervention/Standard of care (SOC) to prevent one of the other outcomes mentioned before.
Up to 27 weeks
Part 2 - Number of Any AEs and SAEs
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; is a congenital anomaly/birth defect and important medical events may jeopardize the participant or may require medical or surgical intervention/SOC to prevent one of the other outcomes mentioned before.
Up to 5 weeks
Part 3 - Number of Any AEs and SAEs
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; is a congenital anomaly/birth defect and important medical events may jeopardize the participant or may require medical or surgical intervention/SOC to prevent one of the other outcomes mentioned before.
Up to 16 weeks
Secondary Outcomes
Measure
Description
Time Frame
Part 1 (Cohort 1 and 2) - AUC(0-24) of GSK3739937
Blood samples were collected at indicated time points for PK analysis of GSK3739937. PK parameters were analyzed using standard non-compartmental analysis.
Pre-dose (within 15 minutes prior to dosing) and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12 and 24 hours post-dose in each treatment period
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Participant must be 18 to 55 years of age inclusive, at the time of signing the informed consent.
Participants who are overtly healthy as determined by the investigator or medically qualified designee based on a medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring (history and ECG).
Participants who are negative on two consecutive tests for severe acute respiratory syndrome coronavirus-2 (SARs-CoV-2), performed at Screening and on admission and (re-)admission to the Phase I unit, using an approved molecular test polymerase chain reaction (PCR).
Participants who are able to understand and comply with protocol requirements and timetables, instructions, and protocol-stated restrictions.
Body weight >=50.0 kilograms (kg) (110 pound [lbs]) for men and >=45.0 kg (99 lbs) for women and body mass index within the range 18.5 to 32.0 kilogram per square meter (kg/m^2).
Male participants are eligible to participate if they agree to use contraceptive methods
A female participant is eligible to participate if she is not pregnant or breastfeeding, and is not a woman of childbearing potential (WOCBP). - Capable of giving signed informed consent
Exclusion Criteria:
Signs and symptoms which in the opinion of the investigator are suggestive of coronavirus disease 2019 (COVID-19) (i.e. fever, cough etc) within 14 days of inpatient admission.
Contact with known COVID-19 positive persons in the 14 days prior to inpatient admission.
History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, distribution, metabolism, or elimination of drugs; constituting a risk when taking the study intervention or interfering with the interpretation of data.
Pre-existing clinically relevant, in the opinion of the principal investigator (PI), gastro-intestinal pathology or diagnosis - e.g. irritable bowel syndrome, inflammatory bowel disease, and/or significant baseline signs and symptoms.
Medical history of cardiac arrhythmias or cardiac disease or a family and personal history of long QT syndrome.
Any known or suspected pre-existing psychiatric condition
Any positive (abnormal) response confirmed by the investigator or clinician (or qualified designee) administered Columbia Suicide Severity Rating Scale (CSSRS) at screening .
Any other clinical condition (including but not limited to active substance use) or prior therapy that, in the opinion of the Investigator, would make the participant unsuitable for the study; unable to comply with dosing requirements; or unable to comply with study visits; or a condition that could affect the absorption, distribution, metabolism or excretion of the drug.
Estimated glomerular filtration rate (eGFR) <90 milliliters/minute (mL/min) or serum creatinine >1.1 x upper limit of normal (ULN).
Hemoglobin <12.5 grams/deciliter (g/dL) for men and <11 g/dL for women.
ALT or AST >1.1x ULN.
Bilirubin >1.1 x ULN (isolated bilirubin >1.1 x ULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).
Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones)
Any significant arrhythmia or ECG finding (e.g., prior myocardial infarction in the past 3 months (does not include ST segment changes associated with repolarization), symptomatic bradycardia, non-sustained or sustained atrial arrhythmias, non-sustained or sustained ventricular tachycardia (>=3 consecutive ventricular ectopic beats), second-degree atrioventricular (AV) block Mobitz Type II, third-degree atrioventricular block, complete heart block, or conduction abnormality (including but not specific to left or right complete bundle branch; AV block [2nd degree or higher]; Wolff-Parkinson-White [WPW] syndrome), Sinus Pauses > 3 seconds, which, in the opinion of the investigator or ViiV Healthcare (VH)/ GlaxoSmithKline (GSK) Medical Monitor, will interfere with the safety for the individual participant.
Exclusion criteria for Screening ECG. Heart rate <45 or >100 beats per minute (bpm) for males and <50 or >100 bpm for females; PR interval <120 or >220 millisecond (msec); QRS duration <70 or >120 msec; the Fridericia's QT correction formula (QTcF) interval >450 msec.
Past or intended use of over-the-counter or prescription medication [including cytochrome p450 enzyme inducers or inhibitors, vitamins, herbal and dietary supplements ] within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to dosing and for the duration of the study, unless in the opinion of the Investigator and Sponsor, the medication will not interfere with the study medications, procedures, or compromise participant safety.
Unwillingness to abstain from ingestion of any food or drink containing grapefruit and grapefruit juice, Seville oranges, blood oranges, or pomelos within 7 days prior to the first dose of study treatments or until the end of the study.
Participation in the study would result in loss of blood or blood products in excess of 500 mL within 56 days
Exposure to more than 4 new chemical entities within 12 months prior to the first dosing day
Current enrolment or past participation within the last 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer) before signing of consent in this or any other clinical study involving an investigational study intervention or any other type of medical research
Presence of Hepatitis B surface antigen (HBsAg) at screening or within 3 months prior to first dose of study intervention
Positive Hepatitis C antibody test result at screening or within 3 months prior to first dose of study intervention.
Positive Hepatitis C ribonucleic acid (RNA) test result at screening or within 3 months prior to first dose of study intervention
Positive pre-study drug/alcohol screen
Positive HIV antibody/antigen test
Regular use of known drugs of abuse
Regular alcohol consumption within 6 months prior to the study defined as: An average weekly intake of >14 units for males or >7 units for females.
Urinary cotinine levels indicative of smoking or history or regular use of tobacco- or nicotine-containing products (e.g. nicotine patches or vaporizing devices) within 6 months prior to screening and at admission.
Sensitivity to any of the study interventions, or components thereof, or drug or other allergy that, in the opinion of the investigator or medical monitor, contraindicates participation in the study.
Benn PD, Zhang Y, Kahl L, Greene TJ, Bainbridge V, Fishman C, Wen B, Gartland M. A phase I, first-in-human study investigating the safety, tolerability, and pharmacokinetics of the maturation inhibitor GSK3739937. Pharmacol Res Perspect. 2023 Jun;11(3):e01093. doi: 10.1002/prp2.1093.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
Plan to Share IPD
Yes
Description
Study Sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.viiv-studyregister.com/en/study/?id=212548
Types
Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame
Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or asset(s) with development terminated across all indications.
Access Criteria
Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.
This study includes 3 parts. In part 1, 34 participants were randomized. In part 2, 40 participants were randomized. In part 3, 17 participants were randomized.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Part 1 (Cohort 1) - Single Dose (SD) Placebo (PBO)/GSK3739937 SD 80 mg/GSK3739937 SD 320 mg
Participants received single oral dose of placebo as suspension in Treatment Period 1, followed by single oral dose of 80 milligrams (mg) of GSK3739937 in Treatment Period 2, and followed by single oral dose of 320 mg of GSK3739937 in Treatment Period 3.
Participants received single oral dose of 10 mg of GSK3739937 as suspension in Treatment Period 1, followed by single oral dose of placebo as suspension in Treatment Period 2, and followed by single oral dose of 320 mg of GSK3739937 as suspension in Treatment Period 3.
Participants received single oral dose of 10 mg of GSK3739937 as suspension in Treatment Period 1, followed by single oral dose of 80 mg of GSK3739937 as suspension in Treatment Period 2, and followed by single oral dose of placebo as suspension in Treatment Period 3.
FG003
Part 1 (Cohort 1) - GSK3739937 SD 800 mg
Participants received single oral dose of 800 mg of GSK3739937 as suspension in Treatment Period 1.
FG004
Part 1 (Cohort 1) - SD PBO
Participants received single oral dose of Placebo in Treatment Period 1.
Participants received single oral dose of Placebo as suspension in Treatment Period 1, followed by single oral dose of 160 mg of GSK3739937 as suspension in Treatment Period 2, and followed by single oral dose of 640 mg of GSK3739937 as suspension Treatment in Period 3.
Participants received single oral dose of 30 mg of GSK3739937 as suspension in Treatment Period 1, followed by single oral dose of Placebo as suspension in Treatment Period 2, and followed by single oral dose of 640 mg of GSK3739937 as suspension in Treatment Period 3.
Participants received single oral dose of 30 mg of GSK3739937 as suspension in Treatment Period 1, followed by single oral dose of 160 mg of GSK3739937 in Period 2, and followed by single oral dose of Placebo in Period 3.
FG008
Part 2 - Once Daily (QD) PBO
Participants received once daily oral doses of Placebo as suspension for 14 days in Treatment Period 1.
FG009
Part 2 (Cohort 3) - GSK3739937 QD 25 mg
Participants received once daily oral doses of 25 mg of GSK3739937 as suspension for 14 days in Treatment Period 1.
FG010
Part 2 (Cohort 4) - GSK3739937 QD 50 mg
Participants received once daily oral doses of 50 mg of GSK3739937 as suspension for 14 days in Treatment Period 1.
FG011
Part 2 (Cohort 5) - GSK3739937 QD 100 mg
Participants received once daily oral doses of 100 mg of GSK3739937 as suspension for 18 days in Treatment Period 1.
FG012
Part 2 - Once Weekly (QW) PBO
Participants received once weekly oral doses of Placebo as suspension for over 3 weeks in Treatment Period 1.
FG013
Part 2 (Cohort 6) - GSK3739937 QW 500 mg
Participants received once weekly oral doses of 500 mg of GSK3739937 as suspension for over 3 weeks in Treatment Period 1.
Participants received single dose of 100 mg of powder in bottle (PiB) as oral suspension under moderate fed conditions in Treatment Period 1, followed by single oral dose of 100 mg of GSK3739937 tablet under moderate fed conditions in Treatment Period 2 and followed by single dose of 100 mg of GSK3739937 tablet under fasted conditions in Treatment Period 3.
Participants received single oral dose of 100 mg of GSK3739937 tablet under moderate fed conditions in Treatment Period 1, followed by single oral dose of 100 mg GSK3739937 tablet under fasted conditions in Treatment Period 2 and followed by single dose of 100 mg PiB as oral suspension under moderate fed conditions in Treatment Period 3.
Participants received single oral dose of 100 mg of GSK3739937 tablet under fasted condition in Treatment Period 1, followed by single oral dose of 100 mg PiB as oral suspension under moderate fed conditions in Treatment Period 2 and followed by single oral dose of 100 mg GSK3739937 tablet under fed conditions in Treatment Period 3.
Periods
Title
Milestones
Reasons Not Completed
Part 1:Treatment Period 1-Up to 9 Weeks
Type
Comment
Milestone Data
STARTED
FG0003 subjects
FG0013 subjects
FG0023 subjects
FG0036 subjects
FG004
COMPLETED
FG0002 subjects
FG0013 subjects
FG0022 subjects
FG0036 subjects
FG004
NOT COMPLETED
FG0001 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Withdrawal by Subject
FG0001 subjects
FG0010 subjects
FG0021 subjects
FG003
Part 1:Treatment Period 2-Up to 9 Weeks
Type
Comment
Milestone Data
STARTED
FG0004 subjects2 additional participants were enrolled and dosed.
FG0013 subjects
FG0023 subjects1 additional participant was enrolled and dosed.
FG003
Part 1:Treatment Period 3-Up to 9 Weeks
Type
Comment
Milestone Data
STARTED
FG0004 subjects1 additional participant was enrolled and dosed.
FG0013 subjects
FG0023 subjects
FG003
Part 2:Treatment Period 1-Up to 5 Weeks
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Part 3:Treatment Period 1-Up to 4 Weeks
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Part 3:Treatment Period 2-Up to 4 Weeks
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Part 3:Treatment Period 3-Up to 4 Weeks
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Part 1 (Cohort 1) - Single Dose (SD) Placebo (PBO)/GSK3739937 SD 80 mg/GSK3739937 SD 320 mg
Participants received single oral dose of placebo as suspension in Treatment Period 1, followed by single oral dose of 80 milligrams (mg) of GSK3739937 in Treatment Period 2, and followed by single oral dose of 320 mg of GSK3739937 in Treatment Period 3.
Denominators
Units
Counts
Participants
BG000
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Customized
Count of Participants
Outcome Measures Module
Outcome Measures
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Part 1 - Number of Any Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; is a congenital anomaly/birth defect and important medical events may jeopardize the participant or may require medical or surgical intervention/Standard of care (SOC) to prevent one of the other outcomes mentioned before.
Safety Population included all randomized participants who received at least one dose of study treatment.
Posted
Number
Events
Up to 27 weeks
ID
Title
Description
OG000
Placebo (PBO) Single Dose
Adverse Events Module
Frequency Threshold
5
Time Frame
All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Description
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Placebo (PBO) Single Dose
In Cohort 1 and 2 of Part 1, participants received single oral dose of Placebo.
Part 1 is a single ascending dose study, Part 2 is multiple ascending dose study while Part 3 is a 3-period crossover design.
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Double
Masking Description
This will be a double-blind study with participants and the site-staff blinded and sponsor unblended. Part 3 of the study will be open-label.
Who Masked
ParticipantInvestigator
Drug: GSK3739937 (PIB)
Part 2: Cohort 3: Participants receiving Placebo
Placebo Comparator
Eligible participants in part 2 cohort 3, will consist of approximately 10 participants out of 3 participants will be randomized to receive a once-daily dose of placebo for 14 days.
Drug: Placebo
Part 2: Cohort 4: Participants receiving GSK3739937
Experimental
Eligible participants in part 2 cohort 4, will consist of approximately 10 participants out of 7 participants will be randomized to receive a once-daily dose of 50 mg GSK3739937 for 14 days.
Drug: GSK3739937 (PIB)
Part 2: Cohort 4: Participants receiving Placebo
Placebo Comparator
Eligible participants in part 2 cohort 4, will consist of approximately 10 participants out of 3 participants will be randomized to receive a once-daily dose of placebo for 14 days.
Drug: Placebo
Part 2: Cohort 5: Participants receiving GSK3739937
Experimental
Eligible participants in part 2 cohort 5, will consist of approximately 10 participants out of 7 participants will be randomized to receive a once-daily dose of 100 mg GSK3739937 for 18 days.
Drug: GSK3739937 (PIB)
Part 2: Cohort 5: Participants receiving placebo
Placebo Comparator
Eligible participants in part 2 cohort 5, will consist of approximately 10 participants out of 3 participants will be randomized to receive a once-daily dose of placebo for 18 days.
Drug: Placebo
Part 2: Cohort 6: Participants receiving GSK3739937
Experimental
Eligible participants in part 2 cohort 6, will consist of approximately 10 participants out of 7 participants will be randomized to receive three 500 mg doses of GSK3739937 administered at once weekly intervals over two weeks.
Drug: GSK3739937 (PIB)
Part 2: Cohort 6: Participants receiving placebo
Placebo Comparator
Eligible participants in part 2 cohort 6, will consist of approximately 10 participants out of 3 participants will be randomized to receive three doses of placebo administered at once weekly intervals over two weeks.
Drug: Placebo
Part 3: Cohort 7: Participants receiving treatment sequence ABC
Experimental
Participants will receive Treatment A: GSK3739937 PiB, 100 mg administered under moderate fat conditions in Period 1; Treatment B: GSK3739937 Tablet, 100 mg administered under moderate fat conditions in Period 2; and Treatment C: GSK3739937 Tablet, 100 mg administered under fasted conditions in Period 3.
Drug: GSK3739937 (PIB)
Drug: GSK3739937 (Tablet)
Part 3: Cohort 7: Participants receiving treatment sequence BCA
Experimental
Participants will receive Treatment B: GSK3739937 Tablet, 100 mg administered under moderate fat conditions in Period 1; Treatment C: GSK3739937 Tablet, 100 mg administered under fasted conditions in Period 2; and Treatment A: GSK3739937 PiB, 100 mg administered under moderate fat conditions in Period 3.
Drug: GSK3739937 (PIB)
Drug: GSK3739937 (Tablet)
Part 3: Cohort 7: Participants receiving treatment sequence CAB
Experimental
Participants will receive Treatment C: GSK3739937 Tablet, 100 mg administered under fasted conditions in Period 1; Treatment A: GSK3739937 PiB, 100 mg administered under moderate fat conditions in Period 2; and Treatment B: GSK3739937 Tablet, 100 mg administered under moderate fat conditions in Period 3.
Drug: GSK3739937 (PIB)
Drug: GSK3739937 (Tablet)
Part 2: Cohort 3: Participants receiving GSK3739937
Part 2: Cohort 4: Participants receiving GSK3739937
Part 2: Cohort 5: Participants receiving GSK3739937
Part 2: Cohort 6: Participants receiving GSK3739937
Part 3: Cohort 7: Participants receiving treatment sequence ABC
Part 3: Cohort 7: Participants receiving treatment sequence BCA
Part 3: Cohort 7: Participants receiving treatment sequence CAB
Placebo
Drug
Placebo will be given orally during each dosing day.
Part 1: Cohort 1: Participants receiving Placebo
Part 1: Cohort 2: Participants receiving Placebo
Part 2: Cohort 3: Participants receiving Placebo
Part 2: Cohort 4: Participants receiving Placebo
Part 2: Cohort 5: Participants receiving placebo
Part 2: Cohort 6: Participants receiving placebo
GSK3739937 (Tablet)
Drug
GSK3739937 Tablet will be administered via oral route.
Part 3: Cohort 7: Participants receiving treatment sequence ABC
Part 3: Cohort 7: Participants receiving treatment sequence BCA
Part 3: Cohort 7: Participants receiving treatment sequence CAB
Part 1 - Change From Baseline in Hematology Parameters - Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets
Blood samples were collected to assess change from baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline value is presented and was calculated as post-dose visit value minus Baseline value.
Baseline (Day -1) and Day 6
Part 2 (QD PBO and Cohort 3, 4 and 5) - Change From Baseline in Hematology Parameters - Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets
Blood samples were collected to assess change from baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline value is presented and was calculated as post-dose visit value minus Baseline value.
Baseline (Day 1, pre-dose) and Day 14
Part 2 (QW PBO and Cohort 6) - Change From Baseline in Hematology Parameters - Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets
Blood samples were collected to assess change from baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline value is presented and was calculated as post-dose visit value minus Baseline value.
Baseline (Day 1, pre-dose) and Day 15
Part 3 - Change From Baseline in Hematology Parameters - Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets
Blood samples were collected to assess change from baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline value is presented and was calculated as post-dose visit value minus Baseline value.
Baseline (Day -1) and Day 6
Part 1 - Change From Baseline in Hematology Parameters - Erythrocytes Count
Blood samples were collected to assess change from baseline in Erythrocytes count. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline value is presented and was calculated as post-dose visit value minus Baseline value.
Baseline (Day -1) and Day 6
Part 2 (QD PBO and Cohort 3, 4 and 5) - Change From Baseline in Hematology Parameters - Erythrocytes Count
Blood samples were collected to assess change from baseline in Erythrocytes count. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline value is presented and was calculated as post-dose visit value minus Baseline value.
Baseline (Day 1, pre-dose) and Day 14
Part 2 (QW PBO and Cohort 6) - Change From Baseline in Hematology Parameters - Erythrocytes Count
Blood samples were collected to assess change from baseline in Erythrocytes count. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline value is presented and was calculated as post-dose visit value minus Baseline value.
Baseline (Day 1, pre-dose) and Day 15
Part 3 - Change From Baseline in Hematology Parameters - Erythrocytes Count
Blood samples were collected to assess change from baseline in Erythrocytes count. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline value is presented and was calculated as post-dose visit value minus Baseline value.
Baseline (Day -1) and Day 6
Part 1 - Change From Baseline in Hematology Parameter - Erythrocytes Mean Corpuscular Hemoglobin (MCH)
Blood samples were collected to assess change from baseline in Erythrocytes Mean Corpuscular Hemoglobin (MCH). Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline value is presented and was calculated as post-dose visit value minus Baseline value.
Baseline (Day -1) and Day 6
Part 2 (QD PBO and Cohort 3, 4 and 5) - Change From Baseline in Hematology Parameter - Erythrocytes Mean Corpuscular Hemoglobin (MCH)
Blood samples were collected to assess change from baseline in Erythrocytes Mean Corpuscular Hemoglobin (MCH). Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline value is presented and was calculated as post-dose visit value minus Baseline value.
Baseline (Day 1, pre-dose) and Day 14
Part 2 (QW PBO and Cohort 6) - Change From Baseline in Hematology Parameter - Erythrocytes Mean Corpuscular Hemoglobin (MCH)
Blood samples were collected to assess change from baseline in Mean Corpuscular Hemoglobin (MCH). Blood samples were collected to assess change from baseline in Erythrocytes Mean Corpuscular Hemoglobin (MCH). Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline value is presented and was calculated as post-dose visit value minus Baseline value.
Baseline (Day 1, pre-dose) and Day 15
Part 3 - Change From Baseline in Hematology Parameter - Erythrocytes Mean Corpuscular Hemoglobin (MCH)
Blood samples were collected to assess change from baseline in Mean Corpuscular Hemoglobin (MCH). Blood samples were collected to assess change from baseline in Erythrocytes Mean Corpuscular Hemoglobin (MCH). Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline value is presented and was calculated as post-dose visit value minus Baseline value.
Baseline (Day -1) and Day 6
Part 1 - Change From Baseline in Hematology Parameter - Hematocrit
Blood samples were collected to assess change from baseline in Hematocrit. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline value is presented and was calculated as post-dose visit value minus Baseline value.
Baseline (Day -1) and Day 6
Part 2 (QD PBO and Cohort 3, 4 and 5) - Change From Baseline in Hematology Parameter - Hematocrit
Blood samples were collected to assess change from baseline in Hematocrit. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline value is presented and was calculated as post-dose visit value minus Baseline value.
Baseline (Day 1, pre-dose) and Day 14
Part 2 (QW PBO and Cohort 6) - Change From Baseline in Hematology Parameter - Hematocrit
Blood samples were collected to assess change from baseline in Hematocrit. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline value is presented and was calculated as post-dose visit value minus Baseline value.
Baseline (Day 1, pre-dose) and Day 15
Part 3 - Change From Baseline in Hematology Parameter - Hematocrit
Blood samples were collected to assess change from baseline in Hematocrit. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline value is presented and was calculated as post-dose visit value minus Baseline value.
Baseline (Day -1) and Day 6
Part 1 - Change From Baseline in Hematology Parameter - Reticulocytes
Blood samples were collected to assess change from baseline in Reticulocytes. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline value is presented and was calculated as post-dose visit value minus Baseline value.
Baseline (Day -1) and Day 6
Part 2 (QD PBO and Cohort 3, 4 and 5) - Change From Baseline in Hematology Parameter - Reticulocytes
Blood samples were collected to assess change from baseline in Reticulocytes. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline value is presented and was calculated as post-dose visit value minus Baseline value.
Baseline (Day 1, pre-dose) and Day 14
Part 2 (QW PBO and Cohort 6) - Change From Baseline in Hematology Parameter - Reticulocytes
Blood samples were collected to assess change from baseline in Reticulocytes. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline value is presented and was calculated as post-dose visit value minus Baseline value.
Baseline (Day 1, pre-dose) and Day 15
Part 3 - Change From Baseline in Hematology Parameter - Reticulocytes
Blood samples were collected to assess change from baseline in Reticulocytes. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline value is presented and was calculated as post-dose visit value minus Baseline value.
Baseline (Day -1) and Day 6
Part 1 - Change From Baseline in Hematology Parameter - Hemoglobin (Hb)
Blood samples were collected to assess change from baseline in Hemoglobin (Hb). Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline value is presented and was calculated as post-dose visit value minus Baseline value.
Baseline (Day -1) and Day 6
Part 2 (QD PBO and Cohort 3, 4 and 5) - Change From Baseline in Hematology Parameter - Hemoglobin (Hb)
Blood samples were collected to assess change from baseline in Hemoglobin (Hb). Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline value is presented and was calculated as post-dose visit value minus Baseline value.
Baseline (Day 1, pre-dose) and Day 14
Part 2 (QW PBO and Cohort 6) - Change From Baseline in Hematology Parameter - Hemoglobin (Hb)
Blood samples were collected to assess change from baseline in Hemoglobin (Hb). Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline value is presented and was calculated as post-dose visit value minus Baseline value.
Baseline (Day 1, pre-dose) and Day 15
Part 3 - Change From Baseline in Hematology Parameter - Hemoglobin (Hb)
Blood samples were collected to assess change from baseline in Hemoglobin (Hb). Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline value is presented and was calculated as post-dose visit value minus Baseline value.
Baseline (Day -1) and Day 6
Part 1 - Change From Baseline in Clinical Chemistry Parameter - Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphate (ALP) and Serum Creatine Phosphokinase (CPK)
Blood samples were collected to assess change from baseline in Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphate (ALP) and Serum Creatine Phosphokinase (CPK). Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline value is presented and was calculated as post-dose visit value minus Baseline value.
Baseline (Day -1) and Day 6
Part 2 (QD PBO and Cohort 3, 4 and 5) - Change From Baseline in Clinical Chemistry Parameter - ALT, AST, ALP and Serum CPK
Blood samples were collected to assess change from baseline in Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphate (ALP) and Serum Creatine Phosphokinase (CPK). Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline value is presented and was calculated as post-dose visit value minus Baseline value.
Baseline (Day 1, pre-dose) and Day 14
Part 2 (QW PBO and Cohort 6) - Change From Baseline in Clinical Chemistry Parameter -ALT, AST, ALP and Serum CPK
Blood samples were collected to assess change from baseline in Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphate (ALP) and Serum Creatine Phosphokinase (CPK). Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline value is presented and was calculated as post-dose visit value minus Baseline value.
Baseline (Day 1, pre-dose) and Day 15
Part 3 - Change From Baseline in Clinical Chemistry Parameter - ALT, AST, ALP and CPK
Blood samples were collected to assess change from baseline in Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphate (ALP) and Serum Creatine Phosphokinase (CPK). Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline value is presented and was calculated as post-dose visit value minus Baseline value.
Baseline (Day -1) and Day 6
Part 1 - Change From Baseline in Clinical Chemistry Parameters- Bicarbonate, Calcium, Glucose, Chloride, Magnesium, Phosphate, Potassium, Sodium, Blood Urea Nitrogen, Cholesterol, High Density Lipoprotein, Low Density Lipoprotein, Triglycerides
Blood samples were collected to assess change from baseline in Bicarbonate, Calcium, Glucose, Chloride, Magnesium, Phosphate, Potassium, Sodium, Blood Urea Nitrogen (BUN), Cholesterol, High Density Lipoprotein (HDL), Low Density Lipoprotein (LDL) and Triglycerides. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline value is presented and was calculated as post-dose visit value minus Baseline value.
Baseline (Day -1) and Day 6
Part 2 (QD PBO and Cohort 3, 4 and 5) - Change From Baseline in Clinical Chemistry Parameters- Bicarbonate, Calcium, Glucose, Chloride, Magnesium, Phosphate, Potassium, Sodium, BUN, Cholesterol, HDL, LDL, Triglycerides
Blood samples were collected to assess change from baseline in Bicarbonate, Calcium, Glucose, Chloride, Magnesium, Phosphate, Potassium, Sodium, Blood Urea Nitrogen (BUN), Cholesterol, High Density Lipoprotein (HDL), Low Density Lipoprotein (LDL) and Triglycerides. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline value is presented and was calculated as post-dose visit value minus Baseline value.
Baseline (Day 1, pre-dose) and Day 14
Part 2 (QW PBO and Cohort 6) - Change From Baseline in Clinical Chemistry Parameters- Bicarbonate, Calcium, Glucose, Chloride, Magnesium, Phosphate, Potassium, Sodium, BUN, Cholesterol, HDL, LDL, Triglycerides
Blood samples were collected to assess change from baseline in Bicarbonate, Calcium, Glucose, Chloride, Magnesium, Phosphate, Potassium, Sodium, Blood Urea Nitrogen (BUN), Cholesterol, High Density Lipoprotein (HDL), Low Density Lipoprotein (LDL) and Triglycerides. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline value is presented and was calculated as post-dose visit value minus Baseline value.
Baseline (Day 1, pre-dose) and Day 15
Part 3 - Change From Baseline in Clinical Chemistry Parameters- Bicarbonate, Calcium, Glucose, Chloride, Magnesium, Phosphate, Potassium, Sodium, BUN, Cholesterol, HDL, LDL, Triglycerides Edit Properties | Duplicate Measure
Blood samples were collected to assess change from baseline in Bicarbonate, Calcium, Glucose, Chloride, Magnesium, Phosphate, Potassium, Sodium, Blood Urea Nitrogen (BUN), Cholesterol, High Density Lipoprotein (HDL), Low Density Lipoprotein (LDL) and Triglycerides. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline value is presented and was calculated as post-dose visit value minus Baseline value.
Baseline (Day -1) and Day 6
Part 1 - Change From Baseline in Clinical Chemistry Parameters - Amylase and Lipase
Blood samples were collected to assess change from baseline in Amylase and Lipase. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline value is presented and was calculated as post-dose visit value minus Baseline value.
Baseline (Day -1) and Day 6
Part 2 (QD PBO and Cohort 3, 4 and 5) - Change From Baseline in Clinical Chemistry Parameters - Amylase and Lipase
Blood samples were collected to assess change from baseline in Amylase and Lipase. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline value is presented and was calculated as post-dose visit value minus Baseline value.
Baseline (Day 1, pre-dose) and Day 14
Part 2 (QW PBO and Cohort 6) - Change From Baseline in Clinical Chemistry Parameters - Amylase and Lipase
Blood samples were collected to assess change from baseline in Amylase and Lipase. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline value is presented and was calculated as post-dose visit value minus Baseline value.
Baseline (Day 1, pre-dose) and Day 15
Part 3 - Change From Baseline in Clinical Chemistry Parameters - Amylase and Lipase
Blood samples were collected to assess change from baseline in Amylase and Lipase. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline value is presented and was calculated as post-dose visit value minus Baseline value.
Baseline (Day -1) and Day 6
Part 1 - Change From Baseline in Clinical Chemistry Parameter - Total Bilirubin, Direct Bilirubin and Creatinine
Blood samples were collected to assess change from baseline in Total Bilirubin, Direct Bilirubin and Creatinine. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline value is presented and was calculated as post-dose visit value minus Baseline value.
Baseline (Day -1) and Day 6
Part 2 (QD PBO and Cohort 3, 4 and 5) - Change From Baseline in Clinical Chemistry Parameter - Total Bilirubin, Direct Bilirubin and Creatinine
Blood samples were collected to assess change from baseline in Total Bilirubin, Direct Bilirubin and Creatinine. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline value is presented and was calculated as post-dose visit value minus Baseline value.
Baseline (Day 1, pre-dose) and Day 14
Part 2 (QW PBO and Cohort 6) - Change From Baseline in Clinical Chemistry Parameter - Total Bilirubin, Direct Bilirubin and Creatinine
Blood samples were collected to assess change from baseline in Total Bilirubin, Direct Bilirubin and Creatinine. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline value is presented and was calculated as post-dose visit value minus Baseline value.
Baseline (Day 1, pre-dose) and Day 15
Part 3 - Change From Baseline in Clinical Chemistry Parameter - Total Bilirubin, Direct Bilirubin and Creatinine
Blood samples were collected to assess change from baseline in Total Bilirubin, Direct Bilirubin and Creatinine. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline value is presented and was calculated as post-dose visit value minus Baseline value.
Baseline (Day -1) and Day 6
Part 1 - Change From Baseline in Clinical Chemistry Parameter - Total Protein
Blood samples were collected to assess change from baseline in Total Protein. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline value is presented and was calculated as post-dose visit value minus Baseline value.
Baseline (Day -1) and Day 6
Part 2 - (QD PBO and Cohort 3, 4 and 5) - Change From Baseline in Clinical Chemistry Parameter - Total Protein
Blood samples were collected to assess change from baseline in Total Protein. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline value is presented and was calculated as post-dose visit value minus Baseline value.
Baseline (Day 1, pre-dose) and Day 14
Part 2 (QW PBO and Cohort 6) - Change From Baseline in Clinical Chemistry Parameter - Total Protein
Blood samples were collected to assess change from baseline in Total Protein. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline value is presented and was calculated as post-dose visit value minus Baseline value.
Baseline (Day 1, pre-dose) and Day 15
Part 3 - Change From Baseline in Clinical Chemistry Parameter - Total Protein
Blood samples were collected to assess change from baseline in Total Protein. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline value is presented and was calculated as post-dose visit value minus Baseline value.
Baseline (Day -1) and Day 6
Part 1 - Number of Participants With Abnormal Urinalysis Parameters
Urine samples were collected to detect presence of occult blood and protein through dipstick and random method respectively. The results presented are worst case abnormal urinalysis results post-baseline relative to baseline.
Up to 27 weeks
Part 2 - Number of Participants With Abnormal Urinalysis Parameters
Urine samples were collected to detect presence of occult blood and protein through dipstick and random method respectively. The results presented are worst case abnormal urinalysis results post-baseline relative to baseline.
Up to 5 weeks
Part 3 - Number of Participants With Abnormal Urinalysis Parameters
Urine samples were collected to detect presence of occult blood and protein through dipstick and random method respectively. The results presented are worst case abnormal urinalysis results post-baseline relative to baseline.
Up to 16 weeks
Part 1 - Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
Blood pressure (SBP and DBP) was assessed in semi-supine position with a completely automated device. Blood pressure measurement preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline is defined as the average of the triplicate predose assessments within each treatment. Change from Baseline was calculated as post-dose visit value minus Baseline value.
Baseline (Day 1, pre-dose) and Day 6
Part 2 (QD PBO and Cohort 3, 4 and 5) - Change From Baseline in Vital Signs - Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
Blood pressure (SBP and DBP) was assessed in semi-supine position with a completely automated device. Blood pressure measurement preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline is defined as the average of the triplicate predose assessments within each treatment. Change from Baseline was calculated as post-dose visit value minus Baseline value.
Baseline (Day 1, pre-dose) and Day 14
Part 2 (QW PBO and Cohort 6) - Change From Baseline in Vital Signs - Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
Blood pressure (SBP and DBP) was assessed in semi-supine position with a completely automated device. Blood pressure measurement preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline is defined as the average of the triplicate predose assessments within each treatment. Change from Baseline was calculated as post-dose visit value minus Baseline value.
Baseline (Day 1, pre-dose) and Day 15
Part 3 - Change From Baseline in Vital Signs - Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
Blood pressure (SBP and DBP) was assessed in semi-supine position with a completely automated device. Blood pressure measurement preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline is defined as the average of the triplicate predose assessments within each treatment. Change from Baseline was calculated as post-dose visit value minus Baseline value.
Baseline (Day 1, pre-dose) and Day 6
Part 1 - Change From Baseline in Vital Signs - Pulse Rate
Pulse rate was assessed in semi-supine position with a completely automated device. Pulse rate measurement preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline value is presented and was calculated as post-dose visit value minus Baseline value.
Baseline (Day 1, pre-dose) and Day 6
Part 2 (QD PBO and Cohort 3, 4 and 5) - Change From Baseline in Vital Signs - Pulse Rate
Pulse rate was assessed in semi-supine position with a completely automated device. Pulse rate measurement preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline value is presented and was calculated as post-dose visit value minus Baseline value.
Baseline (Day 1, pre-dose) and Day 14
Part 2 (QW PBO and Cohort 6) - Change From Baseline in Vital Signs - Pulse Rate
Pulse rate was assessed in semi-supine position with a completely automated device. Pulse rate measurement preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline value is presented and was calculated as post-dose visit value minus Baseline value.
Baseline (Day 1, pre-dose) and Day 15
Part 3 - Change From Baseline in Vital Signs - Pulse Rate
Pulse rate was assessed in semi-supine position with a completely automated device. Pulse rate measurement preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline value is presented and was calculated as post-dose visit value minus Baseline value.
Baseline (Day 1, pre-dose) and Day 6
Part 1 - Change From Baseline in Vital Signs - Body Temperature
Temperature was assessed in the semi-recumbent position with a completely automated device, preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline value is presented and was calculated as post-dose visit value minus Baseline value.
Baseline (Day 1, pre-dose) and Day 6
Part 2 (QD PBO and Cohort 3, 4 and 5) - Change From Baseline in Vital Signs - Body Temperature
Body temperature were assessed at indicated time-points. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline value is presented and was calculated as post-dose visit value minus Baseline value.
Baseline (Day 1, pre-dose) and Day 14
Part 2 (QW PBO and Cohort 6) - Change From Baseline in Vital Signs - Body Temperature
Body temperature were assessed at indicated time-points. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline value is presented and was calculated as post-dose visit value minus Baseline value.
Baseline (Day 1, pre-dose) and Day 15
Part 3 - Change From Baseline in Vital Signs - Body Temperature
Body temperature were assessed at indicated time-points. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline value is presented and was calculated as post-dose visit value minus Baseline value.
Baseline (Day 1, pre-dose) and Day 6
Part 1 - Change From Baseline in Vital Signs - Respiratory Rate
Respiratory rate was assessed in the semi-recumbent position with a completely automated device, preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline value is presented and was calculated as post-dose visit value minus Baseline value.
Baseline (Day 1, pre-dose) and Day 6
Part 2 (QD PBO and Cohort 3, 4 and 5) - Change From Baseline in Vital Signs - Respiratory Rate
Respiratory rate was assessed in the semi-recumbent position with a completely automated device, preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline value is presented and was calculated as post-dose visit value minus Baseline value.
Baseline (Day 1, pre-dose) and Day 14
Part 2 (QW PBO and Cohort 6) - Change From Baseline in Vital Signs - Respiratory Rate
Respiratory rate was assessed in the semi-recumbent position with a completely automated device, preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline value is presented and was calculated as post-dose visit value minus Baseline value.
Baseline (Day 1, pre-dose) and Day 15
Part 3 - Change From Baseline in Vital Signs - Respiratory Rate
Respiratory rate was assessed in the semi-recumbent position with a completely automated device, preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline value is presented and was calculated as post-dose visit value minus Baseline value.
Baseline (Day 1, pre-dose) and Day 6
Part 1 - Number of Participants With Worst Case Post-Baseline Electrocardiogram (ECG) Findings
Twelve lead ECGs were obtained using an ECG machine that automatically calculated the heart rate and measured PR, QRS, QT, and QT interval corrected using the Fridericia's formula (QTcF) intervals. ECG findings were categorized as Normal, Abnormal clinically significant (CS) and Abnormal not clinically significant (NCS). Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. Data for number of participants with worst case post-Baseline ECG findings have been presented.
Up to 27 weeks
Part 2 - Number of Participants With Worst Case Post-Baseline ECG Findings
Twelve lead ECGs were obtained using an ECG machine that automatically calculated the heart rate and measured PR, QRS, QT, and QT interval corrected using the Fridericia's formula (QTcF) intervals. ECG findings were categorized as Normal, Abnormal clinically significant (CS) and Abnormal not clinically significant (NCS). Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. Data for number of participants with worst case post-Baseline ECG findings have been presented.
Up to 5 weeks
Part 3 - Number of Participants With Worst Case Post-Baseline ECG Findings
Twelve lead ECGs were obtained using an ECG machine that automatically calculated the heart rate and measured PR, QRS, QT, and QT interval corrected using the Fridericia's formula (QTcF) intervals. ECG findings were categorized as Normal, Abnormal clinically significant (CS) and Abnormal not clinically significant (NCS). Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. Data for number of participants with worst case post-Baseline ECG findings have been presented.
Up to 16 weeks
Part 3 - Area Under the Plasma Concentration Time Curve (AUC) From Zero to 24 Hours (AUC[0-24]) of GSK3739937
Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis of GSK3739937. PK parameters were analyzed using standard non-compartmental analysis.
Pre-dose, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 12, 16 and 24 hours post-dose in each treatment period
Part 3 - AUC From Time Zero (Pre-dose) Extrapolated to Infinite Time (AUC[0-inf]) of GSK3739937
Blood samples were collected at indicated time points for PK analysis of GSK3739937. PK parameters were analyzed using standard non-compartmental analysis.
Pre-dose (within 15 minutes prior to dosing) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 16, 24, 48, 72, 96, 120, 192, 264, and 360 hours post-dose in each treatment period
Part 3 - Maximum Observed Concentration (Cmax) of GSK3739937
Blood samples were collected at indicated time points for PK analysis of GSK3739937. PK parameters were analyzed using standard non-compartmental analysis.
Pre-dose (within 15 minutes prior to dosing) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 16, 24, 48, 72, 96, 120, 192, 264, and 360 hours post-dose in each treatment period
Part 1 (Cohort 1 and 2) - AUC From Zero (Pre-dose) to Time of the Last Quantifiable Concentration (t) (AUC [0-t]) of GSK3739937
Blood samples were collected at indicated time points for PK analysis of GSK3739937. PK parameters were analyzed using standard non-compartmental analysis.
Pre-dose (within 15 minutes prior to dosing) and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72, 96, 120, 192, 264 and 360 hours post-dose in each treatment period
Part 1 (Cohort 1 and 2) - AUC(0-inf) of GSK3739937
Blood samples were collected at indicated time points for PK analysis of GSK3739937. PK parameters were analyzed using standard non-compartmental analysis.
Pre-dose (within 15 minutes prior to dosing) and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72, 96, 120, 192, 264 and 360 hours post-dose in each treatment period
Part 1 (Cohort 1 and 2) - Apparent Terminal Phase Half-life (T1/2) of GSK3739937
Blood samples were collected at indicated time points for PK analysis of GSK3739937. PK parameters were analyzed using standard non-compartmental analysis.
Pre-dose (within 15 minutes prior to dosing) and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72, 96, 120, 192, 264 and 360 hours post-dose in each treatment period
Part 1 (Cohort 1 and 2) - Apparent Oral Clearance (CL/F) of GSK3739937
Blood samples were collected at indicated time points for PK analysis of GSK3739937. PK parameters were analyzed using standard non-compartmental analysis.
Pre-dose (within 15 minutes prior to dosing) and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72, 96, 120, 192, 264 and 360 hours post-dose in each treatment period
Part 1 (Cohort 1 and 2) - Cmax of GSK3739937
Blood samples were collected at indicated time points for PK analysis of GSK3739937. PK parameters were analyzed using standard non-compartmental analysis.
Pre-dose (within 15 minutes prior to dosing) and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72, 96, 120, 192, 264 and 360 hours post-dose in each treatment period
Part 1 (Cohort 1 and 2) - Concentration of GSK3739937 at 24 Hours (C24) of GSK3739937
Blood samples were collected at indicated time points for PK analysis of GSK3739937. PK parameters were analyzed using standard non-compartmental analysis.
Pre-dose, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 12, 16 and 24 hours post-dose in each treatment period
Part 1 (Cohort 1 and 2) - Last Quantifiable Concentration (Clast) of GSK3739937
Blood samples were collected at indicated time points for PK analysis of GSK3739937. PK parameters were analyzed using standard non-compartmental analysis.
Pre-dose (within 15 minutes prior to dosing) and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72, 96, 120, 192, 264 and 360 hours post-dose in each treatment period
Part 1 (Cohort 1 and 2 ) - Time of Occurrence of Cmax (Tmax) of GSK3739937
Blood samples were collected at indicated time points for PK analysis of GSK3739937. PK parameters were analyzed using standard non-compartmental analysis.
Pre-dose (within 15 minutes prior to dosing) and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72, 96, 120, 192, 264 and 360 hours post-dose in each treatment period
Part 1 (Cohort 1 and 2) - Lag Time (Tlag) of GSK3739937
Blood samples were collected at indicated time points for PK analysis of GSK3739937. PK parameters were analyzed using standard non-compartmental analysis.
Pre-dose (within 15 minutes prior to dosing) and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72, 96, 120, 192, 264 and 360 hours post-dose in each treatment period
Part 1 (Cohort 1 and 2) - Time to Reach Clast (Tlast) of GSK3739937
Blood samples were collected at indicated time points for PK analysis of GSK3739937. PK parameters were analyzed using standard non-compartmental analysis
Pre-dose (within 15 minutes prior to dosing) and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72, 96, 120, 192, 264 and 360 hours post-dose in each treatment period.
Part 2 (Cohort 3, 4 and 5) - AUC (0-24) of GSK3739937 on Day 1
Blood samples were collected at indicated time points for PK analysis of GSK3739937. PK parameters were analyzed using standard non-compartmental analysis.
Pre-dose (within 15 minutes prior to dosing) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12 and 16 hours post-dose on Day 1
Part 2 (Cohort 3, 4 and 5) - Cmax of GSK3739937 on Day 1
Blood samples were collected at indicated time points for PK analysis of GSK3739937. PK parameters were analyzed using standard non-compartmental analysis.
Pre-dose (within 15 minutes prior to dosing) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12 and 16 hours post-dose on Day 1
Part 2 (Cohort 3, 4 and 5) - C24 of GSK3739937 on Day 1
Blood samples were collected at indicated time points for PK analysis of GSK3739937. PK parameters were analyzed using standard non-compartmental analysis.
Pre-dose (within 15 minutes prior to dosing) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12 and 16 hours post-dose on Day 1
Part 2 (Cohort 3, 4 and 5) - Tmax of GSK3739937 on Day 1
Blood samples were collected at indicated time points for PK analysis of GSK3739937. PK parameters were analyzed using standard non-compartmental analysis.
Pre-dose (within 15 minutes prior to dosing) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12 and 16 hours post-dose on Day 1
Part 2 (Cohort 3, 4 and 5) - Tlag of GSK3739937 on Day 1
Blood samples were collected at indicated time points for PK analysis of GSK3739937. PK parameters were analyzed using standard non-compartmental analysis.
Pre-dose (within 15 minutes prior to dosing) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12 and 16 hours post-dose on Day 1
Part 2 (Cohort 3 and 4) - Tmax of GSK3739937 on Day 14
Blood samples were collected at indicated time points for PK analysis of GSK3739937. PK parameters were analyzed using standard non-compartmental analysis.
Pre-dose (within 15 minutes prior to dosing) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12 and 16 hours post-dose on Day 14
Part 2 (Cohort 3 and 4) - Cmax of GSK3739937 on Day 14
Blood samples were collected at indicated time points for PK analysis of GSK3739937. PK parameters were analyzed using standard non-compartmental analysis.
Pre-dose (within 15 minutes prior to dosing) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12 and 16 hours post-dose on Day 14
Part 2 (Cohort 3 and 4) - AUC From Pre-dose to the End of the Dosing Interval at Steady State (AUC[0-tau]) of GSK3739937 on Day 14
Blood samples were collected at indicated time points for PK analysis of GSK3739937. PK parameters were analyzed using standard non-compartmental analysis.
Pre-dose (within 15 minutes prior to dosing) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12 and 16 hours post-dose on Day 14
Part 2 (Cohort 3 and 4) - Plasma Trough Concentration (Ctau) of GSK3739937 on Day 14
Blood samples were collected at indicated time points for PK analysis of GSK3739937. PK parameters were analyzed using standard non-compartmental analysis.
Pre-dose (within 15 minutes prior to dosing) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12 and 16 hours post-dose on Day 14
Part 2 (Cohort 3 and 4) - T1/2 of GSK3739937 on Day 14
Blood samples were collected at indicated time points for PK analysis of GSK3739937. PK parameters were analyzed using standard non-compartmental analysis.
Pre-dose (within 15 minutes prior to dosing) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12 and 16 hours post-dose on Day 14
Part 2 (Cohort 3 and 4) - CL/F of GSK3739937 on Day 14
Blood samples were collected at indicated time points for PK analysis of GSK3739937. PK parameters were analyzed using standard non-compartmental analysis.
Pre-dose (within 15 minutes prior to dosing) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12 and 16 hours post-dose on Day 14
Part 2 (Cohort 5) - Tmax of GSK3739937 on Day 18
Blood samples were collected at indicated time points for PK analysis of GSK3739937. PK parameters were analyzed using standard non-compartmental analysis.
Pre-dose (within 15 minutes prior to dosing) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12 and 16 hours post-dose on Day 18
Part 2 (Cohort 5) - Cmax of GSK3739937 on Day 18
Blood samples were collected at indicated time points for PK analysis of GSK3739937. PK parameters were analyzed using standard non-compartmental analysis.
Pre-dose (within 15 minutes prior to dosing) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12 and 16 hours post-dose on Day 18
Part 2 (Cohort 5) - AUC From Pre-dose to the End of the Dosing Interval at Steady State (AUC[0-tau]) on Day 18
Blood samples were collected at indicated time points for PK analysis of GSK3739937. PK parameters were analyzed using standard non-compartmental analysis.
Pre-dose (within 15 minutes prior to dosing) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12 and 16 hours post-dose on Day 18
Part 2 (Cohort 5) - Plasma Trough Concentration (Ctau) of GSK3739937 on Day 18
Blood samples were collected at indicated time points for PK analysis of GSK3739937. PK parameters were analyzed using standard non-compartmental analysis.
Pre-dose (within 15 minutes prior to dosing) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12 and 16 hours post-dose on Day 18
Part 2 (Cohort 5) - T1/2 of GSK3739937 on Day 18
Blood samples were collected at indicated time points for PK analysis of GSK3739937. PK parameters were analyzed using standard non-compartmental analysis.
Pre-dose (within 15 minutes prior to dosing) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12 and 16 hours post-dose on Day 18
Part 2 (Cohort 5) - CL/F of GSK3739937 on Day 18
Blood samples were collected at indicated time points for PK analysis of GSK3739937. PK parameters were analyzed using standard non-compartmental analysis.
Pre-dose (within 15 minutes prior to dosing) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12 and 16 hours post-dose on Day 18
Part 2 (Cohort 6) - AUC From Zero to 168 Hours (AUC[0-168]) of GSK3739937 From Day 1
Blood samples were collected at indicated time points for PK analysis of GSK3739937. PK parameters were analyzed using standard non-compartmental analysis.
Pre-dose (within 15 minutes prior to dosing) and up to 168 hours post-dose from Day 1
Part 2 (Cohort 6) - Cmax of GSK3739937 on Day 1
Blood samples were collected at indicated time points for PK analysis of GSK3739937. PK parameters were analyzed using standard non-compartmental analysis.
Pre-dose (within 15 minutes prior to dosing) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12 and 16 hours post-dose on Day 1
Part 2 (Cohort 6) - Concentration of GSK3739937 at 168 Hours (C168) From Day 1
Blood samples were collected at indicated time points for PK analysis of GSK3739937. PK parameters were analyzed using standard non-compartmental analysis.
Pre-dose (within 15 minutes prior to dosing) and up to 168 hours post-dose from Day 1
Part 2 (Cohort 6) - Tmax of GSK3739937 on Day 1
Blood samples were collected at indicated time points for PK analysis of GSK3739937. PK parameters were analyzed using standard non-compartmental analysis.
Pre-dose (within 15 minutes prior to dosing) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12 and 16 hours post-dose on Day 1
Part 2 (Cohort 6) - Tlag of GSK3739937 on Day 1
Blood samples were collected at indicated time points for PK analysis of GSK3739937. PK parameters were analyzed using standard non-compartmental analysis.
Pre-dose (within 15 minutes prior to dosing) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12 and 16 hours post-dose on Day 1
Part 2 (Cohort 6 ) - AUC(0-t) of GSK3739937 on Day 15
Blood samples were collected at indicated time points for PK analysis of GSK3739937. PK parameters were analyzed using standard non-compartmental analysis.
Pre-dose (within 15 minutes prior to dosing) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12 and 16 hours post-dose on Day 15
Part 2 (Cohort 6) - Cmax of GSK3739937 on Day 15
Blood samples were collected at indicated time points for PK analysis of GSK3739937. PK parameters were analyzed using standard non-compartmental analysis.
Pre-dose (within 15 minutes prior to dosing) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12 and 16 hours post-dose on Day 15
Part 2 (Cohort 6) - Ctau of GSK3739937 on Day 15
Blood samples were collected at indicated time points for PK analysis of GSK3739937. PK parameters were analyzed using standard non-compartmental analysis.
Pre-dose (within 15 minutes prior to dosing) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12 and 16 hours post-dose on Day 15
Part 2 (Cohort 6) - Tmax of GSK3739937 on Day 15
Blood samples were collected at indicated time points for PK analysis of GSK3739937. PK parameters were analyzed using standard non-compartmental analysis.
Pre-dose (within 15 minutes prior to dosing) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12 and 16 hours post-dose on Day 15
Part 2 (Cohort 6) - T1/2 of GSK3739937 on Day 15
Blood samples were collected at indicated time points for PK analysis of GSK3739937. PK parameters were analyzed using standard non-compartmental analysis.
Pre-dose (within 15 minutes prior to dosing) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12 and 16 hours post-dose on Day 15
Part 2 (Cohort 6) - CL/F of GSK3739937 on Day 15
Blood samples were collected at indicated time points for PK analysis of GSK3739937. PK parameters were analyzed using standard non-compartmental analysis.
Pre-dose (within 15 minutes prior to dosing) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12 and 16 hours post-dose on Day 15
Part 3 (Cohort 7) - C24 of GSK3739937
Blood samples were collected at indicated time points for PK analysis of GSK3739937. PK parameters were analyzed using standard non-compartmental analysis.
Pre-dose (within 15 minutes prior to dosing) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 16, 24 hours post-dose in each treatment period
Part 3 (Cohort 7) Clast of GSK3739937
Blood samples were collected at indicated time points for PK analysis of GSK3739937. PK parameters were analyzed using standard non-compartmental analysis.
Pre-dose (within 15 minutes prior to dosing) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 16, 24, 48, 72, 96, 120, 192, 264, and 360 hours post-dose in each treatment period
Part 3 (Cohort 7) - Tmax of GSK3739937
Blood samples were collected at indicated time points for PK analysis of GSK3739937. PK parameters were analyzed using standard non-compartmental analysis.
Pre-dose (within 15 minutes prior to dosing) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 16, 24, 48, 72, 96, 120, 192, 264, and 360 hours post-dose in each treatment period
Part 3 (Cohort 7) - Tlag of GSK3739937
Blood samples were collected at indicated time points for PK analysis of GSK3739937. PK parameters were analyzed using standard non-compartmental analysis.
Pre-dose (within 15 minutes prior to dosing) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 16, 24, 48, 72, 96, 120, 192, 264, and 360 hours post-dose in each treatment period
Part 3 (Cohort 7) - Tlast of GSK3739937
Blood samples were collected at indicated time points for PK analysis of GSK3739937. PK parameters were analyzed using standard non-compartmental analysis.
Pre-dose (within 15 minutes prior to dosing) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 16, 24, 48, 72, 96, 120, 192, 264, and 360 hours post-dose in each treatment period
Part 3 (Cohort 7) - T1/2 of GSK3739937
Blood samples were collected at indicated time points for PK analysis of GSK3739937. PK parameters were analyzed using standard non-compartmental analysis.
Pre-dose (within 15 minutes prior to dosing) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 16, 24, 48, 72, 96, 120, 192, 264, and 360 hours post-dose in each treatment period
Part 3 (Cohort 7) - CL/F of GSK3739937
Blood samples were collected at indicated time points for PK analysis of GSK3739937. PK parameters were analyzed using standard non-compartmental analysis.
Pre-dose (within 15 minutes prior to dosing) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 16, 24, 48, 72, 96, 120, 192, 264, and 360 hours post-dose in each treatment period
Part 1 - Dose Proportionality of GSK3739937 for Dose Levels 30 mg to 800 mg Using AUC(0-infinity) After Single Dose Administration of GSK3739937
Blood samples were collected at indicated time points for PK analysis of GSK3739937. PK parameters were analyzed using standard non-compartmental analysis. Dose proportionality for dose 30 mg, 80 mg, 160 mg, 320 mg, 640 mg and 800 mg was assessed using Power model. Log-e(dose) was fitted as fixed effect and participant was fitted as random effect. Kenward and Roger method and unstructured covariance structure was used. Slope and 90% confidence interval (CI) for the slope are presented.
Up to day 16
Part 1 - Dose Proportionality of GSK3739937 for Dose Levels 10 mg to 800 mg Using Cmax After Single Dose Administration of GSK3739937
Blood samples were collected at indicated time points for PK analysis of GSK3739937. PK parameters were analyzed using standard non-compartmental analysis. Dose proportionality for dose 10 mg, 30 mg, 80 mg, 160 mg, 320 mg, 640 mg and 800 mg was assessed using Power model. Log-e(dose) was fitted as fixed effect and participant was fitted as random effect. Kenward and Roger method and unstructured covariance structure was used. Slope and 90% confidence interval (CI) for the slope are presented.
Up to day 16
Part 2 - Dose Proportionality of GSK3739937 for Dose Levels 25 mg to 100 mg Using AUC(0-24) After Repeated Dose Administration of GSK3739937
Blood samples were collected at indicated time points for PK analysis of GSK3739937. PK parameters were analyzed using standard non-compartmental analysis. Dose proportionality for dose 25 mg, 50 mg and 100 mg was assessed using Power model. Log-e(dose) was fitted as fixed effect and participant was fitted as random effect. Kenward and Roger method and unstructured covariance structure was used. Slope and 90% confidence interval (CI) for the slope are presented.
Up to day 33
Part 2 - Dose Proportionality of GSK3739937 for Dose Levels 25 mg to 100 mg Using Cmax After Repeated Dose Administration of GSK3739937
Blood samples were collected at indicated time points for PK analysis of GSK3739937. PK parameters were analyzed using standard non-compartmental analysis. Dose proportionality for dose 25 mg, 50 mg and 100 mg was assessed using Power model. Log-e(dose) was fitted as fixed effect and participant was fitted as random effect. Kenward and Roger method and unstructured covariance structure was used. Slope and 90% confidence interval (CI) for the slope are presented.
Up to day 33
Part 2 - Dose Proportionality of GSK3739937 for Dose Levels 25 mg to 100 mg Using Ctau After Repeated Dose Administration of GSK3739937
Blood samples were collected at indicated time points for PK analysis of GSK3739937. PK parameters were analyzed using standard non-compartmental analysis. Dose proportionality for dose 25 mg, 50 mg and 100 mg was assessed using Power model. Log-e(dose) was fitted as fixed effect and participant was fitted as random effect. Kenward and Roger method and unstructured covariance structure was used. Slope and 90% confidence interval (CI) for the slope are presented.
Up to day 33
Part 2 (Cohort 3 and 4) - Accumulation Ratio of AUC(0-tau) (R [AUC{0-TAU}])
Blood samples were collected at indicated time points for PK analysis of GSK3739937. PK parameters were analyzed using standard non-compartmental analysis. Accumulation ratio calculated as the ratio of day 14 AUC(0-tau) / day 1 AUC(0-tau).
Pre-dose (within 15 minutes prior to dosing) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12 and 16 hours post-dose on both Day 1 and Day 14
Part 2 (Cohort 5) - Accumulation Ratio of AUC(0-tau) (R [AUC{0-TAU}])
Blood samples were collected at indicated time points for PK analysis of GSK3739937. PK parameters were analyzed using standard non-compartmental analysis. Accumulation ratio calculated as the ratio of day 18 AUC(0-tau) / day 1 AUC(0-tau).
Pre-dose (within 15 minutes prior to dosing) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12 and 16 hours post-dose on both Day 1 and Day 18
Part 2 (Cohort 6) - Accumulation Ratio of AUC(0-tau) (R [AUC{0-TAU}])
Blood samples were collected at indicated time points for PK analysis of GSK3739937. PK parameters were analyzed using standard non-compartmental analysis. Accumulation ratio calculated as the ratio of day 15 AUC(0-tau) / day 1 AUC(0-tau).
Pre-dose (within 15 minutes prior to dosing) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12 and 16 hours post-dose on both Day 1 and Day 15
Part 2 (Cohort 3 and 4) - Accumulation Ratio of Cmax (R [CMAX])
Blood samples were collected at indicated time points for PK analysis of GSK3739937. PK parameters were analyzed using standard non-compartmental analysis. Accumulation ratio calculated as the ratio of day 14 Cmax / day 1 Cmax.
Pre-dose (within 15 minutes prior to dosing) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12 and 16 hours post-dose on both Day 1 and Day 14
Part 2 (Cohort 5) - Accumulation Ratio of Cmax (R [CMAX])
Blood samples were collected at indicated time points for PK analysis of GSK3739937. PK parameters were analyzed using standard non-compartmental analysis. Actual measure type is Ratio. Accumulation ratio calculated as the ratio of day 18 Cmax / day 1 Cmax.
Pre-dose (within 15 minutes prior to dosing) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12 and 16 hours post-dose on both Day 1 and Day 18
Part 2 (Cohort 6) - Accumulation Ratio of Cmax (R [CMAX])
Blood samples were collected at indicated time points for PK analysis of GSK3739937. PK parameters were analyzed using standard non-compartmental analysis. Accumulation ratio calculated as the ratio of day 15 Cmax / day 1 Cmax.
Pre-dose (within 15 minutes prior to dosing) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12 and 16 hours post-dose on both Day 1 and Day 15
Part 2 (Cohort 3 and 4) - Accumulation Ratio of C(Tau) (R[CTAU])
Blood samples were collected at indicated time points for PK analysis of GSK3739937. PK parameters were analyzed using standard non-compartmental analysis. Accumulation ratio calculated as the ratio of day 14 C(Tau) / day 1 C(Tau).
Pre-dose (within 15 minutes prior to dosing) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12 and 16 hours post-dose on both Day 1 and Day 14
Part 2 (Cohort 5) - Accumulation Ratio of C(Tau) (R[CTAU])
Blood samples were collected at indicated time points for PK analysis of GSK3739937. PK parameters were analyzed using standard non-compartmental analysis. Accumulation ratio calculated as the ratio of day 18 C(Tau) / day 1 C(Tau).
Pre-dose (within 15 minutes prior to dosing) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12 and 16 hours post-dose on both Day 1 and Day 18
Part 2 (Cohort 6) - Accumulation Ratio of C(Tau) (R[CTAU])
Blood samples were collected at indicated time points for PK analysis of GSK3739937. PK parameters were analyzed using standard non-compartmental analysis. Accumulation ratio calculated as the ratio of day 15 C(Tau) / day 1 C(Tau).
Pre-dose (within 15 minutes prior to dosing) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12 and 16 hours post-dose on both Day 1 and Day 15
Part 2 (Cohort 3 and 4) - Pre-dose Concentration of GSK3739937
Blood samples were collected at indicated time points for PK analysis of GSK3739937. For Part 2 cohorts 3 and 4, steady-state GSK3739937 concentrations was assessed by estimating the slope of concentrations on pre-dose assessments on Days 2-14 (Part 2 cohort 3 and 4) and the day 15 (24-hr post-dose relative to dosing on day 14). PK parameters were analyzed using standard non-compartmental analysis.
Up to day 15
Part 2 (Cohort 5) - Pre-dose Concentration of GSK3739937
Blood samples were collected at indicated time points for PK analysis of GSK3739937. For Part 2 cohort 5, steady state GSK3739937 concentrations was assessed by estimating the slope of the concentrations of pre-dose assessments on Days 2-18 and the day 19 (24-hr post-dose relative to dosing on day 18). PK parameters were analyzed using standard non-compartmental analysis.
Up to day 19
3 subjects
FG0053 subjects
FG0063 subjects
FG0073 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
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FG0150 subjects
FG0160 subjects
3 subjects
FG0052 subjects
FG0063 subjects
FG0073 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
0 subjects
FG0051 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
0 subjects
FG0040 subjects
FG0051 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
0 subjects
FG0040 subjects
FG0053 subjects1 additional participant was enrolled and dosed.
FG0063 subjects
FG0073 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
COMPLETED
FG0003 subjects
FG0013 subjects
FG0023 subjects
FG0030 subjects
FG0040 subjects
FG0053 subjects
FG0062 subjects
FG0073 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
NOT COMPLETED
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0061 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
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FG0160 subjects
Type
Comment
Reasons
Physician Decision
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
Protocol Deviation
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
0 subjects
FG0040 subjects
FG0054 subjects1 additional participant was enrolled and dosed.
FG0063 subjects1 additional participant was enrolled and dosed.
Participants received single oral dose of 10 mg of GSK3739937 as suspension in Treatment Period 1, followed by single oral dose of placebo as suspension in Treatment Period 2, and followed by single oral dose of 320 mg of GSK3739937 as suspension in Treatment Period 3.
Participants received single oral dose of 10 mg of GSK3739937 as suspension in Treatment Period 1, followed by single oral dose of 80 mg of GSK3739937 as suspension in Treatment Period 2, and followed by single oral dose of placebo as suspension in Treatment Period 3.
BG003
Part 1 (Cohort 1) - GSK3739937 SD 800 mg
Participants received single oral dose of 800 mg of GSK3739937 as suspension in Treatment Period 1.
BG004
Part 1 (Cohort 1) - SD PBO
Participants received single oral dose of Placebo in Treatment Period 1.
Participants received single oral dose of Placebo as suspension in Treatment Period 1, followed by single oral dose of 160 mg of GSK3739937 as suspension in Treatment Period 2, and followed by single oral dose of 640 mg of GSK3739937 as suspension Treatment in Period 3.
Participants received single oral dose of 30 mg of GSK3739937 as suspension in Treatment Period 1, followed by single oral dose of Placebo as suspension in Treatment Period 2, and followed by single oral dose of 640 mg of GSK3739937 as suspension in Treatment Period 3.
Participants received single oral dose of 30 mg of GSK3739937 as suspension in Treatment Period 1, followed by single oral dose of 160 mg of GSK3739937 in Period 2, and followed by single oral dose of Placebo in Period 3.
BG008
Part 2 - Once Daily (QD) PBO
Participants received once daily oral doses of Placebo as suspension for 14 days in Treatment Period 1.
BG009
Part 2 (Cohort 3) - GSK3739937 QD 25 mg
Participants received once daily oral doses of 25 mg of GSK3739937 as suspension for 14 days in Treatment Period 1.
BG010
Part 2 (Cohort 4) - GSK3739937 QD 50 mg
Participants received once daily oral doses of 50 mg of GSK3739937 as suspension for 14 days in Treatment Period 1.
BG011
Part 2 (Cohort 5) - GSK3739937 QD 100 mg
Participants received once daily oral doses of 100 mg of GSK3739937 as suspension for 18 days in Treatment Period 1.
BG012
Part 2 - Once Weekly (QW) PBO
Participants received once weekly oral doses of Placebo as suspension for over 3 weeks in Treatment Period 1.
BG013
Part 2 (Cohort 6) - GSK3739937 QW 500 mg
Participants received once weekly oral doses of 500 mg of GSK3739937 as suspension for over 3 weeks in Treatment Period 1.
Participants received single dose of 100 mg of powder in bottle (PiB) as oral suspension under moderate fed conditions in Treatment Period 1, followed by single oral dose of 100 mg of GSK3739937 tablet under moderate fed conditions in Treatment Period 2 and followed by single dose of 100 mg of GSK3739937 tablet under fasted conditions in Treatment Period 3.
Participants received single oral dose of 100 mg of GSK3739937 tablet under moderate fed conditions in Treatment Period 1, followed by single oral dose of 100 mg GSK3739937 tablet under fasted conditions in Treatment Period 2 and followed by single dose of 100 mg PiB as oral suspension under moderate fed conditions in Treatment Period 3.
Participants received single oral dose of 100 mg of GSK3739937 tablet under fasted condition in Treatment Period 1, followed by single oral dose of 100 mg PiB as oral suspension under moderate fed conditions in Treatment Period 2 and followed by single oral dose of 100 mg GSK3739937 tablet under fed conditions in Treatment Period 3.
BG017
Total
Total of all reporting groups
6
BG0013
BG0024
BG0036
BG0043
BG0055
BG0064
BG0073
BG0089
BG0097
BG0107
BG0117
BG0123
BG0137
BG0145
BG0156
BG0166
BG01791
Participants
Title
Denominators
Categories
Title
Measurements
<=18
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
BG0110
BG0120
BG0130
BG0140
BG0150
BG0160
BG0170
19-64
BG0006
BG0013
BG0024
BG0036
BG004
>=65
BG0000
BG0010
BG0020
BG0030
BG004
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0002
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0081
BG0090
BG0100
BG0111
BG0120
BG0130
BG0140
BG0150
BG0160
BG0174
Male
BG0004
BG0013
BG0024
BG0036
BG004
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
Asian - Central/South Asian Heritage
Title
Measurements
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
BG0110
BG0121
BG0130
BG0140
BG0150
BG0160
BG0171
Asian - Japanese Heritage
Title
Measurements
BG0000
BG0010
BG0020
BG003
Black or African American
Title
Measurements
BG0003
BG0012
BG0022
BG003
Mixed Race
Title
Measurements
BG0000
BG0010
BG0020
BG003
White - White/Caucasian/European Heritage
Title
Measurements
BG0003
BG0011
BG0022
BG003
In Cohort 1 and 2 of Part 1, participants received single oral dose of Placebo.
OG001
GSK3739937 Single Dose (SD) 10 mg
In Cohort 1 of Part 1, participants received single oral dose of 10 mg GSK3739937
OG002
GSK3739937 SD 30 mg
In Cohort 2 of Part 1, participants received single oral dose of 30 mg GSK3739937
OG003
GSK3739937 SD 80 mg
In Cohort 1 of Part 1, participants received single oral dose of 80 mg GSK3739937
OG004
GSK3739937 SD 160 mg
In Cohort 2 of Part 1, participants received single oral dose of 160 mg GSK3739937
OG005
GSK3739937 SD 320 mg
In Cohort 1 of Part 1, participants received single oral dose of 320 mg GSK3739937
OG006
GSK3739937 SD 640 mg
In Cohort 2 of Part 1, participants received single oral dose of 640 mg GSK3739937
OG007
GSK3739937 SD 800 mg
In Cohort 1 of Part 1, participants received single oral dose of 800 mg of GSK3739937
Units
Counts
Participants
OG00021
OG0016
OG0026
OG0036
OG0046
OG0056
OG0066
OG0076
Title
Denominators
Categories
AEs
Title
Measurements
OG0007
OG0011
OG0023
OG0033
OG0040
OG0052
OG0064
OG0072
SAEs
Title
Measurements
OG0000
OG0010
OG0020
OG003
Primary
Part 2 - Number of Any AEs and SAEs
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; is a congenital anomaly/birth defect and important medical events may jeopardize the participant or may require medical or surgical intervention/SOC to prevent one of the other outcomes mentioned before.
Safety Population
Posted
Number
Events
Up to 5 weeks
ID
Title
Description
OG000
PBO Once Daily (QD)
Participants received once daily doses of placebo for 14 days.
OG001
GSK3739937 QD 25 mg
In Cohort 3 of Part 2, participants received once-daily oral dose of 25 mg GSK3739937 for 14 days.
OG002
GSK3739937 QD 50 mg
In Cohort 4 of Part 2, participants received once-daily oral dose of 50 mg GSK3739937 for 14 days.
OG003
GSK3739937 QD 100 mg
In Cohort 5 of Part 2, participants received once-daily oral dose of 100 mg GSK3739937 for 18 days.
OG004
PBO Once Weekly (QW)
Participants received once weekly oral dose of Placebo for over 3 weeks.
OG005
GSK3739937 QW 500 mg
In Cohort 6 of Part 2, participants received one dose per week of 500 mg GSK3739937 for over 3 weeks.
Units
Counts
Participants
OG0009
OG0017
OG0027
OG003
Title
Denominators
Categories
AEs
Title
Measurements
OG0003
OG0010
OG0022
OG003
Primary
Part 3 - Number of Any AEs and SAEs
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; is a congenital anomaly/birth defect and important medical events may jeopardize the participant or may require medical or surgical intervention/SOC to prevent one of the other outcomes mentioned before.
Safety Population
Posted
Number
Events
Up to 16 weeks
ID
Title
Description
OG000
GSK3739937 PiB Fed
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 PiB as an oral suspension under moderate fed conditions in each one of the three periods.
OG001
GSK3739937 Tablet Fed
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under moderate fed conditions in each one of the three periods.
OG002
GSK3739937 Tablet Fasted
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under fasted conditions in each one of the three periods.
Units
Counts
Participants
OG00015
OG00117
OG00215
Title
Denominators
Categories
AEs
Title
Measurements
OG0002
OG0014
OG0026
SAEs
Primary
Part 1 - Change From Baseline in Hematology Parameters - Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets
Blood samples were collected to assess change from baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline value is presented and was calculated as post-dose visit value minus Baseline value.
Safety Population. Only those participants with data available at specified time points have been analyzed.
Posted
Mean
Standard Deviation
Giga cells per liter (10^9 cells/L)
Baseline (Day -1) and Day 6
ID
Title
Description
OG000
Placebo (PBO) Single Dose
In Cohort 1 and 2 of Part 1, participants received single oral dose of Placebo.
OG001
GSK3739937 Single Dose (SD) 10 mg
In Cohort 1 of Part 1, participants received single oral dose of 10 mg GSK3739937
OG002
GSK3739937 SD 30 mg
In Cohort 2 of Part 1, participants received single oral dose of 30 mg GSK3739937
OG003
GSK3739937 SD 80 mg
In Cohort 1 of Part 1, participants received single oral dose of 80 mg GSK3739937
OG004
GSK3739937 SD 160 mg
In Cohort 2 of Part 1, participants received single oral dose of 160 mg GSK3739937
OG005
GSK3739937 SD 320 mg
In Cohort 1 of Part 1, participants received single oral dose of 320 mg GSK3739937
OG006
GSK3739937 SD 640 mg
In Cohort 2 of Part 1, participants received single oral dose of 640 mg GSK3739937
OG007
GSK3739937 SD 800 mg
In Cohort 1 of Part 1, participants received single oral dose of 800 mg of GSK3739937
Units
Counts
Participants
OG00018
OG0011
OG0026
OG003
Title
Denominators
Categories
Basophils
Title
Measurements
OG000-0.01± 0.024
OG0010
OG0020± 0
OG003
Primary
Part 2 (QD PBO and Cohort 3, 4 and 5) - Change From Baseline in Hematology Parameters - Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets
Blood samples were collected to assess change from baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline value is presented and was calculated as post-dose visit value minus Baseline value.
Safety Population. Only those participants with data available at specified time points have been analyzed.
Posted
Mean
Standard Deviation
10^9 cells/L
Baseline (Day 1, pre-dose) and Day 14
ID
Title
Description
OG000
PBO Once Daily (QD)
Participants received once daily doses of placebo for 14 days.
OG001
GSK3739937 QD 25 mg
In Cohort 3 of Part 2, participants received once-daily oral dose of 25 mg GSK3739937 for 14 days.
OG002
GSK3739937 QD 50 mg
In Cohort 4 of Part 2, participants received once-daily oral dose of 50 mg GSK3739937 for 14 days.
OG003
GSK3739937 QD 100 mg
In Cohort 5 of Part 2, participants received once-daily oral dose of 100 mg GSK3739937 for 18 days.
Units
Counts
Participants
OG0009
OG0017
OG0023
OG003
Title
Denominators
Categories
Basophils
Title
Measurements
OG0000± 0
OG0010± 0
OG0020.03± 0.049
OG003
Primary
Part 2 (QW PBO and Cohort 6) - Change From Baseline in Hematology Parameters - Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets
Blood samples were collected to assess change from baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline value is presented and was calculated as post-dose visit value minus Baseline value.
Safety Population. Only those participants with data available at specified time points have been analyzed.
Posted
Mean
Standard Deviation
10^9 cells/L
Baseline (Day 1, pre-dose) and Day 15
ID
Title
Description
OG000
PBO Once Weekly (QW)
Participants received once weekly oral dose of Placebo for over 3 weeks.
OG001
GSK3739937 QW 500 mg
In Cohort 6 of Part 2, participants received one dose per week of 500 mg GSK3739937 for over 3 weeks.
Units
Counts
Participants
OG0003
OG0017
Title
Denominators
Categories
Basophils
Title
Measurements
OG0000± 0
OG0010± 0
Eosinophils
Title
Measurements
OG000
Primary
Part 3 - Change From Baseline in Hematology Parameters - Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets
Blood samples were collected to assess change from baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline value is presented and was calculated as post-dose visit value minus Baseline value.
Safety Population. Only those participants with data available at specified time points have been analyzed.
Posted
Mean
Standard Deviation
10^9 cells/L
Baseline (Day -1) and Day 6
ID
Title
Description
OG000
GSK3739937 PiB Fed
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 PiB as an oral suspension under moderate fed conditions in each one of the three periods.
OG001
GSK3739937 Tablet Fed
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under moderate fed conditions in each one of the three periods.
OG002
GSK3739937 Tablet Fasted
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under fasted conditions in each one of the three periods.
Units
Counts
Participants
OG00015
OG00117
OG00215
Title
Denominators
Categories
Basophils
Title
Measurements
OG0000.01± 0.026
OG0010± 0
OG0020± 0
Eosinophils
Primary
Part 1 - Change From Baseline in Hematology Parameters - Erythrocytes Count
Blood samples were collected to assess change from baseline in Erythrocytes count. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline value is presented and was calculated as post-dose visit value minus Baseline value.
Safety Population. Only those participants with data available at specified time points have been analyzed.
Posted
Mean
Standard Deviation
Trillion cells per liter (10^12 cells/L)
Baseline (Day -1) and Day 6
ID
Title
Description
OG000
Placebo (PBO) Single Dose
In Cohort 1 and 2 of Part 1, participants received single oral dose of Placebo.
OG001
GSK3739937 Single Dose (SD) 10 mg
In Cohort 1 of Part 1, participants received single oral dose of 10 mg GSK3739937
OG002
GSK3739937 SD 30 mg
In Cohort 2 of Part 1, participants received single oral dose of 30 mg GSK3739937
OG003
GSK3739937 SD 80 mg
In Cohort 1 of Part 1, participants received single oral dose of 80 mg GSK3739937
OG004
GSK3739937 SD 160 mg
In Cohort 2 of Part 1, participants received single oral dose of 160 mg GSK3739937
OG005
GSK3739937 SD 320 mg
In Cohort 1 of Part 1, participants received single oral dose of 320 mg GSK3739937
OG006
GSK3739937 SD 640 mg
In Cohort 2 of Part 1, participants received single oral dose of 640 mg GSK3739937
OG007
GSK3739937 SD 800 mg
In Cohort 1 of Part 1, participants received single oral dose of 800 mg of GSK3739937
Units
Counts
Participants
OG00018
OG0011
OG0026
OG003
Title
Denominators
Categories
Title
Measurements
OG0000.079± 0.1441
OG0010.17
OG0020.197± 0.3088
OG003
Primary
Part 2 (QD PBO and Cohort 3, 4 and 5) - Change From Baseline in Hematology Parameters - Erythrocytes Count
Blood samples were collected to assess change from baseline in Erythrocytes count. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline value is presented and was calculated as post-dose visit value minus Baseline value.
Safety Population. Only those participants with data available at specified time points have been analyzed.
Posted
Mean
Standard Deviation
10^12 cells/L
Baseline (Day 1, pre-dose) and Day 14
ID
Title
Description
OG000
PBO Once Daily (QD)
Participants received once daily doses of placebo for 14 days.
OG001
GSK3739937 QD 25 mg
In Cohort 3 of Part 2, participants received once-daily oral dose of 25 mg GSK3739937 for 14 days.
OG002
GSK3739937 QD 50 mg
In Cohort 4 of Part 2, participants received once-daily oral dose of 50 mg GSK3739937 for 14 days.
OG003
GSK3739937 QD 100 mg
In Cohort 5 of Part 2, participants received once-daily oral dose of 100 mg GSK3739937 for 18 days.
Units
Counts
Participants
OG0009
OG0017
OG0027
OG003
Title
Denominators
Categories
Title
Measurements
OG000-0.06± 0.1592
OG0010.017± 0.175
OG002-0.227± 0.2423
OG003
Primary
Part 2 (QW PBO and Cohort 6) - Change From Baseline in Hematology Parameters - Erythrocytes Count
Blood samples were collected to assess change from baseline in Erythrocytes count. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline value is presented and was calculated as post-dose visit value minus Baseline value.
Safety Population. Only those participants with data available at specified time points have been analyzed.
Posted
Mean
Standard Deviation
10^12 cells/L
Baseline (Day 1, pre-dose) and Day 15
ID
Title
Description
OG000
PBO Once Weekly (QW)
Participants received once weekly oral dose of Placebo for over 3 weeks.
OG001
GSK3739937 QW 500 mg
In Cohort 6 of Part 2, participants received one dose per week of 500 mg GSK3739937 for over 3 weeks.
Units
Counts
Participants
OG0003
OG0017
Title
Denominators
Categories
Title
Measurements
OG000-0.060± 0.2787
OG001-0.014± 0.1021
Primary
Part 3 - Change From Baseline in Hematology Parameters - Erythrocytes Count
Blood samples were collected to assess change from baseline in Erythrocytes count. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline value is presented and was calculated as post-dose visit value minus Baseline value.
Safety Population. Only those participants with data available at specified time points have been analyzed.
Posted
Mean
Standard Deviation
10^12 cells/L
Baseline (Day -1) and Day 6
ID
Title
Description
OG000
GSK3739937 PiB Fed
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 PiB as an oral suspension under moderate fed conditions in each one of the three periods.
OG001
GSK3739937 Tablet Fed
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under moderate fed conditions in each one of the three periods.
OG002
GSK3739937 Tablet Fasted
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under fasted conditions in each one of the three periods.
Units
Counts
Participants
OG00015
OG00117
OG00215
Title
Denominators
Categories
Title
Measurements
OG0000.229± 0.2193
OG0010.197± 0.2287
OG0020.189± 0.2014
Primary
Part 1 - Change From Baseline in Hematology Parameter - Erythrocytes Mean Corpuscular Hemoglobin (MCH)
Blood samples were collected to assess change from baseline in Erythrocytes Mean Corpuscular Hemoglobin (MCH). Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline value is presented and was calculated as post-dose visit value minus Baseline value.
Safety Population. Only those participants with data available at specified time points have been analyzed.
Posted
Mean
Standard Deviation
Picogram (pg)
Baseline (Day -1) and Day 6
ID
Title
Description
OG000
Placebo (PBO) Single Dose
In Cohort 1 and 2 of Part 1, participants received single oral dose of Placebo.
OG001
GSK3739937 Single Dose (SD) 10 mg
In Cohort 1 of Part 1, participants received single oral dose of 10 mg GSK3739937
OG002
GSK3739937 SD 30 mg
In Cohort 2 of Part 1, participants received single oral dose of 30 mg GSK3739937
OG003
GSK3739937 SD 80 mg
In Cohort 1 of Part 1, participants received single oral dose of 80 mg GSK3739937
OG004
GSK3739937 SD 160 mg
In Cohort 2 of Part 1, participants received single oral dose of 160 mg GSK3739937
OG005
GSK3739937 SD 320 mg
In Cohort 1 of Part 1, participants received single oral dose of 320 mg GSK3739937
OG006
GSK3739937 SD 640 mg
In Cohort 2 of Part 1, participants received single oral dose of 640 mg GSK3739937
OG007
GSK3739937 SD 800 mg
In Cohort 1 of Part 1, participants received single oral dose of 800 mg of GSK3739937
Units
Counts
Participants
OG00018
OG0011
OG0026
OG003
Title
Denominators
Categories
Title
Measurements
OG0000.09± 0.314
OG001-0.5
OG0020.33± 0.294
OG003
Primary
Part 2 (QD PBO and Cohort 3, 4 and 5) - Change From Baseline in Hematology Parameter - Erythrocytes Mean Corpuscular Hemoglobin (MCH)
Blood samples were collected to assess change from baseline in Erythrocytes Mean Corpuscular Hemoglobin (MCH). Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline value is presented and was calculated as post-dose visit value minus Baseline value.
Safety Population. Only those participants with data available at specified time points have been analyzed.
Posted
Mean
Standard Deviation
Picogram (pg)
Baseline (Day 1, pre-dose) and Day 14
ID
Title
Description
OG000
PBO Once Daily (QD)
Participants received once daily doses of placebo for 14 days.
OG001
GSK3739937 QD 25 mg
In Cohort 3 of Part 2, participants received once-daily oral dose of 25 mg GSK3739937 for 14 days.
OG002
GSK3739937 QD 50 mg
In Cohort 4 of Part 2, participants received once-daily oral dose of 50 mg GSK3739937 for 14 days.
OG003
GSK3739937 QD 100 mg
In Cohort 5 of Part 2, participants received once-daily oral dose of 100 mg GSK3739937 for 18 days.
Units
Counts
Participants
OG0009
OG0017
OG0027
OG003
Title
Denominators
Categories
Title
Measurements
OG0000.02± 0.63
OG001-0.3± 0.44
OG0020.16± 0.172
OG003
Primary
Part 2 (QW PBO and Cohort 6) - Change From Baseline in Hematology Parameter - Erythrocytes Mean Corpuscular Hemoglobin (MCH)
Blood samples were collected to assess change from baseline in Mean Corpuscular Hemoglobin (MCH). Blood samples were collected to assess change from baseline in Erythrocytes Mean Corpuscular Hemoglobin (MCH). Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline value is presented and was calculated as post-dose visit value minus Baseline value.
Safety Population. Only those participants with data available at specified time points have been analyzed.
Posted
Mean
Standard Deviation
Picogram (pg)
Baseline (Day 1, pre-dose) and Day 15
ID
Title
Description
OG000
PBO Once Weekly (QW)
Participants received once weekly oral dose of Placebo for over 3 weeks.
OG001
GSK3739937 QW 500 mg
In Cohort 6 of Part 2, participants received one dose per week of 500 mg GSK3739937 for over 3 weeks.
Units
Counts
Participants
OG0003
OG0017
Title
Denominators
Categories
Title
Measurements
OG000-0.87± 0.666
OG001-0.83± 0.399
Primary
Part 3 - Change From Baseline in Hematology Parameter - Erythrocytes Mean Corpuscular Hemoglobin (MCH)
Blood samples were collected to assess change from baseline in Mean Corpuscular Hemoglobin (MCH). Blood samples were collected to assess change from baseline in Erythrocytes Mean Corpuscular Hemoglobin (MCH). Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline value is presented and was calculated as post-dose visit value minus Baseline value.
Safety Population. Only those participants with data available at specified time points have been analyzed.
Posted
Mean
Standard Deviation
Picogram (pg)
Baseline (Day -1) and Day 6
ID
Title
Description
OG000
GSK3739937 PiB Fed
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 PiB as an oral suspension under moderate fed conditions in each one of the three periods.
OG001
GSK3739937 Tablet Fed
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under moderate fed conditions in each one of the three periods.
OG002
GSK3739937 Tablet Fasted
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under fasted conditions in each one of the three periods.
Units
Counts
Participants
OG00015
OG00117
OG00215
Title
Denominators
Categories
Title
Measurements
OG0000± 0.433
OG001-0.24± 0.487
OG0020.05± 0.54
Primary
Part 1 - Change From Baseline in Hematology Parameter - Hematocrit
Blood samples were collected to assess change from baseline in Hematocrit. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline value is presented and was calculated as post-dose visit value minus Baseline value.
Safety Population. Only those participants with data available at specified time points have been analyzed.
Posted
Mean
Standard Deviation
Proportion of red blood cells in blood
Baseline (Day -1) and Day 6
ID
Title
Description
OG000
Placebo (PBO) Single Dose
In Cohort 1 and 2 of Part 1, participants received single oral dose of Placebo.
OG001
GSK3739937 Single Dose (SD) 10 mg
In Cohort 1 of Part 1, participants received single oral dose of 10 mg GSK3739937
OG002
GSK3739937 SD 30 mg
In Cohort 2 of Part 1, participants received single oral dose of 30 mg GSK3739937
OG003
GSK3739937 SD 80 mg
In Cohort 1 of Part 1, participants received single oral dose of 80 mg GSK3739937
OG004
GSK3739937 SD 160 mg
In Cohort 2 of Part 1, participants received single oral dose of 160 mg GSK3739937
OG005
GSK3739937 SD 320 mg
In Cohort 1 of Part 1, participants received single oral dose of 320 mg GSK3739937
OG006
GSK3739937 SD 640 mg
In Cohort 2 of Part 1, participants received single oral dose of 640 mg GSK3739937
OG007
GSK3739937 SD 800 mg
In Cohort 1 of Part 1, participants received single oral dose of 800 mg of GSK3739937
Units
Counts
Participants
OG00018
OG0011
OG0026
OG003
Title
Denominators
Categories
Title
Measurements
OG0000.0083± 0.01231
OG0010.014
OG0020.015± 0.0304
OG003
Primary
Part 2 (QD PBO and Cohort 3, 4 and 5) - Change From Baseline in Hematology Parameter - Hematocrit
Blood samples were collected to assess change from baseline in Hematocrit. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline value is presented and was calculated as post-dose visit value minus Baseline value.
Safety Population. Only those participants with data available at specified time points have been analyzed.
Posted
Mean
Standard Deviation
Proportion of red blood cells in blood
Baseline (Day 1, pre-dose) and Day 14
ID
Title
Description
OG000
PBO Once Daily (QD)
Participants received once daily doses of placebo for 14 days.
OG001
GSK3739937 QD 25 mg
In Cohort 3 of Part 2, participants received once-daily oral dose of 25 mg GSK3739937 for 14 days.
OG002
GSK3739937 QD 50 mg
In Cohort 4 of Part 2, participants received once-daily oral dose of 50 mg GSK3739937 for 14 days.
OG003
GSK3739937 QD 100 mg
In Cohort 5 of Part 2, participants received once-daily oral dose of 100 mg GSK3739937 for 18 days.
Units
Counts
Participants
OG0009
OG0017
OG0027
OG003
Title
Denominators
Categories
Title
Measurements
OG000-0.0081± 0.01342
OG0010.0066± 0.01838
OG002-0.0217± 0.01963
OG003
Primary
Part 2 (QW PBO and Cohort 6) - Change From Baseline in Hematology Parameter - Hematocrit
Blood samples were collected to assess change from baseline in Hematocrit. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline value is presented and was calculated as post-dose visit value minus Baseline value.
Safety Population. Only those participants with data available at specified time points have been analyzed.
Posted
Mean
Standard Deviation
Proportion of red blood cells in blood
Baseline (Day 1, pre-dose) and Day 15
ID
Title
Description
OG000
PBO Once Weekly (QW)
Participants received once weekly oral dose of Placebo for over 3 weeks.
OG001
GSK3739937 QW 500 mg
In Cohort 6 of Part 2, participants received one dose per week of 500 mg GSK3739937 for over 3 weeks.
Units
Counts
Participants
OG0003
OG0017
Title
Denominators
Categories
Title
Measurements
OG000-0.0120± 0.02685
OG001-0.0094± 0.00781
Primary
Part 3 - Change From Baseline in Hematology Parameter - Hematocrit
Blood samples were collected to assess change from baseline in Hematocrit. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline value is presented and was calculated as post-dose visit value minus Baseline value.
Safety Population. Only those participants with data available at specified time points have been analyzed.
Posted
Mean
Standard Deviation
Proportion of red blood cells in blood
Baseline (Day -1) and Day 6
ID
Title
Description
OG000
GSK3739937 PiB Fed
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 PiB as an oral suspension under moderate fed conditions in each one of the three periods.
OG001
GSK3739937 Tablet Fed
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under moderate fed conditions in each one of the three periods.
OG002
GSK3739937 Tablet Fasted
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under fasted conditions in each one of the three periods.
Units
Counts
Participants
OG00015
OG00117
OG00215
Title
Denominators
Categories
Title
Measurements
OG0000.0182± 0.01826
OG0010.013± 0.02076
OG0020.0159± 0.01793
Primary
Part 1 - Change From Baseline in Hematology Parameter - Reticulocytes
Blood samples were collected to assess change from baseline in Reticulocytes. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline value is presented and was calculated as post-dose visit value minus Baseline value.
Safety Population. Only those participants with data available at specified time points have been analyzed.
Posted
Mean
Standard Deviation
Proportion of reticulocytes in blood
Baseline (Day -1) and Day 6
ID
Title
Description
OG000
Placebo (PBO) Single Dose
In Cohort 1 and 2 of Part 1, participants received single oral dose of Placebo.
OG001
GSK3739937 Single Dose (SD) 10 mg
In Cohort 1 of Part 1, participants received single oral dose of 10 mg GSK3739937
OG002
GSK3739937 SD 30 mg
In Cohort 2 of Part 1, participants received single oral dose of 30 mg GSK3739937
OG003
GSK3739937 SD 80 mg
In Cohort 1 of Part 1, participants received single oral dose of 80 mg GSK3739937
OG004
GSK3739937 SD 160 mg
In Cohort 2 of Part 1, participants received single oral dose of 160 mg GSK3739937
OG005
GSK3739937 SD 320 mg
In Cohort 1 of Part 1, participants received single oral dose of 320 mg GSK3739937
OG006
GSK3739937 SD 640 mg
In Cohort 2 of Part 1, participants received single oral dose of 640 mg GSK3739937
OG007
GSK3739937 SD 800 mg
In Cohort 1 of Part 1, participants received single oral dose of 800 mg of GSK3739937
Units
Counts
Participants
OG00018
OG0011
OG0026
OG003
Title
Denominators
Categories
Title
Measurements
OG0000.0008± 0.00363
OG0010.002
OG002-0.0045± 0.00622
OG003
Primary
Part 2 (QD PBO and Cohort 3, 4 and 5) - Change From Baseline in Hematology Parameter - Reticulocytes
Blood samples were collected to assess change from baseline in Reticulocytes. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline value is presented and was calculated as post-dose visit value minus Baseline value.
Safety Population. Only those participants with data available at specified time points have been analyzed.
Posted
Mean
Standard Deviation
Proportion of reticulocytes in blood
Baseline (Day 1, pre-dose) and Day 14
ID
Title
Description
OG000
PBO Once Daily (QD)
Participants received once daily doses of placebo for 14 days.
OG001
GSK3739937 QD 25 mg
In Cohort 3 of Part 2, participants received once-daily oral dose of 25 mg GSK3739937 for 14 days.
OG002
GSK3739937 QD 50 mg
In Cohort 4 of Part 2, participants received once-daily oral dose of 50 mg GSK3739937 for 14 days.
OG003
GSK3739937 QD 100 mg
In Cohort 5 of Part 2, participants received once-daily oral dose of 100 mg GSK3739937 for 18 days.
Units
Counts
Participants
OG0009
OG0017
OG0027
OG003
Title
Denominators
Categories
Title
Measurements
OG000-0.0017± 0.0024
OG001-0.0011± 0.00219
OG0020.0010± 0.00306
OG003
Primary
Part 2 (QW PBO and Cohort 6) - Change From Baseline in Hematology Parameter - Reticulocytes
Blood samples were collected to assess change from baseline in Reticulocytes. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline value is presented and was calculated as post-dose visit value minus Baseline value.
Safety Population. Only those participants with data available at specified time points have been analyzed.
Posted
Mean
Standard Deviation
Proportion of reticulocytes in blood
Baseline (Day 1, pre-dose) and Day 15
ID
Title
Description
OG000
PBO Once Weekly (QW)
Participants received once weekly oral dose of Placebo for over 3 weeks.
OG001
GSK3739937 QW 500 mg
In Cohort 6 of Part 2, participants received one dose per week of 500 mg GSK3739937 for over 3 weeks.
Units
Counts
Participants
OG0003
OG0017
Title
Denominators
Categories
Title
Measurements
OG0000.0003± 0.00379
OG001-0.0001± 0.00227
Primary
Part 3 - Change From Baseline in Hematology Parameter - Reticulocytes
Blood samples were collected to assess change from baseline in Reticulocytes. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline value is presented and was calculated as post-dose visit value minus Baseline value.
Safety Population. Only those participants with data available at specified time points have been analyzed.
Posted
Mean
Standard Deviation
Proportion of reticulocytes in blood
Baseline (Day -1) and Day 6
ID
Title
Description
OG000
GSK3739937 PiB Fed
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 PiB as an oral suspension under moderate fed conditions in each one of the three periods.
OG001
GSK3739937 Tablet Fed
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under moderate fed conditions in each one of the three periods.
OG002
GSK3739937 Tablet Fasted
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under fasted conditions in each one of the three periods.
Units
Counts
Participants
OG00015
OG00117
OG00215
Title
Denominators
Categories
Title
Measurements
OG000-0.0011± 0.00231
OG001-0.0009± 0.00255
OG002-0.0012± 0.00224
Primary
Part 1 - Change From Baseline in Hematology Parameter - Hemoglobin (Hb)
Blood samples were collected to assess change from baseline in Hemoglobin (Hb). Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline value is presented and was calculated as post-dose visit value minus Baseline value.
Safety Population. Only those participants with data available at specified time points have been analyzed.
Posted
Mean
Standard Deviation
Grams per liter (g/L)
Baseline (Day -1) and Day 6
ID
Title
Description
OG000
Placebo (PBO) Single Dose
In Cohort 1 and 2 of Part 1, participants received single oral dose of Placebo.
OG001
GSK3739937 Single Dose (SD) 10 mg
In Cohort 1 of Part 1, participants received single oral dose of 10 mg GSK3739937
OG002
GSK3739937 SD 30 mg
In Cohort 2 of Part 1, participants received single oral dose of 30 mg GSK3739937
OG003
GSK3739937 SD 80 mg
In Cohort 1 of Part 1, participants received single oral dose of 80 mg GSK3739937
OG004
GSK3739937 SD 160 mg
In Cohort 2 of Part 1, participants received single oral dose of 160 mg GSK3739937
OG005
GSK3739937 SD 320 mg
In Cohort 1 of Part 1, participants received single oral dose of 320 mg GSK3739937
OG006
GSK3739937 SD 640 mg
In Cohort 2 of Part 1, participants received single oral dose of 640 mg GSK3739937
OG007
GSK3739937 SD 800 mg
In Cohort 1 of Part 1, participants received single oral dose of 800 mg of GSK3739937
Units
Counts
Participants
OG00018
OG0011
OG0026
OG003
Title
Denominators
Categories
Title
Measurements
OG0002.8± 4.44
OG0012
OG0027.5± 8.41
OG003
Primary
Part 2 (QD PBO and Cohort 3, 4 and 5) - Change From Baseline in Hematology Parameter - Hemoglobin (Hb)
Blood samples were collected to assess change from baseline in Hemoglobin (Hb). Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline value is presented and was calculated as post-dose visit value minus Baseline value.
Safety Population. Only those participants with data available at specified time points have been analyzed.
Posted
Mean
Standard Deviation
Grams per liter (g/L)
Baseline (Day 1, pre-dose) and Day 14
ID
Title
Description
OG000
PBO Once Daily (QD)
Participants received once daily doses of placebo for 14 days.
OG001
GSK3739937 QD 25 mg
In Cohort 3 of Part 2, participants received once-daily oral dose of 25 mg GSK3739937 for 14 days.
OG002
GSK3739937 QD 50 mg
In Cohort 4 of Part 2, participants received once-daily oral dose of 50 mg GSK3739937 for 14 days.
OG003
GSK3739937 QD 100 mg
In Cohort 5 of Part 2, participants received once-daily oral dose of 100 mg GSK3739937 for 18 days.
Units
Counts
Participants
OG0009
OG0017
OG0027
OG003
Title
Denominators
Categories
Title
Measurements
OG000-1.6± 5.13
OG001-1± 7.21
OG002-5.7± 6.70
OG003
Primary
Part 2 (QW PBO and Cohort 6) - Change From Baseline in Hematology Parameter - Hemoglobin (Hb)
Blood samples were collected to assess change from baseline in Hemoglobin (Hb). Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline value is presented and was calculated as post-dose visit value minus Baseline value.
Safety Population. Only those participants with data available at specified time points have been analyzed.
Posted
Mean
Standard Deviation
Grams per liter (g/L)
Baseline (Day 1, pre-dose) and Day 15
ID
Title
Description
OG000
PBO Once Weekly (QW)
Participants received once weekly oral dose of Placebo for over 3 weeks.
OG001
GSK3739937 QW 500 mg
In Cohort 6 of Part 2, participants received one dose per week of 500 mg GSK3739937 for over 3 weeks.
Units
Counts
Participants
OG0003
OG0017
Title
Denominators
Categories
Title
Measurements
OG000-5.7± 7.64
OG001-4.3± 2.63
Primary
Part 3 - Change From Baseline in Hematology Parameter - Hemoglobin (Hb)
Blood samples were collected to assess change from baseline in Hemoglobin (Hb). Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline value is presented and was calculated as post-dose visit value minus Baseline value.
Safety Population. Only those participants with data available at specified time points have been analyzed.
Posted
Mean
Standard Deviation
Grams per liter (g/L)
Baseline (Day -1) and Day 6
ID
Title
Description
OG000
GSK3739937 PiB Fed
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 PiB as an oral suspension under moderate fed conditions in each one of the three periods.
OG001
GSK3739937 Tablet Fed
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under moderate fed conditions in each one of the three periods.
OG002
GSK3739937 Tablet Fasted
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under fasted conditions in each one of the three periods.
Units
Counts
Participants
OG00015
OG00117
OG00215
Title
Denominators
Categories
Title
Measurements
OG0006.7± 5.87
OG0014.5± 7.07
OG0025.7± 5.37
Primary
Part 1 - Change From Baseline in Clinical Chemistry Parameter - Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphate (ALP) and Serum Creatine Phosphokinase (CPK)
Blood samples were collected to assess change from baseline in Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphate (ALP) and Serum Creatine Phosphokinase (CPK). Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline value is presented and was calculated as post-dose visit value minus Baseline value.
Safety Population. Only those participants with data available at specified time points have been analyzed.
Posted
Mean
Standard Deviation
International units per Liter (IU/L)
Baseline (Day -1) and Day 6
ID
Title
Description
OG000
Placebo (PBO) Single Dose
In Cohort 1 and 2 of Part 1, participants received single oral dose of Placebo.
OG001
GSK3739937 Single Dose (SD) 10 mg
In Cohort 1 of Part 1, participants received single oral dose of 10 mg GSK3739937
OG002
GSK3739937 SD 30 mg
In Cohort 2 of Part 1, participants received single oral dose of 30 mg GSK3739937
OG003
GSK3739937 SD 80 mg
In Cohort 1 of Part 1, participants received single oral dose of 80 mg GSK3739937
OG004
GSK3739937 SD 160 mg
In Cohort 2 of Part 1, participants received single oral dose of 160 mg GSK3739937
OG005
GSK3739937 SD 320 mg
In Cohort 1 of Part 1, participants received single oral dose of 320 mg GSK3739937
OG006
GSK3739937 SD 640 mg
In Cohort 2 of Part 1, participants received single oral dose of 640 mg GSK3739937
OG007
GSK3739937 SD 800 mg
In Cohort 1 of Part 1, participants received single oral dose of 800 mg of GSK3739937
Units
Counts
Participants
OG00018
OG0011
OG0026
OG003
Title
Denominators
Categories
ALP
ParticipantsOG00018
ParticipantsOG0011
ParticipantsOG0026
ParticipantsOG003
Primary
Part 2 (QD PBO and Cohort 3, 4 and 5) - Change From Baseline in Clinical Chemistry Parameter - ALT, AST, ALP and Serum CPK
Blood samples were collected to assess change from baseline in Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphate (ALP) and Serum Creatine Phosphokinase (CPK). Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline value is presented and was calculated as post-dose visit value minus Baseline value.
Safety Population. Only those participants with data available at specified time points have been analyzed.
Posted
Mean
Standard Deviation
International units per Liter (IU/L)
Baseline (Day 1, pre-dose) and Day 14
ID
Title
Description
OG000
PBO Once Daily (QD)
Participants received once daily doses of placebo for 14 days.
OG001
GSK3739937 QD 25 mg
In Cohort 3 of Part 2, participants received once-daily oral dose of 25 mg GSK3739937 for 14 days.
OG002
GSK3739937 QD 50 mg
In Cohort 4 of Part 2, participants received once-daily oral dose of 50 mg GSK3739937 for 14 days.
OG003
GSK3739937 QD 100 mg
In Cohort 5 of Part 2, participants received once-daily oral dose of 100 mg GSK3739937 for 18 days.
Units
Counts
Participants
OG0009
OG0017
OG0027
OG003
Title
Denominators
Categories
ALP
ParticipantsOG0009
ParticipantsOG0017
ParticipantsOG0027
ParticipantsOG003
Primary
Part 2 (QW PBO and Cohort 6) - Change From Baseline in Clinical Chemistry Parameter -ALT, AST, ALP and Serum CPK
Blood samples were collected to assess change from baseline in Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphate (ALP) and Serum Creatine Phosphokinase (CPK). Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline value is presented and was calculated as post-dose visit value minus Baseline value.
Safety Population. Only those participants with data available at specified time points have been analyzed.
Posted
Mean
Standard Deviation
International units per Liter (IU/L)
Baseline (Day 1, pre-dose) and Day 15
ID
Title
Description
OG000
PBO Once Weekly (QW)
Participants received once weekly oral dose of Placebo for over 3 weeks.
OG001
GSK3739937 QW 500 mg
In Cohort 6 of Part 2, participants received one dose per week of 500 mg GSK3739937 for over 3 weeks.
Units
Counts
Participants
OG0003
OG0017
Title
Denominators
Categories
ALP
Title
Measurements
OG0000.0± 2.65
OG0011.9± 4.02
ALT
Title
Measurements
OG000
Primary
Part 3 - Change From Baseline in Clinical Chemistry Parameter - ALT, AST, ALP and CPK
Blood samples were collected to assess change from baseline in Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphate (ALP) and Serum Creatine Phosphokinase (CPK). Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline value is presented and was calculated as post-dose visit value minus Baseline value.
Safety Population. Only those participants with data available at specified time points have been analyzed.
Posted
Mean
Standard Deviation
International units per Liter (IU/L)
Baseline (Day -1) and Day 6
ID
Title
Description
OG000
GSK3739937 PiB Fed
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 PiB as an oral suspension under moderate fed conditions in each one of the three periods.
OG001
GSK3739937 Tablet Fed
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under moderate fed conditions in each one of the three periods.
OG002
GSK3739937 Tablet Fasted
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under fasted conditions in each one of the three periods.
Units
Counts
Participants
OG00015
OG00117
OG00215
Title
Denominators
Categories
ALP
Title
Measurements
OG0005.9± 6.42
OG0015.4± 5.91
OG0025.2± 4.78
ALT
Primary
Part 1 - Change From Baseline in Clinical Chemistry Parameters- Bicarbonate, Calcium, Glucose, Chloride, Magnesium, Phosphate, Potassium, Sodium, Blood Urea Nitrogen, Cholesterol, High Density Lipoprotein, Low Density Lipoprotein, Triglycerides
Blood samples were collected to assess change from baseline in Bicarbonate, Calcium, Glucose, Chloride, Magnesium, Phosphate, Potassium, Sodium, Blood Urea Nitrogen (BUN), Cholesterol, High Density Lipoprotein (HDL), Low Density Lipoprotein (LDL) and Triglycerides. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline value is presented and was calculated as post-dose visit value minus Baseline value.
Safety Population. Only those participants with data available at specified time points have been analyzed.
Posted
Mean
Standard Deviation
Millimoles per Liter (mmol/L)
Baseline (Day -1) and Day 6
ID
Title
Description
OG000
Placebo (PBO) Single Dose
In Cohort 1 and 2 of Part 1, participants received single oral dose of Placebo.
OG001
GSK3739937 Single Dose (SD) 10 mg
In Cohort 1 of Part 1, participants received single oral dose of 10 mg GSK3739937
OG002
GSK3739937 SD 30 mg
In Cohort 2 of Part 1, participants received single oral dose of 30 mg GSK3739937
OG003
GSK3739937 SD 80 mg
In Cohort 1 of Part 1, participants received single oral dose of 80 mg GSK3739937
OG004
GSK3739937 SD 160 mg
In Cohort 2 of Part 1, participants received single oral dose of 160 mg GSK3739937
OG005
GSK3739937 SD 320 mg
In Cohort 1 of Part 1, participants received single oral dose of 320 mg GSK3739937
OG006
GSK3739937 SD 640 mg
In Cohort 2 of Part 1, participants received single oral dose of 640 mg GSK3739937
OG007
GSK3739937 SD 800 mg
In Cohort 1 of Part 1, participants received single oral dose of 800 mg of GSK3739937
Units
Counts
Participants
OG00018
OG0011
OG0026
OG003
Title
Denominators
Categories
Glucose
Title
Measurements
OG000-0.29± 0.46027
OG001-0.499
OG002-0.3147± 0.22689
OG003
Primary
Part 2 (QD PBO and Cohort 3, 4 and 5) - Change From Baseline in Clinical Chemistry Parameters- Bicarbonate, Calcium, Glucose, Chloride, Magnesium, Phosphate, Potassium, Sodium, BUN, Cholesterol, HDL, LDL, Triglycerides
Blood samples were collected to assess change from baseline in Bicarbonate, Calcium, Glucose, Chloride, Magnesium, Phosphate, Potassium, Sodium, Blood Urea Nitrogen (BUN), Cholesterol, High Density Lipoprotein (HDL), Low Density Lipoprotein (LDL) and Triglycerides. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline value is presented and was calculated as post-dose visit value minus Baseline value.
Safety Population. Only those participants with data available at specified time points have been analyzed.
Posted
Mean
Standard Deviation
Millimoles per Liter (mmol/L)
Baseline (Day 1, pre-dose) and Day 14
ID
Title
Description
OG000
PBO Once Daily (QD)
Participants received once daily doses of placebo for 14 days.
OG001
GSK3739937 QD 25 mg
In Cohort 3 of Part 2, participants received once-daily oral dose of 25 mg GSK3739937 for 14 days.
OG002
GSK3739937 QD 50 mg
In Cohort 4 of Part 2, participants received once-daily oral dose of 50 mg GSK3739937 for 14 days.
OG003
GSK3739937 QD 100 mg
In Cohort 5 of Part 2, participants received once-daily oral dose of 100 mg GSK3739937 for 18 days.
Units
Counts
Participants
OG0009
OG0017
OG0027
OG003
Title
Denominators
Categories
Glucose
Title
Measurements
OG000-0.2773± 0.58989
OG001-0.6027± 0.19341
OG0020.0319± 0.35520
OG003
Primary
Part 2 (QW PBO and Cohort 6) - Change From Baseline in Clinical Chemistry Parameters- Bicarbonate, Calcium, Glucose, Chloride, Magnesium, Phosphate, Potassium, Sodium, BUN, Cholesterol, HDL, LDL, Triglycerides
Blood samples were collected to assess change from baseline in Bicarbonate, Calcium, Glucose, Chloride, Magnesium, Phosphate, Potassium, Sodium, Blood Urea Nitrogen (BUN), Cholesterol, High Density Lipoprotein (HDL), Low Density Lipoprotein (LDL) and Triglycerides. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline value is presented and was calculated as post-dose visit value minus Baseline value.
Safety Population. Only those participants with data available at specified time points have been analyzed.
Posted
Mean
Standard Deviation
Millimoles per Liter (mmol/L)
Baseline (Day 1, pre-dose) and Day 15
ID
Title
Description
OG000
PBO Once Weekly (QW)
Participants received once weekly oral dose of Placebo for over 3 weeks.
OG001
GSK3739937 QW 500 mg
In Cohort 6 of Part 2, participants received one dose per week of 500 mg GSK3739937 for over 3 weeks.
Units
Counts
Participants
OG0003
OG0017
Title
Denominators
Categories
Glucose
Title
Measurements
OG000-0.2590± 0.23106
OG001-0.3014± 0.14978
Bicarbonate
Title
Measurements
OG000
Primary
Part 3 - Change From Baseline in Clinical Chemistry Parameters- Bicarbonate, Calcium, Glucose, Chloride, Magnesium, Phosphate, Potassium, Sodium, BUN, Cholesterol, HDL, LDL, Triglycerides Edit Properties | Duplicate Measure
Blood samples were collected to assess change from baseline in Bicarbonate, Calcium, Glucose, Chloride, Magnesium, Phosphate, Potassium, Sodium, Blood Urea Nitrogen (BUN), Cholesterol, High Density Lipoprotein (HDL), Low Density Lipoprotein (LDL) and Triglycerides. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline value is presented and was calculated as post-dose visit value minus Baseline value.
Safety Population. Only those participants with data available at specified time points have been analyzed.
Posted
Mean
Standard Deviation
Millimoles per Liter (mmol/L)
Baseline (Day -1) and Day 6
ID
Title
Description
OG000
GSK3739937 PiB Fed
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 PiB as an oral suspension under moderate fed conditions in each one of the three periods.
OG001
GSK3739937 Tablet Fed
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under moderate fed conditions in each one of the three periods.
OG002
GSK3739937 Tablet Fasted
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under fasted conditions in each one of the three periods.
Units
Counts
Participants
OG00015
OG00117
OG00215
Title
Denominators
Categories
Glucose
Title
Measurements
OG000-0.2033± 0.39
OG001-0.3755± 0.24961
OG002-0.2145± 0.27017
Bicarbonate
Primary
Part 1 - Change From Baseline in Clinical Chemistry Parameters - Amylase and Lipase
Blood samples were collected to assess change from baseline in Amylase and Lipase. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline value is presented and was calculated as post-dose visit value minus Baseline value.
Safety Population. Only those participants with data available at specified time points have been analyzed.
Posted
Mean
Standard Deviation
Units per liter (U/L)
Baseline (Day -1) and Day 6
ID
Title
Description
OG000
Placebo (PBO) Single Dose
In Cohort 1 and 2 of Part 1, participants received single oral dose of Placebo.
OG001
GSK3739937 Single Dose (SD) 10 mg
In Cohort 1 of Part 1, participants received single oral dose of 10 mg GSK3739937
OG002
GSK3739937 SD 30 mg
In Cohort 2 of Part 1, participants received single oral dose of 30 mg GSK3739937
OG003
GSK3739937 SD 80 mg
In Cohort 1 of Part 1, participants received single oral dose of 80 mg GSK3739937
OG004
GSK3739937 SD 160 mg
In Cohort 2 of Part 1, participants received single oral dose of 160 mg GSK3739937
OG005
GSK3739937 SD 320 mg
In Cohort 1 of Part 1, participants received single oral dose of 320 mg GSK3739937
OG006
GSK3739937 SD 640 mg
In Cohort 2 of Part 1, participants received single oral dose of 640 mg GSK3739937
OG007
GSK3739937 SD 800 mg
In Cohort 1 of Part 1, participants received single oral dose of 800 mg of GSK3739937
Units
Counts
Participants
OG00018
OG0011
OG0026
OG003
Title
Denominators
Categories
Amylase
Title
Measurements
OG000-1.2± 17.38
OG00112
OG002-0.7± 6.12
OG003
Primary
Part 2 (QD PBO and Cohort 3, 4 and 5) - Change From Baseline in Clinical Chemistry Parameters - Amylase and Lipase
Blood samples were collected to assess change from baseline in Amylase and Lipase. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline value is presented and was calculated as post-dose visit value minus Baseline value.
Safety Population. Only those participants with data available at specified time points have been analyzed.
Posted
Mean
Standard Deviation
Units per liter (U/L)
Baseline (Day 1, pre-dose) and Day 14
ID
Title
Description
OG000
PBO Once Daily (QD)
Participants received once daily doses of placebo for 14 days.
OG001
GSK3739937 QD 25 mg
In Cohort 3 of Part 2, participants received once-daily oral dose of 25 mg GSK3739937 for 14 days.
OG002
GSK3739937 QD 50 mg
In Cohort 4 of Part 2, participants received once-daily oral dose of 50 mg GSK3739937 for 14 days.
OG003
GSK3739937 QD 100 mg
In Cohort 5 of Part 2, participants received once-daily oral dose of 100 mg GSK3739937 for 18 days.
Units
Counts
Participants
OG0009
OG0017
OG0027
OG003
Title
Denominators
Categories
Amylase
Title
Measurements
OG0003.7± 27.96
OG001-18.3± 17.85
OG0020.3± 5.50
OG003
Primary
Part 2 (QW PBO and Cohort 6) - Change From Baseline in Clinical Chemistry Parameters - Amylase and Lipase
Blood samples were collected to assess change from baseline in Amylase and Lipase. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline value is presented and was calculated as post-dose visit value minus Baseline value.
Safety Population. Only those participants with data available at specified time points have been analyzed.
Posted
Mean
Standard Deviation
Units per liter (U/L)
Baseline (Day 1, pre-dose) and Day 15
ID
Title
Description
OG000
PBO Once Weekly (QW)
Participants received once weekly oral dose of Placebo for over 3 weeks.
OG001
GSK3739937 QW 500 mg
In Cohort 6 of Part 2, participants received one dose per week of 500 mg GSK3739937 for over 3 weeks.
Units
Counts
Participants
OG0003
OG0017
Title
Denominators
Categories
Amylase
Title
Measurements
OG0002.7± 7.51
OG001-10± 22.5
Lipase
Title
Measurements
OG000
Primary
Part 3 - Change From Baseline in Clinical Chemistry Parameters - Amylase and Lipase
Blood samples were collected to assess change from baseline in Amylase and Lipase. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline value is presented and was calculated as post-dose visit value minus Baseline value.
Safety Population. Only those participants with data available at specified time points have been analyzed.
Posted
Mean
Standard Deviation
Units per liter (U/L)
Baseline (Day -1) and Day 6
ID
Title
Description
OG000
GSK3739937 PiB Fed
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 PiB as an oral suspension under moderate fed conditions in each one of the three periods.
OG001
GSK3739937 Tablet Fed
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under moderate fed conditions in each one of the three periods.
OG002
GSK3739937 Tablet Fasted
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under fasted conditions in each one of the three periods.
Units
Counts
Participants
OG00015
OG00117
OG00215
Title
Denominators
Categories
Amylase
Title
Measurements
OG0000.5± 16.41
OG0011.2± 12.08
OG0025.1± 18.24
Lipase
Primary
Part 1 - Change From Baseline in Clinical Chemistry Parameter - Total Bilirubin, Direct Bilirubin and Creatinine
Blood samples were collected to assess change from baseline in Total Bilirubin, Direct Bilirubin and Creatinine. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline value is presented and was calculated as post-dose visit value minus Baseline value.
Safety Population. Only those participants with data available at specified time points have been analyzed.
Posted
Mean
Standard Deviation
Micromoles per Liter (umol/L)
Baseline (Day -1) and Day 6
ID
Title
Description
OG000
Placebo (PBO) Single Dose
In Cohort 1 and 2 of Part 1, participants received single oral dose of Placebo.
OG001
GSK3739937 Single Dose (SD) 10 mg
In Cohort 1 of Part 1, participants received single oral dose of 10 mg GSK3739937
OG002
GSK3739937 SD 30 mg
In Cohort 2 of Part 1, participants received single oral dose of 30 mg GSK3739937
OG003
GSK3739937 SD 80 mg
In Cohort 1 of Part 1, participants received single oral dose of 80 mg GSK3739937
OG004
GSK3739937 SD 160 mg
In Cohort 2 of Part 1, participants received single oral dose of 160 mg GSK3739937
OG005
GSK3739937 SD 320 mg
In Cohort 1 of Part 1, participants received single oral dose of 320 mg GSK3739937
OG006
GSK3739937 SD 640 mg
In Cohort 2 of Part 1, participants received single oral dose of 640 mg GSK3739937
OG007
GSK3739937 SD 800 mg
In Cohort 1 of Part 1, participants received single oral dose of 800 mg of GSK3739937
Units
Counts
Participants
OG00018
OG0011
OG0026
OG003
Title
Denominators
Categories
Direct Bilirubin
Title
Measurements
OG000-0.2839± 1.10348
OG0010
OG002-0.1995± 0.62518
OG003
Primary
Part 2 (QD PBO and Cohort 3, 4 and 5) - Change From Baseline in Clinical Chemistry Parameter - Total Bilirubin, Direct Bilirubin and Creatinine
Blood samples were collected to assess change from baseline in Total Bilirubin, Direct Bilirubin and Creatinine. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline value is presented and was calculated as post-dose visit value minus Baseline value.
Safety Population. Only those participants with data available at specified time points have been analyzed.
Posted
Mean
Standard Deviation
Micromoles per Liter (umol/L)
Baseline (Day 1, pre-dose) and Day 14
ID
Title
Description
OG000
PBO Once Daily (QD)
Participants received once daily doses of placebo for 14 days.
OG001
GSK3739937 QD 25 mg
In Cohort 3 of Part 2, participants received once-daily oral dose of 25 mg GSK3739937 for 14 days.
OG002
GSK3739937 QD 50 mg
In Cohort 4 of Part 2, participants received once-daily oral dose of 50 mg GSK3739937 for 14 days.
OG003
GSK3739937 QD 100 mg
In Cohort 5 of Part 2, participants received once-daily oral dose of 100 mg GSK3739937 for 18 days.
Units
Counts
Participants
OG0009
OG0017
OG0027
OG003
Title
Denominators
Categories
Direct Bilirubin
Title
Measurements
OG000-0.6058± 1.12324
OG0010.5863± 1.10758
OG002-0.8061± 0.95062
OG003
Primary
Part 2 (QW PBO and Cohort 6) - Change From Baseline in Clinical Chemistry Parameter - Total Bilirubin, Direct Bilirubin and Creatinine
Blood samples were collected to assess change from baseline in Total Bilirubin, Direct Bilirubin and Creatinine. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline value is presented and was calculated as post-dose visit value minus Baseline value.
Safety Population. Only those participants with data available at specified time points have been analyzed.
Posted
Mean
Standard Deviation
Micromoles per Liter (umol/L)
Baseline (Day 1, pre-dose) and Day 15
ID
Title
Description
OG000
PBO Once Weekly (QW)
Participants received once weekly oral dose of Placebo for over 3 weeks.
OG001
GSK3739937 QW 500 mg
In Cohort 6 of Part 2, participants received one dose per week of 500 mg GSK3739937 for over 3 weeks.
Units
Counts
Participants
OG0003
OG0017
Title
Denominators
Categories
Direct Bilirubin
Title
Measurements
OG0000.5700± 0.98727
OG0011.4671± 0.64254
Total Bilirubin
Title
Measurements
OG000
Primary
Part 3 - Change From Baseline in Clinical Chemistry Parameter - Total Bilirubin, Direct Bilirubin and Creatinine
Blood samples were collected to assess change from baseline in Total Bilirubin, Direct Bilirubin and Creatinine. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline value is presented and was calculated as post-dose visit value minus Baseline value.
Safety Population. Only those participants with data available at specified time points have been analyzed.
Posted
Mean
Standard Deviation
Micromoles per Liter (umol/L)
Baseline (Day -1) and Day 6
ID
Title
Description
OG000
GSK3739937 PiB Fed
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 PiB as an oral suspension under moderate fed conditions in each one of the three periods.
OG001
GSK3739937 Tablet Fed
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under moderate fed conditions in each one of the three periods.
OG002
GSK3739937 Tablet Fasted
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under fasted conditions in each one of the three periods.
Units
Counts
Participants
OG00015
OG00117
OG00215
Title
Denominators
Categories
Direct Bilirubin
Title
Measurements
OG0000.3306± 0.89198
OG0010.4124± 1.068
OG0020.2059± 1.11784
Total Bilirubin
Primary
Part 1 - Change From Baseline in Clinical Chemistry Parameter - Total Protein
Blood samples were collected to assess change from baseline in Total Protein. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline value is presented and was calculated as post-dose visit value minus Baseline value.
Safety Population. Only those participants with data available at specified time points have been analyzed.
Posted
Mean
Standard Deviation
Grams per Liter (g/L)
Baseline (Day -1) and Day 6
ID
Title
Description
OG000
Placebo (PBO) Single Dose
In Cohort 1 and 2 of Part 1, participants received single oral dose of Placebo.
OG001
GSK3739937 Single Dose (SD) 10 mg
In Cohort 1 of Part 1, participants received single oral dose of 10 mg GSK3739937
OG002
GSK3739937 SD 30 mg
In Cohort 2 of Part 1, participants received single oral dose of 30 mg GSK3739937
OG003
GSK3739937 SD 80 mg
In Cohort 1 of Part 1, participants received single oral dose of 80 mg GSK3739937
OG004
GSK3739937 SD 160 mg
In Cohort 2 of Part 1, participants received single oral dose of 160 mg GSK3739937
OG005
GSK3739937 SD 320 mg
In Cohort 1 of Part 1, participants received single oral dose of 320 mg GSK3739937
OG006
GSK3739937 SD 640 mg
In Cohort 2 of Part 1, participants received single oral dose of 640 mg GSK3739937
OG007
GSK3739937 SD 800 mg
In Cohort 1 of Part 1, participants received single oral dose of 800 mg of GSK3739937
Units
Counts
Participants
OG00018
OG0011
OG0026
OG003
Title
Denominators
Categories
Title
Measurements
OG0003.2± 3.07
OG0012
OG0024.5± 3.83
OG003
Primary
Part 2 - (QD PBO and Cohort 3, 4 and 5) - Change From Baseline in Clinical Chemistry Parameter - Total Protein
Blood samples were collected to assess change from baseline in Total Protein. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline value is presented and was calculated as post-dose visit value minus Baseline value.
Safety Population. Only those participants with data available at specified time points have been analyzed.
Posted
Mean
Standard Deviation
Grams per Liter (g/L)
Baseline (Day 1, pre-dose) and Day 14
ID
Title
Description
OG000
PBO Once Daily (QD)
Participants received once daily doses of placebo for 14 days.
OG001
GSK3739937 QD 25 mg
In Cohort 3 of Part 2, participants received once-daily oral dose of 25 mg GSK3739937 for 14 days.
OG002
GSK3739937 QD 50 mg
In Cohort 4 of Part 2, participants received once-daily oral dose of 50 mg GSK3739937 for 14 days.
OG003
GSK3739937 QD 100 mg
In Cohort 5 of Part 2, participants received once-daily oral dose of 100 mg GSK3739937 for 18 days.
Units
Counts
Participants
OG0009
OG0017
OG0027
OG003
Title
Denominators
Categories
Title
Measurements
OG000-3.7± 3.84
OG001-7.1± 6.26
OG002-5.4± 3.91
OG003
Primary
Part 2 (QW PBO and Cohort 6) - Change From Baseline in Clinical Chemistry Parameter - Total Protein
Blood samples were collected to assess change from baseline in Total Protein. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline value is presented and was calculated as post-dose visit value minus Baseline value.
Safety Population. Only those participants with data available at specified time points have been analyzed.
Posted
Mean
Standard Deviation
Grams per Liter (g/L)
Baseline (Day 1, pre-dose) and Day 15
ID
Title
Description
OG000
PBO Once Weekly (QW)
Participants received once weekly oral dose of Placebo for over 3 weeks.
OG001
GSK3739937 QW 500 mg
In Cohort 6 of Part 2, participants received one dose per week of 500 mg GSK3739937 for over 3 weeks.
Units
Counts
Participants
OG0003
OG0017
Title
Denominators
Categories
Title
Measurements
OG000-1.7± 5.03
OG001-2.1± 4.49
Primary
Part 3 - Change From Baseline in Clinical Chemistry Parameter - Total Protein
Blood samples were collected to assess change from baseline in Total Protein. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline value is presented and was calculated as post-dose visit value minus Baseline value.
Safety Population. Only those participants with data available at specified time points have been analyzed.
Posted
Mean
Standard Deviation
Grams per Liter (g/L)
Baseline (Day -1) and Day 6
ID
Title
Description
OG000
GSK3739937 PiB Fed
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 PiB as an oral suspension under moderate fed conditions in each one of the three periods.
OG001
GSK3739937 Tablet Fed
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under moderate fed conditions in each one of the three periods.
OG002
GSK3739937 Tablet Fasted
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under fasted conditions in each one of the three periods.
Units
Counts
Participants
OG00015
OG00117
OG00215
Title
Denominators
Categories
Title
Measurements
OG0005.1± 5.38
OG0015.4± 4.87
OG0024.5± 4.02
Primary
Part 1 - Number of Participants With Abnormal Urinalysis Parameters
Urine samples were collected to detect presence of occult blood and protein through dipstick and random method respectively. The results presented are worst case abnormal urinalysis results post-baseline relative to baseline.
Safety Population. Only those participants with data available at specified time points have been analyzed.
Posted
Count of Participants
Participants
Up to 27 weeks
ID
Title
Description
OG000
Placebo (PBO) Single Dose
In Cohort 1 and 2 of Part 1, participants received single oral dose of Placebo.
OG001
GSK3739937 Single Dose (SD) 10 mg
In Cohort 1 of Part 1, participants received single oral dose of 10 mg GSK3739937
OG002
GSK3739937 SD 30 mg
In Cohort 2 of Part 1, participants received single oral dose of 30 mg GSK3739937
OG003
GSK3739937 SD 80 mg
In Cohort 1 of Part 1, participants received single oral dose of 80 mg GSK3739937
OG004
GSK3739937 SD 160 mg
In Cohort 2 of Part 1, participants received single oral dose of 160 mg GSK3739937
OG005
GSK3739937 SD 320 mg
In Cohort 1 of Part 1, participants received single oral dose of 320 mg GSK3739937
OG006
GSK3739937 SD 640 mg
In Cohort 2 of Part 1, participants received single oral dose of 640 mg GSK3739937
OG007
GSK3739937 SD 800 mg
In Cohort 1 of Part 1, participants received single oral dose of 800 mg of GSK3739937
Units
Counts
Participants
OG00021
OG0016
OG0026
OG003
Title
Denominators
Categories
Occult Blood
Title
Measurements
OG0004
OG0010
OG0021
OG003
Primary
Part 2 - Number of Participants With Abnormal Urinalysis Parameters
Urine samples were collected to detect presence of occult blood and protein through dipstick and random method respectively. The results presented are worst case abnormal urinalysis results post-baseline relative to baseline.
Safety Population. Only those participants with data available at specified time points have been analyzed.
Posted
Count of Participants
Participants
Up to 5 weeks
ID
Title
Description
OG000
PBO Once Daily (QD)
Participants received once daily doses of placebo for 14 days.
OG001
GSK3739937 QD 25 mg
In Cohort 3 of Part 2, participants received once-daily oral dose of 25 mg GSK3739937 for 14 days.
OG002
GSK3739937 QD 50 mg
In Cohort 4 of Part 2, participants received once-daily oral dose of 50 mg GSK3739937 for 14 days.
OG003
GSK3739937 QD 100 mg
In Cohort 5 of Part 2, participants received once-daily oral dose of 100 mg GSK3739937 for 18 days.
OG004
PBO Once Weekly (QW)
Participants received once weekly oral dose of Placebo for over 3 weeks.
OG005
GSK3739937 QW 500 mg
In Cohort 6 of Part 2, participants received one dose per week of 500 mg GSK3739937 for over 3 weeks.
Units
Counts
Participants
OG0009
OG0017
OG0027
OG003
Title
Denominators
Categories
Occult Blood
Title
Measurements
OG0002
OG0011
OG0023
OG003
Primary
Part 3 - Number of Participants With Abnormal Urinalysis Parameters
Urine samples were collected to detect presence of occult blood and protein through dipstick and random method respectively. The results presented are worst case abnormal urinalysis results post-baseline relative to baseline.
Safety Population. Only those participants with data available at specified time points have been analyzed.
Posted
Count of Participants
Participants
Up to 16 weeks
ID
Title
Description
OG000
GSK3739937 PiB Fed
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 PiB as an oral suspension under moderate fed conditions in each one of the three periods.
OG001
GSK3739937 Tablet Fed
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under moderate fed conditions in each one of the three periods.
OG002
GSK3739937 Tablet Fasted
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under fasted conditions in each one of the three periods.
Units
Counts
Participants
OG00015
OG00117
OG00215
Title
Denominators
Categories
Occult Blood
Title
Measurements
OG0001
OG0011
OG0021
Protein
Primary
Part 1 - Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
Blood pressure (SBP and DBP) was assessed in semi-supine position with a completely automated device. Blood pressure measurement preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline is defined as the average of the triplicate predose assessments within each treatment. Change from Baseline was calculated as post-dose visit value minus Baseline value.
Safety Population. Only those participants with data available at specified time points have been analyzed.
Posted
Mean
Standard Deviation
Millimeters of mercury (mmHg)
Baseline (Day 1, pre-dose) and Day 6
ID
Title
Description
OG000
Placebo (PBO) Single Dose
In Cohort 1 and 2 of Part 1, participants received single oral dose of Placebo.
OG001
GSK3739937 Single Dose (SD) 10 mg
In Cohort 1 of Part 1, participants received single oral dose of 10 mg GSK3739937
OG002
GSK3739937 SD 30 mg
In Cohort 2 of Part 1, participants received single oral dose of 30 mg GSK3739937
OG003
GSK3739937 SD 80 mg
In Cohort 1 of Part 1, participants received single oral dose of 80 mg GSK3739937
OG004
GSK3739937 SD 160 mg
In Cohort 2 of Part 1, participants received single oral dose of 160 mg GSK3739937
OG005
GSK3739937 SD 320 mg
In Cohort 1 of Part 1, participants received single oral dose of 320 mg GSK3739937
OG006
GSK3739937 SD 640 mg
In Cohort 2 of Part 1, participants received single oral dose of 640 mg GSK3739937
OG007
GSK3739937 SD 800 mg
In Cohort 1 of Part 1, participants received single oral dose of 800 mg of GSK3739937
Units
Counts
Participants
OG00018
OG0011
OG0026
OG003
Title
Denominators
Categories
SBP
Title
Measurements
OG0005.3± 7.82
OG0010.5
OG002-0.1± 14.68
OG003
Primary
Part 2 (QD PBO and Cohort 3, 4 and 5) - Change From Baseline in Vital Signs - Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
Blood pressure (SBP and DBP) was assessed in semi-supine position with a completely automated device. Blood pressure measurement preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline is defined as the average of the triplicate predose assessments within each treatment. Change from Baseline was calculated as post-dose visit value minus Baseline value.
Safety Population. Only those participants with data available at specified time points have been analyzed.
Posted
Mean
Standard Deviation
Millimeters of mercury (mmHg)
Baseline (Day 1, pre-dose) and Day 14
ID
Title
Description
OG000
PBO Once Daily (QD)
Participants received once daily doses of placebo for 14 days.
OG001
GSK3739937 QD 25 mg
In Cohort 3 of Part 2, participants received once-daily oral dose of 25 mg GSK3739937 for 14 days.
OG002
GSK3739937 QD 50 mg
In Cohort 4 of Part 2, participants received once-daily oral dose of 50 mg GSK3739937 for 14 days.
OG003
GSK3739937 QD 100 mg
In Cohort 5 of Part 2, participants received once-daily oral dose of 100 mg GSK3739937 for 18 days.
Units
Counts
Participants
OG0009
OG0017
OG0027
OG003
Title
Denominators
Categories
SBP
Title
Measurements
OG000-6.0± 15.26
OG001-2.1± 11.58
OG002-2.1± 5.57
OG003
Primary
Part 2 (QW PBO and Cohort 6) - Change From Baseline in Vital Signs - Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
Blood pressure (SBP and DBP) was assessed in semi-supine position with a completely automated device. Blood pressure measurement preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline is defined as the average of the triplicate predose assessments within each treatment. Change from Baseline was calculated as post-dose visit value minus Baseline value.
Safety Population
Posted
Mean
Standard Deviation
Millimeters of mercury (mmHg)
Baseline (Day 1, pre-dose) and Day 15
ID
Title
Description
OG000
PBO Once Weekly (QW)
Participants received once weekly oral dose of Placebo for over 3 weeks.
OG001
GSK3739937 QW 500 mg
In Cohort 6 of Part 2, participants received one dose per week of 500 mg GSK3739937 for over 3 weeks.
Units
Counts
Participants
OG0003
OG0017
Title
Denominators
Categories
SBP
Title
Measurements
OG0001.0± 11.89
OG0011.5± 5.42
DBP
Title
Measurements
OG000
Primary
Part 3 - Change From Baseline in Vital Signs - Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
Blood pressure (SBP and DBP) was assessed in semi-supine position with a completely automated device. Blood pressure measurement preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline is defined as the average of the triplicate predose assessments within each treatment. Change from Baseline was calculated as post-dose visit value minus Baseline value.
Safety Population
Posted
Mean
Standard Deviation
Millimeters of mercury (mmHg)
Baseline (Day 1, pre-dose) and Day 6
ID
Title
Description
OG000
GSK3739937 PiB Fed
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 PiB as an oral suspension under moderate fed conditions in each one of the three periods.
OG001
GSK3739937 Tablet Fed
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under moderate fed conditions in each one of the three periods.
OG002
GSK3739937 Tablet Fasted
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under fasted conditions in each one of the three periods.
Units
Counts
Participants
OG00015
OG00117
OG00215
Title
Denominators
Categories
SBP
Title
Measurements
OG0006.2± 7.20
OG0013.8± 10.10
OG0029.3± 8.08
DBP
Primary
Part 1 - Change From Baseline in Vital Signs - Pulse Rate
Pulse rate was assessed in semi-supine position with a completely automated device. Pulse rate measurement preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline value is presented and was calculated as post-dose visit value minus Baseline value.
Safety Population. Only those participants with data available at specified time points have been analyzed.
Posted
Mean
Standard Deviation
Beats per minute
Baseline (Day 1, pre-dose) and Day 6
ID
Title
Description
OG000
Placebo (PBO) Single Dose
In Cohort 1 and 2 of Part 1, participants received single oral dose of Placebo.
OG001
GSK3739937 Single Dose (SD) 10 mg
In Cohort 1 of Part 1, participants received single oral dose of 10 mg GSK3739937
OG002
GSK3739937 SD 30 mg
In Cohort 2 of Part 1, participants received single oral dose of 30 mg GSK3739937
OG003
GSK3739937 SD 80 mg
In Cohort 1 of Part 1, participants received single oral dose of 80 mg GSK3739937
OG004
GSK3739937 SD 160 mg
In Cohort 2 of Part 1, participants received single oral dose of 160 mg GSK3739937
OG005
GSK3739937 SD 320 mg
In Cohort 1 of Part 1, participants received single oral dose of 320 mg GSK3739937
OG006
GSK3739937 SD 640 mg
In Cohort 2 of Part 1, participants received single oral dose of 640 mg GSK3739937
OG007
GSK3739937 SD 800 mg
In Cohort 1 of Part 1, participants received single oral dose of 800 mg of GSK3739937
Units
Counts
Participants
OG00018
OG0011
OG0026
OG003
Title
Denominators
Categories
Title
Measurements
OG0001.5± 5.03
OG00115.7
OG0023.5± 7.40
OG003
Primary
Part 2 (QD PBO and Cohort 3, 4 and 5) - Change From Baseline in Vital Signs - Pulse Rate
Pulse rate was assessed in semi-supine position with a completely automated device. Pulse rate measurement preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline value is presented and was calculated as post-dose visit value minus Baseline value.
Safety Population. Only those participants with data available at specified time points have been analyzed.
Posted
Mean
Standard Deviation
Beats per minute
Baseline (Day 1, pre-dose) and Day 14
ID
Title
Description
OG000
PBO Once Daily (QD)
Participants received once daily doses of placebo for 14 days.
OG001
GSK3739937 QD 25 mg
In Cohort 3 of Part 2, participants received once-daily oral dose of 25 mg GSK3739937 for 14 days.
OG002
GSK3739937 QD 50 mg
In Cohort 4 of Part 2, participants received once-daily oral dose of 50 mg GSK3739937 for 14 days.
OG003
GSK3739937 QD 100 mg
In Cohort 5 of Part 2, participants received once-daily oral dose of 100 mg GSK3739937 for 18 days.
Units
Counts
Participants
OG0009
OG0017
OG0027
OG003
Title
Denominators
Categories
Title
Measurements
OG0001.1± 4.59
OG001-2.8± 4.98
OG0025.0± 5.49
OG003
Primary
Part 2 (QW PBO and Cohort 6) - Change From Baseline in Vital Signs - Pulse Rate
Pulse rate was assessed in semi-supine position with a completely automated device. Pulse rate measurement preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline value is presented and was calculated as post-dose visit value minus Baseline value.
Safety Population
Posted
Mean
Standard Deviation
Beats per minute
Baseline (Day 1, pre-dose) and Day 15
ID
Title
Description
OG000
PBO Once Weekly (QW)
Participants received once weekly oral dose of Placebo for over 3 weeks.
OG001
GSK3739937 QW 500 mg
In Cohort 6 of Part 2, participants received one dose per week of 500 mg GSK3739937 for over 3 weeks.
Units
Counts
Participants
OG0003
OG0017
Title
Denominators
Categories
Title
Measurements
OG0000.9± 1.60
OG0015.2± 5.29
Primary
Part 3 - Change From Baseline in Vital Signs - Pulse Rate
Pulse rate was assessed in semi-supine position with a completely automated device. Pulse rate measurement preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline value is presented and was calculated as post-dose visit value minus Baseline value.
Safety Population
Posted
Mean
Standard Deviation
Beats per minute
Baseline (Day 1, pre-dose) and Day 6
ID
Title
Description
OG000
GSK3739937 PiB Fed
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 PiB as an oral suspension under moderate fed conditions in each one of the three periods.
OG001
GSK3739937 Tablet Fed
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under moderate fed conditions in each one of the three periods.
OG002
GSK3739937 Tablet Fasted
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under fasted conditions in each one of the three periods.
Units
Counts
Participants
OG00015
OG00117
OG00215
Title
Denominators
Categories
Title
Measurements
OG0006.2± 6.80
OG0017.4± 4.98
OG0026.6± 5.48
Primary
Part 1 - Change From Baseline in Vital Signs - Body Temperature
Temperature was assessed in the semi-recumbent position with a completely automated device, preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline value is presented and was calculated as post-dose visit value minus Baseline value.
Safety Population. Only those participants with data available at specified time points have been analyzed.
Posted
Mean
Standard Deviation
Degrees Celsius
Baseline (Day 1, pre-dose) and Day 6
ID
Title
Description
OG000
Placebo (PBO) Single Dose
In Cohort 1 and 2 of Part 1, participants received single oral dose of Placebo.
OG001
GSK3739937 Single Dose (SD) 10 mg
In Cohort 1 of Part 1, participants received single oral dose of 10 mg GSK3739937
OG002
GSK3739937 SD 30 mg
In Cohort 2 of Part 1, participants received single oral dose of 30 mg GSK3739937
OG003
GSK3739937 SD 80 mg
In Cohort 1 of Part 1, participants received single oral dose of 80 mg GSK3739937
OG004
GSK3739937 SD 160 mg
In Cohort 2 of Part 1, participants received single oral dose of 160 mg GSK3739937
OG005
GSK3739937 SD 320 mg
In Cohort 1 of Part 1, participants received single oral dose of 320 mg GSK3739937
OG006
GSK3739937 SD 640 mg
In Cohort 2 of Part 1, participants received single oral dose of 640 mg GSK3739937
OG007
GSK3739937 SD 800 mg
In Cohort 1 of Part 1, participants received single oral dose of 800 mg of GSK3739937
Units
Counts
Participants
OG00018
OG0011
OG0026
OG003
Title
Denominators
Categories
Title
Measurements
OG000-0.06± 0.320
OG001-0.10
OG0020.12± 0.248
OG003
Primary
Part 2 (QD PBO and Cohort 3, 4 and 5) - Change From Baseline in Vital Signs - Body Temperature
Body temperature were assessed at indicated time-points. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline value is presented and was calculated as post-dose visit value minus Baseline value.
Safety Population. Only those participants with data available at specified time points have been analyzed.
Posted
Mean
Standard Deviation
Degrees Celsius
Baseline (Day 1, pre-dose) and Day 14
ID
Title
Description
OG000
PBO Once Daily (QD)
Participants received once daily doses of placebo for 14 days.
OG001
GSK3739937 QD 25 mg
In Cohort 3 of Part 2, participants received once-daily oral dose of 25 mg GSK3739937 for 14 days.
OG002
GSK3739937 QD 50 mg
In Cohort 4 of Part 2, participants received once-daily oral dose of 50 mg GSK3739937 for 14 days.
OG003
GSK3739937 QD 100 mg
In Cohort 5 of Part 2, participants received once-daily oral dose of 100 mg GSK3739937 for 18 days.
Units
Counts
Participants
OG0009
OG0017
OG0027
OG003
Title
Denominators
Categories
Title
Measurements
OG0000.16± 0.283
OG001-0.07± 0.170
OG0020.09± 0.135
OG003
Primary
Part 2 (QW PBO and Cohort 6) - Change From Baseline in Vital Signs - Body Temperature
Body temperature were assessed at indicated time-points. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline value is presented and was calculated as post-dose visit value minus Baseline value.
Safety Population
Posted
Mean
Standard Deviation
Degrees Celsius
Baseline (Day 1, pre-dose) and Day 15
ID
Title
Description
OG000
PBO Once Weekly (QW)
Participants received once weekly oral dose of Placebo for over 3 weeks.
OG001
GSK3739937 QW 500 mg
In Cohort 6 of Part 2, participants received one dose per week of 500 mg GSK3739937 for over 3 weeks.
Units
Counts
Participants
OG0003
OG0017
Title
Denominators
Categories
Title
Measurements
OG000-0.07± 0.153
OG001-0.06± 0.113
Primary
Part 3 - Change From Baseline in Vital Signs - Body Temperature
Body temperature were assessed at indicated time-points. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline value is presented and was calculated as post-dose visit value minus Baseline value.
Safety Population
Posted
Mean
Standard Deviation
Degrees Celsius
Baseline (Day 1, pre-dose) and Day 6
ID
Title
Description
OG000
GSK3739937 PiB Fed
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 PiB as an oral suspension under moderate fed conditions in each one of the three periods.
OG001
GSK3739937 Tablet Fed
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under moderate fed conditions in each one of the three periods.
OG002
GSK3739937 Tablet Fasted
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under fasted conditions in each one of the three periods.
Units
Counts
Participants
OG00015
OG00117
OG00215
Title
Denominators
Categories
Title
Measurements
OG0000.08± 0.231
OG0010.06± 0.237
OG0020.15± 0.233
Primary
Part 1 - Change From Baseline in Vital Signs - Respiratory Rate
Respiratory rate was assessed in the semi-recumbent position with a completely automated device, preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline value is presented and was calculated as post-dose visit value minus Baseline value.
Safety Population. Only those participants with data available at specified time points have been analyzed.
Posted
Mean
Standard Deviation
Breaths per minute
Baseline (Day 1, pre-dose) and Day 6
ID
Title
Description
OG000
Placebo (PBO) Single Dose
In Cohort 1 and 2 of Part 1, participants received single oral dose of Placebo.
OG001
GSK3739937 Single Dose (SD) 10 mg
In Cohort 1 of Part 1, participants received single oral dose of 10 mg GSK3739937
OG002
GSK3739937 SD 30 mg
In Cohort 2 of Part 1, participants received single oral dose of 30 mg GSK3739937
OG003
GSK3739937 SD 80 mg
In Cohort 1 of Part 1, participants received single oral dose of 80 mg GSK3739937
OG004
GSK3739937 SD 160 mg
In Cohort 2 of Part 1, participants received single oral dose of 160 mg GSK3739937
OG005
GSK3739937 SD 320 mg
In Cohort 1 of Part 1, participants received single oral dose of 320 mg GSK3739937
OG006
GSK3739937 SD 640 mg
In Cohort 2 of Part 1, participants received single oral dose of 640 mg GSK3739937
OG007
GSK3739937 SD 800 mg
In Cohort 1 of Part 1, participants received single oral dose of 800 mg of GSK3739937
Units
Counts
Participants
OG00021
OG0011
OG0026
OG003
Title
Denominators
Categories
Title
Measurements
OG0000.7± 2.97
OG001-5.0
OG002-3.0± 1.41
OG003
Primary
Part 2 (QD PBO and Cohort 3, 4 and 5) - Change From Baseline in Vital Signs - Respiratory Rate
Respiratory rate was assessed in the semi-recumbent position with a completely automated device, preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline value is presented and was calculated as post-dose visit value minus Baseline value.
Safety Population. Only those participants with data available at specified time points have been analyzed.
Posted
Mean
Standard Deviation
Breaths per minute
Baseline (Day 1, pre-dose) and Day 14
ID
Title
Description
OG000
PBO Once Daily (QD)
Participants received once daily doses of placebo for 14 days.
OG001
GSK3739937 QD 25 mg
In Cohort 3 of Part 2, participants received once-daily oral dose of 25 mg GSK3739937 for 14 days.
OG002
GSK3739937 QD 50 mg
In Cohort 4 of Part 2, participants received once-daily oral dose of 50 mg GSK3739937 for 14 days.
OG003
GSK3739937 QD 100 mg
In Cohort 5 of Part 2, participants received once-daily oral dose of 100 mg GSK3739937 for 18 days.
Units
Counts
Participants
OG0009
OG0017
OG0027
OG003
Title
Denominators
Categories
Title
Measurements
OG000-0.4± 2.19
OG001-3.4± 1.51
OG0020.0± 1.63
OG003
Primary
Part 2 (QW PBO and Cohort 6) - Change From Baseline in Vital Signs - Respiratory Rate
Respiratory rate was assessed in the semi-recumbent position with a completely automated device, preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline value is presented and was calculated as post-dose visit value minus Baseline value.
Safety Population. Only those participants with data available at specified time points have been analyzed.
Posted
Mean
Standard Deviation
Breaths per minute
Baseline (Day 1, pre-dose) and Day 15
ID
Title
Description
OG000
PBO Once Weekly (QW)
Participants received once weekly oral dose of Placebo for over 3 weeks.
OG001
GSK3739937 QW 500 mg
In Cohort 6 of Part 2, participants received one dose per week of 500 mg GSK3739937 for over 3 weeks.
Units
Counts
Participants
OG0003
OG0017
Title
Denominators
Categories
Title
Measurements
OG0000.0± 2.00
OG001-1.4± 2.23
Primary
Part 3 - Change From Baseline in Vital Signs - Respiratory Rate
Respiratory rate was assessed in the semi-recumbent position with a completely automated device, preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline value is presented and was calculated as post-dose visit value minus Baseline value.
Safety Population
Posted
Mean
Standard Deviation
Breaths per minute
Baseline (Day 1, pre-dose) and Day 6
ID
Title
Description
OG000
GSK3739937 PiB Fed
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 PiB as an oral suspension under moderate fed conditions in each one of the three periods.
OG001
GSK3739937 Tablet Fed
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under moderate fed conditions in each one of the three periods.
OG002
GSK3739937 Tablet Fasted
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under fasted conditions in each one of the three periods.
Units
Counts
Participants
OG00015
OG00117
OG00215
Title
Denominators
Categories
Title
Measurements
OG0000.4± 2.03
OG001-0.3± 2.31
OG0021.2± 2.24
Primary
Part 1 - Number of Participants With Worst Case Post-Baseline Electrocardiogram (ECG) Findings
Twelve lead ECGs were obtained using an ECG machine that automatically calculated the heart rate and measured PR, QRS, QT, and QT interval corrected using the Fridericia's formula (QTcF) intervals. ECG findings were categorized as Normal, Abnormal clinically significant (CS) and Abnormal not clinically significant (NCS). Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. Data for number of participants with worst case post-Baseline ECG findings have been presented.
Safety Population
Posted
Count of Participants
Participants
Up to 27 weeks
ID
Title
Description
OG000
Placebo (PBO) Single Dose
In Cohort 1 and 2 of Part 1, participants received single oral dose of Placebo.
OG001
GSK3739937 Single Dose (SD) 10 mg
In Cohort 1 of Part 1, participants received single oral dose of 10 mg GSK3739937
OG002
GSK3739937 SD 30 mg
In Cohort 2 of Part 1, participants received single oral dose of 30 mg GSK3739937
OG003
GSK3739937 SD 80 mg
In Cohort 1 of Part 1, participants received single oral dose of 80 mg GSK3739937
OG004
GSK3739937 SD 160 mg
In Cohort 2 of Part 1, participants received single oral dose of 160 mg GSK3739937
OG005
GSK3739937 SD 320 mg
In Cohort 1 of Part 1, participants received single oral dose of 320 mg GSK3739937
OG006
GSK3739937 SD 640 mg
In Cohort 2 of Part 1, participants received single oral dose of 640 mg GSK3739937
OG007
GSK3739937 SD 800 mg
In Cohort 1 of Part 1, participants received single oral dose of 800 mg of GSK3739937
Units
Counts
Participants
OG00021
OG0016
OG0026
OG003
Title
Denominators
Categories
Normal
Title
Measurements
OG0001
OG0012
OG0020
OG003
Primary
Part 2 - Number of Participants With Worst Case Post-Baseline ECG Findings
Twelve lead ECGs were obtained using an ECG machine that automatically calculated the heart rate and measured PR, QRS, QT, and QT interval corrected using the Fridericia's formula (QTcF) intervals. ECG findings were categorized as Normal, Abnormal clinically significant (CS) and Abnormal not clinically significant (NCS). Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. Data for number of participants with worst case post-Baseline ECG findings have been presented.
Safety Population
Posted
Count of Participants
Participants
Up to 5 weeks
ID
Title
Description
OG000
PBO Once Daily (QD)
Participants received once daily doses of placebo for 14 days.
OG001
GSK3739937 QD 25 mg
In Cohort 3 of Part 2, participants received once-daily oral dose of 25 mg GSK3739937 for 14 days.
OG002
GSK3739937 QD 50 mg
In Cohort 4 of Part 2, participants received once-daily oral dose of 50 mg GSK3739937 for 14 days.
OG003
GSK3739937 QD 100 mg
In Cohort 5 of Part 2, participants received once-daily oral dose of 100 mg GSK3739937 for 18 days.
OG004
PBO Once Weekly (QW)
Participants received once weekly oral dose of Placebo for over 3 weeks.
OG005
GSK3739937 QW 500 mg
In Cohort 6 of Part 2, participants received one dose per week of 500 mg GSK3739937 for over 3 weeks.
Units
Counts
Participants
OG0009
OG0017
OG0027
OG003
Title
Denominators
Categories
Normal
Title
Measurements
OG0000
OG0010
OG0020
OG003
Primary
Part 3 - Number of Participants With Worst Case Post-Baseline ECG Findings
Twelve lead ECGs were obtained using an ECG machine that automatically calculated the heart rate and measured PR, QRS, QT, and QT interval corrected using the Fridericia's formula (QTcF) intervals. ECG findings were categorized as Normal, Abnormal clinically significant (CS) and Abnormal not clinically significant (NCS). Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. Data for number of participants with worst case post-Baseline ECG findings have been presented.
Safety Population
Posted
Count of Participants
Participants
Up to 16 weeks
ID
Title
Description
OG000
GSK3739937 PiB Fed
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 PiB as an oral suspension under moderate fed conditions in each one of the three periods.
OG001
GSK3739937 Tablet Fed
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under moderate fed conditions in each one of the three periods.
OG002
GSK3739937 Tablet Fasted
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under fasted conditions in each one of the three periods.
Units
Counts
Participants
OG00015
OG00117
OG00215
Title
Denominators
Categories
Normal
Title
Measurements
OG0001
OG0011
OG0021
Abnormal - Not Clinically Significant
Primary
Part 3 - Area Under the Plasma Concentration Time Curve (AUC) From Zero to 24 Hours (AUC[0-24]) of GSK3739937
Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis of GSK3739937. PK parameters were analyzed using standard non-compartmental analysis.
Pharmacokinetic (PK) Population: The PK Population included all participants who undergo plasma or urine PK sampling and have evaluable PK assay results. Only those participants with data available at specified time points have been analyzed.
Posted
Geometric Mean
Geometric Coefficient of Variation
Hour*nanogram/ millilitre (h*ng/mL)
Pre-dose, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 12, 16 and 24 hours post-dose in each treatment period
ID
Title
Description
OG000
GSK3739937 PiB Fed
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 PiB as an oral suspension under moderate fed conditions in each one of the three periods.
OG001
GSK3739937 Tablet Fed
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under moderate fed conditions in each one of the three periods.
OG002
GSK3739937 Tablet Fasted
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under fasted conditions in each one of the three periods.
Units
Counts
Participants
OG00015
OG00116
OG00215
Title
Denominators
Categories
Title
Measurements
OG0006455.362± 25
OG0018646.757± 33.9
OG0023522.969± 91
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG001
OG002
The mixed model was used to estimate Food Effect for the log transformed parameter AUC (0-24). Analysis was performed using fed/ fasted state and tablet/ PiB as fixed effects and participant as a random effect.
Mixed Models Analysis
Geometric Least Square Mean Ratio
2.462
2-Sided
90
1.823
3.323
Other
OG000
OG001
Primary
Part 3 - AUC From Time Zero (Pre-dose) Extrapolated to Infinite Time (AUC[0-inf]) of GSK3739937
Blood samples were collected at indicated time points for PK analysis of GSK3739937. PK parameters were analyzed using standard non-compartmental analysis.
Pharmacokinetic Population. Only those participants with data available at specified time points have been analyzed.
Posted
Geometric Mean
Geometric Coefficient of Variation
h*ng/mL
Pre-dose (within 15 minutes prior to dosing) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 16, 24, 48, 72, 96, 120, 192, 264, and 360 hours post-dose in each treatment period
ID
Title
Description
OG000
GSK3739937 PiB Fed
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 PiB as an oral suspension under moderate fed conditions in each one of the three periods.
OG001
GSK3739937 Tablet Fed
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under moderate fed conditions in each one of the three periods.
OG002
GSK3739937 Tablet Fasted
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under fasted conditions in each one of the three periods.
Units
Counts
Participants
OG00015
OG00115
OG00215
Title
Denominators
Categories
Title
Measurements
OG00043323.02± 27.3
OG00158892.29± 23.6
OG00227326.99± 64
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG001
OG002
The mixed model was used to estimate Food Effect for the log transformed parameter AUC (0-inf). Analysis was performed using fed/ fasted state and tablet/ PiB as fixed effects and participant as a random effect.
Mixed Models Analysis
Geometric Least Square Mean Ratio
2.103
2-Sided
90
1.629
2.717
Other
OG000
OG001
Primary
Part 3 - Maximum Observed Concentration (Cmax) of GSK3739937
Blood samples were collected at indicated time points for PK analysis of GSK3739937. PK parameters were analyzed using standard non-compartmental analysis.
Pharmacokinetic Population. Only those participants with data available at specified time points have been analyzed.
Posted
Geometric Mean
Geometric Coefficient of Variation
nanogram per millilitre (ng/mL)
Pre-dose (within 15 minutes prior to dosing) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 16, 24, 48, 72, 96, 120, 192, 264, and 360 hours post-dose in each treatment period
ID
Title
Description
OG000
GSK3739937 PiB Fed
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 PiB as an oral suspension under moderate fed conditions in each one of the three periods.
OG001
GSK3739937 Tablet Fed
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under moderate fed conditions in each one of the three periods.
OG002
GSK3739937 Tablet Fasted
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under fasted conditions in each one of the three periods.
Units
Counts
Participants
OG00015
OG00116
OG00215
Title
Denominators
Categories
Title
Measurements
OG000389.81± 23.4
OG001524.99± 31.8
OG002227.88± 93.5
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG001
OG002
The mixed model was used to estimate Food Effect for the log transformed parameter Cmax. Analysis was performed using fed/ fasted state and tablet/ PiB as fixed effects and participant as a random effect.
Mixed Models Analysis
Geometric Least Square Mean Ratio
2.307
2-Sided
90
1.668
3.19
Other
OG000
OG001
Secondary
Part 1 (Cohort 1 and 2) - AUC(0-24) of GSK3739937
Blood samples were collected at indicated time points for PK analysis of GSK3739937. PK parameters were analyzed using standard non-compartmental analysis.
Pharmacokinetic Population
Posted
Geometric Mean
Geometric Coefficient of Variation
h*ng/mL
Pre-dose (within 15 minutes prior to dosing) and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12 and 24 hours post-dose in each treatment period
ID
Title
Description
OG000
GSK3739937 Single Dose (SD) 10 mg
In Cohort 1 of Part 1, participants received single oral dose of 10 mg GSK3739937
OG001
GSK3739937 SD 30 mg
In Cohort 2 of Part 1, participants received single oral dose of 30 mg GSK3739937
OG002
GSK3739937 SD 80 mg
In Cohort 1 of Part 1, participants received single oral dose of 80 mg GSK3739937
OG003
GSK3739937 SD 160 mg
In Cohort 2 of Part 1, participants received single oral dose of 160 mg GSK3739937
OG004
GSK3739937 SD 320 mg
In Cohort 1 of Part 1, participants received single oral dose of 320 mg GSK3739937
OG005
GSK3739937 SD 640 mg
In Cohort 2 of Part 1, participants received single oral dose of 640 mg GSK3739937
OG006
GSK3739937 SD 800 mg
In Cohort 1 of Part 1, participants received single oral dose of 800 mg of GSK3739937
Units
Counts
Participants
OG0006
OG0016
OG0026
OG003
Title
Denominators
Categories
Title
Measurements
OG000637.8486± 38.8
OG0011976.944± 24.3
OG0025027.183± 27.4
OG003
Secondary
Part 1 (Cohort 1 and 2) - AUC From Zero (Pre-dose) to Time of the Last Quantifiable Concentration (t) (AUC [0-t]) of GSK3739937
Blood samples were collected at indicated time points for PK analysis of GSK3739937. PK parameters were analyzed using standard non-compartmental analysis.
Pharmacokinetic Population
Posted
Geometric Mean
Geometric Coefficient of Variation
h*ng/mL
Pre-dose (within 15 minutes prior to dosing) and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72, 96, 120, 192, 264 and 360 hours post-dose in each treatment period
ID
Title
Description
OG000
GSK3739937 Single Dose (SD) 10 mg
In Cohort 1 of Part 1, participants received single oral dose of 10 mg GSK3739937
OG001
GSK3739937 SD 30 mg
In Cohort 2 of Part 1, participants received single oral dose of 30 mg GSK3739937
OG002
GSK3739937 SD 80 mg
In Cohort 1 of Part 1, participants received single oral dose of 80 mg GSK3739937
OG003
GSK3739937 SD 160 mg
In Cohort 2 of Part 1, participants received single oral dose of 160 mg GSK3739937
OG004
GSK3739937 SD 320 mg
In Cohort 1 of Part 1, participants received single oral dose of 320 mg GSK3739937
OG005
GSK3739937 SD 640 mg
In Cohort 2 of Part 1, participants received single oral dose of 640 mg GSK3739937
OG006
GSK3739937 SD 800 mg
In Cohort 1 of Part 1, participants received single oral dose of 800 mg of GSK3739937
Units
Counts
Participants
OG0006
OG0016
OG0026
OG003
Title
Denominators
Categories
Title
Measurements
OG0002486.061± 46.4
OG00111441.28± 31.5
OG00233650.11± 42.5
OG003
Secondary
Part 1 (Cohort 1 and 2) - AUC(0-inf) of GSK3739937
Blood samples were collected at indicated time points for PK analysis of GSK3739937. PK parameters were analyzed using standard non-compartmental analysis.
Pharmacokinetic Population. Only those participants with data available at specified time points have been analyzed.
Posted
Geometric Mean
Geometric Coefficient of Variation
h*ng/mL
Pre-dose (within 15 minutes prior to dosing) and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72, 96, 120, 192, 264 and 360 hours post-dose in each treatment period
ID
Title
Description
OG000
GSK3739937 Single Dose (SD) 10 mg
In Cohort 1 of Part 1, participants received single oral dose of 10 mg GSK3739937
OG001
GSK3739937 SD 30 mg
In Cohort 2 of Part 1, participants received single oral dose of 30 mg GSK3739937
OG002
GSK3739937 SD 80 mg
In Cohort 1 of Part 1, participants received single oral dose of 80 mg GSK3739937
OG003
GSK3739937 SD 160 mg
In Cohort 2 of Part 1, participants received single oral dose of 160 mg GSK3739937
OG004
GSK3739937 SD 320 mg
In Cohort 1 of Part 1, participants received single oral dose of 320 mg GSK3739937
OG005
GSK3739937 SD 640 mg
In Cohort 2 of Part 1, participants received single oral dose of 640 mg GSK3739937
OG006
GSK3739937 SD 800 mg
In Cohort 1 of Part 1, participants received single oral dose of 800 mg of GSK3739937
Units
Counts
Participants
OG0006
OG0015
OG0024
OG003
Title
Denominators
Categories
Title
Measurements
OG000NA± NA'NA' refers to not quantifiable as the GSK3739937 concentration was below the lower limit of quantification (10 ng/mL)
OG00112788.34± 32.4
OG00240287.05
Secondary
Part 1 (Cohort 1 and 2) - Apparent Terminal Phase Half-life (T1/2) of GSK3739937
Blood samples were collected at indicated time points for PK analysis of GSK3739937. PK parameters were analyzed using standard non-compartmental analysis.
Pharmacokinetic Population. Only those participants with data available at specified time points have been analyzed.
Posted
Geometric Mean
Geometric Coefficient of Variation
Hours
Pre-dose (within 15 minutes prior to dosing) and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72, 96, 120, 192, 264 and 360 hours post-dose in each treatment period
ID
Title
Description
OG000
GSK3739937 Single Dose (SD) 10 mg
In Cohort 1 of Part 1, participants received single oral dose of 10 mg GSK3739937
OG001
GSK3739937 SD 30 mg
In Cohort 2 of Part 1, participants received single oral dose of 30 mg GSK3739937
OG002
GSK3739937 SD 80 mg
In Cohort 1 of Part 1, participants received single oral dose of 80 mg GSK3739937
OG003
GSK3739937 SD 160 mg
In Cohort 2 of Part 1, participants received single oral dose of 160 mg GSK3739937
OG004
GSK3739937 SD 320 mg
In Cohort 1 of Part 1, participants received single oral dose of 320 mg GSK3739937
OG005
GSK3739937 SD 640 mg
In Cohort 2 of Part 1, participants received single oral dose of 640 mg GSK3739937
OG006
GSK3739937 SD 800 mg
In Cohort 1 of Part 1, participants received single oral dose of 800 mg of GSK3739937
Units
Counts
Participants
OG0006
OG0015
OG0024
OG003
Title
Denominators
Categories
Title
Measurements
OG000NA± NA'NA' refers to not quantifiable as the GSK3739937 concentration was below the lower limit of quantification (10 ng/mL)
OG00175.8706± 7.4
OG00279.0711
Secondary
Part 1 (Cohort 1 and 2) - Apparent Oral Clearance (CL/F) of GSK3739937
Blood samples were collected at indicated time points for PK analysis of GSK3739937. PK parameters were analyzed using standard non-compartmental analysis.
Pharmacokinetic Population. Only those participants with data available at specified time points have been analyzed.
Posted
Geometric Mean
Geometric Coefficient of Variation
litre/ hour (L/h)
Pre-dose (within 15 minutes prior to dosing) and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72, 96, 120, 192, 264 and 360 hours post-dose in each treatment period
ID
Title
Description
OG000
GSK3739937 Single Dose (SD) 10 mg
In Cohort 1 of Part 1, participants received single oral dose of 10 mg GSK3739937
OG001
GSK3739937 SD 30 mg
In Cohort 2 of Part 1, participants received single oral dose of 30 mg GSK3739937
OG002
GSK3739937 SD 80 mg
In Cohort 1 of Part 1, participants received single oral dose of 80 mg GSK3739937
OG003
GSK3739937 SD 160 mg
In Cohort 2 of Part 1, participants received single oral dose of 160 mg GSK3739937
OG004
GSK3739937 SD 320 mg
In Cohort 1 of Part 1, participants received single oral dose of 320 mg GSK3739937
OG005
GSK3739937 SD 640 mg
In Cohort 2 of Part 1, participants received single oral dose of 640 mg GSK3739937
OG006
GSK3739937 SD 800 mg
In Cohort 1 of Part 1, participants received single oral dose of 800 mg of GSK3739937
Units
Counts
Participants
OG0006
OG0015
OG0024
OG003
Title
Denominators
Categories
Title
Measurements
OG000NA± NA'NA' refers to not quantifiable as the GSK3739937 concentration was below the lower limit of quantification (10 ng/mL)
OG0012.3459± 32.4
OG0021.9857
Secondary
Part 1 (Cohort 1 and 2) - Cmax of GSK3739937
Blood samples were collected at indicated time points for PK analysis of GSK3739937. PK parameters were analyzed using standard non-compartmental analysis.
Pharmacokinetic Population
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/mL
Pre-dose (within 15 minutes prior to dosing) and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72, 96, 120, 192, 264 and 360 hours post-dose in each treatment period
ID
Title
Description
OG000
GSK3739937 Single Dose (SD) 10 mg
In Cohort 1 of Part 1, participants received single oral dose of 10 mg GSK3739937
OG001
GSK3739937 SD 30 mg
In Cohort 2 of Part 1, participants received single oral dose of 30 mg GSK3739937
OG002
GSK3739937 SD 80 mg
In Cohort 1 of Part 1, participants received single oral dose of 80 mg GSK3739937
OG003
GSK3739937 SD 160 mg
In Cohort 2 of Part 1, participants received single oral dose of 160 mg GSK3739937
OG004
GSK3739937 SD 320 mg
In Cohort 1 of Part 1, participants received single oral dose of 320 mg GSK3739937
OG005
GSK3739937 SD 640 mg
In Cohort 2 of Part 1, participants received single oral dose of 640 mg GSK3739937
OG006
GSK3739937 SD 800 mg
In Cohort 1 of Part 1, participants received single oral dose of 800 mg of GSK3739937
Units
Counts
Participants
OG0006
OG0016
OG0026
OG003
Title
Denominators
Categories
Title
Measurements
OG00039.22± 41.6
OG001127.3± 22.9
OG002310.43± 21
OG003
Secondary
Part 1 (Cohort 1 and 2) - Concentration of GSK3739937 at 24 Hours (C24) of GSK3739937
Blood samples were collected at indicated time points for PK analysis of GSK3739937. PK parameters were analyzed using standard non-compartmental analysis.
Pharmacokinetic Population
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/mL
Pre-dose, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 12, 16 and 24 hours post-dose in each treatment period
ID
Title
Description
OG000
GSK3739937 Single Dose (SD) 10 mg
In Cohort 1 of Part 1, participants received single oral dose of 10 mg GSK3739937
OG001
GSK3739937 SD 30 mg
In Cohort 2 of Part 1, participants received single oral dose of 30 mg GSK3739937
OG002
GSK3739937 SD 80 mg
In Cohort 1 of Part 1, participants received single oral dose of 80 mg GSK3739937
OG003
GSK3739937 SD 160 mg
In Cohort 2 of Part 1, participants received single oral dose of 160 mg GSK3739937
OG004
GSK3739937 SD 320 mg
In Cohort 1 of Part 1, participants received single oral dose of 320 mg GSK3739937
OG005
GSK3739937 SD 640 mg
In Cohort 2 of Part 1, participants received single oral dose of 640 mg GSK3739937
OG006
GSK3739937 SD 800 mg
In Cohort 1 of Part 1, participants received single oral dose of 800 mg of GSK3739937
Units
Counts
Participants
OG0006
OG0016
OG0026
OG003
Title
Denominators
Categories
Title
Measurements
OG00029.46± 37.9
OG00185.3± 25.9
OG002247.73± 40
OG003
Secondary
Part 1 (Cohort 1 and 2) - Last Quantifiable Concentration (Clast) of GSK3739937
Blood samples were collected at indicated time points for PK analysis of GSK3739937. PK parameters were analyzed using standard non-compartmental analysis.
Pharmacokinetic Population
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/mL
Pre-dose (within 15 minutes prior to dosing) and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72, 96, 120, 192, 264 and 360 hours post-dose in each treatment period
ID
Title
Description
OG000
GSK3739937 Single Dose (SD) 10 mg
In Cohort 1 of Part 1, participants received single oral dose of 10 mg GSK3739937
OG001
GSK3739937 SD 30 mg
In Cohort 2 of Part 1, participants received single oral dose of 30 mg GSK3739937
OG002
GSK3739937 SD 80 mg
In Cohort 1 of Part 1, participants received single oral dose of 80 mg GSK3739937
OG003
GSK3739937 SD 160 mg
In Cohort 2 of Part 1, participants received single oral dose of 160 mg GSK3739937
OG004
GSK3739937 SD 320 mg
In Cohort 1 of Part 1, participants received single oral dose of 320 mg GSK3739937
OG005
GSK3739937 SD 640 mg
In Cohort 2 of Part 1, participants received single oral dose of 640 mg GSK3739937
OG006
GSK3739937 SD 800 mg
In Cohort 1 of Part 1, participants received single oral dose of 800 mg of GSK3739937
Units
Counts
Participants
OG0006
OG0016
OG0026
OG003
Title
Denominators
Categories
Title
Measurements
OG00015.09± 31.1
OG00114.41± 23.7
OG00218.24± 54.1
OG003
Secondary
Part 1 (Cohort 1 and 2 ) - Time of Occurrence of Cmax (Tmax) of GSK3739937
Blood samples were collected at indicated time points for PK analysis of GSK3739937. PK parameters were analyzed using standard non-compartmental analysis.
Pharmacokinetic Population
Posted
Median
Full Range
Hours
Pre-dose (within 15 minutes prior to dosing) and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72, 96, 120, 192, 264 and 360 hours post-dose in each treatment period
ID
Title
Description
OG000
GSK3739937 Single Dose (SD) 10 mg
In Cohort 1 of Part 1, participants received single oral dose of 10 mg GSK3739937
OG001
GSK3739937 SD 30 mg
In Cohort 2 of Part 1, participants received single oral dose of 30 mg GSK3739937
OG002
GSK3739937 SD 80 mg
In Cohort 1 of Part 1, participants received single oral dose of 80 mg GSK3739937
OG003
GSK3739937 SD 160 mg
In Cohort 2 of Part 1, participants received single oral dose of 160 mg GSK3739937
OG004
GSK3739937 SD 320 mg
In Cohort 1 of Part 1, participants received single oral dose of 320 mg GSK3739937
OG005
GSK3739937 SD 640 mg
In Cohort 2 of Part 1, participants received single oral dose of 640 mg GSK3739937
OG006
GSK3739937 SD 800 mg
In Cohort 1 of Part 1, participants received single oral dose of 800 mg of GSK3739937
Units
Counts
Participants
OG0006
OG0016
OG0026
OG003
Title
Denominators
Categories
Title
Measurements
OG0006.98(6 to 8)
OG0018(5 to 12.1)
OG0027.98(5 to 24.1)
OG003
Secondary
Part 1 (Cohort 1 and 2) - Lag Time (Tlag) of GSK3739937
Blood samples were collected at indicated time points for PK analysis of GSK3739937. PK parameters were analyzed using standard non-compartmental analysis.
Pharmacokinetic Population
Posted
Median
Full Range
Hours
Pre-dose (within 15 minutes prior to dosing) and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72, 96, 120, 192, 264 and 360 hours post-dose in each treatment period
ID
Title
Description
OG000
GSK3739937 Single Dose (SD) 10 mg
In Cohort 1 of Part 1, participants received single oral dose of 10 mg GSK3739937
OG001
GSK3739937 SD 30 mg
In Cohort 2 of Part 1, participants received single oral dose of 30 mg GSK3739937
OG002
GSK3739937 SD 80 mg
In Cohort 1 of Part 1, participants received single oral dose of 80 mg GSK3739937
OG003
GSK3739937 SD 160 mg
In Cohort 2 of Part 1, participants received single oral dose of 160 mg GSK3739937
OG004
GSK3739937 SD 320 mg
In Cohort 1 of Part 1, participants received single oral dose of 320 mg GSK3739937
OG005
GSK3739937 SD 640 mg
In Cohort 2 of Part 1, participants received single oral dose of 640 mg GSK3739937
OG006
GSK3739937 SD 800 mg
In Cohort 1 of Part 1, participants received single oral dose of 800 mg of GSK3739937
Units
Counts
Participants
OG0006
OG0016
OG0026
OG003
Title
Denominators
Categories
Title
Measurements
OG0003.47(2.5 to 4.6)
OG0011.99(1.5 to 3)
OG0021.23(0.9 to 2)
OG003
Secondary
Part 1 (Cohort 1 and 2) - Time to Reach Clast (Tlast) of GSK3739937
Blood samples were collected at indicated time points for PK analysis of GSK3739937. PK parameters were analyzed using standard non-compartmental analysis
Pharmacokinetic Population
Posted
Median
Full Range
Hours
Pre-dose (within 15 minutes prior to dosing) and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72, 96, 120, 192, 264 and 360 hours post-dose in each treatment period.
ID
Title
Description
OG000
GSK3739937 Single Dose (SD) 10 mg
In Cohort 1 of Part 1, participants received single oral dose of 10 mg GSK3739937
OG001
GSK3739937 SD 30 mg
In Cohort 2 of Part 1, participants received single oral dose of 30 mg GSK3739937
OG002
GSK3739937 SD 80 mg
In Cohort 1 of Part 1, participants received single oral dose of 80 mg GSK3739937
OG003
GSK3739937 SD 160 mg
In Cohort 2 of Part 1, participants received single oral dose of 160 mg GSK3739937
OG004
GSK3739937 SD 320 mg
In Cohort 1 of Part 1, participants received single oral dose of 320 mg GSK3739937
OG005
GSK3739937 SD 640 mg
In Cohort 2 of Part 1, participants received single oral dose of 640 mg GSK3739937
OG006
GSK3739937 SD 800 mg
In Cohort 1 of Part 1, participants received single oral dose of 800 mg of GSK3739937
Units
Counts
Participants
OG0006
OG0016
OG0026
OG003
Title
Denominators
Categories
Title
Measurements
OG00095.7(95.55 to 192.15)
OG001261.967(192.07 to 287.8)
OG002359.967(263.38 to 383.82)
OG003
Secondary
Part 2 (Cohort 3, 4 and 5) - AUC (0-24) of GSK3739937 on Day 1
Blood samples were collected at indicated time points for PK analysis of GSK3739937. PK parameters were analyzed using standard non-compartmental analysis.
Pharmacokinetic Population
Posted
Geometric Mean
Geometric Coefficient of Variation
h*ng/mL
Pre-dose (within 15 minutes prior to dosing) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12 and 16 hours post-dose on Day 1
ID
Title
Description
OG000
GSK3739937 QD 25 mg
In Cohort 3 of Part 2, participants received once-daily oral dose of 25 mg GSK3739937 for 14 days.
OG001
GSK3739937 QD 50 mg
In Cohort 4 of Part 2, participants received once-daily oral dose of 50 mg GSK3739937 for 14 days.
OG002
GSK3739937 QD 100 mg
In Cohort 5 of Part 2, participants received once-daily oral dose of 100 mg GSK3739937 for 18 days.
Units
Counts
Participants
OG0007
OG0017
OG0027
Title
Denominators
Categories
Title
Measurements
OG0001888.173± 24.6
OG0013559.102± 26.3
OG0025893.917± 54.8
Secondary
Part 2 (Cohort 3, 4 and 5) - Cmax of GSK3739937 on Day 1
Blood samples were collected at indicated time points for PK analysis of GSK3739937. PK parameters were analyzed using standard non-compartmental analysis.
Pharmacokinetic Population
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/mL
Pre-dose (within 15 minutes prior to dosing) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12 and 16 hours post-dose on Day 1
ID
Title
Description
OG000
GSK3739937 QD 25 mg
In Cohort 3 of Part 2, participants received once-daily oral dose of 25 mg GSK3739937 for 14 days.
OG001
GSK3739937 QD 50 mg
In Cohort 4 of Part 2, participants received once-daily oral dose of 50 mg GSK3739937 for 14 days.
OG002
GSK3739937 QD 100 mg
In Cohort 5 of Part 2, participants received once-daily oral dose of 100 mg GSK3739937 for 18 days.
Units
Counts
Participants
OG0007
OG0017
OG0027
Title
Denominators
Categories
Title
Measurements
OG000132.12± 23.3
OG001232.07± 30
OG002375.26± 50.2
Secondary
Part 2 (Cohort 3, 4 and 5) - C24 of GSK3739937 on Day 1
Blood samples were collected at indicated time points for PK analysis of GSK3739937. PK parameters were analyzed using standard non-compartmental analysis.
Pharmacokinetic Population
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/mL
Pre-dose (within 15 minutes prior to dosing) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12 and 16 hours post-dose on Day 1
ID
Title
Description
OG000
GSK3739937 QD 25 mg
In Cohort 3 of Part 2, participants received once-daily oral dose of 25 mg GSK3739937 for 14 days.
OG001
GSK3739937 QD 50 mg
In Cohort 4 of Part 2, participants received once-daily oral dose of 50 mg GSK3739937 for 14 days.
OG002
GSK3739937 QD 100 mg
In Cohort 5 of Part 2, participants received once-daily oral dose of 100 mg GSK3739937 for 18 days.
Units
Counts
Participants
OG0007
OG0017
OG0027
Title
Denominators
Categories
Title
Measurements
OG00089.33± 26.9
OG001188.65± 41.1
OG002271.59± 75.3
Secondary
Part 2 (Cohort 3, 4 and 5) - Tmax of GSK3739937 on Day 1
Blood samples were collected at indicated time points for PK analysis of GSK3739937. PK parameters were analyzed using standard non-compartmental analysis.
Pharmacokinetic Population
Posted
Median
Full Range
Hours
Pre-dose (within 15 minutes prior to dosing) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12 and 16 hours post-dose on Day 1
ID
Title
Description
OG000
GSK3739937 QD 25 mg
In Cohort 3 of Part 2, participants received once-daily oral dose of 25 mg GSK3739937 for 14 days.
OG001
GSK3739937 QD 50 mg
In Cohort 4 of Part 2, participants received once-daily oral dose of 50 mg GSK3739937 for 14 days.
OG002
GSK3739937 QD 100 mg
In Cohort 5 of Part 2, participants received once-daily oral dose of 100 mg GSK3739937 for 18 days.
Units
Counts
Participants
OG0007
OG0017
OG0027
Title
Denominators
Categories
Title
Measurements
OG0009(6 to 16)
OG0018(7 to 23.8)
OG0029(6 to 23.8)
Secondary
Part 2 (Cohort 3, 4 and 5) - Tlag of GSK3739937 on Day 1
Blood samples were collected at indicated time points for PK analysis of GSK3739937. PK parameters were analyzed using standard non-compartmental analysis.
Pharmacokinetic Population
Posted
Median
Full Range
Hours
Pre-dose (within 15 minutes prior to dosing) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12 and 16 hours post-dose on Day 1
ID
Title
Description
OG000
GSK3739937 QD 25 mg
In Cohort 3 of Part 2, participants received once-daily oral dose of 25 mg GSK3739937 for 14 days.
OG001
GSK3739937 QD 50 mg
In Cohort 4 of Part 2, participants received once-daily oral dose of 50 mg GSK3739937 for 14 days.
OG002
GSK3739937 QD 100 mg
In Cohort 5 of Part 2, participants received once-daily oral dose of 100 mg GSK3739937 for 18 days.
Units
Counts
Participants
OG0007
OG0017
OG0027
Title
Denominators
Categories
Title
Measurements
OG0002(1 to 4)
OG0012(1 to 2)
OG0021.03(0.9 to 2.0)
Secondary
Part 2 (Cohort 3 and 4) - Tmax of GSK3739937 on Day 14
Blood samples were collected at indicated time points for PK analysis of GSK3739937. PK parameters were analyzed using standard non-compartmental analysis.
Pharmacokinetic Population
Posted
Median
Full Range
Hour
Pre-dose (within 15 minutes prior to dosing) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12 and 16 hours post-dose on Day 14
ID
Title
Description
OG000
GSK3739937 QD 25 mg
In Cohort 3 of Part 2, participants received once-daily oral dose of 25 mg GSK3739937 for 14 days.
OG001
GSK3739937 QD 50 mg
In Cohort 4 of Part 2, participants received once-daily oral dose of 50 mg GSK3739937 for 14 days.
Units
Counts
Participants
OG0007
OG0017
Title
Denominators
Categories
Title
Measurements
OG0006.95(0 to 9)
OG0017.03(3 to 9)
Secondary
Part 2 (Cohort 3 and 4) - Cmax of GSK3739937 on Day 14
Blood samples were collected at indicated time points for PK analysis of GSK3739937. PK parameters were analyzed using standard non-compartmental analysis.
Pharmacokinetic Population
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/mL
Pre-dose (within 15 minutes prior to dosing) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12 and 16 hours post-dose on Day 14
ID
Title
Description
OG000
GSK3739937 QD 25 mg
In Cohort 3 of Part 2, participants received once-daily oral dose of 25 mg GSK3739937 for 14 days.
OG001
GSK3739937 QD 50 mg
In Cohort 4 of Part 2, participants received once-daily oral dose of 50 mg GSK3739937 for 14 days.
Units
Counts
Participants
OG0007
OG0017
Title
Denominators
Categories
Title
Measurements
OG000766.32± 16
OG0011149.32± 15.1
Secondary
Part 2 (Cohort 3 and 4) - AUC From Pre-dose to the End of the Dosing Interval at Steady State (AUC[0-tau]) of GSK3739937 on Day 14
Blood samples were collected at indicated time points for PK analysis of GSK3739937. PK parameters were analyzed using standard non-compartmental analysis.
Pharmacokinetic Population
Posted
Geometric Mean
Geometric Coefficient of Variation
h*ng/mL
Pre-dose (within 15 minutes prior to dosing) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12 and 16 hours post-dose on Day 14
ID
Title
Description
OG000
GSK3739937 QD 25 mg
In Cohort 3 of Part 2, participants received once-daily oral dose of 25 mg GSK3739937 for 14 days.
OG001
GSK3739937 QD 50 mg
In Cohort 4 of Part 2, participants received once-daily oral dose of 50 mg GSK3739937 for 14 days.
Units
Counts
Participants
OG0007
OG0017
Title
Denominators
Categories
Title
Measurements
OG00014592.19± 12.6
OG00124888.49± 14.4
Secondary
Part 2 (Cohort 3 and 4) - Plasma Trough Concentration (Ctau) of GSK3739937 on Day 14
Blood samples were collected at indicated time points for PK analysis of GSK3739937. PK parameters were analyzed using standard non-compartmental analysis.
Pharmacokinetic Population
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/mL
Pre-dose (within 15 minutes prior to dosing) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12 and 16 hours post-dose on Day 14
ID
Title
Description
OG000
GSK3739937 QD 25 mg
In Cohort 3 of Part 2, participants received once-daily oral dose of 25 mg GSK3739937 for 14 days.
OG001
GSK3739937 QD 50 mg
In Cohort 4 of Part 2, participants received once-daily oral dose of 50 mg GSK3739937 for 14 days.
Units
Counts
Participants
OG0007
OG0017
Title
Denominators
Categories
Title
Measurements
OG000588.1557± 22.5
OG001990.3205± 13.2
Secondary
Part 2 (Cohort 3 and 4) - T1/2 of GSK3739937 on Day 14
Blood samples were collected at indicated time points for PK analysis of GSK3739937. PK parameters were analyzed using standard non-compartmental analysis.
Pharmacokinetic Population. Only those participants with data available at specified time points have been analyzed.
Posted
Geometric Mean
Geometric Coefficient of Variation
Hours
Pre-dose (within 15 minutes prior to dosing) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12 and 16 hours post-dose on Day 14
ID
Title
Description
OG000
GSK3739937 QD 25 mg
In Cohort 3 of Part 2, participants received once-daily oral dose of 25 mg GSK3739937 for 14 days.
OG001
GSK3739937 QD 50 mg
In Cohort 4 of Part 2, participants received once-daily oral dose of 50 mg GSK3739937 for 14 days.
Units
Counts
Participants
OG0003
OG0016
Title
Denominators
Categories
Title
Measurements
OG00085.7725± 25.9
OG00172.2484± 28.4
Secondary
Part 2 (Cohort 3 and 4) - CL/F of GSK3739937 on Day 14
Blood samples were collected at indicated time points for PK analysis of GSK3739937. PK parameters were analyzed using standard non-compartmental analysis.
Pharmacokinetic Population
Posted
Geometric Mean
Geometric Coefficient of Variation
L/h
Pre-dose (within 15 minutes prior to dosing) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12 and 16 hours post-dose on Day 14
ID
Title
Description
OG000
GSK3739937 QD 25 mg
In Cohort 3 of Part 2, participants received once-daily oral dose of 25 mg GSK3739937 for 14 days.
OG001
GSK3739937 QD 50 mg
In Cohort 4 of Part 2, participants received once-daily oral dose of 50 mg GSK3739937 for 14 days.
Units
Counts
Participants
OG0007
OG0017
Title
Denominators
Categories
Title
Measurements
OG0001.7132± 12.6
OG0012.009± 14.4
Secondary
Part 2 (Cohort 5) - Tmax of GSK3739937 on Day 18
Blood samples were collected at indicated time points for PK analysis of GSK3739937. PK parameters were analyzed using standard non-compartmental analysis.
Pharmacokinetic Population. Only those participants with data available at specified time points have been analyzed.
Posted
Median
Full Range
Hours
Pre-dose (within 15 minutes prior to dosing) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12 and 16 hours post-dose on Day 18
ID
Title
Description
OG000
GSK3739937 QD 100 mg
In Cohort 5 of Part 2, participants received once-daily oral dose of 100 mg GSK3739937 for 18 days.
Units
Counts
Participants
OG0006
Title
Denominators
Categories
Title
Measurements
OG0009.01(8.1 to 24.1)
Secondary
Part 2 (Cohort 5) - Cmax of GSK3739937 on Day 18
Blood samples were collected at indicated time points for PK analysis of GSK3739937. PK parameters were analyzed using standard non-compartmental analysis.
Pharmacokinetic Population. Only those participants with data available at specified time points have been analyzed.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/mL
Pre-dose (within 15 minutes prior to dosing) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12 and 16 hours post-dose on Day 18
ID
Title
Description
OG000
GSK3739937 QD 100 mg
In Cohort 5 of Part 2, participants received once-daily oral dose of 100 mg GSK3739937 for 18 days.
Units
Counts
Participants
OG0006
Title
Denominators
Categories
Title
Measurements
OG0002748± 21.1
Secondary
Part 2 (Cohort 5) - AUC From Pre-dose to the End of the Dosing Interval at Steady State (AUC[0-tau]) on Day 18
Blood samples were collected at indicated time points for PK analysis of GSK3739937. PK parameters were analyzed using standard non-compartmental analysis.
Pharmacokinetic Population. Only those participants with data available at specified time points have been analyzed.
Posted
Geometric Mean
Geometric Coefficient of Variation
h*ng/mL
Pre-dose (within 15 minutes prior to dosing) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12 and 16 hours post-dose on Day 18
ID
Title
Description
OG000
GSK3739937 QD 100 mg
In Cohort 5 of Part 2, participants received once-daily oral dose of 100 mg GSK3739937 for 18 days.
Units
Counts
Participants
OG0006
Title
Denominators
Categories
Title
Measurements
OG00058417.64± 21
Secondary
Part 2 (Cohort 5) - Plasma Trough Concentration (Ctau) of GSK3739937 on Day 18
Blood samples were collected at indicated time points for PK analysis of GSK3739937. PK parameters were analyzed using standard non-compartmental analysis.
Pharmacokinetic Population. Only those participants with data available at specified time points have been analyzed.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/mL
Pre-dose (within 15 minutes prior to dosing) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12 and 16 hours post-dose on Day 18
ID
Title
Description
OG000
GSK3739937 QD 100 mg
In Cohort 5 of Part 2, participants received once-daily oral dose of 100 mg GSK3739937 for 18 days.
Units
Counts
Participants
OG0006
Title
Denominators
Categories
Title
Measurements
OG0002458.275± 21.2
Secondary
Part 2 (Cohort 5) - T1/2 of GSK3739937 on Day 18
Blood samples were collected at indicated time points for PK analysis of GSK3739937. PK parameters were analyzed using standard non-compartmental analysis.
Pharmacokinetic Population. Only those participants with data available at specified time points have been analyzed.
Posted
Geometric Mean
Geometric Coefficient of Variation
Hours
Pre-dose (within 15 minutes prior to dosing) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12 and 16 hours post-dose on Day 18
ID
Title
Description
OG000
GSK3739937 QD 100 mg
In Cohort 5 of Part 2, participants received once-daily oral dose of 100 mg GSK3739937 for 18 days.
Units
Counts
Participants
OG0006
Title
Denominators
Categories
Title
Measurements
OG00078.5264± 26.7
Secondary
Part 2 (Cohort 5) - CL/F of GSK3739937 on Day 18
Blood samples were collected at indicated time points for PK analysis of GSK3739937. PK parameters were analyzed using standard non-compartmental analysis.
Pharmacokinetic Population. Only those participants with data available at specified time points have been analyzed.
Posted
Geometric Mean
Geometric Coefficient of Variation
Litre/ hour (L/h)
Pre-dose (within 15 minutes prior to dosing) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12 and 16 hours post-dose on Day 18
ID
Title
Description
OG000
GSK3739937 QD 100 mg
In Cohort 5 of Part 2, participants received once-daily oral dose of 100 mg GSK3739937 for 18 days.
Units
Counts
Participants
OG0006
Title
Denominators
Categories
Title
Measurements
OG0001.7118± 21
Secondary
Part 2 (Cohort 6) - AUC From Zero to 168 Hours (AUC[0-168]) of GSK3739937 From Day 1
Blood samples were collected at indicated time points for PK analysis of GSK3739937. PK parameters were analyzed using standard non-compartmental analysis.
Pharmacokinetic Population. Only those participants with data available at specified time points have been analyzed.
Posted
Geometric Mean
Geometric Coefficient of Variation
h*ng/mL
Pre-dose (within 15 minutes prior to dosing) and up to 168 hours post-dose from Day 1
ID
Title
Description
OG000
GSK3739937 QW 500 mg
In Cohort 6 of Part 2, participants received one dose per week of 500 mg GSK3739937 for over 3 weeks.
Units
Counts
Participants
OG0007
Title
Denominators
Categories
Title
Measurements
OG00096434.63± 14.1
Secondary
Part 2 (Cohort 6) - Cmax of GSK3739937 on Day 1
Blood samples were collected at indicated time points for PK analysis of GSK3739937. PK parameters were analyzed using standard non-compartmental analysis.
Pharmacokinetic Population
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/mL
Pre-dose (within 15 minutes prior to dosing) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12 and 16 hours post-dose on Day 1
ID
Title
Description
OG000
GSK3739937 QW 500 mg
In Cohort 6 of Part 2, participants received one dose per week of 500 mg GSK3739937 for over 3 weeks.
Units
Counts
Participants
OG0007
Title
Denominators
Categories
Title
Measurements
OG0001106.61± 12.8
Secondary
Part 2 (Cohort 6) - Concentration of GSK3739937 at 168 Hours (C168) From Day 1
Blood samples were collected at indicated time points for PK analysis of GSK3739937. PK parameters were analyzed using standard non-compartmental analysis.
Pharmacokinetic Population
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/mL
Pre-dose (within 15 minutes prior to dosing) and up to 168 hours post-dose from Day 1
ID
Title
Description
OG000
GSK3739937 QW 500 mg
In Cohort 6 of Part 2, participants received one dose per week of 500 mg GSK3739937 for over 3 weeks.
Units
Counts
Participants
OG0007
Title
Denominators
Categories
Title
Measurements
OG000250.62± 36.3
Secondary
Part 2 (Cohort 6) - Tmax of GSK3739937 on Day 1
Blood samples were collected at indicated time points for PK analysis of GSK3739937. PK parameters were analyzed using standard non-compartmental analysis.
Pharmacokinetic Population
Posted
Median
Full Range
Hours
Pre-dose (within 15 minutes prior to dosing) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12 and 16 hours post-dose on Day 1
ID
Title
Description
OG000
GSK3739937 QW 500 mg
In Cohort 6 of Part 2, participants received one dose per week of 500 mg GSK3739937 for over 3 weeks.
Units
Counts
Participants
OG0007
Title
Denominators
Categories
Title
Measurements
OG0009.88(8 to 48.1)
Secondary
Part 2 (Cohort 6) - Tlag of GSK3739937 on Day 1
Blood samples were collected at indicated time points for PK analysis of GSK3739937. PK parameters were analyzed using standard non-compartmental analysis.
Pharmacokinetic Population
Posted
Median
Full Range
Hours
Pre-dose (within 15 minutes prior to dosing) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12 and 16 hours post-dose on Day 1
ID
Title
Description
OG000
GSK3739937 QW 500 mg
In Cohort 6 of Part 2, participants received one dose per week of 500 mg GSK3739937 for over 3 weeks.
Units
Counts
Participants
OG0007
Title
Denominators
Categories
Title
Measurements
OG0000(0 to 1)
Secondary
Part 2 (Cohort 6 ) - AUC(0-t) of GSK3739937 on Day 15
Blood samples were collected at indicated time points for PK analysis of GSK3739937. PK parameters were analyzed using standard non-compartmental analysis.
Pharmacokinetic Population
Posted
Geometric Mean
Geometric Coefficient of Variation
h*ng/mL
Pre-dose (within 15 minutes prior to dosing) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12 and 16 hours post-dose on Day 15
ID
Title
Description
OG000
GSK3739937 QW 500 mg
In Cohort 6 of Part 2, participants received one dose per week of 500 mg GSK3739937 for over 3 weeks.
Units
Counts
Participants
OG0007
Title
Denominators
Categories
Title
Measurements
OG000169693.1± 31.9
Secondary
Part 2 (Cohort 6) - Cmax of GSK3739937 on Day 15
Blood samples were collected at indicated time points for PK analysis of GSK3739937. PK parameters were analyzed using standard non-compartmental analysis.
Pharmacokinetic Population
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/mL
Pre-dose (within 15 minutes prior to dosing) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12 and 16 hours post-dose on Day 15
ID
Title
Description
OG000
GSK3739937 QW 500 mg
In Cohort 6 of Part 2, participants received one dose per week of 500 mg GSK3739937 for over 3 weeks.
Units
Counts
Participants
OG0007
Title
Denominators
Categories
Title
Measurements
OG0001855.67± 24.1
Secondary
Part 2 (Cohort 6) - Ctau of GSK3739937 on Day 15
Blood samples were collected at indicated time points for PK analysis of GSK3739937. PK parameters were analyzed using standard non-compartmental analysis.
Pharmacokinetic Population
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/mL
Pre-dose (within 15 minutes prior to dosing) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12 and 16 hours post-dose on Day 15
ID
Title
Description
OG000
GSK3739937 QW 500 mg
In Cohort 6 of Part 2, participants received one dose per week of 500 mg GSK3739937 for over 3 weeks.
Units
Counts
Participants
OG0007
Title
Denominators
Categories
Title
Measurements
OG000455.4447± 46.5
Secondary
Part 2 (Cohort 6) - Tmax of GSK3739937 on Day 15
Blood samples were collected at indicated time points for PK analysis of GSK3739937. PK parameters were analyzed using standard non-compartmental analysis.
Pharmacokinetic Population
Posted
Median
Full Range
Hours
Pre-dose (within 15 minutes prior to dosing) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12 and 16 hours post-dose on Day 15
ID
Title
Description
OG000
GSK3739937 QW 500 mg
In Cohort 6 of Part 2, participants received one dose per week of 500 mg GSK3739937 for over 3 weeks.
Units
Counts
Participants
OG0007
Title
Denominators
Categories
Title
Measurements
OG00010(9 to 12)
Secondary
Part 2 (Cohort 6) - T1/2 of GSK3739937 on Day 15
Blood samples were collected at indicated time points for PK analysis of GSK3739937. PK parameters were analyzed using standard non-compartmental analysis.
Pharmacokinetic Population
Posted
Geometric Mean
Geometric Coefficient of Variation
Hours
Pre-dose (within 15 minutes prior to dosing) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12 and 16 hours post-dose on Day 15
ID
Title
Description
OG000
GSK3739937 QW 500 mg
In Cohort 6 of Part 2, participants received one dose per week of 500 mg GSK3739937 for over 3 weeks.
Units
Counts
Participants
OG0007
Title
Denominators
Categories
Title
Measurements
OG00074.5404± 19.1
Secondary
Part 2 (Cohort 6) - CL/F of GSK3739937 on Day 15
Blood samples were collected at indicated time points for PK analysis of GSK3739937. PK parameters were analyzed using standard non-compartmental analysis.
Pharmacokinetic Population
Posted
Geometric Mean
Geometric Coefficient of Variation
L/h
Pre-dose (within 15 minutes prior to dosing) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12 and 16 hours post-dose on Day 15
ID
Title
Description
OG000
GSK3739937 QW 500 mg
In Cohort 6 of Part 2, participants received one dose per week of 500 mg GSK3739937 for over 3 weeks.
Units
Counts
Participants
OG0007
Title
Denominators
Categories
Title
Measurements
OG0002.9465± 31.9
Secondary
Part 3 (Cohort 7) - C24 of GSK3739937
Blood samples were collected at indicated time points for PK analysis of GSK3739937. PK parameters were analyzed using standard non-compartmental analysis.
Pharmacokinetic Population. Only those participants with data available at specified time points have been analyzed.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/mL
Pre-dose (within 15 minutes prior to dosing) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 16, 24 hours post-dose in each treatment period
ID
Title
Description
OG000
GSK3739937 PiB Fed
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 PiB as an oral suspension under moderate fed conditions in each one of the three periods.
OG001
GSK3739937 Tablet Fed
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under moderate fed conditions in each one of the three periods.
OG002
GSK3739937 Tablet Fasted
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under moderate fasted conditions in each one of the three periods.
Units
Counts
Participants
OG00015
OG00116
OG00215
Title
Denominators
Categories
Title
Measurements
OG000316.7± 29.4
OG001407.5± 39.7
OG002153.97± 91.2
Secondary
Part 3 (Cohort 7) Clast of GSK3739937
Blood samples were collected at indicated time points for PK analysis of GSK3739937. PK parameters were analyzed using standard non-compartmental analysis.
Pharmacokinetic Population. Only those participants with data available at specified time points have been analyzed.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/mL
Pre-dose (within 15 minutes prior to dosing) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 16, 24, 48, 72, 96, 120, 192, 264, and 360 hours post-dose in each treatment period
ID
Title
Description
OG000
GSK3739937 PiB Fed
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 PiB as an oral suspension under moderate fed conditions in each one of the three periods.
OG001
GSK3739937 Tablet Fed
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under moderate fed conditions in each one of the three periods.
OG002
GSK3739937 Tablet Fasted
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under moderate fasted conditions in each one of the three periods.
Units
Counts
Participants
OG00015
OG00116
OG00215
Title
Denominators
Categories
Title
Measurements
OG00019.76± 40.8
OG00125.09± 51.6
OG00215.44± 37
Secondary
Part 3 (Cohort 7) - Tmax of GSK3739937
Blood samples were collected at indicated time points for PK analysis of GSK3739937. PK parameters were analyzed using standard non-compartmental analysis.
Pharmacokinetic Population. Only those participants with data available at specified time points have been analyzed.
Posted
Median
Full Range
Hours
Pre-dose (within 15 minutes prior to dosing) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 16, 24, 48, 72, 96, 120, 192, 264, and 360 hours post-dose in each treatment period
ID
Title
Description
OG000
GSK3739937 PiB Fed
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 PiB as an oral suspension under moderate fed conditions in each one of the three periods.
OG001
GSK3739937 Tablet Fed
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under moderate fed conditions in each one of the three periods.
OG002
GSK3739937 Tablet Fasted
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under moderate fasted conditions in each one of the three periods.
Units
Counts
Participants
OG00015
OG00116
OG00215
Title
Denominators
Categories
Title
Measurements
OG0009(7 to 24)
OG0018.42(5 to 15.9)
OG0026(4 to 47.7)
Secondary
Part 3 (Cohort 7) - Tlag of GSK3739937
Blood samples were collected at indicated time points for PK analysis of GSK3739937. PK parameters were analyzed using standard non-compartmental analysis.
Pharmacokinetic Population. Only those participants with data available at specified time points have been analyzed.
Posted
Median
Full Range
Hours
Pre-dose (within 15 minutes prior to dosing) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 16, 24, 48, 72, 96, 120, 192, 264, and 360 hours post-dose in each treatment period
ID
Title
Description
OG000
GSK3739937 PiB Fed
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 PiB as an oral suspension under moderate fed conditions in each one of the three periods.
OG001
GSK3739937 Tablet Fed
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under moderate fed conditions in each one of the three periods.
OG002
GSK3739937 Tablet Fasted
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under moderate fasted conditions in each one of the three periods.
Units
Counts
Participants
OG00015
OG00116
OG00215
Title
Denominators
Categories
Title
Measurements
OG0001(0 to 2)
OG0012(0 to 3)
OG0020.98(0 to 3)
Secondary
Part 3 (Cohort 7) - Tlast of GSK3739937
Blood samples were collected at indicated time points for PK analysis of GSK3739937. PK parameters were analyzed using standard non-compartmental analysis.
Pharmacokinetic Population. Only those participants with data available at specified time points have been analyzed.
Posted
Median
Full Range
Hours
Pre-dose (within 15 minutes prior to dosing) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 16, 24, 48, 72, 96, 120, 192, 264, and 360 hours post-dose in each treatment period
ID
Title
Description
OG000
GSK3739937 PiB Fed
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 PiB as an oral suspension under moderate fed conditions in each one of the three periods.
OG001
GSK3739937 Tablet Fed
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under moderate fed conditions in each one of the three periods.
OG002
GSK3739937 Tablet Fasted
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under moderate fasted conditions in each one of the three periods.
Units
Counts
Participants
OG00015
OG00116
OG00215
Title
Denominators
Categories
Title
Measurements
OG000336.75(263.63 to 389.92)
OG001360.067(120.08 to 362.27)
OG002267.4(195.12 to 361.15)
Secondary
Part 3 (Cohort 7) - T1/2 of GSK3739937
Blood samples were collected at indicated time points for PK analysis of GSK3739937. PK parameters were analyzed using standard non-compartmental analysis.
Pharmacokinetic Population. Only those participants with data available at specified time points have been analyzed.
Posted
Geometric Mean
Geometric Coefficient of Variation
Hours
Pre-dose (within 15 minutes prior to dosing) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 16, 24, 48, 72, 96, 120, 192, 264, and 360 hours post-dose in each treatment period
ID
Title
Description
OG000
GSK3739937 PiB Fed
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 PiB as an oral suspension under moderate fed conditions in each one of the three periods.
OG001
GSK3739937 Tablet Fed
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under moderate fed conditions in each one of the three periods.
OG002
GSK3739937 Tablet Fasted
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under moderate fasted conditions in each one of the three periods.
Units
Counts
Participants
OG00013
OG00115
OG00210
Title
Denominators
Categories
Title
Measurements
OG00074.7429± 21.5
OG00172.9842± 17.5
OG00272.8066± 16.9
Secondary
Part 3 (Cohort 7) - CL/F of GSK3739937
Blood samples were collected at indicated time points for PK analysis of GSK3739937. PK parameters were analyzed using standard non-compartmental analysis.
Pharmacokinetic Population. Only those participants with data available at specified time points have been analyzed.
Posted
Geometric Mean
Geometric Coefficient of Variation
L/h
Pre-dose (within 15 minutes prior to dosing) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 16, 24, 48, 72, 96, 120, 192, 264, and 360 hours post-dose in each treatment period
ID
Title
Description
OG000
GSK3739937 PiB Fed
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 PiB as an oral suspension under moderate fed conditions in each one of the three periods.
OG001
GSK3739937 Tablet Fed
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under moderate fed conditions in each one of the three periods.
OG002
GSK3739937 Tablet Fasted
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under moderate fasted conditions in each one of the three periods.
Units
Counts
Participants
OG00013
OG00115
OG00210
Title
Denominators
Categories
Title
Measurements
OG0002.3082± 27.3
OG0011.698± 23.6
OG0023.6594± 64
Secondary
Part 1 - Dose Proportionality of GSK3739937 for Dose Levels 30 mg to 800 mg Using AUC(0-infinity) After Single Dose Administration of GSK3739937
Blood samples were collected at indicated time points for PK analysis of GSK3739937. PK parameters were analyzed using standard non-compartmental analysis. Dose proportionality for dose 30 mg, 80 mg, 160 mg, 320 mg, 640 mg and 800 mg was assessed using Power model. Log-e(dose) was fitted as fixed effect and participant was fitted as random effect. Kenward and Roger method and unstructured covariance structure was used. Slope and 90% confidence interval (CI) for the slope are presented.
Pharmacokinetic Population. Only those participants with data available at specified time points have been analyzed.
Posted
Number
90% Confidence Interval
Slope of log dose
Up to day 16
ID
Title
Description
OG000
Part 1: GSK3739937 Single Dose of 30 mg to 800 mg
Participants received single dose of GSK3739937 30 mg, 80 mg, 160 mg, 320 mg, 640 mg and 800 mg in either of treatment Period 1, 2 and 3 according to randomization schedule.
Units
Counts
Participants
OG00028
Title
Denominators
Categories
Title
Measurements
OG0000.882(0.784 to 0.976)
Secondary
Part 1 - Dose Proportionality of GSK3739937 for Dose Levels 10 mg to 800 mg Using Cmax After Single Dose Administration of GSK3739937
Blood samples were collected at indicated time points for PK analysis of GSK3739937. PK parameters were analyzed using standard non-compartmental analysis. Dose proportionality for dose 10 mg, 30 mg, 80 mg, 160 mg, 320 mg, 640 mg and 800 mg was assessed using Power model. Log-e(dose) was fitted as fixed effect and participant was fitted as random effect. Kenward and Roger method and unstructured covariance structure was used. Slope and 90% confidence interval (CI) for the slope are presented.
Pharmacokinetic Population. Only those participants with data available at specified time points have been analyzed.
Posted
Number
90% Confidence Interval
Slope of log dose
Up to day 16
ID
Title
Description
OG000
Part 1: GSK3739937 Single Dose of 10 mg to 800 mg
Participants received single dose of GSK3739937 10 mg, 30 mg, 80 mg, 160 mg, 320 mg, 640 mg and 800 mg in either of treatment Period 1, 2, and 3 according to randomization schedule.
Units
Counts
Participants
OG00042
Title
Denominators
Categories
Title
Measurements
OG0000.914(0.855 to 0.966)
Secondary
Part 2 - Dose Proportionality of GSK3739937 for Dose Levels 25 mg to 100 mg Using AUC(0-24) After Repeated Dose Administration of GSK3739937
Blood samples were collected at indicated time points for PK analysis of GSK3739937. PK parameters were analyzed using standard non-compartmental analysis. Dose proportionality for dose 25 mg, 50 mg and 100 mg was assessed using Power model. Log-e(dose) was fitted as fixed effect and participant was fitted as random effect. Kenward and Roger method and unstructured covariance structure was used. Slope and 90% confidence interval (CI) for the slope are presented.
Pharmacokinetic Population. Only those participants with data available at specified time points have been analyzed.
Posted
Number
90% Confidence Interval
Slope of log dose
Up to day 33
ID
Title
Description
OG000
Part 2: GSK3739937 Repeated Dose of 25 mg to 100 mg
Participants received repeated dose of GSK3739937 25 mg, 50 mg and 100 mg in treatment Period 1.
Units
Counts
Participants
OG00021
Title
Denominators
Categories
Title
Measurements
OG0000.997(0.864 to 1.109)
Secondary
Part 2 - Dose Proportionality of GSK3739937 for Dose Levels 25 mg to 100 mg Using Cmax After Repeated Dose Administration of GSK3739937
Blood samples were collected at indicated time points for PK analysis of GSK3739937. PK parameters were analyzed using standard non-compartmental analysis. Dose proportionality for dose 25 mg, 50 mg and 100 mg was assessed using Power model. Log-e(dose) was fitted as fixed effect and participant was fitted as random effect. Kenward and Roger method and unstructured covariance structure was used. Slope and 90% confidence interval (CI) for the slope are presented.
Pharmacokinetic Population. Only those participants with data available at specified time points have been analyzed.
Posted
Number
90% Confidence Interval
Slope of log dose
Up to day 33
ID
Title
Description
OG000
Part 2: GSK3739937 Repeated Dose of 25 mg to 100 mg
Participants received repeated dose of GSK3739937 25 mg, 50 mg and 100 mg in treatment Period 1.
Units
Counts
Participants
OG00028
Title
Denominators
Categories
Title
Measurements
OG0000.914(0.777 to 1.066)
Secondary
Part 2 - Dose Proportionality of GSK3739937 for Dose Levels 25 mg to 100 mg Using Ctau After Repeated Dose Administration of GSK3739937
Blood samples were collected at indicated time points for PK analysis of GSK3739937. PK parameters were analyzed using standard non-compartmental analysis. Dose proportionality for dose 25 mg, 50 mg and 100 mg was assessed using Power model. Log-e(dose) was fitted as fixed effect and participant was fitted as random effect. Kenward and Roger method and unstructured covariance structure was used. Slope and 90% confidence interval (CI) for the slope are presented.
Pharmacokinetic Population. Only those participants with data available at specified time points have been analyzed.
Posted
Number
90% Confidence Interval
Slope of log dose
Up to day 33
ID
Title
Description
OG000
Part 2: GSK3739937 Repeated Dose of 25 mg to 100 mg
Participants received repeated dose of GSK3739937 25 mg, 50 mg and 100 mg in treatment Period 1.
Units
Counts
Participants
OG00027
Title
Denominators
Categories
Title
Measurements
OG0001.023(0.878 to 1.184)
Secondary
Part 2 (Cohort 3 and 4) - Accumulation Ratio of AUC(0-tau) (R [AUC{0-TAU}])
Blood samples were collected at indicated time points for PK analysis of GSK3739937. PK parameters were analyzed using standard non-compartmental analysis. Accumulation ratio calculated as the ratio of day 14 AUC(0-tau) / day 1 AUC(0-tau).
Pharmacokinetic Population
Posted
Number
90% Confidence Interval
Ratio
Pre-dose (within 15 minutes prior to dosing) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12 and 16 hours post-dose on both Day 1 and Day 14
ID
Title
Description
OG000
GSK3739937 QD 25 mg
In Cohort 3 of Part 2, participants received once-daily oral dose of 25 mg GSK3739937 for 14 days.
OG001
GSK3739937 QD 50 mg
In Cohort 4 of Part 2, participants received once-daily oral dose of 50 mg GSK3739937 for 14 days.
Units
Counts
Participants
OG0007
OG0017
Title
Denominators
Categories
Title
Measurements
OG0007.728(6.418 to 9.305)
OG0016.993(6.025 to 8.117)
Secondary
Part 2 (Cohort 5) - Accumulation Ratio of AUC(0-tau) (R [AUC{0-TAU}])
Blood samples were collected at indicated time points for PK analysis of GSK3739937. PK parameters were analyzed using standard non-compartmental analysis. Accumulation ratio calculated as the ratio of day 18 AUC(0-tau) / day 1 AUC(0-tau).
Pharmacokinetic Population
Posted
Number
90% Confidence Interval
Ratio
Pre-dose (within 15 minutes prior to dosing) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12 and 16 hours post-dose on both Day 1 and Day 18
ID
Title
Description
OG000
GSK3739937 QD 100 mg
In Cohort 5 of Part 2, participants received once-daily oral dose of 100 mg GSK3739937 for 18 days.
Units
Counts
Participants
OG0007
Title
Denominators
Categories
Title
Measurements
OG0009.943(6.987 to 14.149)
Secondary
Part 2 (Cohort 6) - Accumulation Ratio of AUC(0-tau) (R [AUC{0-TAU}])
Blood samples were collected at indicated time points for PK analysis of GSK3739937. PK parameters were analyzed using standard non-compartmental analysis. Accumulation ratio calculated as the ratio of day 15 AUC(0-tau) / day 1 AUC(0-tau).
Pharmacokinetic Population
Posted
Number
90% Confidence Interval
Ratio
Pre-dose (within 15 minutes prior to dosing) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12 and 16 hours post-dose on both Day 1 and Day 15
ID
Title
Description
OG000
GSK3739937 QW 500 mg
In Cohort 6 of Part 2, participants received one dose per week of 500 mg GSK3739937 for over 3 weeks.
Units
Counts
Participants
OG0007
Title
Denominators
Categories
Title
Measurements
OG0001.76(1.448 to 2.138)
Secondary
Part 2 (Cohort 3 and 4) - Accumulation Ratio of Cmax (R [CMAX])
Blood samples were collected at indicated time points for PK analysis of GSK3739937. PK parameters were analyzed using standard non-compartmental analysis. Accumulation ratio calculated as the ratio of day 14 Cmax / day 1 Cmax.
Pharmacokinetic Population
Posted
Number
90% Confidence Interval
Ratio
Pre-dose (within 15 minutes prior to dosing) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12 and 16 hours post-dose on both Day 1 and Day 14
ID
Title
Description
OG000
GSK3739937 QD 25 mg
In Cohort 3 of Part 2, participants received once-daily oral dose of 25 mg GSK3739937 for 14 days.
OG001
GSK3739937 QD 50 mg
In Cohort 4 of Part 2, participants received once-daily oral dose of 50 mg GSK3739937 for 14 days.
Units
Counts
Participants
OG0007
OG0017
Title
Denominators
Categories
Title
Measurements
OG0005.8(4.962 to 6.78)
OG0014.952(4.198 to 5.842)
Secondary
Part 2 (Cohort 5) - Accumulation Ratio of Cmax (R [CMAX])
Blood samples were collected at indicated time points for PK analysis of GSK3739937. PK parameters were analyzed using standard non-compartmental analysis. Actual measure type is Ratio. Accumulation ratio calculated as the ratio of day 18 Cmax / day 1 Cmax.
Pharmacokinetic Population
Posted
Number
90% Confidence Interval
Ratio
Pre-dose (within 15 minutes prior to dosing) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12 and 16 hours post-dose on both Day 1 and Day 18
ID
Title
Description
OG000
GSK3739937 QD 100 mg
In Cohort 5 of Part 2, participants received once-daily oral dose of 100 mg GSK3739937 for 18 days.
Units
Counts
Participants
OG0007
Title
Denominators
Categories
Title
Measurements
OG0007.325(5.333 to 10.06)
Secondary
Part 2 (Cohort 6) - Accumulation Ratio of Cmax (R [CMAX])
Blood samples were collected at indicated time points for PK analysis of GSK3739937. PK parameters were analyzed using standard non-compartmental analysis. Accumulation ratio calculated as the ratio of day 15 Cmax / day 1 Cmax.
Pharmacokinetic Population
Posted
Number
90% Confidence Interval
Ratio
Pre-dose (within 15 minutes prior to dosing) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12 and 16 hours post-dose on both Day 1 and Day 15
ID
Title
Description
OG000
GSK3739937 QW 500 mg
In Cohort 6 of Part 2, participants received one dose per week of 500 mg GSK3739937 for over 3 weeks.
Units
Counts
Participants
OG0007
Title
Denominators
Categories
Title
Measurements
OG0001.677(1.381 to 2.036)
Secondary
Part 2 (Cohort 3 and 4) - Accumulation Ratio of C(Tau) (R[CTAU])
Blood samples were collected at indicated time points for PK analysis of GSK3739937. PK parameters were analyzed using standard non-compartmental analysis. Accumulation ratio calculated as the ratio of day 14 C(Tau) / day 1 C(Tau).
Pharmacokinetic Population
Posted
Number
90% Confidence Interval
Ratio
Pre-dose (within 15 minutes prior to dosing) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12 and 16 hours post-dose on both Day 1 and Day 14
ID
Title
Description
OG000
GSK3739937 QD 25 mg
In Cohort 3 of Part 2, participants received once-daily oral dose of 25 mg GSK3739937 for 14 days.
OG001
GSK3739937 QD 50 mg
In Cohort 4 of Part 2, participants received once-daily oral dose of 50 mg GSK3739937 for 14 days.
Units
Counts
Participants
OG0007
OG0017
Title
Denominators
Categories
Title
Measurements
OG0006.584(5.256 to 8.248)
OG0015.25(4.07 to 6.771)
Secondary
Part 2 (Cohort 5) - Accumulation Ratio of C(Tau) (R[CTAU])
Blood samples were collected at indicated time points for PK analysis of GSK3739937. PK parameters were analyzed using standard non-compartmental analysis. Accumulation ratio calculated as the ratio of day 18 C(Tau) / day 1 C(Tau).
Pharmacokinetic Population
Posted
Number
90% Confidence Interval
Ratio
Pre-dose (within 15 minutes prior to dosing) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12 and 16 hours post-dose on both Day 1 and Day 18
ID
Title
Description
OG000
GSK3739937 QD 100 mg
In Cohort 5 of Part 2, participants received once-daily oral dose of 100 mg GSK3739937 for 18 days.
Units
Counts
Participants
OG0007
Title
Denominators
Categories
Title
Measurements
OG0009.133(5.562 to 14.995)
Secondary
Part 2 (Cohort 6) - Accumulation Ratio of C(Tau) (R[CTAU])
Blood samples were collected at indicated time points for PK analysis of GSK3739937. PK parameters were analyzed using standard non-compartmental analysis. Accumulation ratio calculated as the ratio of day 15 C(Tau) / day 1 C(Tau).
Pharmacokinetic Population
Posted
Number
90% Confidence Interval
Ratio
Pre-dose (within 15 minutes prior to dosing) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12 and 16 hours post-dose on both Day 1 and Day 15
ID
Title
Description
OG000
GSK3739937 QW 500 mg
In Cohort 6 of Part 2, participants received one dose per week of 500 mg GSK3739937 for over 3 weeks.
Units
Counts
Participants
OG0007
Title
Denominators
Categories
Title
Measurements
OG0001.817(1.428 to 2.313)
Secondary
Part 2 (Cohort 3 and 4) - Pre-dose Concentration of GSK3739937
Blood samples were collected at indicated time points for PK analysis of GSK3739937. For Part 2 cohorts 3 and 4, steady-state GSK3739937 concentrations was assessed by estimating the slope of concentrations on pre-dose assessments on Days 2-14 (Part 2 cohort 3 and 4) and the day 15 (24-hr post-dose relative to dosing on day 14). PK parameters were analyzed using standard non-compartmental analysis.
Pharmacokinetic Population
Posted
Number
90% Confidence Interval
Slope of log dose
Up to day 15
ID
Title
Description
OG000
GSK3739937 QD 25 mg
In Cohort 3 of Part 2, participants received once-daily oral dose of 25 mg GSK3739937 for 14 days.
OG001
GSK3739937 QD 50 mg
In Cohort 4 of Part 2, participants received once-daily oral dose of 50 mg GSK3739937 for 14 days.
Units
Counts
Participants
OG0007
OG0017
Title
Denominators
Categories
Title
Measurements
OG00037.1872(33.0332 to 41.3412)
OG00157.1056(51.9304 to 62.2808)
Secondary
Part 2 (Cohort 5) - Pre-dose Concentration of GSK3739937
Blood samples were collected at indicated time points for PK analysis of GSK3739937. For Part 2 cohort 5, steady state GSK3739937 concentrations was assessed by estimating the slope of the concentrations of pre-dose assessments on Days 2-18 and the day 19 (24-hr post-dose relative to dosing on day 18). PK parameters were analyzed using standard non-compartmental analysis.
Pharmacokinetic Population
Posted
Number
90% Confidence Interval
Slope of log dose
Up to day 19
ID
Title
Description
OG000
GSK3739937 QD 100 mg
In Cohort 5 of Part 2, participants received once-daily oral dose of 100 mg GSK3739937 for 18 days.
Units
Counts
Participants
OG0007
Title
Denominators
Categories
Title
Measurements
OG000114.9742(103.8293 to 126.119)
0
21
0
21
4
21
EG001
GSK3739937 Single Dose (SD) 10 mg
In Cohort 1 of Part 1, participants received single oral dose of 10 mg GSK3739937
0
6
0
6
1
6
EG002
GSK3739937 SD 30 mg
In Cohort 2 of Part 1, participants received single oral dose of 30 mg GSK3739937
0
6
0
6
3
6
EG003
GSK3739937 SD 80 mg
In Cohort 1 of Part 1, participants received single oral dose of 80 mg GSK3739937
0
6
0
6
3
6
EG004
GSK3739937 SD 160 mg
In Cohort 2 of Part 1, participants received single oral dose of 160 mg GSK3739937
0
6
0
6
0
6
EG005
GSK3739937 SD 320 mg
In Cohort 1 of Part 1, participants received single oral dose of 320 mg GSK3739937
0
6
0
6
2
6
EG006
GSK3739937 SD 640 mg
In Cohort 2 of Part 1, participants received single oral dose of 640 mg GSK3739937
0
6
0
6
4
6
EG007
GSK3739937 SD 800 mg
In Cohort 1 of Part 1, participants received single oral dose of 800 mg of GSK3739937
0
6
0
6
2
6
EG008
PBO Once Daily (QD)
Participants received once daily doses of Placebo for 14 days
0
9
0
9
3
9
EG009
GSK3739937 QD 25 mg
In Cohort 3 of Part 2, participants received once-daily oral dose of 25 mg GSK3739937 for 14 days.
0
7
0
7
0
7
EG010
GSK3739937 QD 50 mg
In Cohort 4 of Part 2, participants received once-daily oral dose of 50 mg GSK3739937 for 14 days.
0
7
0
7
2
7
EG011
GSK3739937 QD 100 mg
In Cohort 5 of Part 2, participants received once-daily oral dose of 100 mg GSK3739937 for 18 days.
0
7
0
7
5
7
EG012
PBO Once Weekly (QW)
Participants received once weekly oral dose of Placebo for over 3 weeks.
0
3
0
3
0
3
EG013
GSK3739937 QW 500 mg
In Cohort 6 of Part 2, participants received one dose per week of 500 mg GSK3739937 for over 3 weeks.
0
7
0
7
4
7
EG014
GSK3739937 PiB Fed
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 PiB as an oral suspension under moderate fed conditions in each one of the three periods.
0
15
0
15
2
15
EG015
GSK3739937 Tablet Fed
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under moderate fed conditions in each one of the three periods.
0
17
0
17
4
17
EG016
GSK3739937 Tablet Fasted
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under fasted conditions in each one of the three periods.
0
15
0
15
6
15
EG0000 events0 affected21 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected9 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected7 at risk
EG0111 events1 affected7 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected7 at risk
EG0140 events0 affected15 at risk
EG0150 events0 affected17 at risk
EG0160 events0 affected15 at risk
Eye irritation
Eye disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected6 at risk
EG0081 events1 affected9 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected7 at risk
EG0110 events0 affected7 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected7 at risk
EG0140 events0 affected15 at risk
EG0150 events0 affected17 at risk
EG0160 events0 affected15 at risk
Abdominal pain
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0051 events1 affected6 at risk
EG0061 events1 affected6 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected9 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected7 at risk
EG0110 events0 affected7 at risk
EG0120 events0 affected3 at risk
EG0131 events1 affected7 at risk
EG0140 events0 affected15 at risk
EG0150 events0 affected17 at risk
EG0160 events0 affected15 at risk
Constipation
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected21 at risk
EG0010 events0 affected6 at risk
EG0022 events2 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0061 events1 affected6 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected9 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected7 at risk
EG0110 events0 affected7 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected7 at risk
EG0140 events0 affected15 at risk
EG0150 events0 affected17 at risk
EG0160 events0 affected15 at risk
Diarrhoea
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected21 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0051 events1 affected6 at risk
EG0061 events1 affected6 at risk
EG0072 events2 affected6 at risk
EG0080 events0 affected9 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected7 at risk
EG0110 events0 affected7 at risk
EG0120 events0 affected3 at risk
EG0134 events3 affected7 at risk
EG0140 events0 affected15 at risk
EG0150 events0 affected17 at risk
EG0160 events0 affected15 at risk
Dry mouth
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0051 events1 affected6 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected6 at risk
EG0081 events1 affected9 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected7 at risk
EG0110 events0 affected7 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected7 at risk
EG0140 events0 affected15 at risk
EG0150 events0 affected17 at risk
EG0160 events0 affected15 at risk
Flatulence
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0051 events1 affected6 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected9 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected7 at risk
EG0110 events0 affected7 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected7 at risk
EG0140 events0 affected15 at risk
EG0150 events0 affected17 at risk
EG0160 events0 affected15 at risk
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected9 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected7 at risk
EG0111 events1 affected7 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected7 at risk
EG0140 events0 affected15 at risk
EG0151 events1 affected17 at risk
EG0160 events0 affected15 at risk
Nausea
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected6 at risk
EG0031 events1 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected9 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected7 at risk
EG0110 events0 affected7 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected7 at risk
EG0140 events0 affected15 at risk
EG0150 events0 affected17 at risk
EG0160 events0 affected15 at risk
Medical device site dermatitis
General disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected21 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0064 events4 affected6 at risk
EG0071 events1 affected6 at risk
EG0081 events1 affected9 at risk
EG0090 events0 affected7 at risk
EG0101 events1 affected7 at risk
EG0111 events1 affected7 at risk
EG0120 events0 affected3 at risk
EG0131 events1 affected7 at risk
EG0140 events0 affected15 at risk
EG0150 events0 affected17 at risk
EG0160 events0 affected15 at risk
Vaccination site pain
General disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
EG0071 events1 affected6 at risk
EG0080 events0 affected9 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected7 at risk
EG0110 events0 affected7 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected7 at risk
EG0140 events0 affected15 at risk
EG0150 events0 affected17 at risk
EG0160 events0 affected15 at risk
Vessel puncture site bruise
General disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected6 at risk
EG0081 events1 affected9 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected7 at risk
EG0112 events1 affected7 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected7 at risk
EG0140 events0 affected15 at risk
EG0150 events0 affected17 at risk
EG0160 events0 affected15 at risk
Vessel puncture site haematoma
General disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected9 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected7 at risk
EG0110 events0 affected7 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected7 at risk
EG0141 events1 affected15 at risk
EG0150 events0 affected17 at risk
EG0160 events0 affected15 at risk
Vessel puncture site pain
General disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected9 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected7 at risk
EG0112 events1 affected7 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected7 at risk
EG0140 events0 affected15 at risk
EG0150 events0 affected17 at risk
EG0161 events1 affected15 at risk
Vessel puncture site swelling
General disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected9 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected7 at risk
EG0111 events1 affected7 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected7 at risk
EG0140 events0 affected15 at risk
EG0150 events0 affected17 at risk
EG0161 events1 affected15 at risk
COVID-19
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected9 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected7 at risk
EG0110 events0 affected7 at risk
EG0120 events0 affected3 at risk
EG0131 events1 affected7 at risk
EG0141 events1 affected15 at risk
EG0150 events0 affected17 at risk
EG0161 events1 affected15 at risk
Folliculitis
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected9 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected7 at risk
EG0110 events0 affected7 at risk
EG0120 events0 affected3 at risk
EG0131 events1 affected7 at risk
EG0140 events0 affected15 at risk
EG0150 events0 affected17 at risk
EG0160 events0 affected15 at risk
Arthropod bite
Injury, poisoning and procedural complications
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected9 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected7 at risk
EG0110 events0 affected7 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected7 at risk
EG0140 events0 affected15 at risk
EG0151 events1 affected17 at risk
EG0160 events0 affected15 at risk
Burn oral cavity
Injury, poisoning and procedural complications
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected9 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected7 at risk
EG0110 events0 affected7 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected7 at risk
EG0140 events0 affected15 at risk
EG0151 events1 affected17 at risk
EG0160 events0 affected15 at risk
Procedural pain
Injury, poisoning and procedural complications
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected6 at risk
EG0081 events1 affected9 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected7 at risk
EG0110 events0 affected7 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected7 at risk
EG0140 events0 affected15 at risk
EG0150 events0 affected17 at risk
EG0160 events0 affected15 at risk
Skin abrasion
Injury, poisoning and procedural complications
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0061 events1 affected6 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected9 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected7 at risk
EG0110 events0 affected7 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected7 at risk
EG0140 events0 affected15 at risk
EG0150 events0 affected17 at risk
EG0162 events2 affected15 at risk
Skin injury
Injury, poisoning and procedural complications
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected9 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected7 at risk
EG0110 events0 affected7 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected7 at risk
EG0140 events0 affected15 at risk
EG0150 events0 affected17 at risk
EG0160 events0 affected15 at risk
Skin laceration
Injury, poisoning and procedural complications
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected9 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected7 at risk
EG0111 events1 affected7 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected7 at risk
EG0140 events0 affected15 at risk
EG0151 events1 affected17 at risk
EG0160 events0 affected15 at risk
SARS-CoV-2 test positive
Investigations
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected21 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0031 events1 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected6 at risk
EG0081 events1 affected9 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected7 at risk
EG0110 events0 affected7 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected7 at risk
EG0140 events0 affected15 at risk
EG0150 events0 affected17 at risk
EG0160 events0 affected15 at risk
Headache
Nervous system disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected6 at risk
EG0031 events1 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected9 at risk
EG0090 events0 affected7 at risk
EG0101 events1 affected7 at risk
EG0110 events0 affected7 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected7 at risk
EG0140 events0 affected15 at risk
EG0152 events2 affected17 at risk
EG0162 events2 affected15 at risk
Euphoric mood
Psychiatric disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected6 at risk
EG0081 events1 affected9 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected7 at risk
EG0110 events0 affected7 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected7 at risk
EG0140 events0 affected15 at risk
EG0150 events0 affected17 at risk
EG0160 events0 affected15 at risk
Premenstrual pain
Reproductive system and breast disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0051 events1 affected6 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected9 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected7 at risk
EG0110 events0 affected7 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected7 at risk
EG0140 events0 affected15 at risk
EG0150 events0 affected17 at risk
EG0160 events0 affected15 at risk
Dry throat
Respiratory, thoracic and mediastinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected6 at risk
EG0081 events1 affected9 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected7 at risk
EG0110 events0 affected7 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected7 at risk
EG0140 events0 affected15 at risk
EG0150 events0 affected17 at risk
EG0160 events0 affected15 at risk
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected9 at risk
EG0090 events0 affected7 at risk
EG0101 events1 affected7 at risk
EG0110 events0 affected7 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected7 at risk
EG0140 events0 affected15 at risk
EG0150 events0 affected17 at risk
EG0160 events0 affected15 at risk
Dry skin
Skin and subcutaneous tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected9 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected7 at risk
EG0111 events1 affected7 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected7 at risk
EG0140 events0 affected15 at risk
EG0150 events0 affected17 at risk
EG0160 events0 affected15 at risk
Eczema
Skin and subcutaneous tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected9 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected7 at risk
EG0110 events0 affected7 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected7 at risk
EG0140 events0 affected15 at risk
EG0151 events1 affected17 at risk
EG0160 events0 affected15 at risk
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0031 events1 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected9 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected7 at risk
EG0110 events0 affected7 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected7 at risk
EG0140 events0 affected15 at risk
EG0150 events0 affected17 at risk
EG0160 events0 affected15 at risk
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single site data not precede the primary publication of the entire clinical trial.
D012749
Sexually Transmitted Diseases
D016180
Lentivirus Infections
D012192
Retroviridae Infections
D012327
RNA Virus Infections
D014777
Virus Diseases
D000091662
Genital Diseases
D000091642
Urogenital Diseases
D007153
Immunologic Deficiency Syndromes
D007154
Immune System Diseases
D012897
Slow Virus Diseases
0 subjects
FG0050 subjects
FG0061 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
0 subjects
FG0051 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
3
BG0055
BG0064
BG0073
BG0089
BG0097
BG0107
BG0117
BG0123
BG0137
BG0145
BG0156
BG0166
BG01791
0
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
BG0110
BG0120
BG0130
BG0140
BG0150
BG0160
BG0170
3
BG0055
BG0064
BG0073
BG0088
BG0097
BG0107
BG0116
BG0123
BG0137
BG0145
BG0156
BG0166
BG01787
0
BG0040
BG0050
BG0060
BG0070
BG0080
BG0091
BG0100
BG0110
BG0120
BG0130
BG0140
BG0150
BG0160
BG0171
5
BG0042
BG0054
BG0061
BG0072
BG0086
BG0092
BG0104
BG0113
BG0122
BG0134
BG0142
BG0155
BG0165
BG01754
0
BG0040
BG0050
BG0062
BG0070
BG0080
BG0091
BG0100
BG0110
BG0120
BG0130
BG0140
BG0150
BG0160
BG0173
1
BG0041
BG0051
BG0061
BG0071
BG0083
BG0093
BG0103
BG0114
BG0120
BG0133
BG0143
BG0151
BG0161
BG01732
0
OG0040
OG0050
OG0060
OG0070
7
OG0043
OG0057
5
OG0040
OG0054
SAEs
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
Title
Measurements
OG0000
OG0010
OG0020
6
OG0046
OG0056
OG0066
OG0076
0
± 0
OG004-0.02± 0.041
OG0050± 0
OG0060± 0
OG0070± 0
Eosinophils
Title
Measurements
OG000-0.05± 0.092
OG001-0.2
OG0020.02± 0.147
OG003-0.08± 0.075
OG004-0.02± 0.075
OG005-0.02± 0.041
OG0060.08± 0.223
OG007-0.07± 0.082
Lymphocytes
Title
Measurements
OG0000.14± 0.391
OG001-0.5
OG0020± 0.482
OG003-0.02± 0.248
OG004-0.13± 0.463
OG0050.23± 0.339
OG0060.25± 0.084
OG007-0.22± 0.248
Monocytes
Title
Measurements
OG0000.04± 0.124
OG001-0.1
OG0020± 0.063
OG003-0.02± 0.194
OG004-0.03± 0.121
OG0050.02± 0.133
OG0060± 0.11
OG007-0.08± 0.117
Neutrophils
Title
Measurements
OG0000.3± 0.486
OG0010.7
OG0020.22± 0.306
OG0030.08± 1.303
OG0040.03± 0.468
OG0050.33± 0.48
OG0060.22± 0.117
OG007-0.03± 0.7
Platelets
Title
Measurements
OG0000.3± 26.73
OG0012
OG0028.2± 25.59
OG00316± 27.71
OG004-6.3± 7.87
OG0058.8± 20.5
OG00613.2± 19.05
OG0070.2± 13
6
-0.02
± 0.041
Eosinophils
Title
Measurements
OG0000.03± 0.05
OG001-0.03± 0.095
OG002-0.01± 0.090
OG0030.02± 0.075
Lymphocytes
Title
Measurements
OG000-0.13± 0.26
OG001-0.07± 0.281
OG0020.03± 0.427
OG0030.15± 0.274
Monocytes
Title
Measurements
OG0000.02± 0.139
OG0010.04± 0.113
OG0020.01± 0.135
OG003-0.02± 0.117
Neutrophils
Title
Measurements
OG000-0.47± 0.784
OG001-0.19± 0.682
OG0020.03± 0.496
OG003-0.18± 0.877
Platelets
Title
Measurements
OG000-11.9± 16.24
OG001-3.4± 18.12
OG002-9.7± 20.11
OG003-15.5± 32.93
0.03
± 0.115
OG001-0.01± 0.069
Lymphocytes
Title
Measurements
OG0000.23± 0.115
OG0010.04± 0.378
Monocytes
Title
Measurements
OG0000.07± 0.058
OG0010.06± 0.079
Neutrophils
Title
Measurements
OG000-0.10± 0.173
OG001-0.27± 0.315
Platelets
Title
Measurements
OG000-21.3± 47.72
OG001-9.3± 30.8
Title
Measurements
OG000-0.05± 0.052
OG001-0.05± 0.087
OG002-0.05± 0.092
Lymphocytes
Title
Measurements
OG0000.11± 0.253
OG001-0.08± 0.407
OG0020.16± 0.184
Monocytes
Title
Measurements
OG0000.01± 0.099
OG001-0.01± 0.132
OG0020.04± 0.083
Neutrophils
Title
Measurements
OG0000.16± 0.703
OG001-0.15± 1.253
OG0020.17± 0.594
Platelets
Title
Measurements
OG0007± 15.83
OG0011.5± 22.48
OG002-6.7± 21.4
6
OG0046
OG0056
OG0066
OG0076
0.245
± 0.1623
OG0040.048± 0.2548
OG0050.11± 0.1368
OG0060.157± 0.1833
OG0070.182± 0.1526
6
0.037
± 0.2601
6
OG0046
OG0056
OG0066
OG0076
-0.08
± 0.387
OG004-0.13± 0.32
OG005-0.13± 0.528
OG006-0.02± 0.232
OG007-0.03± 0.103
6
-0.08
± 0.605
6
OG0046
OG0056
OG0066
OG0076
0.0237
± 0.01491
OG0040.0012± 0.02409
OG0050.0047± 0.00866
OG0060.0117± 0.01862
OG0070.0175± 0.01319
6
0.0043
± 0.01929
6
OG0046
OG0056
OG0066
OG0076
-0.0008
± 0.00264
OG004-0.0007± 0.00234
OG005-0.0015± 0.00302
OG006-0.0008± 0.00194
OG007-0.0008± 0.0016
6
-0.0012
± 0.00264
6
OG0046
OG0056
OG0066
OG0076
6.7
± 5.2
OG0041± 8.51
OG0052.7± 2.73
OG0064.3± 5.68
OG0075.2± 4.07
6
0.5
± 7.74
6
OG0046
OG0056
OG0066
OG0076
6
ParticipantsOG0046
ParticipantsOG0056
ParticipantsOG0066
ParticipantsOG0076
Title
Measurements
OG0004.6± 6.06
OG0015
OG0028.3± 4.27
OG0036.7± 3.72
OG0043± 3.95
OG0056.2± 4.92
OG0068.8± 8.04
OG0076.2± 2.14
ALT
ParticipantsOG00018
ParticipantsOG0011
ParticipantsOG0026
ParticipantsOG0036
ParticipantsOG0046
ParticipantsOG0056
ParticipantsOG0066
ParticipantsOG0076
Title
Measurements
OG0001.6± 7.78
OG001-1
OG002-4.2± 6.05
OG003
AST
ParticipantsOG00018
ParticipantsOG0011
ParticipantsOG0026
ParticipantsOG0036
ParticipantsOG0046
ParticipantsOG0056
ParticipantsOG0066
ParticipantsOG0076
Title
Measurements
OG000-1.5± 6.07
OG001-8
OG002-4.5± 4.93
OG003
CPK
ParticipantsOG0006
ParticipantsOG0011
ParticipantsOG0026
ParticipantsOG0036
ParticipantsOG0046
ParticipantsOG0056
ParticipantsOG0064
ParticipantsOG0076
Title
Measurements
OG000-29.3± 140.65
OG0010.776
OG002-0.1978± 0.48809
OG003
6
6
Title
Measurements
OG000-0.4± 14.44
OG001-4.6± 10.61
OG0025.9± 5.34
OG0033.0± 9.76
ALT
ParticipantsOG0009
ParticipantsOG0017
ParticipantsOG0027
ParticipantsOG0036
Title
Measurements
OG000-3.1± 6.9
OG001-5.9± 5.84
OG002-3.9± 7.10
OG003
AST
ParticipantsOG0009
ParticipantsOG0017
ParticipantsOG0027
ParticipantsOG0036
Title
Measurements
OG000-4.6± 5.2
OG001-7.1± 5.52
OG002-4.1± 4.53
OG003
CPK
ParticipantsOG0006
ParticipantsOG0010
ParticipantsOG0027
ParticipantsOG0036
Title
Measurements
OG000-1± 26.43
OG00219.4± 88.50
OG00314.8± 41.63
-2.3
± 7.77
OG001-3.1± 2.91
AST
Title
Measurements
OG000-3.0± 2.65
OG001-3± 1.83
CPK
Title
Measurements
OG000-18.7± 14.84
OG001-22.6± 35.72
Title
Measurements
OG0001.3± 4.32
OG001-0.2± 4.92
OG002-0.4± 3.16
AST
Title
Measurements
OG0000.3± 3.67
OG0010.4± 4.4
OG002-0.9± 3.02
CPK
Title
Measurements
OG000-27.3± 52.49
OG001-22.2± 45.6
OG002-62.1± 73.59
6
OG0046
OG0056
OG0066
OG0076
-0.1387
± 0.36972
OG004-0.157± 0.22077
OG005-0.379± 0.22041
OG006-0.1848± 0.25449
OG007-0.3147± 0.25488
Bicarbonate
Title
Measurements
OG0001.8± 2.62
OG0012
OG0021.8± 2.48
OG0033.3± 3.5
OG0041.7± 1.97
OG005-0.2± 2.14
OG0060.7± 2.25
OG0071.3± 1.51
Calcium
Title
Measurements
OG0000.0693± 0.10417
OG001-0.025
OG0020.0208± 0.10249
OG0030.1453± 0.04816
OG0040.0707± 0.13915
OG0050.0208± 0.10888
OG0060.2203± 0.17728
OG0070.0375± 0.05646
Cholesterol
Title
Measurements
OG0000.1294± 0.59228
OG0010.104
OG002-0.2627± 0.52795
OG0030.444± 0.16643
OG004-0.224± 0.87169
OG0050.0047± 0.5061
OG0060.1898± 0.3552
OG0070.142± 0.09784
Chloride
Title
Measurements
OG000-1.6± 2.79
OG001-1
OG002-0.3± 1.75
OG003-5± 1.41
OG0041.7± 1.51
OG005-1.3± 1.51
OG006-0.8± 1.83
OG0070.3± 1.03
HDL
Title
Measurements
OG000-0.0187± 0.20182
OG0010.181
OG002-0.069± 0.20186
OG0030.1247± 0.15293
OG004-0.086± 0.13432
OG0050.082± 0.11534
OG006-0.0388± 0.30208
OG007-0.043± 0.07956
Potassium
Title
Measurements
OG000-0.02± 0.303
OG001-0.2
OG0020.18± 0.354
OG0030.18± 0.293
OG0040.1± 0.261
OG005-0.28± 0.24
OG006-0.07± 0.234
OG007-0.12± 0.214
LDL
Title
Measurements
OG000-0.0027± 0.44009
OG001-0.078
OG002-0.0605± 0.51701
OG0030.5217± 0.21608
OG004-0.5298± 0.52526
OG0050.004± 0.35306
OG0060.2023± 0.22274
OG007-0.0388± 0.29351
Magnesium
Title
Measurements
OG0000.0046± 0.05426
OG0010
OG002-0.0137± 0.06173
OG0030.0068± 0.03086
OG004-0.0478± 0.03086
OG0050.0752± 0.06035
OG0060.0342± 0.03086
OG0070.0137± 0.02117
Phosphate
Title
Measurements
OG0000.0611± 0.13184
OG0010.097
OG0020.0377± 0.1266
OG0030.124± 0.13169
OG004-0.0108± 0.16164
OG0050.0052± 0.08782
OG0060.043± 0.12387
OG007-0.0108± 0.05669
Sodium
Title
Measurements
OG0000± 1.64
OG0010
OG0021± 1.26
OG0030.2± 0.98
OG0041± 1.26
OG005-0.7± 1.51
OG006-0.3± 1.37
OG0072.2± 0.98
Triglycerides
Title
Measurements
OG0000.1683± 0.46481
OG0010.18
OG002-0.2225± 0.43845
OG0030.0318± 0.41469
OG004-0.2337± 0.3573
OG005-0.0863± 0.32709
OG0060.087± 0.12521
OG0070.1467± 0.25766
BUN
Title
Measurements
OG000-0.2777± 0.7798
OG0011.071
OG002-0.4165± 0.79561
OG0030.2975± 0.7629
OG004-0.119± 0.62517
OG0050.2975± 0.47451
OG006-0.2975± 0.72872
OG007-0.595± 0.29149
6
-0.3978
± 0.24715
Bicarbonate
Title
Measurements
OG000-1± 1.94
OG001-1.4± 1.4
OG002-0.6± 2.44
OG003-0.3± 2.07
Calcium
Title
Measurements
OG000-0.0306± 0.14997
OG001-0.2136± 0.12771
OG002-0.0286± 0.08469
OG0030.0373± 0.07016
Cholesterol
Title
Measurements
OG000-0.2701± 0.56002
OG001-0.6503± 0.68612
OG002-0.2843± 0.42535
OG0030.3708± 0.43447
Chloride
Title
Measurements
OG0000.3± 2.5
OG0013± 1.15
OG002-1.0± 1.63
OG003-1.3± 2.16
HDL
Title
Measurements
OG000-0.1438± 0.15951
OG001-0.1849± 0.13459
OG002-0.0777± 0.14711
OG003-0.0948± 0.21847
Potassium
Title
Measurements
OG000-0.09± 0.44
OG001-0.29± 0.261
OG0020± 0.191
OG003-0.22± 0.449
LDL
Title
Measurements
OG000-0.2902± 0.38135
OG001-0.5244± 0.48959
OG002-0.2807± 0.30973
OG003-0.0903± 0.86478
Magnesium
Title
Measurements
OG000-0.0547± 0.09168
OG001-0.0996± 0.06635
OG002-0.0527± 0.05659
OG003-0.0205± 0.06737
Phosphate
Title
Measurements
OG000-0.0573± 0.12367
OG001-0.1477± 0.10973
OG0020.0831± 0.11469
OG0030.0485± 0.09964
Sodium
Title
Measurements
OG0000.6± 1.67
OG0011.3± 0.76
OG002-0.9± 1.07
OG0030.3± 1.97
Triglycerides
Title
Measurements
OG0000.0403± 0.20877
OG001-0.1614± 0.26907
OG0020.0434± 0.20744
OG0030.2577± 0.33429
BUN
Title
Measurements
OG0000.0397± 0.9849
OG0010.408± 0.90851
OG002-0.1020± 1.02466
OG0030.1190± 0.53748
-0.7
± 2.08
OG001-0.3± 1.38
Calcium
Title
Measurements
OG000-0.0913± 0.14160
OG001-0.0391± 0.10029
Cholesterol
Title
Measurements
OG000-0.4483± 0.39167
OG001-0.203± 0.56917
Chloride
Title
Measurements
OG0001.3± 0.58
OG0010.4± 1.62
HDL
Title
Measurements
OG000-0.1037± 0.11860
OG001-0.0703± 0.14776
Potassium
Title
Measurements
OG000-0.10± 0.346
OG001-0.21± 0.418
LDL
Title
Measurements
OG000-0.4137± 0.34187
OG001-0.1107± 0.36147
Magnesium
Title
Measurements
OG0000.0137± 0.02367
OG0010.0059± 0.04981
Phosphate
Title
Measurements
OG0000.0540± 0.10437
OG0010.0464± 0.08088
Sodium
Title
Measurements
OG000-0.3± 1.15
OG001-0.7± 1.5
Triglycerides
Title
Measurements
OG0000.0267± 0.07243
OG0010.0129± 0.25175
BUN
Title
Measurements
OG0000.1190± 0.54533
OG0010.408± 0.32121
Title
Measurements
OG0001.5± 1.96
OG0010.4± 2.12
OG0021.5± 1.64
Calcium
Title
Measurements
OG0000.055± 0.10971
OG0010.0793± 0.10607
OG0020.0666± 0.07293
Cholesterol
Title
Measurements
OG0000.1087± 0.30739
OG0010.1218± 0.3317
OG0020.0569± 0.47643
Chloride
Title
Measurements
OG000-1.2± 2.57
OG001-2.2± 2.14
OG002-1.6± 1.92
HDL
Title
Measurements
OG000-0.0259± 0.13992
OG001-0.0549± 0.12044
OG002-0.0415± 0.1084
Potassium
Title
Measurements
OG000-0.03± 0.422
OG001-0.04± 0.361
OG002-0.17± 0.364
LDL
Title
Measurements
OG0000.219± 0.42617
OG0010.2312± 0.46471
OG0020.0484± 0.55487
Magnesium
Title
Measurements
OG0000.0109± 0.07972
OG0010.0217± 0.06338
OG0020.0109± 0.0883
Phosphate
Title
Measurements
OG000-0.0021± 0.11269
OG001-0.0058± 0.07409
OG002-0.0021± 0.0965
Sodium
Title
Measurements
OG0000.5± 2.47
OG001-1.1± 1.45
OG0020.3± 1.95
Triglycerides
Title
Measurements
OG0000.1558± 0.44508
OG0010.1801± 0.37021
OG0020.0082± 0.30805
BUN
Title
Measurements
OG0000.6426± 0.91715
OG0010.504± 0.81856
OG0020.4046± 1.00855
6
OG0046
OG0056
OG0066
OG0076
-0.7
± 4.46
OG0043.7± 4.76
OG0055.8± 12.02
OG006-1.7± 11.52
OG0073.7± 17.24
Lipase
Title
Measurements
OG0007.8± 25.41
OG001-31
OG002-15.5± 25.76
OG003-8± 20.01
OG004-1.3± 3.93
OG0053.7± 3.67
OG0063.7± 4.27
OG0073.8± 5.19
6
7.2
± 15.30
Lipase
Title
Measurements
OG0003.8± 22.06
OG001-6.3± 8.62
OG0021.1± 2.54
OG0031.2± 2.48
-2.0
± 5.57
OG001-1.9± 4.67
Title
Measurements
OG0000.4± 18.92
OG001-0.6± 6.25
OG0022.7± 10.06
6
OG0046
OG0056
OG0066
OG0076
0.4895
± 0.46819
OG004-0.285± 1.28724
OG0050.2565± 1.18349
OG006-0.3705± 0.86801
OG007-0.855± 1.43069
Total Bilirubin
Title
Measurements
OG000-0.19± 3.2598
OG001-1.71
OG002-0.855± 2.8098
OG0030.57± 0.883
OG0040.285± 2.5171
OG0050.285± 2.7396
OG006-1.71± 2.163
OG007-3.135± 3.8109
Creatinine
Title
Measurements
OG0001.8171± 5.38547
OG001-8.84
OG0026.188± 8.27379
OG0036.0407± 3.93024
OG0044.5673± 8.82968
OG005-0.442± 3.65553
OG0063.978± 4.80135
OG0073.536± 2.56208
6
0.2817
± 1.28814
Total Bilirubin
Title
Measurements
OG0000.19± 3.9593
OG0010.244± 3.6178
OG002-0.977± 2.7674
OG0031.425± 3.8109
Creatinine
Title
Measurements
OG0003.536± 7.48795
OG001-1.768± 5.35289
OG002-0.6314± 4.55680
OG0038.3980± 2.89164
-1.140
± 2.6121
OG0011.71± 1.71
Creatinine
Title
Measurements
OG000-1.1787± 2.55189
OG0012.2731± 2.88068
Title
Measurements
OG0000.456± 1.9886
OG0010.905± 3.7813
OG0021.026± 3.5282
Creatinine
Title
Measurements
OG0003.0645± 6.90318
OG0011.716± 6.168
OG0022.9467± 6.70465
6
OG0046
OG0056
OG0066
OG0076
6.3
± 3.33
OG0041± 4.15
OG0053.7± 2.88
OG0064± 3.85
OG0073.5± 1.97
6
2.0
± 2.83
6
OG0046
OG0056
OG0066
OG0076
1
OG0042
OG0053
OG0061
OG0072
Protein
Title
Measurements
OG0002
OG0012
OG0022
OG0031
OG0040
OG0051
OG0060
OG0071
7
OG0043
OG0057
0
OG0041
OG0053
Protein
Title
Measurements
OG0001
OG0010
OG0022
OG0030
OG0041
OG0051
Title
Measurements
OG0004
OG0012
OG0022
6
OG0046
OG0056
OG0066
OG0076
4.6
± 7.07
OG0042.3± 7.30
OG0051.3± 8.04
OG0062.4± 6.34
OG0075.5± 8.95
DBP
Title
Measurements
OG0004.0± 4.36
OG0011.8
OG0023.0± 8.20
OG0033.7± 9.57
OG0041.7± 6.15
OG005-1.2± 4.05
OG0062.7± 8.13
OG0074.7± 7.06
7
-0.8
± 4.08
DBP
Title
Measurements
OG000-3.4± 8.73
OG0010.8± 7.21
OG0021.4± 5.45
OG0030.0± 6.17
4.2
± 9.56
OG0010.9± 6.52
Title
Measurements
OG0002.3± 4.02
OG0013.4± 8.63
OG0024.4± 5.79
6
OG0046
OG0056
OG0066
OG0076
-0.2
± 3.45
OG0045.9± 2.64
OG0054.8± 5.74
OG006-0.9± 7.98
OG0070.0± 9.71
6
3.0
± 4.75
6
OG0046
OG0056
OG0066
OG0076
-0.05
± 0.226
OG0040.10± 0.190
OG0050.02± 0.117
OG0060.08± 0.286
OG0070.20± 0.155
7
-0.08
± 0.204
6
OG0046
OG0056
OG0066
OG0076
3.7
± 1.03
OG0040.7± 2.07
OG0050.3± 1.51
OG0060.3± 1.51
OG0070.7± 3.27
7
1.2
± 3.13
6
OG0046
OG0056
OG0066
OG0076
0
OG0040
OG0051
OG0060
OG0070
Abnormal - Not Clinically Significant
Title
Measurements
OG00020
OG0014
OG0026
OG0036
OG0046
OG0055
OG0066
OG0076
Abnormal - Clinically Significant
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
7
OG0043
OG0057
0
OG0040
OG0050
Abnormal - Not Clinically Significant
Title
Measurements
OG0009
OG0017
OG0027
OG0037
OG0043
OG0057
Abnormal - Clinically Significant
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
Title
Measurements
OG00014
OG00116
OG00214
Abnormal - Clinically Significant
Title
Measurements
OG0000
OG0010
OG0020
The mixed model was used to estimate Tablet vs. PiB effect for the log transformed parameter AUC (0-24). Analysis was performed using the independent variables included a fixed effect for treatment (PiB or Tablet) and period, and participant as a random effect.
Mixed Models Analysis
Geometric Least Square Mean Ratio
1.381
2-Sided
90
1.223
1.56
Other
The mixed model was used to estimate Tablet vs. PiB effect for the log transformed parameter AUC (0-inf). Analysis was performed using the independent variables included a fixed effect for treatment (PiB or Tablet) and period, and participant as a random effect.
Mixed Models Analysis
Geometric Least Square Mean Ratio
1.351
2-Sided
90
1.22
1.497
Other
The mixed model was used to estimate Tablet vs. PiB effect for the log transformed parameter Cmax. Analysis was performed using the independent variables included a fixed effect for treatment (PiB or Tablet) and period, and participant as a random effect.