GSK3640254 First Time in Human (FTIH) Study in Healthy Vo... | NCT03231943 | Trialant
NCT03231943
Sponsor
ViiV Healthcare
Status
Completed
Last Update Posted
Jun 10, 2021Actual
Enrollment
78Actual
Phase
Phase 1
Conditions
Infection, Human Immunodeficiency Virus
HIV Infections
Interventions
GSK3640254
Placebo
Countries
United Kingdom
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
NCT03231943
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
207187
Secondary IDs
ID
Type
Description
Link
2017-001367-21
EudraCT Number
Brief Title
GSK3640254 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 GSK3640254 in Healthy Participants
Acronym
Not provided
Organization
ViiV HealthcareINDUSTRY
Status Module
Record Verification Date
May 2021
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
Sep 19, 2017Actual
Primary Completion Date
Sep 9, 2018Actual
Completion Date
Sep 9, 2018Actual
First Submitted Date
Jul 24, 2017
First Submission Date that Met QC Criteria
Jul 24, 2017
First Posted Date
Jul 27, 2017Actual
Results Waived
Not provided
Results First Submitted Date
Sep 9, 2019
Results First Submitted that Met QC Criteria
Oct 16, 2019
Results First Posted Date
Oct 18, 2019Actual
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
May 28, 2021
Last Update Posted Date
Jun 10, 2021Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
ViiV HealthcareINDUSTRY
Collaborators
Name
Class
GlaxoSmithKline
INDUSTRY
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
No
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
Human immuno deficiency virus 1 (HIV-1) infections continues to be a serious health threat throughout the world and development of medicines with new mechanism of action have an important role to play. GSK3640254 is a maturation inhibitor (MI) and can be effective in HIV-1 treatment. This randomized, 2-part, single and repeat increasing dose study will collect information on safety, tolerability and drug levels in the body of in healthy subjects for GSK3640254. The information collected in this study will help in further clinical development of GSK3640254, including a Phase IIA Proof of Concept (PoC) study in HIV-infected subjects. Approximately 16 healthy subjects will be randomized to receive single oral dose of GSK3640254 and placebo in Part 1 and approximately 56 healthy subjects will be randomized to receive repeat oral dose of GSK3640254 or placebo in Part 2. All doses will be given immediately after a moderate fat meal. Maximum duration of study participation will be approximately 12 weeks.
Detailed Description
Not provided
Conditions Module
Conditions
Infection, Human Immunodeficiency Virus
HIV Infections
Keywords
FTIH
Healthy
Tolerability
Dose-escalation
HIV-1
Safety
PK
GSK3640254
Maturation inhibitor
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
78Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Subjects in cohort 1-2: Part 1
Experimental
Eligible subjects will participate in cohort 1 or 2 and each of these two cohorts will contain up to four escalating doses of GSK3640254. In each cohort, 6 subjects will be randomized to receive single oral dose of GSK3640254 and 2 subjects will be randomized to receive placebo. Hence, each subject in cohort 1 and 2 will receive up to 3 escalating doses of GSK3640254 and one placebo in crossover manner.
Drug: GSK3640254
Drug: Placebo
GSK3640254 receivers (cohort 3-6 and expansion): Part 2
Experimental
Eligible subjects will participate in one of the 4 cohorts (3,4,5,6). In each cohort, 6 subjects will be randomized to receive a once-daily oral dose of GSK3640254 for 14 days. After the safety data of cohort 3-6 is available, 18 eligible subjects will be randomized to receive once daily oral dose of GSK3640254 for 14 days in expansion cohort.
Drug: GSK3640254
Subjects receiving placebo (cohort 3-6): Part 2
Placebo Comparator
Eligible subjects will participate in one of the 4 cohorts (3,4,5,6). In each cohort, 2 subjects will be randomized to receive a once-daily oral dose of placebo for 14 days. After the safety data of cohort 3-6 is available, 6 eligible subjects will be randomized to receive once daily oral dose of placebo for 14 days in expansion cohort.
Drug: Placebo
Interventions
Name
Type
Description
Arm Group Labels
Other Names
GSK3640254
Drug
GSK3640254 is a capsule available in 1 milligram (mg), 10 mg and 100 mg dosing strength. GSK3640254 capsule will be given via oral route during each dosing day with approximately 240 mL of water.
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Part 1:Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs)
An AE is any untoward medical occurrence in a subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment will be categorized as SAE. Results are presented treatment wise.
Up to Day 15
Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets.
Blood samples were collected to analyze the hematology parameters: basophils, eosinophils, leukocytes, lymphocytes, monocytes, neutrophils and platelets. Day -2 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Results are presented treatment wise.
Baseline (Day -2), 24 hours, 48 hours, 96 hours and Follow up (Day 15)
Part 1: Change From Baseline in Hematology Parameters: Erythrocytes.
Blood samples were collected to analyze the hematology parameters: erythrocytes. Day -2 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.Results are presented treatment wise.
Baseline (Day -2), 24 hours, 48 hours, 96 hours and Follow up (Day 15)
Part 1: Change From Baseline in Hematology Parameters: Erythrocytes Mean Corpuscular Volume (Erythrocyte MCV).
Blood samples were collected to analyze the hematology parameters: erythrocyte MCV. Day -2 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Baseline (Day -2), 24 hours, 48 hours, 96 hours and Follow up (Day 15)
Secondary Outcomes
Measure
Description
Time Frame
Part 1: Area Under the Plasma Concentration Time Curve (AUC) From Zero to 24 Hour (AUC[0-24]) of GSK3640254
Blood samples were collected at indicated time points and PK analysis was performed. PK parameters were determined by non-compartmental methods with Phoenix WinNonlin. Results are presented treatment wise.
Pre-dose and 0.5,1,1.5,2,2.5,3,3.5,4,4.5,5,6,8,12,24 hours post-dose
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Subjects must be 18 to 55 years of age inclusive, at the time of signing the informed consent.
Subjects who are overtly healthy as determined by medical evaluation including medical history and psychiatric history, physical examination, laboratory tests, and 24 hour Holter monitoring.
Body weight >=50.0 kilogram (kg) (110 pounds) for men and 45.0kg (99 pounds) for women and body mass index (BMI) within the range 18.5-32.0 kg per meter square (kg/m^2) (inclusive).
Male or female subjects. A male subject must agree to use contraception during the treatment period and for at least 14 weeks following the last dose, corresponding to the time needed to eliminate study treatment for potential genotoxic and teratogenic study treatments plus an additional 90 days (spermatogenesis cycle). In addition, male subjects must refrain from donating sperm during this period. A female subject is eligible to participate if she is not a woman of childbearing potential (WOCBP).
Capable of giving signed informed consent.
Exclusion Criteria:
Alanine transaminase (ALT) >1.5 into upper limit of normal (ULN).
Bilirubin >1.5 into ULN (isolated bilirubin >1.5 into ULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).
Current or chronic history of liver disease, or known hepatic or biliary abnormalities.
Pre-existing clinically relevant, in the opinion of the primary investigator (PI), gastro-intestinal pathology or diagnosis - example irritable bowel syndrome, inflammatory bowel disease, and/or significant Baseline signs and symptoms.
Medical history of cardiac arrhythmias or cardiac disease or a family or personal history of long QT syndrome.
Any known or suspected pre-existing psychiatric condition.
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 subject 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.
Unable to refrain from the use of prescription or non-prescription drugs (with the exception of paracetamol), including vitamins, herbal and dietary supplements (including St John's Wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the first dose of study medication and for the duration of the study, unless in the opinion of the Investigator and ViiV Healthcare Sponsor and medical monitor, the medication will not interfere with the study medications, procedures, or compromise subject 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 treatment(s) or until the end of the study.
Participation in another concurrent clinical study or prior clinical study (with the exception of imaging trials) prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).
Where participation in the study would result in donation of blood or blood products in excess of 500 milliliter (mL) within 56 days.
Presence of hepatitis B surface antigen (HBsAg), or positive hepatitis C antibody test result at screening or within 3 months prior to first dose of study treatment.
A positive pre-study drug/alcohol screen.
A positive test for a diagnostic HIV-1 polymerase chain reaction (PCR).
Exposure to more than four new chemical entities within 12 months prior to the first dosing day.
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.
Evidence of previous myocardial infarction (does not include ST segment changes associated with re-polarization).
Any conduction abnormality (including but not specific to left or right complete bundle branch block, Atrioventricular block [2nd degree or higher], Wolff-Parkinson-White [WPW] syndrome).
Sinus Pauses >3 seconds.
Any significant arrhythmia which, in the opinion of the Investigator or GlaxoSmithKline/ViiV medical monitor, will interfere with the safety for the individual subject.
Non-sustained or sustained ventricular tachycardia (3 consecutive ventricular ectopic beats).
History of regular alcohol consumption within 6 months of the study defined as: an average weekly intake of >14 units. One unit is equivalent to 8 gram of alcohol: a half-pint approximately 240 mL of beer, 1 glass (125 mL) of wine or 1 (25 mL) measure of spirits.
Regular use of tobacco- or nicotine-containing products within 3 months prior to screening.
History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the Investigator or medical monitor, contraindicates their participation.
Joshi SR, Fernando D, Igwe S, McKenzie L, Krishnatry AS, Halliday F, Zhan J, Greene TJ, Xu J, Ferron-Brady G, Lataillade M, Min S. Phase I evaluation of the safety, tolerability, and pharmacokinetics of GSK3640254, a next-generation HIV-1 maturation inhibitor. Pharmacol Res Perspect. 2020 Dec;8(6):e00671. doi: 10.1002/prp2.671.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
Plan to Share IPD
Yes
Description
IPD for this study is available via the Clinical Study Data Request site.
Types
Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame
IPD is available via the Clinical Study Data Request site (copy the URL below to your browser)
Access Criteria
Access is provided after a research proposal is submitted and has received approval from the 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 can be granted, when justified, for up to another 12 months.
Total 78 participants were enrolled in the study. This was a two part study, Part 1 was single ascending dose (SAD) and Part 2 was multiple ascending dose (MAD).
Recruitment Details
This study was conducted to evaluate safety, tolerability and pharmacokinetic (PK) of GSK3640254 in healthy participants at one center in United Kingdom from 19-September-2017 to 09-September-2018
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Part 1: Placebo Followed by GSK3640254 10mg/100mg/400mg
Participants received single dose placebo followed by GSK3640254 10 milligram (mg) followed by GSK3640254 100 mg followed by GSK3640254 400 mg oral dose on Day 1
FG001
Part 1: GSK3640254 1mg/ Placebo /100 mg/400 mg
Participants received single dose GSK3640254 1mg followed by placebo followed by GSK3640254 100 mg followed by GSK3640254 400 mg oral dose on Day 1
FG002
Part 1: GSK3640254 1mg/10mg/Placebo /400mg
Participants received single dose GSK3640254 1mg followed by GSK3640254 10 mg followed by placebo followed by GSK3640254 400 mg oral dose on Day 1
FG003
Part 1: GSK3640254 1mg/10mg/100mg/Placebo
Participants received single dose GSK3640254 1mg followed by GSK3640254 10 mg followed by GSK3640254 100 mg followed by placebo as oral dose on Day 1
FG004
Part 1: Placebo/ GSK3640254 30mg/200 mg/700 mg
Participants received single dose placebo followed by GSK3640254 30mg followed by GSK3640254 200 mg followed by GSK3640254 700 mg as oral dose on Day 1
FG005
Part1:GSK3640254 3mg/Placebo/200mg/700mg
Participants received single dose GSK3640254 3mg followed by placebo followed by GSK3640254 200 mg followed by GSK3640254 700 mg as oral dose on Day 1
FG006
Part 1:GSK3640254 3mg/30mg/Placebo/GSK3640254 700mg
Participants received single dose GSK3640254 3 mg followed by GSK3640254 30 mg followed by placebo followed by GSK3640254 700 mg as oral dose on Day 1
FG007
Part 1:GSK3640254 3mg/30mg/GSK3640254 200mg/Placebo
Participants received single dose GSK3640254 3mg followed by GSK3640254 30mg followed by GSK3640254 200mg followed by placebo as oral dose on Day 1
FG008
Part 2: Repeated Dose GSK3640254 50 mg
Participants received repeated dose of GSK3640254 50 mg once daily up to 14 days
FG009
Part 2: Repeated Dose GSK3640254 100mg
Participants received repeated dose of GSK3640254 100 mg once daily up to 14 days
FG010
Part 2: GSK3640254 200mg + Expansion
Participants received repeated dose of GSK3640254 200 mg once daily up to 14 days
FG011
Part 2: Repeated Dose GSK3640254 320mg
Participants received repeated dose of GSK3640254 320 mg once daily up to 14 days
FG012
Part 2: Repeated Dose Placebo
Participants received repeated dose of matching placebo once daily up to 14 days
Periods
Title
Milestones
Reasons Not Completed
Part 1, Period 1 (up to Day 15)
Type
Comment
Milestone Data
STARTED
FG0002 subjects
FG0012 subjects
FG0022 subjects
FG0032 subjects
FG004
COMPLETED
FG0002 subjects
FG0012 subjects
FG0022 subjects
FG0032 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Part 1, Period 2 (up to Day 30)
Type
Comment
Milestone Data
STARTED
FG0002 subjects
FG0012 subjects
FG0022 subjects
FG003
Part 1, Period 3 (up to Day 45)
Type
Comment
Milestone Data
STARTED
FG0002 subjects
FG0012 subjects
FG0022 subjects
FG003
Part 1 Period 4 (up to Day 60)
Type
Comment
Milestone Data
STARTED
FG0002 subjects
FG0012 subjects
FG0022 subjects
FG003
Part 2
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
Participants received GSK3640254 1mg, GSK3640254 10 mg, GSK3640254 100mg, GSK3640254 400mg as ascending single dose on Day 1 of each period, each participant received placebo in one of the four periods
BG001
Part 1: Cohort 2
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, Categorical
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 Participants With Adverse Events (AEs) and Serious AEs (SAEs)
An AE is any untoward medical occurrence in a subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment will be categorized as SAE. Results are presented treatment wise.
Safety Population. It is comprised of all participants who received at least one dose of a study treatment.
Posted
Count of Participants
Participants
Up to Day 15
ID
Title
Description
OG000
Part 1: GSK3640254 1 mg
Participants received single dose of GSK3640254 1 mg following a moderate fat meal on Day 1
Adverse Events Module
Frequency Threshold
5
Time Frame
On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Description
Safety Population was used to collect the adverse events
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
Part 1:GSK3640254 1 mg
Participants received single dose of GSK3640254 1 mg following a moderate fat meal on Day 1
This is a dose-escalation study and dose will be escalated based on the safety data of the initial dose.
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 subjects and the site-staff blinded and sponsor unblinded.
Who Masked
ParticipantInvestigator
GSK3640254 receivers (cohort 3-6 and expansion): Part 2
Subjects in cohort 1-2: Part 1
Placebo
Drug
Placebo capsule matching to the study treatment will be given via oral route during each dosing day with approximately 240 mL of water.
Subjects in cohort 1-2: Part 1
Subjects receiving placebo (cohort 3-6): Part 2
Part 1: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin (Erythrocyte MCH)
Blood samples were collected to analyze the hematology parameter: Erythrocyte MCH. Day -2 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.Results are presented treatment wise.
Baseline (Day -2), 24 hours, 48 hours, 96 hours and Follow up (Day 15)
Part 1: Change From Baseline in Hematology Parameter: Hematocrit
Blood samples were collected to analyze the hematology parameter: hematocrit. Day -2 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Results are presented treatment wise.
Baseline (Day -2), 24 hours, 48 hours, 96 hours and Follow up (Day 15)
Part 1: Change From Baseline in Hematology Parameter: Percentage of Reticulocytes
Blood samples were collected to analyze the hematology parameter: percentage of reticulocytes. Day -2 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Results are presented treatment wise.
Baseline (Day -2), 24 hours, 48 hours, 96 hours and Follow up (Day 15)
Part 1: Change From Baseline in Hematology Parameter: Hemoglobin (Hb)
Blood samples were collected to analyze the hematology parameter: Hb. Day -2 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Results are presented treatment wise.
Baseline (Day -2), 24 hours, 48 hours, 96 hours and Follow up (Day 15)
Part 1: Change From Baseline in Clinical Chemistry Parameter: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphate (ALP)
Blood samples were collected to analyze the chemistry parameter: ALT, AST, and ALP. Day -2 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Results are presented treatment wise.
Baseline (Day -2), 24 hours, 48 hours, 96 hours and Follow up (Day 15)
Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea
Blood samples were collected to analyze the chemistry parameter: bicarbonate, calcium, chloride, magnesium, phosphate, potassium, sodium, urea. Day -2 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Results are presented treatment wise.
Baseline (Day -2), 24 hours, 48 hours, 96 hours and Follow up (Day 15)
Part 1: Change From Baseline in Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Cholesterol (LDL) Cholesterol, Triglycerides
Blood samples were collected to analyze the chemistry parameter: cholesterol, glucose, HDL cholesterol, LDL cholesterol, triglycerides. Day -2 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Results are presented treatment wise.
Baseline (Day -2) and Day 1 (96 hours) and Follow up (Day 15)
Part 1: Change From Baseline in Chemistry Parameter: Glucose
Blood samples were collected to analyze the chemistry parameter: glucose . Day -2 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Results are presented treatment wise.
Baseline (Day -2) and Day 1 (96 hours) and Follow up (Day 15)
Part 1: Change From Baseline in Clinical Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin
Blood samples were collected to analyze the chemistry parameter: bilirubin, creatinine, direct bilirubin . Day -2 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Results are presented treatment wise.
Baseline (Day -2), 24 hours, 48 hours, 96 hours and Follow up (Day 15)
Part 1: Change From Baseline in Clinical Chemistry Parameter: Protein
Blood samples were collected to analyze the chemistry parameter: Protein. Day -2 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Baseline (Day -2), 24 hours, 48 hours, 96 hours and Follow up (Day 15)
Part 1: Number of Participants With Abnormal Urinalysis
Urine samples were collected at given time points to analyze the abnormal findings for potential of hydrogen (pH), glucose, protein, blood, ketones, bilirubin, urobilinogen, nitrite, leukocyte esterase by dipstick.
Up to Day 15
Part 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
SBP and DBP were measured in semi-supine position after 5 minutes rest for the participants at indicated time points. Day -1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Results are presented treatment wise.
Baseline (Day -1), 1,2,4.5,6,12,24,48,72,96 hours post dose and Follow up (Day 15)
Part 1: Change From Baseline in Vital Signs: Pulse Rate
Pulse rate was measured in semi-supine position after 5 minutes rest for the participants at indicated time points. Day -1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Results are presented treatment wise.
Baseline (Day -1), 1,2,4.5,6,12,24,48,72,96 hours post dose and Follow up (Day 15)
Part 1: Change From Baseline in Vital Signs: Temperature
Temperature was measured in semi-supine position after 5 minutes rest for the participants at indicated time points. Day -1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Results are presented treatment wise.
Baseline (Day -1), 1,2,4.5,6,12,24,48,72,96 hours post dose and Follow up (Day 15)
Part 1: Change From Baseline in Vital Sign: Respiratory Rate
Respiratory rate was measured in semi-supine position after 5 minutes rest for the participants at indicated time points. Day -1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Results are presented treatment wise.
Baseline (Day -1), 1,2,4.5,6,12,24,48,72,96 hours post dose and Follow up (Day 15)
Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings
12-lead ECGs were measured in a semi-supine position using an automated ECG machine after approximately 5 minutes of rest for the participant. Abnormal findings were categorized as clinically significant (CS) and not clinically significant (NCS).
Baseline (Day 1 predose), 1,2,4,6,12,24,48,72,96 hours post dose and Follow up (Day 15)
Part 2: Number of Participants AEs and SAEs
An AE is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment were categorized as SAE. Results are presented treatment wise.
Up to Day 28
Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets.
Blood samples were collected at indicated time points to analyze the hematology parameters: basophils, eosinophils, leukocytes, lymphocytes, monocytes, neutrophils and platelets. Day -2 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Results are presented treatment wise.
Baseline (Day -2), Pre dose on Days 2,4,6,8,10,12,14 Day 14 : 48 and 96 hours post dose, Follow up (Day 28)
Part 2: Change From Baseline in Hematology Parameter: Erythrocytes
Blood samples were collected at indicated time points to analyze the hematology parameters: Erythrocytes. Day -2 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Baseline (Day -2), Pre dose on Days 2,4,6,8,10,12,14 Day 14: 48 and 96 hours post dose, Follow up (Day 28)
Part 2: Change From Baseline in Hematology Parameter: Erythrocytes MCV
Blood samples were collected at indicated time points to analyze the hematology parameters: Erythrocyte MCV. Day -2 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Baseline (Day -2), pre dose on Days 2,4,6,8,10,12,14 Day 14: 48 and 96 hours post dose, Follow up (Day 28)
Part 2: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin (Erythrocyte MCH)
Blood samples were collected at indicated time points to analyze the hematology parameter: Erythrocyte MCH. Day -1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Baseline (Day -2), pre dose on Days 2,4,6,8,10,12,14 Day 14: 48 and 96 hours post dose, Follow up (Day 28)
Part 2: Change From Baseline in Hematology Parameter: Hematocrit
Blood samples were collected at indicated time points to analyze the hematology parameter: hematocrit. Day -2 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Results are presented treatment wise.
Baseline (Day -2), pre dose on Days 2,4,6,8,10,12,14 Day 14: 48 and 96 hours post dose, Follow up (Day 28)
Part 2: Change From Baseline in Hematology Parameter: Percentage of Reticulocytes
Blood samples were collected to analyze the hematology parameter: percentage of reticulocytes. Day -2 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Results are presented treatment wise.
Baseline (Day -2), pre dose on Days 2,4,6,8,10,12,14 Day 14: 48 and 96 hours post dose, Follow up (Day 28)
Part 2: Change From Baseline in Hematology Parameter: Hb
Blood samples were collected at indicated time points to analyze the hematology parameter: Hb. Day -2 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Baseline (Day -2), pre dose on Days 2,4,6,8,10,12,14 Day 14: 48 and 96 hours post dose, Follow up (Day 28)
Part 2: Change From Baseline in Chemistry Parameter: ALT, AST,ALP
Blood samples were collected to analyze the chemistry parameter: ALT, AST,ALP. Day -2was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Results are presented treatment wise.
Baseline (Day -2), pre dose on Days 2,4,6,8,10,12,14 Day14: 48 and 96 hours post dose, Follow up (Day 28)
Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea
Blood samples were collected to analyze the chemistry parameter: bicarbonate, calcium, chloride, magnesium, phosphate, potassium, sodium, urea. Day -2 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Baseline (Day -2), pre dose on Days 2,4,6,8,10,12,14 Day 14: 48 and 96 hours post dose, Follow up (Day 28)
Part 2: Change From Baseline in Cholesterol, HDL Cholesterol, LDL Cholesterol, Triglycerides
Blood samples were collected at indicated time points to analyze the chemistry parameter: cholesterol, HDL cholesterol, LDL cholesterol, triglycerides. Day -2 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Results are presented treatment wise.
Baseline (Day -2), Day 8 (pre dose), Day 14 (48 hours) post dose and Follow up (Day 28)
Part 2: Change From Baseline in Chemistry Parameter: Glucose
Blood samples were collected at indicated time points to analyze the chemistry parameter: glucose . Day -2 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Results are presented treatment wise.
Baseline (Day -2), Day 8 (predose), Day 14 (48 hours) post dose and Follow up (Day 28)
Part 2: Change From Baseline in Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin
Blood samples were collected to analyze the chemistry parameter: bilirubin, creatinine, direct bilirubin . Day -2 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Results are presented treatment wise.
Baseline (Day -2), pre dose on Days 2,4,6,8,10,12,14 Day 14: 48 and 96 hours post dose, Follow up (Day 28)
Part 2: Change From Baseline in Chemistry Parameter: Protein
Blood samples were collected to analyze the chemistry parameter: Protein. Day -2 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Results are presented treatment wise.
Baseline (Day -2), pre dose on Days 2,4,6,8,10,12,14 Day 14: 48 and 96 hours post dose, Follow up (Day 28)
Part 2: Number of Participants With Abnormal Urinalysis
Urine samples were collected analyze the abnormal findings for potential of hydrogen (pH), glucose, protein, blood, ketones, bilirubin, urobilinogen, nitrite, leukocyte esterase by dipstick.
Up to Day 28
Part 2: Change From Baseline in Vital Signs: SBP and DBP
SBP and DBP were measured in semi-supine position after 5 minutes rest for the participants at indicated time points. Day -1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Results are presented treatment wise.
Baseline (Day -1), pre dose on Days 1,2,4,6,8,10,12,and 14 (pre dose and 72 hours) and Follow up (Day 28)
Part 2: Change From Baseline in Vital Sign: Pulse Rate
Pulse rate was measured in semi-supine position after 5 minutes rest for the participants at indicated time points. Day -1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Baseline (Day -1), pre dose on Days 1,2,4,6,8,10,12, and 14 (pre dose and 72 hours) and Follow up (Day 28)
Part 2: Change From Baseline in Vital Sign: Temperature
Temperature was measured in semi-supine position after 5 minutes rest for the participants at indicated time points. Day -1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Results are presented treatment wise.
Baseline (Day -1), pre dose on Days 1,2,4,6,8,10,12, and 14 (pre dose and 72 hours) and Follow up (Day 28)
Part 2: Change From Baseline in Vital Sign: Respiratory Rate
Respiratory rate was measured in semi-supine position after 5 minutes rest for the participants at indicated time points. Day -1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Results are presented treatment wise.
Baseline (Day -1), pre dose on Days 1,2,4,6,8,10,12 and 14 (pre dose and 72 hours) and Follow up (Day 28)
Part 2: Number of Participants With Abnormal ECG Findings
12-lead ECG were obtained at given time points. Abnormal findings were categorized as clinically significant (CS) and not clinically significant (NCS).Results are presented treatment wise.
Day 1 (0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4.5, 5, 5.5, 6, 8, 12, 24 hours); Pre-dose on Days 3, 4, 6, 8, 10, 12; Day 14: Pre-dose, 1, 2, 4.5, 5, 6, 12, 24, 48, 72 and 96 hours post-dose and follow up (Day 28)
Part 1: AUC From Zero to Time of Last Sample Taken (AUC[0-Tlast]) of GSK3640254
Blood samples were collected at indicated time points and PK analysis was performed. PK parameters were determined by non-compartmental methods with Phoenix WinNonlin. Results are presented treatment wise.
Pre-dose and 0.5,1,1.5,2,2.5,3,3.5,4,4.5,5,6,8,12, 24, 48, 72 and 96 hours post-dose
Part 1: AUC From Time Zero (Pre-dose) Extrapolated to Infinite Time (AUC[0-inf]) of GSK3640254
Blood samples were collected at indicated time points and PK analysis was performed. PK parameters were determined by non-compartmental methods with Phoenix WinNonlin. Results are presented treatment wise.
Pre-dose and 0.5,1,1.5,2,2.5,3,3.5,4,4.5,5,6,8,12, 24, 48, 72 and 96 hours post-dose
Part 1: Apparent Terminal Phase Half-life (T1/2) of GSK3640254
Blood samples were collected at indicated time points and PK analysis was performed. PK parameters were determined by non-compartmental methods with Phoenix WinNonlin. Most of the concentrations were below limit of quantification (BLQ) at this dose group this value and/ or %AUC extrapolated was >20% for all participants so this value should be used with caution. Results are presented treatment wise.
Pre-dose and 0.5,1,1.5,2,2.5,3,3.5,4,4.5,5,6,8,12, 24, 48, 72 and 96 hours post-dose
Part 1: Apparent Oral Clearance (CL/F) of GSK3640254
Blood samples were collected at indicated time points and PK analysis was performed. PK parameters were determined by non-compartmental methods with Phoenix WinNonlin. Results are presented treatment wise.
Pre-dose and 0.5,1,1.5,2,2.5,3,3.5,4,4.5,5,6,8,12, 24, 48, 72 and 96 hours post-dose
Part 1: Maximum Observed Concentration (Cmax), Concentration of GSK3640254 at 24 Hours (C24) and Last Quantifiable Concentration (Clast) of GSK3640254
Blood samples were collected at indicated time points and PK analysis was performed. PK parameters were determined by non-compartmental methods with Phoenix WinNonlin.
Pre-dose and 0.5,1,1.5,2,2.5,3,3.5,4,4.5,5,6,8,12, 24, 48, 72 and 96 hours post-dose
Part 1: Time of Occurrence of Cmax (Tmax), Lag Time (Tlag), and Time to Reach Clast (Tlast) of GSK3640254
Blood samples were collected at indicated time points and PK analysis was performed. PK parameters were determined by non-compartmental methods with Phoenix WinNonlin. Results are presented treatment wise.
Pre-dose and 0.5,1,1.5,2,2.5,3,3.5,4,4.5,5,6,8,12, 24, 48, 72 and 96 hours post-dose
Part 2: AUC(0-24) of GSK3640254: Day 1
Blood samples were collected at indicated time points and PK analysis was performed. PK parameters were determined by non-compartmental methods with Phoenix WinNonlin. Results are presented treatment wise.
Pre-dose and 0.5,1,1.5,2,2.5,3,3.5,4,4.5,5,6,8,12 and 24 hours post-dose on Day 1
Part 2: Cmax, C24 of GSK3640254 on Day 1
Blood samples were collected at indicated time points and PK analysis was performed. PK parameters were determined by non-compartmental methods with Phoenix WinNonlin. Results are presented treatment wise.
Pre-dose and 0.5,1,1.5,2,2.5,3,3.5,4,4.5,5,6,8,12 hours post-dose on Day 1
Part 2: Tmax, Tlag of GSK3640254 on Day 1
Blood samples were collected at indicated timepoints and PK analysis was performed. PK parameters were determined by non-compartmental methods with Phoenix WinNonlin.
Pre-dose and 0.5,1,1.5,2,2.5,3,3.5,4,4.5,5,6,8,12 hours post-dose on Day 1
Part 2: Tmax GSK3640254 on Day 14
Blood samples were collected at indicated time points and PK analysis was performed. PK parameters were determined by non-compartmental methods with Phoenix WinNonlin. Results are presented treatment wise.
Pre-dose and 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72 and 96 hours after Day 14 dose
Part 2: Cmax of GSK3640254 on Day 14
Blood samples were collected at indicated time points and PK analysis was performed. PK parameters were determined by non-compartmental methods with Phoenix WinNonlin. Results are presented treatment wise.
Pre-dose and 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72 and 96 hours after Day 14 dose
Part 2: AUC From Pre-dose to the End of the Dosing Interval at Steady State (AUC[0-tau]): Day 14
Blood samples were collected at indicated time points and PK analysis was performed. PK parameters were determined by non-compartmental methods with Phoenix WinNonlin. Results are presented treatment wise.
Pre-dose and 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24 hours after Day 14 dose
Part 2: Plasma Trough Concentration (Ctau) of GSK3640254: Day 14
Blood samples were collected at indicated timepoints and PK analysis was performed. PK parameters were determined by non-compartmental methods with Phoenix WinNonlin. The PK parameter name for Part 2 (Day 14) trough concentration was changed using Phoenix WinNonlin 8 from Ct to Ctrough. Day 15 Ctrough values were used for dose proportionality and time to steady-state assessments.
Pre-dose and 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72 and 96 hours after Day 14 dose
Part 2: T1/2 of GSK3640254: Day 14
Blood samples were collected at indicated time points and PK analysis was performed. PK parameters were determined by non-compartmental methods with Phoenix WinNonlin. Results are presented treatment wise.
Pre-dose and 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72 and 96 hours after Day 14 dose
Part 2: CL/F of GSK3640254: Day 14
Blood samples were collected at indicated time points and PK analysis was performed. PK parameters were determined by non-compartmental methods with Phoenix WinNonlin.
Pre-dose and 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72 and 96 hours after Day 14 dose
Part 1: Dose Proportionality (AUC[0-inf]) Following Single Dose of GSK3640254 on Day 1
Blood samples were collected at indicated time points and PK analysis was performed. Dose proportionality was assessed using the power model. Results are presented treatment wise.
Pre-dose and 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72 and 96 hours post dose
Part 1: Dose Proportionality (AUC0-24) Following Single Dose of GSK3640254 on Day 1
Blood samples were collected at indicated time points and PK analysis was performed. Dose proportionality was assessed using the power model. Results are presented treatment wise.
Pre-dose and 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24 hours post dose
Part 1: Dose Proportionality for Cmax Following Single Dose of GSK3640254 on Day 1
Blood samples were collected at indicated time points and PK analysis was performed. Dose proportionality was assessed using the power model. Results are presented treatment wise.
Pre-dose and 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72 and 96 hours post dose
Part 2: Dose Proportionality (AUC0-tau) Following Repeated Dose of GSK3640254 on Day 14
Blood samples were collected at indicated time points and PK analysis was performed. Dose proportionality was assessed using the power model. Results are presented treatment wise.
Pre-dose and 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72 and 96 hours after Day 14 dose
Part 2: Dose Proportionality (Ctrough) Following Repeated Dose of GSK3640254 on Day 14
Blood samples were collected at indicated time points and PK analysis was performed. Dose proportionality was assessed using the power model. Results are presented treatment wise.
Pre-dose and 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72 and 96 hours after Day 14 dose
Part 2: Dose Proportionality (Cmax) Following Repeated Dose of GSK3640254 on Day 14
Blood samples were collected at indicated time points and PK analysis was performed. Dose proportionality was assessed using the power model. Results are presented treatment wise.
Pre-dose and 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72 and 96 hours after Day 14 dose
Part 2: Accumulation Ratio of AUC(0-tau) (R [AUC{0-TAU}]) From Day 1 to Day 14
Blood samples were collected at indicated time points and PK analysis was performed. PK parameters were determined by non-compartmental methods with Phoenix WinNonlin. The accumulation ratio was estimated by calculating the ratio of the geometric least squares (GLS) means of PK parameters between Day 14 and Day 1, and the corresponding 90% CI for each dose. Ratio and 90% confidence interval is presented. Results are presented treatment wise.
Pre-dose and 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72 and 96 hours after Day 14 dose
Part 2: Accumulation Ratio of Cmax (R [CMAX]) From Day 1 to Day 14
Blood samples were collected at indicated time points and PK analysis was performed. PK parameters were determined by non-compartmental methods with Phoenix WinNonlin. The accumulation ratio was estimated by calculating the ratio of the geometric least squares (GLS) means of PK parameters between Day 14 and Day 1, and the corresponding 90% CI for each dose. Ratio and 90% confidence interval is presented. Results are presented treatment wise.
Pre-dose and 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72 and 96 hours after Day 14 dose
Part 2: Accumulation Ratio of C(Tau) (R[CTAU]) From Day 2 to Day 15
Blood samples were collected at indicated time points and PK analysis was performed. PK parameters were determined by non-compartmental methods with Phoenix WinNonlin. The accumulation ratio was estimated by calculating the ratio of the geometric least squares (GLS) means of PK parameters between Day 15 and Day 2, and the corresponding 90% CI for each dose. Ratio and 90% confidence interval is presented. Results are presented treatment wise.
Pre-dose and 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72 and 96 hours after Day 15 dose
Part 2: Pre-dose Concentration of GSK3640254 on Day 2 to Day 14
Blood samples were collected at indicated time points and PK analysis was performed. PK parameters were determined by non-compartmental methods with Phoenix WinNonlin. results are presented treatment wise.
Pre-dose on Days 2,3,4,6,8,10,12 and 14
Part 2: Dose Proportionality (Cmax) Following Repeated Dose of GSK3640254 at Day 1
Blood samples were collected at indicated time points and PK analysis was performed. Dose proportionality was assessed using the power model. Results are presented treatment wise.
Pre-dose and 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72 and 96 hours post dose
Part 2: Dose Proportionality (AUC0-24) Following Repeated Dose of GSK3640254 at Day 1
Blood samples were collected at indicated time points and PK analysis was performed. Dose proportionality was assessed using the power model. Results are presented treatment wise.
Pre-dose and 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72 and 96 hours post dose
2 subjects
FG0052 subjects
FG0062 subjects
FG0072 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
2 subjects
FG0052 subjects
FG0062 subjects
FG0072 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
2 subjects
FG0042 subjects
FG0052 subjects
FG0062 subjects
FG0072 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
COMPLETED
FG0002 subjects
FG0010 subjectsTwo participants withdrawn were replaced
FG0021 subjectsOne participant withdrawn was replaced
FG0032 subjects
FG0042 subjects
FG0052 subjects
FG0062 subjects
FG0072 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
NOT COMPLETED
FG0000 subjects
FG0012 subjects
FG0021 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0011 subjects
FG0021 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
Withdrawal by Subject
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
2 subjects
FG0042 subjects
FG0052 subjects
FG0062 subjects
FG0072 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
COMPLETED
FG0001 subjectsOne participant withdrawn was replaced
FG0012 subjects
FG0022 subjects
FG0032 subjects
FG0042 subjects
FG0052 subjects
FG0062 subjects
FG0072 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
NOT COMPLETED
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
Type
Comment
Reasons
Adverse Event
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
2 subjects
FG0042 subjects
FG0052 subjects
FG0062 subjects
FG0072 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
COMPLETED
FG0002 subjects
FG0012 subjects
FG0022 subjects
FG0032 subjects
FG0042 subjects
FG0052 subjects
FG0062 subjects
FG0072 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
NOT COMPLETED
FG0000 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
0 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0086 subjects
FG0096 subjects
FG01025 subjects
FG0117 subjects
FG01214 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0086 subjects
FG0096 subjects
FG01024 subjects
FG0116 subjects
FG01214 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0101 subjects
FG0111 subjects
FG0120 subjects
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0101 subjects
FG0110 subjects
FG0120 subjects
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Participants received GSK3640254 3mg, GSK3640254 30 mg, GSK3640254 200mg, GSK3640254 700mg as ascending single dose on Day 1 of each period, each participant received placebo in one of the four periods
BG002
Part 2: Repeated Dose GSK3640254 50 mg
Participants received repeated dose of GSK3640254 50 mg once daily up to 14 days
BG003
Part 2: Repeated Dose GSK3640254 100 mg
Participants received repeated dose of GSK3640254 100 mg once daily up to 14 days
BG004
Part 2: Repeated Dose GSK3640254 200 mg + Expansion
Participants received repeated dose of GSK3640254 200 mg once daily up to 14 days
BG005
Part 2: Repeated Dose GSK3640254 320 mg
Participants received repeated dose of GSK3640254 320 mg once daily up to 14 days
BG006
Part 2: Repeated Dose Placebo
Participants received repeated dose of matching placebo once daily up to 14 days
BG007
Total
Total of all reporting groups
12
BG0018
BG0026
BG0036
BG00425
BG0057
BG00614
BG00778
Participants
Title
Denominators
Categories
Title
Measurements
<=18 years
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
Between 18 and 65 years
BG00012
BG0018
BG0026
BG0036
BG004
>=65 years
BG0000
BG0010
BG0020
BG0030
BG004
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
Male
BG00012
BG0018
BG0026
BG0036
BG004
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
ASIAN - CENTRAL/SOUTH ASIAN HERITAGE
Title
Measurements
BG0002
BG0010
BG0020
BG0030
BG0040
BG0051
BG0060
BG0073
BLACK OR AFRICAN AMERICAN
Title
Measurements
BG0001
BG0011
BG0021
BG003
WHITE-WHITE/CAUCASIAN/EUROPEAN HERITAGE
Title
Measurements
BG0009
BG0016
BG0025
BG003
MULTIPLE
Title
Measurements
BG0000
BG0011
BG0020
BG003
ASIAN - EAST ASIAN HERITAGE
Title
Measurements
BG0000
BG0010
BG0020
BG003
ASIAN - SOUTH EAST ASIAN HERITAGE
Title
Measurements
BG0000
BG0010
BG0020
BG003
WHITE - ARABIC/NORTH AFRICAN HERITAGE
Title
Measurements
BG0000
BG0010
BG0020
BG003
OG001
Part 1: GSK3640254 3 mg
Participants received single dose of GSK3640254 3 mg following a moderate fat meal on Day 1
OG002
Part 1: GSK3640254 10 mg
Participants received single dose of GSK3640254 10 mg following a moderate fat meal on Day 1
OG003
Part 1: GSK3640254 30mg
Participants received single dose of GSK3640254 30 mg following a moderate fat meal on Day 1
OG004
Part 1: GSK3640254 100 mg
Participants received single dose of GSK3640254 100 mg following a moderate fat meal on Day 1
OG005
Part 1: GSK3640254 200 mg
Participants received single dose of GSK3640254 200 mg following a moderate fat meal on Day 1
OG006
Part 1: GSK3640254 400 mg
Participants received single dose of GSK3640254 400 mg following a moderate fat meal on Day 1
OG007
Part 1: GSK3640254 700 mg
Participants received single dose of GSK3640254 700 mg following a moderate fat meal on Day 1
OG008
Part 1: Single Dose Placebo
Participants received single dose of matching placebo following a moderate fat meal on Day 1
Units
Counts
Participants
OG0006
OG0016
OG0026
OG0036
OG0046
OG0056
OG0066
OG0076
OG00816
Title
Denominators
Categories
AE
Title
Measurements
OG0003
OG0012
OG0024
OG0033
OG0043
OG0054
OG0064
OG0071
OG0087
SAE
Title
Measurements
OG0000
OG0010
OG0020
OG003
Primary
Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets.
Blood samples were collected to analyze the hematology parameters: basophils, eosinophils, leukocytes, lymphocytes, monocytes, neutrophils and platelets. Day -2 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Results are presented treatment wise.
Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Posted
Mean
Standard Deviation
10^9 cells /Liter
Baseline (Day -2), 24 hours, 48 hours, 96 hours and Follow up (Day 15)
ID
Title
Description
OG000
Part 1: GSK3640254 1 mg
Participants received single dose of GSK3640254 1 mg following a moderate fat meal on Day 1
OG001
Part 1: GSK3640254 3 mg
Participants received single dose of GSK3640254 3 mg following a moderate fat meal on Day 1
OG002
Part 1: GSK3640254 10 mg
Participants received single dose of GSK3640254 10 mg following a moderate fat meal on Day 1
OG003
Part 1: GSK3640254 30mg
Participants received single dose of GSK3640254 30 mg following a moderate fat meal on Day 1
OG004
Part 1: GSK3640254 100 mg
Participants received single dose of GSK3640254 100 mg following a moderate fat meal on Day 1
OG005
Part 1: GSK3640254 200 mg
Participants received single dose of GSK3640254 200 mg following a moderate fat meal on Day 1
OG006
Part 1: GSK3640254 400 mg
Participants received single dose of GSK3640254 400 mg following a moderate fat meal on Day 1
OG007
Part 1: GSK3640254 700 mg
Participants received single dose of GSK3640254 700 mg following a moderate fat meal on Day 1
OG008
Part 1: Single Dose Placebo
Participants received single dose of matching placebo following a moderate fat meal on Day 1
Units
Counts
Participants
OG0006
OG0016
OG0026
OG003
Title
Denominators
Categories
Basophils, 24 hours, n=6,6,6,6,6,6,5,6,16
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG003
Primary
Part 1: Change From Baseline in Hematology Parameters: Erythrocytes.
Blood samples were collected to analyze the hematology parameters: erythrocytes. Day -2 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.Results are presented treatment wise.
Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Posted
Mean
Standard Deviation
10^12 cells/Liter
Baseline (Day -2), 24 hours, 48 hours, 96 hours and Follow up (Day 15)
ID
Title
Description
OG000
Part 1: GSK3640254 1 mg
Participants received single dose of GSK3640254 1 mg following a moderate fat meal on Day 1
OG001
Part 1: GSK3640254 3 mg
Participants received single dose of GSK3640254 3 mg following a moderate fat meal on Day 1
OG002
Part 1: GSK3640254 10 mg
Participants received single dose of GSK3640254 10 mg following a moderate fat meal on Day 1
OG003
Part 1: GSK3640254 30mg
Participants received single dose of GSK3640254 30 mg following a moderate fat meal on Day 1
OG004
Part 1: GSK3640254 100 mg
Participants received single dose of GSK3640254 100 mg following a moderate fat meal on Day 1
OG005
Part 1: GSK3640254 200 mg
Participants received single dose of GSK3640254 200 mg following a moderate fat meal on Day 1
OG006
Part 1: GSK3640254 400 mg
Participants received single dose of GSK3640254 400 mg following a moderate fat meal on Day 1
OG007
Part 1: GSK3640254 700 mg
Participants received single dose of GSK3640254 700 mg following a moderate fat meal on Day 1
OG008
Part 1: Single Dose Placebo
Participants received single dose of matching placebo following a moderate fat meal on Day 1
Units
Counts
Participants
OG0006
OG0016
OG0026
OG003
Title
Denominators
Categories
24 hours, n=6,6,6,6,6,6,5,6,16
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG003
Primary
Part 1: Change From Baseline in Hematology Parameters: Erythrocytes Mean Corpuscular Volume (Erythrocyte MCV).
Blood samples were collected to analyze the hematology parameters: erythrocyte MCV. Day -2 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Posted
Mean
Standard Deviation
Femtoliter
Baseline (Day -2), 24 hours, 48 hours, 96 hours and Follow up (Day 15)
ID
Title
Description
OG000
Part 1: GSK3640254 1 mg
Participants received single dose of GSK3640254 1 mg following a moderate fat meal on Day 1
OG001
Part 1: GSK3640254 3 mg
Participants received single dose of GSK3640254 3 mg following a moderate fat meal on Day 1
OG002
Part 1: GSK3640254 10 mg
Participants received single dose of GSK3640254 10 mg following a moderate fat meal on Day 1
OG003
Part 1: GSK3640254 30mg
Participants received single dose of GSK3640254 30 mg following a moderate fat meal on Day 1
OG004
Part 1: GSK3640254 100 mg
Participants received single dose of GSK3640254 100 mg following a moderate fat meal on Day 1
OG005
Part 1: GSK3640254 200 mg
Participants received single dose of GSK3640254 200 mg following a moderate fat meal on Day 1
OG006
Part 1: GSK3640254 400 mg
Participants received single dose of GSK3640254 400 mg following a moderate fat meal on Day 1
OG007
Part 1: GSK3640254 700 mg
Participants received single dose of GSK3640254 700 mg following a moderate fat meal on Day 1
OG008
Part 1: Single Dose Placebo
Participants received single dose of matching placebo following a moderate fat meal on Day 1
Units
Counts
Participants
OG0006
OG0016
OG0026
OG003
Title
Denominators
Categories
24 hour, n=6,6,6,6,6,6,5,6,16
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG003
Primary
Part 1: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin (Erythrocyte MCH)
Blood samples were collected to analyze the hematology parameter: Erythrocyte MCH. Day -2 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.Results are presented treatment wise.
Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Posted
Mean
Standard Deviation
Picograms
Baseline (Day -2), 24 hours, 48 hours, 96 hours and Follow up (Day 15)
ID
Title
Description
OG000
Part 1: GSK3640254 1 mg
Participants received single dose of GSK3640254 1 mg following a moderate fat meal on Day 1
OG001
Part 1: GSK3640254 3 mg
Participants received single dose of GSK3640254 3 mg following a moderate fat meal on Day 1
OG002
Part 1: GSK3640254 10 mg
Participants received single dose of GSK3640254 10 mg following a moderate fat meal on Day 1
OG003
Part 1: GSK3640254 30mg
Participants received single dose of GSK3640254 30 mg following a moderate fat meal on Day 1
OG004
Part 1: GSK3640254 100 mg
Participants received single dose of GSK3640254 100 mg following a moderate fat meal on Day 1
OG005
Part 1: GSK3640254 200 mg
Participants received single dose of GSK3640254 200 mg following a moderate fat meal on Day 1
OG006
Part 1: GSK3640254 400 mg
Participants received single dose of GSK3640254 400 mg following a moderate fat meal on Day 1
OG007
Part 1: GSK3640254 700 mg
Participants received single dose of GSK3640254 700 mg following a moderate fat meal on Day 1
OG008
Part 1: Single Dose Placebo
Participants received single dose of matching placebo following a moderate fat meal on Day 1
Units
Counts
Participants
OG0006
OG0016
OG0026
OG003
Title
Denominators
Categories
24 hours, n=6,6,6,6,6,6,5,6,16
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG003
Primary
Part 1: Change From Baseline in Hematology Parameter: Hematocrit
Blood samples were collected to analyze the hematology parameter: hematocrit. Day -2 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Results are presented treatment wise.
Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Posted
Mean
Standard Deviation
Percentage of red blood cells in blood
Baseline (Day -2), 24 hours, 48 hours, 96 hours and Follow up (Day 15)
ID
Title
Description
OG000
Part 1: GSK3640254 1 mg
Participants received single dose of GSK3640254 1 mg following a moderate fat meal on Day 1
OG001
Part 1: GSK3640254 3 mg
Participants received single dose of GSK3640254 3 mg following a moderate fat meal on Day 1
OG002
Part 1: GSK3640254 10 mg
Participants received single dose of GSK3640254 10 mg following a moderate fat meal on Day 1
OG003
Part 1: GSK3640254 30mg
Participants received single dose of GSK3640254 30 mg following a moderate fat meal on Day 1
OG004
Part 1: GSK3640254 100 mg
Participants received single dose of GSK3640254 100 mg following a moderate fat meal on Day 1
OG005
Part 1: GSK3640254 200 mg
Participants received single dose of GSK3640254 200 mg following a moderate fat meal on Day 1
OG006
Part 1: GSK3640254 400 mg
Participants received single dose of GSK3640254 400 mg following a moderate fat meal on Day 1
OG007
Part 1: GSK3640254 700 mg
Participants received single dose of GSK3640254 700 mg following a moderate fat meal on Day 1
OG008
Part 1: Single Dose Placebo
Participants received single dose of matching placebo following a moderate fat meal on Day 1
Units
Counts
Participants
OG0006
OG0016
OG0026
OG003
Title
Denominators
Categories
24 hours, n=6,6,6,6,6,6,5,6,16
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG003
Primary
Part 1: Change From Baseline in Hematology Parameter: Percentage of Reticulocytes
Blood samples were collected to analyze the hematology parameter: percentage of reticulocytes. Day -2 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Results are presented treatment wise.
Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Posted
Mean
Standard Deviation
10^12 cells per liter
Baseline (Day -2), 24 hours, 48 hours, 96 hours and Follow up (Day 15)
ID
Title
Description
OG000
Part 1: GSK3640254 1 mg
Participants received single dose of GSK3640254 1 mg following a moderate fat meal on Day 1
OG001
Part 1: GSK3640254 3 mg
Participants received single dose of GSK3640254 3 mg following a moderate fat meal on Day 1
OG002
Part 1: GSK3640254 10 mg
Participants received single dose of GSK3640254 10 mg following a moderate fat meal on Day 1
OG003
Part 1: GSK3640254 30mg
Participants received single dose of GSK3640254 30 mg following a moderate fat meal on Day 1
OG004
Part 1: GSK3640254 100 mg
Participants received single dose of GSK3640254 100 mg following a moderate fat meal on Day 1
OG005
Part 1: GSK3640254 200 mg
Participants received single dose of GSK3640254 200 mg following a moderate fat meal on Day 1
OG006
Part 1: GSK3640254 400 mg
Participants received single dose of GSK3640254 400 mg following a moderate fat meal on Day 1
OG007
Part 1: GSK3640254 700 mg
Participants received single dose of GSK3640254 700 mg following a moderate fat meal on Day 1
OG008
Part 1: Single Dose Placebo
Participants received single dose of matching placebo following a moderate fat meal on Day 1
Units
Counts
Participants
OG0006
OG0016
OG0026
OG003
Title
Denominators
Categories
24 hours, n=6,6,6,6,6,6,5,6,16
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG003
Primary
Part 1: Change From Baseline in Hematology Parameter: Hemoglobin (Hb)
Blood samples were collected to analyze the hematology parameter: Hb. Day -2 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Results are presented treatment wise.
Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Posted
Mean
Standard Deviation
Grams per liter
Baseline (Day -2), 24 hours, 48 hours, 96 hours and Follow up (Day 15)
ID
Title
Description
OG000
Part 1: GSK3640254 1 mg
Participants received single dose of GSK3640254 1 mg following a moderate fat meal on Day 1
OG001
Part 1: GSK3640254 3 mg
Participants received single dose of GSK3640254 3 mg following a moderate fat meal on Day 1
OG002
Part 1: GSK3640254 10 mg
Participants received single dose of GSK3640254 10 mg following a moderate fat meal on Day 1
OG003
Part 1: GSK3640254 30mg
Participants received single dose of GSK3640254 30 mg following a moderate fat meal on Day 1
OG004
Part 1: GSK3640254 100 mg
Participants received single dose of GSK3640254 100 mg following a moderate fat meal on Day 1
OG005
Part 1: GSK3640254 200 mg
Participants received single dose of GSK3640254 200 mg following a moderate fat meal on Day 1
OG006
Part 1: GSK3640254 400 mg
Participants received single dose of GSK3640254 400 mg following a moderate fat meal on Day 1
OG007
Part 1: GSK3640254 700 mg
Participants received single dose of GSK3640254 700 mg following a moderate fat meal on Day 1
OG008
Part 1: Single Dose Placebo
Participants received single dose of matching placebo following a moderate fat meal on Day 1
Units
Counts
Participants
OG0006
OG0016
OG0026
OG003
Title
Denominators
Categories
24 hours, n=6,6,6,6,6,6,5,6,16
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG003
Primary
Part 1: Change From Baseline in Clinical Chemistry Parameter: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphate (ALP)
Blood samples were collected to analyze the chemistry parameter: ALT, AST, and ALP. Day -2 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Results are presented treatment wise.
Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Posted
Mean
Standard Deviation
International units per liter
Baseline (Day -2), 24 hours, 48 hours, 96 hours and Follow up (Day 15)
ID
Title
Description
OG000
Part 1: GSK3640254 1 mg
Participants received single dose of GSK3640254 1 mg following a moderate fat meal on Day 1
OG001
Part 1: GSK3640254 3 mg
Participants received single dose of GSK3640254 3 mg following a moderate fat meal on Day 1
OG002
Part 1: GSK3640254 10 mg
Participants received single dose of GSK3640254 10 mg following a moderate fat meal on Day 1
OG003
Part 1: GSK3640254 30mg
Participants received single dose of GSK3640254 30 mg following a moderate fat meal on Day 1
OG004
Part 1: GSK3640254 100 mg
Participants received single dose of GSK3640254 100 mg following a moderate fat meal on Day 1
OG005
Part 1: GSK3640254 200 mg
Participants received single dose of GSK3640254 200 mg following a moderate fat meal on Day 1
OG006
Part 1: GSK3640254 400 mg
Participants received single dose of GSK3640254 400 mg following a moderate fat meal on Day 1
OG007
Part 1: GSK3640254 700 mg
Participants received single dose of GSK3640254 700 mg following a moderate fat meal on Day 1
OG008
Part 1: Single Dose Placebo
Participants received single dose of matching placebo following a moderate fat meal on Day 1
Units
Counts
Participants
OG0006
OG0016
OG0026
OG003
Title
Denominators
Categories
ALT, 24 hours, n=6,6,6,6,6,6,6,6,16
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG003
Primary
Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea
Blood samples were collected to analyze the chemistry parameter: bicarbonate, calcium, chloride, magnesium, phosphate, potassium, sodium, urea. Day -2 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Results are presented treatment wise.
Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Posted
Mean
Standard Deviation
Millimoles per liter
Baseline (Day -2), 24 hours, 48 hours, 96 hours and Follow up (Day 15)
ID
Title
Description
OG000
Part 1: GSK3640254 1 mg
Participants received single dose of GSK3640254 1 mg following a moderate fat meal on Day 1
OG001
Part 1: GSK3640254 3 mg
Participants received single dose of GSK3640254 3 mg following a moderate fat meal on Day 1
OG002
Part 1: GSK3640254 10 mg
Participants received single dose of GSK3640254 10 mg following a moderate fat meal on Day 1
OG003
Part 1: GSK3640254 30mg
Participants received single dose of GSK3640254 30 mg following a moderate fat meal on Day 1
OG004
Part 1: GSK3640254 100 mg
Participants received single dose of GSK3640254 100 mg following a moderate fat meal on Day 1
OG005
Part 1: GSK3640254 200 mg
Participants received single dose of GSK3640254 200 mg following a moderate fat meal on Day 1
OG006
Part 1: GSK3640254 400 mg
Participants received single dose of GSK3640254 400 mg following a moderate fat meal on Day 1
OG007
Part 1: GSK3640254 700 mg
Participants received single dose of GSK3640254 700 mg following a moderate fat meal on Day 1
OG008
Part 1: Single Dose Placebo
Participants received single dose of matching placebo following a moderate fat meal on Day 1
Units
Counts
Participants
OG0006
OG0016
OG0026
OG003
Title
Denominators
Categories
Bicarbonate, 24 hours, n=6,6,6,6,6,6,6,6,16
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG003
Primary
Part 1: Change From Baseline in Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Cholesterol (LDL) Cholesterol, Triglycerides
Blood samples were collected to analyze the chemistry parameter: cholesterol, glucose, HDL cholesterol, LDL cholesterol, triglycerides. Day -2 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Results are presented treatment wise.
Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Posted
Mean
Standard Deviation
Millimoles per liter
Baseline (Day -2) and Day 1 (96 hours) and Follow up (Day 15)
ID
Title
Description
OG000
Part 1: GSK3640254 1 mg
Participants received single dose of GSK3640254 1 mg following a moderate fat meal on Day 1
OG001
Part 1: GSK3640254 3 mg
Participants received single dose of GSK3640254 3 mg following a moderate fat meal on Day 1
OG002
Part 1: GSK3640254 10 mg
Participants received single dose of GSK3640254 10 mg following a moderate fat meal on Day 1
OG003
Part 1: GSK3640254 30mg
Participants received single dose of GSK3640254 30 mg following a moderate fat meal on Day 1
OG004
Part 1: GSK3640254 100 mg
Participants received single dose of GSK3640254 100 mg following a moderate fat meal on Day 1
OG005
Part 1: GSK3640254 200 mg
Participants received single dose of GSK3640254 200 mg following a moderate fat meal on Day 1
OG006
Part 1: GSK3640254 400 mg
Participants received single dose of GSK3640254 400 mg following a moderate fat meal on Day 1
OG007
Part 1: GSK3640254 700 mg
Participants received single dose of GSK3640254 700 mg following a moderate fat meal on Day 1
OG008
Part 1: Single Dose Placebo
Participants received single dose of matching placebo following a moderate fat meal on Day 1
Units
Counts
Participants
OG0006
OG0016
OG0026
OG003
Title
Denominators
Categories
Cholesterol,Day1,96 hours,n=5,6,6,6,5,6,6,6,14
ParticipantsOG0005
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG003
Primary
Part 1: Change From Baseline in Chemistry Parameter: Glucose
Blood samples were collected to analyze the chemistry parameter: glucose . Day -2 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Results are presented treatment wise.
Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Posted
Mean
Standard Deviation
Millimoles per liter
Baseline (Day -2) and Day 1 (96 hours) and Follow up (Day 15)
ID
Title
Description
OG000
Part 1: GSK3640254 1 mg
Participants received single dose of GSK3640254 1 mg following a moderate fat meal on Day 1
OG001
Part 1: GSK3640254 3 mg
Participants received single dose of GSK3640254 3 mg following a moderate fat meal on Day 1
OG002
Part 1: GSK3640254 10 mg
Participants received single dose of GSK3640254 10 mg following a moderate fat meal on Day 1
OG003
Part 1: GSK3640254 30mg
Participants received single dose of GSK3640254 30 mg following a moderate fat meal on Day 1
OG004
Part 1: GSK3640254 100 mg
Participants received single dose of GSK3640254 100 mg following a moderate fat meal on Day 1
OG005
Part 1: GSK3640254 200 mg
Participants received single dose of GSK3640254 200 mg following a moderate fat meal on Day 1
OG006
Part 1: GSK3640254 400 mg
Participants received single dose of GSK3640254 400 mg following a moderate fat meal on Day 1
OG007
Part 1: GSK3640254 700 mg
Participants received single dose of GSK3640254 700 mg following a moderate fat meal on Day 1
OG008
Part 1: Single Dose Placebo
Participants received single dose of matching placebo following a moderate fat meal on Day 1
Units
Counts
Participants
OG0006
OG0016
OG0026
OG003
Title
Denominators
Categories
Day 1 (96 hours), n=5,6,6,6,6,6,6,6,14
ParticipantsOG0005
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG003
Primary
Part 1: Change From Baseline in Clinical Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin
Blood samples were collected to analyze the chemistry parameter: bilirubin, creatinine, direct bilirubin . Day -2 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Results are presented treatment wise.
Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Posted
Mean
Standard Deviation
Grams per liter
Baseline (Day -2), 24 hours, 48 hours, 96 hours and Follow up (Day 15)
ID
Title
Description
OG000
Part 1: GSK3640254 1 mg
Participants received single dose of GSK3640254 1 mg following a moderate fat meal on Day 1
OG001
Part 1: GSK3640254 3 mg
Participants received single dose of GSK3640254 3 mg following a moderate fat meal on Day 1
OG002
Part 1: GSK3640254 10 mg
Participants received single dose of GSK3640254 10 mg following a moderate fat meal on Day 1
OG003
Part 1: GSK3640254 30mg
Participants received single dose of GSK3640254 30 mg following a moderate fat meal on Day 1
OG004
Part 1: GSK3640254 100 mg
Participants received single dose of GSK3640254 100 mg following a moderate fat meal on Day 1
OG005
Part 1: GSK3640254 200 mg
Participants received single dose of GSK3640254 200 mg following a moderate fat meal on Day 1
OG006
Part 1: GSK3640254 400 mg
Participants received single dose of GSK3640254 400 mg following a moderate fat meal on Day 1
OG007
Part 1: GSK3640254 700 mg
Participants received single dose of GSK3640254 700 mg following a moderate fat meal on Day 1
OG008
Part 1: Single Dose Placebo
Participants received single dose of matching placebo following a moderate fat meal on Day 1
Units
Counts
Participants
OG0006
OG0016
OG0026
OG003
Title
Denominators
Categories
Bilirubin, 24 hours, n=6,6,6,6,6,6,6,6,16
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG003
Primary
Part 1: Change From Baseline in Clinical Chemistry Parameter: Protein
Blood samples were collected to analyze the chemistry parameter: Protein. Day -2 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Posted
Mean
Standard Deviation
Grams per liter
Baseline (Day -2), 24 hours, 48 hours, 96 hours and Follow up (Day 15)
ID
Title
Description
OG000
Part 1: GSK3640254 1 mg
Participants received single dose of GSK3640254 1 mg following a moderate fat meal on Day 1
OG001
Part 1: GSK3640254 3 mg
Participants received single dose of GSK3640254 3 mg following a moderate fat meal on Day 1
OG002
Part 1: GSK3640254 10 mg
Participants received single dose of GSK3640254 10 mg following a moderate fat meal on Day 1
OG003
Part 1: GSK3640254 30mg
Participants received single dose of GSK3640254 30 mg following a moderate fat meal on Day 1
OG004
Part 1: GSK3640254 100 mg
Participants received single dose of GSK3640254 100 mg following a moderate fat meal on Day 1
OG005
Part 1: GSK3640254 200 mg
Participants received single dose of GSK3640254 200 mg following a moderate fat meal on Day 1
OG006
Part 1: GSK3640254 400 mg
Participants received single dose of GSK3640254 400 mg following a moderate fat meal on Day 1
OG007
Part 1: GSK3640254 700 mg
Participants received single dose of GSK3640254 700 mg following a moderate fat meal on Day 1
OG008
Part 1: Single Dose Placebo
Participants received single dose of matching placebo following a moderate fat meal on Day 1
Units
Counts
Participants
OG0006
OG0016
OG0026
OG003
Title
Denominators
Categories
24 hours, n=6,6,6,6,6,6,6,6,16
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG003
Primary
Part 1: Number of Participants With Abnormal Urinalysis
Urine samples were collected at given time points to analyze the abnormal findings for potential of hydrogen (pH), glucose, protein, blood, ketones, bilirubin, urobilinogen, nitrite, leukocyte esterase by dipstick.
Safety Population.
Posted
Count of Participants
Participants
Up to Day 15
ID
Title
Description
OG000
Part 1: GSK3640254 1 mg
Participants received single dose of GSK3640254 1 mg following a moderate fat meal on Day 1
OG001
Part 1: GSK3640254 3 mg
Participants received single dose of GSK3640254 3 mg following a moderate fat meal on Day 1
OG002
Part 1: GSK3640254 10 mg
Participants received single dose of GSK3640254 10 mg following a moderate fat meal on Day 1
OG003
Part 1: GSK3640254 30mg
Participants received single dose of GSK3640254 30 mg following a moderate fat meal on Day 1
OG004
Part 1: GSK3640254 100 mg
Participants received single dose of GSK3640254 100 mg following a moderate fat meal on Day 1
OG005
Part 1: GSK3640254 200 mg
Participants received single dose of GSK3640254 200 mg following a moderate fat meal on Day 1
OG006
Part 1: GSK3640254 400 mg
Participants received single dose of GSK3640254 400 mg following a moderate fat meal on Day 1
OG007
Part 1: GSK3640254 700 mg
Participants received single dose of GSK3640254 700 mg following a moderate fat meal on Day 1
OG008
Part 1: Single Dose Placebo
Participants received single dose of matching placebo following a moderate fat meal on Day 1
Units
Counts
Participants
OG0006
OG0016
OG0026
OG003
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG003
Primary
Part 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
SBP and DBP were measured in semi-supine position after 5 minutes rest for the participants at indicated time points. Day -1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Results are presented treatment wise.
Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Posted
Mean
Standard Deviation
Millimeters of mercury (mmHg)
Baseline (Day -1), 1,2,4.5,6,12,24,48,72,96 hours post dose and Follow up (Day 15)
ID
Title
Description
OG000
Part 1: GSK3640254 1 mg
Participants received single dose of GSK3640254 1 mg following a moderate fat meal on Day 1
OG001
Part 1: GSK3640254 3 mg
Participants received single dose of GSK3640254 3 mg following a moderate fat meal on Day 1
OG002
Part 1: GSK3640254 10 mg
Participants received single dose of GSK3640254 10 mg following a moderate fat meal on Day 1
OG003
Part 1: GSK3640254 30mg
Participants received single dose of GSK3640254 30 mg following a moderate fat meal on Day 1
OG004
Part 1: GSK3640254 100 mg
Participants received single dose of GSK3640254 100 mg following a moderate fat meal on Day 1
OG005
Part 1: GSK3640254 200 mg
Participants received single dose of GSK3640254 200 mg following a moderate fat meal on Day 1
OG006
Part 1: GSK3640254 400 mg
Participants received single dose of GSK3640254 400 mg following a moderate fat meal on Day 1
OG007
Part 1: GSK3640254 700 mg
Participants received single dose of GSK3640254 700 mg following a moderate fat meal on Day 1
OG008
Part 1: Single Dose Placebo
Participants received single dose of matching placebo following a moderate fat meal on Day 1
Units
Counts
Participants
OG0006
OG0016
OG0026
OG003
Title
Denominators
Categories
SBP, 1 hour n=6,6,6,6,6,6,6,6,16
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG003
Primary
Part 1: Change From Baseline in Vital Signs: Pulse Rate
Pulse rate was measured in semi-supine position after 5 minutes rest for the participants at indicated time points. Day -1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Results are presented treatment wise.
Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Posted
Mean
Standard Deviation
Beats per minute
Baseline (Day -1), 1,2,4.5,6,12,24,48,72,96 hours post dose and Follow up (Day 15)
ID
Title
Description
OG000
Part 1: GSK3640254 1 mg
Participants received single dose of GSK3640254 1 mg following a moderate fat meal on Day 1
OG001
Part 1: GSK3640254 3 mg
Participants received single dose of GSK3640254 3 mg following a moderate fat meal on Day 1
OG002
Part 1: GSK3640254 10 mg
Participants received single dose of GSK3640254 10 mg following a moderate fat meal on Day 1
OG003
Part 1: GSK3640254 30mg
Participants received single dose of GSK3640254 30 mg following a moderate fat meal on Day 1
OG004
Part 1: GSK3640254 100 mg
Participants received single dose of GSK3640254 100 mg following a moderate fat meal on Day 1
OG005
Part 1: GSK3640254 200 mg
Participants received single dose of GSK3640254 200 mg following a moderate fat meal on Day 1
OG006
Part 1: GSK3640254 400 mg
Participants received single dose of GSK3640254 400 mg following a moderate fat meal on Day 1
OG007
Part 1: GSK3640254 700 mg
Participants received single dose of GSK3640254 700 mg following a moderate fat meal on Day 1
OG008
Part 1: Single Dose Placebo
Participants received single dose of matching placebo following a moderate fat meal on Day 1
Units
Counts
Participants
OG0006
OG0016
OG0026
OG003
Title
Denominators
Categories
1 hour n=6,6,6,6,6,6,6,6,16
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG003
Primary
Part 1: Change From Baseline in Vital Signs: Temperature
Temperature was measured in semi-supine position after 5 minutes rest for the participants at indicated time points. Day -1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Results are presented treatment wise.
Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Posted
Mean
Standard Deviation
Degree Celsius
Baseline (Day -1), 1,2,4.5,6,12,24,48,72,96 hours post dose and Follow up (Day 15)
ID
Title
Description
OG000
Part 1: GSK3640254 1 mg
Participants received single dose of GSK3640254 1 mg following a moderate fat meal on Day 1
OG001
Part 1: GSK3640254 3 mg
Participants received single dose of GSK3640254 3 mg following a moderate fat meal on Day 1
OG002
Part 1: GSK3640254 10 mg
Participants received single dose of GSK3640254 10 mg following a moderate fat meal on Day 1
OG003
Part 1: GSK3640254 30mg
Participants received single dose of GSK3640254 30 mg following a moderate fat meal on Day 1
OG004
Part 1: GSK3640254 100 mg
Participants received single dose of GSK3640254 100 mg following a moderate fat meal on Day 1
OG005
Part 1: GSK3640254 200 mg
Participants received single dose of GSK3640254 200 mg following a moderate fat meal on Day 1
OG006
Part 1: GSK3640254 400 mg
Participants received single dose of GSK3640254 400 mg following a moderate fat meal on Day 1
OG007
Part 1: GSK3640254 700 mg
Participants received single dose of GSK3640254 700 mg following a moderate fat meal on Day 1
OG008
Part 1: Single Dose Placebo
Participants received single dose of matching placebo following a moderate fat meal on Day 1
Units
Counts
Participants
OG0006
OG0016
OG0026
OG003
Title
Denominators
Categories
1 hour, n=6,6,6,6,6,6,6,6,16
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG003
Primary
Part 1: Change From Baseline in Vital Sign: Respiratory Rate
Respiratory rate was measured in semi-supine position after 5 minutes rest for the participants at indicated time points. Day -1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Results are presented treatment wise.
Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Posted
Mean
Standard Deviation
Breaths per minute
Baseline (Day -1), 1,2,4.5,6,12,24,48,72,96 hours post dose and Follow up (Day 15)
ID
Title
Description
OG000
Part 1: GSK3640254 1 mg
Participants received single dose of GSK3640254 1 mg following a moderate fat meal on Day 1
OG001
Part 1: GSK3640254 3 mg
Participants received single dose of GSK3640254 3 mg following a moderate fat meal on Day 1
OG002
Part 1: GSK3640254 10 mg
Participants received single dose of GSK3640254 10 mg following a moderate fat meal on Day 1
OG003
Part 1: GSK3640254 30mg
Participants received single dose of GSK3640254 30 mg following a moderate fat meal on Day 1
OG004
Part 1: GSK3640254 100 mg
Participants received single dose of GSK3640254 100 mg following a moderate fat meal on Day 1
OG005
Part 1: GSK3640254 200 mg
Participants received single dose of GSK3640254 200 mg following a moderate fat meal on Day 1
OG006
Part 1: GSK3640254 400 mg
Participants received single dose of GSK3640254 400 mg following a moderate fat meal on Day 1
OG007
Part 1: GSK3640254 700 mg
Participants received single dose of GSK3640254 700 mg following a moderate fat meal on Day 1
OG008
Part 1: Single Dose Placebo
Participants received single dose of matching placebo following a moderate fat meal on Day 1
Units
Counts
Participants
OG0006
OG0016
OG0026
OG003
Title
Denominators
Categories
1 hour, n=6,6,6,6,6,6,6,6,16
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG003
Primary
Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings
12-lead ECGs were measured in a semi-supine position using an automated ECG machine after approximately 5 minutes of rest for the participant. Abnormal findings were categorized as clinically significant (CS) and not clinically significant (NCS).
Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Posted
Count of Participants
Participants
Baseline (Day 1 predose), 1,2,4,6,12,24,48,72,96 hours post dose and Follow up (Day 15)
ID
Title
Description
OG000
Part 1: GSK3640254 1 mg
Participants received single dose of GSK3640254 1 mg following a moderate fat meal on Day 1
OG001
Part 1: GSK3640254 3 mg
Participants received single dose of GSK3640254 3 mg following a moderate fat meal on Day 1
OG002
Part 1: GSK3640254 10 mg
Participants received single dose of GSK3640254 10 mg following a moderate fat meal on Day 1
OG003
Part 1: GSK3640254 30mg
Participants received single dose of GSK3640254 30 mg following a moderate fat meal on Day 1
OG004
Part 1: GSK3640254 100 mg
Participants received single dose of GSK3640254 100 mg following a moderate fat meal on Day 1
OG005
Part 1: GSK3640254 200 mg
Participants received single dose of GSK3640254 200 mg following a moderate fat meal on Day 1
OG006
Part 1: GSK3640254 400 mg
Participants received single dose of GSK3640254 400 mg following a moderate fat meal on Day 1
OG007
Part 1: GSK3640254 700 mg
Participants received single dose of GSK3640254 700 mg following a moderate fat meal on Day 1
OG008
Part 1: Single Dose Placebo
Participants received single dose of matching placebo following a moderate fat meal on Day 1
Units
Counts
Participants
OG0006
OG0016
OG0026
OG003
Title
Denominators
Categories
CS, Day 1,1 hour n=6,6,6,6,6,6,6,6,16
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG003
Primary
Part 2: Number of Participants AEs and SAEs
An AE is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment were categorized as SAE. Results are presented treatment wise.
Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Posted
Count of Participants
Participants
Up to Day 28
ID
Title
Description
OG000
Part 2: GSK3640254 50 mg
Participants received repeated dose of GSK3640254 50 mg once daily up to 14 days
OG001
Part 2: GSK3640254 100 mg
Participants received repeated dose of GSK3640254 100 mg once daily up to 14 days
OG002
Part 2: GSK3640254 200 mg + Expansion
Participants received repeated dose of GSK3640254 200 mg once daily up to 14 days
OG003
Part 2: GSK3640254 320 mg
Participants received repeated dose of GSK3640254 320 mg once daily up to 14 days
OG004
Part 2: Repeated Dose Placebo
Participants received repeated dose of matching placebo once daily up to 14 days
Units
Counts
Participants
OG0006
OG0016
OG00225
OG003
Title
Denominators
Categories
AE
Title
Measurements
OG0004
OG0015
OG00219
OG003
Primary
Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets.
Blood samples were collected at indicated time points to analyze the hematology parameters: basophils, eosinophils, leukocytes, lymphocytes, monocytes, neutrophils and platelets. Day -2 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Results are presented treatment wise.
Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Posted
Mean
Standard Deviation
10^9 cells/Liter
Baseline (Day -2), Pre dose on Days 2,4,6,8,10,12,14 Day 14 : 48 and 96 hours post dose, Follow up (Day 28)
ID
Title
Description
OG000
Part 2: GSK3640254 50 mg
Participants received repeated dose of GSK3640254 50 mg once daily up to 14 days
OG001
Part 2: GSK3640254 100 mg
Participants received repeated dose of GSK3640254 100 mg once daily up to 14 days
OG002
Part 2: GSK3640254 200 mg + Expansion
Participants received repeated dose of GSK3640254 200 mg once daily up to 14 days
OG003
Part 2: GSK3640254 320 mg
Participants received repeated dose of GSK3640254 320 mg once daily up to 14 days
OG004
Part 2: Repeated Dose Placebo
Participants received repeated dose of matching placebo once daily up to 14 days
Units
Counts
Participants
OG0006
OG0016
OG00225
OG003
Title
Denominators
Categories
Basophils, Day 2, predose, n=6,6,25,7,14
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG00225
ParticipantsOG003
Primary
Part 2: Change From Baseline in Hematology Parameter: Erythrocytes
Blood samples were collected at indicated time points to analyze the hematology parameters: Erythrocytes. Day -2 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Posted
Mean
Standard Deviation
10^12 cells/Liter
Baseline (Day -2), Pre dose on Days 2,4,6,8,10,12,14 Day 14: 48 and 96 hours post dose, Follow up (Day 28)
ID
Title
Description
OG000
Part 2: GSK3640254 50 mg
Participants received repeated dose of GSK3640254 50 mg once daily up to 14 days
OG001
Part 2: GSK3640254 100 mg
Participants received repeated dose of GSK3640254 100 mg once daily up to 14 days
OG002
Part 2: GSK3640254 200 mg + Expansion
Participants received repeated dose of GSK3640254 200 mg once daily up to 14 days
OG003
Part 2: GSK3640254 320 mg
Participants received repeated dose of GSK3640254 320 mg once daily up to 14 days
OG004
Part 2: Repeated Dose Placebo
Participants received repeated dose of matching placebo once daily up to 14 days
Units
Counts
Participants
OG0006
OG0016
OG00225
OG003
Title
Denominators
Categories
Day 2, predose, n=6,6,25,7,14
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG00225
ParticipantsOG003
Primary
Part 2: Change From Baseline in Hematology Parameter: Erythrocytes MCV
Blood samples were collected at indicated time points to analyze the hematology parameters: Erythrocyte MCV. Day -2 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Posted
Mean
Standard Deviation
Femtoliter
Baseline (Day -2), pre dose on Days 2,4,6,8,10,12,14 Day 14: 48 and 96 hours post dose, Follow up (Day 28)
ID
Title
Description
OG000
Part 2: GSK3640254 50 mg
Participants received repeated dose of GSK3640254 50 mg once daily up to 14 days
OG001
Part 2: GSK3640254 100 mg
Participants received repeated dose of GSK3640254 100 mg once daily up to 14 days
OG002
Part 2: GSK3640254 200 mg + Expansion
Participants received repeated dose of GSK3640254 200 mg once daily up to 14 days
OG003
Part 2: GSK3640254 320 mg
Participants received repeated dose of GSK3640254 320 mg once daily up to 14 days
OG004
Part 2: Repeated Dose Placebo
Participants received repeated dose of matching placebo once daily up to 14 days
Units
Counts
Participants
OG0006
OG0016
OG00225
OG003
Title
Denominators
Categories
Day 2, predose, n=6,6,25,7,14
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG00225
ParticipantsOG003
Primary
Part 2: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin (Erythrocyte MCH)
Blood samples were collected at indicated time points to analyze the hematology parameter: Erythrocyte MCH. Day -1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Posted
Mean
Standard Deviation
Picograms
Baseline (Day -2), pre dose on Days 2,4,6,8,10,12,14 Day 14: 48 and 96 hours post dose, Follow up (Day 28)
ID
Title
Description
OG000
Part 2: GSK3640254 50 mg
Participants received repeated dose of GSK3640254 50 mg once daily up to 14 days
OG001
Part 2: GSK3640254 100 mg
Participants received repeated dose of GSK3640254 100 mg once daily up to 14 days
OG002
Part 2: GSK3640254 200 mg + Expansion
Participants received repeated dose of GSK3640254 200 mg once daily up to 14 days
OG003
Part 2: GSK3640254 320 mg
Participants received repeated dose of GSK3640254 320 mg once daily up to 14 days
OG004
Part 2: Repeated Dose Placebo
Participants received repeated dose of matching placebo once daily up to 14 days
Units
Counts
Participants
OG0006
OG0016
OG00225
OG003
Title
Denominators
Categories
Day 2, predose, n=6,6,25,7,14
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG00225
ParticipantsOG003
Primary
Part 2: Change From Baseline in Hematology Parameter: Hematocrit
Blood samples were collected at indicated time points to analyze the hematology parameter: hematocrit. Day -2 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Results are presented treatment wise.
Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Posted
Mean
Standard Deviation
Percentage of red blood cells in blood
Baseline (Day -2), pre dose on Days 2,4,6,8,10,12,14 Day 14: 48 and 96 hours post dose, Follow up (Day 28)
ID
Title
Description
OG000
Part 2: GSK3640254 50 mg
Participants received repeated dose of GSK3640254 50 mg once daily up to 14 days
OG001
Part 2: GSK3640254 100 mg
Participants received repeated dose of GSK3640254 100 mg once daily up to 14 days
OG002
Part 2: GSK3640254 200 mg + Expansion
Participants received repeated dose of GSK3640254 200 mg once daily up to 14 days
OG003
Part 2: GSK3640254 320 mg
Participants received repeated dose of GSK3640254 320 mg once daily up to 14 days
OG004
Part 2: Repeated Dose Placebo
Participants received repeated dose of matching placebo once daily up to 14 days
Units
Counts
Participants
OG0006
OG0016
OG00225
OG003
Title
Denominators
Categories
Day 2, predose, n=6,6,25,7,14
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG00225
ParticipantsOG003
Primary
Part 2: Change From Baseline in Hematology Parameter: Percentage of Reticulocytes
Blood samples were collected to analyze the hematology parameter: percentage of reticulocytes. Day -2 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Results are presented treatment wise.
Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Posted
Mean
Standard Deviation
10^12 cells per liter
Baseline (Day -2), pre dose on Days 2,4,6,8,10,12,14 Day 14: 48 and 96 hours post dose, Follow up (Day 28)
ID
Title
Description
OG000
Part 2: GSK3640254 50 mg
Participants received repeated dose of GSK3640254 50 mg once daily up to 14 days
OG001
Part 2: GSK3640254 100 mg
Participants received repeated dose of GSK3640254 100 mg once daily up to 14 days
OG002
Part 2: GSK3640254 200 mg + Expansion
Participants received repeated dose of GSK3640254 200 mg once daily up to 14 days
OG003
Part 2: GSK3640254 320 mg
Participants received repeated dose of GSK3640254 320 mg once daily up to 14 days
OG004
Part 2: Repeated Dose Placebo
Participants received repeated dose of matching placebo once daily up to 14 days
Units
Counts
Participants
OG0006
OG0016
OG00225
OG003
Title
Denominators
Categories
Day 2, predose, n=6,6,25,7,14
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG00225
ParticipantsOG003
Primary
Part 2: Change From Baseline in Hematology Parameter: Hb
Blood samples were collected at indicated time points to analyze the hematology parameter: Hb. Day -2 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Posted
Mean
Standard Deviation
Grams per liter
Baseline (Day -2), pre dose on Days 2,4,6,8,10,12,14 Day 14: 48 and 96 hours post dose, Follow up (Day 28)
ID
Title
Description
OG000
Part 2: GSK3640254 50 mg
Participants received repeated dose of GSK3640254 50 mg once daily up to 14 days
OG001
Part 2: GSK3640254 100 mg
Participants received repeated dose of GSK3640254 100 mg once daily up to 14 days
OG002
Part 2: GSK3640254 200 mg + Expansion
Participants received repeated dose of GSK3640254 200 mg once daily up to 14 days
OG003
Part 2: GSK3640254 320 mg
Participants received repeated dose of GSK3640254 320 mg once daily up to 14 days
OG004
Part 2: Repeated Dose Placebo
Participants received repeated dose of matching placebo once daily up to 14 days
Units
Counts
Participants
OG0006
OG0016
OG00225
OG003
Title
Denominators
Categories
Day 2, predose, n=6,6,25,7,14
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG00225
ParticipantsOG003
Primary
Part 2: Change From Baseline in Chemistry Parameter: ALT, AST,ALP
Blood samples were collected to analyze the chemistry parameter: ALT, AST,ALP. Day -2was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Results are presented treatment wise.
Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Posted
Mean
Standard Deviation
International units per liter
Baseline (Day -2), pre dose on Days 2,4,6,8,10,12,14 Day14: 48 and 96 hours post dose, Follow up (Day 28)
ID
Title
Description
OG000
Part 2: GSK3640254 50 mg
Participants received repeated dose of GSK3640254 50 mg once daily up to 14 days
OG001
Part 2: GSK3640254 100 mg
Participants received repeated dose of GSK3640254 100 mg once daily up to 14 days
OG002
Part 2: GSK3640254 200 mg + Expansion
Participants received repeated dose of GSK3640254 200 mg once daily up to 14 days
OG003
Part 2: GSK3640254 320 mg
Participants received repeated dose of GSK3640254 320 mg once daily up to 14 days
OG004
Part 2: Repeated Dose Placebo
Participants received repeated dose of matching placebo once daily up to 14 days
Units
Counts
Participants
OG0006
OG0016
OG00225
OG003
Title
Denominators
Categories
ALT, Day 2, predose, n=6,6,25,7,14
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG00225
ParticipantsOG003
Primary
Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea
Blood samples were collected to analyze the chemistry parameter: bicarbonate, calcium, chloride, magnesium, phosphate, potassium, sodium, urea. Day -2 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Posted
Mean
Standard Deviation
Millimoles per liter
Baseline (Day -2), pre dose on Days 2,4,6,8,10,12,14 Day 14: 48 and 96 hours post dose, Follow up (Day 28)
ID
Title
Description
OG000
Part 2: GSK3640254 50 mg
Participants received repeated dose of GSK3640254 50 mg once daily up to 14 days
OG001
Part 2: GSK3640254 100 mg
Participants received repeated dose of GSK3640254 100 mg once daily up to 14 days
OG002
Part 2: GSK3640254 200 mg + Expansion
Participants received repeated dose of GSK3640254 200 mg once daily up to 14 days
OG003
Part 2: GSK3640254 320 mg
Participants received repeated dose of GSK3640254 320 mg once daily up to 14 days
OG004
Part 2: Repeated Dose Placebo
Participants received repeated dose of matching placebo once daily up to 14 days
Units
Counts
Participants
OG0006
OG0016
OG00225
OG003
Title
Denominators
Categories
Bicarbonate, Day 2, predose, n=6,6,25,7,14
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG00225
ParticipantsOG003
Primary
Part 2: Change From Baseline in Cholesterol, HDL Cholesterol, LDL Cholesterol, Triglycerides
Blood samples were collected at indicated time points to analyze the chemistry parameter: cholesterol, HDL cholesterol, LDL cholesterol, triglycerides. Day -2 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Results are presented treatment wise.
Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Posted
Mean
Standard Deviation
Millimoles per liter
Baseline (Day -2), Day 8 (pre dose), Day 14 (48 hours) post dose and Follow up (Day 28)
ID
Title
Description
OG000
Part 2: GSK3640254 50 mg
Participants received repeated dose of GSK3640254 50 mg once daily up to 14 days
OG001
Part 2: GSK3640254 100 mg
Participants received repeated dose of GSK3640254 100 mg once daily up to 14 days
OG002
Part 2: GSK3640254 200 mg + Expansion
Participants received repeated dose of GSK3640254 200 mg once daily up to 14 days
OG003
Part 2: GSK3640254 320 mg
Participants received repeated dose of GSK3640254 320 mg once daily up to 14 days
OG004
Part 2: Repeated Dose Placebo
Participants received repeated dose of matching placebo once daily up to 14 days
Units
Counts
Participants
OG0006
OG0016
OG00225
OG003
Title
Denominators
Categories
Cholesterol, Day 8, (predose) n=5,6,25,7,13
ParticipantsOG0005
ParticipantsOG0016
ParticipantsOG00225
ParticipantsOG003
Primary
Part 2: Change From Baseline in Chemistry Parameter: Glucose
Blood samples were collected at indicated time points to analyze the chemistry parameter: glucose . Day -2 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Results are presented treatment wise.
Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Posted
Mean
Standard Deviation
Millimoles per liter
Baseline (Day -2), Day 8 (predose), Day 14 (48 hours) post dose and Follow up (Day 28)
ID
Title
Description
OG000
Part 2: GSK3640254 50 mg
Participants received repeated dose of GSK3640254 50 mg once daily up to 14 days
OG001
Part 2: GSK3640254 100 mg
Participants received repeated dose of GSK3640254 100 mg once daily up to 14 days
OG002
Part 2: GSK3640254 200 mg + Expansion
Participants received repeated dose of GSK3640254 200 mg once daily up to 14 days
OG003
Part 2: GSK3640254 320 mg
Participants received repeated dose of GSK3640254 320 mg once daily up to 14 days
OG004
Part 2: Repeated Dose Placebo
Participants received repeated dose of matching placebo once daily up to 14 days
Units
Counts
Participants
OG0006
OG0016
OG00225
OG003
Title
Denominators
Categories
Day 8, (predose) n=5,6,25,7,13
ParticipantsOG0005
ParticipantsOG0016
ParticipantsOG00225
ParticipantsOG003
Primary
Part 2: Change From Baseline in Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin
Blood samples were collected to analyze the chemistry parameter: bilirubin, creatinine, direct bilirubin . Day -2 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Results are presented treatment wise.
Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Posted
Mean
Standard Deviation
Micromoles per liter
Baseline (Day -2), pre dose on Days 2,4,6,8,10,12,14 Day 14: 48 and 96 hours post dose, Follow up (Day 28)
ID
Title
Description
OG000
Part 2: GSK3640254 50 mg
Participants received repeated dose of GSK3640254 50 mg once daily up to 14 days
OG001
Part 2: GSK3640254 100 mg
Participants received repeated dose of GSK3640254 100 mg once daily up to 14 days
OG002
Part 2: GSK3640254 200 mg + Expansion
Participants received repeated dose of GSK3640254 200 mg once daily up to 14 days
OG003
Part 2: GSK3640254 320 mg
Participants received repeated dose of GSK3640254 320 mg once daily up to 14 days
OG004
Part 2: Repeated Dose Placebo
Participants received repeated dose of matching placebo once daily up to 14 days
Units
Counts
Participants
OG0006
OG0016
OG00225
OG003
Title
Denominators
Categories
Bilirubin, Day 2, predose, n=6,6,25,7,14
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG00225
ParticipantsOG003
Primary
Part 2: Change From Baseline in Chemistry Parameter: Protein
Blood samples were collected to analyze the chemistry parameter: Protein. Day -2 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Results are presented treatment wise.
Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Posted
Mean
Standard Deviation
Grams per liter
Baseline (Day -2), pre dose on Days 2,4,6,8,10,12,14 Day 14: 48 and 96 hours post dose, Follow up (Day 28)
ID
Title
Description
OG000
Part 2: GSK3640254 50 mg
Participants received repeated dose of GSK3640254 50 mg once daily up to 14 days
OG001
Part 2: GSK3640254 100 mg
Participants received repeated dose of GSK3640254 100 mg once daily up to 14 days
OG002
Part 2: GSK3640254 200 mg + Expansion
Participants received repeated dose of GSK3640254 200 mg once daily up to 14 days
OG003
Part 2: GSK3640254 320 mg
Participants received repeated dose of GSK3640254 320 mg once daily up to 14 days
OG004
Part 2: Repeated Dose Placebo
Participants received repeated dose of matching placebo once daily up to 14 days
Units
Counts
Participants
OG0006
OG0016
OG00225
OG003
Title
Denominators
Categories
Day 2, predose, n=6,6,25,7,14
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG00225
ParticipantsOG003
Primary
Part 2: Number of Participants With Abnormal Urinalysis
Urine samples were collected analyze the abnormal findings for potential of hydrogen (pH), glucose, protein, blood, ketones, bilirubin, urobilinogen, nitrite, leukocyte esterase by dipstick.
Safety Population
Posted
Count of Participants
Participants
Up to Day 28
ID
Title
Description
OG000
Part 2: GSK3640254 50 mg
Participants received repeated dose of GSK3640254 50 mg once daily up to 14 days
OG001
Part 2: GSK3640254 100 mg
Participants received repeated dose of GSK3640254 100 mg once daily up to 14 days
OG002
Part 2: GSK3640254 200 mg + Expansion
Participants received repeated dose of GSK3640254 200 mg once daily up to 14 days
OG003
Part 2: GSK3640254 320 mg
Participants received repeated dose of GSK3640254 320 mg once daily up to 14 days
OG004
Part 2: Repeated Dose Placebo
Participants received repeated dose of matching placebo once daily up to 14 days
Units
Counts
Participants
OG0006
OG0016
OG00225
OG003
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG003
Primary
Part 2: Change From Baseline in Vital Signs: SBP and DBP
SBP and DBP were measured in semi-supine position after 5 minutes rest for the participants at indicated time points. Day -1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Results are presented treatment wise.
Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Posted
Mean
Standard Deviation
Millimeters of mercury (mmHg)
Baseline (Day -1), pre dose on Days 1,2,4,6,8,10,12,and 14 (pre dose and 72 hours) and Follow up (Day 28)
ID
Title
Description
OG000
Part 2: GSK3640254 50 mg
Participants received repeated dose of GSK3640254 50 mg once daily up to 14 days
OG001
Part 2: GSK3640254 100 mg
Participants received repeated dose of GSK3640254 100 mg once daily up to 14 days
OG002
Part 2: GSK3640254 200 mg + Expansion
Participants received repeated dose of GSK3640254 200 mg once daily up to 14 days
OG003
Part 2: GSK3640254 320 mg
Participants received repeated dose of GSK3640254 320 mg once daily up to 14 days
OG004
Part 2: Repeated Dose Placebo
Participants received repeated dose of matching placebo once daily up to 14 days
Units
Counts
Participants
OG0006
OG0016
OG00225
OG003
Title
Denominators
Categories
SBP, Day 1, predose, n=6,6,25,7,14
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG00225
ParticipantsOG003
Primary
Part 2: Change From Baseline in Vital Sign: Pulse Rate
Pulse rate was measured in semi-supine position after 5 minutes rest for the participants at indicated time points. Day -1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Posted
Mean
Standard Deviation
Beats per minute
Baseline (Day -1), pre dose on Days 1,2,4,6,8,10,12, and 14 (pre dose and 72 hours) and Follow up (Day 28)
ID
Title
Description
OG000
Part 2: GSK3640254 50 mg
Participants received repeated dose of GSK3640254 50 mg once daily up to 14 days
OG001
Part 2: GSK3640254 100 mg
Participants received repeated dose of GSK3640254 100 mg once daily up to 14 days
OG002
Part 2: GSK3640254 200 mg + Expansion
Participants received repeated dose of GSK3640254 200 mg once daily up to 14 days
OG003
Part 2: GSK3640254 320 mg
Participants received repeated dose of GSK3640254 320 mg once daily up to 14 days
OG004
Part 2: Repeated Dose Placebo
Participants received repeated dose of matching placebo once daily up to 14 days
Units
Counts
Participants
OG0006
OG0016
OG00225
OG003
Title
Denominators
Categories
Day 1, predose, n=6,6,25,7,14
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG00225
ParticipantsOG003
Primary
Part 2: Change From Baseline in Vital Sign: Temperature
Temperature was measured in semi-supine position after 5 minutes rest for the participants at indicated time points. Day -1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Results are presented treatment wise.
Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Posted
Mean
Standard Deviation
Degree Celsius
Baseline (Day -1), pre dose on Days 1,2,4,6,8,10,12, and 14 (pre dose and 72 hours) and Follow up (Day 28)
ID
Title
Description
OG000
Part 2: GSK3640254 50 mg
Participants received repeated dose of GSK3640254 50 mg once daily up to 14 days
OG001
Part 2: GSK3640254 100 mg
Participants received repeated dose of GSK3640254 100 mg once daily up to 14 days
OG002
Part 2: GSK3640254 200 mg + Expansion
Participants received repeated dose of GSK3640254 200 mg once daily up to 14 days
OG003
Part 2: GSK3640254 320 mg
Participants received repeated dose of GSK3640254 320 mg once daily up to 14 days
OG004
Part 2: Repeated Dose Placebo
Participants received repeated dose of matching placebo once daily up to 14 days
Units
Counts
Participants
OG0006
OG0016
OG00225
OG003
Title
Denominators
Categories
Day 1, predose, n=6,6,25,7,14
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG00225
ParticipantsOG003
Primary
Part 2: Change From Baseline in Vital Sign: Respiratory Rate
Respiratory rate was measured in semi-supine position after 5 minutes rest for the participants at indicated time points. Day -1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Results are presented treatment wise.
Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Posted
Mean
Standard Deviation
Breaths per minute
Baseline (Day -1), pre dose on Days 1,2,4,6,8,10,12 and 14 (pre dose and 72 hours) and Follow up (Day 28)
ID
Title
Description
OG000
Part 2: GSK3640254 50 mg
Participants received repeated dose of GSK3640254 50 mg once daily up to 14 days
OG001
Part 2: GSK3640254 100 mg
Participants received repeated dose of GSK3640254 100 mg once daily up to 14 days
OG002
Part 2: GSK3640254 200 mg + Expansion
Participants received repeated dose of GSK3640254 200 mg once daily up to 14 days
OG003
Part 2: GSK3640254 320 mg
Participants received repeated dose of GSK3640254 320 mg once daily up to 14 days
OG004
Part 2: Repeated Dose Placebo
Participants received repeated dose of matching placebo once daily up to 14 days
Units
Counts
Participants
OG0006
OG0016
OG00225
OG003
Title
Denominators
Categories
Day 1, predose, n=6,6,25,7,14
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG00225
ParticipantsOG003
Primary
Part 2: Number of Participants With Abnormal ECG Findings
12-lead ECG were obtained at given time points. Abnormal findings were categorized as clinically significant (CS) and not clinically significant (NCS).Results are presented treatment wise.
Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Posted
Count of Participants
Participants
Day 1 (0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4.5, 5, 5.5, 6, 8, 12, 24 hours); Pre-dose on Days 3, 4, 6, 8, 10, 12; Day 14: Pre-dose, 1, 2, 4.5, 5, 6, 12, 24, 48, 72 and 96 hours post-dose and follow up (Day 28)
ID
Title
Description
OG000
Part 2: GSK3640254 50 mg
Participants received repeated dose of GSK3640254 50 mg once daily up to 14 days
OG001
Part 2: GSK3640254 100 mg
Participants received repeated dose of GSK3640254 100 mg once daily up to 14 days
OG002
Part 2: GSK3640254 200 mg + Expansion
Participants received repeated dose of GSK3640254 200 mg once daily up to 14 days
OG003
Part 2: GSK3640254 320 mg
Participants received repeated dose of GSK3640254 320 mg once daily up to 14 days
OG004
Part 2: Repeated Dose Placebo
Participants received repeated dose of matching placebo once daily up to 14 days
Units
Counts
Participants
OG0006
OG0016
OG00225
OG003
Title
Denominators
Categories
CS, Day 1, 0.5 hours, n=4,0,0,0,2
ParticipantsOG0004
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG003
Secondary
Part 1: Area Under the Plasma Concentration Time Curve (AUC) From Zero to 24 Hour (AUC[0-24]) of GSK3640254
Blood samples were collected at indicated time points and PK analysis was performed. PK parameters were determined by non-compartmental methods with Phoenix WinNonlin. Results are presented treatment wise.
PK Population. The PK Population include all participants who undergo plasma PK sampling and have evaluable PK parameters estimated during the single dose phase of the study Part 1. Only those participants with data available at the specified data points were analyzed.
Posted
Geometric Mean
95% Confidence Interval
Hour*microgram per milliliter
Pre-dose and 0.5,1,1.5,2,2.5,3,3.5,4,4.5,5,6,8,12,24 hours post-dose
ID
Title
Description
OG000
Part 1: GSK3640254 1 mg
Participants received single dose of GSK3640254 1 mg following a moderate fat meal on Day 1
OG001
Part 1: GSK3640254 3 mg
Participants received single dose of GSK3640254 3 mg following a moderate fat meal on Day 1
OG002
Part 1: GSK3640254 10 mg
Participants received single dose of GSK3640254 10 mg following a moderate fat meal on Day 1
OG003
Part 1: GSK3640254 30mg
Participants received single dose of GSK3640254 30 mg following a moderate fat meal on Day 1
OG004
Part 1: GSK3640254 100 mg
Participants received single dose of GSK3640254 100 mg following a moderate fat meal on Day 1
OG005
Part 1: GSK3640254 200 mg
Participants received single dose of GSK3640254 200 mg following a moderate fat meal on Day 1
OG006
Part 1: GSK3640254 400 mg
Participants received single dose of GSK3640254 400 mg following a moderate fat meal on Day 1
OG007
Part 1: GSK3640254 700 mg
Participants received single dose of GSK3640254 700 mg following a moderate fat meal on Day 1
Units
Counts
Participants
OG0004
OG0016
OG0026
OG003
Title
Denominators
Categories
Title
Measurements
OG0000.056(0.030 to 0.103)
OG0010.171(0.126 to 0.231)
OG0020.576(0.454 to 0.730)
OG003
Secondary
Part 1: AUC From Zero to Time of Last Sample Taken (AUC[0-Tlast]) of GSK3640254
Blood samples were collected at indicated time points and PK analysis was performed. PK parameters were determined by non-compartmental methods with Phoenix WinNonlin. Results are presented treatment wise.
PK Population. The PK Population include all participants who undergo plasma PK sampling and have evaluable PK parameters estimated during the single dose phase of the study Part 1.
Posted
Geometric Mean
95% Confidence Interval
Hour*microgram per milliliter
Pre-dose and 0.5,1,1.5,2,2.5,3,3.5,4,4.5,5,6,8,12, 24, 48, 72 and 96 hours post-dose
ID
Title
Description
OG000
Part 1: GSK3640254 1 mg
Participants received single dose of GSK3640254 1 mg following a moderate fat meal on Day 1
OG001
Part 1: GSK3640254 3 mg
Participants received single dose of GSK3640254 3 mg following a moderate fat meal on Day 1
OG002
Part 1: GSK3640254 10 mg
Participants received single dose of GSK3640254 10 mg following a moderate fat meal on Day 1
OG003
Part 1: GSK3640254 30mg
Participants received single dose of GSK3640254 30 mg following a moderate fat meal on Day 1
OG004
Part 1: GSK3640254 100 mg
Participants received single dose of GSK3640254 100 mg following a moderate fat meal on Day 1
OG005
Part 1: GSK3640254 200 mg
Participants received single dose of GSK3640254 200 mg following a moderate fat meal on Day 1
OG006
Part 1: GSK3640254 400 mg
Participants received single dose of GSK3640254 400 mg following a moderate fat meal on Day 1
OG007
Part 1: GSK3640254 700 mg
Participants received single dose of GSK3640254 700 mg following a moderate fat meal on Day 1
Units
Counts
Participants
OG0006
OG0016
OG0026
OG003
Title
Denominators
Categories
Title
Measurements
OG0000.020(0.005 to 0.080)
OG0010.184(0.120 to 0.282)
OG0021.082(0.875 to 1.338)
OG003
Secondary
Part 1: AUC From Time Zero (Pre-dose) Extrapolated to Infinite Time (AUC[0-inf]) of GSK3640254
Blood samples were collected at indicated time points and PK analysis was performed. PK parameters were determined by non-compartmental methods with Phoenix WinNonlin. Results are presented treatment wise.
PK Population. The PK Population include all participants who undergo plasma PK sampling and have evaluable PK parameters estimated during the single dose phase of the study Part 1. Only those participants with data available at the specified data points were analyzed.
Posted
Geometric Mean
95% Confidence Interval
Hour*microgram per milliliter
Pre-dose and 0.5,1,1.5,2,2.5,3,3.5,4,4.5,5,6,8,12, 24, 48, 72 and 96 hours post-dose
ID
Title
Description
OG000
Part 1: GSK3640254 1 mg
Participants received single dose of GSK3640254 1 mg following a moderate fat meal on Day 1
OG001
Part 1: GSK3640254 3 mg
Participants received single dose of GSK3640254 3 mg following a moderate fat meal on Day 1
OG002
Part 1: GSK3640254 10 mg
Participants received single dose of GSK3640254 10 mg following a moderate fat meal on Day 1
OG003
Part 1: GSK3640254 30mg
Participants received single dose of GSK3640254 30 mg following a moderate fat meal on Day 1
OG004
Part 1: GSK3640254 100 mg
Participants received single dose of GSK3640254 100 mg following a moderate fat meal on Day 1
OG005
Part 1: GSK3640254 200 mg
Participants received single dose of GSK3640254 200 mg following a moderate fat meal on Day 1
OG006
Part 1: GSK3640254 400 mg
Participants received single dose of GSK3640254 400 mg following a moderate fat meal on Day 1
OG007
Part 1: GSK3640254 700 mg
Participants received single dose of GSK3640254 700 mg following a moderate fat meal on Day 1
Units
Counts
Participants
OG0003
OG0016
OG0026
OG003
Title
Denominators
Categories
Title
Measurements
OG0000.057(0.022 to 0.145)
OG0010.329(0.232 to 0.467)
OG0021.227(1.008 to 1.493)
OG003
Secondary
Part 1: Apparent Terminal Phase Half-life (T1/2) of GSK3640254
Blood samples were collected at indicated time points and PK analysis was performed. PK parameters were determined by non-compartmental methods with Phoenix WinNonlin. Most of the concentrations were below limit of quantification (BLQ) at this dose group this value and/ or %AUC extrapolated was >20% for all participants so this value should be used with caution. Results are presented treatment wise.
PK Population. The PK Population include all participants who undergo plasma PK sampling and have evaluable PK parameters estimated during the single dose phase of the study Part 1. Only those participants with data available at the specified data points were analyzed.
Posted
Geometric Mean
95% Confidence Interval
Hour
Pre-dose and 0.5,1,1.5,2,2.5,3,3.5,4,4.5,5,6,8,12, 24, 48, 72 and 96 hours post-dose
ID
Title
Description
OG000
Part 1: GSK3640254 1 mg
Participants received single dose of GSK3640254 1 mg following a moderate fat meal on Day 1
OG001
Part 1: GSK3640254 3 mg
Participants received single dose of GSK3640254 3 mg following a moderate fat meal on Day 1
OG002
Part 1: GSK3640254 10 mg
Participants received single dose of GSK3640254 10 mg following a moderate fat meal on Day 1
OG003
Part 1: GSK3640254 30mg
Participants received single dose of GSK3640254 30 mg following a moderate fat meal on Day 1
OG004
Part 1: GSK3640254 100 mg
Participants received single dose of GSK3640254 100 mg following a moderate fat meal on Day 1
OG005
Part 1: GSK3640254 200 mg
Participants received single dose of GSK3640254 200 mg following a moderate fat meal on Day 1
OG006
Part 1: GSK3640254 400 mg
Participants received single dose of GSK3640254 400 mg following a moderate fat meal on Day 1
OG007
Part 1: GSK3640254 700 mg
Participants received single dose of GSK3640254 700 mg following a moderate fat meal on Day 1
Units
Counts
Participants
OG0003
OG0016
OG0026
OG003
Title
Denominators
Categories
Title
Measurements
OG0007.886(3.427 to 18.145)
OG00120.486(16.450 to 25.514)
OG00225.332(20.741 to 30.938)
OG003
Secondary
Part 1: Apparent Oral Clearance (CL/F) of GSK3640254
Blood samples were collected at indicated time points and PK analysis was performed. PK parameters were determined by non-compartmental methods with Phoenix WinNonlin. Results are presented treatment wise.
PK Population. The PK Population include all participants who undergo plasma PK sampling and have evaluable PK parameters estimated during the single dose phase of the study Part 1. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Posted
Geometric Mean
95% Confidence Interval
Liters/hour
Pre-dose and 0.5,1,1.5,2,2.5,3,3.5,4,4.5,5,6,8,12, 24, 48, 72 and 96 hours post-dose
ID
Title
Description
OG000
Part 1: GSK3640254 1 mg
Participants received single dose of GSK3640254 1 mg following a moderate fat meal on Day 1
OG001
Part 1: GSK3640254 3 mg
Participants received single dose of GSK3640254 3 mg following a moderate fat meal on Day 1
OG002
Part 1: GSK3640254 10 mg
Participants received single dose of GSK3640254 10 mg following a moderate fat meal on Day 1
OG003
Part 1: GSK3640254 30mg
Participants received single dose of GSK3640254 30 mg following a moderate fat meal on Day 1
OG004
Part 1: GSK3640254 100 mg
Participants received single dose of GSK3640254 100 mg following a moderate fat meal on Day 1
OG005
Part 1: GSK3640254 200 mg
Participants received single dose of GSK3640254 200 mg following a moderate fat meal on Day 1
OG006
Part 1: GSK3640254 400 mg
Participants received single dose of GSK3640254 400 mg following a moderate fat meal on Day 1
OG007
Part 1: GSK3640254 700 mg
Participants received single dose of GSK3640254 700 mg following a moderate fat meal on Day 1
Units
Counts
Participants
OG0003
OG0016
OG0026
OG003
Title
Denominators
Categories
Title
Measurements
OG00017.685(6.889 to 45.399)
OG0019.119(6.428 to 12.937)
OG0028.152(6.697 to 9.922)
OG003
Secondary
Part 1: Maximum Observed Concentration (Cmax), Concentration of GSK3640254 at 24 Hours (C24) and Last Quantifiable Concentration (Clast) of GSK3640254
Blood samples were collected at indicated time points and PK analysis was performed. PK parameters were determined by non-compartmental methods with Phoenix WinNonlin.
PK Population. The PK Population include all participants who undergo plasma PK sampling and have evaluable PK parameters estimated during the single dose phase of the study Part 1.
Posted
Geometric Mean
95% Confidence Interval
Micrograms per milliliter
Pre-dose and 0.5,1,1.5,2,2.5,3,3.5,4,4.5,5,6,8,12, 24, 48, 72 and 96 hours post-dose
ID
Title
Description
OG000
Part 1: GSK3640254 1 mg
Participants received single dose of GSK3640254 1 mg following a moderate fat meal on Day 1
OG001
Part 1: GSK3640254 3 mg
Participants received single dose of GSK3640254 3 mg following a moderate fat meal on Day 1
OG002
Part 1: GSK3640254 10 mg
Participants received single dose of GSK3640254 10 mg following a moderate fat meal on Day 1
OG003
Part 1: GSK3640254 30mg
Participants received single dose of GSK3640254 30 mg following a moderate fat meal on Day 1
OG004
Part 1: GSK3640254 100 mg
Participants received single dose of GSK3640254 100 mg following a moderate fat meal on Day 1
OG005
Part 1: GSK3640254 200 mg
Participants received single dose of GSK3640254 200 mg following a moderate fat meal on Day 1
OG006
Part 1: GSK3640254 400 mg
Participants received single dose of GSK3640254 400 mg following a moderate fat meal on Day 1
OG007
Part 1: GSK3640254 700 mg
Participants received single dose of GSK3640254 700 mg following a moderate fat meal on Day 1
Units
Counts
Participants
OG0006
OG0016
OG0026
OG003
Title
Denominators
Categories
Cmax
Title
Measurements
OG0000.005(0.004 to 0.006)
OG0010.014(0.010 to 0.019)
OG0020.047(0.034 to 0.064)
OG003
Secondary
Part 1: Time of Occurrence of Cmax (Tmax), Lag Time (Tlag), and Time to Reach Clast (Tlast) of GSK3640254
Blood samples were collected at indicated time points and PK analysis was performed. PK parameters were determined by non-compartmental methods with Phoenix WinNonlin. Results are presented treatment wise.
PK Population. The PK Population include all participants who undergo plasma PK sampling and have evaluable PK parameters estimated during the single dose phase of the study Part 1.
Posted
Median
Full Range
Hour
Pre-dose and 0.5,1,1.5,2,2.5,3,3.5,4,4.5,5,6,8,12, 24, 48, 72 and 96 hours post-dose
ID
Title
Description
OG000
Part 1: GSK3640254 1 mg
Participants received single dose of GSK3640254 1 mg following a moderate fat meal on Day 1
OG001
Part 1: GSK3640254 3 mg
Participants received single dose of GSK3640254 3 mg following a moderate fat meal on Day 1
OG002
Part 1: GSK3640254 10 mg
Participants received single dose of GSK3640254 10 mg following a moderate fat meal on Day 1
OG003
Part 1: GSK3640254 30mg
Participants received single dose of GSK3640254 30 mg following a moderate fat meal on Day 1
OG004
Part 1: GSK3640254 100 mg
Participants received single dose of GSK3640254 100 mg following a moderate fat meal on Day 1
OG005
Part 1: GSK3640254 200 mg
Participants received single dose of GSK3640254 200 mg following a moderate fat meal on Day 1
OG006
Part 1: GSK3640254 400 mg
Participants received single dose of GSK3640254 400 mg following a moderate fat meal on Day 1
OG007
Part 1: GSK3640254 700 mg
Participants received single dose of GSK3640254 700 mg following a moderate fat meal on Day 1
Units
Counts
Participants
OG0006
OG0016
OG0026
OG003
Title
Denominators
Categories
Tmax
Title
Measurements
OG0003.500(2.500 to 6.000)
OG0014.500(2.000 to 5.000)
OG0023.500(2.500 to 5.000)
OG003
Secondary
Part 2: AUC(0-24) of GSK3640254: Day 1
Blood samples were collected at indicated time points and PK analysis was performed. PK parameters were determined by non-compartmental methods with Phoenix WinNonlin. Results are presented treatment wise.
PK Population. The PK Population include all participants who undergo plasma PK sampling and have evaluable PK parameters estimated during the repeat dose phase of the study Part 2.
Posted
Geometric Mean
Geometric Coefficient of Variation
Hour*micrograms per milliliter
Pre-dose and 0.5,1,1.5,2,2.5,3,3.5,4,4.5,5,6,8,12 and 24 hours post-dose on Day 1
ID
Title
Description
OG000
Part 2: GSK3640254 50 mg
Participants received repeated dose of GSK3640254 50 mg once daily up to 14 days
OG001
Part 2: GSK3640254 100 mg
Participants received repeated dose of GSK3640254 100 mg once daily up to 14 days
OG002
Part 2: GSK3640254 200 mg + Expansion
Participants received repeated dose of GSK3640254 200 mg once daily up to 14 days
OG003
Part 2: GSK3640254 320 mg
Participants received repeated dose of GSK3640254 320 mg once daily up to 14 days
Units
Counts
Participants
OG0006
OG0016
OG00225
OG003
Title
Denominators
Categories
Title
Measurements
OG0002.855± 29.621
OG0016.801± 22.970
OG0028.257± 49.782
OG003
Secondary
Part 2: Cmax, C24 of GSK3640254 on Day 1
Blood samples were collected at indicated time points and PK analysis was performed. PK parameters were determined by non-compartmental methods with Phoenix WinNonlin. Results are presented treatment wise.
PK Population. The PK Population include all participants who undergo plasma PK sampling and have evaluable PK parameters estimated during the repeat dose phase of the study Part 2.
Posted
Geometric Mean
Geometric Coefficient of Variation
Micrograms per milliliter
Pre-dose and 0.5,1,1.5,2,2.5,3,3.5,4,4.5,5,6,8,12 hours post-dose on Day 1
ID
Title
Description
OG000
Part 2: GSK3640254 50 mg
Participants received repeated dose of GSK3640254 50 mg once daily up to 14 days
OG001
Part 2: GSK3640254 100 mg
Participants received repeated dose of GSK3640254 100 mg once daily up to 14 days
OG002
Part 2: GSK3640254 200 mg + Expansion
Participants received repeated dose of GSK3640254 200 mg once daily up to 14 days
OG003
Part 2: GSK3640254 320 mg
Participants received repeated dose of GSK3640254 320 mg once daily up to 14 days
Units
Counts
Participants
OG0006
OG0016
OG00225
OG003
Title
Denominators
Categories
Cmax
Title
Measurements
OG0000.215± 24.412
OG0010.536± 22.959
OG0020.614± 44.354
OG003
Secondary
Part 2: Tmax, Tlag of GSK3640254 on Day 1
Blood samples were collected at indicated timepoints and PK analysis was performed. PK parameters were determined by non-compartmental methods with Phoenix WinNonlin.
PK Population. The PK Population include all participants who undergo plasma PK sampling and have evaluable PK parameters estimated during the repeat dose phase of the study Part 2.
Posted
Median
Full Range
Hour
Pre-dose and 0.5,1,1.5,2,2.5,3,3.5,4,4.5,5,6,8,12 hours post-dose on Day 1
ID
Title
Description
OG000
Part 2: GSK3640254 50 mg
Participants received repeated dose of GSK3640254 50 mg once daily up to 14 days
OG001
Part 2: GSK3640254 100 mg
Participants received repeated dose of GSK3640254 100 mg once daily up to 14 days
OG002
Part 2: GSK3640254 200 mg + Expansion
Participants received repeated dose of GSK3640254 200 mg once daily up to 14 days
OG003
Part 2: GSK3640254 320 mg
Participants received repeated dose of GSK3640254 320 mg once daily up to 14 days
Units
Counts
Participants
OG0006
OG0016
OG00225
OG003
Title
Denominators
Categories
Tmax
Title
Measurements
OG0003.750(3.000 to 5.017)
OG0014.250(2.000 to 5.000)
OG0024.000(1.500 to 5.633)
OG003
Secondary
Part 2: Tmax GSK3640254 on Day 14
Blood samples were collected at indicated time points and PK analysis was performed. PK parameters were determined by non-compartmental methods with Phoenix WinNonlin. Results are presented treatment wise.
PK Population, The PK Population include all participants who undergo plasma PK sampling and have evaluable PK parameters estimated during the repeat dose phase of the study Part 2. Only those participants with data available at the specified data points were analyzed.
Posted
Median
Full Range
Hour
Pre-dose and 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72 and 96 hours after Day 14 dose
ID
Title
Description
OG000
Part 2: GSK3640254 50 mg
Participants received repeated dose of GSK3640254 50 mg once daily up to 14 days
OG001
Part 2: GSK3640254 100 mg
Participants received repeated dose of GSK3640254 100 mg once daily up to 14 days
OG002
Part 2: GSK3640254 200 mg + Expansion
Participants received repeated dose of GSK3640254 200 mg once daily up to 14 days
OG003
Part 2: GSK3640254 320 mg
Participants received repeated dose of GSK3640254 320 mg once daily up to 14 days
Units
Counts
Participants
OG0006
OG0016
OG00224
OG003
Title
Denominators
Categories
Title
Measurements
OG0003.775(2.500 to 5.000)
OG0014.000(1.500 to 4.500)
OG0023.750(1.500 to 5.500)
OG003
Secondary
Part 2: Cmax of GSK3640254 on Day 14
Blood samples were collected at indicated time points and PK analysis was performed. PK parameters were determined by non-compartmental methods with Phoenix WinNonlin. Results are presented treatment wise.
PK Population, The PK Population include all participants who undergo plasma PK sampling and have evaluable PK parameters estimated during the repeat dose phase of the study Part 2. Only those participants with data available at the specified data points were analyzed.
Posted
Geometric Mean
Geometric Coefficient of Variation
Micrograms per milliliter
Pre-dose and 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72 and 96 hours after Day 14 dose
ID
Title
Description
OG000
Part 2: GSK3640254 50 mg
Participants received repeated dose of GSK3640254 50 mg once daily up to 14 days
OG001
Part 2: GSK3640254 100 mg
Participants received repeated dose of GSK3640254 100 mg once daily up to 14 days
OG002
Part 2: GSK3640254 200 mg + Expansion
Participants received repeated dose of GSK3640254 200 mg once daily up to 14 days
OG003
Part 2: GSK3640254 320 mg
Participants received repeated dose of GSK3640254 320 mg once daily up to 14 days
Units
Counts
Participants
OG0006
OG0016
OG00224
OG003
Title
Denominators
Categories
Title
Measurements
OG0000.414± 31.556
OG0011.182± 10.264
OG0021.402± 30.839
OG003
Secondary
Part 2: AUC From Pre-dose to the End of the Dosing Interval at Steady State (AUC[0-tau]): Day 14
Blood samples were collected at indicated time points and PK analysis was performed. PK parameters were determined by non-compartmental methods with Phoenix WinNonlin. Results are presented treatment wise.
PK Population, The PK Population include all participants who undergo plasma PK sampling and have evaluable PK parameters estimated during the repeat dose phase of the study Part 2. Only those participants with data available at the specified data points were analyzed.
Posted
Geometric Mean
Geometric Coefficient of Variation
hour* micrograms per milliliter
Pre-dose and 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24 hours after Day 14 dose
ID
Title
Description
OG000
Part 2: GSK3640254 50 mg
Participants received repeated dose of GSK3640254 50 mg once daily up to 14 days
OG001
Part 2: GSK3640254 100 mg
Participants received repeated dose of GSK3640254 100 mg once daily up to 14 days
OG002
Part 2: GSK3640254 200 mg + Expansion
Participants received repeated dose of GSK3640254 200 mg once daily up to 14 days
OG003
Part 2: GSK3640254 320 mg
Participants received repeated dose of GSK3640254 320 mg once daily up to 14 days
Units
Counts
Participants
OG0006
OG0016
OG00224
OG003
Title
Denominators
Categories
Title
Measurements
OG0006.282± 34.010
OG00117.506± 13.794
OG00221.501± 34.205
OG003
Secondary
Part 2: Plasma Trough Concentration (Ctau) of GSK3640254: Day 14
Blood samples were collected at indicated timepoints and PK analysis was performed. PK parameters were determined by non-compartmental methods with Phoenix WinNonlin. The PK parameter name for Part 2 (Day 14) trough concentration was changed using Phoenix WinNonlin 8 from Ct to Ctrough. Day 15 Ctrough values were used for dose proportionality and time to steady-state assessments.
PK Population, The PK Population include all participants who undergo plasma PK sampling and have evaluable PK parameters estimated during the repeat dose phase of the study Part 2.
Posted
Geometric Mean
Geometric Coefficient of Variation
micrograms per milliliter
Pre-dose and 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72 and 96 hours after Day 14 dose
ID
Title
Description
OG000
Part 2: GSK3640254 50 mg
Participants received repeated dose of GSK3640254 50 mg once daily up to 14 days
OG001
Part 2: GSK3640254 100 mg
Participants received repeated dose of GSK3640254 100 mg once daily up to 14 days
OG002
Part 2: GSK3640254 200 mg + Expansion
Participants received repeated dose of GSK3640254 200 mg once daily up to 14 days
OG003
Part 2: GSK3640254 320 mg
Participants received repeated dose of GSK3640254 320 mg once daily up to 14 days
Units
Counts
Participants
OG0006
OG0016
OG00224
OG003
Title
Denominators
Categories
Title
Measurements
OG0000.186± 35.128
OG0010.558± 21.407
OG0020.630± 37.814
OG003
Secondary
Part 2: T1/2 of GSK3640254: Day 14
Blood samples were collected at indicated time points and PK analysis was performed. PK parameters were determined by non-compartmental methods with Phoenix WinNonlin. Results are presented treatment wise.
PK Population, The PK Population include all participants who undergo plasma PK sampling and have evaluable PK parameters estimated during the repeat dose phase of the study Part 2. Only those participants with data available at the specified data points were analyzed.
Posted
Geometric Mean
Geometric Coefficient of Variation
Hour
Pre-dose and 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72 and 96 hours after Day 14 dose
ID
Title
Description
OG000
Part 2: GSK3640254 50 mg
Participants received repeated dose of GSK3640254 50 mg once daily up to 14 days
OG001
Part 2: GSK3640254 100 mg
Participants received repeated dose of GSK3640254 100 mg once daily up to 14 days
OG002
Part 2: GSK3640254 200 mg + Expansion
Participants received repeated dose of GSK3640254 200 mg once daily up to 14 days
OG003
Part 2: GSK3640254 320 mg
Participants received repeated dose of GSK3640254 320 mg once daily up to 14 days
Units
Counts
Participants
OG0006
OG0016
OG00224
OG003
Title
Denominators
Categories
Title
Measurements
OG00024.847± 5.087
OG00128.358± 19.199
OG00222.125± 14.515
OG003
Secondary
Part 2: CL/F of GSK3640254: Day 14
Blood samples were collected at indicated time points and PK analysis was performed. PK parameters were determined by non-compartmental methods with Phoenix WinNonlin.
PK Population, The PK Population include all participants who undergo plasma PK sampling and have evaluable PK parameters estimated during the repeat dose phase of the study Part 2. Only those participants with data available at the specified data points were analyzed.
Posted
Geometric Mean
Geometric Coefficient of Variation
Liter per hour
Pre-dose and 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72 and 96 hours after Day 14 dose
ID
Title
Description
OG000
Part 2: GSK3640254 50 mg
Participants received repeated dose of GSK3640254 50 mg once daily up to 14 days
OG001
Part 2: GSK3640254 100 mg
Participants received repeated dose of GSK3640254 100 mg once daily up to 14 days
OG002
Part 2: GSK3640254 200 mg + Expansion
Participants received repeated dose of GSK3640254 200 mg once daily up to 14 days
OG003
Part 2: GSK3640254 320 mg
Participants received repeated dose of GSK3640254 320 mg once daily up to 14 days
Units
Counts
Participants
OG0006
OG0016
OG00224
OG003
Title
Denominators
Categories
Title
Measurements
OG0007.959± 34.010
OG0015.712± 13.794
OG0029.302± 34.205
OG003
Secondary
Part 1: Dose Proportionality (AUC[0-inf]) Following Single Dose of GSK3640254 on Day 1
Blood samples were collected at indicated time points and PK analysis was performed. Dose proportionality was assessed using the power model. Results are presented treatment wise.
PK Population, The PK Population include all participants who undergo plasma PK sampling and have evaluable PK parameters estimated during the single dose phase of the study Part 1.
Posted
Geometric Mean
95% Confidence Interval
hour*micrograms per mililiter
Pre-dose and 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72 and 96 hours post dose
ID
Title
Description
OG000
Part 1: GSK3640254 1 mg
Participants received single dose of GSK3640254 1 mg following a moderate fat meal on Day 1
OG001
Part 1: GSK3640254 3 mg
Participants received single dose of GSK3640254 3 mg following a moderate fat meal on Day 1
OG002
Part 1: GSK3640254 10 mg
Participants received single dose of GSK3640254 10 mg following a moderate fat meal on Day 1
OG003
Part 1: GSK3640254 30mg
Participants received single dose of GSK3640254 30 mg following a moderate fat meal on Day 1
OG004
Part 1: GSK3640254 100 mg
Participants received single dose of GSK3640254 100 mg following a moderate fat meal on Day 1
OG005
Part 1: GSK3640254 200 mg
Participants received single dose of GSK3640254 200 mg following a moderate fat meal on Day 1
OG006
Part 1: GSK3640254 400 mg
Participants received single dose of GSK3640254 400 mg following a moderate fat meal on Day 1
OG007
Part 1: GSK3640254 700 mg
Participants received single dose of GSK3640254 700 mg following a moderate fat meal on Day 1
Units
Counts
Participants
OG0006
OG0016
OG0026
OG003
Title
Denominators
Categories
Title
Measurements
OG0000.057(0.022 to 0.145)
OG0010.329(0.232 to 0.467)
OG0021.1227(1.008 to 1.493)
OG003
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
OG000
OG001
OG002
OG003
OG004
OG005
OG006
OG007
Power model
0.9476
2-Sided
90
0.8982
0.9971
The statistical model (power model) is based on the PK parameters (AUC0-inf) from all active doses in Part 1
Other
Secondary
Part 1: Dose Proportionality (AUC0-24) Following Single Dose of GSK3640254 on Day 1
Blood samples were collected at indicated time points and PK analysis was performed. Dose proportionality was assessed using the power model. Results are presented treatment wise.
PK Population, The PK Population include all participants who undergo plasma PK sampling and have evaluable PK parameters estimated during the single dose phase of the study Part 1.
Posted
Geometric Mean
95% Confidence Interval
hour*micrograms per mililiter
Pre-dose and 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24 hours post dose
ID
Title
Description
OG000
Part 1: GSK3640254 1 mg
Participants received single dose of GSK3640254 1 mg following a moderate fat meal on Day 1
OG001
Part 1: GSK3640254 3 mg
Participants received single dose of GSK3640254 3 mg following a moderate fat meal on Day 1
OG002
Part 1: GSK3640254 10 mg
Participants received single dose of GSK3640254 10 mg following a moderate fat meal on Day 1
OG003
Part 1: GSK3640254 30mg
Participants received single dose of GSK3640254 30 mg following a moderate fat meal on Day 1
OG004
Part 1: GSK3640254 100 mg
Participants received single dose of GSK3640254 100 mg following a moderate fat meal on Day 1
OG005
Part 1: GSK3640254 200 mg
Participants received single dose of GSK3640254 200 mg following a moderate fat meal on Day 1
OG006
Part 1: GSK3640254 400 mg
Participants received single dose of GSK3640254 400 mg following a moderate fat meal on Day 1
OG007
Part 1: GSK3640254 700 mg
Participants received single dose of GSK3640254 700 mg following a moderate fat meal on Day 1
Units
Counts
Participants
OG0006
OG0016
OG0026
OG003
Title
Denominators
Categories
Title
Measurements
OG0000.056(0.030 to 0.103)
OG0010.171(0.126 to 0.231)
OG0020.576(0.454 to 0.730)
OG003
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
OG000
OG001
OG002
OG003
OG004
OG005
OG006
OG007
Power model
0.9280
2-Sided
90
0.8877
0.9683
The statistical model (power model) is based on the PK parameters (AUC0-24) from all active doses in Part 1
Other
Secondary
Part 1: Dose Proportionality for Cmax Following Single Dose of GSK3640254 on Day 1
Blood samples were collected at indicated time points and PK analysis was performed. Dose proportionality was assessed using the power model. Results are presented treatment wise.
PK Population, The PK Population include all participants who undergo plasma PK sampling and have evaluable PK parameters estimated during the single dose phase of the study Part 1.
Posted
Geometric Mean
95% Confidence Interval
Micrograms per mililiter
Pre-dose and 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72 and 96 hours post dose
ID
Title
Description
OG000
Part 1: GSK3640254 1 mg
Participants received single dose of GSK3640254 1 mg following a moderate fat meal on Day 1
OG001
Part 1: GSK3640254 3 mg
Participants received single dose of GSK3640254 3 mg following a moderate fat meal on Day 1
OG002
Part 1: GSK3640254 10 mg
Participants received single dose of GSK3640254 10 mg following a moderate fat meal on Day 1
OG003
Part 1: GSK3640254 30mg
Participants received single dose of GSK3640254 30 mg following a moderate fat meal on Day 1
OG004
Part 1: GSK3640254 100 mg
Participants received single dose of GSK3640254 100 mg following a moderate fat meal on Day 1
OG005
Part 1: GSK3640254 200 mg
Participants received single dose of GSK3640254 200 mg following a moderate fat meal on Day 1
OG006
Part 1: GSK3640254 400 mg
Participants received single dose of GSK3640254 400 mg following a moderate fat meal on Day 1
OG007
Part 1: GSK3640254 700 mg
Participants received single dose of GSK3640254 700 mg following a moderate fat meal on Day 1
Units
Counts
Participants
OG0006
OG0016
OG0026
OG003
Title
Denominators
Categories
Title
Measurements
OG0000.005(0.004 to 0.006)
OG0010.014(0.010 to 0.019)
OG0020.047(0.034 to 0.064)
OG003
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
OG000
OG001
OG002
OG003
OG004
OG005
OG006
OG007
Power Model
0.9352
2-Sided
90
0.8970
0.9734
The statistical model (power model) is based on the PK parameters (Cmax) from all active doses in Part 1
Other
Secondary
Part 2: Dose Proportionality (AUC0-tau) Following Repeated Dose of GSK3640254 on Day 14
Blood samples were collected at indicated time points and PK analysis was performed. Dose proportionality was assessed using the power model. Results are presented treatment wise.
PK Population, The PK Population include all participants who undergo plasma PK sampling and have evaluable PK parameters estimated during the repeat dose phase of the study Part 2. Only those participants with data available at the specified data points were analyzed.
Posted
Geometric Mean
Geometric Coefficient of Variation
hour*microgram per milliliter
Pre-dose and 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72 and 96 hours after Day 14 dose
ID
Title
Description
OG000
Part 2: GSK3640254 50 mg
Participants received repeated dose of GSK3640254 50 mg once daily up to 14 days
OG001
Part 2: GSK3640254 100 mg
Participants received repeated dose of GSK3640254 100 mg once daily up to 14 days
OG002
Part 2: GSK3640254 200 mg + Expansion
Participants received repeated dose of GSK3640254 200 mg once daily up to 14 days
OG003
Part 2: GSK3640254 320 mg
Participants received repeated dose of GSK3640254 320 mg once daily up to 14 days
Units
Counts
Participants
OG0006
OG0016
OG00224
OG003
Title
Denominators
Categories
Title
Measurements
OG0006.282± 34.010
OG00117.506± 13.794
OG00221.501± 34.205
OG003
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
OG000
OG001
OG002
OG003
Power model
0.7968
2-Sided
90
0.6424
0.9512
The statistical model (power model) is based on the PK parameters (AUC0-tau) from all active doses in Part 1
Other
Secondary
Part 2: Dose Proportionality (Ctrough) Following Repeated Dose of GSK3640254 on Day 14
Blood samples were collected at indicated time points and PK analysis was performed. Dose proportionality was assessed using the power model. Results are presented treatment wise.
PK Population, The PK Population include all participants who undergo plasma PK sampling and have evaluable PK parameters estimated during the repeat dose phase of the study Part 2. Only those participants with data available at the specified data points were analyzed.
Posted
Geometric Mean
Geometric Coefficient of Variation
Micrograms per milliliter
Pre-dose and 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72 and 96 hours after Day 14 dose
ID
Title
Description
OG000
Part 2: GSK3640254 50 mg
Participants received repeated dose of GSK3640254 50 mg once daily up to 14 days
OG001
Part 2: GSK3640254 100 mg
Participants received repeated dose of GSK3640254 100 mg once daily up to 14 days
OG002
Part 2: GSK3640254 200 mg + Expansion
Participants received repeated dose of GSK3640254 200 mg once daily up to 14 days
OG003
Part 2: GSK3640254 320 mg
Participants received repeated dose of GSK3640254 320 mg once daily up to 14 days
Units
Counts
Participants
OG0006
OG0016
OG00224
OG003
Title
Denominators
Categories
Title
Measurements
OG0000.205± 33.414
OG0010.593± 16.359
OG0020.615± 74.191
OG003
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
OG000
OG001
OG002
OG003
Power model
0.7890
2-Sided
90
0.6149
0.9631
The statistical model (power model) is based on the PK parameters (Ctrough) from all active doses in Part 2
Other
Secondary
Part 2: Dose Proportionality (Cmax) Following Repeated Dose of GSK3640254 on Day 14
Blood samples were collected at indicated time points and PK analysis was performed. Dose proportionality was assessed using the power model. Results are presented treatment wise.
PK Population, The PK Population include all participants who undergo plasma PK sampling and have evaluable PK parameters estimated during the repeat dose phase of the study Part 2. Only those participants with data available at the specified data points were analyzed.
Posted
Geometric Mean
Geometric Coefficient of Variation
Microgram per milliliter
Pre-dose and 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72 and 96 hours after Day 14 dose
ID
Title
Description
OG000
Part 2: GSK3640254 50 mg
Participants received repeated dose of GSK3640254 50 mg once daily up to 14 days
OG001
Part 2: GSK3640254 100 mg
Participants received repeated dose of GSK3640254 100 mg once daily up to 14 days
OG002
Part 2: GSK3640254 200 mg + Expansion
Participants received repeated dose of GSK3640254 200 mg once daily up to 14 days
OG003
Part 2: GSK3640254 320 mg
Participants received repeated dose of GSK3640254 320 mg once daily up to 14 days
Units
Counts
Participants
OG0006
OG0016
OG00224
OG003
Title
Denominators
Categories
Title
Measurements
OG0000.414± 31.556
OG0011.182± 10.264
OG0021.402± 30.839
OG003
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
OG000
OG001
OG002
OG003
Power model
0.7955
2-Sided
90
0.6562
0.9349
The statistical model (power model) is based on the PK parameters (Cmax) from all active doses in Part 2
Other
Secondary
Part 2: Accumulation Ratio of AUC(0-tau) (R [AUC{0-TAU}]) From Day 1 to Day 14
Blood samples were collected at indicated time points and PK analysis was performed. PK parameters were determined by non-compartmental methods with Phoenix WinNonlin. The accumulation ratio was estimated by calculating the ratio of the geometric least squares (GLS) means of PK parameters between Day 14 and Day 1, and the corresponding 90% CI for each dose. Ratio and 90% confidence interval is presented. Results are presented treatment wise.
PK Population, The PK Population include all participants who undergo plasma PK sampling and have evaluable PK parameters estimated during the repeat dose phase of the study Part 2.
Posted
Number
90% Confidence Interval
Ratio of AUC(0-tau)
Pre-dose and 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72 and 96 hours after Day 14 dose
ID
Title
Description
OG000
Part 2: GSK3640254 50 mg
Participants received repeated dose of GSK3640254 50 mg once daily up to 14 days
OG001
Part 2: GSK3640254 100 mg
Participants received repeated dose of GSK3640254 100 mg once daily up to 14 days
OG002
Part 2: GSK3640254 200 mg + Expansion
Participants received repeated dose of GSK3640254 200 mg once daily up to 14 days
OG003
Part 2: GSK3640254 320 mg
Participants received repeated dose of GSK3640254 320 mg once daily up to 14 days
Units
Counts
Participants
OG0006
OG0016
OG00225
OG003
Title
Denominators
Categories
Title
Measurements
OG0002.2005(1.9116 to 2.5330)
OG0012.5739(2.2067 to 3.0022)
OG0022.6167(2.3460 to 2.9185)
OG003
Secondary
Part 2: Accumulation Ratio of Cmax (R [CMAX]) From Day 1 to Day 14
Blood samples were collected at indicated time points and PK analysis was performed. PK parameters were determined by non-compartmental methods with Phoenix WinNonlin. The accumulation ratio was estimated by calculating the ratio of the geometric least squares (GLS) means of PK parameters between Day 14 and Day 1, and the corresponding 90% CI for each dose. Ratio and 90% confidence interval is presented. Results are presented treatment wise.
PK Population, The PK Population include all participants who undergo plasma PK sampling and have evaluable PK parameters estimated during the repeat dose phase of the study Part 2.
Posted
Number
90% Confidence Interval
Ratio of Cmax
Pre-dose and 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72 and 96 hours after Day 14 dose
ID
Title
Description
OG000
Part 2: GSK3640254 50 mg
Participants received repeated dose of GSK3640254 50 mg once daily up to 14 days
OG001
Part 2: GSK3640254 100 mg
Participants received repeated dose of GSK3640254 100 mg once daily up to 14 days
OG002
Part 2: GSK3640254 200 mg + Expansion
Participants received repeated dose of GSK3640254 200 mg once daily up to 14 days
OG003
Part 2: GSK3640254 320 mg
Participants received repeated dose of GSK3640254 320 mg once daily up to 14 days
Units
Counts
Participants
OG0006
OG0016
OG00225
OG003
Title
Denominators
Categories
Title
Measurements
OG0001.9276(1.6283 to 2.2818)
OG0012.2069(1.8360 to 2.6528)
OG0022.2994(2.0872 to 2.5331)
OG003
Secondary
Part 2: Accumulation Ratio of C(Tau) (R[CTAU]) From Day 2 to Day 15
Blood samples were collected at indicated time points and PK analysis was performed. PK parameters were determined by non-compartmental methods with Phoenix WinNonlin. The accumulation ratio was estimated by calculating the ratio of the geometric least squares (GLS) means of PK parameters between Day 15 and Day 2, and the corresponding 90% CI for each dose. Ratio and 90% confidence interval is presented. Results are presented treatment wise.
PK Population, The PK Population include all participants who undergo plasma PK sampling and have evaluable PK parameters estimated during the repeat dose phase of the study Part 2.
Posted
Number
90% Confidence Interval
Ratio of Ctau
Pre-dose and 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72 and 96 hours after Day 15 dose
ID
Title
Description
OG000
Part 2: GSK3640254 50 mg
Participants received repeated dose of GSK3640254 50 mg once daily up to 14 days
OG001
Part 2: GSK3640254 100 mg
Participants received repeated dose of GSK3640254 100 mg once daily up to 14 days
OG002
Part 2: GSK3640254 200 mg + Expansion
Participants received repeated dose of GSK3640254 200 mg once daily up to 14 days
OG003
Part 2: GSK3640254 320 mg
Participants received repeated dose of GSK3640254 320 mg once daily up to 14 days
Units
Counts
Participants
OG0006
OG0016
OG00225
OG003
Title
Denominators
Categories
Title
Measurements
OG0002.1408(1.9402 to 2.3621)
OG0012.5847(2.1437 to 3.1165)
OG0022.5335(2.2133 to 2.9001)
OG003
Secondary
Part 2: Pre-dose Concentration of GSK3640254 on Day 2 to Day 14
Blood samples were collected at indicated time points and PK analysis was performed. PK parameters were determined by non-compartmental methods with Phoenix WinNonlin. results are presented treatment wise.
PK Population. The PK Population include all participants who undergo plasma PK sampling and have evaluable PK parameters estimated during the repeat dose phase of the study Part 2.
Posted
Mean
Standard Deviation
Nanogram per milliliter
Pre-dose on Days 2,3,4,6,8,10,12 and 14
ID
Title
Description
OG000
Part 2: GSK3640254 50 mg
Participants received repeated dose of GSK3640254 50 mg once daily up to 14 days
OG001
Part 2: GSK3640254 100 mg
Participants received repeated dose of GSK3640254 100 mg once daily up to 14 days
OG002
Part 2: GSK3640254 200 mg + Expansion
Participants received repeated dose of GSK3640254 200 mg once daily up to 14 days
OG003
Part 2: GSK3640254 320 mg
Participants received repeated dose of GSK3640254 320 mg once daily up to 14 days
Units
Counts
Participants
OG0006
OG0016
OG00225
OG003
Title
Denominators
Categories
Day 2 Predose
Title
Measurements
OG00090.20± 25.312
OG001221.55± 55.722
OG002283.37± 137.243
OG003
Secondary
Part 2: Dose Proportionality (Cmax) Following Repeated Dose of GSK3640254 at Day 1
Blood samples were collected at indicated time points and PK analysis was performed. Dose proportionality was assessed using the power model. Results are presented treatment wise.
PK Population, The PK Population include all participants who undergo plasma PK sampling and have evaluable PK parameters estimated during the repeat dose phase of the study Part 2. Only those participants with data available at the specified data points were analyzed.
Posted
Geometric Mean
Geometric Coefficient of Variation
Microgram per milliliter
Pre-dose and 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72 and 96 hours post dose
ID
Title
Description
OG000
Part 2: GSK3640254 50 mg
Participants received repeated dose of GSK3640254 50 mg once daily up to 14 days
OG001
Part 2: GSK3640254 100 mg
Participants received repeated dose of GSK3640254 100 mg once daily up to 14 days
OG002
Part 2: GSK3640254 200 mg + Expansion
Participants received repeated dose of GSK3640254 200 mg once daily up to 14 days
OG003
Part 2: GSK3640254 320 mg
Participants received repeated dose of GSK3640254 320 mg once daily up to 14 days
Units
Counts
Participants
OG0006
OG0016
OG00225
OG003
Title
Denominators
Categories
Title
Measurements
OG0000.215± 24.412
OG0010.536± 22.959
OG0020.614± 44.354
OG003
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
OG000
OG001
OG002
OG003
Power model
0.7370
2-Sided
90
0.5649
0.9091
The statistical model (power model) is based on the PK parameters (Cmax) from all active doses in Part 2
Other
Secondary
Part 2: Dose Proportionality (AUC0-24) Following Repeated Dose of GSK3640254 at Day 1
Blood samples were collected at indicated time points and PK analysis was performed. Dose proportionality was assessed using the power model. Results are presented treatment wise.
PK Population, The PK Population include all participants who undergo plasma PK sampling and have evaluable PK parameters estimated during the repeat dose phase of the study Part 2. Only those participants with data available at the specified data points were analyzed.
Posted
Geometric Mean
Geometric Coefficient of Variation
hour*micrograms per mililiter
Pre-dose and 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72 and 96 hours post dose
ID
Title
Description
OG000
Part 2: GSK3640254 50 mg
Participants received repeated dose of GSK3640254 50 mg once daily up to 14 days
OG001
Part 2: GSK3640254 100 mg
Participants received repeated dose of GSK3640254 100 mg once daily up to 14 days
OG002
Part 2: GSK3640254 200 mg + Expansion
Participants received repeated dose of GSK3640254 200 mg once daily up to 14 days
OG003
Part 2: GSK3640254 320 mg
Participants received repeated dose of GSK3640254 320 mg once daily up to 14 days
Units
Counts
Participants
OG0006
OG0016
OG00225
OG003
Title
Denominators
Categories
Title
Measurements
OG0002.855± 29.621
OG0016.801± 22.970
OG0028.257± 49.782
OG003
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
OG000
OG001
OG002
OG003
Power model
0.7397
2-Sided
90
0.5576
0.9218
The statistical model (power model) is based on the PK parameters (AUC0-24) from all active doses in Part 2
Other
0
6
0
6
3
6
EG001
Part 1:GSK3640254 3 mg
Participants received single dose of GSK3640254 3 mg following a moderate fat meal on Day 1
0
6
0
6
2
6
EG002
Part 1:GSK3640254 10 mg
Participants received single dose of GSK3640254 10 mg following a moderate fat meal on Day 1
0
6
0
6
4
6
EG003
Part 1:GSK3640254 30 mg
Participants received single dose of GSK3640254 30 mg following a moderate fat meal on Day 1
0
6
0
6
3
6
EG004
Part 1:GSK3640254 100 mg
Participants received single dose of GSK3640254 100 mg following a moderate fat meal on Day 1
0
6
0
6
3
6
EG005
Part 1:GSK3640254 200 mg
Participants received single dose of GSK3640254 200 mg following a moderate fat meal on Day 1
0
6
0
6
4
6
EG006
Part 1:GSK3640254 400 mg
Participants received single dose of GSK3640254 400 mg following a moderate fat meal on Day 1
0
6
0
6
4
6
EG007
Part 1:GSK3640254 700 mg
Participants received single dose of GSK3640254 700 mg following a moderate fat meal on Day 1
0
6
0
6
1
6
EG008
Part 1: Single Dose Placebo
Participants received single dose of matching placebo following a moderate fat meal on Day 1
0
16
0
16
7
16
EG009
Part 2: Repeated Dose GSK3640254 50 mg
Participants received repeated dose of GSK3640254 50 mg once daily up to 14 days
0
6
0
6
4
6
EG010
Part 2: Repeated Dose GSK3640254 100 mg
Participants received repeated dose of GSK3640254 100 mg once daily up to 14 days
0
6
0
6
5
6
EG011
Part 2: Repeated Dose GSK3640254 200mg +Expansion
Participants received repeated dose of GSK3640254 200 mg once daily up to 14 days
0
25
0
25
19
25
EG012
Part 2: Repeated Dose GSK3640254 320 mg
Participants received repeated dose of GSK3640254 320 mg once daily up to 14 days
0
7
0
7
6
7
EG013
Part 2: Repeated Dose Placebo
Participants received repeated dose of matching placebo once daily up to 14 days
0
14
0
14
10
14
EG0001 events1 affected6 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected6 at risk
EG0031 events1 affected6 at risk
EG0042 events2 affected6 at risk
EG0052 events1 affected6 at risk
EG0062 events2 affected6 at risk
EG0070 events0 affected6 at risk
EG0081 events1 affected16 at risk
EG0093 events3 affected6 at risk
EG0101 events1 affected6 at risk
EG0115 events3 affected25 at risk
EG0122 events2 affected7 at risk
EG0136 events6 affected14 at risk
Dizziness
Nervous system disorders
MedDRA Version 21.1
Systematic Assessment
EG0001 events1 affected6 at risk
EG0011 events1 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
EG0071 events1 affected6 at risk
EG0080 events0 affected16 at risk
EG0091 events1 affected6 at risk
EG0102 events2 affected6 at risk
EG0112 events2 affected25 at risk
EG0121 events1 affected7 at risk
EG0131 events1 affected14 at risk
Migraine
Nervous system disorders
MedDRA Version 21.1
Systematic Assessment
EG0000 events0 affected6 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 affected16 at risk
EG0090 events0 affected6 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected25 at risk
EG0120 events0 affected7 at risk
EG0130 events0 affected14 at risk
Paraesthesia
Nervous system disorders
MedDRA Version 21.1
Systematic Assessment
EG0000 events0 affected6 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 affected16 at risk
EG0090 events0 affected6 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected25 at risk
EG0121 events1 affected7 at risk
EG0130 events0 affected14 at risk
Diarrhoea
Gastrointestinal disorders
MedDRA Version 21.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected6 at risk
EG0031 events1 affected6 at risk
EG0042 events2 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected6 at risk
EG0081 events1 affected16 at risk
EG0090 events0 affected6 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected25 at risk
EG0121 events1 affected7 at risk
EG0130 events0 affected14 at risk
Vomiting
Gastrointestinal disorders
MedDRA Version 21.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0042 events2 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected16 at risk
EG0090 events0 affected6 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected25 at risk
EG0120 events0 affected7 at risk
EG0130 events0 affected14 at risk
Abdominal pain
Gastrointestinal disorders
MedDRA Version 21.1
Systematic Assessment
EG0000 events0 affected6 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 affected16 at risk
EG0091 events1 affected6 at risk
EG0100 events0 affected6 at risk
EG0111 events1 affected25 at risk
EG0120 events0 affected7 at risk
EG0130 events0 affected14 at risk
Faeces discoloured
Gastrointestinal disorders
MedDRA Version 21.1
Systematic Assessment
EG0000 events0 affected6 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 affected16 at risk
EG0090 events0 affected6 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected25 at risk
EG0120 events0 affected7 at risk
EG0130 events0 affected14 at risk
Faeces pale
Gastrointestinal disorders
MedDRA Version 21.1
Systematic Assessment
EG0000 events0 affected6 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 affected16 at risk
EG0090 events0 affected6 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected25 at risk
EG0120 events0 affected7 at risk
EG0130 events0 affected14 at risk
Faeces soft
Gastrointestinal disorders
MedDRA Version 21.1
Systematic Assessment
EG0001 events1 affected6 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 affected16 at risk
EG0090 events0 affected6 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected25 at risk
EG0120 events0 affected7 at risk
EG0130 events0 affected14 at risk
Nasopharyngitis
Infections and infestations
MedDRA Version 21.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected6 at risk
EG0030 events0 affected6 at risk
EG0041 events1 affected6 at risk
EG0050 events0 affected6 at risk
EG0061 events1 affected6 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected16 at risk
EG0090 events0 affected6 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected25 at risk
EG0120 events0 affected7 at risk
EG0130 events0 affected14 at risk
Viral infection
Infections and infestations
MedDRA Version 21.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected6 at risk
EG0030 events0 affected6 at risk
EG0041 events1 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected16 at risk
EG0090 events0 affected6 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected25 at risk
EG0120 events0 affected7 at risk
EG0130 events0 affected14 at risk
Oral herpes
Infections and infestations
MedDRA Version 21.1
Systematic Assessment
EG0000 events0 affected6 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 affected16 at risk
EG0090 events0 affected6 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected25 at risk
EG0120 events0 affected7 at risk
EG0130 events0 affected14 at risk
Upper respiratory tract infection
Infections and infestations
MedDRA Version 21.1
Systematic Assessment
EG0000 events0 affected6 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 affected16 at risk
EG0090 events0 affected6 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected25 at risk
EG0120 events0 affected7 at risk
EG0130 events0 affected14 at risk
Nasal obstruction
Respiratory, thoracic and mediastinal disorders
MedDRA Version 21.1
Systematic Assessment
EG0000 events0 affected6 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
EG0082 events2 affected16 at risk
EG0090 events0 affected6 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected25 at risk
EG0120 events0 affected7 at risk
EG0130 events0 affected14 at risk
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA Version 21.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected6 at risk
EG0030 events0 affected6 at risk
EG0041 events1 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected16 at risk
EG0090 events0 affected6 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected25 at risk
EG0120 events0 affected7 at risk
EG0130 events0 affected14 at risk
Haemoptysis
Respiratory, thoracic and mediastinal disorders
MedDRA Version 21.1
Systematic Assessment
EG0000 events0 affected6 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 affected16 at risk
EG0090 events0 affected6 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected25 at risk
EG0120 events0 affected7 at risk
EG0130 events0 affected14 at risk
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA Version 21.1
Systematic Assessment
EG0000 events0 affected6 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 affected16 at risk
EG0090 events0 affected6 at risk
EG0100 events0 affected6 at risk
EG0111 events1 affected25 at risk
EG0121 events1 affected7 at risk
EG0130 events0 affected14 at risk
Dermatitis contact
Skin and subcutaneous tissue disorders
MedDRA Version 21.1
Systematic Assessment
EG0001 events1 affected6 at risk
EG0011 events1 affected6 at risk
EG0021 events1 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 affected16 at risk
EG0091 events1 affected6 at risk
EG0100 events0 affected6 at risk
EG0117 events7 affected25 at risk
EG0120 events0 affected7 at risk
EG0130 events0 affected14 at risk
Contusion
Injury, poisoning and procedural complications
MedDRA Version 21.1
Systematic Assessment
EG0000 events0 affected6 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 affected16 at risk
EG0091 events1 affected6 at risk
EG0101 events1 affected6 at risk
EG0113 events3 affected25 at risk
EG0120 events0 affected7 at risk
EG0131 events1 affected14 at risk
Face injury
Injury, poisoning and procedural complications
MedDRA Version 21.1
Systematic Assessment
EG0000 events0 affected6 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 affected16 at risk
EG0090 events0 affected6 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected25 at risk
EG0120 events0 affected7 at risk
EG0130 events0 affected14 at risk
Limb injury
Injury, poisoning and procedural complications
MedDRA Version 21.1
Systematic Assessment
EG0001 events1 affected6 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 affected16 at risk
EG0090 events0 affected6 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected25 at risk
EG0120 events0 affected7 at risk
EG0130 events0 affected14 at risk
Skin abrasion
Injury, poisoning and procedural complications
MedDRA Version 21.1
Systematic Assessment
EG0000 events0 affected6 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 affected16 at risk
EG0090 events0 affected6 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected25 at risk
EG0120 events0 affected7 at risk
EG0130 events0 affected14 at risk
Nightmare
Psychiatric disorders
MedDRA Version 21.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 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 affected16 at risk
EG0090 events0 affected6 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected25 at risk
EG0120 events0 affected7 at risk
EG0131 events1 affected14 at risk
Depression
Psychiatric disorders
MedDRA Version 21.1
Systematic Assessment
EG0001 events1 affected6 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 affected16 at risk
EG0090 events0 affected6 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected25 at risk
EG0120 events0 affected7 at risk
EG0130 events0 affected14 at risk
Insomnia
Psychiatric disorders
MedDRA Version 21.1
Systematic Assessment
EG0001 events1 affected6 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 affected16 at risk
EG0090 events0 affected6 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected25 at risk
EG0121 events1 affected7 at risk
EG0130 events0 affected14 at risk
Catheter site pain
General disorders
MedDRA Version 21.1
Systematic Assessment
EG0000 events0 affected6 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 affected16 at risk
EG0090 events0 affected6 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected25 at risk
EG0121 events1 affected7 at risk
EG0131 events1 affected14 at risk
Chest pain
General disorders
MedDRA Version 21.1
Systematic Assessment
EG0001 events1 affected6 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 affected16 at risk
EG0090 events0 affected6 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected25 at risk
EG0120 events0 affected7 at risk
EG0130 events0 affected14 at risk
Vessel puncture site bruise
General disorders
MedDRA Version 21.1
Systematic Assessment
EG0000 events0 affected6 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 affected16 at risk
EG0090 events0 affected6 at risk
EG0100 events0 affected6 at risk
EG0111 events1 affected25 at risk
EG0120 events0 affected7 at risk
EG0131 events1 affected14 at risk
Transaminases increased
Investigations
MedDRA Version 21.1
Systematic Assessment
EG0000 events0 affected6 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 affected16 at risk
EG0091 events1 affected6 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected25 at risk
EG0120 events0 affected7 at risk
EG0130 events0 affected14 at risk
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA Version 21.1
Systematic Assessment
EG0000 events0 affected6 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 affected16 at risk
EG0090 events0 affected6 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected25 at risk
EG0120 events0 affected7 at risk
EG0130 events0 affected14 at risk
Lethargy
Nervous system disorders
MedDRA Version 21.1
Systematic Assessment
EG0000 events0 affected6 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 affected16 at risk
EG0090 events0 affected6 at risk
EG0100 events0 affected6 at risk
EG0111 events1 affected25 at risk
EG0121 events1 affected7 at risk
EG0131 events1 affected14 at risk
Disturbance in attention
Nervous system disorders
MedDRA Version 21.1
Systematic Assessment
EG0000 events0 affected6 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 affected16 at risk
EG0090 events0 affected6 at risk
EG0100 events0 affected6 at risk
EG0111 events1 affected25 at risk
EG0120 events0 affected7 at risk
EG0131 events1 affected14 at risk
Somnolence
Nervous system disorders
MedDRA Version 21.1
Systematic Assessment
EG0000 events0 affected6 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 affected16 at risk
EG0091 events1 affected6 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected25 at risk
EG0121 events1 affected7 at risk
EG0130 events0 affected14 at risk
Abdominal distension
Gastrointestinal disorders
MedDRA Version 21.1
Systematic Assessment
EG0000 events0 affected6 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 affected16 at risk
EG0090 events0 affected6 at risk
EG0100 events0 affected6 at risk
EG0111 events1 affected25 at risk
EG0120 events0 affected7 at risk
EG0131 events1 affected14 at risk
Constipation
Gastrointestinal disorders
MedDRA Version 21.1
Systematic Assessment
EG0000 events0 affected6 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 affected16 at risk
EG0090 events0 affected6 at risk
EG0100 events0 affected6 at risk
EG0112 events2 affected25 at risk
EG0120 events0 affected7 at risk
EG0130 events0 affected14 at risk
Nausea
Gastrointestinal disorders
MedDRA Version 21.1
Systematic Assessment
EG0000 events0 affected6 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 affected16 at risk
EG0090 events0 affected6 at risk
EG0100 events0 affected6 at risk
EG0111 events1 affected25 at risk
EG0121 events1 affected7 at risk
EG0130 events0 affected14 at risk
Aphthous ulcer
Gastrointestinal disorders
MedDRA Version 21.1
Systematic Assessment
EG0000 events0 affected6 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 affected16 at risk
EG0091 events1 affected6 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected25 at risk
EG0120 events0 affected7 at risk
EG0130 events0 affected14 at risk
Glossodynia
Gastrointestinal disorders
MedDRA Version 21.1
Systematic Assessment
EG0000 events0 affected6 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 affected16 at risk
EG0090 events0 affected6 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected25 at risk
EG0120 events0 affected7 at risk
EG0131 events1 affected14 at risk
Lip dry
Gastrointestinal disorders
MedDRA Version 21.1
Systematic Assessment
EG0000 events0 affected6 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 affected16 at risk
EG0091 events1 affected6 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected25 at risk
EG0120 events0 affected7 at risk
EG0130 events0 affected14 at risk
Lip ulceration
Gastrointestinal disorders
MedDRA Version 21.1
Systematic Assessment
EG0000 events0 affected6 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 affected16 at risk
EG0090 events0 affected6 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected25 at risk
EG0120 events0 affected7 at risk
EG0131 events1 affected14 at risk
Mouth ulceration
Gastrointestinal disorders
MedDRA Version 21.1
Systematic Assessment
EG0000 events0 affected6 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 affected16 at risk
EG0091 events1 affected6 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected25 at risk
EG0120 events0 affected7 at risk
EG0130 events0 affected14 at risk
Fatigue
General disorders
MedDRA Version 21.1
Systematic Assessment
EG0000 events0 affected6 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 affected16 at risk
EG0092 events2 affected6 at risk
EG0101 events1 affected6 at risk
EG0111 events1 affected25 at risk
EG0120 events0 affected7 at risk
EG0132 events2 affected14 at risk
Catheter site bruise
General disorders
MedDRA Version 21.1
Systematic Assessment
EG0000 events0 affected6 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 affected16 at risk
EG0090 events0 affected6 at risk
EG0101 events1 affected6 at risk
EG0111 events1 affected25 at risk
EG0120 events0 affected7 at risk
EG0131 events1 affected14 at risk
Feeling cold
General disorders
MedDRA Version 21.1
Systematic Assessment
EG0000 events0 affected6 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 affected16 at risk
EG0091 events1 affected6 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected25 at risk
EG0120 events0 affected7 at risk
EG0130 events0 affected14 at risk
Mass
General disorders
MedDRA Version 21.1
Systematic Assessment
EG0000 events0 affected6 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 affected16 at risk
EG0090 events0 affected6 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected25 at risk
EG0120 events0 affected7 at risk
EG0131 events1 affected14 at risk
Dry skin
Skin and subcutaneous tissue disorders
MedDRA Version 21.1
Systematic Assessment
EG0000 events0 affected6 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 affected16 at risk
EG0090 events0 affected6 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected25 at risk
EG0121 events1 affected7 at risk
EG0131 events1 affected14 at risk
Rash
Skin and subcutaneous tissue disorders
MedDRA Version 21.1
Systematic Assessment
EG0000 events0 affected6 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 affected16 at risk
EG0090 events0 affected6 at risk
EG0100 events0 affected6 at risk
EG0111 events1 affected25 at risk
EG0120 events0 affected7 at risk
EG0131 events1 affected14 at risk
Blister
Skin and subcutaneous tissue disorders
MedDRA Version 21.1
Systematic Assessment
EG0000 events0 affected6 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 affected16 at risk
EG0090 events0 affected6 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected25 at risk
EG0120 events0 affected7 at risk
EG0131 events1 affected14 at risk
Eczema nummular
Skin and subcutaneous tissue disorders
MedDRA Version 21.1
Systematic Assessment
EG0000 events0 affected6 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 affected16 at risk
EG0090 events0 affected6 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected25 at risk
EG0121 events1 affected7 at risk
EG0130 events0 affected14 at risk
Arthropod bite
Injury, poisoning and procedural complications
MedDRA Version 21.1
Systematic Assessment
EG0000 events0 affected6 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 affected16 at risk
EG0090 events0 affected6 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected25 at risk
EG0122 events2 affected7 at risk
EG0130 events0 affected14 at risk
Back pain
Musculoskeletal and connective tissue disorders
MedDRA Version 21.1
Systematic Assessment
EG0000 events0 affected6 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 affected16 at risk
EG0090 events0 affected6 at risk
EG0101 events1 affected6 at risk
EG0112 events2 affected25 at risk
EG0120 events0 affected7 at risk
EG0132 events2 affected14 at risk
Musculoskeletal stiffness
Musculoskeletal and connective tissue disorders
MedDRA Version 21.1
Systematic Assessment
EG0000 events0 affected6 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 affected16 at risk
EG0091 events1 affected6 at risk
EG0100 events0 affected6 at risk
EG0111 events1 affected25 at risk
EG0120 events0 affected7 at risk
EG0130 events0 affected14 at risk
Muscle twitching
Musculoskeletal and connective tissue disorders
MedDRA Version 21.1
Systematic Assessment
EG0000 events0 affected6 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 affected16 at risk
EG0090 events0 affected6 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected25 at risk
EG0120 events0 affected7 at risk
EG0131 events1 affected14 at risk
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA Version 21.1
Systematic Assessment
EG0000 events0 affected6 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 affected16 at risk
EG0090 events0 affected6 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected25 at risk
EG0120 events0 affected7 at risk
EG0131 events1 affected14 at risk
Agitation
Psychiatric disorders
MedDRA Version 21.1
Systematic Assessment
EG0000 events0 affected6 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 affected16 at risk
EG0090 events0 affected6 at risk
EG0101 events1 affected6 at risk
EG0111 events1 affected25 at risk
EG0120 events0 affected7 at risk
EG0130 events0 affected14 at risk
Abnormal dreams
Psychiatric disorders
MedDRA Version 21.1
Systematic Assessment
EG0000 events0 affected6 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 affected16 at risk
EG0090 events0 affected6 at risk
EG0100 events0 affected6 at risk
EG0112 events2 affected25 at risk
EG0120 events0 affected7 at risk
EG0130 events0 affected14 at risk
Depressed mood
Psychiatric disorders
MedDRA Version 21.1
Systematic Assessment
EG0000 events0 affected6 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 affected16 at risk
EG0090 events0 affected6 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected25 at risk
EG0120 events0 affected7 at risk
EG0131 events1 affected14 at risk
Abscess
Infections and infestations
MedDRA Version 21.1
Systematic Assessment
EG0000 events0 affected6 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 affected16 at risk
EG0090 events0 affected6 at risk
EG0101 events1 affected6 at risk
EG0110 events0 affected25 at risk
EG0120 events0 affected7 at risk
EG0130 events0 affected14 at risk
Folliculitis
Infections and infestations
MedDRA Version 21.1
Systematic Assessment
EG0000 events0 affected6 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 affected16 at risk
EG0090 events0 affected6 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected25 at risk
EG0120 events0 affected7 at risk
EG0131 events1 affected14 at risk
Hordeolum
Infections and infestations
MedDRA Version 21.1
Systematic Assessment
EG0000 events0 affected6 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 affected16 at risk
EG0090 events0 affected6 at risk
EG0101 events1 affected6 at risk
EG0110 events0 affected25 at risk
EG0120 events0 affected7 at risk
EG0130 events0 affected14 at risk
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA Version 21.1
Systematic Assessment
EG0000 events0 affected6 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 affected16 at risk
EG0091 events1 affected6 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected25 at risk
EG0120 events0 affected7 at risk
EG0130 events0 affected14 at risk
Hiccups
Respiratory, thoracic and mediastinal disorders
MedDRA Version 21.1
Systematic Assessment
EG0000 events0 affected6 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 affected16 at risk
EG0090 events0 affected6 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected25 at risk
EG0121 events1 affected7 at risk
EG0130 events0 affected14 at risk
Bicuspid aortic valve
Congenital, familial and genetic disorders
MedDRA Version 21.1
Systematic Assessment
EG0000 events0 affected6 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 affected16 at risk
EG0090 events0 affected6 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected25 at risk
EG0121 events1 affected7 at risk
EG0130 events0 affected14 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.