Safety, Tolerability and Pharmacokinetic Investigation of... | NCT04488770 | Trialant
NCT04488770
Sponsor
GlaxoSmithKline
Status
Completed
Last Update Posted
Feb 17, 2023Actual
Enrollment
61Actual
Phase
Phase 1
Conditions
Urinary Tract Infections
Interventions
GSK3882347
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
NCT04488770
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
212148
Secondary IDs
ID
Type
Description
Link
2020-000680-23
EudraCT Number
Brief Title
Safety, Tolerability and Pharmacokinetic Investigation of GSK3882347 in Healthy Participants.
Official Title
A Double-Blind Randomized, Placebo-Controlled, Single and Repeated Oral Dose Escalation Study to Investigate the Safety, Tolerability, Pharmacokinetics (Including Food Effect) of GSK3882347 in Healthy Participants
Acronym
Not provided
Organization
GlaxoSmithKlineINDUSTRY
Status Module
Record Verification Date
May 2022
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
Aug 24, 2020Actual
Primary Completion Date
May 14, 2021Actual
Completion Date
May 14, 2021Actual
First Submitted Date
Jul 23, 2020
First Submission Date that Met QC Criteria
Jul 23, 2020
First Posted Date
Jul 28, 2020Actual
Results Waived
Not provided
Results First Submitted Date
May 10, 2022
Results First Submitted that Met QC Criteria
May 10, 2022
Results First Posted Date
Feb 17, 2023Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
May 10, 2022
Last Update Posted Date
Feb 17, 2023Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
GlaxoSmithKlineINDUSTRY
Collaborators
Name
Class
Department of Health and Human Services
FED
Wellcome Trust
OTHER
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
This is a phase 1, 2-part, double-blind (sponsor-unblinded), randomized, placebo-controlled, first time in human (FTIH) study, that includes both single-ascending and multiple-ascending dose phase to assess the safety, tolerability, and pharmacokinetics (PK) of GSK3882347 in healthy adult men and Woman of Non Childbearing Potential (WONCBP). Part 1 will be the single ascending dose (SAD) phase and Part 2 will be the multiple ascending dose (MAD) phase. Each participant in the SAD cohort will receive a single dose of GSK3882347 or placebo (PBO) in 3:1 ratio and in Part 2 (MAD), participants will be randomized in a 4:1 ratio to receive active treatment and placebo. Part 1 will consist of two cohorts with a maximum of four-period for each cohort, the food effect evaluation will be conducted in last period (Period 4) in only one of the cohorts based on the observed human pharmacokinetics (PK). Part 2 will consist of maximum of four cohorts for each of the MAD dose or placebo.
Detailed Description
Not provided
Conditions Module
Conditions
Urinary Tract Infections
Keywords
SAD
MAD
FTIH
Pharmacokinetics
Urinary Tract Infections
GSK3882347
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
61Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Part 1 (SAD) Cohort 1:Participants receiving GSK3882347
Experimental
In this single ascending dose phase, participants will receive GSK3882347 50 milligram (mg), 150 mg and 250 mg orally on Day 1 of period 1, 2 and 3 respectively. Period 4 will be conducted to assess food effect based on the observed human PK.
Drug: GSK3882347
Part 1 (SAD),Cohort 1:Participants receiving Placebo
Placebo Comparator
In this single ascending dose phase, participants will receive matching Placebo orally on Day 1 of period 1, 2 and 3. Period 4 will be conducted to assess food effect based on the observed human PK.
Drug: Placebo
Part 1 (SAD),Cohort 2: Participants receiving GSK3882347
Experimental
In this single ascending dose phase, participants will receive GSK3882347 500 mg, 15 mg and 900 mg orally on Day 1 of period 1, 3 and 2 respectively.
Drug: GSK3882347
Part 1 (SAD),Cohort 2: Participants receiving Placebo
Placebo Comparator
In this single ascending dose phase, participants will receive matching Placebo orally on Day 1 of period 1, 3 and 2.
Drug: Placebo
Part 2 (MAD),Cohort 3: Participants receiving GSK3882347 50mg
Experimental
Interventions
Name
Type
Description
Arm Group Labels
Other Names
GSK3882347
Drug
Capsule of 10-200mg dose strength will be provided in labelled High Density Polyethylene (HDPE) bottles.
Part 1 (SAD) Cohort 1:Participants receiving GSK3882347
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Part 1: Number of Participants With Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgment. Number of participants with common (greater than or equal to [>=]5 percent [%]) non-serious AEs is presented.
Up to 3 months
Part 2: Number of Participants With Non-serious AEs and SAEs
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgment. Number of participants with common (>=5%) non-serious AEs is presented.
Up to 26 days
Part 1: Number of Participants With Treatment Related AEs
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. Number of participants with treatment related AEs is presented.
Up to 3 months
Part 2: Number of Participants With Treatment Related AEs
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. Number of participants with treatment related AEs is presented.
Secondary Outcomes
Measure
Description
Time Frame
Part 1: Area Under the Concentration-time Curve From Time Zero to 12 Hours (AUC[0-12]) After Single Dose Administration of GSK3882347
Blood samples were collected at indicated time points for PK analysis of GSK3882347. PK parameters were analyzed using standard non-compartmental analysis.
Pre-dose, 15, 30 minutes, 1, 1.5, 2, 4, 6, 8 and 12 hours post-dose in each treatment period
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Participant must be 18 to 50 years of age inclusive, at the time of signing the informed consent.
Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring. A participant with a clinical abnormality or laboratory parameter(s) not specifically listed in the exclusion or exclusion criteria that is outside the reference range for the population being studied may be included only if the investigator, in consultation with the Medical Monitor (if required), agree and document that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
Participants with Body weight at least 50.0 kilograms (kg) (110 pound [lbs]) for males and 45.0 kg (99 lbs.) for females; and body mass index (BMI) within the range 18.5 - 32.0 kilograms per meter square (kg/m^2) (inclusive).
Male and female participants; a female participant is eligible to participate if she is of WONCBP; Male participants are eligible to participate if they agree to the following during the intervention period for at least five days, corresponding to time needed to eliminate study intervention(s) (e.g. 5 terminal half-lives) after the last dose of study intervention), refrain from donating sperm, be abstinent from heterosexual or homosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent; must agree to use contraception/barrier, agree to use a male condom.
Capable of giving signed informed consent as described in which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
Exclusion Criteria:
Participants with history or presence of cardiovascular, respiratory, hepatic, urological, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention; or interfering with the interpretation of data
Alanine transaminase (ALT) greater than 1.5 times upper limit of normal (ULN).
Bilirubin greater than 1.5 times ULN (isolated bilirubin greater than1.5 times ULN is acceptable if bilirubin is fractionated and direct bilirubin is less than 35%)
Current or chronic history of liver disease or known hepatic or biliary abnormalities (except for Gilbert's syndrome or asymptomatic gallstones).
Medical history of cardiac arrhythmias or cardiac disease or a family or personal history of long QT syndrome.
Male participants with heart rate of less than 45 or greater than 100 beats per minute (bpm), females with less than 50 or greater than 100 bpm.
Participants with PR interval less than 120 or greater than 220 milliseconds (msec); QRS duration less than 70 msec or greater than 120 msec; QTcF interval greater than 450 msec.
Evidence of previous myocardial infarction on ECG (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 (AV) block [2nd degree or higher], Wolff-Parkinson-White [WPW] syndrome).
Sinus Pauses greater than 3 seconds.
Any significant arrhythmia which, in the opinion of the Investigator or GSK Medical Monitor, will interfere with the safety for the individual participant.
Non-sustained or sustained ventricular tachycardia (3 consecutive ventricular ectopic beats).
Current or history of renal disease, or estimated creatinine clearance <90 milliliter (mL)/minute/1.73meter^2 or serum creatinine greater than ULN at screening.
Unable to refrain from the use of prescription or non-prescription drugs, 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) before the first dose of study intervention, unless in the opinion of the Investigator and the GSK medical monitor, the medication will not interfere with the study procedures or compromise participant safety.
Use of a systemic antimicrobial within 30 days of screening.
Participation in the study would result in loss of blood or blood products in excess of 500 mL within 56 days.
Exposure to more than 4 new chemical entities within 12 months prior to the first dosing day.
Current enrolment or past participation within the last 30 days before signing of consent in any other clinical study involving an investigational study intervention or any other type of medical research.
Positive human immunodeficiency virus (HIV) antibody test.
Presence of Hepatitis B surface antigen (HBsAg) at screening or within 3 months prior to first dose of study intervention.
Positive Hepatitis C antibody test result at screening or within 3 months prior to first dose of study intervention.
Positive Hepatitis C ribonucleic acid (RNA) test result at screening or within 3 months prior to first dose of study intervention.
Positive pre-study drug/alcohol screen.
Any history of substance abuse or a positive test for drugs of abuse at screening or admission.
A positive highly sensitive pregnancy test (urine or serum as required by local regulations) at screening.
A positive laboratory confirmation of COVID-19 infection, or high clinical index of suspicion for COVID-19.
Part 1 (Food Effect): Participant must have no dietary restrictions (e.g., lactose intolerance) or inability to eat a high fat meal.
Regular alcohol consumption within 6 months prior to the study defined as: An average weekly intake of greater than 21 units for males or greater than 14 units for females. One unit is equivalent to approximately (250 mL) of beer, (100 mL) of wine or (35 mL) measure of spirits.
Positive smoke breathalyzer indicative of smoking history at screening and each in-house admission to the clinical research unit or regular use of tobacco- or nicotine-containing products (e.g. nicotine patches or vaporizing devices) within 6 months prior to screening.
Hypersensitivity to any of the study interventions, or components thereof, or drug or other allergy that, in the opinion of the investigator or medical monitor, contraindicates participation in the study.
Accepts Healthy Volunteers
Yes
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
50 Years
Standard Ages
Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
GSK Clinical Trials
GlaxoSmithKline
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
GSK Investigational Site
Cambridge
CB2 2GG
United Kingdom
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
Plan to Share IPD
Yes
Description
IPD for this study will be made 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 will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study.
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.
A total of 61 participants (21 participants in Part 1 and 40 participants in Part 2) were enrolled in the study.
Recruitment Details
This was a 2-part, first-time-in-human (FTIH), dose-escalation, placebo (PBO)-controlled, single dose (SD) (Part 1) and repeat dose (RD) (Part 2) study to determine the safety, tolerability and pharmacokinetic (PK) profile of GSK3882347 in healthy participants. The study was conducted at a single center in the United Kingdom.
Healthy participants in Part 1 Cohort 1 received a single dose (SD) of GSK3882347 50 milligrams (mg) on Day 1 in treatment Period 1, followed by a SD of GSK3882347 150 mg on Day 1 in treatment Period 2, followed by a SD of GSK3882347 250 mg on Day 1 in treatment Period 3, further followed by a SD of Placebo (PBO) on Day 1 in treatment Period 4. Cohort 1 was a 4-period cross-over.
Healthy participants in Part 1 Cohort 1 received a SD of GSK3882347 50 mg on Day 1 in treatment Period 1, followed by a SD of GSK3882347 150 mg on Day 1 in treatment Period 2, followed by a SD of PBO on Day 1 in treatment Period 3, further followed by a SD of GSK3882347 250 mg under fed condition on Day 1 in treatment Period 4. Cohort 1 was a 4-period cross-over.
Healthy participants in Part 1 Cohort 1 received a SD of GSK3882347 50 mg on Day 1 in treatment Period 1, followed by a SD of PBO on Day 1 in treatment Period 2, followed by a SD of GSK3882347 250 mg on Day 1 in treatment Period 3, further followed by a SD of GSK3882347 250 mg under fed condition on Day 1 in treatment Period 4. Cohort 1 was a 4-period cross-over.
Healthy participants in Part 1 Cohort 1 received a SD of PBO on Day 1 in treatment Period 1, followed by a SD of GSK3882347 150 mg on Day 1 in treatment Period 2, followed by a SD of GSK3882347 250 mg on Day 1 in treatment Period 3, further followed by a SD of GSK3882347 250 mg under fed condition on Day 1 in treatment Period 4. Cohort 1 was a 4-period cross-over.
FG004
Part 1-Cohort 2: SD PBO/GSK3882347 SD 900 mg/SD 15 mg
Healthy participants in Part 1 Cohort 2 received a SD of PBO on Day 1 in treatment Period 1, followed by a SD of GSK3882347 900 mg on Day 1 in treatment Period 2, further followed by a SD of GSK3882347 15 mg on Day 1 in treatment Period 3. Cohort 2 was a 3-period cross-over.
FG005
Part 1-Cohort 2: GSK3882347 SD 500 mg/SD PBO/SD 15 mg
Healthy participants in Part 1 Cohort 2 received a SD of GSK3882347 500 mg on Day 1 in treatment Period 1, followed by a SD of PBO on Day 1 in treatment Period 2, further followed by a SD of GSK3882347 15 mg on Day 1 in treatment Period 3. Cohort 2 was a 3-period cross-over.
FG006
Part 1-Cohort 2: GSK3882347 SD 500 mg/SD 900 mg/SD PBO
Healthy participants in Part 1 Cohort 2 received a SD of GSK3882347 500 mg on Day 1 in treatment Period 1, followed by a SD of GSK3882347 900 mg on Day 1 in treatment Period 2, further followed by a SD of PBO on Day 1 in treatment Period 3. Cohort 2 was a 3-period cross-over.
Healthy participants in Part 1 Cohort 2 received a SD of GSK3882347 500 mg on Day 1 in treatment Period 1, followed by a SD of GSK3882347 900 mg on Day 1 in treatment Period 2, further followed by a SD of GSK3882347 15 mg on Day 1 in treatment Period 3. Cohort 2 was a 3-period cross-over.
FG008
Part 2: Repeat Dose Placebo
Healthy participants in Part 2 received repeat dose (RD) of Placebo on Days 1 to 7.
FG009
Part 2: Repeat Dose GSK3882347 50 mg
Healthy participants in Part 2 received RD of GSK3882347 50 mg on Days 1 to 7.
FG010
Part 2: Repeat Dose GSK3882347 150 mg
Healthy participants in Part 2 received RD of GSK3882347 150 mg on Days 1 to 7.
FG011
Part 2: Repeat Dose GSK3882347 500 mg
Healthy participants in Part 2 received RD of GSK3882347 500 mg on Days 1 to 7.
FG012
Part 2: Repeat Dose GSK3882347 900 mg
Healthy participants in Part 2 received RD of GSK3882347 900 mg on Days 1 to 7.
Periods
Title
Milestones
Reasons Not Completed
Part 1-Cohort 1: Period 1 (Up to 5 Days)
Type
Comment
Milestone Data
STARTED
FG0002 subjects
FG0012 subjects
FG0022 subjects
FG0032 subjects
FG004
COMPLETED
FG0002 subjects
FG0012 subjects
FG0022 subjects
FG0031 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Part 1-Cohort 1: Period 2 (Up to 5 Days)
Type
Comment
Milestone Data
STARTED
FG0002 subjects
FG0012 subjects
FG0022 subjects
FG003
Part 1-Cohort 1: Period 3 (Up to 5 Days)
Type
Comment
Milestone Data
STARTED
FG0002 subjects
FG0012 subjects
FG0022 subjects
FG003
Part 1-Cohort 1: Period 4 (Up to 5 Days)
Type
Comment
Milestone Data
STARTED
FG0002 subjectsNew participant enrolled and dosed as a replacement of withdrawn participant
Healthy participants in Part 1 Cohort 1 received a single dose (SD) of GSK3882347 50 milligrams (mg) on Day 1 in treatment Period 1, followed by a SD of GSK3882347 150 mg on Day 1 in treatment Period 2, followed by a SD of GSK3882347 250 mg on Day 1 in treatment Period 3, further followed by a SD of Placebo (PBO) on Day 1 in treatment Period 4. Cohort 1 was a 4-period cross-over.
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 Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgment. Number of participants with common (greater than or equal to [>=]5 percent [%]) non-serious AEs is presented.
Safety Population comprised of all participants who received at least one dose of study intervention.
Posted
Count of Participants
Participants
Up to 3 months
ID
Title
Description
OG000
Part 1: Single Dose Placebo
Adverse Events Module
Frequency Threshold
5
Time Frame
All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
Description
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
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: Single Dose Placebo
Healthy participants in Part 1 received a SD of Placebo on Day 1 in either treatment Periods 1, 2, 3 and 4.
Female Urogenital Diseases and Pregnancy Complications
Browse Leaves
Not provided
Browse Branches
Not provided
Intervention Browse Module
No data available
No data is available for this block.
Randomized
Intervention Model
Crossover Assignment
Intervention Model Description
Part 1 will consist of two cohorts (Cohorts 1 and 2) with a maximum of four periods in a cross-over design conducted in two separate cohorts. Part 2 consists of a maximum of four ascending repeat-dose cohorts (Cohorts 3 to 6) for which participants, will receive a single oral dose of GSK3882347 or placebo for 7 days.
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Double
Masking Description
This will be a double-blind study with participants and the site staff blinded.
Who Masked
ParticipantInvestigator
In this multiple ascending dose phase, participants will receive GSK3882347 50 mg orally on Day 1 to Day 7 of the study. The dose to be administered may be changed based on clinical safety, tolerability and PK findings in Part 1.
Drug: GSK3882347
Part 2 (MAD),Cohort 3: Participants receiving Placebo
Placebo Comparator
In this multiple ascending dose phase, participants will receive matching Placebo orally on Day 1 to Day 7 of the study.
Drug: Placebo
Part 2 (MAD),Cohort 4: Participants receiving GSK3882347 150mg
Experimental
GSK3882347 150 mg will be administered orally to the participants on Day 1 to day 7 of the study. This is a projected dose. The dose administered in Part 2, Cohort 4 will be based on PK/PD results from preceding dosing cohorts.
Drug: GSK3882347
Part 2 (MAD),Cohort 4: Participants receiving Placebo
Placebo Comparator
In this multiple ascending dose phase, participants will receive matching Placebo orally on Day 1 to Day 7 of the study.
Drug: Placebo
Part 2(MAD),Cohort 5: Participants receiving GSK3882347 500mg
Experimental
GSK3882347 500 mg will be administered orally to the participants on Day 1 to day 7 of the study. This is a projected dose. The dose administered in Part 2, Cohort 5 will be based on PK/PD results from preceding dosing cohorts.
Drug: GSK3882347
Part 2 (MAD),Cohort 5: Participants receiving Placebo
Placebo Comparator
In this multiple ascending dose phase, participants will receive matching Placebo orally on Day 1 to Day 7 of the study.
Drug: Placebo
Part 2(MAD),Cohort 6: Participants receiving GSK3882347 900mg
Experimental
GSK3882347 900 mg will be administered orally to the participants on Day 1 to day 7 of the study. This is a projected dose. The dose administered in Part 2, Cohort 6 will be based on PK/PD results from preceding dosing cohorts.
Drug: GSK3882347
Part 2(MAD),Cohort 6: Participants receiving Placebo
Placebo Comparator
In this multiple ascending dose phase, participants will receive matching Placebo orally on Day 1 to Day 7 of the study.
Drug: Placebo
Part 1 (SAD),Cohort 2: Participants receiving GSK3882347
Part 2 (MAD),Cohort 3: Participants receiving GSK3882347 50mg
Part 2 (MAD),Cohort 4: Participants receiving GSK3882347 150mg
Part 2(MAD),Cohort 5: Participants receiving GSK3882347 500mg
Part 2(MAD),Cohort 6: Participants receiving GSK3882347 900mg
Placebo
Drug
Matching strength placebo capsules will be provided
Part 1 (SAD),Cohort 1:Participants receiving Placebo
Part 1 (SAD),Cohort 2: Participants receiving Placebo
Part 2 (MAD),Cohort 3: Participants receiving Placebo
Part 2 (MAD),Cohort 4: Participants receiving Placebo
Part 2 (MAD),Cohort 5: Participants receiving Placebo
Part 2(MAD),Cohort 6: Participants receiving Placebo
Up to 26 days
Part 1: Number of Participants With Worst-case Hematology Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Blood samples were collected to analyze hematocrit,hemoglobin,leukocytes,lymphocytes,neutrophils and platelets. PCI ranges were <0.075 or >0.54 proportion of red blood cells in blood for hematocrit, <25 or >180 grams per liter(g/L) for hemoglobin,<3 or >20 x10^9 cells per liter(cells/L) for leukocytes,<0.8 x10^9 cells/L for lymphocytes,<1.5 x10^9 cells/L for neutrophils and <100 or >550 x10^9 cells/L for platelets.Participants were counted in worst case category that their value changes to(low,within range or no change or high),unless there is no change in their category.Participants whose laboratory value category was unchanged(for example[e.g.],High to High),or whose value became within range, were recorded in"To within Range or No Change" category.Participants were counted twice if the participant has values that changed 'To Low' and 'To High',so the percentages may not add to 100%.Baseline=latest pre-dose assessment with a non-missing value, including those from unscheduled visits
Up to 3 months
Part 2: Number of Participants With Worst-case Hematology Results Relative to PCI Criteria Post-Baseline Relative to Baseline
Blood samples were collected to analyze hematocrit,hemoglobin,leukocytes,lymphocytes,neutrophils and platelets. PCI ranges were <0.075 or >0.54 proportion of red blood cells in blood for hematocrit, <25 or >180 grams per liter(g/L) for hemoglobin,<3 or >20 x10^9 cells per liter(cells/L) for leukocytes,<0.8 x10^9 cells/L for lymphocytes,<1.5 x10^9 cells/L for neutrophils and <100 or >550 x10^9 cells/L for platelets.Participants were counted in worst case category that their value changes to(low,within range or no change or high),unless there is no change in their category.Participants whose laboratory value category was unchanged(e.g.,High to High),or whose value became within range, were recorded in"To within Range or No Change" category.Participants were counted twice if the participant has values that changed 'To Low' and 'To High',so the percentages may not add to 100%.Baseline=latest pre-dose assessment with a non-missing value, including those from unscheduled visits
Up to 26 days
Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline
Blood samples were collected to analyze PCI ranges: >=2 times Upper limit of Normal(ULN) Units per Liter(U/L) for Alanine aminotransferase(ALT),>=2 times ULN U/L for alkaline phosphatase(ALP), >=2 times ULN U/L for aspartate aminotransferase(AST),>=1.5 times ULN micromoles/L for bilirubin,<2 or >2.75 millimoles/L (mmol/L) for calcium,<3 or >9 mmol/L for glucose,<3 or >5.5 mmol/L for potassium and <130 or >150 mmol/L for sodium.Participants were counted in worst case category that their value changes to(low,within range or no change or high),unless there is no change in their category.Participants whose laboratory value category was unchanged(e.g.,High to High),or whose value became within range,were recorded in"To within Range or No Change" category.Participants were counted twice if the participant has values that changed 'To Low' and 'To High',so the percentages may not add to 100%.Baseline=latest pre-dose assessment with a non-missing value,including those from unscheduled visits
Up to 3 months
Part 2: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline
Blood samples were collected to analyze PCI ranges: >=2 times ULN U/L for Alanine aminotransferase(ALT),>=2 times ULN U/L for alkaline phosphatase(ALP), >=2 times ULN U/L for aspartate aminotransferase(AST),>=1.5 times ULN micromoles/L for bilirubin,<2 or >2.75 mmol/L for calcium,<3 or >9 mmol/L for glucose,<3 or >5.5 mmol/L for potassium and <130 or >150 mmol/L for sodium.Participants were counted in worst case category that their value changes to(low,within range or no change or high),unless there is no change in their category.Participants whose laboratory value category was unchanged(e.g.,High to High),or whose value became within range,were recorded in"To within Range or No Change" category.Participants were counted twice if the participant has values that changed 'To Low' and 'To High',so the percentages may not add to 100%.Baseline=latest pre-dose assessment with a non-missing value,including those from unscheduled visits.
Up to 26 days
Part 1: Number of Participants With Worst Case Urinalysis Results Post Baseline Relative to Baseline
Urine samples were collected for the analysis of urine parameters including occult blood and protein by dipstick. The dipstick test gave results in a semi-quantitative manner, and results for urinalysis parameters were recorded as no change/decreased, increase to positive for urine occult blood and protein indicating proportional concentrations in the urine sample. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Number of participants with worst case urinalysis results Post Baseline relative to Baseline is presented.
Up to 3 months
Part 2: Number of Participants With Worst Case Urinalysis Results Post Baseline Relative to Baseline
Urine samples were collected for the analysis of urine parameters including occult blood and protein by dipstick. The dipstick test gave results in a semi-quantitative manner (proportional concentrations in urine samples), and results for urinalysis parameters were recorded as no change/decreased, increase to positive for urine occult blood and protein. 'No change/decreased' indicates no change from Baseline results or decreased in results from Baseline including change in negative results. 'Increase to positive' indicates increase in result from Baseline. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Number of participants with worst case urinalysis results Post Baseline relative to Baseline is presented.
Up to 26 days
Part 1: Number of Participants With Worst Case Vital Signs Results Relative to PCI Criteria Post Baseline Relative to Baseline
Vital signs were assessed including Systolic blood pressure (SBP), diastolic blood pressure (DBP) and pulse rate (PR). PCI ranges were <85 (Low), 85-160 (Normal) and >160 (High) for SBP; <45 (Low), 45-100 (Normal), >100 (High) for DBP; <40 (Low), 40-110 (Normal), >110 (High) for pulse rate. Participants were counted in worst case category that their value changes to(low,within range or no change, high),unless there is no change in their category.Participants whose laboratory value category was unchanged(e.g.,High to High),or whose value became within range, were recorded in"To within Range or No Change" category.Participants were counted twice if the participant has values that changed 'To Low' and 'To High',so the percentages may not add to 100%.Baseline was defined as latest pre-dose assessment with a non-missing value, including those from unscheduled visits
Up to 3 months
Part 2: Number of Participants With Worst Case Vital Signs Results Relative to PCI Criteria Post Baseline Relative to Baseline
Vital signs were assessed including Systolic blood pressure (SBP), diastolic blood pressure (DBP) and pulse rate (PR). PCI ranges were <85 (Low), 85-160 (Normal) and >160 (High) for SBP; <45 (Low), 45-100 (Normal), >100 (High) for DBP; <40 (Low), 40-110 (Normal), >110 (High) for pulse rate. Participants were counted in worst case category that their value changes to(low,within range or no change, high),unless there is no change in their category.Participants whose laboratory value category was unchanged(e.g.,High to High),or whose value became within range, were recorded in"To within Range or No Change" category.Participants were counted twice if the participant has values that changed 'To Low' and 'To High',so the percentages may not add to 100%.Baseline was defined as latest pre-dose assessment with a non-missing value, including those from unscheduled visits
Up to 26 days
Part 1: Number of Participants With Worst Case Abnormal Electrocardiogram (ECG) Results Post Baseline Relative to Baseline
A 12-lead ECG was recorded with the participant in a semi-supine position after a rest of at least 10 minutes. Twelve lead ECGs were obtained by using an automated ECG machine that measured PR, QRS, QT, and corrected QT (QTc) intervals and calculated heart rate. Data for abnormal not clinically significant (NCS) and clinically significant (CS) ECG findings are presented. CS abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. Baseline was defined as latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Up to 3 months
Part 2: Number of Participants With Worst Case Abnormal ECG Results Post Baseline Relative to Baseline
A 12-lead ECG was recorded with the participant in a semi-supine position after a rest of at least 10 minutes. Twelve lead ECGs were obtained by using an automated ECG machine that measured PR, QRS, QT, and corrected QT (QTc) intervals and calculated heart rate. Data for abnormal not clinically significant (NCS) and clinically significant (CS) ECG findings are presented. CS abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. Baseline was defined as latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Up to 26 days
Part 1: Area Under the Concentration-time Curve From Time Zero to 24 Hours (AUC[0-24]) After Single Dose Administration of GSK3882347
Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis of GSK3882347. PK parameters were analyzed using standard non-compartmental analysis.
Pre-dose, 15, 30 minutes, 1, 1.5, 2, 4, 6, 8, 12, 16 and 24 hours post-dose in each treatment period
Part 1: Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUC[0-t]) After Single Dose Administration of GSK3882347
Blood samples were collected at indicated time points for PK analysis of GSK3882347. PK parameters were analyzed using standard non-compartmental analysis.
Pre-dose, 15, 30 minutes, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 32, 48, 72 and 96 hours post-dose in each treatment period
Part 1: Area Under the Concentration-time Curve Extrapolated From Time Zero to Infinity (AUC[0-infinity]) After Single Dose Administration of GSK3882347
Blood samples were collected at indicated time points for PK analysis of GSK3882347. PK parameters were analyzed using standard non-compartmental analysis.
Pre-dose, 15, 30 minutes, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 32, 48, 72 and 96 hours post-dose in each treatment period
Part 1: Maximum Plasma Concentration (Cmax) After Single Dose Administration of GSK3882347
Blood samples were collected at indicated time points for PK analysis of GSK3882347. PK parameters were analyzed using standard non-compartmental analysis.
Pre-dose, 15, 30 minutes, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 32, 48, 72 and 96 hours post-dose in each treatment period
Part 1: Plasma Concentrations at 24 Hours (C24h) After Single Dose Administration of GSK3882347
Blood samples were collected at indicated time points for PK analysis of GSK3882347. PK parameters were analyzed using standard non-compartmental analysis.
Pre-dose, 15, 30 minutes, 1, 1.5, 2, 4, 6, 8, 12, 16 and 24 hours post-dose in each treatment period
Part 1: Time to Cmax (Tmax) After Single Dose Administration of GSK3882347
Blood samples were collected at indicated time points for PK analysis of GSK3882347. PK parameters were analyzed using standard non-compartmental analysis.
Pre-dose, 15, 30 minutes, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 32, 48, 72 and 96 hours post-dose in each treatment period
Part 1: Lag Time for Absorption (Tlag) After Single Dose Administration of GSK3882347
Blood samples were collected at indicated time points for PK analysis of GSK3882347. PK parameters were analyzed using standard non-compartmental analysis.
Pre-dose, 15, 30 minutes, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 32, 48, 72 and 96 hours post-dose in each treatment period
Part 1: Terminal Elimination Half-life (T1/2) After Single Dose Administration of GSK3882347
Blood samples were collected at indicated time points for PK analysis of GSK3882347. PK parameters were analyzed using standard non-compartmental analysis.
Pre-dose, 15, 30 minutes, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 32, 48, 72 and 96 hours post-dose in each treatment period
Part 2: Area Under the Concentration-time Curve Over the Dosing Interval Tau (AUC[0-tau]) After Repeat Dose Administration of GSK3882347
Blood samples were collected at indicated time points for PK analysis of GSK3882347. PK parameters were analyzed using standard non-compartmental analysis.
Days 1 and 7: Pre-dose, 15, 30 minutes, 1, 1.5, 2, 4, 6, 8, 12, 16, 24 hours post-dose
Part 2: Cmax After Repeat Dose Administration of GSK3882347
Blood samples were collected at indicated time points for PK analysis of GSK3882347. PK parameters were analyzed using standard non-compartmental analysis.
Days 1 and 7: Pre-dose, 15, 30 minutes, 1, 1.5, 2, 4, 6, 8, 12, 16, 24 hours post-dose
Part 2: Tmax After Repeat Dose Administration of GSK3882347
Blood samples were collected at indicated time points for PK analysis of GSK3882347. PK parameters were analyzed using standard non-compartmental analysis.
Days 1 and 7: Pre-dose, 15, 30 minutes, 1, 1.5, 2, 4, 6, 8, 12, 16, 24 hours post-dose
Part 2: Plasma Concentrations Over the Dosing Interval (Ctau) After Repeat Dose Administration of GSK3882347
Blood samples were collected at indicated time points for PK analysis of GSK3882347. PK parameters were analyzed using standard non-compartmental analysis.
Days 1 and 7: Pre-dose, 15, 30 minutes, 1, 1.5, 2, 4, 6, 8, 12, 16, 24 hours post-dose
Part 1: Urine Concentration Between 22-24 Hours (C22-24) After Single Dose Administration of GSK3882347
Urine samples were collected at indicated time points for PK analysis of GSK3882347. PK parameters were analyzed using standard non-compartmental analysis.
Day 1: 22-24 hours post-dose in each treatment period
Part 2: Urine Concentration Between 22-24 Hours (C22-24) After Repeat Dose Administration of GSK3882347
Urine samples were collected at indicated time points for PK analysis of GSK3882347. PK parameters were analyzed using standard non-compartmental analysis.
Day 1 and Day 7: 22-24 hours post-dose
Part 1: Amount of Drug Excreted in Urine of Unchanged Drug (Ae Total) After Single Dose Administration of GSK3882347
Urine samples were collected at indicated time points for PK analysis of GSK3882347. PK parameters were analyzed using standard non-compartmental analysis.
At 0-2, 2-4, 4-6, 6-8, 8-10, 10-12, 12-22, 22-24, 24-26, 26-32, 32-38, 38-48, 48-60, 60-72, 72-84, 84-96 hours post-dose in each treatment period
Part 2: Amount of Drug Excreted in Urine of Unchanged Drug (Ae Total) After Repeat Dose Administration of GSK3882347
Urine samples were collected at indicated time points for PK analysis of GSK3882347. PK parameters were analyzed using standard non-compartmental analysis.
Days 1 and 7: At 0-2, 2-4, 4-6, 6-8, 8-10, 10-12, 12-22, 22-24 hours post-dose
Part 1: Percentage of the Given Dose of Drug Excreted in Urine (%fe Total) After Single Dose Administration of GSK3882347
Urine samples were collected at indicated time points for PK analysis of GSK3882347. PK parameters were analyzed using standard non-compartmental analysis. %fe was calculated as: (Ae total/Dose)*100 percent (%).
At 0-2, 2-4, 4-6, 6-8, 8-10, 10-12, 12-22, 22-24, 24-26, 26-32, 32-38, 38-48, 48-60, 60-72, 72-84, 84-96 hours post-dose in each treatment period
Part 2: Percentage of the Given Dose of Drug Excreted in Urine (%fe Total) After Single Dose Administration of GSK3882347
Urine samples were collected at indicated time points for PK analysis of GSK3882347. PK parameters were analyzed using standard non-compartmental analysis. %fe was calculated as: (Ae total/Dose)*100%.
Day 1 and Day 7: At 0-2, 2-4, 4-6, 6-8, 8-10, 10-12, 12-22, 22-24 hours post-dose
Part 1: Renal Clearance of Drug (CLr) After Single Dose Administration of GSK3882347
Urine samples were collected at indicated time points for PK analysis of GSK3882347. PK parameters were analyzed using standard non-compartmental analysis. CLr was calculated as: Ae total/AUC(0-t)
At 0-2, 2-4, 4-6, 6-8, 8-10, 10-12, 12-22, 22-24, 24-26, 26-32, 32-38, 38-48, 48-60, 60-72, 72-84, 84-96 hours post-dose in each treatment period
Part 2: Renal Clearance of Drug (CLr) After Repeat Dose Administration of GSK3882347
Urine samples were collected at indicated time points for PK analysis of GSK3882347. PK parameters were analyzed using standard non-compartmental analysis. CLr was calculated as: Ae total/AUC(0-t).
Day 1 and Day 7: At 0-2, 2-4, 4-6, 6-8, 8-10, 10-12, 12-22, 22-24 hours post-dose
Part 1: Plasma Concentrations at 12 Hours (C12) After Single Dose Administration of GSK3882347
Blood samples were collected at indicated time points for PK analysis of GSK3882347. PK parameters were analyzed using standard non-compartmental analysis.
Pre-dose, 15, 30 minutes, 1, 1.5, 2, 4, 6, 8 and 12 hours post-dose in each treatment period
Part 1: Apparent Oral Clearance (CL/F) After Single Dose Administration of GSK3882347
Blood samples were collected at indicated time points for PK analysis of GSK3882347. PK parameters were analyzed using standard non-compartmental analysis.
Pre-dose, 15, 30 minutes, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 32, 48, 72 and 96 hours post-dose in each treatment period
Part 1: Apparent Volume of Distribution After Oral Administration (Vz/F) After Single Dose Administration of GSK3882347
Blood samples were collected at indicated time points for PK analysis of GSK3882347. PK parameters were analyzed using standard non-compartmental analysis.
Pre-dose, 15, 30 minutes, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 32, 48, 72 and 96 hours post-dose in each treatment period
Part 1: Mean Residence Time (MRT) After Single Dose Administration of GSK3882347
Blood samples were collected at indicated time points for PK analysis of GSK3882347. PK parameters were analyzed using standard non-compartmental analysis.
Pre-dose, 15, 30 minutes, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 32, 48, 72 and 96 hours post-dose in each treatment period
Part 2: Area Under the Concentration-time Curve From Time Zero to 12 Hours (AUC[0-12]) After Repeat Dose Administration of GSK3882347
Blood samples were collected at indicated time points for PK analysis of GSK3882347. PK parameters were analyzed using standard non-compartmental analysis.
Days 1 and 7: Pre-dose, 15, 30 minutes, 1, 1.5, 2, 4, 6, 8 and 12 hours post-dose
Part 2: Plasma Concentrations at 12 Hours (C12) After Repeat Dose Administration of GSK3882347
Blood samples were collected at indicated time points for PK analysis of GSK3882347. PK parameters were analyzed using standard non-compartmental analysis.
Days 1 and 7: Pre-dose, 15, 30 minutes, 1, 1.5, 2, 4, 6, 8 and 12 hours post-dose
Part 1: Dose Proportionality of GSK3882347 for Dose Levels 15 mg to 900 mg Using AUC(0-infinity) After Single Dose Administration of GSK3882347 Under Fasted Condition
Blood samples were collected at indicated time points for PK analysis of GSK3882347. PK parameters were analyzed using standard non-compartmental analysis. Dose proportionality was assessed using Power model. Log-e(dose) was fitted as fixed effect and participant was fitted as random effect. Kenward and Roger method and unstructured covariance structure was used. Slope and 90% confidence interval (CI) for the slope are presented. The SD 250 mg fed treatment was not considered in the analysis.
Pre-dose, 15, 30 minutes, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 32, 48, 72 and 96 hours post-dose in each treatment period
Part 1: Dose Proportionality of GSK3882347 for Dose Levels 15 mg to 900 mg Using Cmax After Single Dose Administration of GSK3882347 Under Fasted Condition
Blood samples were collected at indicated time points for PK analysis of GSK3882347. PK parameters were analyzed using standard non-compartmental analysis. Dose proportionality was assessed using Power model. Log-e(dose) was fitted as fixed effect and participant was fitted as random effect. Kenward and Roger method and unstructured covariance structure was used. Slope and 90% CI for the slope are presented. The SD 250 mg fed treatment was not considered in the analysis.
Pre-dose, 15, 30 minutes, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 32, 48, 72 and 96 hours post-dose in each treatment period
Part 2: Dose Proportionality of GSK3882347 for Dose Levels 50 mg to 900 mg Using AUC(0-tau) After Repeat Dose Administration of GSK3882347
Blood samples were collected at indicated time points for PK analysis of GSK3882347. PK parameters were analyzed using standard non-compartmental analysis. Dose proportionality was assessed using Power model. Log-e(dose) was fitted as fixed effect and participant was fitted as random effect. Kenward and Roger method and unstructured covariance structure was used. Slope and 90% CI for the slope are presented.
Day 1 and Day 7: Pre-dose, 15, 30 minutes, 1, 1.5, 2, 4, 6, 8, 12, 16, 24 hours post-dose
Part 2: Dose Proportionality of GSK3882347 for Dose Levels 50 mg to 900 mg Using Cmax After Repeat Dose Administration of GSK3882347
Blood samples were collected at indicated time points for PK analysis of GSK3882347. PK parameters were analyzed using standard non-compartmental analysis. Dose proportionality was assessed using Power model. Log-e(dose) was fitted as fixed effect and participant was fitted as random effect. Kenward and Roger method and unstructured covariance structure was used. Slope and 90% CI for the slope are presented.
Day 1 and Day 7: Pre-dose, 15, 30 minutes, 1, 1.5, 2, 4, 6, 8, 12, 16, 24 hours post-dose
Part 2: Observed Accumulation Ratio (Ro) Using AUC(0-tau) After Repeat Dose Administration of GSK3882347
Blood samples were collected at indicated time points for PK analysis of GSK3882347. PK parameters were analyzed using standard non-compartmental analysis. Accumulation ratio was calculated as AUC(0-tau) at Day 7 divided by AUC(0-tau) at Day 1 for GSK3882347. Mixed effect model was used to assess accumulation ratio for the log transformed parameters. Treatment, day and the interaction of treatment and day were fitted as fixed effect. Participant was fitted as random effect. Kenward and Roger method and unstructured covariance structure was used.
Day 1 and Day 7: Pre-dose, 15, 30 minutes, 1, 1.5, 2, 4, 6, 8, 12, 16, 24 hours post-dose
Part 2: Time Invariance of GSK3882347
Blood samples were collected at indicated time points for the analysis of time invariance. Time invariance was calculated as AUC(0-tau) at Day 7 divided by AUC(0-infinity) at Day 1 for GSK3882347. Mixed effect ANOVA model was used to assess time invariance for the log transformed parameters. Treatment, day and the interaction of treatment and day were fitted as fixed effect. Participant was fitted as random effect. Kenward and Roger method and unstructured covariance structure was used.
Day 1 and Day 7: Pre-dose, 15, 30 minutes, 1, 1.5, 2, 4, 6, 8, 12, 16, 24 hours post-dose
Part 2: Pre-dose Plasma Concentrations After Repeat Dose Administration of GSK3882347 From Days 3 to 7
Blood samples were collected at indicated time points for PK analysis of GSK3882347.
Days 3, 4, 5, 6 and 7: Pre-dose
Part 1: Area Under the Concentration-time Curve From Time Zero to 24 Hours (AUC[0-24]) After Single Dose Administration of GSK3882347 250 mg Under Fasted and Fed Conditions for Assessment of Food Effect
Blood samples were collected at indicated time points for PK analysis of GSK3882347 250 mg under fasted and fed conditions for assessment of food effect. PK parameters were analyzed using standard non-compartmental analysis.
Part 1: Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUC [0-t]) After Single Dose Administration of GSK3882347 250 mg Under Fasted and Fed Conditions for Assessment of Food Effect
Blood samples were collected at indicated time points for PK analysis of GSK3882347 250 mg under fasted and fed conditions for assessment of food effect. PK parameters were analyzed using standard non-compartmental analysis.
Part 1: Area Under the Concentration-time Curve Extrapolated From Time Zero to Infinity (AUC [0-infinity]) After Single Dose Administration of GSK3882347 250 mg Under Fasted and Fed Conditions for Assessment of Food Effect
Blood samples were collected at indicated time points for PK analysis of GSK3882347 250 mg under fasted and fed conditions for assessment of food effect. PK parameters were analyzed using standard non-compartmental analysis.
Part 1: Maximum Plasma Concentration (Cmax) After Single Dose Administration of GSK3882347 250 mg Under Fasted and Fed Conditions for Assessment of Food Effect
Blood samples were collected at indicated time points for PK analysis of GSK3882347 250 mg under fasted and fed conditions for assessment of food effect. PK parameters were analyzed using standard non-compartmental analysis.
Part 1: Plasma Concentrations at 24 Hours (C24h) After Single Dose Administration of GSK3882347 250 mg Under Fasted and Fed Conditions for Assessment of Food Effect
Blood samples were collected at indicated time points for PK analysis of GSK3882347 250 mg under fasted and fed conditions for assessment of food effect. PK parameters were analyzed using standard non-compartmental analysis.
Part 1: Tmax After Single Dose Administration of GSK3882347 250 mg Under Fasted and Fed Conditions for Assessment of Food Effect
Blood samples were collected at indicated time points for PK analysis of GSK3882347 250 mg under fasted and fed conditions for assessment of food effect. PK parameters were analyzed using standard non-compartmental analysis.
Part 1: Tlag After Single Dose Administration of GSK3882347 250 mg Under Fasted and Fed Conditions for Assessment of Food Effect
Blood samples were collected at indicated time points for PK analysis of GSK3882347 250 mg under fasted and fed conditions for assessment of food effect. PK parameters were analyzed using standard non-compartmental analysis.
Healthy participants in Part 1 Cohort 1 received a SD of GSK3882347 50 mg on Day 1 in treatment Period 1, followed by a SD of GSK3882347 150 mg on Day 1 in treatment Period 2, followed by a SD of PBO on Day 1 in treatment Period 3, further followed by a SD of GSK3882347 250 mg under fed condition on Day 1 in treatment Period 4. Cohort 1 was a 4-period cross-over.
Healthy participants in Part 1 Cohort 1 received a SD of GSK3882347 50 mg on Day 1 in treatment Period 1, followed by a SD of PBO on Day 1 in treatment Period 2, followed by a SD of GSK3882347 250 mg on Day 1 in treatment Period 3, further followed by a SD of GSK3882347 250 mg under fed condition on Day 1 in treatment Period 4. Cohort 1 was a 4-period cross-over.
Healthy participants in Part 1 Cohort 1 received a SD of PBO on Day 1 in treatment Period 1, followed by a SD of GSK3882347 150 mg on Day 1 in treatment Period 2, followed by a SD of GSK3882347 250 mg on Day 1 in treatment Period 3, further followed by a SD of GSK3882347 250 mg under fed condition on Day 1 in treatment Period 4. Cohort 1 was a 4-period cross-over.
BG004
Part 1-Cohort 2: SD PBO/GSK3882347 SD 900 mg/SD 15 mg
Healthy participants in Part 1 Cohort 2 received a SD of PBO on Day 1 in treatment Period 1, followed by a SD of GSK3882347 900 mg on Day 1 in treatment Period 2, further followed by a SD of GSK3882347 15 mg on Day 1 in treatment Period 3. Cohort 2 was a 3-period cross-over.
BG005
Part 1-Cohort 2: GSK3882347 SD 500 mg/SD PBO/SD 15 mg
Healthy participants in Part 1 Cohort 2 received a SD of GSK3882347 500 mg on Day 1 in treatment Period 1, followed by a SD of PBO on Day 1 in treatment Period 2, further followed by a SD of GSK3882347 15 mg on Day 1 in treatment Period 3. Cohort 2 was a 3-period cross-over.
BG006
Part 1-Cohort 2: GSK3882347 SD 500 mg/SD 900 mg/SD PBO
Healthy participants in Part 1 Cohort 2 received a SD of GSK3882347 500 mg on Day 1 in treatment Period 1, followed by a SD of GSK3882347 900 mg on Day 1 in treatment Period 2, further followed by a SD of PBO on Day 1 in treatment Period 3. Cohort 2 was a 3-period cross-over.
Healthy participants in Part 1 Cohort 2 received a SD of GSK3882347 500 mg on Day 1 in treatment Period 1, followed by a SD of GSK3882347 900 mg on Day 1 in treatment Period 2, further followed by a SD of GSK3882347 15 mg on Day 1 in treatment Period 3. Cohort 2 was a 3-period cross-over.
BG008
Part 2: Repeat Dose Placebo
Healthy participants in Part 2 received repeat dose (RD) of Placebo on Days 1 to 7.
BG009
Part 2: Repeat Dose GSK3882347 50 mg
Healthy participants in Part 2 received RD of GSK3882347 50 mg on Days 1 to 7.
BG010
Part 2: Repeat Dose GSK3882347 150 mg
Healthy participants in Part 2 received RD of GSK3882347 150 mg on Days 1 to 7.
BG011
Part 2: Repeat Dose GSK3882347 500 mg
Healthy participants in Part 2 received RD of GSK3882347 500 mg on Days 1 to 7.
BG012
Part 2: Repeat Dose GSK3882347 900 mg
Healthy participants in Part 2 received RD of GSK3882347 900 mg on Days 1 to 7.
BG013
Total
Total of all reporting groups
3
BG0012
BG0022
BG0033
BG0043
BG0053
BG0063
BG0072
BG0088
BG0098
BG0108
BG0118
BG0128
BG01361
Participants
Title
Denominators
Categories
Title
Measurements
<=18 years
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
BG0110
BG0120
BG0130
Between 18 and 65 years
BG0003
BG0012
BG0022
BG0033
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
BG0080
BG0090
BG0100
BG0110
BG0120
BG0130
Male
BG0003
BG0012
BG0022
BG0033
BG004
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Black or African American
BG0000
BG0010
BG0020
BG0031
BG0040
BG0051
BG0060
BG0070
BG0081
BG0090
BG0101
BG0110
BG0121
BG0135
Asian- South East Asian Heritage
BG0000
BG0010
BG0021
BG0030
BG004
White- White/Caucasian/European Heritage
BG0003
BG0012
BG0021
BG0032
BG004
Mixed race
BG0000
BG0010
BG0020
BG0030
BG004
Healthy participants in Part 1 received a SD of Placebo on Day 1 in either treatment Periods 1, 2, 3 and 4.
OG001
Part 1: Single Dose GSK3882347 15 mg
Healthy participants in Part 1 received a SD of GSK3882347 15 mg on Day 1 in treatment Period 3.
OG002
Part 1: Single Dose GSK3882347 50 mg
Healthy participants in Part 1 received a SD of GSK3882347 50 mg on Day 1 in treatment Period 1.
OG003
Part 1: Single Dose GSK3882347 150 mg
Healthy participants in Part 1 received a SD of GSK3882347 150 mg on Day 1 in treatment Period 2.
OG004
Part 1: Single Dose GSK3882347 250 mg
Healthy participants in Part 1 received a SD of GSK3882347 250 mg on Day 1 in treatment Period 3.
OG005
Part 1: Single Dose GSK3882347 250 mg Fed
Healthy participants in Part 1 received a SD of GSK3882347 250 mg under fed condition on Day 1 in treatment Period 4.
OG006
Part 1: Single Dose GSK3882347 500 mg
Healthy participants in Part 1 received a SD of GSK3882347 500 mg on Day 1 in treatment Period 1.
OG007
Part 1: Single Dose GSK3882347 900 mg
Healthy participants in Part 1 received a SD of GSK3882347 900 mg on Day 1 in treatment Period 2.
Units
Counts
Participants
OG00014
OG0016
OG0026
OG0036
OG0046
OG0056
OG0066
OG0076
Title
Denominators
Categories
Non-serious AEs
Title
Measurements
OG0007
OG0011
OG0022
OG0032
OG0043
OG0052
OG0063
OG0072
SAEs
Title
Measurements
OG0000
OG0010
OG0020
OG003
Primary
Part 2: Number of Participants With Non-serious AEs and SAEs
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgment. Number of participants with common (>=5%) non-serious AEs is presented.
Safety Population.
Posted
Count of Participants
Participants
Up to 26 days
ID
Title
Description
OG000
Part 2: Repeat Dose Placebo
Healthy participants in Part 2 received repeat dose (RD) of Placebo on Days 1 to 7.
OG001
Part 2: Repeat Dose GSK3882347 50 mg
Healthy participants in Part 2 received RD of GSK3882347 50 mg on Days 1 to 7.
OG002
Part 2: Repeat Dose GSK3882347 150 mg
Healthy participants in Part 2 received RD of GSK3882347 150 mg on Days 1 to 7.
OG003
Part 2: Repeat Dose GSK3882347 500 mg
Healthy participants in Part 2 received RD of GSK3882347 500 mg on Days 1 to 7.
OG004
Part 2: Repeat Dose GSK3882347 900 mg
Healthy participants in Part 2 received RD of GSK3882347 900 mg on Days 1 to 7.
Units
Counts
Participants
OG0008
OG0018
OG0028
OG003
Title
Denominators
Categories
Non-serious AEs
Title
Measurements
OG0005
OG0014
OG0022
OG003
Primary
Part 1: Number of Participants With Treatment Related AEs
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. Number of participants with treatment related AEs is presented.
Safety Population
Posted
Count of Participants
Participants
Up to 3 months
ID
Title
Description
OG000
Part 1: Single Dose Placebo
Healthy participants in Part 1 received a SD of Placebo on Day 1 in either treatment Periods 1, 2, 3 and 4.
OG001
Part 1: Single Dose GSK3882347 15 mg
Healthy participants in Part 1 received a SD of GSK3882347 15 mg on Day 1 in treatment Period 3.
OG002
Part 1: Single Dose GSK3882347 50 mg
Healthy participants in Part 1 received a SD of GSK3882347 50 mg on Day 1 in treatment Period 1.
OG003
Part 1: Single Dose GSK3882347 150 mg
Healthy participants in Part 1 received a SD of GSK3882347 150 mg on Day 1 in treatment Period 2.
OG004
Part 1: Single Dose GSK3882347 250 mg
Healthy participants in Part 1 received a SD of GSK3882347 250 mg on Day 1 in treatment Period 3.
OG005
Part 1: Single Dose GSK3882347 250 mg Fed
Healthy participants in Part 1 received a SD of GSK3882347 250 mg under fed condition on Day 1 in treatment Period 4.
OG006
Part 1: Single Dose GSK3882347 500 mg
Healthy participants in Part 1 received a SD of GSK3882347 500 mg on Day 1 in treatment Period 1.
OG007
Part 1: Single Dose GSK3882347 900 mg
Healthy participants in Part 1 received a SD of GSK3882347 900 mg on Day 1 in treatment Period 2.
Units
Counts
Participants
OG00014
OG0016
OG0026
OG003
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG003
Primary
Part 2: Number of Participants With Treatment Related AEs
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. Number of participants with treatment related AEs is presented.
Safety Population.
Posted
Count of Participants
Participants
Up to 26 days
ID
Title
Description
OG000
Part 2: Repeat Dose Placebo
Healthy participants in Part 2 received repeat dose (RD) of Placebo on Days 1 to 7.
OG001
Part 2: Repeat Dose GSK3882347 50 mg
Healthy participants in Part 2 received RD of GSK3882347 50 mg on Days 1 to 7.
OG002
Part 2: Repeat Dose GSK3882347 150 mg
Healthy participants in Part 2 received RD of GSK3882347 150 mg on Days 1 to 7.
OG003
Part 2: Repeat Dose GSK3882347 500 mg
Healthy participants in Part 2 received RD of GSK3882347 500 mg on Days 1 to 7.
OG004
Part 2: Repeat Dose GSK3882347 900 mg
Healthy participants in Part 2 received RD of GSK3882347 900 mg on Days 1 to 7.
Units
Counts
Participants
OG0008
OG0018
OG0028
OG003
Title
Denominators
Categories
Title
Measurements
OG0001
OG0012
OG0020
OG003
Primary
Part 1: Number of Participants With Worst-case Hematology Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Blood samples were collected to analyze hematocrit,hemoglobin,leukocytes,lymphocytes,neutrophils and platelets. PCI ranges were <0.075 or >0.54 proportion of red blood cells in blood for hematocrit, <25 or >180 grams per liter(g/L) for hemoglobin,<3 or >20 x10^9 cells per liter(cells/L) for leukocytes,<0.8 x10^9 cells/L for lymphocytes,<1.5 x10^9 cells/L for neutrophils and <100 or >550 x10^9 cells/L for platelets.Participants were counted in worst case category that their value changes to(low,within range or no change or high),unless there is no change in their category.Participants whose laboratory value category was unchanged(for example[e.g.],High to High),or whose value became within range, were recorded in"To within Range or No Change" category.Participants were counted twice if the participant has values that changed 'To Low' and 'To High',so the percentages may not add to 100%.Baseline=latest pre-dose assessment with a non-missing value, including those from unscheduled visits
Safety Population
Posted
Count of Participants
Participants
Up to 3 months
ID
Title
Description
OG000
Part 1: Single Dose Placebo
Healthy participants in Part 1 received a SD of Placebo on Day 1 in either treatment Periods 1, 2, 3 and 4.
OG001
Part 1: Single Dose GSK3882347 15 mg
Healthy participants in Part 1 received a SD of GSK3882347 15 mg on Day 1 in treatment Period 3.
OG002
Part 1: Single Dose GSK3882347 50 mg
Healthy participants in Part 1 received a SD of GSK3882347 50 mg on Day 1 in treatment Period 1.
OG003
Part 1: Single Dose GSK3882347 150 mg
Healthy participants in Part 1 received a SD of GSK3882347 150 mg on Day 1 in treatment Period 2.
OG004
Part 1: Single Dose GSK3882347 250 mg
Healthy participants in Part 1 received a SD of GSK3882347 250 mg on Day 1 in treatment Period 3.
OG005
Part 1: Single Dose GSK3882347 250 mg Fed
Healthy participants in Part 1 received a SD of GSK3882347 250 mg under fed condition on Day 1 in treatment Period 4.
OG006
Part 1: Single Dose GSK3882347 500 mg
Healthy participants in Part 1 received a SD of GSK3882347 500 mg on Day 1 in treatment Period 1.
OG007
Part 1: Single Dose GSK3882347 900 mg
Healthy participants in Part 1 received a SD of GSK3882347 900 mg on Day 1 in treatment Period 2.
Units
Counts
Participants
OG00014
OG0016
OG0026
OG003
Title
Denominators
Categories
Hematocrit: To Low
Title
Measurements
OG0002
OG0012
OG0020
OG003
Primary
Part 2: Number of Participants With Worst-case Hematology Results Relative to PCI Criteria Post-Baseline Relative to Baseline
Blood samples were collected to analyze hematocrit,hemoglobin,leukocytes,lymphocytes,neutrophils and platelets. PCI ranges were <0.075 or >0.54 proportion of red blood cells in blood for hematocrit, <25 or >180 grams per liter(g/L) for hemoglobin,<3 or >20 x10^9 cells per liter(cells/L) for leukocytes,<0.8 x10^9 cells/L for lymphocytes,<1.5 x10^9 cells/L for neutrophils and <100 or >550 x10^9 cells/L for platelets.Participants were counted in worst case category that their value changes to(low,within range or no change or high),unless there is no change in their category.Participants whose laboratory value category was unchanged(e.g.,High to High),or whose value became within range, were recorded in"To within Range or No Change" category.Participants were counted twice if the participant has values that changed 'To Low' and 'To High',so the percentages may not add to 100%.Baseline=latest pre-dose assessment with a non-missing value, including those from unscheduled visits
Safety Population.
Posted
Count of Participants
Participants
Up to 26 days
ID
Title
Description
OG000
Part 2: Repeat Dose Placebo
Healthy participants in Part 2 received repeat dose (RD) of Placebo on Days 1 to 7.
OG001
Part 2: Repeat Dose GSK3882347 50 mg
Healthy participants in Part 2 received RD of GSK3882347 50 mg on Days 1 to 7.
OG002
Part 2: Repeat Dose GSK3882347 150 mg
Healthy participants in Part 2 received RD of GSK3882347 150 mg on Days 1 to 7.
OG003
Part 2: Repeat Dose GSK3882347 500 mg
Healthy participants in Part 2 received RD of GSK3882347 500 mg on Days 1 to 7.
OG004
Part 2: Repeat Dose GSK3882347 900 mg
Healthy participants in Part 2 received RD of GSK3882347 900 mg on Days 1 to 7.
Units
Counts
Participants
OG0008
OG0018
OG0028
OG003
Title
Denominators
Categories
Hematocrit: To Low
Title
Measurements
OG0002
OG0012
OG0021
OG003
Primary
Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline
Blood samples were collected to analyze PCI ranges: >=2 times Upper limit of Normal(ULN) Units per Liter(U/L) for Alanine aminotransferase(ALT),>=2 times ULN U/L for alkaline phosphatase(ALP), >=2 times ULN U/L for aspartate aminotransferase(AST),>=1.5 times ULN micromoles/L for bilirubin,<2 or >2.75 millimoles/L (mmol/L) for calcium,<3 or >9 mmol/L for glucose,<3 or >5.5 mmol/L for potassium and <130 or >150 mmol/L for sodium.Participants were counted in worst case category that their value changes to(low,within range or no change or high),unless there is no change in their category.Participants whose laboratory value category was unchanged(e.g.,High to High),or whose value became within range,were recorded in"To within Range or No Change" category.Participants were counted twice if the participant has values that changed 'To Low' and 'To High',so the percentages may not add to 100%.Baseline=latest pre-dose assessment with a non-missing value,including those from unscheduled visits
Safety Population
Posted
Count of Participants
Participants
Up to 3 months
ID
Title
Description
OG000
Part 1: Single Dose Placebo
Healthy participants in Part 1 received a SD of Placebo on Day 1 in either treatment Periods 1, 2, 3 and 4.
OG001
Part 1: Single Dose GSK3882347 15 mg
Healthy participants in Part 1 received a SD of GSK3882347 15 mg on Day 1 in treatment Period 3.
OG002
Part 1: Single Dose GSK3882347 50 mg
Healthy participants in Part 1 received a SD of GSK3882347 50 mg on Day 1 in treatment Period 1.
OG003
Part 1: Single Dose GSK3882347 150 mg
Healthy participants in Part 1 received a SD of GSK3882347 150 mg on Day 1 in treatment Period 2.
OG004
Part 1: Single Dose GSK3882347 250 mg
Healthy participants in Part 1 received a SD of GSK3882347 250 mg on Day 1 in treatment Period 3.
OG005
Part 1: Single Dose GSK3882347 250 mg Fed
Healthy participants in Part 1 received a SD of GSK3882347 250 mg under fed condition on Day 1 in treatment Period 4.
OG006
Part 1: Single Dose GSK3882347 500 mg
Healthy participants in Part 1 received a SD of GSK3882347 500 mg on Day 1 in treatment Period 1.
OG007
Part 1: Single Dose GSK3882347 900 mg
Healthy participants in Part 1 received a SD of GSK3882347 900 mg on Day 1 in treatment Period 2.
Units
Counts
Participants
OG00014
OG0016
OG0026
OG003
Title
Denominators
Categories
ALT: To Low
Title
Measurements
OG0000
OG0010
OG0020
OG003
Primary
Part 2: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline
Blood samples were collected to analyze PCI ranges: >=2 times ULN U/L for Alanine aminotransferase(ALT),>=2 times ULN U/L for alkaline phosphatase(ALP), >=2 times ULN U/L for aspartate aminotransferase(AST),>=1.5 times ULN micromoles/L for bilirubin,<2 or >2.75 mmol/L for calcium,<3 or >9 mmol/L for glucose,<3 or >5.5 mmol/L for potassium and <130 or >150 mmol/L for sodium.Participants were counted in worst case category that their value changes to(low,within range or no change or high),unless there is no change in their category.Participants whose laboratory value category was unchanged(e.g.,High to High),or whose value became within range,were recorded in"To within Range or No Change" category.Participants were counted twice if the participant has values that changed 'To Low' and 'To High',so the percentages may not add to 100%.Baseline=latest pre-dose assessment with a non-missing value,including those from unscheduled visits.
Safety Population. Only those participants with data available at the specified data points were analyzed.
Posted
Count of Participants
Participants
Up to 26 days
ID
Title
Description
OG000
Part 2: Repeat Dose Placebo
Healthy participants in Part 2 received repeat dose (RD) of Placebo on Days 1 to 7.
OG001
Part 2: Repeat Dose GSK3882347 50 mg
Healthy participants in Part 2 received RD of GSK3882347 50 mg on Days 1 to 7.
OG002
Part 2: Repeat Dose GSK3882347 150 mg
Healthy participants in Part 2 received RD of GSK3882347 150 mg on Days 1 to 7.
OG003
Part 2: Repeat Dose GSK3882347 500 mg
Healthy participants in Part 2 received RD of GSK3882347 500 mg on Days 1 to 7.
OG004
Part 2: Repeat Dose GSK3882347 900 mg
Healthy participants in Part 2 received RD of GSK3882347 900 mg on Days 1 to 7.
Units
Counts
Participants
OG0008
OG0018
OG0028
OG003
Title
Denominators
Categories
ALT: To Low
ParticipantsOG0008
ParticipantsOG0018
ParticipantsOG0028
ParticipantsOG003
Primary
Part 1: Number of Participants With Worst Case Urinalysis Results Post Baseline Relative to Baseline
Urine samples were collected for the analysis of urine parameters including occult blood and protein by dipstick. The dipstick test gave results in a semi-quantitative manner, and results for urinalysis parameters were recorded as no change/decreased, increase to positive for urine occult blood and protein indicating proportional concentrations in the urine sample. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Number of participants with worst case urinalysis results Post Baseline relative to Baseline is presented.
Safety Population
Posted
Count of Participants
Participants
Up to 3 months
ID
Title
Description
OG000
Part 1: Single Dose Placebo
Healthy participants in Part 1 received a SD of Placebo on Day 1 in either treatment Periods 1, 2, 3 and 4.
OG001
Part 1: Single Dose GSK3882347 15 mg
Healthy participants in Part 1 received a SD of GSK3882347 15 mg on Day 1 in treatment Period 3.
OG002
Part 1: Single Dose GSK3882347 50 mg
Healthy participants in Part 1 received a SD of GSK3882347 50 mg on Day 1 in treatment Period 1.
OG003
Part 1: Single Dose GSK3882347 150 mg
Healthy participants in Part 1 received a SD of GSK3882347 150 mg on Day 1 in treatment Period 2.
OG004
Part 1: Single Dose GSK3882347 250 mg
Healthy participants in Part 1 received a SD of GSK3882347 250 mg on Day 1 in treatment Period 3.
OG005
Part 1: Single Dose GSK3882347 250 mg Fed
Healthy participants in Part 1 received a SD of GSK3882347 250 mg under fed condition on Day 1 in treatment Period 4.
OG006
Part 1: Single Dose GSK3882347 500 mg
Healthy participants in Part 1 received a SD of GSK3882347 500 mg on Day 1 in treatment Period 1.
OG007
Part 1: Single Dose GSK3882347 900 mg
Healthy participants in Part 1 received a SD of GSK3882347 900 mg on Day 1 in treatment Period 2.
Units
Counts
Participants
OG00014
OG0016
OG0026
OG003
Title
Denominators
Categories
Occult Blood, No change/decreased
Title
Measurements
OG00014
OG0016
OG0026
OG003
Primary
Part 2: Number of Participants With Worst Case Urinalysis Results Post Baseline Relative to Baseline
Urine samples were collected for the analysis of urine parameters including occult blood and protein by dipstick. The dipstick test gave results in a semi-quantitative manner (proportional concentrations in urine samples), and results for urinalysis parameters were recorded as no change/decreased, increase to positive for urine occult blood and protein. 'No change/decreased' indicates no change from Baseline results or decreased in results from Baseline including change in negative results. 'Increase to positive' indicates increase in result from Baseline. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Number of participants with worst case urinalysis results Post Baseline relative to Baseline is presented.
Safety Population.
Posted
Count of Participants
Participants
Up to 26 days
ID
Title
Description
OG000
Part 2: Repeat Dose Placebo
Healthy participants in Part 2 received repeat dose (RD) of Placebo on Days 1 to 7.
OG001
Part 2: Repeat Dose GSK3882347 50 mg
Healthy participants in Part 2 received RD of GSK3882347 50 mg on Days 1 to 7.
OG002
Part 2: Repeat Dose GSK3882347 150 mg
Healthy participants in Part 2 received RD of GSK3882347 150 mg on Days 1 to 7.
OG003
Part 2: Repeat Dose GSK3882347 500 mg
Healthy participants in Part 2 received RD of GSK3882347 500 mg on Days 1 to 7.
OG004
Part 2: Repeat Dose GSK3882347 900 mg
Healthy participants in Part 2 received RD of GSK3882347 900 mg on Days 1 to 7.
Units
Counts
Participants
OG0008
OG0018
OG0028
OG003
Title
Denominators
Categories
Occult Blood, No change/decreased
Title
Measurements
OG0008
OG0018
OG0027
OG003
Primary
Part 1: Number of Participants With Worst Case Vital Signs Results Relative to PCI Criteria Post Baseline Relative to Baseline
Vital signs were assessed including Systolic blood pressure (SBP), diastolic blood pressure (DBP) and pulse rate (PR). PCI ranges were <85 (Low), 85-160 (Normal) and >160 (High) for SBP; <45 (Low), 45-100 (Normal), >100 (High) for DBP; <40 (Low), 40-110 (Normal), >110 (High) for pulse rate. Participants were counted in worst case category that their value changes to(low,within range or no change, high),unless there is no change in their category.Participants whose laboratory value category was unchanged(e.g.,High to High),or whose value became within range, were recorded in"To within Range or No Change" category.Participants were counted twice if the participant has values that changed 'To Low' and 'To High',so the percentages may not add to 100%.Baseline was defined as latest pre-dose assessment with a non-missing value, including those from unscheduled visits
Safety Population
Posted
Count of Participants
Participants
Up to 3 months
ID
Title
Description
OG000
Part 1: Single Dose Placebo
Healthy participants in Part 1 received a SD of Placebo on Day 1 in either treatment Periods 1, 2, 3 and 4.
OG001
Part 1: Single Dose GSK3882347 15 mg
Healthy participants in Part 1 received a SD of GSK3882347 15 mg on Day 1 in treatment Period 3.
OG002
Part 1: Single Dose GSK3882347 50 mg
Healthy participants in Part 1 received a SD of GSK3882347 50 mg on Day 1 in treatment Period 1.
OG003
Part 1: Single Dose GSK3882347 150 mg
Healthy participants in Part 1 received a SD of GSK3882347 150 mg on Day 1 in treatment Period 2.
OG004
Part 1: Single Dose GSK3882347 250 mg
Healthy participants in Part 1 received a SD of GSK3882347 250 mg on Day 1 in treatment Period 3.
OG005
Part 1: Single Dose GSK3882347 250 mg Fed
Healthy participants in Part 1 received a SD of GSK3882347 250 mg under fed condition on Day 1 in treatment Period 4.
OG006
Part 1: Single Dose GSK3882347 500 mg
Healthy participants in Part 1 received a SD of GSK3882347 500 mg on Day 1 in treatment Period 1.
OG007
Part 1: Single Dose GSK3882347 900 mg
Healthy participants in Part 1 received a SD of GSK3882347 900 mg on Day 1 in treatment Period 2.
Units
Counts
Participants
OG00014
OG0016
OG0026
OG003
Title
Denominators
Categories
SBP: To Low
Title
Measurements
OG0000
OG0010
OG0020
OG003
Primary
Part 2: Number of Participants With Worst Case Vital Signs Results Relative to PCI Criteria Post Baseline Relative to Baseline
Vital signs were assessed including Systolic blood pressure (SBP), diastolic blood pressure (DBP) and pulse rate (PR). PCI ranges were <85 (Low), 85-160 (Normal) and >160 (High) for SBP; <45 (Low), 45-100 (Normal), >100 (High) for DBP; <40 (Low), 40-110 (Normal), >110 (High) for pulse rate. Participants were counted in worst case category that their value changes to(low,within range or no change, high),unless there is no change in their category.Participants whose laboratory value category was unchanged(e.g.,High to High),or whose value became within range, were recorded in"To within Range or No Change" category.Participants were counted twice if the participant has values that changed 'To Low' and 'To High',so the percentages may not add to 100%.Baseline was defined as latest pre-dose assessment with a non-missing value, including those from unscheduled visits
Safety Population.
Posted
Count of Participants
Participants
Up to 26 days
ID
Title
Description
OG000
Part 2: Repeat Dose Placebo
Healthy participants in Part 2 received repeat dose (RD) of Placebo on Days 1 to 7.
OG001
Part 2: Repeat Dose GSK3882347 50 mg
Healthy participants in Part 2 received RD of GSK3882347 50 mg on Days 1 to 7.
OG002
Part 2: Repeat Dose GSK3882347 150 mg
Healthy participants in Part 2 received RD of GSK3882347 150 mg on Days 1 to 7.
OG003
Part 2: Repeat Dose GSK3882347 500 mg
Healthy participants in Part 2 received RD of GSK3882347 500 mg on Days 1 to 7.
OG004
Part 2: Repeat Dose GSK3882347 900 mg
Healthy participants in Part 2 received RD of GSK3882347 900 mg on Days 1 to 7.
Units
Counts
Participants
OG0008
OG0018
OG0028
OG003
Title
Denominators
Categories
SBP: To Low
Title
Measurements
OG0000
OG0010
OG0020
OG003
Primary
Part 1: Number of Participants With Worst Case Abnormal Electrocardiogram (ECG) Results Post Baseline Relative to Baseline
A 12-lead ECG was recorded with the participant in a semi-supine position after a rest of at least 10 minutes. Twelve lead ECGs were obtained by using an automated ECG machine that measured PR, QRS, QT, and corrected QT (QTc) intervals and calculated heart rate. Data for abnormal not clinically significant (NCS) and clinically significant (CS) ECG findings are presented. CS abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. Baseline was defined as latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Safety Population
Posted
Count of Participants
Participants
Up to 3 months
ID
Title
Description
OG000
Part 1: Single Dose Placebo
Healthy participants in Part 1 received a SD of Placebo on Day 1 in either treatment Periods 1, 2, 3 and 4.
OG001
Part 1: Single Dose GSK3882347 15 mg
Healthy participants in Part 1 received a SD of GSK3882347 15 mg on Day 1 in treatment Period 3.
OG002
Part 1: Single Dose GSK3882347 50 mg
Healthy participants in Part 1 received a SD of GSK3882347 50 mg on Day 1 in treatment Period 1.
OG003
Part 1: Single Dose GSK3882347 150 mg
Healthy participants in Part 1 received a SD of GSK3882347 150 mg on Day 1 in treatment Period 2.
OG004
Part 1: Single Dose GSK3882347 250 mg
Healthy participants in Part 1 received a SD of GSK3882347 250 mg on Day 1 in treatment Period 3.
OG005
Part 1: Single Dose GSK3882347 250 mg Fed
Healthy participants in Part 1 received a SD of GSK3882347 250 mg under fed condition on Day 1 in treatment Period 4.
OG006
Part 1: Single Dose GSK3882347 500 mg
Healthy participants in Part 1 received a SD of GSK3882347 500 mg on Day 1 in treatment Period 1.
OG007
Part 1: Single Dose GSK3882347 900 mg
Healthy participants in Part 1 received a SD of GSK3882347 900 mg on Day 1 in treatment Period 2.
Units
Counts
Participants
OG00014
OG0016
OG0026
OG003
Title
Denominators
Categories
Abnormal: NCS
Title
Measurements
OG0003
OG0011
OG0021
OG003
Primary
Part 2: Number of Participants With Worst Case Abnormal ECG Results Post Baseline Relative to Baseline
A 12-lead ECG was recorded with the participant in a semi-supine position after a rest of at least 10 minutes. Twelve lead ECGs were obtained by using an automated ECG machine that measured PR, QRS, QT, and corrected QT (QTc) intervals and calculated heart rate. Data for abnormal not clinically significant (NCS) and clinically significant (CS) ECG findings are presented. CS abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. Baseline was defined as latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Safety Population.
Posted
Count of Participants
Participants
Up to 26 days
ID
Title
Description
OG000
Part 2: Repeat Dose Placebo
Healthy participants in Part 2 received repeat dose (RD) of Placebo on Days 1 to 7.
OG001
Part 2: Repeat Dose GSK3882347 50 mg
Healthy participants in Part 2 received RD of GSK3882347 50 mg on Days 1 to 7.
OG002
Part 2: Repeat Dose GSK3882347 150 mg
Healthy participants in Part 2 received RD of GSK3882347 150 mg on Days 1 to 7.
OG003
Part 2: Repeat Dose GSK3882347 500 mg
Healthy participants in Part 2 received RD of GSK3882347 500 mg on Days 1 to 7.
OG004
Part 2: Repeat Dose GSK3882347 900 mg
Healthy participants in Part 2 received RD of GSK3882347 900 mg on Days 1 to 7.
Units
Counts
Participants
OG0008
OG0018
OG0028
OG003
Title
Denominators
Categories
Abnormal: NCS
Title
Measurements
OG0003
OG0013
OG0026
OG003
Primary
Part 1: Area Under the Concentration-time Curve From Time Zero to 24 Hours (AUC[0-24]) After Single Dose Administration of GSK3882347
Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis of GSK3882347. PK parameters were analyzed using standard non-compartmental analysis.
PK Population comprised of all participants in the safety population who had at least 1 non-missing PK assessment.
Posted
Geometric Mean
Geometric Coefficient of Variation
Hours*nanograms per milliliter
Pre-dose, 15, 30 minutes, 1, 1.5, 2, 4, 6, 8, 12, 16 and 24 hours post-dose in each treatment period
ID
Title
Description
OG000
Part 1: Single Dose GSK3882347 15 mg
Healthy participants in Part 1 received a SD of GSK3882347 15 mg on Day 1 in treatment Period 3.
OG001
Part 1: Single Dose GSK3882347 50 mg
Healthy participants in Part 1 received a SD of GSK3882347 50 mg on Day 1 in treatment Period 1.
OG002
Part 1: Single Dose GSK3882347 150 mg
Healthy participants in Part 1 received a SD of GSK3882347 150 mg on Day 1 in treatment Period 2.
OG003
Part 1: Single Dose GSK3882347 250 mg
Healthy participants in Part 1 received a SD of GSK3882347 250 mg on Day 1 in treatment Period 3.
OG004
Part 1: Single Dose GSK3882347 250 mg Fed
Healthy participants in Part 1 received a SD of GSK3882347 250 mg under fed condition on Day 1 in treatment Period 4.
OG005
Part 1: Single Dose GSK3882347 500 mg
Healthy participants in Part 1 received a SD of GSK3882347 500 mg on Day 1 in treatment Period 1.
OG006
Part 1: Single Dose GSK3882347 900 mg
Healthy participants in Part 1 received a SD of GSK3882347 900 mg on Day 1 in treatment Period 2.
Units
Counts
Participants
OG0006
OG0016
OG0026
OG003
Title
Denominators
Categories
Title
Measurements
OG0001671.7± 20.9
OG0016514.1± 12.3
OG00217717.9± 18.0
OG003
Primary
Part 1: Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUC[0-t]) After Single Dose Administration of GSK3882347
Blood samples were collected at indicated time points for PK analysis of GSK3882347. PK parameters were analyzed using standard non-compartmental analysis.
PK Population
Posted
Geometric Mean
Geometric Coefficient of Variation
Hours*nanograms per milliliter
Pre-dose, 15, 30 minutes, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 32, 48, 72 and 96 hours post-dose in each treatment period
ID
Title
Description
OG000
Part 1: Single Dose GSK3882347 15 mg
Healthy participants in Part 1 received a SD of GSK3882347 15 mg on Day 1 in treatment Period 3.
OG001
Part 1: Single Dose GSK3882347 50 mg
Healthy participants in Part 1 received a SD of GSK3882347 50 mg on Day 1 in treatment Period 1.
OG002
Part 1: Single Dose GSK3882347 150 mg
Healthy participants in Part 1 received a SD of GSK3882347 150 mg on Day 1 in treatment Period 2.
OG003
Part 1: Single Dose GSK3882347 250 mg
Healthy participants in Part 1 received a SD of GSK3882347 250 mg on Day 1 in treatment Period 3.
OG004
Part 1: Single Dose GSK3882347 250 mg Fed
Healthy participants in Part 1 received a SD of GSK3882347 250 mg under fed condition on Day 1 in treatment Period 4.
OG005
Part 1: Single Dose GSK3882347 500 mg
Healthy participants in Part 1 received a SD of GSK3882347 500 mg on Day 1 in treatment Period 1.
OG006
Part 1: Single Dose GSK3882347 900 mg
Healthy participants in Part 1 received a SD of GSK3882347 900 mg on Day 1 in treatment Period 2.
Units
Counts
Participants
OG0006
OG0016
OG0026
OG003
Title
Denominators
Categories
Title
Measurements
OG0001954.3± 24.7
OG0018249.8± 18.2
OG00222266.9± 16.9
OG003
Primary
Part 1: Area Under the Concentration-time Curve Extrapolated From Time Zero to Infinity (AUC[0-infinity]) After Single Dose Administration of GSK3882347
Blood samples were collected at indicated time points for PK analysis of GSK3882347. PK parameters were analyzed using standard non-compartmental analysis.
PK Population
Posted
Geometric Mean
Geometric Coefficient of Variation
Hours*nanograms per milliliter
Pre-dose, 15, 30 minutes, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 32, 48, 72 and 96 hours post-dose in each treatment period
ID
Title
Description
OG000
Part 1: Single Dose GSK3882347 15 mg
Healthy participants in Part 1 received a SD of GSK3882347 15 mg on Day 1 in treatment Period 3.
OG001
Part 1: Single Dose GSK3882347 50 mg
Healthy participants in Part 1 received a SD of GSK3882347 50 mg on Day 1 in treatment Period 1.
OG002
Part 1: Single Dose GSK3882347 150 mg
Healthy participants in Part 1 received a SD of GSK3882347 150 mg on Day 1 in treatment Period 2.
OG003
Part 1: Single Dose GSK3882347 250 mg
Healthy participants in Part 1 received a SD of GSK3882347 250 mg on Day 1 in treatment Period 3.
OG004
Part 1: Single Dose GSK3882347 250 mg Fed
Healthy participants in Part 1 received a SD of GSK3882347 250 mg under fed condition on Day 1 in treatment Period 4.
OG005
Part 1: Single Dose GSK3882347 500 mg
Healthy participants in Part 1 received a SD of GSK3882347 500 mg on Day 1 in treatment Period 1.
OG006
Part 1: Single Dose GSK3882347 900 mg
Healthy participants in Part 1 received a SD of GSK3882347 900 mg on Day 1 in treatment Period 2.
Units
Counts
Participants
OG0006
OG0016
OG0026
OG003
Title
Denominators
Categories
Title
Measurements
OG0002167.0± 23.4
OG0018425.5± 18.1
OG00222433.7± 16.8
OG003
Primary
Part 1: Maximum Plasma Concentration (Cmax) After Single Dose Administration of GSK3882347
Blood samples were collected at indicated time points for PK analysis of GSK3882347. PK parameters were analyzed using standard non-compartmental analysis.
PK Population
Posted
Geometric Mean
Geometric Coefficient of Variation
Nanograms per milliliter
Pre-dose, 15, 30 minutes, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 32, 48, 72 and 96 hours post-dose in each treatment period
ID
Title
Description
OG000
Part 1: Single Dose GSK3882347 15 mg
Healthy participants in Part 1 received a SD of GSK3882347 15 mg on Day 1 in treatment Period 3.
OG001
Part 1: Single Dose GSK3882347 50 mg
Healthy participants in Part 1 received a SD of GSK3882347 50 mg on Day 1 in treatment Period 1.
OG002
Part 1: Single Dose GSK3882347 150 mg
Healthy participants in Part 1 received a SD of GSK3882347 150 mg on Day 1 in treatment Period 2.
OG003
Part 1: Single Dose GSK3882347 250 mg
Healthy participants in Part 1 received a SD of GSK3882347 250 mg on Day 1 in treatment Period 3.
OG004
Part 1: Single Dose GSK3882347 250 mg Fed
Healthy participants in Part 1 received a SD of GSK3882347 250 mg under fed condition on Day 1 in treatment Period 4.
OG005
Part 1: Single Dose GSK3882347 500 mg
Healthy participants in Part 1 received a SD of GSK3882347 500 mg on Day 1 in treatment Period 1.
OG006
Part 1: Single Dose GSK3882347 900 mg
Healthy participants in Part 1 received a SD of GSK3882347 900 mg on Day 1 in treatment Period 2.
Units
Counts
Participants
OG0006
OG0016
OG0026
OG003
Title
Denominators
Categories
Title
Measurements
OG000165.7± 22.3
OG001661.7± 14.8
OG0021825.8± 21.2
OG003
Primary
Part 1: Plasma Concentrations at 24 Hours (C24h) After Single Dose Administration of GSK3882347
Blood samples were collected at indicated time points for PK analysis of GSK3882347. PK parameters were analyzed using standard non-compartmental analysis.
PK Population
Posted
Geometric Mean
Geometric Coefficient of Variation
Nanograms per milliliter
Pre-dose, 15, 30 minutes, 1, 1.5, 2, 4, 6, 8, 12, 16 and 24 hours post-dose in each treatment period
ID
Title
Description
OG000
Part 1: Single Dose GSK3882347 15 mg
Healthy participants in Part 1 received a SD of GSK3882347 15 mg on Day 1 in treatment Period 3.
OG001
Part 1: Single Dose GSK3882347 50 mg
Healthy participants in Part 1 received a SD of GSK3882347 50 mg on Day 1 in treatment Period 1.
OG002
Part 1: Single Dose GSK3882347 150 mg
Healthy participants in Part 1 received a SD of GSK3882347 150 mg on Day 1 in treatment Period 2.
OG003
Part 1: Single Dose GSK3882347 250 mg
Healthy participants in Part 1 received a SD of GSK3882347 250 mg on Day 1 in treatment Period 3.
OG004
Part 1: Single Dose GSK3882347 250 mg Fed
Healthy participants in Part 1 received a SD of GSK3882347 250 mg under fed condition on Day 1 in treatment Period 4.
OG005
Part 1: Single Dose GSK3882347 500 mg
Healthy participants in Part 1 received a SD of GSK3882347 500 mg on Day 1 in treatment Period 1.
OG006
Part 1: Single Dose GSK3882347 900 mg
Healthy participants in Part 1 received a SD of GSK3882347 900 mg on Day 1 in treatment Period 2.
Units
Counts
Participants
OG0006
OG0016
OG0026
OG003
Title
Denominators
Categories
Title
Measurements
OG00027.32± 29.7
OG001106.70± 39.5
OG002283.18± 24.7
OG003
Primary
Part 1: Time to Cmax (Tmax) After Single Dose Administration of GSK3882347
Blood samples were collected at indicated time points for PK analysis of GSK3882347. PK parameters were analyzed using standard non-compartmental analysis.
PK Population
Posted
Median
Full Range
Hours
Pre-dose, 15, 30 minutes, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 32, 48, 72 and 96 hours post-dose in each treatment period
ID
Title
Description
OG000
Part 1: Single Dose GSK3882347 15 mg
Healthy participants in Part 1 received a SD of GSK3882347 15 mg on Day 1 in treatment Period 3.
OG001
Part 1: Single Dose GSK3882347 50 mg
Healthy participants in Part 1 received a SD of GSK3882347 50 mg on Day 1 in treatment Period 1.
OG002
Part 1: Single Dose GSK3882347 150 mg
Healthy participants in Part 1 received a SD of GSK3882347 150 mg on Day 1 in treatment Period 2.
OG003
Part 1: Single Dose GSK3882347 250 mg
Healthy participants in Part 1 received a SD of GSK3882347 250 mg on Day 1 in treatment Period 3.
OG004
Part 1: Single Dose GSK3882347 250 mg Fed
Healthy participants in Part 1 received a SD of GSK3882347 250 mg under fed condition on Day 1 in treatment Period 4.
OG005
Part 1: Single Dose GSK3882347 500 mg
Healthy participants in Part 1 received a SD of GSK3882347 500 mg on Day 1 in treatment Period 1.
OG006
Part 1: Single Dose GSK3882347 900 mg
Healthy participants in Part 1 received a SD of GSK3882347 900 mg on Day 1 in treatment Period 2.
Units
Counts
Participants
OG0006
OG0016
OG0026
OG003
Title
Denominators
Categories
Title
Measurements
OG0003.000(2.00 to 4.00)
OG0014.000(2.00 to 4.18)
OG0024.000(2.00 to 6.00)
OG003
Primary
Part 1: Lag Time for Absorption (Tlag) After Single Dose Administration of GSK3882347
Blood samples were collected at indicated time points for PK analysis of GSK3882347. PK parameters were analyzed using standard non-compartmental analysis.
PK Population
Posted
Median
Full Range
Hours
Pre-dose, 15, 30 minutes, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 32, 48, 72 and 96 hours post-dose in each treatment period
ID
Title
Description
OG000
Part 1: Single Dose GSK3882347 15 mg
Healthy participants in Part 1 received a SD of GSK3882347 15 mg on Day 1 in treatment Period 3.
OG001
Part 1: Single Dose GSK3882347 50 mg
Healthy participants in Part 1 received a SD of GSK3882347 50 mg on Day 1 in treatment Period 1.
OG002
Part 1: Single Dose GSK3882347 150 mg
Healthy participants in Part 1 received a SD of GSK3882347 150 mg on Day 1 in treatment Period 2.
OG003
Part 1: Single Dose GSK3882347 250 mg
Healthy participants in Part 1 received a SD of GSK3882347 250 mg on Day 1 in treatment Period 3.
OG004
Part 1: Single Dose GSK3882347 250 mg Fed
Healthy participants in Part 1 received a SD of GSK3882347 250 mg under fed condition on Day 1 in treatment Period 4.
OG005
Part 1: Single Dose GSK3882347 500 mg
Healthy participants in Part 1 received a SD of GSK3882347 500 mg on Day 1 in treatment Period 1.
OG006
Part 1: Single Dose GSK3882347 900 mg
Healthy participants in Part 1 received a SD of GSK3882347 900 mg on Day 1 in treatment Period 2.
Units
Counts
Participants
OG0006
OG0016
OG0026
OG003
Title
Denominators
Categories
Title
Measurements
OG0000.375(0.25 to 0.50)
OG0010.250(0 to 0.50)
OG0020.250(0 to 0.50)
OG003
Primary
Part 1: Terminal Elimination Half-life (T1/2) After Single Dose Administration of GSK3882347
Blood samples were collected at indicated time points for PK analysis of GSK3882347. PK parameters were analyzed using standard non-compartmental analysis.
PK Population
Posted
Geometric Mean
Geometric Coefficient of Variation
Hours
Pre-dose, 15, 30 minutes, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 32, 48, 72 and 96 hours post-dose in each treatment period
ID
Title
Description
OG000
Part 1: Single Dose GSK3882347 15 mg
Healthy participants in Part 1 received a SD of GSK3882347 15 mg on Day 1 in treatment Period 3.
OG001
Part 1: Single Dose GSK3882347 50 mg
Healthy participants in Part 1 received a SD of GSK3882347 50 mg on Day 1 in treatment Period 1.
OG002
Part 1: Single Dose GSK3882347 150 mg
Healthy participants in Part 1 received a SD of GSK3882347 150 mg on Day 1 in treatment Period 2.
OG003
Part 1: Single Dose GSK3882347 250 mg
Healthy participants in Part 1 received a SD of GSK3882347 250 mg on Day 1 in treatment Period 3.
OG004
Part 1: Single Dose GSK3882347 250 mg Fed
Healthy participants in Part 1 received a SD of GSK3882347 250 mg under fed condition on Day 1 in treatment Period 4.
OG005
Part 1: Single Dose GSK3882347 500 mg
Healthy participants in Part 1 received a SD of GSK3882347 500 mg on Day 1 in treatment Period 1.
OG006
Part 1: Single Dose GSK3882347 900 mg
Healthy participants in Part 1 received a SD of GSK3882347 900 mg on Day 1 in treatment Period 2.
Units
Counts
Participants
OG0006
OG0016
OG0026
OG003
Title
Denominators
Categories
Title
Measurements
OG00011.407± 17.7
OG00112.269± 14.5
OG00211.538± 10.1
OG003
Primary
Part 2: Area Under the Concentration-time Curve Over the Dosing Interval Tau (AUC[0-tau]) After Repeat Dose Administration of GSK3882347
Blood samples were collected at indicated time points for PK analysis of GSK3882347. PK parameters were analyzed using standard non-compartmental analysis.
PK Population
Posted
Geometric Mean
Geometric Coefficient of Variation
Hours*nanograms per milliliter
Days 1 and 7: Pre-dose, 15, 30 minutes, 1, 1.5, 2, 4, 6, 8, 12, 16, 24 hours post-dose
ID
Title
Description
OG000
Part 2: Repeat Dose GSK3882347 50 mg
Healthy participants in Part 2 received RD of GSK3882347 50 mg on Days 1 to 7.
OG001
Part 2: Repeat Dose GSK3882347 150 mg
Healthy participants in Part 2 received RD of GSK3882347 150 mg on Days 1 to 7.
OG002
Part 2: Repeat Dose GSK3882347 500 mg
Healthy participants in Part 2 received RD of GSK3882347 500 mg on Days 1 to 7.
OG003
Part 2: Repeat Dose GSK3882347 900 mg
Healthy participants in Part 2 received RD of GSK3882347 900 mg on Days 1 to 7.
Units
Counts
Participants
OG0008
OG0018
OG0028
OG003
Title
Denominators
Categories
Day 1
Title
Measurements
OG0005862.9± 16.2
OG00120191.4± 25.6
OG00245400.0± 38.8
OG003
Primary
Part 2: Cmax After Repeat Dose Administration of GSK3882347
Blood samples were collected at indicated time points for PK analysis of GSK3882347. PK parameters were analyzed using standard non-compartmental analysis.
PK Population
Posted
Geometric Mean
Geometric Coefficient of Variation
Nanograms per milliliter
Days 1 and 7: Pre-dose, 15, 30 minutes, 1, 1.5, 2, 4, 6, 8, 12, 16, 24 hours post-dose
ID
Title
Description
OG000
Part 2: Repeat Dose GSK3882347 50 mg
Healthy participants in Part 2 received RD of GSK3882347 50 mg on Days 1 to 7.
OG001
Part 2: Repeat Dose GSK3882347 150 mg
Healthy participants in Part 2 received RD of GSK3882347 150 mg on Days 1 to 7.
OG002
Part 2: Repeat Dose GSK3882347 500 mg
Healthy participants in Part 2 received RD of GSK3882347 500 mg on Days 1 to 7.
OG003
Part 2: Repeat Dose GSK3882347 900 mg
Healthy participants in Part 2 received RD of GSK3882347 900 mg on Days 1 to 7.
Units
Counts
Participants
OG0008
OG0018
OG0028
OG003
Title
Denominators
Categories
Day 1
Title
Measurements
OG000586.0± 20.8
OG0012179.1± 29.5
OG0024409.4± 34.2
OG003
Primary
Part 2: Tmax After Repeat Dose Administration of GSK3882347
Blood samples were collected at indicated time points for PK analysis of GSK3882347. PK parameters were analyzed using standard non-compartmental analysis.
PK Population
Posted
Median
Full Range
Hours
Days 1 and 7: Pre-dose, 15, 30 minutes, 1, 1.5, 2, 4, 6, 8, 12, 16, 24 hours post-dose
ID
Title
Description
OG000
Part 2: Repeat Dose GSK3882347 50 mg
Healthy participants in Part 2 received RD of GSK3882347 50 mg on Days 1 to 7.
OG001
Part 2: Repeat Dose GSK3882347 150 mg
Healthy participants in Part 2 received RD of GSK3882347 150 mg on Days 1 to 7.
OG002
Part 2: Repeat Dose GSK3882347 500 mg
Healthy participants in Part 2 received RD of GSK3882347 500 mg on Days 1 to 7.
OG003
Part 2: Repeat Dose GSK3882347 900 mg
Healthy participants in Part 2 received RD of GSK3882347 900 mg on Days 1 to 7.
Units
Counts
Participants
OG0008
OG0018
OG0028
OG0038
Title
Denominators
Categories
Day 1
Title
Measurements
OG0004.000(2.00 to 6.00)
OG0013.000(1.50 to 4.00)
OG0024.000(4.00 to 6.00)
OG003
Primary
Part 2: Plasma Concentrations Over the Dosing Interval (Ctau) After Repeat Dose Administration of GSK3882347
Blood samples were collected at indicated time points for PK analysis of GSK3882347. PK parameters were analyzed using standard non-compartmental analysis.
PK Population
Posted
Geometric Mean
Geometric Coefficient of Variation
Nanograms per milliliter
Days 1 and 7: Pre-dose, 15, 30 minutes, 1, 1.5, 2, 4, 6, 8, 12, 16, 24 hours post-dose
ID
Title
Description
OG000
Part 2: Repeat Dose GSK3882347 50 mg
Healthy participants in Part 2 received RD of GSK3882347 50 mg on Days 1 to 7.
OG001
Part 2: Repeat Dose GSK3882347 150 mg
Healthy participants in Part 2 received RD of GSK3882347 150 mg on Days 1 to 7.
OG002
Part 2: Repeat Dose GSK3882347 500 mg
Healthy participants in Part 2 received RD of GSK3882347 500 mg on Days 1 to 7.
OG003
Part 2: Repeat Dose GSK3882347 900 mg
Healthy participants in Part 2 received RD of GSK3882347 900 mg on Days 1 to 7.
Units
Counts
Participants
OG0008
OG0018
OG0028
OG003
Title
Denominators
Categories
Day 1
Title
Measurements
OG00090.98± 46.8
OG001292.53± 22.2
OG002789.85± 46.7
OG003
Primary
Part 1: Urine Concentration Between 22-24 Hours (C22-24) After Single Dose Administration of GSK3882347
Urine samples were collected at indicated time points for PK analysis of GSK3882347. PK parameters were analyzed using standard non-compartmental analysis.
PK Population
Posted
Geometric Mean
Geometric Coefficient of Variation
Micrograms per milliliter
Day 1: 22-24 hours post-dose in each treatment period
ID
Title
Description
OG000
Part 1: Single Dose GSK3882347 15 mg
Healthy participants in Part 1 received a SD of GSK3882347 15 mg on Day 1 in treatment Period 3.
OG001
Part 1: Single Dose GSK3882347 50 mg
Healthy participants in Part 1 received a SD of GSK3882347 50 mg on Day 1 in treatment Period 1.
OG002
Part 1: Single Dose GSK3882347 150 mg
Healthy participants in Part 1 received a SD of GSK3882347 150 mg on Day 1 in treatment Period 2.
OG003
Part 1: Single Dose GSK3882347 250 mg
Healthy participants in Part 1 received a SD of GSK3882347 250 mg on Day 1 in treatment Period 3.
OG004
Part 1: Single Dose GSK3882347 250 mg Fed
Healthy participants in Part 1 received a SD of GSK3882347 250 mg under fed condition on Day 1 in treatment Period 4.
OG005
Part 1: Single Dose GSK3882347 500 mg
Healthy participants in Part 1 received a SD of GSK3882347 500 mg on Day 1 in treatment Period 1.
OG006
Part 1: Single Dose GSK3882347 900 mg
Healthy participants in Part 1 received a SD of GSK3882347 900 mg on Day 1 in treatment Period 2.
Units
Counts
Participants
OG0006
OG0016
OG0026
OG003
Title
Denominators
Categories
Title
Measurements
OG0001.55± 71.3
OG0012.99± 95.9
OG00211.27± 146.7
OG003
Primary
Part 2: Urine Concentration Between 22-24 Hours (C22-24) After Repeat Dose Administration of GSK3882347
Urine samples were collected at indicated time points for PK analysis of GSK3882347. PK parameters were analyzed using standard non-compartmental analysis.
PK Population
Posted
Geometric Mean
Geometric Coefficient of Variation
Micrograms per milliliter
Day 1 and Day 7: 22-24 hours post-dose
ID
Title
Description
OG000
Part 2: Repeat Dose GSK3882347 50 mg
Healthy participants in Part 2 received RD of GSK3882347 50 mg on Days 1 to 7.
OG001
Part 2: Repeat Dose GSK3882347 150 mg
Healthy participants in Part 2 received RD of GSK3882347 150 mg on Days 1 to 7.
OG002
Part 2: Repeat Dose GSK3882347 500 mg
Healthy participants in Part 2 received RD of GSK3882347 500 mg on Days 1 to 7.
OG003
Part 2: Repeat Dose GSK3882347 900 mg
Healthy participants in Part 2 received RD of GSK3882347 900 mg on Days 1 to 7.
Units
Counts
Participants
OG0008
OG0018
OG0028
OG003
Title
Denominators
Categories
Day 1
Title
Measurements
OG0002.95± 52.5
OG00111.98± 64.8
OG00218.15± 42.8
OG003
Primary
Part 1: Amount of Drug Excreted in Urine of Unchanged Drug (Ae Total) After Single Dose Administration of GSK3882347
Urine samples were collected at indicated time points for PK analysis of GSK3882347. PK parameters were analyzed using standard non-compartmental analysis.
PK Population
Posted
Geometric Mean
Geometric Coefficient of Variation
Milligrams
At 0-2, 2-4, 4-6, 6-8, 8-10, 10-12, 12-22, 22-24, 24-26, 26-32, 32-38, 38-48, 48-60, 60-72, 72-84, 84-96 hours post-dose in each treatment period
ID
Title
Description
OG000
Part 1: Single Dose GSK3882347 15 mg
Healthy participants in Part 1 received a SD of GSK3882347 15 mg on Day 1 in treatment Period 3.
OG001
Part 1: Single Dose GSK3882347 50 mg
Healthy participants in Part 1 received a SD of GSK3882347 50 mg on Day 1 in treatment Period 1.
OG002
Part 1: Single Dose GSK3882347 150 mg
Healthy participants in Part 1 received a SD of GSK3882347 150 mg on Day 1 in treatment Period 2.
OG003
Part 1: Single Dose GSK3882347 250 mg
Healthy participants in Part 1 received a SD of GSK3882347 250 mg on Day 1 in treatment Period 3.
OG004
Part 1: Single Dose GSK3882347 250 mg Fed
Healthy participants in Part 1 received a SD of GSK3882347 250 mg under fed condition on Day 1 in treatment Period 4.
OG005
Part 1: Single Dose GSK3882347 500 mg
Healthy participants in Part 1 received a SD of GSK3882347 500 mg on Day 1 in treatment Period 1.
OG006
Part 1: Single Dose GSK3882347 900 mg
Healthy participants in Part 1 received a SD of GSK3882347 900 mg on Day 1 in treatment Period 2.
Units
Counts
Participants
OG0006
OG0016
OG0026
OG003
Title
Denominators
Categories
Title
Measurements
OG00011.16± 15.7
OG00132.01± 9.4
OG002106.86± 25.5
OG003
Primary
Part 2: Amount of Drug Excreted in Urine of Unchanged Drug (Ae Total) After Repeat Dose Administration of GSK3882347
Urine samples were collected at indicated time points for PK analysis of GSK3882347. PK parameters were analyzed using standard non-compartmental analysis.
PK Population
Posted
Geometric Mean
Geometric Coefficient of Variation
Milligrams
Days 1 and 7: At 0-2, 2-4, 4-6, 6-8, 8-10, 10-12, 12-22, 22-24 hours post-dose
ID
Title
Description
OG000
Part 2: Repeat Dose GSK3882347 50 mg
Healthy participants in Part 2 received RD of GSK3882347 50 mg on Days 1 to 7.
OG001
Part 2: Repeat Dose GSK3882347 150 mg
Healthy participants in Part 2 received RD of GSK3882347 150 mg on Days 1 to 7.
OG002
Part 2: Repeat Dose GSK3882347 500 mg
Healthy participants in Part 2 received RD of GSK3882347 500 mg on Days 1 to 7.
OG003
Part 2: Repeat Dose GSK3882347 900 mg
Healthy participants in Part 2 received RD of GSK3882347 900 mg on Days 1 to 7.
Units
Counts
Participants
OG0008
OG0018
OG0028
OG003
Title
Denominators
Categories
Day 1
Title
Measurements
OG00024.77± 17.6
OG00188.30± 14.2
OG002188.49± 32.5
OG003
Primary
Part 1: Percentage of the Given Dose of Drug Excreted in Urine (%fe Total) After Single Dose Administration of GSK3882347
Urine samples were collected at indicated time points for PK analysis of GSK3882347. PK parameters were analyzed using standard non-compartmental analysis. %fe was calculated as: (Ae total/Dose)*100 percent (%).
PK Population
Posted
Geometric Mean
Geometric Coefficient of Variation
Percent dose excreted
At 0-2, 2-4, 4-6, 6-8, 8-10, 10-12, 12-22, 22-24, 24-26, 26-32, 32-38, 38-48, 48-60, 60-72, 72-84, 84-96 hours post-dose in each treatment period
ID
Title
Description
OG000
Part 1: Single Dose GSK3882347 15 mg
Healthy participants in Part 1 received a SD of GSK3882347 15 mg on Day 1 in treatment Period 3.
OG001
Part 1: Single Dose GSK3882347 50 mg
Healthy participants in Part 1 received a SD of GSK3882347 50 mg on Day 1 in treatment Period 1.
OG002
Part 1: Single Dose GSK3882347 150 mg
Healthy participants in Part 1 received a SD of GSK3882347 150 mg on Day 1 in treatment Period 2.
OG003
Part 1: Single Dose GSK3882347 250 mg
Healthy participants in Part 1 received a SD of GSK3882347 250 mg on Day 1 in treatment Period 3.
OG004
Part 1: Single Dose GSK3882347 250 mg Fed
Healthy participants in Part 1 received a SD of GSK3882347 250 mg under fed condition on Day 1 in treatment Period 4.
OG005
Part 1: Single Dose GSK3882347 500 mg
Healthy participants in Part 1 received a SD of GSK3882347 500 mg on Day 1 in treatment Period 1.
OG006
Part 1: Single Dose GSK3882347 900 mg
Healthy participants in Part 1 received a SD of GSK3882347 900 mg on Day 1 in treatment Period 2.
Units
Counts
Participants
OG0006
OG0016
OG0026
OG003
Title
Denominators
Categories
Title
Measurements
OG00074.43± 15.7
OG00164.02± 9.4
OG00271.24± 25.5
OG003
Primary
Part 2: Percentage of the Given Dose of Drug Excreted in Urine (%fe Total) After Single Dose Administration of GSK3882347
Urine samples were collected at indicated time points for PK analysis of GSK3882347. PK parameters were analyzed using standard non-compartmental analysis. %fe was calculated as: (Ae total/Dose)*100%.
PK Population
Posted
Geometric Mean
Geometric Coefficient of Variation
Percent dose excreted
Day 1 and Day 7: At 0-2, 2-4, 4-6, 6-8, 8-10, 10-12, 12-22, 22-24 hours post-dose
ID
Title
Description
OG000
Part 2: Repeat Dose GSK3882347 50 mg
Healthy participants in Part 2 received RD of GSK3882347 50 mg on Days 1 to 7.
OG001
Part 2: Repeat Dose GSK3882347 150 mg
Healthy participants in Part 2 received RD of GSK3882347 150 mg on Days 1 to 7.
OG002
Part 2: Repeat Dose GSK3882347 500 mg
Healthy participants in Part 2 received RD of GSK3882347 500 mg on Days 1 to 7.
OG003
Part 2: Repeat Dose GSK3882347 900 mg
Healthy participants in Part 2 received RD of GSK3882347 900 mg on Days 1 to 7.
Units
Counts
Participants
OG0008
OG0018
OG0028
OG003
Title
Denominators
Categories
Day 1
Title
Measurements
OG00049.54± 17.6
OG00158.87± 14.2
OG00237.70± 32.5
OG003
Primary
Part 1: Renal Clearance of Drug (CLr) After Single Dose Administration of GSK3882347
Urine samples were collected at indicated time points for PK analysis of GSK3882347. PK parameters were analyzed using standard non-compartmental analysis. CLr was calculated as: Ae total/AUC(0-t)
PK Population
Posted
Geometric Mean
Geometric Coefficient of Variation
Liters per hour
At 0-2, 2-4, 4-6, 6-8, 8-10, 10-12, 12-22, 22-24, 24-26, 26-32, 32-38, 38-48, 48-60, 60-72, 72-84, 84-96 hours post-dose in each treatment period
ID
Title
Description
OG000
Part 1: Single Dose GSK3882347 15 mg
Healthy participants in Part 1 received a SD of GSK3882347 15 mg on Day 1 in treatment Period 3.
OG001
Part 1: Single Dose GSK3882347 50 mg
Healthy participants in Part 1 received a SD of GSK3882347 50 mg on Day 1 in treatment Period 1.
OG002
Part 1: Single Dose GSK3882347 150 mg
Healthy participants in Part 1 received a SD of GSK3882347 150 mg on Day 1 in treatment Period 2.
OG003
Part 1: Single Dose GSK3882347 250 mg
Healthy participants in Part 1 received a SD of GSK3882347 250 mg on Day 1 in treatment Period 3.
OG004
Part 1: Single Dose GSK3882347 250 mg Fed
Healthy participants in Part 1 received a SD of GSK3882347 250 mg under fed condition on Day 1 in treatment Period 4.
OG005
Part 1: Single Dose GSK3882347 500 mg
Healthy participants in Part 1 received a SD of GSK3882347 500 mg on Day 1 in treatment Period 1.
OG006
Part 1: Single Dose GSK3882347 900 mg
Healthy participants in Part 1 received a SD of GSK3882347 900 mg on Day 1 in treatment Period 2.
Units
Counts
Participants
OG0006
OG0016
OG0026
OG003
Title
Denominators
Categories
Title
Measurements
OG0005.71± 31.7
OG0013.88± 25.8
OG0024.80± 30.9
OG003
Primary
Part 2: Renal Clearance of Drug (CLr) After Repeat Dose Administration of GSK3882347
Urine samples were collected at indicated time points for PK analysis of GSK3882347. PK parameters were analyzed using standard non-compartmental analysis. CLr was calculated as: Ae total/AUC(0-t).
PK Population
Posted
Geometric Mean
Geometric Coefficient of Variation
Liters per hour
Day 1 and Day 7: At 0-2, 2-4, 4-6, 6-8, 8-10, 10-12, 12-22, 22-24 hours post-dose
ID
Title
Description
OG000
Part 2: Repeat Dose GSK3882347 50 mg
Healthy participants in Part 2 received RD of GSK3882347 50 mg on Days 1 to 7.
OG001
Part 2: Repeat Dose GSK3882347 150 mg
Healthy participants in Part 2 received RD of GSK3882347 150 mg on Days 1 to 7.
OG002
Part 2: Repeat Dose GSK3882347 500 mg
Healthy participants in Part 2 received RD of GSK3882347 500 mg on Days 1 to 7.
OG003
Part 2: Repeat Dose GSK3882347 900 mg
Healthy participants in Part 2 received RD of GSK3882347 900 mg on Days 1 to 7.
Units
Counts
Participants
OG0008
OG0018
OG0028
OG003
Title
Denominators
Categories
Day 1
Title
Measurements
OG0004.24± 20.8
OG0014.38± 28.6
OG0024.16± 28.7
OG003
Secondary
Part 1: Area Under the Concentration-time Curve From Time Zero to 12 Hours (AUC[0-12]) After Single Dose Administration of GSK3882347
Blood samples were collected at indicated time points for PK analysis of GSK3882347. PK parameters were analyzed using standard non-compartmental analysis.
PK Population
Posted
Geometric Mean
Geometric Coefficient of Variation
Hours*nanogram per milliliter
Pre-dose, 15, 30 minutes, 1, 1.5, 2, 4, 6, 8 and 12 hours post-dose in each treatment period
ID
Title
Description
OG000
Part 1: Single Dose GSK3882347 15 mg
Healthy participants in Part 1 received a SD of GSK3882347 15 mg on Day 1 in treatment Period 3.
OG001
Part 1: Single Dose GSK3882347 50 mg
Healthy participants in Part 1 received a SD of GSK3882347 50 mg on Day 1 in treatment Period 1.
OG002
Part 1: Single Dose GSK3882347 150 mg
Healthy participants in Part 1 received a SD of GSK3882347 150 mg on Day 1 in treatment Period 2.
OG003
Part 1: Single Dose GSK3882347 250 mg
Healthy participants in Part 1 received a SD of GSK3882347 250 mg on Day 1 in treatment Period 3.
OG004
Part 1: Single Dose GSK3882347 250 mg Fed
Healthy participants in Part 1 received a SD of GSK3882347 250 mg under fed condition on Day 1 in treatment Period 4.
OG005
Part 1: Single Dose GSK3882347 500 mg
Healthy participants in Part 1 received a SD of GSK3882347 500 mg on Day 1 in treatment Period 1.
OG006
Part 1: Single Dose GSK3882347 900 mg
Healthy participants in Part 1 received a SD of GSK3882347 900 mg on Day 1 in treatment Period 2.
Units
Counts
Participants
OG0006
OG0016
OG0026
OG003
Title
Denominators
Categories
Title
Measurements
OG0001181.6± 20.3
OG0014609.1± 10.2
OG00212519.7± 19.7
OG003
Secondary
Part 1: Plasma Concentrations at 12 Hours (C12) After Single Dose Administration of GSK3882347
Blood samples were collected at indicated time points for PK analysis of GSK3882347. PK parameters were analyzed using standard non-compartmental analysis.
PK Population
Posted
Geometric Mean
Geometric Coefficient of Variation
Nanograms per milliliter
Pre-dose, 15, 30 minutes, 1, 1.5, 2, 4, 6, 8 and 12 hours post-dose in each treatment period
ID
Title
Description
OG000
Part 1: Single Dose GSK3882347 15 mg
Healthy participants in Part 1 received a SD of GSK3882347 15 mg on Day 1 in treatment Period 3.
OG001
Part 1: Single Dose GSK3882347 50 mg
Healthy participants in Part 1 received a SD of GSK3882347 50 mg on Day 1 in treatment Period 1.
OG002
Part 1: Single Dose GSK3882347 150 mg
Healthy participants in Part 1 received a SD of GSK3882347 150 mg on Day 1 in treatment Period 2.
OG003
Part 1: Single Dose GSK3882347 250 mg
Healthy participants in Part 1 received a SD of GSK3882347 250 mg on Day 1 in treatment Period 3.
OG004
Part 1: Single Dose GSK3882347 250 mg Fed
Healthy participants in Part 1 received a SD of GSK3882347 250 mg under fed condition on Day 1 in treatment Period 4.
OG005
Part 1: Single Dose GSK3882347 500 mg
Healthy participants in Part 1 received a SD of GSK3882347 500 mg on Day 1 in treatment Period 1.
OG006
Part 1: Single Dose GSK3882347 900 mg
Healthy participants in Part 1 received a SD of GSK3882347 900 mg on Day 1 in treatment Period 2.
Units
Counts
Participants
OG0006
OG0016
OG0026
OG003
Title
Denominators
Categories
Title
Measurements
OG00058.73± 26.7
OG001232.96± 17.1
OG002636.41± 18.5
OG003
Secondary
Part 1: Apparent Oral Clearance (CL/F) After Single Dose Administration of GSK3882347
Blood samples were collected at indicated time points for PK analysis of GSK3882347. PK parameters were analyzed using standard non-compartmental analysis.
PK Population
Posted
Geometric Mean
Geometric Coefficient of Variation
Liters per hour
Pre-dose, 15, 30 minutes, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 32, 48, 72 and 96 hours post-dose in each treatment period
ID
Title
Description
OG000
Part 1: Single Dose GSK3882347 15 mg
Healthy participants in Part 1 received a SD of GSK3882347 15 mg on Day 1 in treatment Period 3.
OG001
Part 1: Single Dose GSK3882347 50 mg
Healthy participants in Part 1 received a SD of GSK3882347 50 mg on Day 1 in treatment Period 1.
OG002
Part 1: Single Dose GSK3882347 150 mg
Healthy participants in Part 1 received a SD of GSK3882347 150 mg on Day 1 in treatment Period 2.
OG003
Part 1: Single Dose GSK3882347 250 mg
Healthy participants in Part 1 received a SD of GSK3882347 250 mg on Day 1 in treatment Period 3.
OG004
Part 1: Single Dose GSK3882347 250 mg Fed
Healthy participants in Part 1 received a SD of GSK3882347 250 mg under fed condition on Day 1 in treatment Period 4.
OG005
Part 1: Single Dose GSK3882347 500 mg
Healthy participants in Part 1 received a SD of GSK3882347 500 mg on Day 1 in treatment Period 1.
OG006
Part 1: Single Dose GSK3882347 900 mg
Healthy participants in Part 1 received a SD of GSK3882347 900 mg on Day 1 in treatment Period 2.
Units
Counts
Participants
OG0006
OG0016
OG0026
OG003
Title
Denominators
Categories
Title
Measurements
OG0006.92± 23.4
OG0015.93± 18.1
OG0026.69± 16.8
OG003
Secondary
Part 1: Apparent Volume of Distribution After Oral Administration (Vz/F) After Single Dose Administration of GSK3882347
Blood samples were collected at indicated time points for PK analysis of GSK3882347. PK parameters were analyzed using standard non-compartmental analysis.
PK Population
Posted
Geometric Mean
Geometric Coefficient of Variation
Liters
Pre-dose, 15, 30 minutes, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 32, 48, 72 and 96 hours post-dose in each treatment period
ID
Title
Description
OG000
Part 1: Single Dose GSK3882347 15 mg
Healthy participants in Part 1 received a SD of GSK3882347 15 mg on Day 1 in treatment Period 3.
OG001
Part 1: Single Dose GSK3882347 50 mg
Healthy participants in Part 1 received a SD of GSK3882347 50 mg on Day 1 in treatment Period 1.
OG002
Part 1: Single Dose GSK3882347 150 mg
Healthy participants in Part 1 received a SD of GSK3882347 150 mg on Day 1 in treatment Period 2.
OG003
Part 1: Single Dose GSK3882347 250 mg
Healthy participants in Part 1 received a SD of GSK3882347 250 mg on Day 1 in treatment Period 3.
OG004
Part 1: Single Dose GSK3882347 250 mg Fed
Healthy participants in Part 1 received a SD of GSK3882347 250 mg under fed condition on Day 1 in treatment Period 4.
OG005
Part 1: Single Dose GSK3882347 500 mg
Healthy participants in Part 1 received a SD of GSK3882347 500 mg on Day 1 in treatment Period 1.
OG006
Part 1: Single Dose GSK3882347 900 mg
Healthy participants in Part 1 received a SD of GSK3882347 900 mg on Day 1 in treatment Period 2.
Units
Counts
Participants
OG0006
OG0016
OG0026
OG003
Title
Denominators
Categories
Title
Measurements
OG000113.92± 22.8
OG001105.04± 6.7
OG002111.30± 22.7
OG003
Secondary
Part 1: Mean Residence Time (MRT) After Single Dose Administration of GSK3882347
Blood samples were collected at indicated time points for PK analysis of GSK3882347. PK parameters were analyzed using standard non-compartmental analysis.
PK Population
Posted
Median
Full Range
Hours
Pre-dose, 15, 30 minutes, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 32, 48, 72 and 96 hours post-dose in each treatment period
ID
Title
Description
OG000
Part 1: Single Dose GSK3882347 15 mg
Healthy participants in Part 1 received a SD of GSK3882347 15 mg on Day 1 in treatment Period 3.
OG001
Part 1: Single Dose GSK3882347 50 mg
Healthy participants in Part 1 received a SD of GSK3882347 50 mg on Day 1 in treatment Period 1.
OG002
Part 1: Single Dose GSK3882347 150 mg
Healthy participants in Part 1 received a SD of GSK3882347 150 mg on Day 1 in treatment Period 2.
OG003
Part 1: Single Dose GSK3882347 250 mg
Healthy participants in Part 1 received a SD of GSK3882347 250 mg on Day 1 in treatment Period 3.
OG004
Part 1: Single Dose GSK3882347 250 mg Fed
Healthy participants in Part 1 received a SD of GSK3882347 250 mg under fed condition on Day 1 in treatment Period 4.
OG005
Part 1: Single Dose GSK3882347 500 mg
Healthy participants in Part 1 received a SD of GSK3882347 500 mg on Day 1 in treatment Period 1.
OG006
Part 1: Single Dose GSK3882347 900 mg
Healthy participants in Part 1 received a SD of GSK3882347 900 mg on Day 1 in treatment Period 2.
Units
Counts
Participants
OG0006
OG0016
OG0026
OG003
Title
Denominators
Categories
Title
Measurements
OG00015.775(12.76 to 23.46)
OG00116.843(12.45 to 19.61)
OG00215.614(13.38 to 19.62)
OG003
Secondary
Part 2: Area Under the Concentration-time Curve From Time Zero to 12 Hours (AUC[0-12]) After Repeat Dose Administration of GSK3882347
Blood samples were collected at indicated time points for PK analysis of GSK3882347. PK parameters were analyzed using standard non-compartmental analysis.
PK Population
Posted
Geometric Mean
Geometric Coefficient of Variation
Hours*nanogram per milliliter
Days 1 and 7: Pre-dose, 15, 30 minutes, 1, 1.5, 2, 4, 6, 8 and 12 hours post-dose
ID
Title
Description
OG000
Part 2: Repeat Dose GSK3882347 50 mg
Healthy participants in Part 2 received RD of GSK3882347 50 mg on Days 1 to 7.
OG001
Part 2: Repeat Dose GSK3882347 150 mg
Healthy participants in Part 2 received RD of GSK3882347 150 mg on Days 1 to 7.
OG002
Part 2: Repeat Dose GSK3882347 500 mg
Healthy participants in Part 2 received RD of GSK3882347 500 mg on Days 1 to 7.
OG003
Part 2: Repeat Dose GSK3882347 900 mg
Healthy participants in Part 2 received RD of GSK3882347 900 mg on Days 1 to 7.
Units
Counts
Participants
OG0008
OG0018
OG0028
OG003
Title
Denominators
Categories
Day 1
Title
Measurements
OG0004076.3± 16.4
OG00114411.9± 28.9
OG00230660.3± 37.1
OG003
Secondary
Part 2: Plasma Concentrations at 12 Hours (C12) After Repeat Dose Administration of GSK3882347
Blood samples were collected at indicated time points for PK analysis of GSK3882347. PK parameters were analyzed using standard non-compartmental analysis.
PK Population
Posted
Geometric Mean
Geometric Coefficient of Variation
Nanograms per milliliter
Days 1 and 7: Pre-dose, 15, 30 minutes, 1, 1.5, 2, 4, 6, 8 and 12 hours post-dose
ID
Title
Description
OG000
Part 2: Repeat Dose GSK3882347 50 mg
Healthy participants in Part 2 received RD of GSK3882347 50 mg on Days 1 to 7.
OG001
Part 2: Repeat Dose GSK3882347 150 mg
Healthy participants in Part 2 received RD of GSK3882347 150 mg on Days 1 to 7.
OG002
Part 2: Repeat Dose GSK3882347 500 mg
Healthy participants in Part 2 received RD of GSK3882347 500 mg on Days 1 to 7.
OG003
Part 2: Repeat Dose GSK3882347 900 mg
Healthy participants in Part 2 received RD of GSK3882347 900 mg on Days 1 to 7.
Units
Counts
Participants
OG0008
OG0018
OG0028
OG003
Title
Denominators
Categories
Day 1
Title
Measurements
OG000214.4± 23.5
OG001709.1± 19.9
OG0021704.8± 42.1
OG003
Secondary
Part 1: Dose Proportionality of GSK3882347 for Dose Levels 15 mg to 900 mg Using AUC(0-infinity) After Single Dose Administration of GSK3882347 Under Fasted Condition
Blood samples were collected at indicated time points for PK analysis of GSK3882347. PK parameters were analyzed using standard non-compartmental analysis. Dose proportionality was assessed using Power model. Log-e(dose) was fitted as fixed effect and participant was fitted as random effect. Kenward and Roger method and unstructured covariance structure was used. Slope and 90% confidence interval (CI) for the slope are presented. The SD 250 mg fed treatment was not considered in the analysis.
PK Population. Only those participants with data available at the specified data points were analyzed. The dose proportionality was assessed for doses administered under fasted conditions only. Being a FTIH study, the impact of food on drug PK was unknown; hence it would have been inaccurate to include fed arm in dose proportionality assessment in this FTIH study. Therefore, 250 mg fed arm was not considered in dose proportionality assessment
Posted
Number
90% Confidence Interval
Slope of log dose
Pre-dose, 15, 30 minutes, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 32, 48, 72 and 96 hours post-dose in each treatment period
ID
Title
Description
OG000
Part 1: GSK3882347 SD 15 mg to 900 mg
Healthy participants were administered single dose of GSK3882347 15 mg, 50 mg, 150 mg, 250 mg, 500 mg and 900 mg under fasted condition in either of treatment Period 1, 2, 3 or 4 according to randomization schedule
Units
Counts
Participants
OG00019
Title
Denominators
Categories
Title
Measurements
OG0000.919(0.889 to 0.949)
Secondary
Part 1: Dose Proportionality of GSK3882347 for Dose Levels 15 mg to 900 mg Using Cmax After Single Dose Administration of GSK3882347 Under Fasted Condition
Blood samples were collected at indicated time points for PK analysis of GSK3882347. PK parameters were analyzed using standard non-compartmental analysis. Dose proportionality was assessed using Power model. Log-e(dose) was fitted as fixed effect and participant was fitted as random effect. Kenward and Roger method and unstructured covariance structure was used. Slope and 90% CI for the slope are presented. The SD 250 mg fed treatment was not considered in the analysis.
PK Population. Only those participants with data available at the specified data points were analyzed. The dose proportionality was assessed for doses administered under fasted conditions only. Being a FTIH study, the impact of food on drug PK was unknown; hence it would have been inaccurate to include fed arm in dose proportionality assessment in this FTIH study. Therefore, 250 mg fed arm was not considered in dose proportionality assessment
Posted
Number
90% Confidence Interval
Slope of log dose
Pre-dose, 15, 30 minutes, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 32, 48, 72 and 96 hours post-dose in each treatment period
ID
Title
Description
OG000
Part 1: GSK3882347 SD 15 mg to 900 mg
Healthy participants were administered single dose of GSK3882347 15 mg, 50 mg, 150 mg, 250 mg, 500 mg and 900 mg under fasted condition in either of Treatment period 1, 2, 3 or 4 according to randomization schedule
Units
Counts
Participants
OG00019
Title
Denominators
Categories
Title
Measurements
OG0000.903(0.865 to 0.941)
Secondary
Part 2: Dose Proportionality of GSK3882347 for Dose Levels 50 mg to 900 mg Using AUC(0-tau) After Repeat Dose Administration of GSK3882347
Blood samples were collected at indicated time points for PK analysis of GSK3882347. PK parameters were analyzed using standard non-compartmental analysis. Dose proportionality was assessed using Power model. Log-e(dose) was fitted as fixed effect and participant was fitted as random effect. Kenward and Roger method and unstructured covariance structure was used. Slope and 90% CI for the slope are presented.
PK Population. Only those participants with data available at the specified data points were analyzed.
Posted
Number
90% Confidence Interval
Slope of log dose
Day 1 and Day 7: Pre-dose, 15, 30 minutes, 1, 1.5, 2, 4, 6, 8, 12, 16, 24 hours post-dose
ID
Title
Description
OG000
Part 2: GSK3882347 RD 50 mg to 900 mg
Participants were administered repeat dose of GSK3882347 50 mg, 150 mg, 500 mg or 900 mg
Units
Counts
Participants
OG00032
Title
Denominators
Categories
Day 1
Title
Measurements
OG0000.770(0.684 to 0.857)
Day 7
Title
Measurements
OG0000.908(0.841 to 0.976)
Secondary
Part 2: Dose Proportionality of GSK3882347 for Dose Levels 50 mg to 900 mg Using Cmax After Repeat Dose Administration of GSK3882347
Blood samples were collected at indicated time points for PK analysis of GSK3882347. PK parameters were analyzed using standard non-compartmental analysis. Dose proportionality was assessed using Power model. Log-e(dose) was fitted as fixed effect and participant was fitted as random effect. Kenward and Roger method and unstructured covariance structure was used. Slope and 90% CI for the slope are presented.
PK Population. Only those participants with data available at the specified data points were analyzed.
Posted
Number
90% Confidence Interval
Slope of log dose
Day 1 and Day 7: Pre-dose, 15, 30 minutes, 1, 1.5, 2, 4, 6, 8, 12, 16, 24 hours post-dose
ID
Title
Description
OG000
Part 2: GSK3882347 RD 50 mg to 900 mg
Participants were administered repeat dose of GSK3882347 50 mg, 150 mg, 500 mg or 900 mg
Units
Counts
Participants
OG00032
Title
Denominators
Categories
Day 1
Title
Measurements
OG0000.736(0.644 to 0.829)
Day 7
Title
Measurements
OG0000.841(0.763 to 0.920)
Secondary
Part 2: Observed Accumulation Ratio (Ro) Using AUC(0-tau) After Repeat Dose Administration of GSK3882347
Blood samples were collected at indicated time points for PK analysis of GSK3882347. PK parameters were analyzed using standard non-compartmental analysis. Accumulation ratio was calculated as AUC(0-tau) at Day 7 divided by AUC(0-tau) at Day 1 for GSK3882347. Mixed effect model was used to assess accumulation ratio for the log transformed parameters. Treatment, day and the interaction of treatment and day were fitted as fixed effect. Participant was fitted as random effect. Kenward and Roger method and unstructured covariance structure was used.
PK Population
Posted
Number
90% Confidence Interval
Ratio
Day 1 and Day 7: Pre-dose, 15, 30 minutes, 1, 1.5, 2, 4, 6, 8, 12, 16, 24 hours post-dose
ID
Title
Description
OG000
Part 2: Repeat Dose GSK3882347 50 mg
Healthy participants in Part 2 received RD of GSK3882347 50 mg on Days 1 to 7.
OG001
Part 2: Repeat Dose GSK3882347 150 mg
Healthy participants in Part 2 received RD of GSK3882347 150 mg on Days 1 to 7.
OG002
Part 2: Repeat Dose GSK3882347 500 mg
Healthy participants in Part 2 received RD of GSK3882347 500 mg on Days 1 to 7.
OG003
Part 2: Repeat Dose GSK3882347 900 mg
Healthy participants in Part 2 received RD of GSK3882347 900 mg on Days 1 to 7.
Units
Counts
Participants
OG0008
OG0018
OG0028
OG003
Title
Denominators
Categories
Title
Measurements
OG0001.05(0.93 to 1.18)
OG0011.05(0.93 to 1.18)
OG0021.35(1.20 to 1.52)
OG003
Secondary
Part 2: Time Invariance of GSK3882347
Blood samples were collected at indicated time points for the analysis of time invariance. Time invariance was calculated as AUC(0-tau) at Day 7 divided by AUC(0-infinity) at Day 1 for GSK3882347. Mixed effect ANOVA model was used to assess time invariance for the log transformed parameters. Treatment, day and the interaction of treatment and day were fitted as fixed effect. Participant was fitted as random effect. Kenward and Roger method and unstructured covariance structure was used.
PK Population
Posted
Number
90% Confidence Interval
Ratio
Day 1 and Day 7: Pre-dose, 15, 30 minutes, 1, 1.5, 2, 4, 6, 8, 12, 16, 24 hours post-dose
ID
Title
Description
OG000
Part 2: Repeat Dose GSK3882347 50 mg
Healthy participants in Part 2 received RD of GSK3882347 50 mg on Days 1 to 7.
OG001
Part 2: Repeat Dose GSK3882347 150 mg
Healthy participants in Part 2 received RD of GSK3882347 150 mg on Days 1 to 7.
OG002
Part 2: Repeat Dose GSK3882347 500 mg
Healthy participants in Part 2 received RD of GSK3882347 500 mg on Days 1 to 7.
OG003
Part 2: Repeat Dose GSK3882347 900 mg
Healthy participants in Part 2 received RD of GSK3882347 900 mg on Days 1 to 7.
Units
Counts
Participants
OG0008
OG0018
OG0028
OG003
Title
Denominators
Categories
Title
Measurements
OG0000.83(0.74 to 0.94)
OG0010.87(0.77 to 0.99)
OG0021.07(0.95 to 1.20)
OG003
Secondary
Part 2: Pre-dose Plasma Concentrations After Repeat Dose Administration of GSK3882347 From Days 3 to 7
Blood samples were collected at indicated time points for PK analysis of GSK3882347.
PK Population
Posted
Mean
Standard Deviation
Nanograms per milliliter
Days 3, 4, 5, 6 and 7: Pre-dose
ID
Title
Description
OG000
Part 2: Repeat Dose GSK3882347 50 mg
Healthy participants in Part 2 received RD of GSK3882347 50 mg on Days 1 to 7.
OG001
Part 2: Repeat Dose GSK3882347 150 mg
Healthy participants in Part 2 received RD of GSK3882347 150 mg on Days 1 to 7.
OG002
Part 2: Repeat Dose GSK3882347 500 mg
Healthy participants in Part 2 received RD of GSK3882347 500 mg on Days 1 to 7.
OG003
Part 2: Repeat Dose GSK3882347 900 mg
Healthy participants in Part 2 received RD of GSK3882347 900 mg on Days 1 to 7.
Units
Counts
Participants
OG0008
OG0018
OG0028
OG0038
Title
Denominators
Categories
Day 3: Pre-dose
Title
Measurements
OG00099.48± 19.360
OG001326.89± 81.306
OG0021157.589± 432.3864
OG003
Secondary
Part 1: Area Under the Concentration-time Curve From Time Zero to 24 Hours (AUC[0-24]) After Single Dose Administration of GSK3882347 250 mg Under Fasted and Fed Conditions for Assessment of Food Effect
Blood samples were collected at indicated time points for PK analysis of GSK3882347 250 mg under fasted and fed conditions for assessment of food effect. PK parameters were analyzed using standard non-compartmental analysis.
Healthy participants in Part 1 received a SD of GSK3882347 250 mg on Day 1 in treatment Period 3.
OG001
Part 1: Single Dose GSK3882347 250 mg Fed
Healthy participants in Part 1 received a SD of GSK3882347 250 mg under fed condition on Day 1 in treatment Period 4.
Units
Counts
Participants
OG0006
OG0016
Title
Denominators
Categories
Title
Measurements
OG00028472.2± 0.08
OG00121456.4± 0.08
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
Ratio of Geometric Mean
0.75
2-Sided
90
0.61
0.93
Mixed Effect Model has been used to assess Food Effect for the log transformed parameter AUC(0-24). Treatment in the fed/fasted state is fitted as Fixed Effect. Participant is fitted as Random Effect. Unstructured covariance structure is used.
Other
Secondary
Part 1: Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUC [0-t]) After Single Dose Administration of GSK3882347 250 mg Under Fasted and Fed Conditions for Assessment of Food Effect
Blood samples were collected at indicated time points for PK analysis of GSK3882347 250 mg under fasted and fed conditions for assessment of food effect. PK parameters were analyzed using standard non-compartmental analysis.
Healthy participants in Part 1 received a SD of GSK3882347 250 mg on Day 1 in treatment Period 3.
OG001
Part 1: Single Dose GSK3882347 250 mg Fed
Healthy participants in Part 1 received a SD of GSK3882347 250 mg under fed condition on Day 1 in treatment Period 4.
Units
Counts
Participants
OG0006
OG0016
Title
Denominators
Categories
Title
Measurements
OG00036561.0± 0.08
OG00129091.9± 0.08
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
Ratio of Geometric Mean
0.80
2-Sided
90
0.65
0.98
Mixed Effect Model was used to assess Food Effect for the log transformed parameter AUC(0-t). Treatment in the fed/fasted state was fitted as Fixed Effect. Participant was fitted as Random Effect. Unstructured covariance structure was used.
Other
Secondary
Part 1: Area Under the Concentration-time Curve Extrapolated From Time Zero to Infinity (AUC [0-infinity]) After Single Dose Administration of GSK3882347 250 mg Under Fasted and Fed Conditions for Assessment of Food Effect
Blood samples were collected at indicated time points for PK analysis of GSK3882347 250 mg under fasted and fed conditions for assessment of food effect. PK parameters were analyzed using standard non-compartmental analysis.
Healthy participants in Part 1 received a SD of GSK3882347 250 mg on Day 1 in treatment Period 3.
OG001
Part 1: Single Dose GSK3882347 250 mg Fed
Healthy participants in Part 1 received a SD of GSK3882347 250 mg under fed condition on Day 1 in treatment Period 4.
Units
Counts
Participants
OG0006
OG0016
Title
Denominators
Categories
Title
Measurements
OG00036768.0± 0.08
OG00129316.1± 0.08
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
Ratio of Geometric Mean
0.80
2-Sided
90
0.65
0.98
Mixed Effect Model was used to assess Food Effect for log transformed parameter AUC(0-infinity). Treatment in the fed/fasted state was fitted as Fixed Effect. Participant was fitted as Random Effect. Unstructured covariance structure was used.
Other
Secondary
Part 1: Maximum Plasma Concentration (Cmax) After Single Dose Administration of GSK3882347 250 mg Under Fasted and Fed Conditions for Assessment of Food Effect
Blood samples were collected at indicated time points for PK analysis of GSK3882347 250 mg under fasted and fed conditions for assessment of food effect. PK parameters were analyzed using standard non-compartmental analysis.
Healthy participants in Part 1 received a SD of GSK3882347 250 mg on Day 1 in treatment Period 3.
OG001
Part 1: Single Dose GSK3882347 250 mg Fed
Healthy participants in Part 1 received a SD of GSK3882347 250 mg under fed condition on Day 1 in treatment Period 4.
Units
Counts
Participants
OG0006
OG0016
Title
Denominators
Categories
Title
Measurements
OG0003126.7± 0.10
OG0011834.5± 0.10
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
Ratio of Geometric Mean
0.59
2-Sided
90
0.46
0.75
Mixed Effect Model was used to assess Food Effect for the log transformed parameter Cmax. Treatment in the fed/fasted state was fitted as Fixed Effect. Participant was fitted as Random Effect. Unstructured covariance structure was used.
Other
Secondary
Part 1: Plasma Concentrations at 24 Hours (C24h) After Single Dose Administration of GSK3882347 250 mg Under Fasted and Fed Conditions for Assessment of Food Effect
Blood samples were collected at indicated time points for PK analysis of GSK3882347 250 mg under fasted and fed conditions for assessment of food effect. PK parameters were analyzed using standard non-compartmental analysis.
Healthy participants in Part 1 received a SD of GSK3882347 250 mg on Day 1 in treatment Period 3.
OG001
Part 1: Single Dose GSK3882347 250 mg Fed
Healthy participants in Part 1 received a SD of GSK3882347 250 mg under fed condition on Day 1 in treatment Period 4.
Units
Counts
Participants
OG0006
OG0016
Title
Denominators
Categories
Title
Measurements
OG000494.7± 0.09
OG001449.2± 0.09
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
Ratio of Geometric Mean
0.91
2-Sided
90
0.74
1.11
Mixed Effect Model was used to assess Food Effect for the log transformed parameter C24h. Treatment in the fed/fasted state was fitted as Fixed Effect. Participant was fitted as Random Effect. Unstructured covariance structure was used.
Other
Secondary
Part 1: Tmax After Single Dose Administration of GSK3882347 250 mg Under Fasted and Fed Conditions for Assessment of Food Effect
Blood samples were collected at indicated time points for PK analysis of GSK3882347 250 mg under fasted and fed conditions for assessment of food effect. PK parameters were analyzed using standard non-compartmental analysis.
Healthy participants in Part 1 received a SD of GSK3882347 250 mg on Day 1 in treatment Period 3.
OG001
Part 1: Single Dose GSK3882347 250 mg Fed
Healthy participants in Part 1 received a SD of GSK3882347 250 mg under fed condition on Day 1 in treatment Period 4.
Units
Counts
Participants
OG0006
OG0016
Title
Denominators
Categories
Title
Measurements
OG0004.000(2.00 to 6.00)
OG0014.000(2.00 to 8.00)
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
Median Difference (Net)
0.000
2-Sided
90
0.000
2.000
Wilcoxon matched pair test was used to assess Food Effect for the parameter Tmax.
Other
Secondary
Part 1: Tlag After Single Dose Administration of GSK3882347 250 mg Under Fasted and Fed Conditions for Assessment of Food Effect
Blood samples were collected at indicated time points for PK analysis of GSK3882347 250 mg under fasted and fed conditions for assessment of food effect. PK parameters were analyzed using standard non-compartmental analysis.
Healthy participants in Part 1 received a SD of GSK3882347 250 mg on Day 1 in treatment Period 3.
OG001
Part 1: Single Dose GSK3882347 250 mg Fed
Healthy participants in Part 1 received a SD of GSK3882347 250 mg under fed condition on Day 1 in treatment Period 4.
Units
Counts
Participants
OG0006
OG0016
Title
Denominators
Categories
Title
Measurements
OG0000.250(0 to 0.25)
OG0010.250(0.25 to 1.50)
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
Median Difference (Net)
0.000
2-Sided
90
0.000
0.250
Wilcoxon matched pair test was used to assess Food Effect for the parameter Tlag.
Other
0
14
0
14
7
14
EG001
Part 1: Single Dose GSK3882347 15 mg
Healthy participants in Part 1 received a SD of GSK3882347 15 mg on Day 1 in treatment Period 3.
0
6
0
6
1
6
EG002
Part 1: Single Dose GSK3882347 50 mg
Healthy participants in Part 1 received a SD of GSK3882347 50 mg on Day 1 in treatment Period 1.
0
6
0
6
2
6
EG003
Part 1: Single Dose GSK3882347 150 mg
Healthy participants in Part 1 received a SD of GSK3882347 150 mg on Day 1 in treatment Period 2.
0
6
0
6
2
6
EG004
Part 1: Single Dose GSK3882347 250 mg
Healthy participants in Part 1 received a SD of GSK3882347 250 mg on Day 1 in treatment Period 3.
0
6
0
6
3
6
EG005
Part 1: Single Dose GSK3882347 250 mg Fed
Healthy participants in Part 1 received a SD of GSK3882347 250 mg under fed condition on Day 1 in treatment Period 4.
0
6
0
6
2
6
EG006
Part 1: Single Dose GSK3882347 500 mg
Healthy participants in Part 1 received a SD of GSK3882347 500 mg on Day 1 in treatment Period 1.
0
6
0
6
3
6
EG007
Part 1: Single Dose GSK3882347 900 mg
Healthy participants in Part 1 received a SD of GSK3882347 900 mg on Day 1 in treatment Period 2.
0
6
0
6
2
6
EG008
Part 2: Repeat Dose Placebo
Healthy participants in Part 2 received repeat dose (RD) of Placebo on Days 1 to 7.
0
8
0
8
5
8
EG009
Part 2: Repeat Dose GSK3882347 50 mg
Healthy participants in Part 2 received RD of GSK3882347 50 mg on Days 1 to 7.
0
8
0
8
4
8
EG010
Part 2: Repeat Dose GSK3882347 150 mg
Healthy participants in Part 2 received RD of GSK3882347 150 mg on Days 1 to 7.
0
8
0
8
2
8
EG011
Part 2: Repeat Dose GSK3882347 500 mg
Healthy participants in Part 2 received RD of GSK3882347 500 mg on Days 1 to 7.
0
8
0
8
7
8
EG012
Part 2: Repeat Dose GSK3882347 900 mg
Healthy participants in Part 2 received RD of GSK3882347 900 mg on Days 1 to 7.
0
8
0
8
7
8
EG0002 events2 affected14 at risk
EG0012 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
EG0081 events1 affected8 at risk
EG0090 events0 affected8 at risk
EG0100 events0 affected8 at risk
EG0110 events0 affected8 at risk
EG0121 events1 affected8 at risk
Burning sensation
Nervous system disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected14 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 affected8 at risk
EG0090 events0 affected8 at risk
EG0100 events0 affected8 at risk
EG0110 events0 affected8 at risk
EG0120 events0 affected8 at risk
Dizziness
Nervous system disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected6 at risk
EG0020 events0 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
EG0081 events1 affected8 at risk
EG0090 events0 affected8 at risk
EG0100 events0 affected8 at risk
EG0110 events0 affected8 at risk
EG0120 events0 affected8 at risk
Presyncope
Nervous system disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected14 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
EG0080 events0 affected8 at risk
EG0090 events0 affected8 at risk
EG0100 events0 affected8 at risk
EG0110 events0 affected8 at risk
EG0120 events0 affected8 at risk
Abdominal discomfort
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected14 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 affected8 at risk
EG0090 events0 affected8 at risk
EG0100 events0 affected8 at risk
EG0110 events0 affected8 at risk
EG0121 events1 affected8 at risk
Abdominal pain
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected14 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 affected8 at risk
EG0091 events1 affected8 at risk
EG0100 events0 affected8 at risk
EG0110 events0 affected8 at risk
EG0120 events0 affected8 at risk
Abdominal pain lower
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected14 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 affected8 at risk
EG0090 events0 affected8 at risk
EG0100 events0 affected8 at risk
EG0110 events0 affected8 at risk
EG0120 events0 affected8 at risk
Constipation
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected14 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 affected8 at risk
EG0090 events0 affected8 at risk
EG0100 events0 affected8 at risk
EG0110 events0 affected8 at risk
EG0120 events0 affected8 at risk
Mouth ulceration
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected14 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 affected8 at risk
EG0090 events0 affected8 at risk
EG0100 events0 affected8 at risk
EG0110 events0 affected8 at risk
EG0120 events0 affected8 at risk
Nausea
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected14 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 affected8 at risk
EG0090 events0 affected8 at risk
EG0100 events0 affected8 at risk
EG0110 events0 affected8 at risk
EG0120 events0 affected8 at risk
Toothache
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
EG0071 events1 affected6 at risk
EG0080 events0 affected8 at risk
EG0090 events0 affected8 at risk
EG0100 events0 affected8 at risk
EG0110 events0 affected8 at risk
EG0120 events0 affected8 at risk
Vomiting
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected14 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 affected8 at risk
EG0090 events0 affected8 at risk
EG0100 events0 affected8 at risk
EG0110 events0 affected8 at risk
EG0120 events0 affected8 at risk
Contusion
Injury, poisoning and procedural complications
MedDRA 24.0
Systematic Assessment
EG0003 events2 affected14 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 affected8 at risk
EG0091 events1 affected8 at risk
EG0100 events0 affected8 at risk
EG0112 events2 affected8 at risk
EG0121 events1 affected8 at risk
Fall
Injury, poisoning and procedural complications
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected14 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 affected8 at risk
EG0090 events0 affected8 at risk
EG0100 events0 affected8 at risk
EG0110 events0 affected8 at risk
EG0120 events0 affected8 at risk
Head injury
Injury, poisoning and procedural complications
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected14 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
EG0080 events0 affected8 at risk
EG0090 events0 affected8 at risk
EG0100 events0 affected8 at risk
EG0110 events0 affected8 at risk
EG0120 events0 affected8 at risk
Dermatitis contact
Skin and subcutaneous tissue disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected14 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
EG0073 events2 affected6 at risk
EG0081 events1 affected8 at risk
EG0090 events0 affected8 at risk
EG0101 events1 affected8 at risk
EG0111 events1 affected8 at risk
EG0120 events0 affected8 at risk
Night sweats
Skin and subcutaneous tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected14 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 affected8 at risk
EG0090 events0 affected8 at risk
EG0100 events0 affected8 at risk
EG0110 events0 affected8 at risk
EG0121 events1 affected8 at risk
Application site erythema
General disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected14 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 affected8 at risk
EG0090 events0 affected8 at risk
EG0100 events0 affected8 at risk
EG0110 events0 affected8 at risk
EG0120 events0 affected8 at risk
Application site vesicles
General disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected6 at risk
EG0020 events0 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 affected8 at risk
EG0090 events0 affected8 at risk
EG0100 events0 affected8 at risk
EG0110 events0 affected8 at risk
EG0120 events0 affected8 at risk
Catheter site pain
General disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected14 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 affected8 at risk
EG0090 events0 affected8 at risk
EG0100 events0 affected8 at risk
EG0110 events0 affected8 at risk
EG0120 events0 affected8 at risk
Swelling
General disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected14 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 affected8 at risk
EG0090 events0 affected8 at risk
EG0100 events0 affected8 at risk
EG0110 events0 affected8 at risk
EG0120 events0 affected8 at risk
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected14 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 affected8 at risk
EG0090 events0 affected8 at risk
EG0101 events1 affected8 at risk
EG0110 events0 affected8 at risk
EG0120 events0 affected8 at risk
Lymphadenopathy
Blood and lymphatic system disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected14 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 affected8 at risk
EG0090 events0 affected8 at risk
EG0100 events0 affected8 at risk
EG0110 events0 affected8 at risk
EG0120 events0 affected8 at risk
Hepatic enzyme increased
Investigations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected6 at risk
EG0020 events0 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 affected8 at risk
EG0090 events0 affected8 at risk
EG0100 events0 affected8 at risk
EG0110 events0 affected8 at risk
EG0120 events0 affected8 at risk
Diarrhoea
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected14 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 affected8 at risk
EG0091 events1 affected8 at risk
EG0100 events0 affected8 at risk
EG0111 events1 affected8 at risk
EG0121 events1 affected8 at risk
Flatulence
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected14 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 affected8 at risk
EG0090 events0 affected8 at risk
EG0100 events0 affected8 at risk
EG0112 events2 affected8 at risk
EG0121 events1 affected8 at risk
Anal pruritus
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected14 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 affected8 at risk
EG0090 events0 affected8 at risk
EG0100 events0 affected8 at risk
EG0111 events1 affected8 at risk
EG0120 events0 affected8 at risk
Defaecation urgency
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected14 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 affected8 at risk
EG0090 events0 affected8 at risk
EG0100 events0 affected8 at risk
EG0110 events0 affected8 at risk
EG0121 events1 affected8 at risk
Dry mouth
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected14 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 affected8 at risk
EG0091 events1 affected8 at risk
EG0100 events0 affected8 at risk
EG0110 events0 affected8 at risk
EG0120 events0 affected8 at risk
Product use complaint
Injury, poisoning and procedural complications
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected14 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 affected8 at risk
EG0090 events0 affected8 at risk
EG0100 events0 affected8 at risk
EG0110 events0 affected8 at risk
EG0121 events1 affected8 at risk
Dysgeusia
Nervous system disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected14 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 affected8 at risk
EG0090 events0 affected8 at risk
EG0100 events0 affected8 at risk
EG0111 events1 affected8 at risk
EG0120 events0 affected8 at risk
Syncope
Nervous system disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected14 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 affected8 at risk
EG0090 events0 affected8 at risk
EG0100 events0 affected8 at risk
EG0111 events1 affected8 at risk
EG0120 events0 affected8 at risk
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected14 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 affected8 at risk
EG0090 events0 affected8 at risk
EG0100 events0 affected8 at risk
EG0110 events0 affected8 at risk
EG0121 events1 affected8 at risk
Limb discomfort
Musculoskeletal and connective tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected14 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 affected8 at risk
EG0090 events0 affected8 at risk
EG0100 events0 affected8 at risk
EG0110 events0 affected8 at risk
EG0120 events0 affected8 at risk
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected14 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 affected8 at risk
EG0090 events0 affected8 at risk
EG0101 events1 affected8 at risk
EG0110 events0 affected8 at risk
EG0120 events0 affected8 at risk
Oral herpes
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected14 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 affected8 at risk
EG0090 events0 affected8 at risk
EG0101 events1 affected8 at risk
EG0110 events0 affected8 at risk
EG0120 events0 affected8 at risk
Blood creatinine increased
Investigations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected14 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 affected8 at risk
EG0091 events1 affected8 at risk
EG0100 events0 affected8 at risk
EG0110 events0 affected8 at risk
EG0120 events0 affected8 at risk
Dysuria
Renal and urinary disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected14 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 affected8 at risk
EG0090 events0 affected8 at risk
EG0100 events0 affected8 at risk
EG0111 events1 affected8 at risk
EG0120 events0 affected8 at risk
Pruritus genital
Reproductive system and breast disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected14 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 affected8 at risk
EG0090 events0 affected8 at risk
EG0100 events0 affected8 at risk
EG0111 events1 affected8 at risk
EG0120 events0 affected8 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.