Trial Outcomes & Findings for A Relative Bioavailability and Food-Effect Study of GSK3640254 Tablet and Capsule Formulations in Healthy Participants (NCT NCT04128293)
NCT ID: NCT04128293
Last Updated: 2020-08-25
Results Overview
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3640254. The pharmacokinetic (PK) parameters were calculated by standard non-compartmental analysis. PK Parameter Population included all participants who underwent plasma PK sampling and had evaluable PK parameters estimated.
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
16 participants
Primary outcome timeframe
Pre-dose and at 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72 and 96 hours post-dose
Results posted on
2020-08-25
Participant Flow
This was a randomized, open-label, single dose, 4 period crossover study in healthy participants conducted at a single center in the United States.
A total of 16 participants were enrolled in this study. The study was early terminated by sponsor due to a potential contamination issue in the study drug after completion of treatment Period 2. Hence, treatment Periods 3 and 4 were not conducted.
Participant milestones
| Measure |
Sequence 1 - Treatment ABCD
Participants received a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions (Treatment A-reference) on Day 1 in treatment Period 1; followed by a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions (Treatment B-test) on Day 1 in treatment Period 2. There was a washout period of at least 7 days between two treatment periods. Participants were planned to receive a single dose of GSK3640254 200 mg tablets, orally under fasted conditions (Treatment C-reference) on Day 1 in treatment Period 3; and a single dose of GSK3640254 200 mg tablets, orally under high fat conditions (Treatment D-test) on Day 1 in treatment Period 4. Treatment Periods 3 and 4 were planned but no participants were enrolled due to early termination of the study.
|
Sequence 2 - Treatment BADC
Participants received a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions (Treatment B-Test) on Day 1 in treatment Period 1; followed by a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions (Treatment A-Reference) on Day 1 in treatment Period 2. There was a washout period of at least 7 days between two treatment periods. Participants were planned to receive a single dose of GSK3640254 200 mg tablets, orally under high fat conditions (Treatment D-Test) on Day 1 in treatment Period 3; and a single dose of GSK3640254 200 mg tablets, orally under fasted conditions (Treatment C-Reference) on Day 1 in treatment Period 4. The treatment Periods 3 and 4 were planned but no participants were enrolled due to early termination of the study.
|
Sequence 3 - Treatment CDAB
Participants received a single dose of GSK3640254 200 mg tablets, orally under fasted conditions (Treatment C-Reference) on Day 1 in treatment Period 1; followed by a single dose of GSK3640254 200 mg tablets, orally under high fat conditions (Treatment D-Test) on Day 1 in treatment Period 2. There was a washout period of at least 7 days between 2 treatment periods. Participants were planned to receive a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions (Treatment A-Reference) on Day 1 in treatment Period 3; and a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions (Treatment B-Test) on Day 1 in treatment Period 4. The treatment Periods 3 and 4 were planned but no participants were enrolled due to early termination of the study.
|
Sequence 4 - Treatment DCBA
Participants received a single dose of GSK3640254 200 mg tablets, orally under high fat conditions (Treatment D-Test) on Day 1 in treatment Period 1; followed by a single dose of GSK3640254 200 mg tablets, orally under fasted conditions (Treatment C-Reference) on Day 1 in treatment Period 2. There was a washout period of at least 7 days between 2 treatment periods. Participants were planned to receive a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions (Treatment B-Test) on Day 1 in treatment Period 3; and a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions (Treatment A-Reference) on Day 1 in treatment Period 4. The treatment Periods 3 and 4 were planned but no participants were enrolled due to early termination of the study.
|
|---|---|---|---|---|
|
Treatment Period 1 (1 Day)
STARTED
|
4
|
4
|
4
|
4
|
|
Treatment Period 1 (1 Day)
COMPLETED
|
4
|
4
|
4
|
4
|
|
Treatment Period 1 (1 Day)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Washout Period 1 (Up to 7 Days)
STARTED
|
4
|
4
|
4
|
4
|
|
Washout Period 1 (Up to 7 Days)
COMPLETED
|
4
|
4
|
4
|
4
|
|
Washout Period 1 (Up to 7 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Treatment Period 2 (1 Day)
STARTED
|
4
|
4
|
4
|
4
|
|
Treatment Period 2 (1 Day)
COMPLETED
|
4
|
4
|
4
|
4
|
|
Treatment Period 2 (1 Day)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Washout Period 2 (Up to 7 Days)
STARTED
|
4
|
4
|
4
|
4
|
|
Washout Period 2 (Up to 7 Days)
COMPLETED
|
0
|
0
|
0
|
0
|
|
Washout Period 2 (Up to 7 Days)
NOT COMPLETED
|
4
|
4
|
4
|
4
|
|
Treatment Period 3 (1 Day)
STARTED
|
0
|
0
|
0
|
0
|
|
Treatment Period 3 (1 Day)
COMPLETED
|
0
|
0
|
0
|
0
|
|
Treatment Period 3 (1 Day)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Washout Period 3 (Up to 7 Days)
STARTED
|
0
|
0
|
0
|
0
|
|
Washout Period 3 (Up to 7 Days)
COMPLETED
|
0
|
0
|
0
|
0
|
|
Washout Period 3 (Up to 7 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Treatment Period 4 (1 Day)
STARTED
|
0
|
0
|
0
|
0
|
|
Treatment Period 4 (1 Day)
COMPLETED
|
0
|
0
|
0
|
0
|
|
Treatment Period 4 (1 Day)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Sequence 1 - Treatment ABCD
Participants received a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions (Treatment A-reference) on Day 1 in treatment Period 1; followed by a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions (Treatment B-test) on Day 1 in treatment Period 2. There was a washout period of at least 7 days between two treatment periods. Participants were planned to receive a single dose of GSK3640254 200 mg tablets, orally under fasted conditions (Treatment C-reference) on Day 1 in treatment Period 3; and a single dose of GSK3640254 200 mg tablets, orally under high fat conditions (Treatment D-test) on Day 1 in treatment Period 4. Treatment Periods 3 and 4 were planned but no participants were enrolled due to early termination of the study.
|
Sequence 2 - Treatment BADC
Participants received a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions (Treatment B-Test) on Day 1 in treatment Period 1; followed by a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions (Treatment A-Reference) on Day 1 in treatment Period 2. There was a washout period of at least 7 days between two treatment periods. Participants were planned to receive a single dose of GSK3640254 200 mg tablets, orally under high fat conditions (Treatment D-Test) on Day 1 in treatment Period 3; and a single dose of GSK3640254 200 mg tablets, orally under fasted conditions (Treatment C-Reference) on Day 1 in treatment Period 4. The treatment Periods 3 and 4 were planned but no participants were enrolled due to early termination of the study.
|
Sequence 3 - Treatment CDAB
Participants received a single dose of GSK3640254 200 mg tablets, orally under fasted conditions (Treatment C-Reference) on Day 1 in treatment Period 1; followed by a single dose of GSK3640254 200 mg tablets, orally under high fat conditions (Treatment D-Test) on Day 1 in treatment Period 2. There was a washout period of at least 7 days between 2 treatment periods. Participants were planned to receive a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions (Treatment A-Reference) on Day 1 in treatment Period 3; and a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions (Treatment B-Test) on Day 1 in treatment Period 4. The treatment Periods 3 and 4 were planned but no participants were enrolled due to early termination of the study.
|
Sequence 4 - Treatment DCBA
Participants received a single dose of GSK3640254 200 mg tablets, orally under high fat conditions (Treatment D-Test) on Day 1 in treatment Period 1; followed by a single dose of GSK3640254 200 mg tablets, orally under fasted conditions (Treatment C-Reference) on Day 1 in treatment Period 2. There was a washout period of at least 7 days between 2 treatment periods. Participants were planned to receive a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions (Treatment B-Test) on Day 1 in treatment Period 3; and a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions (Treatment A-Reference) on Day 1 in treatment Period 4. The treatment Periods 3 and 4 were planned but no participants were enrolled due to early termination of the study.
|
|---|---|---|---|---|
|
Washout Period 2 (Up to 7 Days)
Study Closed/Terminated
|
4
|
4
|
4
|
4
|
Baseline Characteristics
A Relative Bioavailability and Food-Effect Study of GSK3640254 Tablet and Capsule Formulations in Healthy Participants
Baseline characteristics by cohort
| Measure |
Sequence 1 - Treatment ABCD
n=4 Participants
Participants received a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions (Treatment A-reference) on Day 1 in treatment Period 1; followed by a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions (Treatment B-test) on Day 1 in treatment Period 2. There was a washout period of at least 7 days between two treatment periods. Participants were planned to receive a single dose of GSK3640254 200 mg tablets, orally under fasted conditions (Treatment C-reference) on Day 1 in treatment Period 3; and a single dose of GSK3640254 200 mg tablets, orally under high fat conditions (Treatment D-test) on Day 1 in treatment Period 4. Treatment Periods 3 and 4 were planned but no participants were enrolled due to early termination of the study.
|
Sequence 2 - Treatment BADC
n=4 Participants
Participants received a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions (Treatment B-Test) on Day 1 in treatment Period 1; followed by a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions (Treatment A-Reference) on Day 1 in treatment Period 2. There was a washout period of at least 7 days between two treatment periods. Participants were planned to receive a single dose of GSK3640254 200 mg tablets, orally under high fat conditions (Treatment D-Test) on Day 1 in treatment Period 3; and a single dose of GSK3640254 200 mg tablets, orally under fasted conditions (Treatment C-Reference) on Day 1 in treatment Period 4. The treatment Periods 3 and 4 were planned but no participants were enrolled due to early termination of the study.
|
Sequence 3 - Treatment CDAB
n=4 Participants
Participants received a single dose of GSK3640254 200 mg tablets, orally under fasted conditions (Treatment C-Reference) on Day 1 in treatment Period 1; followed by a single dose of GSK3640254 200 mg tablets, orally under high fat conditions (Treatment D-Test) on Day 1 in treatment Period 2. There was a washout period of at least 7 days between 2 treatment periods. Participants were planned to receive a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions (Treatment A-Reference) on Day 1 in treatment Period 3; and a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions (Treatment B-Test) on Day 1 in treatment Period 4. The treatment Periods 3 and 4 were planned but no participants were enrolled due to early termination of the study.
|
Sequence 4 - Treatment DCBA
n=4 Participants
Participants received a single dose of GSK3640254 200 mg tablets, orally under high fat conditions (Treatment D-Test) on Day 1 in treatment Period 1; followed by a single dose of GSK3640254 200 mg tablets, orally under fasted conditions (Treatment C-Reference) on Day 1 in treatment Period 2. There was a washout period of at least 7 days between 2 treatment periods. Participants were planned to receive a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions (Treatment B-Test) on Day 1 in treatment Period 3; and a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions (Treatment A-Reference) on Day 1 in treatment Period 4. The treatment Periods 3 and 4 were planned but no participants were enrolled due to early termination of the study.
|
Total
n=16 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
33.8 Years
STANDARD_DEVIATION 8.46 • n=5 Participants
|
33.8 Years
STANDARD_DEVIATION 10.21 • n=7 Participants
|
31.3 Years
STANDARD_DEVIATION 7.68 • n=5 Participants
|
38.0 Years
STANDARD_DEVIATION 11.66 • n=4 Participants
|
34.2 Years
STANDARD_DEVIATION 8.97 • n=21 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Asian - South East Asian Heritage
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
White-White/Caucasian/European Heritage
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Pre-dose and at 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72 and 96 hours post-dosePopulation: PK Parameter Population.
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3640254. The pharmacokinetic (PK) parameters were calculated by standard non-compartmental analysis. PK Parameter Population included all participants who underwent plasma PK sampling and had evaluable PK parameters estimated.
Outcome measures
| Measure |
Treatment A- GSK3640254 200 mg Capsules (Fed)
n=8 Participants
Participants received a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions (Treatment A-reference) on Day 1 in treatment Period 1 or 2.
|
Treatment B- GSK3640254 200 mg Tablet (Fed)
n=8 Participants
Participants received a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions (Treatment B-test) on Day 1 in treatment Period 1 or 2.
|
Treatment D- GSK3640254 200 mg Tablet (High Fat)
Participants received a single dose of GSK3640254 200 mg tablets, orally under high fat conditions (Treatment D-test) on Day 1 in treatment Period 1 or 2.
|
Treatment D- GSK3640254 200 mg Tablet (High Fat)
Participants received a single dose of GSK3640254 200 mg tablets, orally under high fat conditions (Treatment D-test) on Day 1 in treatment Period 1 or 2.
|
|---|---|---|---|---|
|
Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC[0-infinity]) for GSK3640254 200 mg Capsules and Tablets Under Fed Condition (Treatment A and B)
|
35.51 Hours*microgram per milliliter
Geometric Coefficient of Variation 16.7
|
31.16 Hours*microgram per milliliter
Geometric Coefficient of Variation 37.4
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose and at 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72 and 96 hours post-dosePopulation: PK Parameter Population. Only those participants with data available at the indicated time points were analyzed.
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis.
Outcome measures
| Measure |
Treatment A- GSK3640254 200 mg Capsules (Fed)
n=6 Participants
Participants received a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions (Treatment A-reference) on Day 1 in treatment Period 1 or 2.
|
Treatment B- GSK3640254 200 mg Tablet (Fed)
n=8 Participants
Participants received a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions (Treatment B-test) on Day 1 in treatment Period 1 or 2.
|
Treatment D- GSK3640254 200 mg Tablet (High Fat)
Participants received a single dose of GSK3640254 200 mg tablets, orally under high fat conditions (Treatment D-test) on Day 1 in treatment Period 1 or 2.
|
Treatment D- GSK3640254 200 mg Tablet (High Fat)
Participants received a single dose of GSK3640254 200 mg tablets, orally under high fat conditions (Treatment D-test) on Day 1 in treatment Period 1 or 2.
|
|---|---|---|---|---|
|
AUC(0-infinity) for GSK3640254 200 mg Tablets Under Fasted and High Fat Condition (Treatment C and D)
|
15.54 Hours*microgram per milliliter
Geometric Coefficient of Variation 49.4
|
37.85 Hours*microgram per milliliter
Geometric Coefficient of Variation 30.1
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose and at 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72 and 96 hours post-dosePopulation: PK Parameter Population.
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis.
Outcome measures
| Measure |
Treatment A- GSK3640254 200 mg Capsules (Fed)
n=8 Participants
Participants received a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions (Treatment A-reference) on Day 1 in treatment Period 1 or 2.
|
Treatment B- GSK3640254 200 mg Tablet (Fed)
n=8 Participants
Participants received a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions (Treatment B-test) on Day 1 in treatment Period 1 or 2.
|
Treatment D- GSK3640254 200 mg Tablet (High Fat)
Participants received a single dose of GSK3640254 200 mg tablets, orally under high fat conditions (Treatment D-test) on Day 1 in treatment Period 1 or 2.
|
Treatment D- GSK3640254 200 mg Tablet (High Fat)
Participants received a single dose of GSK3640254 200 mg tablets, orally under high fat conditions (Treatment D-test) on Day 1 in treatment Period 1 or 2.
|
|---|---|---|---|---|
|
Area Under the Plasma Concentration-time Curve From Time Zero to Time t (AUC[0-t]) for GSK3640254 200 mg Capsules and Tablets Under Fed Condition (Treatment A and B)
|
33.05 Hours*microgram per milliliter
Geometric Coefficient of Variation 18.2
|
29.50 Hours*microgram per milliliter
Geometric Coefficient of Variation 37.7
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose and at 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72 and 96 hours post-dosePopulation: PK Parameter Population. Only those participants with data available at the indicated time points were analyzed.
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis.
Outcome measures
| Measure |
Treatment A- GSK3640254 200 mg Capsules (Fed)
n=6 Participants
Participants received a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions (Treatment A-reference) on Day 1 in treatment Period 1 or 2.
|
Treatment B- GSK3640254 200 mg Tablet (Fed)
n=8 Participants
Participants received a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions (Treatment B-test) on Day 1 in treatment Period 1 or 2.
|
Treatment D- GSK3640254 200 mg Tablet (High Fat)
Participants received a single dose of GSK3640254 200 mg tablets, orally under high fat conditions (Treatment D-test) on Day 1 in treatment Period 1 or 2.
|
Treatment D- GSK3640254 200 mg Tablet (High Fat)
Participants received a single dose of GSK3640254 200 mg tablets, orally under high fat conditions (Treatment D-test) on Day 1 in treatment Period 1 or 2.
|
|---|---|---|---|---|
|
AUC(0-t) for GSK3640254 200 mg Tablets Under Fasted and High Fat Condition (Treatment C and D)
|
14.43 Hours*microgram per milliliter
Geometric Coefficient of Variation 52.3
|
34.99 Hours*microgram per milliliter
Geometric Coefficient of Variation 29.1
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose and at 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72 and 96 hours post-dosePopulation: PK Parameter Population.
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis.
Outcome measures
| Measure |
Treatment A- GSK3640254 200 mg Capsules (Fed)
n=8 Participants
Participants received a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions (Treatment A-reference) on Day 1 in treatment Period 1 or 2.
|
Treatment B- GSK3640254 200 mg Tablet (Fed)
n=8 Participants
Participants received a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions (Treatment B-test) on Day 1 in treatment Period 1 or 2.
|
Treatment D- GSK3640254 200 mg Tablet (High Fat)
Participants received a single dose of GSK3640254 200 mg tablets, orally under high fat conditions (Treatment D-test) on Day 1 in treatment Period 1 or 2.
|
Treatment D- GSK3640254 200 mg Tablet (High Fat)
Participants received a single dose of GSK3640254 200 mg tablets, orally under high fat conditions (Treatment D-test) on Day 1 in treatment Period 1 or 2.
|
|---|---|---|---|---|
|
Maximum Observed Concentration (Cmax) for GSK3640254 200 mg Capsules and Tablets Under Fed Condition (Treatment A and B)
|
1.151 Microgram per milliliter
Geometric Coefficient of Variation 16.8
|
1.088 Microgram per milliliter
Geometric Coefficient of Variation 23.3
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose and at 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72 and 96 hours post-dosePopulation: PK Parameter Population. Only those participants with data available at the indicated time points were analyzed.
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis.
Outcome measures
| Measure |
Treatment A- GSK3640254 200 mg Capsules (Fed)
n=6 Participants
Participants received a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions (Treatment A-reference) on Day 1 in treatment Period 1 or 2.
|
Treatment B- GSK3640254 200 mg Tablet (Fed)
n=8 Participants
Participants received a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions (Treatment B-test) on Day 1 in treatment Period 1 or 2.
|
Treatment D- GSK3640254 200 mg Tablet (High Fat)
Participants received a single dose of GSK3640254 200 mg tablets, orally under high fat conditions (Treatment D-test) on Day 1 in treatment Period 1 or 2.
|
Treatment D- GSK3640254 200 mg Tablet (High Fat)
Participants received a single dose of GSK3640254 200 mg tablets, orally under high fat conditions (Treatment D-test) on Day 1 in treatment Period 1 or 2.
|
|---|---|---|---|---|
|
Cmax for GSK3640254 200 mg Tablets Under Fasted and High Fat Condition (Treatment C and D)
|
0.5557 Microgram per milliliter
Geometric Coefficient of Variation 71.3
|
1.168 Microgram per milliliter
Geometric Coefficient of Variation 30.0
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose and at 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72 and 96 hours post-dosePopulation: PK Parameter Population.
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis.
Outcome measures
| Measure |
Treatment A- GSK3640254 200 mg Capsules (Fed)
n=8 Participants
Participants received a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions (Treatment A-reference) on Day 1 in treatment Period 1 or 2.
|
Treatment B- GSK3640254 200 mg Tablet (Fed)
Participants received a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions (Treatment B-test) on Day 1 in treatment Period 1 or 2.
|
Treatment D- GSK3640254 200 mg Tablet (High Fat)
Participants received a single dose of GSK3640254 200 mg tablets, orally under high fat conditions (Treatment D-test) on Day 1 in treatment Period 1 or 2.
|
Treatment D- GSK3640254 200 mg Tablet (High Fat)
Participants received a single dose of GSK3640254 200 mg tablets, orally under high fat conditions (Treatment D-test) on Day 1 in treatment Period 1 or 2.
|
|---|---|---|---|---|
|
Time of Cmax (Tmax) for GSK3640254 200 mg Capsules Under Fed Condition (Treatment A)
|
6.000 Hours
Interval 4.5 to 8.03
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose and at 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72 and 96 hours post-dosePopulation: PK Parameter Population. Only those participants with data available at the indicated time points were analyzed.
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis.
Outcome measures
| Measure |
Treatment A- GSK3640254 200 mg Capsules (Fed)
n=8 Participants
Participants received a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions (Treatment A-reference) on Day 1 in treatment Period 1 or 2.
|
Treatment B- GSK3640254 200 mg Tablet (Fed)
n=6 Participants
Participants received a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions (Treatment B-test) on Day 1 in treatment Period 1 or 2.
|
Treatment D- GSK3640254 200 mg Tablet (High Fat)
n=8 Participants
Participants received a single dose of GSK3640254 200 mg tablets, orally under high fat conditions (Treatment D-test) on Day 1 in treatment Period 1 or 2.
|
Treatment D- GSK3640254 200 mg Tablet (High Fat)
Participants received a single dose of GSK3640254 200 mg tablets, orally under high fat conditions (Treatment D-test) on Day 1 in treatment Period 1 or 2.
|
|---|---|---|---|---|
|
Time of Cmax (Tmax) for GSK3640254 200 mg Tablets Under Fed, Fasted and High Fat Condition (Treatment B, C and D)
|
5.033 Hours
Interval 3.0 to 6.07
|
4.250 Hours
Interval 2.5 to 6.0
|
4.500 Hours
Interval 2.0 to 12.0
|
—
|
SECONDARY outcome
Timeframe: Up to Day 14Population: Safety Population.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; is a congenital anomaly/birth defect; and other important medical events which may require medical or surgical intervention. Safety Population consisted of all participants who received at least 1 dose of study medication.
Outcome measures
| Measure |
Treatment A- GSK3640254 200 mg Capsules (Fed)
n=8 Participants
Participants received a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions (Treatment A-reference) on Day 1 in treatment Period 1 or 2.
|
Treatment B- GSK3640254 200 mg Tablet (Fed)
n=8 Participants
Participants received a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions (Treatment B-test) on Day 1 in treatment Period 1 or 2.
|
Treatment D- GSK3640254 200 mg Tablet (High Fat)
n=8 Participants
Participants received a single dose of GSK3640254 200 mg tablets, orally under high fat conditions (Treatment D-test) on Day 1 in treatment Period 1 or 2.
|
Treatment D- GSK3640254 200 mg Tablet (High Fat)
n=8 Participants
Participants received a single dose of GSK3640254 200 mg tablets, orally under high fat conditions (Treatment D-test) on Day 1 in treatment Period 1 or 2.
|
|---|---|---|---|---|
|
Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs)
Any AEs
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs)
Any SAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 2Population: Safety Population.
Blood samples were collected to analyze the hematology parameters: basophils, eosinophils, lymphocytes, monocytes, neutrophils and platelet count.
Outcome measures
| Measure |
Treatment A- GSK3640254 200 mg Capsules (Fed)
n=8 Participants
Participants received a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions (Treatment A-reference) on Day 1 in treatment Period 1 or 2.
|
Treatment B- GSK3640254 200 mg Tablet (Fed)
n=8 Participants
Participants received a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions (Treatment B-test) on Day 1 in treatment Period 1 or 2.
|
Treatment D- GSK3640254 200 mg Tablet (High Fat)
n=8 Participants
Participants received a single dose of GSK3640254 200 mg tablets, orally under high fat conditions (Treatment D-test) on Day 1 in treatment Period 1 or 2.
|
Treatment D- GSK3640254 200 mg Tablet (High Fat)
n=8 Participants
Participants received a single dose of GSK3640254 200 mg tablets, orally under high fat conditions (Treatment D-test) on Day 1 in treatment Period 1 or 2.
|
|---|---|---|---|---|
|
Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count
Basophils
|
0.024 10^9 cells per liter
Standard Deviation 0.0092
|
0.028 10^9 cells per liter
Standard Deviation 0.0175
|
0.036 10^9 cells per liter
Standard Deviation 0.0119
|
0.038 10^9 cells per liter
Standard Deviation 0.0139
|
|
Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count
Eosinophils
|
0.086 10^9 cells per liter
Standard Deviation 0.0472
|
0.096 10^9 cells per liter
Standard Deviation 0.0910
|
0.126 10^9 cells per liter
Standard Deviation 0.0761
|
0.128 10^9 cells per liter
Standard Deviation 0.0740
|
|
Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count
Lymphocytes
|
1.673 10^9 cells per liter
Standard Deviation 0.3314
|
1.689 10^9 cells per liter
Standard Deviation 0.2283
|
1.890 10^9 cells per liter
Standard Deviation 0.4366
|
1.753 10^9 cells per liter
Standard Deviation 0.4307
|
|
Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count
Monocytes
|
0.365 10^9 cells per liter
Standard Deviation 0.0849
|
0.384 10^9 cells per liter
Standard Deviation 0.0968
|
0.434 10^9 cells per liter
Standard Deviation 0.1492
|
0.410 10^9 cells per liter
Standard Deviation 0.1610
|
|
Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count
Neutrophils
|
2.324 10^9 cells per liter
Standard Deviation 0.6459
|
2.403 10^9 cells per liter
Standard Deviation 0.6452
|
2.470 10^9 cells per liter
Standard Deviation 0.6709
|
2.403 10^9 cells per liter
Standard Deviation 0.6713
|
|
Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count
Platelet count
|
252.1 10^9 cells per liter
Standard Deviation 22.64
|
241.5 10^9 cells per liter
Standard Deviation 28.91
|
271.8 10^9 cells per liter
Standard Deviation 44.08
|
270.9 10^9 cells per liter
Standard Deviation 40.47
|
SECONDARY outcome
Timeframe: Day 2Population: Safety Population.
Blood samples were collected to analyze the hematology parameter: hemoglobin.
Outcome measures
| Measure |
Treatment A- GSK3640254 200 mg Capsules (Fed)
n=8 Participants
Participants received a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions (Treatment A-reference) on Day 1 in treatment Period 1 or 2.
|
Treatment B- GSK3640254 200 mg Tablet (Fed)
n=8 Participants
Participants received a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions (Treatment B-test) on Day 1 in treatment Period 1 or 2.
|
Treatment D- GSK3640254 200 mg Tablet (High Fat)
n=8 Participants
Participants received a single dose of GSK3640254 200 mg tablets, orally under high fat conditions (Treatment D-test) on Day 1 in treatment Period 1 or 2.
|
Treatment D- GSK3640254 200 mg Tablet (High Fat)
n=8 Participants
Participants received a single dose of GSK3640254 200 mg tablets, orally under high fat conditions (Treatment D-test) on Day 1 in treatment Period 1 or 2.
|
|---|---|---|---|---|
|
Absolute Values for Hematology Parameter: Hemoglobin
|
145.1 Grams per liter
Standard Deviation 8.61
|
143.1 Grams per liter
Standard Deviation 8.63
|
144.8 Grams per liter
Standard Deviation 14.50
|
145.5 Grams per liter
Standard Deviation 12.81
|
SECONDARY outcome
Timeframe: Day 2Population: Safety Population.
Blood samples were collected to analyze the hematology parameter: hematocrit.
Outcome measures
| Measure |
Treatment A- GSK3640254 200 mg Capsules (Fed)
n=8 Participants
Participants received a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions (Treatment A-reference) on Day 1 in treatment Period 1 or 2.
|
Treatment B- GSK3640254 200 mg Tablet (Fed)
n=8 Participants
Participants received a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions (Treatment B-test) on Day 1 in treatment Period 1 or 2.
|
Treatment D- GSK3640254 200 mg Tablet (High Fat)
n=8 Participants
Participants received a single dose of GSK3640254 200 mg tablets, orally under high fat conditions (Treatment D-test) on Day 1 in treatment Period 1 or 2.
|
Treatment D- GSK3640254 200 mg Tablet (High Fat)
n=8 Participants
Participants received a single dose of GSK3640254 200 mg tablets, orally under high fat conditions (Treatment D-test) on Day 1 in treatment Period 1 or 2.
|
|---|---|---|---|---|
|
Absolute Values for Hematology Parameter: Hematocrit
|
0.4406 Proportion of red blood cells in blood
Standard Deviation 0.02272
|
0.4344 Proportion of red blood cells in blood
Standard Deviation 0.02477
|
0.4294 Proportion of red blood cells in blood
Standard Deviation 0.04147
|
0.4345 Proportion of red blood cells in blood
Standard Deviation 0.03691
|
SECONDARY outcome
Timeframe: Day 2Population: Safety Population.
Blood samples were collected to analyze the hematology parameter: erythrocytes.
Outcome measures
| Measure |
Treatment A- GSK3640254 200 mg Capsules (Fed)
n=8 Participants
Participants received a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions (Treatment A-reference) on Day 1 in treatment Period 1 or 2.
|
Treatment B- GSK3640254 200 mg Tablet (Fed)
n=8 Participants
Participants received a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions (Treatment B-test) on Day 1 in treatment Period 1 or 2.
|
Treatment D- GSK3640254 200 mg Tablet (High Fat)
n=8 Participants
Participants received a single dose of GSK3640254 200 mg tablets, orally under high fat conditions (Treatment D-test) on Day 1 in treatment Period 1 or 2.
|
Treatment D- GSK3640254 200 mg Tablet (High Fat)
n=8 Participants
Participants received a single dose of GSK3640254 200 mg tablets, orally under high fat conditions (Treatment D-test) on Day 1 in treatment Period 1 or 2.
|
|---|---|---|---|---|
|
Absolute Values for Hematology Parameter: Erythrocytes
|
5.199 10^12 cells per liter
Standard Deviation 0.3468
|
5.120 10^12 cells per liter
Standard Deviation 0.3829
|
5.013 10^12 cells per liter
Standard Deviation 0.5337
|
5.066 10^12 cells per liter
Standard Deviation 0.4719
|
SECONDARY outcome
Timeframe: Day 2Population: Safety Population.
Blood samples were collected to analyze the hematology parameter: erythrocytes mean corpuscular volume.
Outcome measures
| Measure |
Treatment A- GSK3640254 200 mg Capsules (Fed)
n=8 Participants
Participants received a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions (Treatment A-reference) on Day 1 in treatment Period 1 or 2.
|
Treatment B- GSK3640254 200 mg Tablet (Fed)
n=8 Participants
Participants received a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions (Treatment B-test) on Day 1 in treatment Period 1 or 2.
|
Treatment D- GSK3640254 200 mg Tablet (High Fat)
n=8 Participants
Participants received a single dose of GSK3640254 200 mg tablets, orally under high fat conditions (Treatment D-test) on Day 1 in treatment Period 1 or 2.
|
Treatment D- GSK3640254 200 mg Tablet (High Fat)
n=8 Participants
Participants received a single dose of GSK3640254 200 mg tablets, orally under high fat conditions (Treatment D-test) on Day 1 in treatment Period 1 or 2.
|
|---|---|---|---|---|
|
Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Volume
|
84.88 Femtoliter
Standard Deviation 4.055
|
85.00 Femtoliter
Standard Deviation 4.184
|
85.84 Femtoliter
Standard Deviation 4.373
|
85.90 Femtoliter
Standard Deviation 4.178
|
SECONDARY outcome
Timeframe: Day 2Population: Safety Population.
Blood samples were collected to analyze the hematology parameter: erythrocytes mean corpuscular hemoglobin.
Outcome measures
| Measure |
Treatment A- GSK3640254 200 mg Capsules (Fed)
n=8 Participants
Participants received a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions (Treatment A-reference) on Day 1 in treatment Period 1 or 2.
|
Treatment B- GSK3640254 200 mg Tablet (Fed)
n=8 Participants
Participants received a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions (Treatment B-test) on Day 1 in treatment Period 1 or 2.
|
Treatment D- GSK3640254 200 mg Tablet (High Fat)
n=8 Participants
Participants received a single dose of GSK3640254 200 mg tablets, orally under high fat conditions (Treatment D-test) on Day 1 in treatment Period 1 or 2.
|
Treatment D- GSK3640254 200 mg Tablet (High Fat)
n=8 Participants
Participants received a single dose of GSK3640254 200 mg tablets, orally under high fat conditions (Treatment D-test) on Day 1 in treatment Period 1 or 2.
|
|---|---|---|---|---|
|
Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin
|
28.01 Picograms
Standard Deviation 1.864
|
28.06 Picograms
Standard Deviation 1.905
|
28.94 Picograms
Standard Deviation 1.614
|
28.73 Picograms
Standard Deviation 1.424
|
SECONDARY outcome
Timeframe: Day 2Population: Safety Population.
Blood samples were collected to analyze the chemistry parameters: glucose, cholesterol, triglycerides, anion gap, calcium, carbon dioxide, chloride, phosphate, potassium, sodium and blood urea nitrogen.
Outcome measures
| Measure |
Treatment A- GSK3640254 200 mg Capsules (Fed)
n=8 Participants
Participants received a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions (Treatment A-reference) on Day 1 in treatment Period 1 or 2.
|
Treatment B- GSK3640254 200 mg Tablet (Fed)
n=8 Participants
Participants received a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions (Treatment B-test) on Day 1 in treatment Period 1 or 2.
|
Treatment D- GSK3640254 200 mg Tablet (High Fat)
n=8 Participants
Participants received a single dose of GSK3640254 200 mg tablets, orally under high fat conditions (Treatment D-test) on Day 1 in treatment Period 1 or 2.
|
Treatment D- GSK3640254 200 mg Tablet (High Fat)
n=8 Participants
Participants received a single dose of GSK3640254 200 mg tablets, orally under high fat conditions (Treatment D-test) on Day 1 in treatment Period 1 or 2.
|
|---|---|---|---|---|
|
Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Glucose
|
4.774 Millimoles per liter
Standard Deviation 0.2447
|
4.780 Millimoles per liter
Standard Deviation 0.1336
|
4.843 Millimoles per liter
Standard Deviation 0.3617
|
4.838 Millimoles per liter
Standard Deviation 0.2467
|
|
Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Cholesterol
|
4.853 Millimoles per liter
Standard Deviation 1.0266
|
4.630 Millimoles per liter
Standard Deviation 0.8081
|
5.028 Millimoles per liter
Standard Deviation 1.5207
|
4.960 Millimoles per liter
Standard Deviation 1.3009
|
|
Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Triglycerides
|
1.048 Millimoles per liter
Standard Deviation 0.5887
|
0.989 Millimoles per liter
Standard Deviation 0.6469
|
1.509 Millimoles per liter
Standard Deviation 1.1537
|
1.379 Millimoles per liter
Standard Deviation 0.8660
|
|
Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Anion gap
|
9.8 Millimoles per liter
Standard Deviation 1.58
|
9.9 Millimoles per liter
Standard Deviation 1.25
|
11.1 Millimoles per liter
Standard Deviation 2.03
|
10.9 Millimoles per liter
Standard Deviation 1.64
|
|
Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Calcium
|
2.473 Millimoles per liter
Standard Deviation 0.0453
|
2.430 Millimoles per liter
Standard Deviation 0.0609
|
2.421 Millimoles per liter
Standard Deviation 0.1025
|
2.431 Millimoles per liter
Standard Deviation 0.1005
|
|
Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Carbon dioxide
|
31.8 Millimoles per liter
Standard Deviation 1.16
|
31.3 Millimoles per liter
Standard Deviation 1.04
|
30.1 Millimoles per liter
Standard Deviation 2.30
|
30.5 Millimoles per liter
Standard Deviation 1.93
|
|
Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Chloride
|
101.1 Millimoles per liter
Standard Deviation 0.99
|
101.0 Millimoles per liter
Standard Deviation 1.60
|
101.5 Millimoles per liter
Standard Deviation 2.14
|
101.6 Millimoles per liter
Standard Deviation 1.92
|
|
Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Phosphate
|
1.173 Millimoles per liter
Standard Deviation 0.1278
|
1.201 Millimoles per liter
Standard Deviation 0.0606
|
1.199 Millimoles per liter
Standard Deviation 0.1929
|
1.230 Millimoles per liter
Standard Deviation 0.1292
|
|
Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Potassium
|
4.56 Millimoles per liter
Standard Deviation 0.334
|
4.50 Millimoles per liter
Standard Deviation 0.239
|
4.28 Millimoles per liter
Standard Deviation 0.282
|
4.36 Millimoles per liter
Standard Deviation 0.272
|
|
Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Sodium
|
138.1 Millimoles per liter
Standard Deviation 0.99
|
137.5 Millimoles per liter
Standard Deviation 2.00
|
138.5 Millimoles per liter
Standard Deviation 1.31
|
138.4 Millimoles per liter
Standard Deviation 1.19
|
|
Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Blood urea nitrogen
|
4.785 Millimoles per liter
Standard Deviation 0.9271
|
4.509 Millimoles per liter
Standard Deviation 1.1031
|
4.351 Millimoles per liter
Standard Deviation 1.0179
|
4.096 Millimoles per liter
Standard Deviation 0.8941
|
SECONDARY outcome
Timeframe: Day 2Population: Safety Population.
Blood samples were collected to analyze the chemistry parameters: creatine kinase, lactate dehydrogenase, ALT, ALP, AST and gamma-glutamyl transferase.
Outcome measures
| Measure |
Treatment A- GSK3640254 200 mg Capsules (Fed)
n=8 Participants
Participants received a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions (Treatment A-reference) on Day 1 in treatment Period 1 or 2.
|
Treatment B- GSK3640254 200 mg Tablet (Fed)
n=8 Participants
Participants received a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions (Treatment B-test) on Day 1 in treatment Period 1 or 2.
|
Treatment D- GSK3640254 200 mg Tablet (High Fat)
n=8 Participants
Participants received a single dose of GSK3640254 200 mg tablets, orally under high fat conditions (Treatment D-test) on Day 1 in treatment Period 1 or 2.
|
Treatment D- GSK3640254 200 mg Tablet (High Fat)
n=8 Participants
Participants received a single dose of GSK3640254 200 mg tablets, orally under high fat conditions (Treatment D-test) on Day 1 in treatment Period 1 or 2.
|
|---|---|---|---|---|
|
Absolute Values for Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase
Creatine kinase
|
116.1 International units per liter
Standard Deviation 36.01
|
116.8 International units per liter
Standard Deviation 48.18
|
94.8 International units per liter
Standard Deviation 44.83
|
111.9 International units per liter
Standard Deviation 55.35
|
|
Absolute Values for Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase
Lactate dehydrogenase
|
125.8 International units per liter
Standard Deviation 9.54
|
122.1 International units per liter
Standard Deviation 20.33
|
120.1 International units per liter
Standard Deviation 18.18
|
122.3 International units per liter
Standard Deviation 17.77
|
|
Absolute Values for Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase
ALT
|
18.1 International units per liter
Standard Deviation 3.09
|
15.0 International units per liter
Standard Deviation 3.46
|
17.9 International units per liter
Standard Deviation 14.22
|
18.5 International units per liter
Standard Deviation 15.32
|
|
Absolute Values for Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase
ALP
|
61.1 International units per liter
Standard Deviation 8.89
|
58.3 International units per liter
Standard Deviation 8.07
|
57.5 International units per liter
Standard Deviation 14.82
|
60.8 International units per liter
Standard Deviation 20.15
|
|
Absolute Values for Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase
AST
|
15.5 International units per liter
Standard Deviation 2.39
|
14.4 International units per liter
Standard Deviation 2.56
|
15.6 International units per liter
Standard Deviation 3.11
|
16.1 International units per liter
Standard Deviation 3.56
|
|
Absolute Values for Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase
Gamma-glutamyl transferase
|
18.3 International units per liter
Standard Deviation 7.74
|
17.5 International units per liter
Standard Deviation 7.54
|
28.4 International units per liter
Standard Deviation 24.07
|
28.3 International units per liter
Standard Deviation 21.26
|
SECONDARY outcome
Timeframe: Day 2Population: Safety Population.
Blood samples were collected to analyze the chemistry parameters: urate, creatinine, bilirubin and direct bilirubin.
Outcome measures
| Measure |
Treatment A- GSK3640254 200 mg Capsules (Fed)
n=8 Participants
Participants received a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions (Treatment A-reference) on Day 1 in treatment Period 1 or 2.
|
Treatment B- GSK3640254 200 mg Tablet (Fed)
n=8 Participants
Participants received a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions (Treatment B-test) on Day 1 in treatment Period 1 or 2.
|
Treatment D- GSK3640254 200 mg Tablet (High Fat)
n=8 Participants
Participants received a single dose of GSK3640254 200 mg tablets, orally under high fat conditions (Treatment D-test) on Day 1 in treatment Period 1 or 2.
|
Treatment D- GSK3640254 200 mg Tablet (High Fat)
n=8 Participants
Participants received a single dose of GSK3640254 200 mg tablets, orally under high fat conditions (Treatment D-test) on Day 1 in treatment Period 1 or 2.
|
|---|---|---|---|---|
|
Absolute Values for Chemistry Parameters: Urate, Creatinine, Bilirubin, Direct Bilirubin
Urate
|
289.9 Micromoles per liter
Standard Deviation 60.74
|
282.6 Micromoles per liter
Standard Deviation 60.69
|
287.0 Micromoles per liter
Standard Deviation 72.44
|
276.6 Micromoles per liter
Standard Deviation 60.99
|
|
Absolute Values for Chemistry Parameters: Urate, Creatinine, Bilirubin, Direct Bilirubin
Creatinine
|
92.84 Micromoles per liter
Standard Deviation 12.612
|
92.71 Micromoles per liter
Standard Deviation 12.136
|
84.95 Micromoles per liter
Standard Deviation 13.200
|
82.78 Micromoles per liter
Standard Deviation 13.843
|
|
Absolute Values for Chemistry Parameters: Urate, Creatinine, Bilirubin, Direct Bilirubin
Bilirubin
|
10.85 Micromoles per liter
Standard Deviation 2.838
|
10.78 Micromoles per liter
Standard Deviation 3.283
|
12.24 Micromoles per liter
Standard Deviation 5.172
|
11.09 Micromoles per liter
Standard Deviation 4.149
|
|
Absolute Values for Chemistry Parameters: Urate, Creatinine, Bilirubin, Direct Bilirubin
Direct bilirubin
|
2.04 Micromoles per liter
Standard Deviation 0.526
|
2.13 Micromoles per liter
Standard Deviation 0.607
|
2.29 Micromoles per liter
Standard Deviation 1.241
|
2.14 Micromoles per liter
Standard Deviation 1.041
|
SECONDARY outcome
Timeframe: Day 2Population: Safety Population.
Blood samples were collected to analyze the chemistry parameters: albumin, globulin and protein.
Outcome measures
| Measure |
Treatment A- GSK3640254 200 mg Capsules (Fed)
n=8 Participants
Participants received a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions (Treatment A-reference) on Day 1 in treatment Period 1 or 2.
|
Treatment B- GSK3640254 200 mg Tablet (Fed)
n=8 Participants
Participants received a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions (Treatment B-test) on Day 1 in treatment Period 1 or 2.
|
Treatment D- GSK3640254 200 mg Tablet (High Fat)
n=8 Participants
Participants received a single dose of GSK3640254 200 mg tablets, orally under high fat conditions (Treatment D-test) on Day 1 in treatment Period 1 or 2.
|
Treatment D- GSK3640254 200 mg Tablet (High Fat)
n=8 Participants
Participants received a single dose of GSK3640254 200 mg tablets, orally under high fat conditions (Treatment D-test) on Day 1 in treatment Period 1 or 2.
|
|---|---|---|---|---|
|
Absolute Values for Chemistry Parameters: Albumin, Globulin, Protein
Albumin
|
45.8 Grams per liter
Standard Deviation 1.49
|
44.0 Grams per liter
Standard Deviation 1.77
|
45.9 Grams per liter
Standard Deviation 2.85
|
46.4 Grams per liter
Standard Deviation 3.20
|
|
Absolute Values for Chemistry Parameters: Albumin, Globulin, Protein
Globulin
|
27.8 Grams per liter
Standard Deviation 3.20
|
27.1 Grams per liter
Standard Deviation 4.02
|
25.3 Grams per liter
Standard Deviation 3.11
|
25.8 Grams per liter
Standard Deviation 2.92
|
|
Absolute Values for Chemistry Parameters: Albumin, Globulin, Protein
Protein
|
73.5 Grams per liter
Standard Deviation 2.56
|
71.1 Grams per liter
Standard Deviation 3.36
|
71.1 Grams per liter
Standard Deviation 3.98
|
72.1 Grams per liter
Standard Deviation 5.06
|
SECONDARY outcome
Timeframe: Day 2Population: Safety Population.
Blood samples were collected to analyze the chemistry parameters: amylase and lipase.
Outcome measures
| Measure |
Treatment A- GSK3640254 200 mg Capsules (Fed)
n=8 Participants
Participants received a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions (Treatment A-reference) on Day 1 in treatment Period 1 or 2.
|
Treatment B- GSK3640254 200 mg Tablet (Fed)
n=8 Participants
Participants received a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions (Treatment B-test) on Day 1 in treatment Period 1 or 2.
|
Treatment D- GSK3640254 200 mg Tablet (High Fat)
n=8 Participants
Participants received a single dose of GSK3640254 200 mg tablets, orally under high fat conditions (Treatment D-test) on Day 1 in treatment Period 1 or 2.
|
Treatment D- GSK3640254 200 mg Tablet (High Fat)
n=8 Participants
Participants received a single dose of GSK3640254 200 mg tablets, orally under high fat conditions (Treatment D-test) on Day 1 in treatment Period 1 or 2.
|
|---|---|---|---|---|
|
Absolute Values for Chemistry Parameters: Amylase, Lipase
Amylase
|
53.8 Units per liter
Standard Deviation 11.51
|
54.3 Units per liter
Standard Deviation 14.39
|
66.3 Units per liter
Standard Deviation 26.29
|
68.8 Units per liter
Standard Deviation 24.84
|
|
Absolute Values for Chemistry Parameters: Amylase, Lipase
Lipase
|
19.6 Units per liter
Standard Deviation 10.00
|
21.6 Units per liter
Standard Deviation 13.67
|
21.6 Units per liter
Standard Deviation 11.69
|
22.9 Units per liter
Standard Deviation 10.08
|
SECONDARY outcome
Timeframe: Day 2Population: Safety Population.
Urine samples were collected to analyze the urine parameter: specific gravity. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine.
Outcome measures
| Measure |
Treatment A- GSK3640254 200 mg Capsules (Fed)
n=8 Participants
Participants received a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions (Treatment A-reference) on Day 1 in treatment Period 1 or 2.
|
Treatment B- GSK3640254 200 mg Tablet (Fed)
n=8 Participants
Participants received a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions (Treatment B-test) on Day 1 in treatment Period 1 or 2.
|
Treatment D- GSK3640254 200 mg Tablet (High Fat)
n=8 Participants
Participants received a single dose of GSK3640254 200 mg tablets, orally under high fat conditions (Treatment D-test) on Day 1 in treatment Period 1 or 2.
|
Treatment D- GSK3640254 200 mg Tablet (High Fat)
n=8 Participants
Participants received a single dose of GSK3640254 200 mg tablets, orally under high fat conditions (Treatment D-test) on Day 1 in treatment Period 1 or 2.
|
|---|---|---|---|---|
|
Absolute Values for Urine Parameter: Specific Gravity
|
1.0169 Ratio
Standard Deviation 0.00666
|
1.0108 Ratio
Standard Deviation 0.00774
|
1.0165 Ratio
Standard Deviation 0.00590
|
1.0150 Ratio
Standard Deviation 0.00632
|
SECONDARY outcome
Timeframe: Day 2Population: Safety Population.
Urine samples were collected to analyze the urine parameter: urobilinogen.
Outcome measures
| Measure |
Treatment A- GSK3640254 200 mg Capsules (Fed)
n=8 Participants
Participants received a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions (Treatment A-reference) on Day 1 in treatment Period 1 or 2.
|
Treatment B- GSK3640254 200 mg Tablet (Fed)
n=8 Participants
Participants received a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions (Treatment B-test) on Day 1 in treatment Period 1 or 2.
|
Treatment D- GSK3640254 200 mg Tablet (High Fat)
n=8 Participants
Participants received a single dose of GSK3640254 200 mg tablets, orally under high fat conditions (Treatment D-test) on Day 1 in treatment Period 1 or 2.
|
Treatment D- GSK3640254 200 mg Tablet (High Fat)
n=8 Participants
Participants received a single dose of GSK3640254 200 mg tablets, orally under high fat conditions (Treatment D-test) on Day 1 in treatment Period 1 or 2.
|
|---|---|---|---|---|
|
Absolute Values for Urine Parameter: Urobilinogen
|
3.3860 Micromoles per liter
Standard Deviation 0.00000
|
5.0790 Micromoles per liter
Standard Deviation 4.78853
|
8.4650 Micromoles per liter
Standard Deviation 7.00969
|
5.0790 Micromoles per liter
Standard Deviation 4.78853
|
SECONDARY outcome
Timeframe: Day 2Population: Safety Population.
Urine samples were collected to analyze the urine parameter: pH. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acidic pH (5.0 - 6.0).
Outcome measures
| Measure |
Treatment A- GSK3640254 200 mg Capsules (Fed)
n=8 Participants
Participants received a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions (Treatment A-reference) on Day 1 in treatment Period 1 or 2.
|
Treatment B- GSK3640254 200 mg Tablet (Fed)
n=8 Participants
Participants received a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions (Treatment B-test) on Day 1 in treatment Period 1 or 2.
|
Treatment D- GSK3640254 200 mg Tablet (High Fat)
n=8 Participants
Participants received a single dose of GSK3640254 200 mg tablets, orally under high fat conditions (Treatment D-test) on Day 1 in treatment Period 1 or 2.
|
Treatment D- GSK3640254 200 mg Tablet (High Fat)
n=8 Participants
Participants received a single dose of GSK3640254 200 mg tablets, orally under high fat conditions (Treatment D-test) on Day 1 in treatment Period 1 or 2.
|
|---|---|---|---|---|
|
Absolute Values for Urine Parameter: Potential of Hydrogen (pH)
|
6.38 pH
Standard Deviation 0.518
|
6.31 pH
Standard Deviation 0.704
|
6.31 pH
Standard Deviation 0.530
|
6.13 pH
Standard Deviation 0.641
|
SECONDARY outcome
Timeframe: Day 1: 2 hours and 4 hoursPopulation: Safety Population.
Twelve-lead ECGs were obtained to measure PR Interval, QRS Duration, QT Interval, QTcF Interval and QTcB Interval. Twelve-lead ECGs were performed with the participant in a supine or semi-supine position after a rest of at least 10 minutes.
Outcome measures
| Measure |
Treatment A- GSK3640254 200 mg Capsules (Fed)
n=8 Participants
Participants received a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions (Treatment A-reference) on Day 1 in treatment Period 1 or 2.
|
Treatment B- GSK3640254 200 mg Tablet (Fed)
n=8 Participants
Participants received a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions (Treatment B-test) on Day 1 in treatment Period 1 or 2.
|
Treatment D- GSK3640254 200 mg Tablet (High Fat)
n=8 Participants
Participants received a single dose of GSK3640254 200 mg tablets, orally under high fat conditions (Treatment D-test) on Day 1 in treatment Period 1 or 2.
|
Treatment D- GSK3640254 200 mg Tablet (High Fat)
n=8 Participants
Participants received a single dose of GSK3640254 200 mg tablets, orally under high fat conditions (Treatment D-test) on Day 1 in treatment Period 1 or 2.
|
|---|---|---|---|---|
|
Absolute Values for Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval, Corrected QT Interval Using Fridericia's Formula (QTcF), Corrected QT Interval Using Bazett's Formula (QTcB)
PR Interval: Day 1, 2 hours
|
173.3 Milliseconds
Standard Deviation 9.62
|
173.4 Milliseconds
Standard Deviation 11.07
|
158.3 Milliseconds
Standard Deviation 17.85
|
156.9 Milliseconds
Standard Deviation 18.37
|
|
Absolute Values for Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval, Corrected QT Interval Using Fridericia's Formula (QTcF), Corrected QT Interval Using Bazett's Formula (QTcB)
PR Interval: Day 1, 4 hours
|
174.4 Milliseconds
Standard Deviation 11.25
|
173.0 Milliseconds
Standard Deviation 9.55
|
157.5 Milliseconds
Standard Deviation 14.29
|
149.6 Milliseconds
Standard Deviation 17.07
|
|
Absolute Values for Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval, Corrected QT Interval Using Fridericia's Formula (QTcF), Corrected QT Interval Using Bazett's Formula (QTcB)
QRS Duration: Day 1, 2 hours
|
90.9 Milliseconds
Standard Deviation 6.60
|
94.3 Milliseconds
Standard Deviation 6.02
|
91.5 Milliseconds
Standard Deviation 11.10
|
92.6 Milliseconds
Standard Deviation 10.68
|
|
Absolute Values for Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval, Corrected QT Interval Using Fridericia's Formula (QTcF), Corrected QT Interval Using Bazett's Formula (QTcB)
QRS Duration: Day 1, 4 hours
|
90.5 Milliseconds
Standard Deviation 5.88
|
91.4 Milliseconds
Standard Deviation 7.95
|
91.3 Milliseconds
Standard Deviation 9.13
|
92.1 Milliseconds
Standard Deviation 6.58
|
|
Absolute Values for Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval, Corrected QT Interval Using Fridericia's Formula (QTcF), Corrected QT Interval Using Bazett's Formula (QTcB)
QT Interval: Day 1, 2 hours
|
372.1 Milliseconds
Standard Deviation 22.03
|
372.8 Milliseconds
Standard Deviation 21.74
|
405.8 Milliseconds
Standard Deviation 25.73
|
387.6 Milliseconds
Standard Deviation 29.34
|
|
Absolute Values for Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval, Corrected QT Interval Using Fridericia's Formula (QTcF), Corrected QT Interval Using Bazett's Formula (QTcB)
QT Interval: Day 1, 4 hours
|
393.0 Milliseconds
Standard Deviation 22.55
|
391.0 Milliseconds
Standard Deviation 25.95
|
411.5 Milliseconds
Standard Deviation 30.29
|
398.3 Milliseconds
Standard Deviation 23.92
|
|
Absolute Values for Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval, Corrected QT Interval Using Fridericia's Formula (QTcF), Corrected QT Interval Using Bazett's Formula (QTcB)
QTcF Interval: Day 1, 2 hours
|
374.8 Milliseconds
Standard Deviation 14.41
|
376.0 Milliseconds
Standard Deviation 20.09
|
406.1 Milliseconds
Standard Deviation 23.12
|
399.9 Milliseconds
Standard Deviation 19.79
|
|
Absolute Values for Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval, Corrected QT Interval Using Fridericia's Formula (QTcF), Corrected QT Interval Using Bazett's Formula (QTcB)
QTcF Interval: Day 1, 4 hours
|
380.9 Milliseconds
Standard Deviation 18.00
|
381.1 Milliseconds
Standard Deviation 15.37
|
406.5 Milliseconds
Standard Deviation 24.60
|
410.6 Milliseconds
Standard Deviation 20.85
|
|
Absolute Values for Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval, Corrected QT Interval Using Fridericia's Formula (QTcF), Corrected QT Interval Using Bazett's Formula (QTcB)
QTcB Interval: Day 1, 2 hours
|
376.3 Milliseconds
Standard Deviation 13.54
|
377.9 Milliseconds
Standard Deviation 20.92
|
406.6 Milliseconds
Standard Deviation 26.45
|
406.8 Milliseconds
Standard Deviation 24.77
|
|
Absolute Values for Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval, Corrected QT Interval Using Fridericia's Formula (QTcF), Corrected QT Interval Using Bazett's Formula (QTcB)
QTcB Interval: Day 1, 4 hours
|
375.1 Milliseconds
Standard Deviation 18.55
|
376.5 Milliseconds
Standard Deviation 12.93
|
404.5 Milliseconds
Standard Deviation 28.43
|
417.4 Milliseconds
Standard Deviation 24.86
|
SECONDARY outcome
Timeframe: Days 2, 3, 4, and 5Population: Safety Population.
SBP and DBP were measured in the semi-recumbent position with a completely automated device after at least 5 minutes of rest for the participant in a quiet setting without any distractions.
Outcome measures
| Measure |
Treatment A- GSK3640254 200 mg Capsules (Fed)
n=8 Participants
Participants received a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions (Treatment A-reference) on Day 1 in treatment Period 1 or 2.
|
Treatment B- GSK3640254 200 mg Tablet (Fed)
n=8 Participants
Participants received a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions (Treatment B-test) on Day 1 in treatment Period 1 or 2.
|
Treatment D- GSK3640254 200 mg Tablet (High Fat)
n=8 Participants
Participants received a single dose of GSK3640254 200 mg tablets, orally under high fat conditions (Treatment D-test) on Day 1 in treatment Period 1 or 2.
|
Treatment D- GSK3640254 200 mg Tablet (High Fat)
n=8 Participants
Participants received a single dose of GSK3640254 200 mg tablets, orally under high fat conditions (Treatment D-test) on Day 1 in treatment Period 1 or 2.
|
|---|---|---|---|---|
|
Absolute Values for Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SBP: Day 2
|
116.0 Millimeters of mercury
Standard Deviation 8.05
|
115.1 Millimeters of mercury
Standard Deviation 6.77
|
116.4 Millimeters of mercury
Standard Deviation 10.25
|
118.3 Millimeters of mercury
Standard Deviation 15.00
|
|
Absolute Values for Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SBP: Day 3
|
116.4 Millimeters of mercury
Standard Deviation 8.85
|
115.6 Millimeters of mercury
Standard Deviation 10.34
|
117.1 Millimeters of mercury
Standard Deviation 7.57
|
115.6 Millimeters of mercury
Standard Deviation 9.66
|
|
Absolute Values for Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SBP: Day 4
|
114.6 Millimeters of mercury
Standard Deviation 8.45
|
117.6 Millimeters of mercury
Standard Deviation 13.10
|
113.6 Millimeters of mercury
Standard Deviation 11.33
|
116.5 Millimeters of mercury
Standard Deviation 12.25
|
|
Absolute Values for Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SBP: Day 5
|
113.4 Millimeters of mercury
Standard Deviation 8.58
|
113.9 Millimeters of mercury
Standard Deviation 10.58
|
113.8 Millimeters of mercury
Standard Deviation 9.29
|
113.6 Millimeters of mercury
Standard Deviation 7.01
|
|
Absolute Values for Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
DBP: Day 2
|
69.4 Millimeters of mercury
Standard Deviation 6.61
|
69.6 Millimeters of mercury
Standard Deviation 6.61
|
71.0 Millimeters of mercury
Standard Deviation 8.16
|
71.0 Millimeters of mercury
Standard Deviation 12.73
|
|
Absolute Values for Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
DBP: Day 3
|
65.3 Millimeters of mercury
Standard Deviation 7.52
|
66.3 Millimeters of mercury
Standard Deviation 9.75
|
68.6 Millimeters of mercury
Standard Deviation 7.13
|
71.9 Millimeters of mercury
Standard Deviation 9.28
|
|
Absolute Values for Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
DBP: Day 4
|
68.8 Millimeters of mercury
Standard Deviation 9.71
|
68.9 Millimeters of mercury
Standard Deviation 10.76
|
72.0 Millimeters of mercury
Standard Deviation 9.38
|
73.4 Millimeters of mercury
Standard Deviation 9.55
|
|
Absolute Values for Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
DBP: Day 5
|
70.0 Millimeters of mercury
Standard Deviation 10.09
|
68.3 Millimeters of mercury
Standard Deviation 11.65
|
72.4 Millimeters of mercury
Standard Deviation 7.95
|
70.6 Millimeters of mercury
Standard Deviation 6.70
|
SECONDARY outcome
Timeframe: Days 2, 3, 4, and 5Population: Safety Population.
Pulse rate was measured in the semi-recumbent position with a completely automated device after at least 5 minutes of rest for the participant in a quiet setting without any distractions.
Outcome measures
| Measure |
Treatment A- GSK3640254 200 mg Capsules (Fed)
n=8 Participants
Participants received a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions (Treatment A-reference) on Day 1 in treatment Period 1 or 2.
|
Treatment B- GSK3640254 200 mg Tablet (Fed)
n=8 Participants
Participants received a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions (Treatment B-test) on Day 1 in treatment Period 1 or 2.
|
Treatment D- GSK3640254 200 mg Tablet (High Fat)
n=8 Participants
Participants received a single dose of GSK3640254 200 mg tablets, orally under high fat conditions (Treatment D-test) on Day 1 in treatment Period 1 or 2.
|
Treatment D- GSK3640254 200 mg Tablet (High Fat)
n=8 Participants
Participants received a single dose of GSK3640254 200 mg tablets, orally under high fat conditions (Treatment D-test) on Day 1 in treatment Period 1 or 2.
|
|---|---|---|---|---|
|
Absolute Values for Pulse Rate
Day 2
|
60.0 Beats per minute
Standard Deviation 6.19
|
61.3 Beats per minute
Standard Deviation 9.79
|
66.0 Beats per minute
Standard Deviation 11.75
|
64.5 Beats per minute
Standard Deviation 7.91
|
|
Absolute Values for Pulse Rate
Day 3
|
62.5 Beats per minute
Standard Deviation 7.54
|
61.4 Beats per minute
Standard Deviation 9.07
|
63.4 Beats per minute
Standard Deviation 8.94
|
67.9 Beats per minute
Standard Deviation 9.57
|
|
Absolute Values for Pulse Rate
Day 4
|
62.9 Beats per minute
Standard Deviation 9.51
|
61.9 Beats per minute
Standard Deviation 7.20
|
67.1 Beats per minute
Standard Deviation 8.39
|
64.5 Beats per minute
Standard Deviation 10.84
|
|
Absolute Values for Pulse Rate
Day 5
|
60.4 Beats per minute
Standard Deviation 8.47
|
62.8 Beats per minute
Standard Deviation 11.21
|
67.4 Beats per minute
Standard Deviation 5.76
|
65.8 Beats per minute
Standard Deviation 9.27
|
SECONDARY outcome
Timeframe: Days 2, 3, 4, and 5Population: Safety Population.
Respiratory rate was measured in the semi-recumbent position after at least 5 minutes of rest for the participant in a quiet setting without distractions.
Outcome measures
| Measure |
Treatment A- GSK3640254 200 mg Capsules (Fed)
n=8 Participants
Participants received a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions (Treatment A-reference) on Day 1 in treatment Period 1 or 2.
|
Treatment B- GSK3640254 200 mg Tablet (Fed)
n=8 Participants
Participants received a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions (Treatment B-test) on Day 1 in treatment Period 1 or 2.
|
Treatment D- GSK3640254 200 mg Tablet (High Fat)
n=8 Participants
Participants received a single dose of GSK3640254 200 mg tablets, orally under high fat conditions (Treatment D-test) on Day 1 in treatment Period 1 or 2.
|
Treatment D- GSK3640254 200 mg Tablet (High Fat)
n=8 Participants
Participants received a single dose of GSK3640254 200 mg tablets, orally under high fat conditions (Treatment D-test) on Day 1 in treatment Period 1 or 2.
|
|---|---|---|---|---|
|
Absolute Values for Respiratory Rate
Day 2
|
14.3 Breaths per minute
Standard Deviation 2.71
|
13.8 Breaths per minute
Standard Deviation 2.25
|
14.0 Breaths per minute
Standard Deviation 2.83
|
14.0 Breaths per minute
Standard Deviation 3.55
|
|
Absolute Values for Respiratory Rate
Day 3
|
15.8 Breaths per minute
Standard Deviation 1.98
|
15.5 Breaths per minute
Standard Deviation 2.33
|
14.3 Breaths per minute
Standard Deviation 1.98
|
14.3 Breaths per minute
Standard Deviation 2.25
|
|
Absolute Values for Respiratory Rate
Day 4
|
16.0 Breaths per minute
Standard Deviation 0.00
|
16.0 Breaths per minute
Standard Deviation 1.07
|
14.5 Breaths per minute
Standard Deviation 1.41
|
14.3 Breaths per minute
Standard Deviation 2.25
|
|
Absolute Values for Respiratory Rate
Day 5
|
15.8 Breaths per minute
Standard Deviation 3.62
|
15.3 Breaths per minute
Standard Deviation 3.01
|
15.8 Breaths per minute
Standard Deviation 2.25
|
14.5 Breaths per minute
Standard Deviation 3.51
|
SECONDARY outcome
Timeframe: Days 2, 3, 4, and 5Population: Safety Population.
Body temperature was measured in the semi-recumbent position after at least 5 minutes of rest for the participant in a quiet setting without distractions.
Outcome measures
| Measure |
Treatment A- GSK3640254 200 mg Capsules (Fed)
n=8 Participants
Participants received a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions (Treatment A-reference) on Day 1 in treatment Period 1 or 2.
|
Treatment B- GSK3640254 200 mg Tablet (Fed)
n=8 Participants
Participants received a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions (Treatment B-test) on Day 1 in treatment Period 1 or 2.
|
Treatment D- GSK3640254 200 mg Tablet (High Fat)
n=8 Participants
Participants received a single dose of GSK3640254 200 mg tablets, orally under high fat conditions (Treatment D-test) on Day 1 in treatment Period 1 or 2.
|
Treatment D- GSK3640254 200 mg Tablet (High Fat)
n=8 Participants
Participants received a single dose of GSK3640254 200 mg tablets, orally under high fat conditions (Treatment D-test) on Day 1 in treatment Period 1 or 2.
|
|---|---|---|---|---|
|
Absolute Values for Body Temperature
Day 5
|
36.33 Degrees Celsius
Standard Deviation 0.238
|
36.41 Degrees Celsius
Standard Deviation 0.309
|
36.24 Degrees Celsius
Standard Deviation 0.213
|
36.36 Degrees Celsius
Standard Deviation 0.385
|
|
Absolute Values for Body Temperature
Day 2
|
36.15 Degrees Celsius
Standard Deviation 0.378
|
36.28 Degrees Celsius
Standard Deviation 0.292
|
36.15 Degrees Celsius
Standard Deviation 0.548
|
36.16 Degrees Celsius
Standard Deviation 0.407
|
|
Absolute Values for Body Temperature
Day 3
|
36.13 Degrees Celsius
Standard Deviation 0.219
|
36.34 Degrees Celsius
Standard Deviation 0.297
|
36.19 Degrees Celsius
Standard Deviation 0.230
|
36.11 Degrees Celsius
Standard Deviation 0.429
|
|
Absolute Values for Body Temperature
Day 4
|
36.21 Degrees Celsius
Standard Deviation 0.295
|
36.09 Degrees Celsius
Standard Deviation 0.242
|
36.26 Degrees Celsius
Standard Deviation 0.407
|
36.21 Degrees Celsius
Standard Deviation 0.253
|
SECONDARY outcome
Timeframe: Baseline (Day -1) and at Day 2Population: Safety Population.
Blood samples were collected to analyze the hematology parameters: basophils, eosinophils, lymphocytes, monocytes, neutrophils and platelet count. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, prior to the first dose of study drug administration. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Treatment A- GSK3640254 200 mg Capsules (Fed)
n=8 Participants
Participants received a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions (Treatment A-reference) on Day 1 in treatment Period 1 or 2.
|
Treatment B- GSK3640254 200 mg Tablet (Fed)
n=8 Participants
Participants received a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions (Treatment B-test) on Day 1 in treatment Period 1 or 2.
|
Treatment D- GSK3640254 200 mg Tablet (High Fat)
n=8 Participants
Participants received a single dose of GSK3640254 200 mg tablets, orally under high fat conditions (Treatment D-test) on Day 1 in treatment Period 1 or 2.
|
Treatment D- GSK3640254 200 mg Tablet (High Fat)
n=8 Participants
Participants received a single dose of GSK3640254 200 mg tablets, orally under high fat conditions (Treatment D-test) on Day 1 in treatment Period 1 or 2.
|
|---|---|---|---|---|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count
Neutrophils
|
-0.214 10^9 cells per liter
Standard Deviation 0.4939
|
-0.135 10^9 cells per liter
Standard Deviation 0.2945
|
-0.166 10^9 cells per liter
Standard Deviation 0.7631
|
-0.234 10^9 cells per liter
Standard Deviation 0.5199
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count
Platelet count
|
18.3 10^9 cells per liter
Standard Deviation 22.63
|
7.6 10^9 cells per liter
Standard Deviation 11.84
|
6.1 10^9 cells per liter
Standard Deviation 18.76
|
5.3 10^9 cells per liter
Standard Deviation 18.38
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count
Basophils
|
-0.001 10^9 cells per liter
Standard Deviation 0.0099
|
0.003 10^9 cells per liter
Standard Deviation 0.0149
|
-0.004 10^9 cells per liter
Standard Deviation 0.0074
|
-0.003 10^9 cells per liter
Standard Deviation 0.0071
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count
Eosinophils
|
-0.005 10^9 cells per liter
Standard Deviation 0.0338
|
0.005 10^9 cells per liter
Standard Deviation 0.0278
|
0.009 10^9 cells per liter
Standard Deviation 0.0259
|
0.010 10^9 cells per liter
Standard Deviation 0.0169
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count
Lymphocytes
|
-0.170 10^9 cells per liter
Standard Deviation 0.3945
|
-0.154 10^9 cells per liter
Standard Deviation 0.5025
|
0.015 10^9 cells per liter
Standard Deviation 0.1927
|
-0.123 10^9 cells per liter
Standard Deviation 0.1959
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count
Monocytes
|
-0.015 10^9 cells per liter
Standard Deviation 0.0487
|
0.004 10^9 cells per liter
Standard Deviation 0.0721
|
0.019 10^9 cells per liter
Standard Deviation 0.0884
|
-0.005 10^9 cells per liter
Standard Deviation 0.0767
|
SECONDARY outcome
Timeframe: Baseline (Day -1) and at Day 2Population: Safety Population.
Blood samples were collected to analyze the hematology parameter: hemoglobin. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, prior to the first dose of study drug administration. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Treatment A- GSK3640254 200 mg Capsules (Fed)
n=8 Participants
Participants received a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions (Treatment A-reference) on Day 1 in treatment Period 1 or 2.
|
Treatment B- GSK3640254 200 mg Tablet (Fed)
n=8 Participants
Participants received a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions (Treatment B-test) on Day 1 in treatment Period 1 or 2.
|
Treatment D- GSK3640254 200 mg Tablet (High Fat)
n=8 Participants
Participants received a single dose of GSK3640254 200 mg tablets, orally under high fat conditions (Treatment D-test) on Day 1 in treatment Period 1 or 2.
|
Treatment D- GSK3640254 200 mg Tablet (High Fat)
n=8 Participants
Participants received a single dose of GSK3640254 200 mg tablets, orally under high fat conditions (Treatment D-test) on Day 1 in treatment Period 1 or 2.
|
|---|---|---|---|---|
|
Change From Baseline in Hematology Parameter: Hemoglobin
|
6.0 Grams per liter
Standard Deviation 4.34
|
4.0 Grams per liter
Standard Deviation 4.93
|
3.3 Grams per liter
Standard Deviation 6.50
|
4.0 Grams per liter
Standard Deviation 7.33
|
SECONDARY outcome
Timeframe: Baseline (Day -1) and at Day 2Population: Safety Population.
Blood samples were collected to analyze the hematology parameter: hematocrit. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, prior to the first dose of study drug administration. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Treatment A- GSK3640254 200 mg Capsules (Fed)
n=8 Participants
Participants received a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions (Treatment A-reference) on Day 1 in treatment Period 1 or 2.
|
Treatment B- GSK3640254 200 mg Tablet (Fed)
n=8 Participants
Participants received a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions (Treatment B-test) on Day 1 in treatment Period 1 or 2.
|
Treatment D- GSK3640254 200 mg Tablet (High Fat)
n=8 Participants
Participants received a single dose of GSK3640254 200 mg tablets, orally under high fat conditions (Treatment D-test) on Day 1 in treatment Period 1 or 2.
|
Treatment D- GSK3640254 200 mg Tablet (High Fat)
n=8 Participants
Participants received a single dose of GSK3640254 200 mg tablets, orally under high fat conditions (Treatment D-test) on Day 1 in treatment Period 1 or 2.
|
|---|---|---|---|---|
|
Change From Baseline in Hematology Parameter: Hematocrit
|
0.0179 Proportion of red blood cells in blood
Standard Deviation 0.01374
|
0.0116 Proportion of red blood cells in blood
Standard Deviation 0.01430
|
0.0063 Proportion of red blood cells in blood
Standard Deviation 0.01884
|
0.0114 Proportion of red blood cells in blood
Standard Deviation 0.01963
|
SECONDARY outcome
Timeframe: Baseline (Day -1) and at Day 2Population: Safety Population.
Blood samples were collected to analyze the hematology parameter: erythrocytes. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, prior to the first dose of study drug administration. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Treatment A- GSK3640254 200 mg Capsules (Fed)
n=8 Participants
Participants received a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions (Treatment A-reference) on Day 1 in treatment Period 1 or 2.
|
Treatment B- GSK3640254 200 mg Tablet (Fed)
n=8 Participants
Participants received a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions (Treatment B-test) on Day 1 in treatment Period 1 or 2.
|
Treatment D- GSK3640254 200 mg Tablet (High Fat)
n=8 Participants
Participants received a single dose of GSK3640254 200 mg tablets, orally under high fat conditions (Treatment D-test) on Day 1 in treatment Period 1 or 2.
|
Treatment D- GSK3640254 200 mg Tablet (High Fat)
n=8 Participants
Participants received a single dose of GSK3640254 200 mg tablets, orally under high fat conditions (Treatment D-test) on Day 1 in treatment Period 1 or 2.
|
|---|---|---|---|---|
|
Change From Baseline in Hematology Parameter: Erythrocytes
|
0.241 10^12 cells per liter
Standard Deviation 0.1604
|
0.163 10^12 cells per liter
Standard Deviation 0.1521
|
0.100 10^12 cells per liter
Standard Deviation 0.2321
|
0.154 10^12 cells per liter
Standard Deviation 0.2329
|
SECONDARY outcome
Timeframe: Baseline (Day -1) and at Day 2Population: Safety Population.
Blood samples were collected to analyze the hematology parameter: erythrocytes mean corpuscular volume. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, prior to the first dose of study drug administration. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Treatment A- GSK3640254 200 mg Capsules (Fed)
n=8 Participants
Participants received a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions (Treatment A-reference) on Day 1 in treatment Period 1 or 2.
|
Treatment B- GSK3640254 200 mg Tablet (Fed)
n=8 Participants
Participants received a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions (Treatment B-test) on Day 1 in treatment Period 1 or 2.
|
Treatment D- GSK3640254 200 mg Tablet (High Fat)
n=8 Participants
Participants received a single dose of GSK3640254 200 mg tablets, orally under high fat conditions (Treatment D-test) on Day 1 in treatment Period 1 or 2.
|
Treatment D- GSK3640254 200 mg Tablet (High Fat)
n=8 Participants
Participants received a single dose of GSK3640254 200 mg tablets, orally under high fat conditions (Treatment D-test) on Day 1 in treatment Period 1 or 2.
|
|---|---|---|---|---|
|
Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume
|
-0.61 Femtoliter
Standard Deviation 0.416
|
-0.49 Femtoliter
Standard Deviation 0.582
|
-0.45 Femtoliter
Standard Deviation 0.672
|
-0.39 Femtoliter
Standard Deviation 0.340
|
SECONDARY outcome
Timeframe: Baseline (Day -1) and at Day 2Population: Safety Population.
Blood samples were collected to analyze the hematology parameter: erythrocytes mean corpuscular hemoglobin. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, prior to the first dose of study drug administration. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Treatment A- GSK3640254 200 mg Capsules (Fed)
n=8 Participants
Participants received a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions (Treatment A-reference) on Day 1 in treatment Period 1 or 2.
|
Treatment B- GSK3640254 200 mg Tablet (Fed)
n=8 Participants
Participants received a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions (Treatment B-test) on Day 1 in treatment Period 1 or 2.
|
Treatment D- GSK3640254 200 mg Tablet (High Fat)
n=8 Participants
Participants received a single dose of GSK3640254 200 mg tablets, orally under high fat conditions (Treatment D-test) on Day 1 in treatment Period 1 or 2.
|
Treatment D- GSK3640254 200 mg Tablet (High Fat)
n=8 Participants
Participants received a single dose of GSK3640254 200 mg tablets, orally under high fat conditions (Treatment D-test) on Day 1 in treatment Period 1 or 2.
|
|---|---|---|---|---|
|
Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin
|
-0.10 Picograms
Standard Deviation 0.245
|
-0.05 Picograms
Standard Deviation 0.220
|
0.09 Picograms
Standard Deviation 0.387
|
-0.13 Picograms
Standard Deviation 0.306
|
SECONDARY outcome
Timeframe: Baseline (Day -1) and at Day 2Population: Safety Population.
Blood samples were collected to analyze the chemistry parameters: glucose, cholesterol, triglycerides, anion gap, calcium, carbon dioxide, chloride, phosphate, potassium, sodium and blood urea nitrogen. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, prior to the first dose of study drug administration. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Treatment A- GSK3640254 200 mg Capsules (Fed)
n=8 Participants
Participants received a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions (Treatment A-reference) on Day 1 in treatment Period 1 or 2.
|
Treatment B- GSK3640254 200 mg Tablet (Fed)
n=8 Participants
Participants received a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions (Treatment B-test) on Day 1 in treatment Period 1 or 2.
|
Treatment D- GSK3640254 200 mg Tablet (High Fat)
n=8 Participants
Participants received a single dose of GSK3640254 200 mg tablets, orally under high fat conditions (Treatment D-test) on Day 1 in treatment Period 1 or 2.
|
Treatment D- GSK3640254 200 mg Tablet (High Fat)
n=8 Participants
Participants received a single dose of GSK3640254 200 mg tablets, orally under high fat conditions (Treatment D-test) on Day 1 in treatment Period 1 or 2.
|
|---|---|---|---|---|
|
Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Glucose
|
-0.055 Millimoles per liter
Standard Deviation 0.3778
|
-0.049 Millimoles per liter
Standard Deviation 0.2568
|
-0.168 Millimoles per liter
Standard Deviation 0.2530
|
-0.173 Millimoles per liter
Standard Deviation 0.3159
|
|
Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Cholesterol
|
0.498 Millimoles per liter
Standard Deviation 0.7449
|
0.275 Millimoles per liter
Standard Deviation 0.4277
|
0.310 Millimoles per liter
Standard Deviation 0.4079
|
0.243 Millimoles per liter
Standard Deviation 0.3383
|
|
Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Triglycerides
|
0.026 Millimoles per liter
Standard Deviation 0.1434
|
-0.033 Millimoles per liter
Standard Deviation 0.1849
|
0.013 Millimoles per liter
Standard Deviation 0.5576
|
-0.118 Millimoles per liter
Standard Deviation 0.4461
|
|
Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Anion gap
|
-0.9 Millimoles per liter
Standard Deviation 1.89
|
-0.8 Millimoles per liter
Standard Deviation 2.25
|
-0.6 Millimoles per liter
Standard Deviation 1.41
|
-0.9 Millimoles per liter
Standard Deviation 2.17
|
|
Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Calcium
|
0.095 Millimoles per liter
Standard Deviation 0.0674
|
0.053 Millimoles per liter
Standard Deviation 0.0794
|
0.026 Millimoles per liter
Standard Deviation 0.0713
|
0.036 Millimoles per liter
Standard Deviation 0.0965
|
|
Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Carbon dioxide
|
1.4 Millimoles per liter
Standard Deviation 1.19
|
0.9 Millimoles per liter
Standard Deviation 1.46
|
1.3 Millimoles per liter
Standard Deviation 0.89
|
1.6 Millimoles per liter
Standard Deviation 1.51
|
|
Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Chloride
|
0.3 Millimoles per liter
Standard Deviation 1.49
|
0.1 Millimoles per liter
Standard Deviation 2.17
|
-0.1 Millimoles per liter
Standard Deviation 1.25
|
0.0 Millimoles per liter
Standard Deviation 1.85
|
|
Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Phosphate
|
-0.006 Millimoles per liter
Standard Deviation 0.1165
|
0.023 Millimoles per liter
Standard Deviation 0.1499
|
0.044 Millimoles per liter
Standard Deviation 0.1327
|
0.075 Millimoles per liter
Standard Deviation 0.1144
|
|
Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Potassium
|
0.33 Millimoles per liter
Standard Deviation 0.238
|
0.26 Millimoles per liter
Standard Deviation 0.226
|
0.08 Millimoles per liter
Standard Deviation 0.198
|
0.16 Millimoles per liter
Standard Deviation 0.239
|
|
Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Sodium
|
0.4 Millimoles per liter
Standard Deviation 1.60
|
-0.3 Millimoles per liter
Standard Deviation 2.25
|
0.4 Millimoles per liter
Standard Deviation 1.30
|
0.3 Millimoles per liter
Standard Deviation 1.58
|
|
Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Blood urea nitrogen
|
-0.049 Millimoles per liter
Standard Deviation 0.8640
|
-0.325 Millimoles per liter
Standard Deviation 0.7951
|
0.090 Millimoles per liter
Standard Deviation 1.7057
|
-0.165 Millimoles per liter
Standard Deviation 1.4390
|
SECONDARY outcome
Timeframe: Baseline (Day -1) and at Day 2Population: Safety Population.
Blood samples were collected to analyze the chemistry parameters: creatine kinase, lactate dehydrogenase, ALT, ALP, AST and gamma-glutamyl transferase. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, prior to the first dose of study drug administration. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Treatment A- GSK3640254 200 mg Capsules (Fed)
n=8 Participants
Participants received a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions (Treatment A-reference) on Day 1 in treatment Period 1 or 2.
|
Treatment B- GSK3640254 200 mg Tablet (Fed)
n=8 Participants
Participants received a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions (Treatment B-test) on Day 1 in treatment Period 1 or 2.
|
Treatment D- GSK3640254 200 mg Tablet (High Fat)
n=8 Participants
Participants received a single dose of GSK3640254 200 mg tablets, orally under high fat conditions (Treatment D-test) on Day 1 in treatment Period 1 or 2.
|
Treatment D- GSK3640254 200 mg Tablet (High Fat)
n=8 Participants
Participants received a single dose of GSK3640254 200 mg tablets, orally under high fat conditions (Treatment D-test) on Day 1 in treatment Period 1 or 2.
|
|---|---|---|---|---|
|
Change From Baseline in Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST, Gamma-glutamyl Transferase
Creatine kinase
|
-54.3 International units per liter
Standard Deviation 60.14
|
-53.6 International units per liter
Standard Deviation 72.20
|
-24.5 International units per liter
Standard Deviation 24.18
|
-7.4 International units per liter
Standard Deviation 34.16
|
|
Change From Baseline in Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST, Gamma-glutamyl Transferase
Lactate dehydrogenase
|
-9.6 International units per liter
Standard Deviation 16.62
|
-13.3 International units per liter
Standard Deviation 19.02
|
-12.9 International units per liter
Standard Deviation 8.22
|
-10.8 International units per liter
Standard Deviation 7.81
|
|
Change From Baseline in Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST, Gamma-glutamyl Transferase
ALT
|
1.0 International units per liter
Standard Deviation 2.56
|
-2.1 International units per liter
Standard Deviation 3.00
|
0.4 International units per liter
Standard Deviation 2.50
|
1.0 International units per liter
Standard Deviation 2.00
|
|
Change From Baseline in Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST, Gamma-glutamyl Transferase
ALP
|
-0.9 International units per liter
Standard Deviation 8.11
|
-3.8 International units per liter
Standard Deviation 4.77
|
-3.0 International units per liter
Standard Deviation 5.58
|
0.3 International units per liter
Standard Deviation 3.73
|
|
Change From Baseline in Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST, Gamma-glutamyl Transferase
AST
|
-1.1 International units per liter
Standard Deviation 2.03
|
-2.3 International units per liter
Standard Deviation 2.38
|
-0.5 International units per liter
Standard Deviation 1.07
|
0.0 International units per liter
Standard Deviation 2.73
|
|
Change From Baseline in Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST, Gamma-glutamyl Transferase
Gamma-glutamyl transferase
|
1.4 International units per liter
Standard Deviation 2.13
|
0.6 International units per liter
Standard Deviation 1.77
|
-1.1 International units per liter
Standard Deviation 1.46
|
-1.3 International units per liter
Standard Deviation 6.45
|
SECONDARY outcome
Timeframe: Baseline (Day -1) and at Day 2Population: Safety Population.
Blood samples were collected to analyze the chemistry parameters: urate, creatinine, bilirubin and direct bilirubin. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, prior to the first dose of study drug administration. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Treatment A- GSK3640254 200 mg Capsules (Fed)
n=8 Participants
Participants received a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions (Treatment A-reference) on Day 1 in treatment Period 1 or 2.
|
Treatment B- GSK3640254 200 mg Tablet (Fed)
n=8 Participants
Participants received a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions (Treatment B-test) on Day 1 in treatment Period 1 or 2.
|
Treatment D- GSK3640254 200 mg Tablet (High Fat)
n=8 Participants
Participants received a single dose of GSK3640254 200 mg tablets, orally under high fat conditions (Treatment D-test) on Day 1 in treatment Period 1 or 2.
|
Treatment D- GSK3640254 200 mg Tablet (High Fat)
n=8 Participants
Participants received a single dose of GSK3640254 200 mg tablets, orally under high fat conditions (Treatment D-test) on Day 1 in treatment Period 1 or 2.
|
|---|---|---|---|---|
|
Change From Baseline in Chemistry Parameters: Urate, Creatinine, Bilirubin, Direct Bilirubin
Urate
|
-6.3 Micromoles per liter
Standard Deviation 18.71
|
-13.5 Micromoles per liter
Standard Deviation 28.10
|
-14.1 Micromoles per liter
Standard Deviation 37.84
|
-24.5 Micromoles per liter
Standard Deviation 50.08
|
|
Change From Baseline in Chemistry Parameters: Urate, Creatinine, Bilirubin, Direct Bilirubin
Creatinine
|
1.66 Micromoles per liter
Standard Deviation 6.736
|
1.54 Micromoles per liter
Standard Deviation 6.292
|
1.75 Micromoles per liter
Standard Deviation 8.188
|
-0.43 Micromoles per liter
Standard Deviation 7.123
|
|
Change From Baseline in Chemistry Parameters: Urate, Creatinine, Bilirubin, Direct Bilirubin
Bilirubin
|
3.13 Micromoles per liter
Standard Deviation 2.364
|
3.05 Micromoles per liter
Standard Deviation 2.117
|
1.13 Micromoles per liter
Standard Deviation 4.318
|
-0.03 Micromoles per liter
Standard Deviation 4.639
|
|
Change From Baseline in Chemistry Parameters: Urate, Creatinine, Bilirubin, Direct Bilirubin
Direct bilirubin
|
0.43 Micromoles per liter
Standard Deviation 0.590
|
0.51 Micromoles per liter
Standard Deviation 0.449
|
0.06 Micromoles per liter
Standard Deviation 0.609
|
-0.09 Micromoles per liter
Standard Deviation 0.762
|
SECONDARY outcome
Timeframe: Baseline (Day -1) and at Day 2Population: Safety Population.
Blood samples were collected to analyze the chemistry parameters: albumin, globulin and protein. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, prior to the first dose of study drug administration. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Treatment A- GSK3640254 200 mg Capsules (Fed)
n=8 Participants
Participants received a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions (Treatment A-reference) on Day 1 in treatment Period 1 or 2.
|
Treatment B- GSK3640254 200 mg Tablet (Fed)
n=8 Participants
Participants received a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions (Treatment B-test) on Day 1 in treatment Period 1 or 2.
|
Treatment D- GSK3640254 200 mg Tablet (High Fat)
n=8 Participants
Participants received a single dose of GSK3640254 200 mg tablets, orally under high fat conditions (Treatment D-test) on Day 1 in treatment Period 1 or 2.
|
Treatment D- GSK3640254 200 mg Tablet (High Fat)
n=8 Participants
Participants received a single dose of GSK3640254 200 mg tablets, orally under high fat conditions (Treatment D-test) on Day 1 in treatment Period 1 or 2.
|
|---|---|---|---|---|
|
Change From Baseline in Chemistry Parameters: Albumin, Globulin, Protein
Albumin
|
1.5 Grams per liter
Standard Deviation 2.83
|
-0.3 Grams per liter
Standard Deviation 2.38
|
0.1 Grams per liter
Standard Deviation 1.55
|
0.6 Grams per liter
Standard Deviation 2.67
|
|
Change From Baseline in Chemistry Parameters: Albumin, Globulin, Protein
Globulin
|
0.5 Grams per liter
Standard Deviation 1.85
|
-0.1 Grams per liter
Standard Deviation 2.30
|
-0.4 Grams per liter
Standard Deviation 2.13
|
0.1 Grams per liter
Standard Deviation 2.42
|
|
Change From Baseline in Chemistry Parameters: Albumin, Globulin, Protein
Protein
|
2.0 Grams per liter
Standard Deviation 4.60
|
-0.4 Grams per liter
Standard Deviation 3.78
|
-0.3 Grams per liter
Standard Deviation 2.87
|
0.8 Grams per liter
Standard Deviation 4.77
|
SECONDARY outcome
Timeframe: Baseline (Day -1) and at Day 2Population: Safety Population.
Blood samples were collected to analyze the chemistry parameters: amylase and lipase. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, prior to the first dose of study drug administration. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Treatment A- GSK3640254 200 mg Capsules (Fed)
n=8 Participants
Participants received a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions (Treatment A-reference) on Day 1 in treatment Period 1 or 2.
|
Treatment B- GSK3640254 200 mg Tablet (Fed)
n=8 Participants
Participants received a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions (Treatment B-test) on Day 1 in treatment Period 1 or 2.
|
Treatment D- GSK3640254 200 mg Tablet (High Fat)
n=8 Participants
Participants received a single dose of GSK3640254 200 mg tablets, orally under high fat conditions (Treatment D-test) on Day 1 in treatment Period 1 or 2.
|
Treatment D- GSK3640254 200 mg Tablet (High Fat)
n=8 Participants
Participants received a single dose of GSK3640254 200 mg tablets, orally under high fat conditions (Treatment D-test) on Day 1 in treatment Period 1 or 2.
|
|---|---|---|---|---|
|
Change From Baseline in Chemistry Parameters: Amylase, Lipase
Amylase
|
1.0 Units per liter
Standard Deviation 9.29
|
1.5 Units per liter
Standard Deviation 10.21
|
4.0 Units per liter
Standard Deviation 5.98
|
6.5 Units per liter
Standard Deviation 6.32
|
|
Change From Baseline in Chemistry Parameters: Amylase, Lipase
Lipase
|
-9.5 Units per liter
Standard Deviation 16.34
|
-7.5 Units per liter
Standard Deviation 9.93
|
-3.9 Units per liter
Standard Deviation 3.87
|
-2.6 Units per liter
Standard Deviation 6.25
|
SECONDARY outcome
Timeframe: Baseline (Day -1) and at Day 2Population: Safety Population.
Urine samples were collected to analyze the urinalysis parameter: specific gravity. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, prior to the first dose of study drug administration. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Treatment A- GSK3640254 200 mg Capsules (Fed)
n=8 Participants
Participants received a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions (Treatment A-reference) on Day 1 in treatment Period 1 or 2.
|
Treatment B- GSK3640254 200 mg Tablet (Fed)
n=8 Participants
Participants received a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions (Treatment B-test) on Day 1 in treatment Period 1 or 2.
|
Treatment D- GSK3640254 200 mg Tablet (High Fat)
n=8 Participants
Participants received a single dose of GSK3640254 200 mg tablets, orally under high fat conditions (Treatment D-test) on Day 1 in treatment Period 1 or 2.
|
Treatment D- GSK3640254 200 mg Tablet (High Fat)
n=8 Participants
Participants received a single dose of GSK3640254 200 mg tablets, orally under high fat conditions (Treatment D-test) on Day 1 in treatment Period 1 or 2.
|
|---|---|---|---|---|
|
Change From Baseline in Urinalysis Parameter: Specific Gravity
|
0.0034 Ratio
Standard Deviation 0.01006
|
-0.0028 Ratio
Standard Deviation 0.01341
|
-0.0009 Ratio
Standard Deviation 0.01284
|
-0.0024 Ratio
Standard Deviation 0.01097
|
SECONDARY outcome
Timeframe: Baseline (Day -1) and at Day 2Population: Safety Population.
Urine samples were collected to analyze the urinalysis parameter: urobilinogen. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, prior to the first dose of study drug administration. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Treatment A- GSK3640254 200 mg Capsules (Fed)
n=8 Participants
Participants received a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions (Treatment A-reference) on Day 1 in treatment Period 1 or 2.
|
Treatment B- GSK3640254 200 mg Tablet (Fed)
n=8 Participants
Participants received a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions (Treatment B-test) on Day 1 in treatment Period 1 or 2.
|
Treatment D- GSK3640254 200 mg Tablet (High Fat)
n=8 Participants
Participants received a single dose of GSK3640254 200 mg tablets, orally under high fat conditions (Treatment D-test) on Day 1 in treatment Period 1 or 2.
|
Treatment D- GSK3640254 200 mg Tablet (High Fat)
n=8 Participants
Participants received a single dose of GSK3640254 200 mg tablets, orally under high fat conditions (Treatment D-test) on Day 1 in treatment Period 1 or 2.
|
|---|---|---|---|---|
|
Change From Baseline in Urinalysis Parameter: Urobilinogen
|
-1.6930 Micromoles per liter
Standard Deviation 4.78853
|
0.0000 Micromoles per liter
Standard Deviation 7.23957
|
1.6930 Micromoles per liter
Standard Deviation 8.67994
|
-1.6930 Micromoles per liter
Standard Deviation 4.78853
|
SECONDARY outcome
Timeframe: Baseline (Day -1) and at Day 2Population: Safety Population.
Urine samples were collected to analyze the urinalysis parameter: pH. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acidic pH (5.0 - 6.0). Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, prior to the first dose of study drug administration. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Treatment A- GSK3640254 200 mg Capsules (Fed)
n=8 Participants
Participants received a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions (Treatment A-reference) on Day 1 in treatment Period 1 or 2.
|
Treatment B- GSK3640254 200 mg Tablet (Fed)
n=8 Participants
Participants received a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions (Treatment B-test) on Day 1 in treatment Period 1 or 2.
|
Treatment D- GSK3640254 200 mg Tablet (High Fat)
n=8 Participants
Participants received a single dose of GSK3640254 200 mg tablets, orally under high fat conditions (Treatment D-test) on Day 1 in treatment Period 1 or 2.
|
Treatment D- GSK3640254 200 mg Tablet (High Fat)
n=8 Participants
Participants received a single dose of GSK3640254 200 mg tablets, orally under high fat conditions (Treatment D-test) on Day 1 in treatment Period 1 or 2.
|
|---|---|---|---|---|
|
Change From Baseline in Urinalysis Parameter: pH
|
0.25 pH
Standard Deviation 0.463
|
0.19 pH
Standard Deviation 0.651
|
0.44 pH
Standard Deviation 0.623
|
0.25 pH
Standard Deviation 0.926
|
SECONDARY outcome
Timeframe: Baseline (Day 1, Pre-dose), Day 1: 2 hours and 4 hoursPopulation: Safety Population.
Twelve-lead ECGs were obtained to measure PR Interval, QRS Duration, QT Interval, QTcF Interval and QTcB Interval. Twelve-lead ECGs were performed with the participant in a supine or semi-supine position after a rest of at least 10 minutes. Baseline was defined as the average of the triplicate pre-dose assessments within each treatment. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Treatment A- GSK3640254 200 mg Capsules (Fed)
n=8 Participants
Participants received a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions (Treatment A-reference) on Day 1 in treatment Period 1 or 2.
|
Treatment B- GSK3640254 200 mg Tablet (Fed)
n=8 Participants
Participants received a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions (Treatment B-test) on Day 1 in treatment Period 1 or 2.
|
Treatment D- GSK3640254 200 mg Tablet (High Fat)
n=8 Participants
Participants received a single dose of GSK3640254 200 mg tablets, orally under high fat conditions (Treatment D-test) on Day 1 in treatment Period 1 or 2.
|
Treatment D- GSK3640254 200 mg Tablet (High Fat)
n=8 Participants
Participants received a single dose of GSK3640254 200 mg tablets, orally under high fat conditions (Treatment D-test) on Day 1 in treatment Period 1 or 2.
|
|---|---|---|---|---|
|
Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB
PR Interval: Day 1, 2 hours
|
-6.3 Milliseconds
Standard Deviation 3.81
|
2.3 Milliseconds
Standard Deviation 8.24
|
-0.3 Milliseconds
Standard Deviation 5.85
|
5.4 Milliseconds
Standard Deviation 14.35
|
|
Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB
PR Interval: Day 1, 4 hours
|
-5.1 Milliseconds
Standard Deviation 4.79
|
1.9 Milliseconds
Standard Deviation 6.24
|
-1.0 Milliseconds
Standard Deviation 7.21
|
-1.9 Milliseconds
Standard Deviation 15.87
|
|
Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB
QRS Duration: Day 1, 2 hours
|
1.4 Milliseconds
Standard Deviation 3.81
|
3.5 Milliseconds
Standard Deviation 6.74
|
0.3 Milliseconds
Standard Deviation 4.46
|
1.6 Milliseconds
Standard Deviation 5.29
|
|
Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB
QRS Duration: Day 1, 4 hours
|
1.0 Milliseconds
Standard Deviation 5.37
|
0.6 Milliseconds
Standard Deviation 4.44
|
0.0 Milliseconds
Standard Deviation 4.44
|
1.1 Milliseconds
Standard Deviation 3.14
|
|
Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB
QT Interval: Day 1, 2 hours
|
-10.9 Milliseconds
Standard Deviation 11.37
|
-15.6 Milliseconds
Standard Deviation 12.64
|
5.5 Milliseconds
Standard Deviation 7.96
|
-12.6 Milliseconds
Standard Deviation 13.98
|
|
Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB
QT Interval: Day 1, 4 hours
|
10.0 Milliseconds
Standard Deviation 16.40
|
2.6 Milliseconds
Standard Deviation 10.69
|
11.3 Milliseconds
Standard Deviation 13.72
|
-2.0 Milliseconds
Standard Deviation 15.30
|
|
Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB
QTcF Interval: Day 1, 2 hours
|
-6.9 Milliseconds
Standard Deviation 8.92
|
-10.5 Milliseconds
Standard Deviation 6.57
|
-0.1 Milliseconds
Standard Deviation 6.36
|
-7.5 Milliseconds
Standard Deviation 8.00
|
|
Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB
QTcF Interval: Day 1, 4 hours
|
-0.8 Milliseconds
Standard Deviation 11.34
|
-5.4 Milliseconds
Standard Deviation 6.67
|
0.3 Milliseconds
Standard Deviation 7.74
|
3.3 Milliseconds
Standard Deviation 4.89
|
|
Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB
QTcB Interval: Day 1, 2 hours
|
-4.8 Milliseconds
Standard Deviation 14.38
|
-8.1 Milliseconds
Standard Deviation 13.15
|
-3.1 Milliseconds
Standard Deviation 8.79
|
-4.6 Milliseconds
Standard Deviation 11.84
|
|
Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB
QTcB Interval: Day 1, 4 hours
|
-5.9 Milliseconds
Standard Deviation 16.44
|
-9.5 Milliseconds
Standard Deviation 9.81
|
-5.3 Milliseconds
Standard Deviation 11.66
|
6.0 Milliseconds
Standard Deviation 5.37
|
SECONDARY outcome
Timeframe: Baseline (Day 1, Pre-dose), Days 2, 3, 4, and 5Population: Safety Population.
SBP and DBP were measured in the semi-recumbent position with a completely automated device after at least 5 minutes of rest for the participant in a quiet setting without any distractions. Baseline was defined as the average of the triplicate pre-dose assessments within each treatment. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Treatment A- GSK3640254 200 mg Capsules (Fed)
n=8 Participants
Participants received a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions (Treatment A-reference) on Day 1 in treatment Period 1 or 2.
|
Treatment B- GSK3640254 200 mg Tablet (Fed)
n=8 Participants
Participants received a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions (Treatment B-test) on Day 1 in treatment Period 1 or 2.
|
Treatment D- GSK3640254 200 mg Tablet (High Fat)
n=8 Participants
Participants received a single dose of GSK3640254 200 mg tablets, orally under high fat conditions (Treatment D-test) on Day 1 in treatment Period 1 or 2.
|
Treatment D- GSK3640254 200 mg Tablet (High Fat)
n=8 Participants
Participants received a single dose of GSK3640254 200 mg tablets, orally under high fat conditions (Treatment D-test) on Day 1 in treatment Period 1 or 2.
|
|---|---|---|---|---|
|
Change From Baseline in SBP and DBP
SBP: Day 2
|
-0.1 Millimeters of mercury
Standard Deviation 3.87
|
-2.0 Millimeters of mercury
Standard Deviation 4.54
|
-1.8 Millimeters of mercury
Standard Deviation 6.94
|
3.4 Millimeters of mercury
Standard Deviation 10.42
|
|
Change From Baseline in SBP and DBP
SBP: Day 3
|
0.3 Millimeters of mercury
Standard Deviation 3.20
|
-1.5 Millimeters of mercury
Standard Deviation 7.31
|
-1.0 Millimeters of mercury
Standard Deviation 6.70
|
0.8 Millimeters of mercury
Standard Deviation 4.74
|
|
Change From Baseline in SBP and DBP
SBP: Day 4
|
-1.5 Millimeters of mercury
Standard Deviation 8.96
|
0.5 Millimeters of mercury
Standard Deviation 9.21
|
-4.5 Millimeters of mercury
Standard Deviation 7.54
|
1.6 Millimeters of mercury
Standard Deviation 6.59
|
|
Change From Baseline in SBP and DBP
SBP: Day 5
|
-2.8 Millimeters of mercury
Standard Deviation 6.41
|
-3.3 Millimeters of mercury
Standard Deviation 7.09
|
-4.4 Millimeters of mercury
Standard Deviation 9.29
|
-1.3 Millimeters of mercury
Standard Deviation 6.36
|
|
Change From Baseline in SBP and DBP
DBP: Day 2
|
-2.3 Millimeters of mercury
Standard Deviation 4.65
|
-3.0 Millimeters of mercury
Standard Deviation 6.50
|
-1.9 Millimeters of mercury
Standard Deviation 4.55
|
-0.9 Millimeters of mercury
Standard Deviation 6.56
|
|
Change From Baseline in SBP and DBP
DBP: Day 3
|
-6.4 Millimeters of mercury
Standard Deviation 7.98
|
-6.4 Millimeters of mercury
Standard Deviation 5.78
|
-4.3 Millimeters of mercury
Standard Deviation 4.83
|
0.0 Millimeters of mercury
Standard Deviation 3.38
|
|
Change From Baseline in SBP and DBP
DBP: Day 4
|
-2.9 Millimeters of mercury
Standard Deviation 7.00
|
-3.8 Millimeters of mercury
Standard Deviation 7.76
|
-0.9 Millimeters of mercury
Standard Deviation 6.53
|
1.5 Millimeters of mercury
Standard Deviation 5.78
|
|
Change From Baseline in SBP and DBP
DBP: Day 5
|
-1.6 Millimeters of mercury
Standard Deviation 4.75
|
-4.4 Millimeters of mercury
Standard Deviation 7.56
|
-0.5 Millimeters of mercury
Standard Deviation 4.69
|
-1.3 Millimeters of mercury
Standard Deviation 5.28
|
SECONDARY outcome
Timeframe: Baseline (Day 1, Pre-dose), Days 2, 3, 4, and 5Population: Safety Population.
Pulse rate was measured in the semi-recumbent position with a completely automated device after at least 5 minutes of rest for the participant in a quiet setting without any distractions. Baseline was defined as the average of the triplicate pre-dose assessments within each treatment. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Treatment A- GSK3640254 200 mg Capsules (Fed)
n=8 Participants
Participants received a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions (Treatment A-reference) on Day 1 in treatment Period 1 or 2.
|
Treatment B- GSK3640254 200 mg Tablet (Fed)
n=8 Participants
Participants received a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions (Treatment B-test) on Day 1 in treatment Period 1 or 2.
|
Treatment D- GSK3640254 200 mg Tablet (High Fat)
n=8 Participants
Participants received a single dose of GSK3640254 200 mg tablets, orally under high fat conditions (Treatment D-test) on Day 1 in treatment Period 1 or 2.
|
Treatment D- GSK3640254 200 mg Tablet (High Fat)
n=8 Participants
Participants received a single dose of GSK3640254 200 mg tablets, orally under high fat conditions (Treatment D-test) on Day 1 in treatment Period 1 or 2.
|
|---|---|---|---|---|
|
Change From Baseline in Pulse Rate
Day 2
|
-2.0 Beats per minute
Standard Deviation 4.84
|
-0.6 Beats per minute
Standard Deviation 6.67
|
1.4 Beats per minute
Standard Deviation 6.95
|
1.4 Beats per minute
Standard Deviation 3.85
|
|
Change From Baseline in Pulse Rate
Day 3
|
0.5 Beats per minute
Standard Deviation 6.07
|
-0.5 Beats per minute
Standard Deviation 4.38
|
-1.3 Beats per minute
Standard Deviation 5.55
|
4.8 Beats per minute
Standard Deviation 5.97
|
|
Change From Baseline in Pulse Rate
Day 4
|
0.9 Beats per minute
Standard Deviation 5.44
|
0.0 Beats per minute
Standard Deviation 7.93
|
2.5 Beats per minute
Standard Deviation 4.34
|
1.4 Beats per minute
Standard Deviation 6.25
|
|
Change From Baseline in Pulse Rate
Day 5
|
-1.6 Beats per minute
Standard Deviation 5.60
|
0.9 Beats per minute
Standard Deviation 4.94
|
2.8 Beats per minute
Standard Deviation 3.20
|
2.6 Beats per minute
Standard Deviation 7.85
|
SECONDARY outcome
Timeframe: Baseline (Day 1, Pre-dose), Days 2, 3, 4, and 5Population: Safety Population.
Respiratory rate was measured in the semi-recumbent position after at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Treatment A- GSK3640254 200 mg Capsules (Fed)
n=8 Participants
Participants received a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions (Treatment A-reference) on Day 1 in treatment Period 1 or 2.
|
Treatment B- GSK3640254 200 mg Tablet (Fed)
n=8 Participants
Participants received a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions (Treatment B-test) on Day 1 in treatment Period 1 or 2.
|
Treatment D- GSK3640254 200 mg Tablet (High Fat)
n=8 Participants
Participants received a single dose of GSK3640254 200 mg tablets, orally under high fat conditions (Treatment D-test) on Day 1 in treatment Period 1 or 2.
|
Treatment D- GSK3640254 200 mg Tablet (High Fat)
n=8 Participants
Participants received a single dose of GSK3640254 200 mg tablets, orally under high fat conditions (Treatment D-test) on Day 1 in treatment Period 1 or 2.
|
|---|---|---|---|---|
|
Change From Baseline in Respiratory Rate
Day 2
|
-0.3 Breaths per minute
Standard Deviation 4.83
|
0.3 Breaths per minute
Standard Deviation 2.71
|
-0.5 Breaths per minute
Standard Deviation 2.33
|
0.3 Breaths per minute
Standard Deviation 3.62
|
|
Change From Baseline in Respiratory Rate
Day 3
|
1.3 Breaths per minute
Standard Deviation 2.12
|
2.0 Breaths per minute
Standard Deviation 3.21
|
-0.3 Breaths per minute
Standard Deviation 1.98
|
0.5 Breaths per minute
Standard Deviation 2.56
|
|
Change From Baseline in Respiratory Rate
Day 4
|
1.5 Breaths per minute
Standard Deviation 2.56
|
2.5 Breaths per minute
Standard Deviation 2.07
|
0.0 Breaths per minute
Standard Deviation 2.14
|
0.5 Breaths per minute
Standard Deviation 3.16
|
|
Change From Baseline in Respiratory Rate
Day 5
|
1.3 Breaths per minute
Standard Deviation 5.65
|
1.8 Breaths per minute
Standard Deviation 4.06
|
1.3 Breaths per minute
Standard Deviation 1.83
|
0.8 Breaths per minute
Standard Deviation 3.37
|
SECONDARY outcome
Timeframe: Baseline (Day 1, Pre-dose), Days 2, 3, 4, and 5Population: Safety Population.
Body temperature was measured in the semi-recumbent position after at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Treatment A- GSK3640254 200 mg Capsules (Fed)
n=8 Participants
Participants received a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions (Treatment A-reference) on Day 1 in treatment Period 1 or 2.
|
Treatment B- GSK3640254 200 mg Tablet (Fed)
n=8 Participants
Participants received a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions (Treatment B-test) on Day 1 in treatment Period 1 or 2.
|
Treatment D- GSK3640254 200 mg Tablet (High Fat)
n=8 Participants
Participants received a single dose of GSK3640254 200 mg tablets, orally under high fat conditions (Treatment D-test) on Day 1 in treatment Period 1 or 2.
|
Treatment D- GSK3640254 200 mg Tablet (High Fat)
n=8 Participants
Participants received a single dose of GSK3640254 200 mg tablets, orally under high fat conditions (Treatment D-test) on Day 1 in treatment Period 1 or 2.
|
|---|---|---|---|---|
|
Change From Baseline in Body Temperature
Day 2
|
-0.10 Degrees Celsius
Standard Deviation 0.374
|
-0.10 Degrees Celsius
Standard Deviation 0.227
|
-0.15 Degrees Celsius
Standard Deviation 0.469
|
-0.10 Degrees Celsius
Standard Deviation 0.417
|
|
Change From Baseline in Body Temperature
Day 3
|
-0.13 Degrees Celsius
Standard Deviation 0.433
|
-0.04 Degrees Celsius
Standard Deviation 0.311
|
-0.11 Degrees Celsius
Standard Deviation 0.253
|
-0.15 Degrees Celsius
Standard Deviation 0.389
|
|
Change From Baseline in Body Temperature
Day 4
|
-0.04 Degrees Celsius
Standard Deviation 0.262
|
-0.29 Degrees Celsius
Standard Deviation 0.429
|
-0.04 Degrees Celsius
Standard Deviation 0.450
|
-0.05 Degrees Celsius
Standard Deviation 0.288
|
|
Change From Baseline in Body Temperature
Day 5
|
0.08 Degrees Celsius
Standard Deviation 0.354
|
0.04 Degrees Celsius
Standard Deviation 0.256
|
-0.06 Degrees Celsius
Standard Deviation 0.250
|
0.10 Degrees Celsius
Standard Deviation 0.342
|
SECONDARY outcome
Timeframe: Pre-dose and at 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72 and 96 hours post-dosePopulation: PK Parameter Population. Only those participants with data available at the indicated time points were analyzed.
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis.
Outcome measures
| Measure |
Treatment A- GSK3640254 200 mg Capsules (Fed)
n=8 Participants
Participants received a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions (Treatment A-reference) on Day 1 in treatment Period 1 or 2.
|
Treatment B- GSK3640254 200 mg Tablet (Fed)
n=8 Participants
Participants received a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions (Treatment B-test) on Day 1 in treatment Period 1 or 2.
|
Treatment D- GSK3640254 200 mg Tablet (High Fat)
n=6 Participants
Participants received a single dose of GSK3640254 200 mg tablets, orally under high fat conditions (Treatment D-test) on Day 1 in treatment Period 1 or 2.
|
Treatment D- GSK3640254 200 mg Tablet (High Fat)
n=8 Participants
Participants received a single dose of GSK3640254 200 mg tablets, orally under high fat conditions (Treatment D-test) on Day 1 in treatment Period 1 or 2.
|
|---|---|---|---|---|
|
Lag Time for Absorption (Tlag) for GSK3640254
|
0.000 Hours
Interval 0.0 to 2.0
|
0.000 Hours
Interval 0.0 to 1.0
|
0.000 Hours
Interval 0.0 to 0.0
|
0.000 Hours
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Pre-dose and at 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72 and 96 hours post-dosePopulation: PK Parameter Population. Only those participants with data available at the indicated time points were analyzed.
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis.
Outcome measures
| Measure |
Treatment A- GSK3640254 200 mg Capsules (Fed)
n=8 Participants
Participants received a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions (Treatment A-reference) on Day 1 in treatment Period 1 or 2.
|
Treatment B- GSK3640254 200 mg Tablet (Fed)
n=8 Participants
Participants received a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions (Treatment B-test) on Day 1 in treatment Period 1 or 2.
|
Treatment D- GSK3640254 200 mg Tablet (High Fat)
n=6 Participants
Participants received a single dose of GSK3640254 200 mg tablets, orally under high fat conditions (Treatment D-test) on Day 1 in treatment Period 1 or 2.
|
Treatment D- GSK3640254 200 mg Tablet (High Fat)
n=8 Participants
Participants received a single dose of GSK3640254 200 mg tablets, orally under high fat conditions (Treatment D-test) on Day 1 in treatment Period 1 or 2.
|
|---|---|---|---|---|
|
Apparent Terminal Phase Half-life (t1/2) for GSK3640254
|
23.607 Hours
Geometric Coefficient of Variation 18.7
|
22.001 Hours
Geometric Coefficient of Variation 12.3
|
22.948 Hours
Geometric Coefficient of Variation 29.2
|
24.448 Hours
Geometric Coefficient of Variation 22.3
|
SECONDARY outcome
Timeframe: Pre-dose and at 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72 and 96 hours post-dosePopulation: PK Parameter Population. Only those participants with data available at the indicated time points were analyzed.
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis.
Outcome measures
| Measure |
Treatment A- GSK3640254 200 mg Capsules (Fed)
n=8 Participants
Participants received a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions (Treatment A-reference) on Day 1 in treatment Period 1 or 2.
|
Treatment B- GSK3640254 200 mg Tablet (Fed)
n=8 Participants
Participants received a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions (Treatment B-test) on Day 1 in treatment Period 1 or 2.
|
Treatment D- GSK3640254 200 mg Tablet (High Fat)
n=6 Participants
Participants received a single dose of GSK3640254 200 mg tablets, orally under high fat conditions (Treatment D-test) on Day 1 in treatment Period 1 or 2.
|
Treatment D- GSK3640254 200 mg Tablet (High Fat)
n=8 Participants
Participants received a single dose of GSK3640254 200 mg tablets, orally under high fat conditions (Treatment D-test) on Day 1 in treatment Period 1 or 2.
|
|---|---|---|---|---|
|
Apparent Oral Clearance (CL/F) for GSK3640254
|
5.632 Liters per hour
Geometric Coefficient of Variation 16.7
|
6.418 Liters per hour
Geometric Coefficient of Variation 37.4
|
12.87 Liters per hour
Geometric Coefficient of Variation 49.4
|
5.284 Liters per hour
Geometric Coefficient of Variation 30.1
|
SECONDARY outcome
Timeframe: Pre-dose and at 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72 and 96 hours post-dosePopulation: PK Parameter Population. Only those participants with data available at the indicated time points were analyzed.
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis.
Outcome measures
| Measure |
Treatment A- GSK3640254 200 mg Capsules (Fed)
n=8 Participants
Participants received a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions (Treatment A-reference) on Day 1 in treatment Period 1 or 2.
|
Treatment B- GSK3640254 200 mg Tablet (Fed)
n=8 Participants
Participants received a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions (Treatment B-test) on Day 1 in treatment Period 1 or 2.
|
Treatment D- GSK3640254 200 mg Tablet (High Fat)
n=6 Participants
Participants received a single dose of GSK3640254 200 mg tablets, orally under high fat conditions (Treatment D-test) on Day 1 in treatment Period 1 or 2.
|
Treatment D- GSK3640254 200 mg Tablet (High Fat)
n=8 Participants
Participants received a single dose of GSK3640254 200 mg tablets, orally under high fat conditions (Treatment D-test) on Day 1 in treatment Period 1 or 2.
|
|---|---|---|---|---|
|
Apparent Volume of Distribution (Vz/F) for GSK3640254
|
191.8 Liters
Geometric Coefficient of Variation 30.8
|
203.7 Liters
Geometric Coefficient of Variation 42.7
|
426.1 Liters
Geometric Coefficient of Variation 70.7
|
186.4 Liters
Geometric Coefficient of Variation 33.5
|
SECONDARY outcome
Timeframe: Pre-dose and at 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72 and 96 hours post-dosePopulation: PK Concentration Population. Only those participants with data available at the indicated time points were analyzed.
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3640254. The PK Concentration Population included all participants who underwent plasma PK sampling and had evaluable PK assay results.
Outcome measures
| Measure |
Treatment A- GSK3640254 200 mg Capsules (Fed)
n=8 Participants
Participants received a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions (Treatment A-reference) on Day 1 in treatment Period 1 or 2.
|
Treatment B- GSK3640254 200 mg Tablet (Fed)
n=8 Participants
Participants received a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions (Treatment B-test) on Day 1 in treatment Period 1 or 2.
|
Treatment D- GSK3640254 200 mg Tablet (High Fat)
n=6 Participants
Participants received a single dose of GSK3640254 200 mg tablets, orally under high fat conditions (Treatment D-test) on Day 1 in treatment Period 1 or 2.
|
Treatment D- GSK3640254 200 mg Tablet (High Fat)
n=8 Participants
Participants received a single dose of GSK3640254 200 mg tablets, orally under high fat conditions (Treatment D-test) on Day 1 in treatment Period 1 or 2.
|
|---|---|---|---|---|
|
Plasma Pharmacokinetic Concentration of GSK3640254
Pre-dose
|
NA Nanogram per milliliter
Standard Deviation NA
Mean could not be calculated as it was below the limit of quantification; standard deviation (SD) could not be calculated due to the high proportion of NQ values (\>30% of values were imputed i.e. NQ assigned zero concentration) which affected the SD.
|
7.863 Nanogram per milliliter
Standard Deviation NA
Standard deviation could not be calculated due to high proportion of non-quantifiable (NQ) values (more than \[\>\] 30 percent \[%\] of values were imputed i.e., NQ assigned zero concentration) which affected the standard deviation.
|
3.227 Nanogram per milliliter
Standard Deviation NA
Standard deviation could not be calculated due to high proportion of NQ values (\>30% of values were imputed i.e., NQ assigned zero concentration) which affected the standard deviation.
|
NA Nanogram per milliliter
Standard Deviation NA
Mean could not be calculated as it was below the limit of quantification; standard deviation (SD) could not be calculated due to the high proportion of NQ values (\>30% of values were imputed i.e. NQ assigned zero concentration) which affected the SD.
|
|
Plasma Pharmacokinetic Concentration of GSK3640254
1 hour
|
14.83 Nanogram per milliliter
Standard Deviation NA
Standard deviation could not be calculated due to high proportion of NQ values (\>30% of values were imputed i.e., NQ assigned zero concentration) which affected the standard deviation
|
68.15 Nanogram per milliliter
Standard Deviation 70.107
|
61.22 Nanogram per milliliter
Standard Deviation 75.133
|
443.0 Nanogram per milliliter
Standard Deviation 456.37
|
|
Plasma Pharmacokinetic Concentration of GSK3640254
1.5 hours
|
62.30 Nanogram per milliliter
Standard Deviation 87.234
|
291.1 Nanogram per milliliter
Standard Deviation 304.32
|
145.5 Nanogram per milliliter
Standard Deviation 121.20
|
696.0 Nanogram per milliliter
Standard Deviation 627.36
|
|
Plasma Pharmacokinetic Concentration of GSK3640254
2 hours
|
148.5 Nanogram per milliliter
Standard Deviation 176.30
|
486.0 Nanogram per milliliter
Standard Deviation 352.74
|
273.2 Nanogram per milliliter
Standard Deviation 206.53
|
837.6 Nanogram per milliliter
Standard Deviation 602.91
|
|
Plasma Pharmacokinetic Concentration of GSK3640254
2.5 hours
|
293.4 Nanogram per milliliter
Standard Deviation 267.01
|
746.1 Nanogram per milliliter
Standard Deviation 448.03
|
371.0 Nanogram per milliliter
Standard Deviation 261.44
|
946.3 Nanogram per milliliter
Standard Deviation 477.31
|
|
Plasma Pharmacokinetic Concentration of GSK3640254
3 hours
|
490.3 Nanogram per milliliter
Standard Deviation 384.97
|
893.4 Nanogram per milliliter
Standard Deviation 398.47
|
412.4 Nanogram per milliliter
Standard Deviation 286.00
|
1009 Nanogram per milliliter
Standard Deviation 402.66
|
|
Plasma Pharmacokinetic Concentration of GSK3640254
3.5 hours
|
647.1 Nanogram per milliliter
Standard Deviation 375.90
|
926.3 Nanogram per milliliter
Standard Deviation 194.74
|
477.2 Nanogram per milliliter
Standard Deviation 345.06
|
976.3 Nanogram per milliliter
Standard Deviation 339.08
|
|
Plasma Pharmacokinetic Concentration of GSK3640254
4 hours
|
759.3 Nanogram per milliliter
Standard Deviation 334.79
|
955.8 Nanogram per milliliter
Standard Deviation 253.23
|
541.0 Nanogram per milliliter
Standard Deviation 463.54
|
1024 Nanogram per milliliter
Standard Deviation 350.97
|
|
Plasma Pharmacokinetic Concentration of GSK3640254
4.5 hours
|
919.1 Nanogram per milliliter
Standard Deviation 287.70
|
1027 Nanogram per milliliter
Standard Deviation 320.44
|
624.0 Nanogram per milliliter
Standard Deviation 475.10
|
1027 Nanogram per milliliter
Standard Deviation 290.12
|
|
Plasma Pharmacokinetic Concentration of GSK3640254
5 hours
|
1057 Nanogram per milliliter
Standard Deviation 172.77
|
1024 Nanogram per milliliter
Standard Deviation 278.55
|
560.3 Nanogram per milliliter
Standard Deviation 407.61
|
1067 Nanogram per milliliter
Standard Deviation 321.21
|
|
Plasma Pharmacokinetic Concentration of GSK3640254
6 hours
|
1129 Nanogram per milliliter
Standard Deviation 204.39
|
1006 Nanogram per milliliter
Standard Deviation 231.01
|
523.5 Nanogram per milliliter
Standard Deviation 319.40
|
1001 Nanogram per milliliter
Standard Deviation 245.94
|
|
Plasma Pharmacokinetic Concentration of GSK3640254
8 hours
|
1020 Nanogram per milliliter
Standard Deviation 201.61
|
890.6 Nanogram per milliliter
Standard Deviation 277.11
|
471.8 Nanogram per milliliter
Standard Deviation 294.06
|
922.1 Nanogram per milliliter
Standard Deviation 238.72
|
|
Plasma Pharmacokinetic Concentration of GSK3640254
12 hours
|
793.1 Nanogram per milliliter
Standard Deviation 134.74
|
713.6 Nanogram per milliliter
Standard Deviation 247.97
|
359.5 Nanogram per milliliter
Standard Deviation 226.80
|
795.3 Nanogram per milliliter
Standard Deviation 206.96
|
|
Plasma Pharmacokinetic Concentration of GSK3640254
24 hours
|
581.8 Nanogram per milliliter
Standard Deviation 156.89
|
519.8 Nanogram per milliliter
Standard Deviation 184.90
|
262.7 Nanogram per milliliter
Standard Deviation 140.32
|
597.5 Nanogram per milliliter
Standard Deviation 175.90
|
|
Plasma Pharmacokinetic Concentration of GSK3640254
48 hours
|
268.0 Nanogram per milliliter
Standard Deviation 52.285
|
240.5 Nanogram per milliliter
Standard Deviation 84.134
|
124.2 Nanogram per milliliter
Standard Deviation 50.302
|
281.6 Nanogram per milliliter
Standard Deviation 75.989
|
|
Plasma Pharmacokinetic Concentration of GSK3640254
72 hours
|
131.0 Nanogram per milliliter
Standard Deviation 26.340
|
116.5 Nanogram per milliliter
Standard Deviation 38.362
|
56.97 Nanogram per milliliter
Standard Deviation 16.732
|
147.8 Nanogram per milliliter
Standard Deviation 56.122
|
|
Plasma Pharmacokinetic Concentration of GSK3640254
96 hours
|
67.26 Nanogram per milliliter
Standard Deviation 18.506
|
52.96 Nanogram per milliliter
Standard Deviation 17.846
|
28.18 Nanogram per milliliter
Standard Deviation 11.700
|
78.38 Nanogram per milliliter
Standard Deviation 39.314
|
Adverse Events
Treatment A- GSK3640254 200 mg Capsules (Fed)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Treatment B- GSK3640254 200 mg Tablet (Fed)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Treatment C- GSK3640254 200 mg Tablet (Fasted)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Treatment D- GSK3640254 200 mg Tablet (High Fat)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Treatment A- GSK3640254 200 mg Capsules (Fed)
n=8 participants at risk
Participants received a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions (Treatment A-reference) on Day 1 in treatment Period 1 or 2.
|
Treatment B- GSK3640254 200 mg Tablet (Fed)
n=8 participants at risk
Participants received a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions (Treatment B-test) on Day 1 in treatment Period 1 or 2.
|
Treatment C- GSK3640254 200 mg Tablet (Fasted)
n=8 participants at risk
Participants received a single dose of GSK3640254 200 mg tablets, orally under fasted conditions (Treatment C-reference) on Day 1 in treatment Period 1 or 2.
|
Treatment D- GSK3640254 200 mg Tablet (High Fat)
n=8 participants at risk
Participants received a single dose of GSK3640254 200 mg tablets, orally under high fat conditions (Treatment D-test) on Day 1 in treatment Period 1 or 2.
|
|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/8 • AEs and SAEs were collected from start of the treatment (Day 1) up to Day 14
Safety Population consisted of all participants who received at least 1 dose of study medication. Data is presented for Periods 1 and 2 only as data was not collected in Periods 3 and 4 due to early termination of the study following completion of Period 2.
|
12.5%
1/8 • AEs and SAEs were collected from start of the treatment (Day 1) up to Day 14
Safety Population consisted of all participants who received at least 1 dose of study medication. Data is presented for Periods 1 and 2 only as data was not collected in Periods 3 and 4 due to early termination of the study following completion of Period 2.
|
0.00%
0/8 • AEs and SAEs were collected from start of the treatment (Day 1) up to Day 14
Safety Population consisted of all participants who received at least 1 dose of study medication. Data is presented for Periods 1 and 2 only as data was not collected in Periods 3 and 4 due to early termination of the study following completion of Period 2.
|
0.00%
0/8 • AEs and SAEs were collected from start of the treatment (Day 1) up to Day 14
Safety Population consisted of all participants who received at least 1 dose of study medication. Data is presented for Periods 1 and 2 only as data was not collected in Periods 3 and 4 due to early termination of the study following completion of Period 2.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/8 • AEs and SAEs were collected from start of the treatment (Day 1) up to Day 14
Safety Population consisted of all participants who received at least 1 dose of study medication. Data is presented for Periods 1 and 2 only as data was not collected in Periods 3 and 4 due to early termination of the study following completion of Period 2.
|
0.00%
0/8 • AEs and SAEs were collected from start of the treatment (Day 1) up to Day 14
Safety Population consisted of all participants who received at least 1 dose of study medication. Data is presented for Periods 1 and 2 only as data was not collected in Periods 3 and 4 due to early termination of the study following completion of Period 2.
|
0.00%
0/8 • AEs and SAEs were collected from start of the treatment (Day 1) up to Day 14
Safety Population consisted of all participants who received at least 1 dose of study medication. Data is presented for Periods 1 and 2 only as data was not collected in Periods 3 and 4 due to early termination of the study following completion of Period 2.
|
12.5%
1/8 • AEs and SAEs were collected from start of the treatment (Day 1) up to Day 14
Safety Population consisted of all participants who received at least 1 dose of study medication. Data is presented for Periods 1 and 2 only as data was not collected in Periods 3 and 4 due to early termination of the study following completion of Period 2.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER