Trial Outcomes & Findings for A Relative Bioavailability and Food-Effect Study of the Fixed Dose Combination of GSK3640254 and Dolutegravir (DTG) in Healthy Participants (NCT NCT04857892)
NCT ID: NCT04857892
Last Updated: 2024-03-12
Results Overview
Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis of GSK3640254.
COMPLETED
PHASE1
41 participants
Pre-dose, 30 minutes, 1 hour, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72, 96 hours post dose in each treatment period
2024-03-12
Participant Flow
This was a randomized, open-label, single dose, crossover clinical study to assess relative bioavailability and food-effect of the fixed dose combination (FDC) of GSK3640254 and Dolutegravir (DTG) in healthy participants.
A total of 41 participants (23 participants in Part 1 and 18 participants in Part 2) were enrolled in the study.
Participant milestones
| Measure |
Part 1: Cohort 1: Sequence ABC
Participants received Treatment A as a single oral dose of GSK3640254 25 milligrams (mg) (2 tablets), GSK3640254 100 mg (1 tablet)/dolutegravir (DTG) 50 mg (1 tablet) administered together under moderate fat and calorie conditions on Day 1 in treatment period 1 followed by Treatment B as a single oral dose of GSK3640254/DTG, 150 mg/50 mg (1 monolayer tablet) FDC administered under moderate fat and calorie conditions on Day 1 in treatment period 2, further followed by Treatment C as a single oral dose of GSK3640254/DTG, 150 mg/50 mg (1 bilayer tablet) FDC administered under moderate fat and calorie conditions on Day 1 in treatment period 3. There was washout period of 7 days between each treatment period.
|
Part 1: Cohort 2: Sequence BCA
Participants received Treatment B as a single oral dose of GSK3640254/DTG, 150 mg/50 mg (1 monolayer tablet) FDC administered under moderate fat and calorie conditions on Day 1 in treatment period 1 followed by Treatment C as a single oral dose of GSK3640254/DTG, 150 mg/50 mg (1 bilayer tablet) FDC administered under moderate fat and calorie conditions on Day 1 in treatment period 2, further followed by Treatment A as a single oral dose of GSK3640254 25 mg (2 tablets), GSK3640254 100 mg (1 tablet), and DTG 50 mg (1 tablet) administered together under moderate fat and calorie conditions on Day 1 on treatment period 3. There was washout period of 7 days between each treatment period.
|
Part 1: Cohort 3: Sequence CAB
Participants received Treatment C as a single oral dose of GSK3640254/DTG, 150 mg/50 mg (1 bilayer tablet) FDC administered under moderate fat and calorie conditions on Day 1 in treatment period 1 followed by Treatment A as a single oral dose of GSK3640254 25 mg (2 tablets), GSK3640254 100 mg (1 tablet) and DTG 50 mg (1 tablet) administered together under moderate fat and calorie conditions (reference) on Day 1 in treatment period 2, further followed by Treatment B as a single oral dose of GSK3640254/DTG, 150 mg/50 mg (1 monolayer tablet) FDC administered under moderate fat and calorie conditions on Day 1 in treatment period 3. There was washout period of 7 days between each treatment period.
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Part 2: Cohort 1: Sequence DE
Participants received Treatment D as a single oral dose of selected bilayer FDC from Part 1 of GSK3640254/DTG, 150 mg/50 mg administered under high fat and calorie conditions on Day 1 in treatment Period 1, followed by Treatment E as a single oral dose of selected FDC of GSK3640254/DTG, 150 mg/50 mg administered under fasted conditions on Day 1 in treatment Period 2. There was washout period of 7 days between each treatment period.
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Part 2: Cohort 2: Sequence ED
Participants received Treatment E as a single oral dose of selected bilayer FDC from Part 1 of GSK3640254/DTG, 150 mg/50 mg administered under fasted conditions on Day 1 in treatment Period 1, followed by Treatment D as a single oral dose of selected FDC of GSK3640254/DTG, 150 mg/50 mg administered under high fat and calorie conditions on Day 1 in treatment Period 2. There was washout period of 7 days between each treatment period.
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Reasons for withdrawal
| Measure |
Part 1: Cohort 1: Sequence ABC
Participants received Treatment A as a single oral dose of GSK3640254 25 milligrams (mg) (2 tablets), GSK3640254 100 mg (1 tablet)/dolutegravir (DTG) 50 mg (1 tablet) administered together under moderate fat and calorie conditions on Day 1 in treatment period 1 followed by Treatment B as a single oral dose of GSK3640254/DTG, 150 mg/50 mg (1 monolayer tablet) FDC administered under moderate fat and calorie conditions on Day 1 in treatment period 2, further followed by Treatment C as a single oral dose of GSK3640254/DTG, 150 mg/50 mg (1 bilayer tablet) FDC administered under moderate fat and calorie conditions on Day 1 in treatment period 3. There was washout period of 7 days between each treatment period.
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Part 1: Cohort 2: Sequence BCA
Participants received Treatment B as a single oral dose of GSK3640254/DTG, 150 mg/50 mg (1 monolayer tablet) FDC administered under moderate fat and calorie conditions on Day 1 in treatment period 1 followed by Treatment C as a single oral dose of GSK3640254/DTG, 150 mg/50 mg (1 bilayer tablet) FDC administered under moderate fat and calorie conditions on Day 1 in treatment period 2, further followed by Treatment A as a single oral dose of GSK3640254 25 mg (2 tablets), GSK3640254 100 mg (1 tablet), and DTG 50 mg (1 tablet) administered together under moderate fat and calorie conditions on Day 1 on treatment period 3. There was washout period of 7 days between each treatment period.
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Part 1: Cohort 3: Sequence CAB
Participants received Treatment C as a single oral dose of GSK3640254/DTG, 150 mg/50 mg (1 bilayer tablet) FDC administered under moderate fat and calorie conditions on Day 1 in treatment period 1 followed by Treatment A as a single oral dose of GSK3640254 25 mg (2 tablets), GSK3640254 100 mg (1 tablet) and DTG 50 mg (1 tablet) administered together under moderate fat and calorie conditions (reference) on Day 1 in treatment period 2, further followed by Treatment B as a single oral dose of GSK3640254/DTG, 150 mg/50 mg (1 monolayer tablet) FDC administered under moderate fat and calorie conditions on Day 1 in treatment period 3. There was washout period of 7 days between each treatment period.
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Part 2: Cohort 1: Sequence DE
Participants received Treatment D as a single oral dose of selected bilayer FDC from Part 1 of GSK3640254/DTG, 150 mg/50 mg administered under high fat and calorie conditions on Day 1 in treatment Period 1, followed by Treatment E as a single oral dose of selected FDC of GSK3640254/DTG, 150 mg/50 mg administered under fasted conditions on Day 1 in treatment Period 2. There was washout period of 7 days between each treatment period.
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Part 2: Cohort 2: Sequence ED
Participants received Treatment E as a single oral dose of selected bilayer FDC from Part 1 of GSK3640254/DTG, 150 mg/50 mg administered under fasted conditions on Day 1 in treatment Period 1, followed by Treatment D as a single oral dose of selected FDC of GSK3640254/DTG, 150 mg/50 mg administered under high fat and calorie conditions on Day 1 in treatment Period 2. There was washout period of 7 days between each treatment period.
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Part 1: Period 1 (Day 1)
Adverse Event
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1
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0
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0
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Part 1: Washout Period 2 (Up to 7 Days)
Withdrawal by Subject
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2
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1
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1
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0
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Part 2: Washout Period 1 (Up to 7 Days)
Protocol Violation
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0
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0
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1
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Baseline Characteristics
A Relative Bioavailability and Food-Effect Study of the Fixed Dose Combination of GSK3640254 and Dolutegravir (DTG) in Healthy Participants
Baseline characteristics by cohort
| Measure |
Part 1: Cohort 1: Sequence ABC
n=9 Participants
Participants received Treatment A as a single oral dose of GSK3640254 25 milligrams (mg) (2 tablets), GSK3640254 100 mg (1 tablet)/dolutegravir (DTG) 50 mg (1 tablet) administered together under moderate fat and calorie conditions on Day 1 in treatment period 1 followed by Treatment B as a single oral dose of GSK3640254/DTG, 150 mg/50 mg (1 monolayer tablet) FDC administered under moderate fat and calorie conditions on Day 1 in treatment period 2, further followed by Treatment C as a single oral dose of GSK3640254/DTG, 150 mg/50 mg (1 bilayer tablet) FDC administered under moderate fat and calorie conditions on Day 1 in treatment period 3. There was washout period of 7 days between each treatment period.
|
Part 1: Cohort 2: Sequence BCA
n=7 Participants
Participants received Treatment B as a single oral dose of GSK3640254/DTG, 150 mg/50 mg (1 monolayer tablet) FDC administered under moderate fat and calorie conditions on Day 1 in treatment period 1 followed by Treatment C as a single oral dose of GSK3640254/DTG, 150 mg/50 mg (1 bilayer tablet) FDC administered under moderate fat and calorie conditions on Day 1 in treatment period 2, further followed by Treatment A as a single oral dose of GSK3640254 25 mg (2 tablets), GSK3640254 100 mg (1 tablet), and DTG 50 mg (1 tablet) administered together under moderate fat and calorie conditions on Day 1 on treatment period 3. There was washout period of 7 days between each treatment period.
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Part 1: Cohort 3: Sequence CAB
n=7 Participants
Participants received Treatment C as a single oral dose of GSK3640254/DTG, 150 mg/50 mg (1 bilayer tablet) FDC administered under moderate fat and calorie conditions on Day 1 in treatment period 1 followed by Treatment A as a single oral dose of GSK3640254 25 mg (2 tablets), GSK3640254 100 mg (1 tablet) and DTG 50 mg (1 tablet) administered together under moderate fat and calorie conditions (reference) on Day 1 in treatment period 2, further followed by Treatment B as a single oral dose of GSK3640254/DTG, 150 mg/50 mg (1 monolayer tablet) FDC administered under moderate fat and calorie conditions on Day 1 in treatment period 3. There was washout period of 7 days between each treatment period.
|
Part 2: Cohort 1: Sequence DE
n=9 Participants
Participants received Treatment D as a single oral dose of selected bilayer FDC from Part 1 of GSK3640254/DTG, 150 mg/50 mg administered under high fat and calorie conditions on Day 1 in treatment Period 1, followed by Treatment E as a single oral dose of selected FDC of GSK3640254/DTG, 150 mg/50 mg administered under fasted conditions on Day 1 in treatment Period 2. There was washout period of 7 days between each treatment period.
|
Part 2: Cohort 2: Sequence ED
n=9 Participants
Participants received Treatment E as a single oral dose of selected bilayer FDC from Part 1 of GSK3640254/DTG, 150 mg/50 mg administered under fasted conditions on Day 1 in treatment Period 1, followed by Treatment D as a single oral dose of selected FDC of GSK3640254/DTG, 150 mg/50 mg administered under high fat and calorie conditions on Day 1 in treatment Period 2. There was washout period of 7 days between each treatment period.
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Total
n=41 Participants
Total of all reporting groups
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|---|---|---|---|---|---|---|
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Age, Customized
<=18 years
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0 Participants
n=5 Participants
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0 Participants
n=7 Participants
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0 Participants
n=5 Participants
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0 Participants
n=4 Participants
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0 Participants
n=21 Participants
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0 Participants
n=10 Participants
|
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Age, Customized
19-64 years
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9 Participants
n=5 Participants
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7 Participants
n=7 Participants
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7 Participants
n=5 Participants
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9 Participants
n=4 Participants
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9 Participants
n=21 Participants
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41 Participants
n=10 Participants
|
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Age, Customized
>= 65 years
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0 Participants
n=5 Participants
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0 Participants
n=7 Participants
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0 Participants
n=5 Participants
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0 Participants
n=4 Participants
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0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
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Sex: Female, Male
Female
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3 Participants
n=5 Participants
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4 Participants
n=7 Participants
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4 Participants
n=5 Participants
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5 Participants
n=4 Participants
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2 Participants
n=21 Participants
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18 Participants
n=10 Participants
|
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Sex: Female, Male
Male
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6 Participants
n=5 Participants
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3 Participants
n=7 Participants
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3 Participants
n=5 Participants
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4 Participants
n=4 Participants
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7 Participants
n=21 Participants
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23 Participants
n=10 Participants
|
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Race/Ethnicity, Customized
Black or African American
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3 Participants
n=5 Participants
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3 Participants
n=7 Participants
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3 Participants
n=5 Participants
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6 Participants
n=4 Participants
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3 Participants
n=21 Participants
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18 Participants
n=10 Participants
|
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Race/Ethnicity, Customized
White-White/Caucasian/European Heritage
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6 Participants
n=5 Participants
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3 Participants
n=7 Participants
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4 Participants
n=5 Participants
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3 Participants
n=4 Participants
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4 Participants
n=21 Participants
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20 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Multiple
|
0 Participants
n=5 Participants
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1 Participants
n=7 Participants
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0 Participants
n=5 Participants
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0 Participants
n=4 Participants
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0 Participants
n=21 Participants
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1 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=5 Participants
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0 Participants
n=7 Participants
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0 Participants
n=5 Participants
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0 Participants
n=4 Participants
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1 Participants
n=21 Participants
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1 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Asian- South East Asian Heritage
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0 Participants
n=5 Participants
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0 Participants
n=7 Participants
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0 Participants
n=5 Participants
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0 Participants
n=4 Participants
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1 Participants
n=21 Participants
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1 Participants
n=10 Participants
|
PRIMARY outcome
Timeframe: Pre-dose, 30 minutes, 1 hour, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72, 96 hours post dose in each treatment periodPopulation: PK Parameter Population consisted of all participants who underwent plasma PK sampling and had evaluable PK parameters estimated. Only those participants with data available at the specified time points were analyzed.
Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis of GSK3640254.
Outcome measures
| Measure |
Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg
n=18 Participants
Participants received a single oral dose of GSK3640254 25 mg (2 tablets), GSK3640254 100 mg (1 tablet), and DTG 50 mg (1 tablet) together under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet)
n=20 Participants
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 monolayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet)
n=16 Participants
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 bilayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
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|---|---|---|---|
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Part 1: Area Under the Plasma Concentration-time Curve From Time 0 Extrapolated to Infinity (AUC[0-inf]) of GSK3640254
|
22.13 Hours*microgram per milliliter
Geometric Coefficient of Variation 46.8
|
21.93 Hours*microgram per milliliter
Geometric Coefficient of Variation 36.6
|
22.63 Hours*microgram per milliliter
Geometric Coefficient of Variation 38.0
|
PRIMARY outcome
Timeframe: Pre-dose, 30 minutes, 1 hour, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72, 96 hours post dose in each treatment periodPopulation: PK Parameter Population
Blood samples were collected at indicated time points for PK analysis of GSK3640254.
Outcome measures
| Measure |
Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg
n=22 Participants
Participants received a single oral dose of GSK3640254 25 mg (2 tablets), GSK3640254 100 mg (1 tablet), and DTG 50 mg (1 tablet) together under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet)
n=21 Participants
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 monolayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
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Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet)
n=20 Participants
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 bilayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
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|---|---|---|---|
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Part 1: Area Under the Plasma Concentration-time Curve From Time 0 to Time t (AUC[0-t]) of GSK3640254
|
17.62 Hours*microgram per milliliter
Geometric Coefficient of Variation 55.4
|
19.14 Hours*microgram per milliliter
Geometric Coefficient of Variation 42.9
|
18.69 Hours*microgram per milliliter
Geometric Coefficient of Variation 42.4
|
PRIMARY outcome
Timeframe: Pre-dose, 30 minutes, 1 hour, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72, 96 hours post dose in each treatment periodPopulation: PK Parameter Population
Blood samples were collected at indicated time points for PK analysis of GSK3640254.
Outcome measures
| Measure |
Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg
n=22 Participants
Participants received a single oral dose of GSK3640254 25 mg (2 tablets), GSK3640254 100 mg (1 tablet), and DTG 50 mg (1 tablet) together under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet)
n=21 Participants
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 monolayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
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Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet)
n=20 Participants
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 bilayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
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|---|---|---|---|
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Part 1: Maximum Observed Concentration (Cmax) of GSK3640254
|
0.7382 Microgram per milliliter
Geometric Coefficient of Variation 40.3
|
0.7610 Microgram per milliliter
Geometric Coefficient of Variation 33.5
|
0.7579 Microgram per milliliter
Geometric Coefficient of Variation 40.1
|
PRIMARY outcome
Timeframe: Pre-dose, 30 minutes, 1 hour, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72, 96 hours post dose in each treatment periodPopulation: PK Parameter Population
Blood samples were collected at indicated time points for PK analysis of DTG.
Outcome measures
| Measure |
Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg
n=22 Participants
Participants received a single oral dose of GSK3640254 25 mg (2 tablets), GSK3640254 100 mg (1 tablet), and DTG 50 mg (1 tablet) together under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet)
n=21 Participants
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 monolayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet)
n=20 Participants
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 bilayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
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|---|---|---|---|
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Part 1: AUC(0-inf) of DTG
|
74.18 Hours*microgram per milliliter
Geometric Coefficient of Variation 30.7
|
82.13 Hours*microgram per milliliter
Geometric Coefficient of Variation 26.1
|
80.53 Hours*microgram per milliliter
Geometric Coefficient of Variation 34.7
|
PRIMARY outcome
Timeframe: Pre-dose, 30 minutes, 1 hour, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72, 96 hours post dose in each treatment periodPopulation: PK Parameter Population
Blood samples were collected at indicated time points for PK analysis of DTG.
Outcome measures
| Measure |
Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg
n=22 Participants
Participants received a single oral dose of GSK3640254 25 mg (2 tablets), GSK3640254 100 mg (1 tablet), and DTG 50 mg (1 tablet) together under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet)
n=21 Participants
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 monolayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet)
n=20 Participants
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 bilayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
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|---|---|---|---|
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Part 1: AUC(0-t) of DTG
|
68.91 Hours*microgram per milliliter
Geometric Coefficient of Variation 32.5
|
77.89 Hours*microgram per milliliter
Geometric Coefficient of Variation 29.0
|
73.44 Hours*microgram per milliliter
Geometric Coefficient of Variation 37.0
|
PRIMARY outcome
Timeframe: Pre-dose, 30 minutes, 1 hour, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72, 96 hours post dose in each treatment periodPopulation: PK Parameter Population
Blood samples were collected at indicated time points for PK analysis of DTG.
Outcome measures
| Measure |
Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg
n=22 Participants
Participants received a single oral dose of GSK3640254 25 mg (2 tablets), GSK3640254 100 mg (1 tablet), and DTG 50 mg (1 tablet) together under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet)
n=21 Participants
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 monolayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet)
n=20 Participants
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 bilayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
|---|---|---|---|
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Part 1: Cmax of DTG
|
4.182 Microgram per milliliter
Geometric Coefficient of Variation 18.5
|
4.432 Microgram per milliliter
Geometric Coefficient of Variation 17.8
|
4.264 Microgram per milliliter
Geometric Coefficient of Variation 23.2
|
PRIMARY outcome
Timeframe: Pre-dose, 30 minutes, 1 hour, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72, 96 hours post dose in each treatment periodPopulation: PK Parameter Population. Only those participants with data available at the specified time points were analyzed.
Blood samples were collected at indicated time points for PK analysis of GSK3640254.
Outcome measures
| Measure |
Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg
n=17 Participants
Participants received a single oral dose of GSK3640254 25 mg (2 tablets), GSK3640254 100 mg (1 tablet), and DTG 50 mg (1 tablet) together under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet)
n=13 Participants
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 monolayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet)
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 bilayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
|---|---|---|---|
|
Part 2: AUC(0-inf) of GSK3640254
|
21.39 Hours*microgram per milliliter
Geometric Coefficient of Variation 38.0
|
6.622 Hours*microgram per milliliter
Geometric Coefficient of Variation 77.4
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, 30 minutes, 1 hour, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72, 96 hours post dose in each treatment period.Population: PK Parameter Population. Only those participants with data available at the specified time points were analyzed.
Blood samples were collected at indicated time points for PK analysis of GSK3640254.
Outcome measures
| Measure |
Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg
n=17 Participants
Participants received a single oral dose of GSK3640254 25 mg (2 tablets), GSK3640254 100 mg (1 tablet), and DTG 50 mg (1 tablet) together under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet)
n=13 Participants
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 monolayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet)
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 bilayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
|---|---|---|---|
|
Part 2: AUC(0-t) of GSK3640254
|
19.33 Hours*microgram per milliliter
Geometric Coefficient of Variation 36.6
|
6.027 Hours*microgram per milliliter
Geometric Coefficient of Variation 78.8
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, 30 minutes, 1 hour, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72, 96 hours post dose in each treatment periodPopulation: PK Parameter Population. Only those participants with data available at the specified time points were analyzed.
Blood samples were collected at indicated time points for PK analysis of GSK3640254.
Outcome measures
| Measure |
Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg
n=17 Participants
Participants received a single oral dose of GSK3640254 25 mg (2 tablets), GSK3640254 100 mg (1 tablet), and DTG 50 mg (1 tablet) together under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet)
n=13 Participants
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 monolayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet)
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 bilayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
|---|---|---|---|
|
Part 2: Cmax of GSK3640254
|
0.6093 Microgram per milliliter
Geometric Coefficient of Variation 41.3
|
0.2193 Microgram per milliliter
Geometric Coefficient of Variation 92.1
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, 30 minutes, 1 hour, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72, 96 hours post dose in each treatment periodPopulation: PK Parameter Population
Blood samples were collected at indicated time points for PK analysis of DTG.
Outcome measures
| Measure |
Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg
n=17 Participants
Participants received a single oral dose of GSK3640254 25 mg (2 tablets), GSK3640254 100 mg (1 tablet), and DTG 50 mg (1 tablet) together under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet)
n=18 Participants
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 monolayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet)
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 bilayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
|---|---|---|---|
|
Part 2: AUC(0-inf) of DTG
|
85.07 Hours*microgram per milliliter
Geometric Coefficient of Variation 29.0
|
64.61 Hours*microgram per milliliter
Geometric Coefficient of Variation 31.5
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, 30 minutes, 1 hour, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72, 96 hours post dose in each treatment periodPopulation: PK Parameter Population
Blood samples were collected at indicated time points for PK analysis of DTG.
Outcome measures
| Measure |
Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg
n=17 Participants
Participants received a single oral dose of GSK3640254 25 mg (2 tablets), GSK3640254 100 mg (1 tablet), and DTG 50 mg (1 tablet) together under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet)
n=18 Participants
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 monolayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet)
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 bilayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
|---|---|---|---|
|
Part 2: AUC(0-t) of DTG
|
83.18 Hours*microgram per milliliter
Geometric Coefficient of Variation 28.2
|
63.17 Hours*microgram per milliliter
Geometric Coefficient of Variation 31.0
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, 30 minutes, 1 hour, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72, 96 hours post dose in each treatment periodPopulation: PK Parameter Population
Blood samples were collected at indicated time points for PK analysis of DTG.
Outcome measures
| Measure |
Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg
n=17 Participants
Participants received a single oral dose of GSK3640254 25 mg (2 tablets), GSK3640254 100 mg (1 tablet), and DTG 50 mg (1 tablet) together under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet)
n=18 Participants
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 monolayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet)
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 bilayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
|---|---|---|---|
|
Part 2: Cmax of DTG
|
4.000 Microgram per milliliter
Geometric Coefficient of Variation 21.1
|
3.273 Microgram per milliliter
Geometric Coefficient of Variation 28.4
|
—
|
SECONDARY outcome
Timeframe: Up to 17 daysPopulation: Safety Population consisted of all participants who received at least one dose of study intervention.
An adverse event (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. A SAE is defined as any serious adverse event that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or other situations as per medical or scientific judgment. Adverse events which were not Serious Adverse Events were considered as Non-Serious adverse events.
Outcome measures
| Measure |
Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg
n=22 Participants
Participants received a single oral dose of GSK3640254 25 mg (2 tablets), GSK3640254 100 mg (1 tablet), and DTG 50 mg (1 tablet) together under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet)
n=21 Participants
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 monolayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet)
n=20 Participants
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 bilayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
|---|---|---|---|
|
Part 1: Number of Participants With Non-Serious Adverse Events (Non-SAEs) and Serious Adverse Events (SAEs)
Non-SAEs
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Part 1: Number of Participants With Non-Serious Adverse Events (Non-SAEs) and Serious Adverse Events (SAEs)
SAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 9 daysPopulation: 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. A SAE is defined as any serious adverse event that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or other situations as per medical or scientific judgment. Adverse events which were not Serious Adverse Events were considered as Non-Serious adverse events.
Outcome measures
| Measure |
Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg
n=17 Participants
Participants received a single oral dose of GSK3640254 25 mg (2 tablets), GSK3640254 100 mg (1 tablet), and DTG 50 mg (1 tablet) together under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet)
n=18 Participants
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 monolayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet)
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 bilayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
|---|---|---|---|
|
Part 2: Number of Participants With Non-SAEs and SAEs
Non-SAEs
|
1 Participants
|
2 Participants
|
—
|
|
Part 2: Number of Participants With Non-SAEs and SAEs
SAEs
|
0 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day -1) and Days 2, 5 and 7Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
Blood samples were collected to analyze the hematology parameters: basophils, eosinophils, lymphocytes, monocytes, neutrophils, and platelets. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period.
Outcome measures
| Measure |
Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg
n=22 Participants
Participants received a single oral dose of GSK3640254 25 mg (2 tablets), GSK3640254 100 mg (1 tablet), and DTG 50 mg (1 tablet) together under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet)
n=21 Participants
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 monolayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet)
n=20 Participants
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 bilayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
|---|---|---|---|
|
Part 1: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets
Lymphocytes, Day 2
|
1.647 10^9 cells per liter
Standard Deviation 0.3715
|
1.735 10^9 cells per liter
Standard Deviation 0.3019
|
1.711 10^9 cells per liter
Standard Deviation 0.3950
|
|
Part 1: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets
Lymphocytes, Day 5
|
1.835 10^9 cells per liter
Standard Deviation 0.4113
|
1.663 10^9 cells per liter
Standard Deviation 0.4034
|
1.705 10^9 cells per liter
Standard Deviation 0.4574
|
|
Part 1: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets
Lymphocytes, Day 7
|
1.630 10^9 cells per liter
Standard Deviation 0.3049
|
1.675 10^9 cells per liter
Standard Deviation 0.3398
|
1.592 10^9 cells per liter
Standard Deviation 0.3674
|
|
Part 1: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets
Monocytes, Baseline (Day -1)
|
0.396 10^9 cells per liter
Standard Deviation 0.0834
|
0.396 10^9 cells per liter
Standard Deviation 0.0878
|
0.419 10^9 cells per liter
Standard Deviation 0.1464
|
|
Part 1: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets
Monocytes, Day 2
|
0.395 10^9 cells per liter
Standard Deviation 0.0803
|
0.389 10^9 cells per liter
Standard Deviation 0.0861
|
0.410 10^9 cells per liter
Standard Deviation 0.0932
|
|
Part 1: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets
Monocytes, Day 5
|
0.422 10^9 cells per liter
Standard Deviation 0.0987
|
0.387 10^9 cells per liter
Standard Deviation 0.0497
|
0.380 10^9 cells per liter
Standard Deviation 0.1243
|
|
Part 1: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets
Monocytes, Day 7
|
0.380 10^9 cells per liter
Standard Deviation 0.0587
|
0.398 10^9 cells per liter
Standard Deviation 0.1162
|
0.410 10^9 cells per liter
Standard Deviation 0.0903
|
|
Part 1: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets
Neutrophils, Baseline (Day -1)
|
2.729 10^9 cells per liter
Standard Deviation 0.8510
|
2.691 10^9 cells per liter
Standard Deviation 1.0455
|
2.906 10^9 cells per liter
Standard Deviation 1.3028
|
|
Part 1: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets
Neutrophils, Day 2
|
2.756 10^9 cells per liter
Standard Deviation 0.8228
|
2.589 10^9 cells per liter
Standard Deviation 0.9598
|
2.573 10^9 cells per liter
Standard Deviation 0.9203
|
|
Part 1: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets
Neutrophils, Day 5
|
2.967 10^9 cells per liter
Standard Deviation 0.8932
|
2.648 10^9 cells per liter
Standard Deviation 0.8738
|
2.703 10^9 cells per liter
Standard Deviation 2.0389
|
|
Part 1: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets
Neutrophils, Day 7
|
2.462 10^9 cells per liter
Standard Deviation 0.9607
|
2.594 10^9 cells per liter
Standard Deviation 1.1921
|
2.812 10^9 cells per liter
Standard Deviation 0.9202
|
|
Part 1: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets
Platelets, Baseline (Day -1)
|
247.8 10^9 cells per liter
Standard Deviation 45.94
|
252.5 10^9 cells per liter
Standard Deviation 52.73
|
256.5 10^9 cells per liter
Standard Deviation 50.02
|
|
Part 1: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets
Platelets, Day 2
|
254.6 10^9 cells per liter
Standard Deviation 46.26
|
257.0 10^9 cells per liter
Standard Deviation 54.66
|
260.4 10^9 cells per liter
Standard Deviation 52.24
|
|
Part 1: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets
Platelets, Day 5
|
277.8 10^9 cells per liter
Standard Deviation 35.13
|
268.7 10^9 cells per liter
Standard Deviation 52.38
|
212.2 10^9 cells per liter
Standard Deviation 44.62
|
|
Part 1: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets
Platelets, Day 7
|
237.9 10^9 cells per liter
Standard Deviation 40.40
|
257.1 10^9 cells per liter
Standard Deviation 55.49
|
271.4 10^9 cells per liter
Standard Deviation 44.96
|
|
Part 1: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets
Basophils, Baseline (Day -1)
|
0.035 10^9 cells per liter
Standard Deviation 0.0144
|
0.036 10^9 cells per liter
Standard Deviation 0.0140
|
0.036 10^9 cells per liter
Standard Deviation 0.0132
|
|
Part 1: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets
Basophils, Day 2
|
0.036 10^9 cells per liter
Standard Deviation 0.0133
|
0.036 10^9 cells per liter
Standard Deviation 0.0120
|
0.037 10^9 cells per liter
Standard Deviation 0.0184
|
|
Part 1: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets
Basophils, Day 5
|
0.045 10^9 cells per liter
Standard Deviation 0.0138
|
0.035 10^9 cells per liter
Standard Deviation 0.0187
|
0.028 10^9 cells per liter
Standard Deviation 0.0117
|
|
Part 1: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets
Basophils, Day 7
|
0.033 10^9 cells per liter
Standard Deviation 0.0142
|
0.040 10^9 cells per liter
Standard Deviation 0.0108
|
0.038 10^9 cells per liter
Standard Deviation 0.0169
|
|
Part 1: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets
Eosinophils, Baseline (Day -1)
|
0.157 10^9 cells per liter
Standard Deviation 0.1455
|
0.150 10^9 cells per liter
Standard Deviation 0.1300
|
0.171 10^9 cells per liter
Standard Deviation 0.1559
|
|
Part 1: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets
Eosinophils, Day 2
|
0.157 10^9 cells per liter
Standard Deviation 0.1382
|
0.146 10^9 cells per liter
Standard Deviation 0.1229
|
0.170 10^9 cells per liter
Standard Deviation 0.1482
|
|
Part 1: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets
Eosinophils, Day 5
|
0.197 10^9 cells per liter
Standard Deviation 0.1481
|
0.182 10^9 cells per liter
Standard Deviation 0.1512
|
0.120 10^9 cells per liter
Standard Deviation 0.1210
|
|
Part 1: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets
Eosinophils, Day 7
|
0.141 10^9 cells per liter
Standard Deviation 0.1272
|
0.152 10^9 cells per liter
Standard Deviation 0.1194
|
0.189 10^9 cells per liter
Standard Deviation 0.1613
|
|
Part 1: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets
Lymphocytes, Baseline (Day -1)
|
1.683 10^9 cells per liter
Standard Deviation 0.3691
|
1.674 10^9 cells per liter
Standard Deviation 0.2885
|
1.646 10^9 cells per liter
Standard Deviation 0.3375
|
SECONDARY outcome
Timeframe: Baseline (Day -1) and Days 2, 5 and 7Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
Blood samples were collected to analyze the hematology parameters: basophils, eosinophils, lymphocytes, monocytes, neutrophils, leukocytes and platelets. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period.
Outcome measures
| Measure |
Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg
n=17 Participants
Participants received a single oral dose of GSK3640254 25 mg (2 tablets), GSK3640254 100 mg (1 tablet), and DTG 50 mg (1 tablet) together under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet)
n=18 Participants
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 monolayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet)
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 bilayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
|---|---|---|---|
|
Part 2: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets
Basophils, Baseline (Day -1)
|
0.046 10^9 cells per liter
Standard Deviation 0.0289
|
0.041 10^9 cells per liter
Standard Deviation 0.0242
|
—
|
|
Part 2: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets
Basophils, Day 2
|
0.038 10^9 cells per liter
Standard Deviation 0.0183
|
0.041 10^9 cells per liter
Standard Deviation 0.0192
|
—
|
|
Part 2: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets
Basophils, Day 5
|
0.051 10^9 cells per liter
Standard Deviation 0.0253
|
0.037 10^9 cells per liter
Standard Deviation 0.0141
|
—
|
|
Part 2: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets
Basophils, Day 7
|
0.033 10^9 cells per liter
Standard Deviation 0.0141
|
0.057 10^9 cells per liter
Standard Deviation 0.0354
|
—
|
|
Part 2: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets
Eosinophils, Baseline (Day -1)
|
0.128 10^9 cells per liter
Standard Deviation 0.0688
|
0.138 10^9 cells per liter
Standard Deviation 0.0880
|
—
|
|
Part 2: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets
Eosinophils, Day 2
|
0.125 10^9 cells per liter
Standard Deviation 0.0700
|
0.136 10^9 cells per liter
Standard Deviation 0.0786
|
—
|
|
Part 2: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets
Eosinophils, Day 5
|
0.131 10^9 cells per liter
Standard Deviation 0.0869
|
0.111 10^9 cells per liter
Standard Deviation 0.0601
|
—
|
|
Part 2: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets
Eosinophils, Day 7
|
0.123 10^9 cells per liter
Standard Deviation 0.0726
|
0.133 10^9 cells per liter
Standard Deviation 0.0652
|
—
|
|
Part 2: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets
Lymphocytes, Baseline (Day -1)
|
1.786 10^9 cells per liter
Standard Deviation 0.4445
|
1.771 10^9 cells per liter
Standard Deviation 0.4902
|
—
|
|
Part 2: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets
Lymphocytes, Day 2
|
1.884 10^9 cells per liter
Standard Deviation 0.4805
|
1.838 10^9 cells per liter
Standard Deviation 0.4761
|
—
|
|
Part 2: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets
Lymphocytes, Day 5
|
1.663 10^9 cells per liter
Standard Deviation 0.5135
|
1.750 10^9 cells per liter
Standard Deviation 0.3384
|
—
|
|
Part 2: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets
Lymphocytes, Day 7
|
1.827 10^9 cells per liter
Standard Deviation 0.3937
|
1.730 10^9 cells per liter
Standard Deviation 0.5080
|
—
|
|
Part 2: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets
Monocytes, Baseline (Day -1)
|
0.466 10^9 cells per liter
Standard Deviation 0.1086
|
0.443 10^9 cells per liter
Standard Deviation 0.1100
|
—
|
|
Part 2: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets
Monocytes, Day 2
|
0.452 10^9 cells per liter
Standard Deviation 0.1114
|
0.458 10^9 cells per liter
Standard Deviation 0.1070
|
—
|
|
Part 2: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets
Monocytes, Day 5
|
0.479 10^9 cells per liter
Standard Deviation 0.1512
|
0.430 10^9 cells per liter
Standard Deviation 0.1021
|
—
|
|
Part 2: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets
Monocytes, Day 7
|
0.452 10^9 cells per liter
Standard Deviation 0.0987
|
0.469 10^9 cells per liter
Standard Deviation 0.1102
|
—
|
|
Part 2: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets
Neutrophils, Baseline (Day -1)
|
3.094 10^9 cells per liter
Standard Deviation 1.1911
|
3.138 10^9 cells per liter
Standard Deviation 1.1817
|
—
|
|
Part 2: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets
Neutrophils, Day 2
|
2.999 10^9 cells per liter
Standard Deviation 1.1184
|
3.122 10^9 cells per liter
Standard Deviation 1.1220
|
—
|
|
Part 2: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets
Neutrophils, Day 5
|
3.891 10^9 cells per liter
Standard Deviation 2.1672
|
3.234 10^9 cells per liter
Standard Deviation 1.3698
|
—
|
|
Part 2: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets
Neutrophils, Day 7
|
2.967 10^9 cells per liter
Standard Deviation 1.0973
|
3.083 10^9 cells per liter
Standard Deviation 1.1599
|
—
|
|
Part 2: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets
Platelets, Baseline (Day -1)
|
291.6 10^9 cells per liter
Standard Deviation 53.57
|
292.7 10^9 cells per liter
Standard Deviation 59.84
|
—
|
|
Part 2: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets
Platelets, Day 2
|
302.0 10^9 cells per liter
Standard Deviation 56.30
|
299.7 10^9 cells per liter
Standard Deviation 62.53
|
—
|
|
Part 2: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets
Platelets, Day 5
|
278.6 10^9 cells per liter
Standard Deviation 61.63
|
314.1 10^9 cells per liter
Standard Deviation 53.97
|
—
|
|
Part 2: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets
Platelets, Day 7
|
307.4 10^9 cells per liter
Standard Deviation 55.38
|
274.4 10^9 cells per liter
Standard Deviation 61.27
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day -1) and Days 2, 5 and 7Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
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 visit, prior to the first study drug administration in each treatment period.
Outcome measures
| Measure |
Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg
n=22 Participants
Participants received a single oral dose of GSK3640254 25 mg (2 tablets), GSK3640254 100 mg (1 tablet), and DTG 50 mg (1 tablet) together under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet)
n=21 Participants
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 monolayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet)
n=20 Participants
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 bilayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
|---|---|---|---|
|
Part 1: Absolute Values for Hematology Parameter: Hemoglobin
Baseline (Day -1)
|
139.8 Grams per liter
Standard Deviation 16.04
|
142.7 Grams per liter
Standard Deviation 16.64
|
138.8 Grams per liter
Standard Deviation 16.55
|
|
Part 1: Absolute Values for Hematology Parameter: Hemoglobin
Day 2
|
141.1 Grams per liter
Standard Deviation 15.57
|
143.1 Grams per liter
Standard Deviation 15.14
|
139.2 Grams per liter
Standard Deviation 16.11
|
|
Part 1: Absolute Values for Hematology Parameter: Hemoglobin
Day 5
|
134.8 Grams per liter
Standard Deviation 14.74
|
135.0 Grams per liter
Standard Deviation 15.19
|
141.8 Grams per liter
Standard Deviation 14.89
|
|
Part 1: Absolute Values for Hematology Parameter: Hemoglobin
Day 7
|
145.8 Grams per liter
Standard Deviation 14.97
|
140.6 Grams per liter
Standard Deviation 18.11
|
138.1 Grams per liter
Standard Deviation 16.11
|
SECONDARY outcome
Timeframe: Baseline (Day -1) and Days 2, 5 and 7Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
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 visit, prior to the first study drug administration in each treatment period.
Outcome measures
| Measure |
Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg
n=17 Participants
Participants received a single oral dose of GSK3640254 25 mg (2 tablets), GSK3640254 100 mg (1 tablet), and DTG 50 mg (1 tablet) together under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet)
n=18 Participants
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 monolayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet)
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 bilayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
|---|---|---|---|
|
Part 2: Absolute Values for Hematology Parameter: Hemoglobin
Baseline (Day -1)
|
139.8 Grams per liter
Standard Deviation 15.66
|
138.4 Grams per liter
Standard Deviation 14.09
|
—
|
|
Part 2: Absolute Values for Hematology Parameter: Hemoglobin
Day 2
|
141.0 Grams per liter
Standard Deviation 15.86
|
140.7 Grams per liter
Standard Deviation 16.62
|
—
|
|
Part 2: Absolute Values for Hematology Parameter: Hemoglobin
Day 5
|
143.1 Grams per liter
Standard Deviation 11.22
|
135.6 Grams per liter
Standard Deviation 18.04
|
—
|
|
Part 2: Absolute Values for Hematology Parameter: Hemoglobin
Day 7
|
134.3 Grams per liter
Standard Deviation 15.82
|
144.2 Grams per liter
Standard Deviation 11.11
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day -1) and Days 2, 5 and 7Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
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 visit, prior to the first study drug administration in each treatment period.
Outcome measures
| Measure |
Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg
n=22 Participants
Participants received a single oral dose of GSK3640254 25 mg (2 tablets), GSK3640254 100 mg (1 tablet), and DTG 50 mg (1 tablet) together under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet)
n=21 Participants
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 monolayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet)
n=20 Participants
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 bilayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
|---|---|---|---|
|
Part 1: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Volume
Baseline (Day -1)
|
86.45 Femtoliter
Standard Deviation 4.446
|
86.33 Femtoliter
Standard Deviation 4.376
|
86.94 Femtoliter
Standard Deviation 4.244
|
|
Part 1: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Volume
Day 2
|
86.26 Femtoliter
Standard Deviation 4.324
|
86.51 Femtoliter
Standard Deviation 4.392
|
86.99 Femtoliter
Standard Deviation 4.171
|
|
Part 1: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Volume
Day 5
|
86.48 Femtoliter
Standard Deviation 4.642
|
86.08 Femtoliter
Standard Deviation 4.923
|
87.58 Femtoliter
Standard Deviation 4.668
|
|
Part 1: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Volume
Day 7
|
86.12 Femtoliter
Standard Deviation 4.256
|
87.28 Femtoliter
Standard Deviation 4.120
|
86.09 Femtoliter
Standard Deviation 4.703
|
SECONDARY outcome
Timeframe: Baseline (Day -1) and Days 2, 5 and 7Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
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 visit, prior to the first study drug administration in each treatment period.
Outcome measures
| Measure |
Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg
n=17 Participants
Participants received a single oral dose of GSK3640254 25 mg (2 tablets), GSK3640254 100 mg (1 tablet), and DTG 50 mg (1 tablet) together under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet)
n=18 Participants
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 monolayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet)
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 bilayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
|---|---|---|---|
|
Part 2: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Volume
Baseline (Day -1)
|
84.55 Femtoliter
Standard Deviation 5.141
|
84.89 Femtoliter
Standard Deviation 4.925
|
—
|
|
Part 2: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Volume
Day 2
|
84.30 Femtoliter
Standard Deviation 4.926
|
84.74 Femtoliter
Standard Deviation 5.146
|
—
|
|
Part 2: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Volume
Day 5
|
84.33 Femtoliter
Standard Deviation 3.593
|
84.50 Femtoliter
Standard Deviation 6.116
|
—
|
|
Part 2: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Volume
Day 7
|
84.37 Femtoliter
Standard Deviation 5.841
|
85.29 Femtoliter
Standard Deviation 4.042
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day -1) and Days 2, 5 and 7Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
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 visit, prior to the first study drug administration in each treatment period.
Outcome measures
| Measure |
Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg
n=22 Participants
Participants received a single oral dose of GSK3640254 25 mg (2 tablets), GSK3640254 100 mg (1 tablet), and DTG 50 mg (1 tablet) together under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet)
n=21 Participants
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 monolayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet)
n=20 Participants
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 bilayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
|---|---|---|---|
|
Part 1: Absolute Values for Hematology Parameter: Erythrocytes
Baseline (Day -1)
|
4.757 10^12 cells per liter
Standard Deviation 0.4773
|
4.850 10^12 cells per liter
Standard Deviation 0.5190
|
4.686 10^12 cells per liter
Standard Deviation 0.4967
|
|
Part 1: Absolute Values for Hematology Parameter: Erythrocytes
Day 2
|
4.822 10^12 cells per liter
Standard Deviation 0.4863
|
4.855 10^12 cells per liter
Standard Deviation 0.4740
|
4.700 10^12 cells per liter
Standard Deviation 0.4353
|
|
Part 1: Absolute Values for Hematology Parameter: Erythrocytes
Day 5
|
4.658 10^12 cells per liter
Standard Deviation 0.4331
|
4.558 10^12 cells per liter
Standard Deviation 0.3547
|
4.710 10^12 cells per liter
Standard Deviation 0.5284
|
|
Part 1: Absolute Values for Hematology Parameter: Erythrocytes
Day 7
|
4.939 10^12 cells per liter
Standard Deviation 0.5032
|
4.752 10^12 cells per liter
Standard Deviation 0.5521
|
4.700 10^12 cells per liter
Standard Deviation 0.4412
|
SECONDARY outcome
Timeframe: Baseline (Day -1) and Days 2, 5 and 7Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
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 visit, prior to the first study drug administration in each treatment period.
Outcome measures
| Measure |
Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg
n=17 Participants
Participants received a single oral dose of GSK3640254 25 mg (2 tablets), GSK3640254 100 mg (1 tablet), and DTG 50 mg (1 tablet) together under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet)
n=18 Participants
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 monolayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet)
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 bilayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
|---|---|---|---|
|
Part 2: Absolute Values for Hematology Parameter: Erythrocytes
Baseline (Day -1)
|
4.914 10^12 cells per liter
Standard Deviation 0.5070
|
4.853 10^12 cells per liter
Standard Deviation 0.5060
|
—
|
|
Part 2: Absolute Values for Hematology Parameter: Erythrocytes
Day 2
|
4.958 10^12 cells per liter
Standard Deviation 0.4930
|
4.913 10^12 cells per liter
Standard Deviation 0.5727
|
—
|
|
Part 2: Absolute Values for Hematology Parameter: Erythrocytes
Day 5
|
4.976 10^12 cells per liter
Standard Deviation 0.4861
|
4.787 10^12 cells per liter
Standard Deviation 0.4171
|
—
|
|
Part 2: Absolute Values for Hematology Parameter: Erythrocytes
Day 7
|
4.760 10^12 cells per liter
Standard Deviation 0.5021
|
4.942 10^12 cells per liter
Standard Deviation 0.5117
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day -1) and Days 2, 5 and 7Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
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 visit, prior to the first study drug administration in each treatment period.
Outcome measures
| Measure |
Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg
n=22 Participants
Participants received a single oral dose of GSK3640254 25 mg (2 tablets), GSK3640254 100 mg (1 tablet), and DTG 50 mg (1 tablet) together under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet)
n=21 Participants
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 monolayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet)
n=20 Participants
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 bilayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
|---|---|---|---|
|
Part 1: Absolute Values for Hematology Parameters: Hematocrit
Baseline (Day -1)
|
0.4110 Proportion of red blood cells in blood
Standard Deviation 0.04343
|
0.4181 Proportion of red blood cells in blood
Standard Deviation 0.04561
|
0.4070 Proportion of red blood cells in blood
Standard Deviation 0.04490
|
|
Part 1: Absolute Values for Hematology Parameters: Hematocrit
Day 2
|
0.4156 Proportion of red blood cells in blood
Standard Deviation 0.04297
|
0.4195 Proportion of red blood cells in blood
Standard Deviation 0.04087
|
0.4087 Proportion of red blood cells in blood
Standard Deviation 0.04260
|
|
Part 1: Absolute Values for Hematology Parameters: Hematocrit
Day 5
|
0.4025 Proportion of red blood cells in blood
Standard Deviation 0.03930
|
0.3922 Proportion of red blood cells in blood
Standard Deviation 0.03854
|
0.4117 Proportion of red blood cells in blood
Standard Deviation 0.04206
|
|
Part 1: Absolute Values for Hematology Parameters: Hematocrit
Day 7
|
0.4246 Proportion of red blood cells in blood
Standard Deviation 0.04202
|
0.4144 Proportion of red blood cells in blood
Standard Deviation 0.04936
|
0.4047 Proportion of red blood cells in blood
Standard Deviation 0.04553
|
SECONDARY outcome
Timeframe: Baseline (Day -1) and Days 2, 5 and 7Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
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 visit, prior to the first study drug administration in each treatment period.
Outcome measures
| Measure |
Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg
n=17 Participants
Participants received a single oral dose of GSK3640254 25 mg (2 tablets), GSK3640254 100 mg (1 tablet), and DTG 50 mg (1 tablet) together under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet)
n=18 Participants
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 monolayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet)
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 bilayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
|---|---|---|---|
|
Part 2: Absolute Values for Hematology Parameters: Hematocrit
Baseline (Day -1)
|
0.4145 Proportion of red blood cells in blood
Standard Deviation 0.04184
|
0.4106 Proportion of red blood cells in blood
Standard Deviation 0.03687
|
—
|
|
Part 2: Absolute Values for Hematology Parameters: Hematocrit
Day 2
|
0.4173 Proportion of red blood cells in blood
Standard Deviation 0.04269
|
0.4153 Proportion of red blood cells in blood
Standard Deviation 0.04510
|
—
|
|
Part 2: Absolute Values for Hematology Parameters: Hematocrit
Day 5
|
0.4183 Proportion of red blood cells in blood
Standard Deviation 0.03167
|
0.4044 Proportion of red blood cells in blood
Standard Deviation 0.04641
|
—
|
|
Part 2: Absolute Values for Hematology Parameters: Hematocrit
Day 7
|
0.4004 Proportion of red blood cells in blood
Standard Deviation 0.04078
|
0.4201 Proportion of red blood cells in blood
Standard Deviation 0.03113
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day -1) and Days 2, 5 and 7Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
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 visit, prior to the first study drug administration in each treatment period.
Outcome measures
| Measure |
Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg
n=22 Participants
Participants received a single oral dose of GSK3640254 25 mg (2 tablets), GSK3640254 100 mg (1 tablet), and DTG 50 mg (1 tablet) together under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet)
n=21 Participants
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 monolayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet)
n=20 Participants
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 bilayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
|---|---|---|---|
|
Part 1: Absolute Values for Hematology Parameters: Erythrocytes Mean Corpuscular Hemoglobin
Baseline (Day -1)
|
29.37 Picograms
Standard Deviation 1.743
|
29.47 Picograms
Standard Deviation 1.859
|
29.65 Picograms
Standard Deviation 1.819
|
|
Part 1: Absolute Values for Hematology Parameters: Erythrocytes Mean Corpuscular Hemoglobin
Day 2
|
29.28 Picograms
Standard Deviation 1.811
|
29.51 Picograms
Standard Deviation 1.834
|
29.63 Picograms
Standard Deviation 1.823
|
|
Part 1: Absolute Values for Hematology Parameters: Erythrocytes Mean Corpuscular Hemoglobin
Day 5
|
28.95 Picograms
Standard Deviation 2.117
|
29.63 Picograms
Standard Deviation 2.113
|
30.23 Picograms
Standard Deviation 2.111
|
|
Part 1: Absolute Values for Hematology Parameters: Erythrocytes Mean Corpuscular Hemoglobin
Day 7
|
29.61 Picograms
Standard Deviation 1.924
|
29.61 Picograms
Standard Deviation 1.853
|
29.34 Picograms
Standard Deviation 1.735
|
SECONDARY outcome
Timeframe: Baseline (Day -1) and Days 2, 5 and 7Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
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 visit, prior to the first study drug administration in each treatment period.
Outcome measures
| Measure |
Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg
n=17 Participants
Participants received a single oral dose of GSK3640254 25 mg (2 tablets), GSK3640254 100 mg (1 tablet), and DTG 50 mg (1 tablet) together under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet)
n=18 Participants
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 monolayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet)
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 bilayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
|---|---|---|---|
|
Part 2: Absolute Values for Hematology Parameters: Erythrocytes Mean Corpuscular Hemoglobin
Baseline (Day -1)
|
28.51 Picograms
Standard Deviation 2.271
|
28.62 Picograms
Standard Deviation 2.379
|
—
|
|
Part 2: Absolute Values for Hematology Parameters: Erythrocytes Mean Corpuscular Hemoglobin
Day 2
|
28.49 Picograms
Standard Deviation 2.208
|
28.68 Picograms
Standard Deviation 2.266
|
—
|
|
Part 2: Absolute Values for Hematology Parameters: Erythrocytes Mean Corpuscular Hemoglobin
Day 5
|
28.84 Picograms
Standard Deviation 1.508
|
28.32 Picograms
Standard Deviation 2.810
|
—
|
|
Part 2: Absolute Values for Hematology Parameters: Erythrocytes Mean Corpuscular Hemoglobin
Day 7
|
28.32 Picograms
Standard Deviation 2.878
|
29.27 Picograms
Standard Deviation 1.665
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day -1) and Days 2, 5 and 7Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
Blood samples were collected to analyze the hematology parameters: basophils, eosinophils, lymphocytes, monocytes, neutrophils, and platelets. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg
n=21 Participants
Participants received a single oral dose of GSK3640254 25 mg (2 tablets), GSK3640254 100 mg (1 tablet), and DTG 50 mg (1 tablet) together under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet)
n=21 Participants
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 monolayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet)
n=20 Participants
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 bilayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
|---|---|---|---|
|
Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets
Basophils, Day 2
|
0.000 10^9 cells per liter
Standard Deviation 0.0112
|
0.000 10^9 cells per liter
Standard Deviation 0.0128
|
0.002 10^9 cells per liter
Standard Deviation 0.0114
|
|
Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets
Basophils, Day 5
|
0.003 10^9 cells per liter
Standard Deviation 0.0137
|
0.002 10^9 cells per liter
Standard Deviation 0.0117
|
-0.007 10^9 cells per liter
Standard Deviation 0.0121
|
|
Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets
Basophils, Day 7
|
0.002 10^9 cells per liter
Standard Deviation 0.0075
|
0.002 10^9 cells per liter
Standard Deviation 0.0109
|
0.006 10^9 cells per liter
Standard Deviation 0.0117
|
|
Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets
Eosinophils, Day 2
|
-0.005 10^9 cells per liter
Standard Deviation 0.0340
|
-0.004 10^9 cells per liter
Standard Deviation 0.0393
|
-0.001 10^9 cells per liter
Standard Deviation 0.0253
|
|
Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets
Eosinophils, Day 5
|
0.012 10^9 cells per liter
Standard Deviation 0.0722
|
-0.020 10^9 cells per liter
Standard Deviation 0.0379
|
-0.022 10^9 cells per liter
Standard Deviation 0.0739
|
|
Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets
Eosinophils, Day 7
|
0.006 10^9 cells per liter
Standard Deviation 0.0437
|
0.013 10^9 cells per liter
Standard Deviation 0.0632
|
-0.015 10^9 cells per liter
Standard Deviation 0.0450
|
|
Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets
Lymphocytes, Day 2
|
-0.006 10^9 cells per liter
Standard Deviation 0.2568
|
0.061 10^9 cells per liter
Standard Deviation 0.1626
|
0.065 10^9 cells per liter
Standard Deviation 0.1831
|
|
Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets
Lymphocytes, Day 5
|
0.012 10^9 cells per liter
Standard Deviation 0.2670
|
-0.103 10^9 cells per liter
Standard Deviation 0.2293
|
0.053 10^9 cells per liter
Standard Deviation 0.5253
|
|
Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets
Lymphocytes, Day 7
|
-0.023 10^9 cells per liter
Standard Deviation 0.1443
|
0.069 10^9 cells per liter
Standard Deviation 0.2843
|
0.031 10^9 cells per liter
Standard Deviation 0.2409
|
|
Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets
Monocytes, Day 2
|
0.000 10^9 cells per liter
Standard Deviation 0.0662
|
-0.008 10^9 cells per liter
Standard Deviation 0.0650
|
-0.009 10^9 cells per liter
Standard Deviation 0.1268
|
|
Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets
Monocytes, Day 5
|
-0.022 10^9 cells per liter
Standard Deviation 0.0679
|
0.000 10^9 cells per liter
Standard Deviation 0.0672
|
0.012 10^9 cells per liter
Standard Deviation 0.0286
|
|
Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets
Monocytes, Day 7
|
-0.006 10^9 cells per liter
Standard Deviation 0.0585
|
-0.005 10^9 cells per liter
Standard Deviation 0.0901
|
-0.044 10^9 cells per liter
Standard Deviation 0.1607
|
|
Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets
Neutrophils, Day 2
|
0.000 10^9 cells per liter
Standard Deviation 0.6401
|
-0.103 10^9 cells per liter
Standard Deviation 0.6015
|
-0.334 10^9 cells per liter
Standard Deviation 0.9923
|
|
Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets
Neutrophils, Day 5
|
0.092 10^9 cells per liter
Standard Deviation 0.4511
|
0.007 10^9 cells per liter
Standard Deviation 0.1939
|
0.222 10^9 cells per liter
Standard Deviation 1.1719
|
|
Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets
Neutrophils, Day 7
|
-0.269 10^9 cells per liter
Standard Deviation 0.6770
|
-0.066 10^9 cells per liter
Standard Deviation 0.6836
|
-0.642 10^9 cells per liter
Standard Deviation 1.3252
|
|
Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets
Platelets, Day 2
|
4.4 10^9 cells per liter
Standard Deviation 9.28
|
4.5 10^9 cells per liter
Standard Deviation 15.78
|
4.0 10^9 cells per liter
Standard Deviation 14.96
|
|
Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets
Platelets, Day 5
|
5.2 10^9 cells per liter
Standard Deviation 13.27
|
-1.5 10^9 cells per liter
Standard Deviation 15.06
|
-7.5 10^9 cells per liter
Standard Deviation 16.21
|
|
Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets
Platelets, Day 7
|
-2.2 10^9 cells per liter
Standard Deviation 20.03
|
7.9 10^9 cells per liter
Standard Deviation 26.01
|
3.1 10^9 cells per liter
Standard Deviation 32.56
|
SECONDARY outcome
Timeframe: Baseline (Day -1) and Days 2, 5 and 7Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
Blood samples were collected to analyze the hematology parameters: basophils, eosinophils, lymphocytes, monocytes, neutrophils, and platelets. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg
n=16 Participants
Participants received a single oral dose of GSK3640254 25 mg (2 tablets), GSK3640254 100 mg (1 tablet), and DTG 50 mg (1 tablet) together under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet)
n=18 Participants
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 monolayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet)
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 bilayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
|---|---|---|---|
|
Part 2: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets
Basophils, Day 2
|
-0.004 10^9 cells per liter
Standard Deviation 0.0121
|
-0.001 10^9 cells per liter
Standard Deviation 0.0111
|
—
|
|
Part 2: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets
Basophils, Day 5
|
-0.010 10^9 cells per liter
Standard Deviation 0.0200
|
0.003 10^9 cells per liter
Standard Deviation 0.0071
|
—
|
|
Part 2: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets
Basophils, Day 7
|
0.000 10^9 cells per liter
Standard Deviation 0.0100
|
0.008 10^9 cells per liter
Standard Deviation 0.0273
|
—
|
|
Part 2: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets
Eosinophils, Day 2
|
-0.006 10^9 cells per liter
Standard Deviation 0.0234
|
-0.002 10^9 cells per liter
Standard Deviation 0.0342
|
—
|
|
Part 2: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets
Eosinophils, Day 5
|
-0.001 10^9 cells per liter
Standard Deviation 0.0236
|
-0.012 10^9 cells per liter
Standard Deviation 0.0205
|
—
|
|
Part 2: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets
Eosinophils, Day 7
|
0.000 10^9 cells per liter
Standard Deviation 0.0260
|
-0.020 10^9 cells per liter
Standard Deviation 0.0400
|
—
|
|
Part 2: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets
Lymphocytes, Day 2
|
0.068 10^9 cells per liter
Standard Deviation 0.2198
|
0.067 10^9 cells per liter
Standard Deviation 0.1895
|
—
|
|
Part 2: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets
Lymphocytes, Day 5
|
-0.075 10^9 cells per liter
Standard Deviation 0.1507
|
-0.077 10^9 cells per liter
Standard Deviation 0.1678
|
—
|
|
Part 2: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets
Lymphocytes, Day 7
|
-0.003 10^9 cells per liter
Standard Deviation 0.2733
|
0.016 10^9 cells per liter
Standard Deviation 0.1068
|
—
|
|
Part 2: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets
Monocytes, Day 2
|
-0.023 10^9 cells per liter
Standard Deviation 0.0422
|
0.014 10^9 cells per liter
Standard Deviation 0.0497
|
—
|
|
Part 2: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets
Monocytes, Day 5
|
-0.009 10^9 cells per liter
Standard Deviation 0.1040
|
-0.022 10^9 cells per liter
Standard Deviation 0.0851
|
—
|
|
Part 2: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets
Monocytes, Day 7
|
0.006 10^9 cells per liter
Standard Deviation 0.0923
|
0.034 10^9 cells per liter
Standard Deviation 0.0706
|
—
|
|
Part 2: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets
Neutrophils, Day 2
|
-0.077 10^9 cells per liter
Standard Deviation 0.4373
|
-0.016 10^9 cells per liter
Standard Deviation 0.4117
|
—
|
|
Part 2: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets
Neutrophils, Day 5
|
0.719 10^9 cells per liter
Standard Deviation 1.2615
|
0.268 10^9 cells per liter
Standard Deviation 0.8053
|
—
|
|
Part 2: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets
Neutrophils, Day 7
|
-0.058 10^9 cells per liter
Standard Deviation 0.6203
|
-0.226 10^9 cells per liter
Standard Deviation 0.4835
|
—
|
|
Part 2: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets
Platelets, Day 2
|
6.1 10^9 cells per liter
Standard Deviation 16.69
|
7.1 10^9 cells per liter
Standard Deviation 12.62
|
—
|
|
Part 2: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets
Platelets, Day 5
|
0.0 10^9 cells per liter
Standard Deviation 7.19
|
6.7 10^9 cells per liter
Standard Deviation 11.32
|
—
|
|
Part 2: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets
Platelets, Day 7
|
4.2 10^9 cells per liter
Standard Deviation 29.94
|
-3.4 10^9 cells per liter
Standard Deviation 30.53
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day -1) and Days 2, 5 and 7Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
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 visit, prior to the first study drug administration in each treatment period. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg
n=21 Participants
Participants received a single oral dose of GSK3640254 25 mg (2 tablets), GSK3640254 100 mg (1 tablet), and DTG 50 mg (1 tablet) together under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet)
n=21 Participants
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 monolayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet)
n=20 Participants
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 bilayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
|---|---|---|---|
|
Part 1: Change From Baseline in Hematology Parameter: Hemoglobin
Day 2
|
1.2 Grams per liter
Standard Deviation 5.98
|
0.4 Grams per liter
Standard Deviation 5.44
|
0.4 Grams per liter
Standard Deviation 5.09
|
|
Part 1: Change From Baseline in Hematology Parameter: Hemoglobin
Day 5
|
0.5 Grams per liter
Standard Deviation 4.46
|
-2.7 Grams per liter
Standard Deviation 4.59
|
-1.3 Grams per liter
Standard Deviation 5.01
|
|
Part 1: Change From Baseline in Hematology Parameter: Hemoglobin
Day 7
|
-1.8 Grams per liter
Standard Deviation 3.16
|
-3.2 Grams per liter
Standard Deviation 7.57
|
0.0 Grams per liter
Standard Deviation 5.10
|
SECONDARY outcome
Timeframe: Baseline (Day -1) and Days 2, 5 and 7Population: Safety Population. Only those participants with data available at the specified time points were analyzed
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 visit, prior to the first study drug administration in each treatment period. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg
n=16 Participants
Participants received a single oral dose of GSK3640254 25 mg (2 tablets), GSK3640254 100 mg (1 tablet), and DTG 50 mg (1 tablet) together under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet)
n=18 Participants
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 monolayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet)
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 bilayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
|---|---|---|---|
|
Part 2: Change From Baseline in Hematology Parameter: Hemoglobin
Day 2
|
1.4 Grams per liter
Standard Deviation 4.86
|
2.2 Grams per liter
Standard Deviation 4.66
|
—
|
|
Part 2: Change From Baseline in Hematology Parameter: Hemoglobin
Day 5
|
-1.4 Grams per liter
Standard Deviation 4.00
|
1.2 Grams per liter
Standard Deviation 5.52
|
—
|
|
Part 2: Change From Baseline in Hematology Parameter: Hemoglobin
Day 7
|
-1.2 Grams per liter
Standard Deviation 4.35
|
1.7 Grams per liter
Standard Deviation 3.84
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day -1) and Days 2, 5 and 7Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
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 visit, prior to the first study drug administration in each treatment period. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg
n=21 Participants
Participants received a single oral dose of GSK3640254 25 mg (2 tablets), GSK3640254 100 mg (1 tablet), and DTG 50 mg (1 tablet) together under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet)
n=21 Participants
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 monolayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet)
n=20 Participants
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 bilayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
|---|---|---|---|
|
Part 1: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume
Day 2
|
-0.06 Femtoliter
Standard Deviation 0.576
|
0.18 Femtoliter
Standard Deviation 0.658
|
0.05 Femtoliter
Standard Deviation 0.664
|
|
Part 1: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume
Day 5
|
0.32 Femtoliter
Standard Deviation 0.615
|
0.42 Femtoliter
Standard Deviation 0.611
|
0.13 Femtoliter
Standard Deviation 0.423
|
|
Part 1: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume
Day 7
|
-0.58 Femtoliter
Standard Deviation 0.456
|
0.10 Femtoliter
Standard Deviation 0.663
|
-0.09 Femtoliter
Standard Deviation 0.780
|
SECONDARY outcome
Timeframe: Baseline (Day -1) and Days 2, 5 and 7Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
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 visit, prior to the first study drug administration in each treatment period. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg
n=16 Participants
Participants received a single oral dose of GSK3640254 25 mg (2 tablets), GSK3640254 100 mg (1 tablet), and DTG 50 mg (1 tablet) together under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet)
n=18 Participants
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 monolayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet)
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 bilayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
|---|---|---|---|
|
Part 2: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume
Day 2
|
-0.05 Femtoliter
Standard Deviation 0.629
|
-0.16 Femtoliter
Standard Deviation 0.444
|
—
|
|
Part 2: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume
Day 5
|
-0.31 Femtoliter
Standard Deviation 0.479
|
0.13 Femtoliter
Standard Deviation 0.552
|
—
|
|
Part 2: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume
Day 7
|
-0.11 Femtoliter
Standard Deviation 0.992
|
-0.13 Femtoliter
Standard Deviation 0.418
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day -1) and Days 2, 5 and 7Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
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 visit, prior to the first study drug administration in each treatment period. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg
n=21 Participants
Participants received a single oral dose of GSK3640254 25 mg (2 tablets), GSK3640254 100 mg (1 tablet), and DTG 50 mg (1 tablet) together under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet)
n=21 Participants
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 monolayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet)
n=20 Participants
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 bilayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
|---|---|---|---|
|
Part 1: Change From Baseline in Hematology Parameter: Erythrocytes
Day 2
|
0.052 10^12 cells per liter
Standard Deviation 0.1937
|
0.005 10^12 cells per liter
Standard Deviation 0.1651
|
0.014 10^12 cells per liter
Standard Deviation 0.1672
|
|
Part 1: Change From Baseline in Hematology Parameter: Erythrocytes
Day 5
|
0.020 10^12 cells per liter
Standard Deviation 0.1642
|
-0.097 10^12 cells per liter
Standard Deviation 0.1592
|
-0.062 10^12 cells per liter
Standard Deviation 0.1297
|
|
Part 1: Change From Baseline in Hematology Parameter: Erythrocytes
Day 7
|
-0.043 10^12 cells per liter
Standard Deviation 0.1286
|
-0.115 10^12 cells per liter
Standard Deviation 0.2308
|
0.010 10^12 cells per liter
Standard Deviation 0.2011
|
SECONDARY outcome
Timeframe: Baseline (Day -1) and Days 2, 5 and 7Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
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 visit, prior to the first study drug administration in each treatment period. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg
n=16 Participants
Participants received a single oral dose of GSK3640254 25 mg (2 tablets), GSK3640254 100 mg (1 tablet), and DTG 50 mg (1 tablet) together under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet)
n=18 Participants
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 monolayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet)
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 bilayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
|---|---|---|---|
|
Part 2: Change From Baseline in Hematology Parameter: Erythrocytes
Day 2
|
0.034 10^12 cells per liter
Standard Deviation 0.1628
|
0.061 10^12 cells per liter
Standard Deviation 0.1886
|
—
|
|
Part 2: Change From Baseline in Hematology Parameter: Erythrocytes
Day 5
|
-0.024 10^12 cells per liter
Standard Deviation 0.1464
|
0.027 10^12 cells per liter
Standard Deviation 0.2285
|
—
|
|
Part 2: Change From Baseline in Hematology Parameter: Erythrocytes
Day 7
|
-0.077 10^12 cells per liter
Standard Deviation 0.1875
|
-0.003 10^12 cells per liter
Standard Deviation 0.1151
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day -1) and Days 2, 5 and 7Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
Blood samples were collected to analyze the hematology parameter: hemotocrit. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg
n=21 Participants
Participants received a single oral dose of GSK3640254 25 mg (2 tablets), GSK3640254 100 mg (1 tablet), and DTG 50 mg (1 tablet) together under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet)
n=21 Participants
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 monolayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet)
n=20 Participants
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 bilayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
|---|---|---|---|
|
Part 1: Change From Baseline in Hematology Parameter: Hematocrit
Day 2
|
0.0042 Proportion of red blood cells in blood
Standard Deviation 0.01656
|
0.0013 Proportion of red blood cells in blood
Standard Deviation 0.01405
|
0.0017 Proportion of red blood cells in blood
Standard Deviation 0.01477
|
|
Part 1: Change From Baseline in Hematology Parameter: Hematocrit
Day 5
|
0.0027 Proportion of red blood cells in blood
Standard Deviation 0.01253
|
-0.0067 Proportion of red blood cells in blood
Standard Deviation 0.01369
|
-0.0048 Proportion of red blood cells in blood
Standard Deviation 0.01148
|
|
Part 1: Change From Baseline in Hematology Parameter: Hematocrit
Day 7
|
-0.0066 Proportion of red blood cells in blood
Standard Deviation 0.01184
|
-0.0092 Proportion of red blood cells in blood
Standard Deviation 0.01971
|
0.0011 Proportion of red blood cells in blood
Standard Deviation 0.01930
|
SECONDARY outcome
Timeframe: Baseline (Day -1) and Days 2, 5 and 7Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
Blood samples were collected to analyze the hematology parameters: hemotocrit. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg
n=16 Participants
Participants received a single oral dose of GSK3640254 25 mg (2 tablets), GSK3640254 100 mg (1 tablet), and DTG 50 mg (1 tablet) together under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet)
n=18 Participants
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 monolayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet)
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 bilayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
|---|---|---|---|
|
Part 2: Change From Baseline in Hematology Parameter: Hematocrit
Day 2
|
0.0029 Proportion of red blood cells in blood
Standard Deviation 0.01474
|
0.0047 Proportion of red blood cells in blood
Standard Deviation 0.01576
|
—
|
|
Part 2: Change From Baseline in Hematology Parameter: Hematocrit
Day 5
|
-0.0038 Proportion of red blood cells in blood
Standard Deviation 0.01403
|
0.0040 Proportion of red blood cells in blood
Standard Deviation 0.02060
|
—
|
|
Part 2: Change From Baseline in Hematology Parameter: Hematocrit
Day 7
|
-0.0074 Proportion of red blood cells in blood
Standard Deviation 0.01795
|
-0.0007 Proportion of red blood cells in blood
Standard Deviation 0.01093
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day -1) and Days 2, 5, and 7Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
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 visit, prior to the first study drug administration in each treatment period. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg
n=21 Participants
Participants received a single oral dose of GSK3640254 25 mg (2 tablets), GSK3640254 100 mg (1 tablet), and DTG 50 mg (1 tablet) together under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet)
n=21 Participants
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 monolayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet)
n=20 Participants
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 bilayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
|---|---|---|---|
|
Part 1: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin
Day 2
|
-0.02 Picograms
Standard Deviation 0.319
|
0.04 Picograms
Standard Deviation 0.368
|
-0.02 Picograms
Standard Deviation 0.233
|
|
Part 1: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin
Day 5
|
0.05 Picograms
Standard Deviation 0.138
|
0.07 Picograms
Standard Deviation 0.280
|
0.17 Picograms
Standard Deviation 0.301
|
|
Part 1: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin
Day 7
|
-0.05 Picograms
Standard Deviation 0.372
|
0.01 Picograms
Standard Deviation 0.423
|
-0.16 Picograms
Standard Deviation 0.320
|
SECONDARY outcome
Timeframe: Baseline (Day -1) and Days 2, 5 and 7Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
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 visit, prior to the first study drug administration in each treatment period. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg
n=16 Participants
Participants received a single oral dose of GSK3640254 25 mg (2 tablets), GSK3640254 100 mg (1 tablet), and DTG 50 mg (1 tablet) together under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet)
n=18 Participants
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 monolayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet)
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 bilayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
|---|---|---|---|
|
Part 2: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin
Day 2
|
0.07 Picograms
Standard Deviation 0.451
|
0.06 Picograms
Standard Deviation 0.463
|
—
|
|
Part 2: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin
Day 5
|
-0.13 Picograms
Standard Deviation 0.255
|
0.00 Picograms
Standard Deviation 0.387
|
—
|
|
Part 2: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin
Day 7
|
0.21 Picograms
Standard Deviation 0.483
|
0.34 Picograms
Standard Deviation 0.445
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day -1), and Days 2, 5, and 7Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
Blood samples were collected to analyze the chemistry parameters: ALT, ALP, AST, GGT, LDH, CK. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period.
Outcome measures
| Measure |
Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg
n=22 Participants
Participants received a single oral dose of GSK3640254 25 mg (2 tablets), GSK3640254 100 mg (1 tablet), and DTG 50 mg (1 tablet) together under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet)
n=21 Participants
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 monolayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet)
n=20 Participants
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 bilayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
|---|---|---|---|
|
Part 1: Absolute Values for Clinical Chemistry Parameters: Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH), Creatinine Kinase (CK)
ALT, Baseline (Day -1)
|
16.4 International units per Liter
Standard Deviation 9.44
|
19.1 International units per Liter
Standard Deviation 13.65
|
18.9 International units per Liter
Standard Deviation 15.33
|
|
Part 1: Absolute Values for Clinical Chemistry Parameters: Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH), Creatinine Kinase (CK)
ALT, Day 2
|
16.3 International units per Liter
Standard Deviation 9.32
|
17.4 International units per Liter
Standard Deviation 9.99
|
18.4 International units per Liter
Standard Deviation 12.29
|
|
Part 1: Absolute Values for Clinical Chemistry Parameters: Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH), Creatinine Kinase (CK)
ALT, Day 5
|
14.0 International units per Liter
Standard Deviation 4.56
|
16.7 International units per Liter
Standard Deviation 8.64
|
19.5 International units per Liter
Standard Deviation 16.67
|
|
Part 1: Absolute Values for Clinical Chemistry Parameters: Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH), Creatinine Kinase (CK)
ALT, Day 7
|
20.5 International units per Liter
Standard Deviation 14.81
|
20.8 International units per Liter
Standard Deviation 18.34
|
17.2 International units per Liter
Standard Deviation 9.60
|
|
Part 1: Absolute Values for Clinical Chemistry Parameters: Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH), Creatinine Kinase (CK)
ALP, Baseline (Day -1)
|
54.6 International units per Liter
Standard Deviation 14.90
|
55.6 International units per Liter
Standard Deviation 15.14
|
53.4 International units per Liter
Standard Deviation 15.34
|
|
Part 1: Absolute Values for Clinical Chemistry Parameters: Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH), Creatinine Kinase (CK)
ALP, Day 2
|
56.5 International units per Liter
Standard Deviation 14.72
|
57.6 International units per Liter
Standard Deviation 14.03
|
55.2 International units per Liter
Standard Deviation 15.58
|
|
Part 1: Absolute Values for Clinical Chemistry Parameters: Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH), Creatinine Kinase (CK)
ALP, Day 5
|
49.8 International units per Liter
Standard Deviation 13.69
|
60.8 International units per Liter
Standard Deviation 12.62
|
53.8 International units per Liter
Standard Deviation 17.62
|
|
Part 1: Absolute Values for Clinical Chemistry Parameters: Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH), Creatinine Kinase (CK)
ALP, Day 7
|
55.1 International units per Liter
Standard Deviation 14.74
|
52.8 International units per Liter
Standard Deviation 16.34
|
59.3 International units per Liter
Standard Deviation 16.35
|
|
Part 1: Absolute Values for Clinical Chemistry Parameters: Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH), Creatinine Kinase (CK)
AST, Baseline (Day -1)
|
16.3 International units per Liter
Standard Deviation 4.84
|
17.0 International units per Liter
Standard Deviation 5.63
|
17.1 International units per Liter
Standard Deviation 6.23
|
|
Part 1: Absolute Values for Clinical Chemistry Parameters: Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH), Creatinine Kinase (CK)
AST, Day 2
|
15.8 International units per Liter
Standard Deviation 4.02
|
16.1 International units per Liter
Standard Deviation 4.57
|
17.1 International units per Liter
Standard Deviation 5.92
|
|
Part 1: Absolute Values for Clinical Chemistry Parameters: Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH), Creatinine Kinase (CK)
AST, Day 5
|
14.8 International units per Liter
Standard Deviation 4.26
|
16.2 International units per Liter
Standard Deviation 4.92
|
16.3 International units per Liter
Standard Deviation 2.07
|
|
Part 1: Absolute Values for Clinical Chemistry Parameters: Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH), Creatinine Kinase (CK)
AST, Day 7
|
16.5 International units per Liter
Standard Deviation 5.13
|
17.5 International units per Liter
Standard Deviation 7.31
|
17.5 International units per Liter
Standard Deviation 6.19
|
|
Part 1: Absolute Values for Clinical Chemistry Parameters: Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH), Creatinine Kinase (CK)
GGT, Baseline (Day -1)
|
22.1 International units per Liter
Standard Deviation 15.68
|
22.9 International units per Liter
Standard Deviation 16.21
|
22.2 International units per Liter
Standard Deviation 15.53
|
|
Part 1: Absolute Values for Clinical Chemistry Parameters: Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH), Creatinine Kinase (CK)
GGT, Day 2
|
22.0 International units per Liter
Standard Deviation 14.57
|
22.8 International units per Liter
Standard Deviation 15.45
|
22.7 International units per Liter
Standard Deviation 13.77
|
|
Part 1: Absolute Values for Clinical Chemistry Parameters: Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH), Creatinine Kinase (CK)
GGT, Day 5
|
22.3 International units per Liter
Standard Deviation 19.38
|
21.8 International units per Liter
Standard Deviation 6.11
|
20.5 International units per Liter
Standard Deviation 12.36
|
|
Part 1: Absolute Values for Clinical Chemistry Parameters: Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH), Creatinine Kinase (CK)
GGT, Day 7
|
21.4 International units per Liter
Standard Deviation 10.08
|
22.9 International units per Liter
Standard Deviation 18.60
|
26.8 International units per Liter
Standard Deviation 20.97
|
|
Part 1: Absolute Values for Clinical Chemistry Parameters: Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH), Creatinine Kinase (CK)
LDH, Baseline (Day -1)
|
121.7 International units per Liter
Standard Deviation 19.59
|
121.0 International units per Liter
Standard Deviation 24.41
|
119.5 International units per Liter
Standard Deviation 22.30
|
|
Part 1: Absolute Values for Clinical Chemistry Parameters: Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH), Creatinine Kinase (CK)
LDH, Day 2
|
119.1 International units per Liter
Standard Deviation 16.92
|
120.1 International units per Liter
Standard Deviation 23.02
|
123.5 International units per Liter
Standard Deviation 25.15
|
|
Part 1: Absolute Values for Clinical Chemistry Parameters: Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH), Creatinine Kinase (CK)
LDH, Day 5
|
119.5 International units per Liter
Standard Deviation 15.54
|
114.0 International units per Liter
Standard Deviation 21.22
|
107.5 International units per Liter
Standard Deviation 16.08
|
|
Part 1: Absolute Values for Clinical Chemistry Parameters: Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH), Creatinine Kinase (CK)
LDH, Day 7
|
105.3 International units per Liter
Standard Deviation 12.41
|
118.1 International units per Liter
Standard Deviation 22.72
|
116.0 International units per Liter
Standard Deviation 20.23
|
|
Part 1: Absolute Values for Clinical Chemistry Parameters: Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH), Creatinine Kinase (CK)
CK, Baseline (Day -1)
|
101.0 International units per Liter
Standard Deviation 49.01
|
115.1 International units per Liter
Standard Deviation 114.93
|
106.8 International units per Liter
Standard Deviation 93.82
|
|
Part 1: Absolute Values for Clinical Chemistry Parameters: Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH), Creatinine Kinase (CK)
CK, Day 2
|
89.7 International units per Liter
Standard Deviation 51.73
|
104.8 International units per Liter
Standard Deviation 109.70
|
107.0 International units per Liter
Standard Deviation 114.66
|
|
Part 1: Absolute Values for Clinical Chemistry Parameters: Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH), Creatinine Kinase (CK)
CK, Day 5
|
69.0 International units per Liter
Standard Deviation 33.00
|
96.5 International units per Liter
Standard Deviation 63.32
|
85.8 International units per Liter
Standard Deviation 40.74
|
|
Part 1: Absolute Values for Clinical Chemistry Parameters: Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH), Creatinine Kinase (CK)
CK, Day 7
|
90.8 International units per Liter
Standard Deviation 51.77
|
104.6 International units per Liter
Standard Deviation 109.85
|
88.2 International units per Liter
Standard Deviation 46.19
|
SECONDARY outcome
Timeframe: Baseline (Day -1) and Days 2, 5 and 7Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
Blood samples were collected to analyze the chemistry parameters: ALT, ALP, AST, GGT, LDH, CK. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period.
Outcome measures
| Measure |
Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg
n=17 Participants
Participants received a single oral dose of GSK3640254 25 mg (2 tablets), GSK3640254 100 mg (1 tablet), and DTG 50 mg (1 tablet) together under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet)
n=18 Participants
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 monolayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet)
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 bilayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
|---|---|---|---|
|
Part 2: Absolute Values of Clinical Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK
ALT, Baseline (Day -1)
|
18.9 International units per Liter
Standard Deviation 12.42
|
18.8 International units per Liter
Standard Deviation 13.37
|
—
|
|
Part 2: Absolute Values of Clinical Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK
ALT, Day 2
|
18.6 International units per Liter
Standard Deviation 11.57
|
18.9 International units per Liter
Standard Deviation 12.65
|
—
|
|
Part 2: Absolute Values of Clinical Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK
ALT, Day 5
|
18.5 International units per Liter
Standard Deviation 11.82
|
25.2 International units per Liter
Standard Deviation 20.47
|
—
|
|
Part 2: Absolute Values of Clinical Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK
ALT, Day 7
|
21.8 International units per Liter
Standard Deviation 16.34
|
18.1 International units per Liter
Standard Deviation 9.97
|
—
|
|
Part 2: Absolute Values of Clinical Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK
ALP Baseline (Day -1)
|
63.2 International units per Liter
Standard Deviation 18.86
|
61.6 International units per Liter
Standard Deviation 18.57
|
—
|
|
Part 2: Absolute Values of Clinical Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK
ALP, Day 2
|
62.1 International units per Liter
Standard Deviation 18.43
|
62.1 International units per Liter
Standard Deviation 18.75
|
—
|
|
Part 2: Absolute Values of Clinical Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK
ALP, Day 5
|
61.6 International units per Liter
Standard Deviation 18.18
|
70.4 International units per Liter
Standard Deviation 21.18
|
—
|
|
Part 2: Absolute Values of Clinical Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK
ALP, Day 7
|
66.6 International units per Liter
Standard Deviation 17.59
|
58.8 International units per Liter
Standard Deviation 19.73
|
—
|
|
Part 2: Absolute Values of Clinical Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK
AST, Baseline (Day -1)
|
16.4 International units per Liter
Standard Deviation 4.15
|
16.7 International units per Liter
Standard Deviation 4.92
|
—
|
|
Part 2: Absolute Values of Clinical Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK
AST, Day 2
|
15.6 International units per Liter
Standard Deviation 3.36
|
16.1 International units per Liter
Standard Deviation 4.30
|
—
|
|
Part 2: Absolute Values of Clinical Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK
AST, Day 5
|
17.0 International units per Liter
Standard Deviation 2.88
|
20.1 International units per Liter
Standard Deviation 7.79
|
—
|
|
Part 2: Absolute Values of Clinical Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK
AST, Day 7
|
17.7 International units per Liter
Standard Deviation 6.56
|
15.9 International units per Liter
Standard Deviation 2.71
|
—
|
|
Part 2: Absolute Values of Clinical Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK
GGT, Baseline (Day -1)
|
21.6 International units per Liter
Standard Deviation 8.81
|
21.7 International units per Liter
Standard Deviation 9.34
|
—
|
|
Part 2: Absolute Values of Clinical Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK
GGT, Day 2
|
20.9 International units per Liter
Standard Deviation 8.62
|
22.2 International units per Liter
Standard Deviation 9.67
|
—
|
|
Part 2: Absolute Values of Clinical Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK
GGT, Day 5
|
21.6 International units per Liter
Standard Deviation 8.33
|
22.8 International units per Liter
Standard Deviation 11.91
|
—
|
|
Part 2: Absolute Values of Clinical Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK
GGT, Day 7
|
20.8 International units per Liter
Standard Deviation 9.65
|
21.8 International units per Liter
Standard Deviation 8.30
|
—
|
|
Part 2: Absolute Values of Clinical Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK
LDH, Baseline (Day -1)
|
125.5 International units per Liter
Standard Deviation 14.23
|
123.4 International units per Liter
Standard Deviation 14.62
|
—
|
|
Part 2: Absolute Values of Clinical Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK
LDH, Day 2
|
117.8 International units per Liter
Standard Deviation 13.32
|
118.4 International units per Liter
Standard Deviation 11.64
|
—
|
|
Part 2: Absolute Values of Clinical Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK
LDH, Day 5
|
122.6 International units per Liter
Standard Deviation 16.59
|
122.6 International units per Liter
Standard Deviation 14.56
|
—
|
|
Part 2: Absolute Values of Clinical Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK
LDH, Day 7
|
119.2 International units per Liter
Standard Deviation 14.92
|
124.9 International units per Liter
Standard Deviation 17.95
|
—
|
|
Part 2: Absolute Values of Clinical Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK
CK, Baseline (Day -1)
|
101.8 International units per Liter
Standard Deviation 52.32
|
103.3 International units per Liter
Standard Deviation 56.84
|
—
|
|
Part 2: Absolute Values of Clinical Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK
CK, Day 2
|
89.5 International units per Liter
Standard Deviation 45.43
|
89.9 International units per Liter
Standard Deviation 41.11
|
—
|
|
Part 2: Absolute Values of Clinical Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK
CK, Day 5
|
95.8 International units per Liter
Standard Deviation 38.31
|
99.8 International units per Liter
Standard Deviation 65.97
|
—
|
|
Part 2: Absolute Values of Clinical Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK
CK, Day 7
|
97.7 International units per Liter
Standard Deviation 65.84
|
85.9 International units per Liter
Standard Deviation 31.47
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day -1), and Days 2, 5, and 7Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
Blood samples were collected to analyze the chemistry parameters: calcium, CO2, chloride, glucose, potassium, sodium, urea nitrogen, phosphorus, triglycerides, cholesterol, and anion gap. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period.
Outcome measures
| Measure |
Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg
n=22 Participants
Participants received a single oral dose of GSK3640254 25 mg (2 tablets), GSK3640254 100 mg (1 tablet), and DTG 50 mg (1 tablet) together under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet)
n=21 Participants
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 monolayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet)
n=20 Participants
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 bilayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
|---|---|---|---|
|
Part 1: Absolute Values of Clinical Chemistry Parameters: Calcium, Carbon-dioxide (CO2), Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap
Calcium, Baseline (Day -1)
|
2.357 Millimoles per liter
Standard Deviation 0.0999
|
2.366 Millimoles per liter
Standard Deviation 0.1034
|
2.347 Millimoles per liter
Standard Deviation 0.0839
|
|
Part 1: Absolute Values of Clinical Chemistry Parameters: Calcium, Carbon-dioxide (CO2), Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap
Calcium, Day 2
|
2.371 Millimoles per liter
Standard Deviation 0.0986
|
2.377 Millimoles per liter
Standard Deviation 0.0868
|
2.379 Millimoles per liter
Standard Deviation 0.1009
|
|
Part 1: Absolute Values of Clinical Chemistry Parameters: Calcium, Carbon-dioxide (CO2), Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap
Calcium, Day 5
|
2.345 Millimoles per liter
Standard Deviation 0.0948
|
2.407 Millimoles per liter
Standard Deviation 0.0509
|
2.393 Millimoles per liter
Standard Deviation 0.1171
|
|
Part 1: Absolute Values of Clinical Chemistry Parameters: Calcium, Carbon-dioxide (CO2), Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap
Calcium, Day 7
|
2.380 Millimoles per liter
Standard Deviation 0.0949
|
2.348 Millimoles per liter
Standard Deviation 0.1014
|
2.371 Millimoles per liter
Standard Deviation 0.1201
|
|
Part 1: Absolute Values of Clinical Chemistry Parameters: Calcium, Carbon-dioxide (CO2), Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap
CO2, Baseline (Day -1)
|
30.5 Millimoles per liter
Standard Deviation 1.90
|
30.2 Millimoles per liter
Standard Deviation 2.14
|
30.3 Millimoles per liter
Standard Deviation 1.83
|
|
Part 1: Absolute Values of Clinical Chemistry Parameters: Calcium, Carbon-dioxide (CO2), Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap
CO2, Day 2
|
29.4 Millimoles per liter
Standard Deviation 2.24
|
29.8 Millimoles per liter
Standard Deviation 2.12
|
29.8 Millimoles per liter
Standard Deviation 2.36
|
|
Part 1: Absolute Values of Clinical Chemistry Parameters: Calcium, Carbon-dioxide (CO2), Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap
CO2, Day 5
|
28.2 Millimoles per liter
Standard Deviation 1.94
|
29.3 Millimoles per liter
Standard Deviation 2.34
|
29.7 Millimoles per liter
Standard Deviation 2.50
|
|
Part 1: Absolute Values of Clinical Chemistry Parameters: Calcium, Carbon-dioxide (CO2), Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap
CO2, Day 7
|
30.5 Millimoles per liter
Standard Deviation 2.50
|
30.5 Millimoles per liter
Standard Deviation 1.98
|
30.0 Millimoles per liter
Standard Deviation 2.05
|
|
Part 1: Absolute Values of Clinical Chemistry Parameters: Calcium, Carbon-dioxide (CO2), Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap
Chloride, Baseline (Day -1)
|
101.7 Millimoles per liter
Standard Deviation 1.49
|
101.8 Millimoles per liter
Standard Deviation 2.07
|
102.1 Millimoles per liter
Standard Deviation 2.21
|
|
Part 1: Absolute Values of Clinical Chemistry Parameters: Calcium, Carbon-dioxide (CO2), Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap
Chloride, Day 2
|
102.0 Millimoles per liter
Standard Deviation 2.53
|
101.6 Millimoles per liter
Standard Deviation 2.11
|
102.0 Millimoles per liter
Standard Deviation 2.32
|
|
Part 1: Absolute Values of Clinical Chemistry Parameters: Calcium, Carbon-dioxide (CO2), Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap
Chloride, Day 5
|
102.8 Millimoles per liter
Standard Deviation 1.47
|
101.3 Millimoles per liter
Standard Deviation 2.16
|
101.7 Millimoles per liter
Standard Deviation 1.86
|
|
Part 1: Absolute Values of Clinical Chemistry Parameters: Calcium, Carbon-dioxide (CO2), Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap
Chloride, Day 7
|
101.9 Millimoles per liter
Standard Deviation 1.92
|
102.4 Millimoles per liter
Standard Deviation 2.02
|
101.8 Millimoles per liter
Standard Deviation 1.03
|
|
Part 1: Absolute Values of Clinical Chemistry Parameters: Calcium, Carbon-dioxide (CO2), Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap
Glucose, Baseline (Day -1)
|
5.125 Millimoles per liter
Standard Deviation 0.4472
|
5.114 Millimoles per liter
Standard Deviation 0.3745
|
5.074 Millimoles per liter
Standard Deviation 0.3816
|
|
Part 1: Absolute Values of Clinical Chemistry Parameters: Calcium, Carbon-dioxide (CO2), Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap
Glucose, Day 2
|
4.927 Millimoles per liter
Standard Deviation 0.4659
|
4.979 Millimoles per liter
Standard Deviation 0.4960
|
4.813 Millimoles per liter
Standard Deviation 0.4044
|
|
Part 1: Absolute Values of Clinical Chemistry Parameters: Calcium, Carbon-dioxide (CO2), Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap
Glucose, Day 5
|
4.643 Millimoles per liter
Standard Deviation 0.3725
|
5.153 Millimoles per liter
Standard Deviation 0.3527
|
5.123 Millimoles per liter
Standard Deviation 0.4912
|
|
Part 1: Absolute Values of Clinical Chemistry Parameters: Calcium, Carbon-dioxide (CO2), Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap
Glucose, Day 7
|
5.207 Millimoles per liter
Standard Deviation 0.3982
|
4.980 Millimoles per liter
Standard Deviation 0.4112
|
4.946 Millimoles per liter
Standard Deviation 0.3303
|
|
Part 1: Absolute Values of Clinical Chemistry Parameters: Calcium, Carbon-dioxide (CO2), Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap
Potassium, Baseline (Day -1)
|
4.20 Millimoles per liter
Standard Deviation 0.233
|
4.30 Millimoles per liter
Standard Deviation 4.24
|
4.24 Millimoles per liter
Standard Deviation 0.315
|
|
Part 1: Absolute Values of Clinical Chemistry Parameters: Calcium, Carbon-dioxide (CO2), Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap
Potassium, Day 2
|
4.22 Millimoles per liter
Standard Deviation 0.246
|
4.12 Millimoles per liter
Standard Deviation 0.266
|
4.27 Millimoles per liter
Standard Deviation 0.334
|
|
Part 1: Absolute Values of Clinical Chemistry Parameters: Calcium, Carbon-dioxide (CO2), Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap
Potassium, Day 5
|
4.18 Millimoles per liter
Standard Deviation 0.147
|
4.08 Millimoles per liter
Standard Deviation 0.271
|
4.15 Millimoles per liter
Standard Deviation 0.513
|
|
Part 1: Absolute Values of Clinical Chemistry Parameters: Calcium, Carbon-dioxide (CO2), Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap
Potassium, Day 7
|
4.35 Millimoles per liter
Standard Deviation 0.383
|
4.24 Millimoles per liter
Standard Deviation 0.331
|
4.16 Millimoles per liter
Standard Deviation 0.165
|
|
Part 1: Absolute Values of Clinical Chemistry Parameters: Calcium, Carbon-dioxide (CO2), Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap
Sodium, Baseline (Day -1)
|
137.5 Millimoles per liter
Standard Deviation 2.48
|
137.9 Millimoles per liter
Standard Deviation 2.15
|
137.6 Millimoles per liter
Standard Deviation 2.37
|
|
Part 1: Absolute Values of Clinical Chemistry Parameters: Calcium, Carbon-dioxide (CO2), Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap
Sodium, Day 2
|
137.5 Millimoles per liter
Standard Deviation 2.22
|
137.8 Millimoles per liter
Standard Deviation 1.73
|
137.9 Millimoles per liter
Standard Deviation 1.76
|
|
Part 1: Absolute Values of Clinical Chemistry Parameters: Calcium, Carbon-dioxide (CO2), Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap
Sodium, Day 5
|
137.8 Millimoles per liter
Standard Deviation 1.83
|
137.2 Millimoles per liter
Standard Deviation 2.14
|
137.8 Millimoles per liter
Standard Deviation 2.64
|
|
Part 1: Absolute Values of Clinical Chemistry Parameters: Calcium, Carbon-dioxide (CO2), Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap
Sodium, Day 7
|
138.2 Millimoles per liter
Standard Deviation 1.99
|
138.2 Millimoles per liter
Standard Deviation 2.20
|
137.2 Millimoles per liter
Standard Deviation 2.39
|
|
Part 1: Absolute Values of Clinical Chemistry Parameters: Calcium, Carbon-dioxide (CO2), Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap
Urea nitrogen, Baseline (Day -1)
|
4.105 Millimoles per liter
Standard Deviation 0.9931
|
4.398 Millimoles per liter
Standard Deviation 0.9260
|
4.216 Millimoles per liter
Standard Deviation 0.5976
|
|
Part 1: Absolute Values of Clinical Chemistry Parameters: Calcium, Carbon-dioxide (CO2), Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap
Urea nitrogen, Day 2
|
4.625 Millimoles per liter
Standard Deviation 0.8713
|
4.731 Millimoles per liter
Standard Deviation 0.8265
|
4.491 Millimoles per liter
Standard Deviation 0.8115
|
|
Part 1: Absolute Values of Clinical Chemistry Parameters: Calcium, Carbon-dioxide (CO2), Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap
Urea nitrogen, Day 5
|
3.980 Millimoles per liter
Standard Deviation 0.4246
|
4.378 Millimoles per liter
Standard Deviation 0.6674
|
4.368 Millimoles per liter
Standard Deviation 0.6707
|
|
Part 1: Absolute Values of Clinical Chemistry Parameters: Calcium, Carbon-dioxide (CO2), Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap
Urea nitrogen, Day 7
|
4.810 Millimoles per liter
Standard Deviation 1.0170
|
4.220 Millimoles per liter
Standard Deviation 0.5511
|
4.439 Millimoles per liter
Standard Deviation 1.0769
|
|
Part 1: Absolute Values of Clinical Chemistry Parameters: Calcium, Carbon-dioxide (CO2), Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap
Phosphate, Baseline (Day -1)
|
1.126 Millimoles per liter
Standard Deviation 0.1429
|
1.095 Millimoles per liter
Standard Deviation 0.1602
|
1.156 Millimoles per liter
Standard Deviation 0.1414
|
|
Part 1: Absolute Values of Clinical Chemistry Parameters: Calcium, Carbon-dioxide (CO2), Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap
Phosphate, Day 2
|
1.195 Millimoles per liter
Standard Deviation 0.1672
|
1.173 Millimoles per liter
Standard Deviation 0.1474
|
1.238 Millimoles per liter
Standard Deviation 0.1306
|
|
Part 1: Absolute Values of Clinical Chemistry Parameters: Calcium, Carbon-dioxide (CO2), Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap
Phosphate, Day 5
|
1.267 Millimoles per liter
Standard Deviation 0.1007
|
1.142 Millimoles per liter
Standard Deviation 0.2344
|
1.178 Millimoles per liter
Standard Deviation 0.1574
|
|
Part 1: Absolute Values of Clinical Chemistry Parameters: Calcium, Carbon-dioxide (CO2), Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap
Phosphate, Day 7
|
1.114 Millimoles per liter
Standard Deviation 0.0886
|
1.198 Millimoles per liter
Standard Deviation 0.1058
|
1.172 Millimoles per liter
Standard Deviation 0.1494
|
|
Part 1: Absolute Values of Clinical Chemistry Parameters: Calcium, Carbon-dioxide (CO2), Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap
Triglycerides, Baseline (Day -1)
|
1.161 Millimoles per liter
Standard Deviation 0.3495
|
1.284 Millimoles per liter
Standard Deviation 0.6031
|
1.011 Millimoles per liter
Standard Deviation 0.3381
|
|
Part 1: Absolute Values of Clinical Chemistry Parameters: Calcium, Carbon-dioxide (CO2), Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap
Triglycerides, Day 2
|
1.255 Millimoles per liter
Standard Deviation 0.5400
|
1.271 Millimoles per liter
Standard Deviation 0.6676
|
1.022 Millimoles per liter
Standard Deviation 0.3455
|
|
Part 1: Absolute Values of Clinical Chemistry Parameters: Calcium, Carbon-dioxide (CO2), Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap
Triglycerides, Day 5
|
0.907 Millimoles per liter
Standard Deviation 0.2482
|
1.020 Millimoles per liter
Standard Deviation 0.4494
|
0.827 Millimoles per liter
Standard Deviation 0.2523
|
|
Part 1: Absolute Values of Clinical Chemistry Parameters: Calcium, Carbon-dioxide (CO2), Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap
Triglycerides Day 7
|
1.316 Millimoles per liter
Standard Deviation 0.6488
|
0.972 Millimoles per liter
Standard Deviation 0.3031
|
1.048 Millimoles per liter
Standard Deviation 0.3121
|
|
Part 1: Absolute Values of Clinical Chemistry Parameters: Calcium, Carbon-dioxide (CO2), Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap
Cholesterol, Baseline (Day -1)
|
4.666 Millimoles per liter
Standard Deviation 0.6505
|
4.737 Millimoles per liter
Standard Deviation 0.7591
|
4.674 Millimoles per liter
Standard Deviation 0.6908
|
|
Part 1: Absolute Values of Clinical Chemistry Parameters: Calcium, Carbon-dioxide (CO2), Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap
Cholesterol, Day 2
|
4.783 Millimoles per liter
Standard Deviation 0.6972
|
4.795 Millimoles per liter
Standard Deviation 0.7617
|
4.726 Millimoles per liter
Standard Deviation 0.7404
|
|
Part 1: Absolute Values of Clinical Chemistry Parameters: Calcium, Carbon-dioxide (CO2), Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap
Cholesterol, Day 5
|
4.863 Millimoles per liter
Standard Deviation 0.6029
|
4.507 Millimoles per liter
Standard Deviation 1.2255
|
4.292 Millimoles per liter
Standard Deviation 0.4032
|
|
Part 1: Absolute Values of Clinical Chemistry Parameters: Calcium, Carbon-dioxide (CO2), Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap
Cholesterol, Day 7
|
4.415 Millimoles per liter
Standard Deviation 0.5871
|
4.776 Millimoles per liter
Standard Deviation 0.6017
|
4.590 Millimoles per liter
Standard Deviation 0.7417
|
|
Part 1: Absolute Values of Clinical Chemistry Parameters: Calcium, Carbon-dioxide (CO2), Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap
Anion gap, Baseline (Day -1)
|
9.5 Millimoles per liter
Standard Deviation 1.30
|
10.1 Millimoles per liter
Standard Deviation 1.62
|
9.6 Millimoles per liter
Standard Deviation 1.43
|
|
Part 1: Absolute Values of Clinical Chemistry Parameters: Calcium, Carbon-dioxide (CO2), Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap
Anion gap, Day 2
|
10.3 Millimoles per liter
Standard Deviation 1.94
|
10.5 Millimoles per liter
Standard Deviation 1.29
|
10.3 Millimoles per liter
Standard Deviation 2.23
|
|
Part 1: Absolute Values of Clinical Chemistry Parameters: Calcium, Carbon-dioxide (CO2), Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap
Anion gap, Day 5
|
10.8 Millimoles per liter
Standard Deviation 1.72
|
10.7 Millimoles per liter
Standard Deviation 1.63
|
10.8 Millimoles per liter
Standard Deviation 1.72
|
|
Part 1: Absolute Values of Clinical Chemistry Parameters: Calcium, Carbon-dioxide (CO2), Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap
Anion gap, Day 7
|
10.2 Millimoles per liter
Standard Deviation 1.25
|
9.7 Millimoles per liter
Standard Deviation 1.38
|
9.4 Millimoles per liter
Standard Deviation 1.65
|
SECONDARY outcome
Timeframe: Baseline (Day -1) and Days 2, 5 and 7Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
Blood samples were collected to analyze the chemistry parameters: calcium, CO2, chloride, glucose, potassium, sodium, urea nitrogen, phosphorus, triglycerides, cholesterol, and anion gap. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period.
Outcome measures
| Measure |
Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg
n=17 Participants
Participants received a single oral dose of GSK3640254 25 mg (2 tablets), GSK3640254 100 mg (1 tablet), and DTG 50 mg (1 tablet) together under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet)
n=18 Participants
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 monolayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet)
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 bilayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
|---|---|---|---|
|
Part 2: Absolute Values of Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap
Calcium, Baseline (Day -1)
|
2.356 Millimoles per liter
Standard Deviation 0.0947
|
2.354 Millimoles per liter
Standard Deviation 0.0833
|
—
|
|
Part 2: Absolute Values of Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap
Calcium, Day 2
|
2.343 Millimoles per liter
Standard Deviation 0.0922
|
2.362 Millimoles per liter
Standard Deviation 0.0854
|
—
|
|
Part 2: Absolute Values of Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap
Calcium, Day 5
|
2.315 Millimoles per liter
Standard Deviation 0.0991
|
2.381 Millimoles per liter
Standard Deviation 0.0764
|
—
|
|
Part 2: Absolute Values of Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap
Calcium, Day 7
|
2.362 Millimoles per liter
Standard Deviation 0.1049
|
2.340 Millimoles per liter
Standard Deviation 0.0616
|
—
|
|
Part 2: Absolute Values of Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap
CO2, Baseline (Day -1)
|
31.2 Millimoles per liter
Standard Deviation 1.42
|
31.1 Millimoles per liter
Standard Deviation 1.51
|
—
|
|
Part 2: Absolute Values of Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap
CO2, Day 2
|
29.8 Millimoles per liter
Standard Deviation 2.10
|
30.1 Millimoles per liter
Standard Deviation 2.10
|
—
|
|
Part 2: Absolute Values of Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap
CO2, Day 5
|
30.1 Millimoles per liter
Standard Deviation 1.64
|
30.8 Millimoles per liter
Standard Deviation 1.86
|
—
|
|
Part 2: Absolute Values of Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap
CO2, Day 7
|
31.3 Millimoles per liter
Standard Deviation 1.87
|
31.1 Millimoles per liter
Standard Deviation 1.17
|
—
|
|
Part 2: Absolute Values of Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap
Chloride, Baseline (Day -1)
|
101.8 Millimoles per liter
Standard Deviation 2.11
|
102.1 Millimoles per liter
Standard Deviation 1.45
|
—
|
|
Part 2: Absolute Values of Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap
Chloride, Day 2
|
102.3 Millimoles per liter
Standard Deviation 1.34
|
101.7 Millimoles per liter
Standard Deviation 1.64
|
—
|
|
Part 2: Absolute Values of Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap
Chloride, Day 5
|
102.0 Millimoles per liter
Standard Deviation 1.93
|
101.4 Millimoles per liter
Standard Deviation 1.01
|
—
|
|
Part 2: Absolute Values of Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap
Chloride, Day 7
|
102.3 Millimoles per liter
Standard Deviation 1.87
|
102.1 Millimoles per liter
Standard Deviation 2.20
|
—
|
|
Part 2: Absolute Values of Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap
Glucose, Baseline (Day -1)
|
4.872 Millimoles per liter
Standard Deviation 0.3107
|
4.913 Millimoles per liter
Standard Deviation 0.3252
|
—
|
|
Part 2: Absolute Values of Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap
Glucose, Day 2
|
4.784 Millimoles per liter
Standard Deviation 0.3470
|
4.989 Millimoles per liter
Standard Deviation 0.3379
|
—
|
|
Part 2: Absolute Values of Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap
Glucose, Day 5
|
4.606 Millimoles per liter
Standard Deviation 0.3351
|
4.729 Millimoles per liter
Standard Deviation 0.1985
|
—
|
|
Part 2: Absolute Values of Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap
Glucose, Day 7
|
4.984 Millimoles per liter
Standard Deviation 0.3691
|
4.754 Millimoles per liter
Standard Deviation 0.3304
|
—
|
|
Part 2: Absolute Values of Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap
Potassium, Baseline (Day -1)
|
4.29 Millimoles per liter
Standard Deviation 0.183
|
4.27 Millimoles per liter
Standard Deviation 0.225
|
—
|
|
Part 2: Absolute Values of Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap
Potassium, Day 2
|
4.30 Millimoles per liter
Standard Deviation 0.193
|
4.36 Millimoles per liter
Standard Deviation 0.350
|
—
|
|
Part 2: Absolute Values of Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap
Potassium, Day 5
|
4.33 Millimoles per liter
Standard Deviation 0.369
|
4.18 Millimoles per liter
Standard Deviation 0.222
|
—
|
|
Part 2: Absolute Values of Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap
Potassium, Day 7
|
4.26 Millimoles per liter
Standard Deviation 0.133
|
4.46 Millimoles per liter
Standard Deviation 0.364
|
—
|
|
Part 2: Absolute Values of Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap
Sodium, Baseline (Day -1)
|
138.2 Millimoles per liter
Standard Deviation 2.02
|
138.1 Millimoles per liter
Standard Deviation 1.55
|
—
|
|
Part 2: Absolute Values of Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap
Sodium, Day 2
|
137.8 Millimoles per liter
Standard Deviation 1.83
|
137.8 Millimoles per liter
Standard Deviation 2.39
|
—
|
|
Part 2: Absolute Values of Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap
Sodium, Day 5
|
137.4 Millimoles per liter
Standard Deviation 1.69
|
138.1 Millimoles per liter
Standard Deviation 1.90
|
—
|
|
Part 2: Absolute Values of Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap
Sodium, Day 7
|
138.9 Millimoles per liter
Standard Deviation 1.17
|
138.4 Millimoles per liter
Standard Deviation 2.40
|
—
|
|
Part 2: Absolute Values of Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap
Urea nitrogen, Baseline (Day -1)
|
4.193 Millimoles per liter
Standard Deviation 0.9707
|
4.289 Millimoles per liter
Standard Deviation 0.8517
|
—
|
|
Part 2: Absolute Values of Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap
Urea nitrogen, Day 2
|
4.511 Millimoles per liter
Standard Deviation 0.8025
|
4.917 Millimoles per liter
Standard Deviation 1.2215
|
—
|
|
Part 2: Absolute Values of Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap
Urea nitrogen, Day 5
|
4.488 Millimoles per liter
Standard Deviation 0.7840
|
4.197 Millimoles per liter
Standard Deviation 0.9577
|
—
|
|
Part 2: Absolute Values of Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap
Urea nitrogen, Day 7
|
4.130 Millimoles per liter
Standard Deviation 0.9850
|
4.889 Millimoles per liter
Standard Deviation 1.2618
|
—
|
|
Part 2: Absolute Values of Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap
Phosphate, Baseline (Day -1)
|
1.129 Millimoles per liter
Standard Deviation 0.1711
|
1.137 Millimoles per liter
Standard Deviation 0.1644
|
—
|
|
Part 2: Absolute Values of Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap
Phosphate, Day 2
|
1.163 Millimoles per liter
Standard Deviation 0.1414
|
1.181 Millimoles per liter
Standard Deviation 0.1402
|
—
|
|
Part 2: Absolute Values of Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap
Phosphate, Day 5
|
1.149 Millimoles per liter
Standard Deviation 0.1183
|
1.159 Millimoles per liter
Standard Deviation 0.1837
|
—
|
|
Part 2: Absolute Values of Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap
Phosphate, Day 7
|
1.147 Millimoles per liter
Standard Deviation 0.1777
|
1.146 Millimoles per liter
Standard Deviation 0.1261
|
—
|
|
Part 2: Absolute Values of Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap
Triglycerides, Baseline (Day -1)
|
1.380 Millimoles per liter
Standard Deviation 0.5675
|
1.346 Millimoles per liter
Standard Deviation 0.6796
|
—
|
|
Part 2: Absolute Values of Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap
Triglycerides, Day 2
|
1.255 Millimoles per liter
Standard Deviation 0.5644
|
1.226 Millimoles per liter
Standard Deviation 0.4816
|
—
|
|
Part 2: Absolute Values of Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap
Triglycerides, Day 5
|
1.268 Millimoles per liter
Standard Deviation 0.6846
|
1.044 Millimoles per liter
Standard Deviation 0.4087
|
—
|
|
Part 2: Absolute Values of Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap
Triglycerides, Day 7
|
1.200 Millimoles per liter
Standard Deviation 0.5402
|
1.461 Millimoles per liter
Standard Deviation 0.7119
|
—
|
|
Part 2: Absolute Values of Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap
Cholesterol, Baseline (Day -1)
|
4.477 Millimoles per liter
Standard Deviation 0.8449
|
4.454 Millimoles per liter
Standard Deviation 0.7606
|
—
|
|
Part 2: Absolute Values of Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap
Cholesterol, Day 2
|
4.603 Millimoles per liter
Standard Deviation 0.7998
|
4.531 Millimoles per liter
Standard Deviation 0.8227
|
—
|
|
Part 2: Absolute Values of Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap
Cholesterol, Day 5
|
4.591 Millimoles per liter
Standard Deviation 0.8199
|
4.287 Millimoles per liter
Standard Deviation 0.9845
|
—
|
|
Part 2: Absolute Values of Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap
Cholesterol, Day 7
|
4.173 Millimoles per liter
Standard Deviation 0.7740
|
4.617 Millimoles per liter
Standard Deviation 0.8221
|
—
|
|
Part 2: Absolute Values of Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap
Anion Gap, Baseline (Day -1)
|
9.5 Millimoles per liter
Standard Deviation 0.87
|
9.2 Millimoles per liter
Standard Deviation 0.92
|
—
|
|
Part 2: Absolute Values of Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap
Anion Gap, Day 2
|
9.9 Millimoles per liter
Standard Deviation 0.85
|
10.4 Millimoles per liter
Standard Deviation 0.98
|
—
|
|
Part 2: Absolute Values of Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap
Anion Gap, Day 5
|
9.6 Millimoles per liter
Standard Deviation 0.92
|
9.0 Millimoles per liter
Standard Deviation 2.83
|
—
|
|
Part 2: Absolute Values of Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap
Anion Gap, Day 7
|
9.3 Millimoles per liter
Standard Deviation 0.87
|
9.6 Millimoles per liter
Standard Deviation 0.88
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day -1), and Days 2, 5, and 7Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
Blood samples were collected to analyze the chemistry parameters: serum lipase and serum amylase. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period.
Outcome measures
| Measure |
Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg
n=22 Participants
Participants received a single oral dose of GSK3640254 25 mg (2 tablets), GSK3640254 100 mg (1 tablet), and DTG 50 mg (1 tablet) together under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet)
n=21 Participants
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 monolayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet)
n=20 Participants
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 bilayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
|---|---|---|---|
|
Part 1: Absolute Values for Chemistry Parameters: Serum Lipase, Serum Amylase
Serum lipase, Baseline (Day -1)
|
32.5 Units per Liter
Standard Deviation 12.77
|
34.6 Units per Liter
Standard Deviation 17.45
|
31.1 Units per Liter
Standard Deviation 13.95
|
|
Part 1: Absolute Values for Chemistry Parameters: Serum Lipase, Serum Amylase
Serum lipase, Day 2
|
32.1 Units per Liter
Standard Deviation 13.07
|
40.4 Units per Liter
Standard Deviation 27.76
|
34.2 Units per Liter
Standard Deviation 13.50
|
|
Part 1: Absolute Values for Chemistry Parameters: Serum Lipase, Serum Amylase
Serum lipase, Day 5
|
34.3 Units per Liter
Standard Deviation 15.08
|
40.2 Units per Liter
Standard Deviation 19.87
|
27.7 Units per Liter
Standard Deviation 5.61
|
|
Part 1: Absolute Values for Chemistry Parameters: Serum Lipase, Serum Amylase
Serum lipase, Day 7
|
33.1 Units per Liter
Standard Deviation 17.23
|
28.8 Units per Liter
Standard Deviation 11.77
|
35.0 Units per Liter
Standard Deviation 17.18
|
|
Part 1: Absolute Values for Chemistry Parameters: Serum Lipase, Serum Amylase
Serum amylase, Baseline (Day -1)
|
54.9 Units per Liter
Standard Deviation 13.67
|
58.9 Units per Liter
Standard Deviation 16.72
|
58.4 Units per Liter
Standard Deviation 14.51
|
|
Part 1: Absolute Values for Chemistry Parameters: Serum Lipase, Serum Amylase
Serum amylase, Day 2
|
58.9 Units per Liter
Standard Deviation 15.47
|
62.8 Units per Liter
Standard Deviation 18.88
|
61.7 Units per Liter
Standard Deviation 16.92
|
|
Part 1: Absolute Values for Chemistry Parameters: Serum Lipase, Serum Amylase
Serum amylase, Day 5
|
63.3 Units per Liter
Standard Deviation 9.91
|
55.2 Units per Liter
Standard Deviation 15.47
|
62.2 Units per Liter
Standard Deviation 23.16
|
|
Part 1: Absolute Values for Chemistry Parameters: Serum Lipase, Serum Amylase
Serum amylase, Day 7
|
62.0 Units per Liter
Standard Deviation 19.18
|
62.2 Units per Liter
Standard Deviation 14.71
|
56.2 Units per Liter
Standard Deviation 13.57
|
SECONDARY outcome
Timeframe: Baseline (Day -1) and Days 2, 5 and 7Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
Blood samples were collected to analyze the chemistry parameters: serum lipase, serum amylase. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period.
Outcome measures
| Measure |
Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg
n=17 Participants
Participants received a single oral dose of GSK3640254 25 mg (2 tablets), GSK3640254 100 mg (1 tablet), and DTG 50 mg (1 tablet) together under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet)
n=18 Participants
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 monolayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet)
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 bilayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
|---|---|---|---|
|
Part 2: Absolute Values for Chemistry Parameters: Serum Lipase, Serum Amylase
Serum amylase, Baseline (Day -1)
|
58.7 Units per Liter
Standard Deviation 17.33
|
56.7 Units per Liter
Standard Deviation 15.19
|
—
|
|
Part 2: Absolute Values for Chemistry Parameters: Serum Lipase, Serum Amylase
Serum amylase, Day 2
|
58.3 Units per Liter
Standard Deviation 17.08
|
58.8 Units per Liter
Standard Deviation 15.21
|
—
|
|
Part 2: Absolute Values for Chemistry Parameters: Serum Lipase, Serum Amylase
Serum amylase, Day 5
|
53.9 Units per Liter
Standard Deviation 16.40
|
62.7 Units per Liter
Standard Deviation 14.06
|
—
|
|
Part 2: Absolute Values for Chemistry Parameters: Serum Lipase, Serum Amylase
Serum amylase, Day 7
|
63.3 Units per Liter
Standard Deviation 15.98
|
51.7 Units per Liter
Standard Deviation 14.27
|
—
|
|
Part 2: Absolute Values for Chemistry Parameters: Serum Lipase, Serum Amylase
Serum lipase, Baseline (Day -1)
|
32.1 Units per Liter
Standard Deviation 11.73
|
30.2 Units per Liter
Standard Deviation 10.22
|
—
|
|
Part 2: Absolute Values for Chemistry Parameters: Serum Lipase, Serum Amylase
Serum lipase, Day 2
|
30.5 Units per Liter
Standard Deviation 11.60
|
30.4 Units per Liter
Standard Deviation 11.12
|
—
|
|
Part 2: Absolute Values for Chemistry Parameters: Serum Lipase, Serum Amylase
Serum lipase, Day 5
|
28.6 Units per Liter
Standard Deviation 19.28
|
40.3 Units per Liter
Standard Deviation 15.17
|
—
|
|
Part 2: Absolute Values for Chemistry Parameters: Serum Lipase, Serum Amylase
Serum lipase, Day 7
|
35.0 Units per Liter
Standard Deviation 6.22
|
25.2 Units per Liter
Standard Deviation 12.59
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day -1), and Days 2, 5, and 7Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
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 visit, prior to the first study drug administration in each treatment period.
Outcome measures
| Measure |
Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg
n=22 Participants
Participants received a single oral dose of GSK3640254 25 mg (2 tablets), GSK3640254 100 mg (1 tablet), and DTG 50 mg (1 tablet) together under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet)
n=21 Participants
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 monolayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet)
n=20 Participants
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 bilayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
|---|---|---|---|
|
Part 1: Absolute Values of Clinical Chemistry Parameters: Albumin, Globulin and Protein
Albumin, Day 2
|
44.6 Grams per liter
Standard Deviation 2.61
|
44.5 Grams per liter
Standard Deviation 2.29
|
44.5 Grams per liter
Standard Deviation 2.46
|
|
Part 1: Absolute Values of Clinical Chemistry Parameters: Albumin, Globulin and Protein
Albumin, Baseline (Day -1)
|
43.8 Grams per liter
Standard Deviation 2.91
|
43.8 Grams per liter
Standard Deviation 3.12
|
43.8 Grams per liter
Standard Deviation 2.38
|
|
Part 1: Absolute Values of Clinical Chemistry Parameters: Albumin, Globulin and Protein
Albumin, Day 5
|
43.8 Grams per liter
Standard Deviation 2.23
|
43.8 Grams per liter
Standard Deviation 2.32
|
43.2 Grams per liter
Standard Deviation 4.12
|
|
Part 1: Absolute Values of Clinical Chemistry Parameters: Albumin, Globulin and Protein
Albumin, Day 7
|
43.6 Grams per liter
Standard Deviation 2.66
|
43.9 Grams per liter
Standard Deviation 2.22
|
45.3 Grams per liter
Standard Deviation 2.16
|
|
Part 1: Absolute Values of Clinical Chemistry Parameters: Albumin, Globulin and Protein
Globulin, Baseline (Day -1)
|
26.4 Grams per liter
Standard Deviation 4.04
|
27.0 Grams per liter
Standard Deviation 3.25
|
26.0 Grams per liter
Standard Deviation 3.63
|
|
Part 1: Absolute Values of Clinical Chemistry Parameters: Albumin, Globulin and Protein
Globulin, Day 2
|
27.3 Grams per liter
Standard Deviation 3.85
|
27.4 Grams per liter
Standard Deviation 3.72
|
27.1 Grams per liter
Standard Deviation 4.51
|
|
Part 1: Absolute Values of Clinical Chemistry Parameters: Albumin, Globulin and Protein
Globulin, Day 5
|
26.0 Grams per liter
Standard Deviation 2.61
|
28.0 Grams per liter
Standard Deviation 3.52
|
26.2 Grams per liter
Standard Deviation 3.37
|
|
Part 1: Absolute Values of Clinical Chemistry Parameters: Albumin, Globulin and Protein
Globulin, Day 7
|
27.1 Grams per liter
Standard Deviation 3.78
|
25.8 Grams per liter
Standard Deviation 3.60
|
25.9 Grams per liter
Standard Deviation 4.31
|
|
Part 1: Absolute Values of Clinical Chemistry Parameters: Albumin, Globulin and Protein
Protein, Baseline (Day -1)
|
70.1 Grams per liter
Standard Deviation 5.10
|
70.8 Grams per liter
Standard Deviation 4.12
|
69.7 Grams per liter
Standard Deviation 4.46
|
|
Part 1: Absolute Values of Clinical Chemistry Parameters: Albumin, Globulin and Protein
Protein, Day 2
|
71.9 Grams per liter
Standard Deviation 4.86
|
71.9 Grams per liter
Standard Deviation 4.03
|
71.6 Grams per liter
Standard Deviation 5.60
|
|
Part 1: Absolute Values of Clinical Chemistry Parameters: Albumin, Globulin and Protein
Protein, Day 5
|
69.8 Grams per liter
Standard Deviation 1.94
|
71.8 Grams per liter
Standard Deviation 4.71
|
69.3 Grams per liter
Standard Deviation 5.28
|
|
Part 1: Absolute Values of Clinical Chemistry Parameters: Albumin, Globulin and Protein
Protein, Day 7
|
70.7 Grams per liter
Standard Deviation 4.90
|
69.8 Grams per liter
Standard Deviation 4.17
|
71.2 Grams per liter
Standard Deviation 4.71
|
SECONDARY outcome
Timeframe: Baseline (Day -1) and Days 2, 5 and 7Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
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 visit, prior to the first study drug administration in each treatment period.
Outcome measures
| Measure |
Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg
n=17 Participants
Participants received a single oral dose of GSK3640254 25 mg (2 tablets), GSK3640254 100 mg (1 tablet), and DTG 50 mg (1 tablet) together under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet)
n=18 Participants
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 monolayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet)
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 bilayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
|---|---|---|---|
|
Part 2: Absolute Values of Clinical Chemistry Parameters: Albumin, Globulin and Protein
Albumin, Baseline (Day -1)
|
42.9 Grams per liter
Standard Deviation 3.72
|
43.1 Grams per liter
Standard Deviation 3.40
|
—
|
|
Part 2: Absolute Values of Clinical Chemistry Parameters: Albumin, Globulin and Protein
Albumin, Day 2
|
43.3 Grams per liter
Standard Deviation 2.91
|
43.2 Grams per liter
Standard Deviation 3.26
|
—
|
|
Part 2: Absolute Values of Clinical Chemistry Parameters: Albumin, Globulin and Protein
Albumin, Day 5
|
44.4 Grams per liter
Standard Deviation 2.56
|
44.9 Grams per liter
Standard Deviation 4.04
|
—
|
|
Part 2: Absolute Values of Clinical Chemistry Parameters: Albumin, Globulin and Protein
Albumin, Day 7
|
43.3 Grams per liter
Standard Deviation 4.33
|
43.2 Grams per liter
Standard Deviation 2.39
|
—
|
|
Part 2: Absolute Values of Clinical Chemistry Parameters: Albumin, Globulin and Protein
Globulin, Baseline (Day -1)
|
28.0 Grams per liter
Standard Deviation 3.39
|
27.2 Grams per liter
Standard Deviation 3.64
|
—
|
|
Part 2: Absolute Values of Clinical Chemistry Parameters: Albumin, Globulin and Protein
Globulin, Day 2
|
28.5 Grams per liter
Standard Deviation 3.27
|
28.1 Grams per liter
Standard Deviation 3.47
|
—
|
|
Part 2: Absolute Values of Clinical Chemistry Parameters: Albumin, Globulin and Protein
Globulin, Day 5
|
27.1 Grams per liter
Standard Deviation 3.94
|
30.4 Grams per liter
Standard Deviation 3.78
|
—
|
|
Part 2: Absolute Values of Clinical Chemistry Parameters: Albumin, Globulin and Protein
Globulin, Day 7
|
28.4 Grams per liter
Standard Deviation 3.64
|
25.9 Grams per liter
Standard Deviation 3.48
|
—
|
|
Part 2: Absolute Values of Clinical Chemistry Parameters: Albumin, Globulin and Protein
Protein, Baseline (Day -1)
|
70.9 Grams per liter
Standard Deviation 4.83
|
70.3 Grams per liter
Standard Deviation 4.69
|
—
|
|
Part 2: Absolute Values of Clinical Chemistry Parameters: Albumin, Globulin and Protein
Protein, Day 2
|
71.8 Grams per liter
Standard Deviation 3.60
|
71.3 Grams per liter
Standard Deviation 4.60
|
—
|
|
Part 2: Absolute Values of Clinical Chemistry Parameters: Albumin, Globulin and Protein
Protein, Day 5
|
71.5 Grams per liter
Standard Deviation 3.96
|
75.3 Grams per liter
Standard Deviation 5.00
|
—
|
|
Part 2: Absolute Values of Clinical Chemistry Parameters: Albumin, Globulin and Protein
Protein, Day 7
|
71.8 Grams per liter
Standard Deviation 6.04
|
69.1 Grams per liter
Standard Deviation 4.23
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day -1), and Days 2, 5, and 7Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
Blood samples were collected to analyze the chemistry parameters: creatinine, direct bilirubin, bilirubin, urate. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period.
Outcome measures
| Measure |
Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg
n=22 Participants
Participants received a single oral dose of GSK3640254 25 mg (2 tablets), GSK3640254 100 mg (1 tablet), and DTG 50 mg (1 tablet) together under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet)
n=21 Participants
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 monolayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet)
n=20 Participants
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 bilayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
|---|---|---|---|
|
Part 1: Absolute Values of Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate
Creatinine, Baseline (Day -1)
|
74.58 Micromoles per liter
Standard Deviation 13.770
|
77.79 Micromoles per liter
Standard Deviation 14.328
|
75.32 Micromoles per liter
Standard Deviation 15.250
|
|
Part 1: Absolute Values of Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate
Creatinine, Day 2
|
82.89 Micromoles per liter
Standard Deviation 15.880
|
84.90 Micromoles per liter
Standard Deviation 17.025
|
81.47 Micromoles per liter
Standard Deviation 15.445
|
|
Part 1: Absolute Values of Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate
Creatinine, Day 5
|
76.77 Micromoles per liter
Standard Deviation 9.046
|
77.20 Micromoles per liter
Standard Deviation 17.447
|
79.57 Micromoles per liter
Standard Deviation 18.646
|
|
Part 1: Absolute Values of Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate
Creatinine, Day 7
|
82.05 Micromoles per liter
Standard Deviation 14.136
|
78.55 Micromoles per liter
Standard Deviation 15.613
|
74.53 Micromoles per liter
Standard Deviation 13.793
|
|
Part 1: Absolute Values of Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate
Direct bilirubin, Baseline (Day -1)
|
1.93 Micromoles per liter
Standard Deviation 0.540
|
2.03 Micromoles per liter
Standard Deviation 0.597
|
2.03 Micromoles per liter
Standard Deviation 0.634
|
|
Part 1: Absolute Values of Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate
Direct bilirubin, Day 2
|
1.80 Micromoles per liter
Standard Deviation 0.532
|
1.97 Micromoles per liter
Standard Deviation 0.678
|
2.03 Micromoles per liter
Standard Deviation 0.687
|
|
Part 1: Absolute Values of Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate
Direct bilirubin, Day 5
|
1.67 Micromoles per liter
Standard Deviation 0.437
|
2.08 Micromoles per liter
Standard Deviation 0.694
|
2.28 Micromoles per liter
Standard Deviation 0.778
|
|
Part 1: Absolute Values of Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate
Direct bilirubin, Day 7
|
2.00 Micromoles per liter
Standard Deviation 0.548
|
1.88 Micromoles per liter
Standard Deviation 0.577
|
2.04 Micromoles per liter
Standard Deviation 0.648
|
|
Part 1: Absolute Values of Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate
Bilirubin, Baseline (Day -1)
|
10.38 Micromoles per liter
Standard Deviation 3.283
|
11.43 Micromoles per liter
Standard Deviation 3.510
|
10.93 Micromoles per liter
Standard Deviation 3.805
|
|
Part 1: Absolute Values of Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate
Bilirubin, Day 2
|
9.70 Micromoles per liter
Standard Deviation 2.714
|
11.04 Micromoles per liter
Standard Deviation 3.619
|
10.72 Micromoles per liter
Standard Deviation 3.862
|
|
Part 1: Absolute Values of Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate
Bilirubin, Day 5
|
8.38 Micromoles per liter
Standard Deviation 3.021
|
9.95 Micromoles per liter
Standard Deviation 3.605
|
11.05 Micromoles per liter
Standard Deviation 3.553
|
|
Part 1: Absolute Values of Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate
Bilirubin, Day 7
|
10.92 Micromoles per liter
Standard Deviation 2.975
|
10.34 Micromoles per liter
Standard Deviation 3.510
|
10.11 Micromoles per liter
Standard Deviation 3.473
|
|
Part 1: Absolute Values of Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate
Urate, Baseline (Day -1)
|
287.0 Micromoles per liter
Standard Deviation 67.20
|
291.8 Micromoles per liter
Standard Deviation 58.22
|
276.0 Micromoles per liter
Standard Deviation 58.76
|
|
Part 1: Absolute Values of Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate
Urate, Day 2
|
280.1 Micromoles per liter
Standard Deviation 64.07
|
283.9 Micromoles per liter
Standard Deviation 62.39
|
271.9 Micromoles per liter
Standard Deviation 54.52
|
|
Part 1: Absolute Values of Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate
Urate, Day 5
|
235.0 Micromoles per liter
Standard Deviation 40.83
|
290.5 Micromoles per liter
Standard Deviation 53.91
|
292.3 Micromoles per liter
Standard Deviation 53.16
|
|
Part 1: Absolute Values of Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate
Urate, Day 7
|
305.1 Micromoles per liter
Standard Deviation 55.55
|
271.8 Micromoles per liter
Standard Deviation 58.66
|
280.0 Micromoles per liter
Standard Deviation 53.36
|
SECONDARY outcome
Timeframe: Baseline (Day -1) and Days 2, 5 and 7Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
Blood samples were collected to analyze the chemistry parameters: creatinine, direct bilirubin, bilirubin, and urate. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period.
Outcome measures
| Measure |
Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg
n=17 Participants
Participants received a single oral dose of GSK3640254 25 mg (2 tablets), GSK3640254 100 mg (1 tablet), and DTG 50 mg (1 tablet) together under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet)
n=18 Participants
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 monolayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet)
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 bilayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
|---|---|---|---|
|
Part 2: Absolute Values of Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate
Creatinine, Baseline (Day -1)
|
81.02 Micromoles per liter
Standard Deviation 17.857
|
83.19 Micromoles per liter
Standard Deviation 19.817
|
—
|
|
Part 2: Absolute Values of Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate
Creatinine, Day 2
|
88.29 Micromoles per liter
Standard Deviation 21.603
|
90.17 Micromoles per liter
Standard Deviation 22.148
|
—
|
|
Part 2: Absolute Values of Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate
Creatinine, Day 5
|
85.31 Micromoles per liter
Standard Deviation 13.191
|
83.79 Micromoles per liter
Standard Deviation 24.894
|
—
|
|
Part 2: Absolute Values of Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate
Creatinine, Day 7
|
82.51 Micromoles per liter
Standard Deviation 25.513
|
82.90 Micromoles per liter
Standard Deviation 12.663
|
—
|
|
Part 2: Absolute Values of Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate
Direct bilirubin, Baseline (Day -1)
|
1.71 Micromoles per liter
Standard Deviation 0.506
|
1.73 Micromoles per liter
Standard Deviation 0.470
|
—
|
|
Part 2: Absolute Values of Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate
Direct bilirubin, Day 2
|
1.69 Micromoles per liter
Standard Deviation 0.431
|
1.77 Micromoles per liter
Standard Deviation 0.621
|
—
|
|
Part 2: Absolute Values of Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate
Direct bilirubin, Day 5
|
1.89 Micromoles per liter
Standard Deviation 0.295
|
1.99 Micromoles per liter
Standard Deviation 0.851
|
—
|
|
Part 2: Absolute Values of Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate
Direct bilirubin, Day 7
|
1.62 Micromoles per liter
Standard Deviation 0.565
|
1.72 Micromoles per liter
Standard Deviation 0.286
|
—
|
|
Part 2: Absolute Values of Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate
Bilirubin, Baseline (Day -1)
|
9.64 Micromoles per liter
Standard Deviation 3.401
|
9.27 Micromoles per liter
Standard Deviation 2.548
|
—
|
|
Part 2: Absolute Values of Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate
Bilirubin, Day 2
|
8.98 Micromoles per liter
Standard Deviation 1.548
|
9.58 Micromoles per liter
Standard Deviation 3.048
|
—
|
|
Part 2: Absolute Values of Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate
Bilirubin, Day 5
|
9.55 Micromoles per liter
Standard Deviation 1.125
|
10.50 Micromoles per liter
Standard Deviation 5.312
|
—
|
|
Part 2: Absolute Values of Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate
Bilirubin, Day 7
|
8.57 Micromoles per liter
Standard Deviation 3.324
|
9.90 Micromoles per liter
Standard Deviation 0.758
|
—
|
|
Part 2: Absolute Values of Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate
Urate, Baseline (Day -1)
|
324.4 Micromoles per liter
Standard Deviation 66.68
|
329.2 Micromoles per liter
Standard Deviation 73.48
|
—
|
|
Part 2: Absolute Values of Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate
Urate, Day 2
|
307.0 Micromoles per liter
Standard Deviation 64.72
|
331.8 Micromoles per liter
Standard Deviation 81.70
|
—
|
|
Part 2: Absolute Values of Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate
Urate, Day 5
|
330.1 Micromoles per liter
Standard Deviation 68.86
|
306.0 Micromoles per liter
Standard Deviation 73.64
|
—
|
|
Part 2: Absolute Values of Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate
Urate, Day 7
|
308.0 Micromoles per liter
Standard Deviation 74.35
|
332.3 Micromoles per liter
Standard Deviation 62.07
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day -1) and Days 2, 5, and 7Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
Blood samples were collected to analyze the chemistry parameters: ALT, ALP, AST, GGT, LDH, CK. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg
n=22 Participants
Participants received a single oral dose of GSK3640254 25 mg (2 tablets), GSK3640254 100 mg (1 tablet), and DTG 50 mg (1 tablet) together under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet)
n=21 Participants
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 monolayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet)
n=20 Participants
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 bilayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
|---|---|---|---|
|
Part 1: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK
ALT, Day 2
|
-0.1 International units per Liter
Standard Deviation 2.49
|
-1.7 International units per Liter
Standard Deviation 4.74
|
-0.5 International units per Liter
Standard Deviation 5.50
|
|
Part 1: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK
ALT, Day 5
|
-1.7 International units per Liter
Standard Deviation 4.37
|
-0.2 International units per Liter
Standard Deviation 2.23
|
-3.0 International units per Liter
Standard Deviation 8.39
|
|
Part 1: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK
ALT, Day 7
|
1.1 International units per Liter
Standard Deviation 5.97
|
-0.3 International units per Liter
Standard Deviation 9.32
|
0.5 International units per Liter
Standard Deviation 7.93
|
|
Part 1: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK
ALP, Day 2
|
1.8 International units per Liter
Standard Deviation 5.14
|
2.0 International units per Liter
Standard Deviation 3.76
|
1.8 International units per Liter
Standard Deviation 4.66
|
|
Part 1: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK
ALP, Day 5
|
-1.8 International units per Liter
Standard Deviation 3.25
|
-1.0 International units per Liter
Standard Deviation 5.66
|
-2.7 International units per Liter
Standard Deviation 6.74
|
|
Part 1: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK
ALP, Day 7
|
1.4 International units per Liter
Standard Deviation 3.67
|
0.8 International units per Liter
Standard Deviation 3.75
|
3.9 International units per Liter
Standard Deviation 5.55
|
|
Part 1: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK
AST, Day 2
|
-0.5 International units per Liter
Standard Deviation 1.65
|
-0.9 International units per Liter
Standard Deviation 2.32
|
0.0 International units per Liter
Standard Deviation 3.08
|
|
Part 1: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK
AST, Day 5
|
-2.0 International units per Liter
Standard Deviation 2.90
|
0.3 International units per Liter
Standard Deviation 1.63
|
0.0 International units per Liter
Standard Deviation 3.58
|
|
Part 1: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK
AST, Day 7
|
-0.4 International units per Liter
Standard Deviation 2.06
|
-0.9 International units per Liter
Standard Deviation 3.62
|
0.6 International units per Liter
Standard Deviation 2.76
|
|
Part 1: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK
GGT, Day 2
|
-0.1 International units per Liter
Standard Deviation 2.24
|
0.0 International units per Liter
Standard Deviation 1.43
|
0.6 International units per Liter
Standard Deviation 3.76
|
|
Part 1: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK
GGT, Day 5
|
-3.0 International units per Liter
Standard Deviation 4.20
|
-1.3 International units per Liter
Standard Deviation 1.86
|
-1.0 International units per Liter
Standard Deviation 2.28
|
|
Part 1: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK
GGT, Day 7
|
-0.1 International units per Liter
Standard Deviation 3.11
|
-1.2 International units per Liter
Standard Deviation 2.48
|
2.4 International units per Liter
Standard Deviation 8.13
|
|
Part 1: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK
LDH, Day 2
|
-2.6 International units per Liter
Standard Deviation 11.67
|
-0.9 International units per Liter
Standard Deviation 10.41
|
4.0 International units per Liter
Standard Deviation 9.89
|
|
Part 1: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK
LDH, Day 5
|
-16.5 International units per Liter
Standard Deviation 14.90
|
0.3 International units per Liter
Standard Deviation 7.26
|
2.2 International units per Liter
Standard Deviation 14.15
|
|
Part 1: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK
LDH, Day 7
|
-8.8 International units per Liter
Standard Deviation 10.09
|
-10.2 International units per Liter
Standard Deviation 9.54
|
-5.3 International units per Liter
Standard Deviation 15.43
|
|
Part 1: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK
CK, Day 2
|
-11.4 International units per Liter
Standard Deviation 33.22
|
-10.3 International units per Liter
Standard Deviation 20.22
|
0.2 International units per Liter
Standard Deviation 27.16
|
|
Part 1: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK
CK, Day 5
|
-18.5 International units per Liter
Standard Deviation 20.66
|
-1.8 International units per Liter
Standard Deviation 11.58
|
8.8 International units per Liter
Standard Deviation 13.75
|
|
Part 1: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK
CK, Day 7
|
-26.2 International units per Liter
Standard Deviation 43.88
|
-27.3 International units per Liter
Standard Deviation 43.24
|
-9.3 International units per Liter
Standard Deviation 22.62
|
SECONDARY outcome
Timeframe: Baseline (Day -1) and Days 2, 5 and 7Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
Blood samples were collected to analyze the chemistry parameters: ALT, ALP, AST, GGT, LDH, CK. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg
n=16 Participants
Participants received a single oral dose of GSK3640254 25 mg (2 tablets), GSK3640254 100 mg (1 tablet), and DTG 50 mg (1 tablet) together under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet)
n=18 Participants
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 monolayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet)
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 bilayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
|---|---|---|---|
|
Part 2: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK
ALT, Day 2
|
-0.7 International units per Liter
Standard Deviation 3.48
|
0.1 International units per Liter
Standard Deviation 3.30
|
—
|
|
Part 2: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK
ALT, Day 5
|
1.1 International units per Liter
Standard Deviation 2.64
|
3.4 International units per Liter
Standard Deviation 7.21
|
—
|
|
Part 2: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK
ALT, Day 7
|
1.6 International units per Liter
Standard Deviation 5.77
|
2.2 International units per Liter
Standard Deviation 3.67
|
—
|
|
Part 2: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK
ALP, Day 2
|
-0.1 International units per Liter
Standard Deviation 4.22
|
0.4 International units per Liter
Standard Deviation 3.65
|
—
|
|
Part 2: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK
ALP, Day 5
|
1.1 International units per Liter
Standard Deviation 3.56
|
3.9 International units per Liter
Standard Deviation 9.20
|
—
|
|
Part 2: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK
ALP, Day 7
|
1.0 International units per Liter
Standard Deviation 3.81
|
2.1 International units per Liter
Standard Deviation 4.26
|
—
|
|
Part 2: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK
AST, Day 2
|
-0.8 International units per Liter
Standard Deviation 2.32
|
-0.7 International units per Liter
Standard Deviation 1.81
|
—
|
|
Part 2: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK
AST, Day 5
|
1.4 International units per Liter
Standard Deviation 1.06
|
2.4 International units per Liter
Standard Deviation 3.32
|
—
|
|
Part 2: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK
AST, Day 7
|
0.7 International units per Liter
Standard Deviation 2.55
|
0.1 International units per Liter
Standard Deviation 1.69
|
—
|
|
Part 2: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK
GGT, Day 2
|
-0.3 International units per Liter
Standard Deviation 1.08
|
0.5 International units per Liter
Standard Deviation 1.38
|
—
|
|
Part 2: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK
GGT, Day 5
|
0.9 International units per Liter
Standard Deviation 0.83
|
2.0 International units per Liter
Standard Deviation 3.67
|
—
|
|
Part 2: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK
GGT, Day 7
|
-1.6 International units per Liter
Standard Deviation 3.09
|
-0.9 International units per Liter
Standard Deviation 2.71
|
—
|
|
Part 2: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK
LDH, Day 2
|
-7.1 International units per Liter
Standard Deviation 11.65
|
-4.9 International units per Liter
Standard Deviation 8.68
|
—
|
|
Part 2: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK
LDH, Day 5
|
-4.6 International units per Liter
Standard Deviation 10.89
|
3.3 International units per Liter
Standard Deviation 16.90
|
—
|
|
Part 2: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK
LDH, Day 7
|
-4.8 International units per Liter
Standard Deviation 12.02
|
-2.7 International units per Liter
Standard Deviation 11.92
|
—
|
|
Part 2: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK
CK, Day 2
|
-6.9 International units per Liter
Standard Deviation 12.25
|
-13.4 International units per Liter
Standard Deviation 20.32
|
—
|
|
Part 2: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK
CK, Day 5
|
7.6 International units per Liter
Standard Deviation 11.56
|
2.1 International units per Liter
Standard Deviation 13.70
|
—
|
|
Part 2: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK
CK, Day 7
|
-16.3 International units per Liter
Standard Deviation 34.30
|
-23.1 International units per Liter
Standard Deviation 36.97
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day -1) and Days 2, 5, and 7Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
Blood samples were collected to analyze the chemistry parameters: calcium, CO2, chloride, glucose, potassium, sodium, urea nitrogen, phosphorus, triglycerides, cholesterol, and anion gap. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg
n=22 Participants
Participants received a single oral dose of GSK3640254 25 mg (2 tablets), GSK3640254 100 mg (1 tablet), and DTG 50 mg (1 tablet) together under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet)
n=21 Participants
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 monolayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet)
n=20 Participants
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 bilayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
|---|---|---|---|
|
Part 1: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap
Calcium, Day 2
|
0.014 Millimoles per liter
Standard Deviation 0.0547
|
0.011 Millimoles per liter
Standard Deviation 0.0599
|
0.033 Millimoles per liter
Standard Deviation 0.0838
|
|
Part 1: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap
Calcium, Day 5
|
-0.007 Millimoles per liter
Standard Deviation 0.0333
|
0.013 Millimoles per liter
Standard Deviation 0.0432
|
0.007 Millimoles per liter
Standard Deviation 0.0535
|
|
Part 1: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap
Calcium, Day 7
|
0.011 Millimoles per liter
Standard Deviation 0.0650
|
-0.002 Millimoles per liter
Standard Deviation 0.0867
|
0.018 Millimoles per liter
Standard Deviation 0.0875
|
|
Part 1: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap
CO2, Day 2
|
-1.1 Millimoles per liter
Standard Deviation 1.41
|
-0.5 Millimoles per liter
Standard Deviation 1.33
|
-0.5 Millimoles per liter
Standard Deviation 1.57
|
|
Part 1: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap
CO2, Day 5
|
-1.7 Millimoles per liter
Standard Deviation 1.37
|
-0.8 Millimoles per liter
Standard Deviation 1.17
|
-1.7 Millimoles per liter
Standard Deviation 1.63
|
|
Part 1: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap
CO2, Day 7
|
-0.5 Millimoles per liter
Standard Deviation 1.69
|
0.4 Millimoles per liter
Standard Deviation 2.22
|
0.0 Millimoles per liter
Standard Deviation 1.05
|
|
Part 1: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap
Chloride, Day 2
|
0.3 Millimoles per liter
Standard Deviation 1.94
|
-0.1 Millimoles per liter
Standard Deviation 1.15
|
-0.1 Millimoles per liter
Standard Deviation 1.47
|
|
Part 1: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap
Chloride, Day 5
|
1.7 Millimoles per liter
Standard Deviation 2.25
|
-0.3 Millimoles per liter
Standard Deviation 1.03
|
-1.5 Millimoles per liter
Standard Deviation 2.51
|
|
Part 1: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap
Chloride, Day 7
|
0.2 Millimoles per liter
Standard Deviation 1.89
|
0.8 Millimoles per liter
Standard Deviation 2.17
|
-0.1 Millimoles per liter
Standard Deviation 2.23
|
|
Part 1: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap
Glucose, Day 2
|
-0.197 Millimoles per liter
Standard Deviation 0.2209
|
-0.135 Millimoles per liter
Standard Deviation 0.2856
|
-0.262 Millimoles per liter
Standard Deviation 0.1809
|
|
Part 1: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap
Glucose, Day 5
|
-0.093 Millimoles per liter
Standard Deviation 0.2550
|
-0.035 Millimoles per liter
Standard Deviation 0.1792
|
-0.105 Millimoles per liter
Standard Deviation 0.1735
|
|
Part 1: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap
Glucose, Day 7
|
-0.086 Millimoles per liter
Standard Deviation 0.3962
|
-0.066 Millimoles per liter
Standard Deviation 0.3024
|
-0.171 Millimoles per liter
Standard Deviation 0.1920
|
|
Part 1: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap
Potassium, Day 2
|
0.02 Millimoles per liter
Standard Deviation 0.234
|
-0.18 Millimoles per liter
Standard Deviation 0.274
|
0.03 Millimoles per liter
Standard Deviation 0.281
|
|
Part 1: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap
Potassium, Day 5
|
0.10 Millimoles per liter
Standard Deviation 0.290
|
-0.05 Millimoles per liter
Standard Deviation 0.226
|
-0.20 Millimoles per liter
Standard Deviation 0.369
|
|
Part 1: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap
Potassium, Day 7
|
0.10 Millimoles per liter
Standard Deviation 0.310
|
-0.06 Millimoles per liter
Standard Deviation 0.198
|
-0.08 Millimoles per liter
Standard Deviation 0.361
|
|
Part 1: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap
Sodium, Day 2
|
0.0 Millimoles per liter
Standard Deviation 1.95
|
1.64 Millimoles per liter
Standard Deviation 0.3
|
0.3 Millimoles per liter
Standard Deviation 2.24
|
|
Part 1: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap
Sodium, Day 5
|
1.0 Millimoles per liter
Standard Deviation 1.79
|
-0.2 Millimoles per liter
Standard Deviation 1.17
|
-1.3 Millimoles per liter
Standard Deviation 2.66
|
|
Part 1: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap
Sodium, Day 7
|
-0.2 Millimoles per liter
Standard Deviation 2.36
|
0.4 Millimoles per liter
Standard Deviation 2.14
|
-0.3 Millimoles per liter
Standard Deviation 2.31
|
|
Part 1: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap
Urea nitrogen, Day 2
|
0.520 Millimoles per liter
Standard Deviation 0.7073
|
0.333 Millimoles per liter
Standard Deviation 0.4752
|
0.4553 Millimoles per liter
Standard Deviation 0.4553
|
|
Part 1: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap
Urea nitrogen, Day 5
|
0.857 Millimoles per liter
Standard Deviation 0.4584
|
0.143 Millimoles per liter
Standard Deviation 0.5844
|
-0.017 Millimoles per liter
Standard Deviation 0.6301
|
|
Part 1: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap
Urea nitrogen, Day 7
|
0.618 Millimoles per liter
Standard Deviation 0.7434
|
-0.035 Millimoles per liter
Standard Deviation 0.5511
|
0.309 Millimoles per liter
Standard Deviation 0.7935
|
|
Part 1: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap
Phosphate, Day 2
|
0.069 Millimoles per liter
Standard Deviation 0.1242
|
0.078 Millimoles per liter
Standard Deviation 0.0972
|
0.082 Millimoles per liter
Standard Deviation 0.0716
|
|
Part 1: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap
Phosphate, Day 5
|
0.082 Millimoles per liter
Standard Deviation 0.1232
|
0.048 Millimoles per liter
Standard Deviation 0.0952
|
-0.002 Millimoles per liter
Standard Deviation 0.0964
|
|
Part 1: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap
Phosphate, Day 7
|
0.036 Millimoles per liter
Standard Deviation 0.1218
|
0.099 Millimoles per liter
Standard Deviation 0.1245
|
0.052 Millimoles per liter
Standard Deviation 0.0487
|
|
Part 1: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap
Triglycerides, Day 2
|
0.095 Millimoles per liter
Standard Deviation 0.3467
|
-0.013 Millimoles per liter
Standard Deviation 0.2499
|
0.011 Millimoles per liter
Standard Deviation 0.2280
|
|
Part 1: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap
Triglycerides, Day 5
|
-0.192 Millimoles per liter
Standard Deviation 0.1338
|
-0.223 Millimoles per liter
Standard Deviation 0.3551
|
-0.185 Millimoles per liter
Standard Deviation 0.1778
|
|
Part 1: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap
Triglycerides, Day 7
|
0.160 Millimoles per liter
Standard Deviation 0.4290
|
-0.149 Millimoles per liter
Standard Deviation 0.2656
|
-0.016 Millimoles per liter
Standard Deviation 0.1888
|
|
Part 1: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap
Cholesterol, Day 2
|
0.117 Millimoles per liter
Standard Deviation 0.3551
|
0.058 Millimoles per liter
Standard Deviation 0.3115
|
0.052 Millimoles per liter
Standard Deviation 0.2865
|
|
Part 1: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap
Cholesterol, Day 5
|
-0.098 Millimoles per liter
Standard Deviation 0.5254
|
-0.022 Millimoles per liter
Standard Deviation 0.4323
|
-0.252 Millimoles per liter
Standard Deviation 0.3485
|
|
Part 1: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap
Cholesterol, Day 7
|
-0.033 Millimoles per liter
Standard Deviation 0.4137
|
-0.137 Millimoles per liter
Standard Deviation 0.4751
|
0.056 Millimoles per liter
Standard Deviation 0.3841
|
|
Part 1: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap
Anion gap, Day 2
|
0.8 Millimoles per liter
Standard Deviation 2.07
|
0.3 Millimoles per liter
Standard Deviation 1.59
|
0.8 Millimoles per liter
Standard Deviation 2.36
|
|
Part 1: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap
Anion gap, Day 5
|
1.0 Millimoles per liter
Standard Deviation 1.41
|
1.2 Millimoles per liter
Standard Deviation 1.17
|
1.7 Millimoles per liter
Standard Deviation 1.37
|
|
Part 1: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap
Anion gap, Day 7
|
0.4 Millimoles per liter
Standard Deviation 1.29
|
-0.8 Millimoles per liter
Standard Deviation 1.88
|
-0.4 Millimoles per liter
Standard Deviation 1.35
|
SECONDARY outcome
Timeframe: Baseline (Day -1) and Days 2, 5 and 7Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
Blood samples were collected to analyze the chemistry parameters: calcium, CO2, chloride, glucose, potassium, sodium, urea nitrogen, phosphorus, triglycerides, cholesterol, and anion gap. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg
n=17 Participants
Participants received a single oral dose of GSK3640254 25 mg (2 tablets), GSK3640254 100 mg (1 tablet), and DTG 50 mg (1 tablet) together under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet)
n=18 Participants
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 monolayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet)
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 bilayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
|---|---|---|---|
|
Part 2: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap
Calcium, Day 2
|
-0.008 Millimoles per liter
Standard Deviation 0.0764
|
0.007 Millimoles per liter
Standard Deviation 0.0585
|
—
|
|
Part 2: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap
Calcium, Day 5
|
-0.033 Millimoles per liter
Standard Deviation 0.0812
|
0.019 Millimoles per liter
Standard Deviation 0.0971
|
—
|
|
Part 2: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap
Calcium, Day 7
|
-0.002 Millimoles per liter
Standard Deviation 0.0814
|
-0.007 Millimoles per liter
Standard Deviation 0.0779
|
—
|
|
Part 2: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap
Potassium, Day 2
|
0.01 Millimoles per liter
Standard Deviation 0.247
|
0.09 Millimoles per liter
Standard Deviation 0.289
|
—
|
|
Part 2: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap
CO2, Day 2
|
-1.3 Millimoles per liter
Standard Deviation 1.49
|
-1.0 Millimoles per liter
Standard Deviation 1.37
|
—
|
|
Part 2: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap
CO2, Day 5
|
-1.1 Millimoles per liter
Standard Deviation 0.99
|
-0.6 Millimoles per liter
Standard Deviation 0.73
|
—
|
|
Part 2: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap
CO2, Day 7
|
0.2 Millimoles per liter
Standard Deviation 1.48
|
0.3 Millimoles per liter
Standard Deviation 1.41
|
—
|
|
Part 2: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap
Chloride, Day 2
|
0.3 Millimoles per liter
Standard Deviation 1.85
|
-0.4 Millimoles per liter
Standard Deviation 1.89
|
—
|
|
Part 2: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap
Chloride, Day 5
|
0.4 Millimoles per liter
Standard Deviation 2.00
|
-0.9 Millimoles per liter
Standard Deviation 1.90
|
—
|
|
Part 2: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap
Chloride, Day 7
|
0.4 Millimoles per liter
Standard Deviation 1.88
|
0.2 Millimoles per liter
Standard Deviation 2.33
|
—
|
|
Part 2: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap
Glucose, Day 2
|
-0.084 Millimoles per liter
Standard Deviation 0.1480
|
0.077 Millimoles per liter
Standard Deviation 0.2392
|
—
|
|
Part 2: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap
Glucose, Day 5
|
-0.160 Millimoles per liter
Standard Deviation 0.2754
|
-0.256 Millimoles per liter
Standard Deviation 0.3867
|
—
|
|
Part 2: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap
Glucose, Day 7
|
0.019 Millimoles per liter
Standard Deviation 0.3691
|
-0.087 Millimoles per liter
Standard Deviation 0.2601
|
—
|
|
Part 2: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap
Potassium, Day 5
|
-0.01 Millimoles per liter
Standard Deviation 0.476
|
-0.08 Millimoles per liter
Standard Deviation 0.192
|
—
|
|
Part 2: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap
Potassium, Day 7
|
0.01 Millimoles per liter
Standard Deviation 0.145
|
0.18 Millimoles per liter
Standard Deviation 0.393
|
—
|
|
Part 2: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap
Sodium, Day 2
|
-0.4 Millimoles per liter
Standard Deviation 1.41
|
-0.3 Millimoles per liter
Standard Deviation 2.24
|
—
|
|
Part 2: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap
Sodium, Day 5
|
-0.8 Millimoles per liter
Standard Deviation 1.49
|
-0.8 Millimoles per liter
Standard Deviation 1.86
|
—
|
|
Part 2: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap
Sodium, Day 7
|
0.6 Millimoles per liter
Standard Deviation 1.33
|
1.2 Millimoles per liter
Standard Deviation 2.22
|
—
|
|
Part 2: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap
Urea nitrogen, Day 2
|
0.228 Millimoles per liter
Standard Deviation 0.4467
|
0.628 Millimoles per liter
Standard Deviation 0.7585
|
—
|
|
Part 2: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap
Urea nitrogen, Day 5
|
-0.138 Millimoles per liter
Standard Deviation 0.6950
|
0.067 Millimoles per liter
Standard Deviation 0.8951
|
—
|
|
Part 2: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap
Urea nitrogen, Day 7
|
0.321 Millimoles per liter
Standard Deviation 0.7415
|
0.441 Millimoles per liter
Standard Deviation 0.7504
|
—
|
|
Part 2: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap
Phosphate, Day 2
|
0.041 Millimoles per liter
Standard Deviation 0.0842
|
0.044 Millimoles per liter
Standard Deviation 0.0902
|
—
|
|
Part 2: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap
Phosphate, Day 5
|
0.014 Millimoles per liter
Standard Deviation 0.0983
|
0.012 Millimoles per liter
Standard Deviation 0.0349
|
—
|
|
Part 2: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap
Phosphate, Day 7
|
0.023 Millimoles per liter
Standard Deviation 0.0854
|
0.019 Millimoles per liter
Standard Deviation 0.0862
|
—
|
|
Part 2: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap
Triglycerides, Day 2
|
-0.111 Millimoles per liter
Standard Deviation 0.3084
|
-0.121 Millimoles per liter
Standard Deviation 0.2674
|
—
|
|
Part 2: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap
Triglycerides, Day 5
|
-0.215 Millimoles per liter
Standard Deviation 0.3208
|
-0.156 Millimoles per liter
Standard Deviation 0.2584
|
—
|
|
Part 2: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap
Triglycerides, Day 7
|
-0.089 Millimoles per liter
Standard Deviation 0.4124
|
-0.031 Millimoles per liter
Standard Deviation 0.2996
|
—
|
|
Part 2: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap
Cholesterol, Day 2
|
0.121 Millimoles per liter
Standard Deviation 0.4047
|
0.076 Millimoles per liter
Standard Deviation 0.2377
|
—
|
|
Part 2: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap
Cholesterol, Day 5
|
-0.036 Millimoles per liter
Standard Deviation 0.3000
|
0.113 Millimoles per liter
Standard Deviation 0.4685
|
—
|
|
Part 2: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap
Cholesterol, Day 7
|
-0.170 Millimoles per liter
Standard Deviation 0.4438
|
-0.119 Millimoles per liter
Standard Deviation 0.4662
|
—
|
|
Part 2: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap
Anion gap, Day 2
|
0.5 Millimoles per liter
Standard Deviation 0.82
|
1.3 Millimoles per liter
Standard Deviation 0.96
|
—
|
|
Part 2: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap
Anion gap, Day 5
|
0.0 Millimoles per liter
Standard Deviation 1.41
|
-0.3 Millimoles per liter
Standard Deviation 3.08
|
—
|
|
Part 2: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap
Anion gap, Day 7
|
-0.1 Millimoles per liter
Standard Deviation 0.78
|
0.6 Millimoles per liter
Standard Deviation 1.42
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day -1) and Days 2, 5, and 7Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
Blood samples were collected to analyze the chemistry parameters: lipase and amylase. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg
n=22 Participants
Participants received a single oral dose of GSK3640254 25 mg (2 tablets), GSK3640254 100 mg (1 tablet), and DTG 50 mg (1 tablet) together under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet)
n=21 Participants
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 monolayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet)
n=20 Participants
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 bilayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
|---|---|---|---|
|
Part 1: Change From Baseline in Clinical Chemistry Parameters: Lipase and Amylase
Lipase, Day 2
|
-0.4 Units per Liter
Standard Deviation 5.21
|
5.8 Units per Liter
Standard Deviation 13.57
|
3.2 Units per Liter
Standard Deviation 10.59
|
|
Part 1: Change From Baseline in Clinical Chemistry Parameters: Lipase and Amylase
Lipase, Day 5
|
3.3 Units per Liter
Standard Deviation 3.33
|
1.3 Units per Liter
Standard Deviation 3.98
|
2.0 Units per Liter
Standard Deviation 9.92
|
|
Part 1: Change From Baseline in Clinical Chemistry Parameters: Lipase and Amylase
Lipase, Day 7
|
4.5 Units per Liter
Standard Deviation 15.61
|
-3.6 Units per Liter
Standard Deviation 19.59
|
2.1 Units per Liter
Standard Deviation 5.49
|
|
Part 1: Change From Baseline in Clinical Chemistry Parameters: Lipase and Amylase
Amylase, Day 2
|
4.0 Units per Liter
Standard Deviation 5.54
|
3.9 Units per Liter
Standard Deviation 5.21
|
3.3 Units per Liter
Standard Deviation 8.70
|
|
Part 1: Change From Baseline in Clinical Chemistry Parameters: Lipase and Amylase
Amylase, Day 5
|
5.5 Units per Liter
Standard Deviation 4.23
|
0.5 Units per Liter
Standard Deviation 4.32
|
-1.2 Units per Liter
Standard Deviation 7.94
|
|
Part 1: Change From Baseline in Clinical Chemistry Parameters: Lipase and Amylase
Amylase, Day 7
|
5.0 Units per Liter
Standard Deviation 9.08
|
-0.7 Units per Liter
Standard Deviation 10.27
|
3.5 Units per Liter
Standard Deviation 9.23
|
SECONDARY outcome
Timeframe: Baseline (Day -1) and Days 2, 5 and 7Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
Blood samples were collected to analyze the chemistry parameters: lipase and amylase. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg
n=17 Participants
Participants received a single oral dose of GSK3640254 25 mg (2 tablets), GSK3640254 100 mg (1 tablet), and DTG 50 mg (1 tablet) together under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet)
n=18 Participants
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 monolayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet)
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 bilayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
|---|---|---|---|
|
Part 2: Change From Baseline in Clinical Chemistry Parameters: Lipase and Amylase
Lipase, Day 2
|
-1.6 Units per Liter
Standard Deviation 5.77
|
0.3 Units per Liter
Standard Deviation 3.51
|
—
|
|
Part 2: Change From Baseline in Clinical Chemistry Parameters: Lipase and Amylase
Lipase, Day 5
|
2.3 Units per Liter
Standard Deviation 20.10
|
5.3 Units per Liter
Standard Deviation 13.17
|
—
|
|
Part 2: Change From Baseline in Clinical Chemistry Parameters: Lipase and Amylase
Lipase, Day 7
|
-2.2 Units per Liter
Standard Deviation 8.77
|
-0.1 Units per Liter
Standard Deviation 4.65
|
—
|
|
Part 2: Change From Baseline in Clinical Chemistry Parameters: Lipase and Amylase
Amylase, Day 2
|
0.8 Units per Liter
Standard Deviation 4.11
|
2.1 Units per Liter
Standard Deviation 3.83
|
—
|
|
Part 2: Change From Baseline in Clinical Chemistry Parameters: Lipase and Amylase
Amylase, Day 5
|
0.8 Units per Liter
Standard Deviation 7.42
|
-0.7 Units per Liter
Standard Deviation 6.84
|
—
|
|
Part 2: Change From Baseline in Clinical Chemistry Parameters: Lipase and Amylase
Amylase, Day 7
|
-0.3 Units per Liter
Standard Deviation 6.28
|
1.6 Units per Liter
Standard Deviation 4.39
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day -1) and Days 2, 5, 7Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
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 visit, prior to the first study drug administration in each treatment period. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg
n=22 Participants
Participants received a single oral dose of GSK3640254 25 mg (2 tablets), GSK3640254 100 mg (1 tablet), and DTG 50 mg (1 tablet) together under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet)
n=21 Participants
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 monolayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet)
n=20 Participants
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 bilayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
|---|---|---|---|
|
Part 1: Change From Baseline in Clinical Chemistry Parameters: Albumin, Globulin and Protein
Albumin, Day 2
|
0.8 Grams per liter
Standard Deviation 2.65
|
0.7 Grams per liter
Standard Deviation 2.08
|
0.7 Grams per liter
Standard Deviation 1.49
|
|
Part 1: Change From Baseline in Clinical Chemistry Parameters: Albumin, Globulin and Protein
Albumin, Day 5
|
-0.8 Grams per liter
Standard Deviation 1.72
|
0.2 Grams per liter
Standard Deviation 2.32
|
-0.2 Grams per liter
Standard Deviation 2.32
|
|
Part 1: Change From Baseline in Clinical Chemistry Parameters: Albumin, Globulin and Protein
Albumin, Day 7
|
0.2 Grams per liter
Standard Deviation 2.14
|
0.0 Grams per liter
Standard Deviation 2.68
|
1.3 Grams per liter
Standard Deviation 1.49
|
|
Part 1: Change From Baseline in Clinical Chemistry Parameters: Albumin, Globulin and Protein
Globulin, Day 2
|
1.0 Grams per liter
Standard Deviation 2.44
|
0.4 Grams per liter
Standard Deviation 1.80
|
1.2 Grams per liter
Standard Deviation 2.23
|
|
Part 1: Change From Baseline in Clinical Chemistry Parameters: Albumin, Globulin and Protein
Globulin, Day 5
|
0.2 Grams per liter
Standard Deviation 2.40
|
0.2 Grams per liter
Standard Deviation 1.17
|
1.0 Grams per liter
Standard Deviation 2.10
|
|
Part 1: Change From Baseline in Clinical Chemistry Parameters: Albumin, Globulin and Protein
Globulin, Day 7
|
0.0 Grams per liter
Standard Deviation 1.67
|
-0.5 Grams per liter
Standard Deviation 2.33
|
0.6 Grams per liter
Standard Deviation 1.84
|
|
Part 1: Change From Baseline in Clinical Chemistry Parameters: Albumin, Globulin and Protein
Protein, Day 2
|
1.8 Grams per liter
Standard Deviation 4.69
|
1.1 Grams per liter
Standard Deviation 3.65
|
1.9 Grams per liter
Standard Deviation 3.54
|
|
Part 1: Change From Baseline in Clinical Chemistry Parameters: Albumin, Globulin and Protein
Protein, Day 5
|
-0.7 Grams per liter
Standard Deviation 2.80
|
0.3 Grams per liter
Standard Deviation 2.58
|
0.8 Grams per liter
Standard Deviation 3.13
|
|
Part 1: Change From Baseline in Clinical Chemistry Parameters: Albumin, Globulin and Protein
Protein, Day 7
|
0.2 Grams per liter
Standard Deviation 3.49
|
-0.5 Grams per liter
Standard Deviation 4.56
|
1.9 Grams per liter
Standard Deviation 2.81
|
SECONDARY outcome
Timeframe: Baseline (Day -1) and Days 2, 5 and 7Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
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 visit, prior to the first study drug administration in each treatment period. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg
n=16 Participants
Participants received a single oral dose of GSK3640254 25 mg (2 tablets), GSK3640254 100 mg (1 tablet), and DTG 50 mg (1 tablet) together under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet)
n=18 Participants
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 monolayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet)
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 bilayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
|---|---|---|---|
|
Part 2: Change From Baseline in Clinical Chemistry Parameters: Albumin, Globulin and Protein
Albumin, Day 2
|
0.6 Grams per liter
Standard Deviation 2.78
|
0.2 Grams per liter
Standard Deviation 2.18
|
—
|
|
Part 2: Change From Baseline in Clinical Chemistry Parameters: Albumin, Globulin and Protein
Albumin, Day 5
|
0.9 Grams per liter
Standard Deviation 3.00
|
1.6 Grams per liter
Standard Deviation 4.36
|
—
|
|
Part 2: Change From Baseline in Clinical Chemistry Parameters: Albumin, Globulin and Protein
Albumin, Day 7
|
0.9 Grams per liter
Standard Deviation 2.47
|
0.4 Grams per liter
Standard Deviation 3.17
|
—
|
|
Part 2: Change From Baseline in Clinical Chemistry Parameters: Albumin, Globulin and Protein
Globulin, Day 2
|
0.3 Grams per liter
Standard Deviation 1.98
|
0.8 Grams per liter
Standard Deviation 2.28
|
—
|
|
Part 2: Change From Baseline in Clinical Chemistry Parameters: Albumin, Globulin and Protein
Globulin, Day 5
|
0.8 Grams per liter
Standard Deviation 1.67
|
2.0 Grams per liter
Standard Deviation 2.78
|
—
|
|
Part 2: Change From Baseline in Clinical Chemistry Parameters: Albumin, Globulin and Protein
Globulin, Day 7
|
-1.0 Grams per liter
Standard Deviation 3.08
|
-0.1 Grams per liter
Standard Deviation 2.42
|
—
|
|
Part 2: Change From Baseline in Clinical Chemistry Parameters: Albumin, Globulin and Protein
Protein, Day 2
|
0.9 Grams per liter
Standard Deviation 3.95
|
1.0 Grams per liter
Standard Deviation 3.33
|
—
|
|
Part 2: Change From Baseline in Clinical Chemistry Parameters: Albumin, Globulin and Protein
Protein, Day 5
|
1.6 Grams per liter
Standard Deviation 3.85
|
3.6 Grams per liter
Standard Deviation 6.27
|
—
|
|
Part 2: Change From Baseline in Clinical Chemistry Parameters: Albumin, Globulin and Protein
Protein, Day 7
|
-0.1 Grams per liter
Standard Deviation 4.04
|
0.3 Grams per liter
Standard Deviation 4.58
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day -1) and Days 2, 5, and 7Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
Blood samples were collected to analyze the chemistry parameters: creatinine, direct bilirubin, bilirubin, and urate. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg
n=22 Participants
Participants received a single oral dose of GSK3640254 25 mg (2 tablets), GSK3640254 100 mg (1 tablet), and DTG 50 mg (1 tablet) together under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet)
n=21 Participants
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 monolayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet)
n=20 Participants
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 bilayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
|---|---|---|---|
|
Part 1: Change From Baseline in Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate
Creatinine, Day 2
|
8.31 Micromoles per liter
Standard Deviation 4.422
|
7.12 Micromoles per liter
Standard Deviation 5.636
|
6.15 Micromoles per liter
Standard Deviation 4.228
|
|
Part 1: Change From Baseline in Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate
Creatinine, Day 5
|
3.10 Micromoles per liter
Standard Deviation 2.440
|
3.38 Micromoles per liter
Standard Deviation 3.026
|
1.92 Micromoles per liter
Standard Deviation 2.671
|
|
Part 1: Change From Baseline in Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate
Creatinine, Day 7
|
2.18 Micromoles per liter
Standard Deviation 5.799
|
0.97 Micromoles per liter
Standard Deviation 5.027
|
1.34 Micromoles per liter
Standard Deviation 6.215
|
|
Part 1: Change From Baseline in Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate
Direct bilirubin, Day 2
|
-0.12 Micromoles per liter
Standard Deviation 0.267
|
-0.06 Micromoles per liter
Standard Deviation 0.329
|
-0.01 Micromoles per liter
Standard Deviation 0.324
|
|
Part 1: Change From Baseline in Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate
Direct bilirubin, Day 5
|
-0.20 Micromoles per liter
Standard Deviation 0.261
|
0.02 Micromoles per liter
Standard Deviation 0.354
|
0.35 Micromoles per liter
Standard Deviation 0.138
|
|
Part 1: Change From Baseline in Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate
Direct bilirubin, Day 7
|
-0.03 Micromoles per liter
Standard Deviation 0.390
|
-0.11 Micromoles per liter
Standard Deviation 0.330
|
-0.11 Micromoles per liter
Standard Deviation 0.502
|
|
Part 1: Change From Baseline in Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate
Bilirubin, Day 2
|
-0.68 Micromoles per liter
Standard Deviation 1.327
|
-0.39 Micromoles per liter
Standard Deviation 1.742
|
-0.21 Micromoles per liter
Standard Deviation 1.236
|
|
Part 1: Change From Baseline in Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate
Bilirubin, Day 5
|
-1.85 Micromoles per liter
Standard Deviation 1.958
|
-1.12 Micromoles per liter
Standard Deviation 1.306
|
0.55 Micromoles per liter
Standard Deviation 0.602
|
|
Part 1: Change From Baseline in Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate
Bilirubin, Day 7
|
0.10 Micromoles per liter
Standard Deviation 1.638
|
-1.06 Micromoles per liter
Standard Deviation 1.340
|
-1.40 Micromoles per liter
Standard Deviation 2.078
|
|
Part 1: Change From Baseline in Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate
Urate, Day 2
|
-7.0 Micromoles per liter
Standard Deviation 17.31
|
-7.9 Micromoles per liter
Standard Deviation 15.31
|
-4.2 Micromoles per liter
Standard Deviation 21.77
|
|
Part 1: Change From Baseline in Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate
Urate, Day 5
|
-11.7 Micromoles per liter
Standard Deviation 8.36
|
-7.0 Micromoles per liter
Standard Deviation 17.15
|
6.7 Micromoles per liter
Standard Deviation 30.59
|
|
Part 1: Change From Baseline in Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate
Urate, Day 7
|
-6.4 Micromoles per liter
Standard Deviation 28.61
|
-6.8 Micromoles per liter
Standard Deviation 13.36
|
2.3 Micromoles per liter
Standard Deviation 20.74
|
SECONDARY outcome
Timeframe: Baseline (Day -1) and Days 2, 5 and 7Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
Blood samples were collected to analyze the chemistry parameters: Creatinine, direct bilirubin, bilirubin, and urate. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg
n=16 Participants
Participants received a single oral dose of GSK3640254 25 mg (2 tablets), GSK3640254 100 mg (1 tablet), and DTG 50 mg (1 tablet) together under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet)
n=18 Participants
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 monolayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet)
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 bilayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
|---|---|---|---|
|
Part 2: Change From Baseline in Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate
Creatinine, Day 2
|
7.73 Micromoles per liter
Standard Deviation 4.766
|
6.97 Micromoles per liter
Standard Deviation 5.419
|
—
|
|
Part 2: Change From Baseline in Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate
Creatinine, Day 5
|
3.54 Micromoles per liter
Standard Deviation 6.065
|
1.28 Micromoles per liter
Standard Deviation 6.361
|
—
|
|
Part 2: Change From Baseline in Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate
Creatinine, Day 7
|
2.16 Micromoles per liter
Standard Deviation 3.830
|
-0.98 Micromoles per liter
Standard Deviation 3.061
|
—
|
|
Part 2: Change From Baseline in Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate
Direct bilirubin, Day 2
|
0.07 Micromoles per liter
Standard Deviation 0.328
|
0.04 Micromoles per liter
Standard Deviation 0.405
|
—
|
|
Part 2: Change From Baseline in Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate
Direct bilirubin, Day 5
|
0.13 Micromoles per liter
Standard Deviation 0.212
|
0.37 Micromoles per liter
Standard Deviation 0.374
|
—
|
|
Part 2: Change From Baseline in Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate
Direct bilirubin, Day 7
|
-0.04 Micromoles per liter
Standard Deviation 0.300
|
-0.12 Micromoles per liter
Standard Deviation 0.307
|
—
|
|
Part 2: Change From Baseline in Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate
Bilirubin, Day 2
|
0.02 Micromoles per liter
Standard Deviation 1.518
|
0.31 Micromoles per liter
Standard Deviation 1.101
|
—
|
|
Part 2: Change From Baseline in Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate
Bilirubin, Day 5
|
-0.41 Micromoles per liter
Standard Deviation 1.635
|
1.93 Micromoles per liter
Standard Deviation 2.272
|
—
|
|
Part 2: Change From Baseline in Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate
Bilirubin, Day 7
|
-0.78 Micromoles per liter
Standard Deviation 2.499
|
-0.08 Micromoles per liter
Standard Deviation 1.358
|
—
|
|
Part 2: Change From Baseline in Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate
Urate, Day 2
|
-12.4 Micromoles per liter
Standard Deviation 19.25
|
2.6 Micromoles per liter
Standard Deviation 15.74
|
—
|
|
Part 2: Change From Baseline in Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate
Urate, Day 5
|
-5.9 Micromoles per liter
Standard Deviation 12.97
|
-2.0 Micromoles per liter
Standard Deviation 13.42
|
—
|
|
Part 2: Change From Baseline in Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate
Urate, Day 7
|
-6.0 Micromoles per liter
Standard Deviation 19.21
|
-18.0 Micromoles per liter
Standard Deviation 22.32
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day -1) and Days 2, 5, and 7Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
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 visit, prior to the first study drug administration in each treatment period.
Outcome measures
| Measure |
Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg
n=22 Participants
Participants received a single oral dose of GSK3640254 25 mg (2 tablets), GSK3640254 100 mg (1 tablet), and DTG 50 mg (1 tablet) together under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet)
n=21 Participants
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 monolayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet)
n=20 Participants
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 bilayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
|---|---|---|---|
|
Part 1: Absolute Values for Urinalysis Parameter: Specific Gravity
Baseline (Day -1)
|
1.0138 Ratio
Standard Deviation 0.00654
|
1.0168 Ratio
Standard Deviation 0.00685
|
1.0153 Ratio
Standard Deviation 0.00693
|
|
Part 1: Absolute Values for Urinalysis Parameter: Specific Gravity
Day 2
|
1.0137 Ratio
Standard Deviation 0.00683
|
1.0150 Ratio
Standard Deviation 0.00766
|
1.0151 Ratio
Standard Deviation 0.00763
|
|
Part 1: Absolute Values for Urinalysis Parameter: Specific Gravity
Day 5
|
1.0143 Ratio
Standard Deviation 0.00543
|
1.0197 Ratio
Standard Deviation 0.00638
|
1.0197 Ratio
Standard Deviation 0.00799
|
|
Part 1: Absolute Values for Urinalysis Parameter: Specific Gravity
Day 7
|
1.0202 Ratio
Standard Deviation 0.00569
|
1.0159 Ratio
Standard Deviation 0.00760
|
1.0160 Ratio
Standard Deviation 0.00733
|
SECONDARY outcome
Timeframe: Baseline (Day -1) and Days 2, 5 and 7Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
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 visit, prior to the first study drug administration in each treatment period.
Outcome measures
| Measure |
Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg
n=17 Participants
Participants received a single oral dose of GSK3640254 25 mg (2 tablets), GSK3640254 100 mg (1 tablet), and DTG 50 mg (1 tablet) together under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet)
n=18 Participants
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 monolayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet)
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 bilayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
|---|---|---|---|
|
Part 2 : Absolute Values for Urinalysis Parameter: Specific Gravity
Baseline (Day -1)
|
1.0146 Ratio
Standard Deviation 0.00742
|
1.0164 Ratio
Standard Deviation 0.00834
|
—
|
|
Part 2 : Absolute Values for Urinalysis Parameter: Specific Gravity
Day 2
|
1.0157 Ratio
Standard Deviation 0.00778
|
1.0182 Ratio
Standard Deviation 0.00906
|
—
|
|
Part 2 : Absolute Values for Urinalysis Parameter: Specific Gravity
Day 5
|
1.0123 Ratio
Standard Deviation 0.00715
|
1.0142 Ratio
Standard Deviation 0.01284
|
—
|
|
Part 2 : Absolute Values for Urinalysis Parameter: Specific Gravity
Day 7
|
1.0161 Ratio
Standard Deviation 0.01129
|
1.0144 Ratio
Standard Deviation 0.00735
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day -1) and Days 2, 5, and 7Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
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. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period.
Outcome measures
| Measure |
Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg
n=22 Participants
Participants received a single oral dose of GSK3640254 25 mg (2 tablets), GSK3640254 100 mg (1 tablet), and DTG 50 mg (1 tablet) together under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet)
n=21 Participants
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 monolayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet)
n=20 Participants
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 bilayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
|---|---|---|---|
|
Part 1: Absolute Values for Urinalysis Parameters: Potential of Hydrogen (pH)
Baseline (Day -1)
|
6.18 pH
Standard Deviation 0.733
|
5.95 pH
Standard Deviation 0.631
|
5.88 pH
Standard Deviation 0.582
|
|
Part 1: Absolute Values for Urinalysis Parameters: Potential of Hydrogen (pH)
Day 2
|
6.16 pH
Standard Deviation 0.585
|
6.12 pH
Standard Deviation 0.723
|
6.20 pH
Standard Deviation 0.785
|
|
Part 1: Absolute Values for Urinalysis Parameters: Potential of Hydrogen (pH)
Day 5
|
5.83 pH
Standard Deviation 0.408
|
5.83 pH
Standard Deviation 0.258
|
5.75 pH
Standard Deviation 0.274
|
|
Part 1: Absolute Values for Urinalysis Parameters: Potential of Hydrogen (pH)
Day 7
|
5.82 pH
Standard Deviation 0.603
|
5.81 pH
Standard Deviation 0.596
|
6.15 pH
Standard Deviation 0.914
|
SECONDARY outcome
Timeframe: Baseline (Day -1) and Days 2, 5 and 7Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
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. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period.
Outcome measures
| Measure |
Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg
n=17 Participants
Participants received a single oral dose of GSK3640254 25 mg (2 tablets), GSK3640254 100 mg (1 tablet), and DTG 50 mg (1 tablet) together under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet)
n=18 Participants
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 monolayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet)
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 bilayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
|---|---|---|---|
|
Part 1: Absolute Values for Urinalysis Parameter: Potential of Hydrogen
Baseline (Day -1)
|
6.12 pH
Standard Deviation 0.574
|
6.08 pH
Standard Deviation 0.354
|
—
|
|
Part 1: Absolute Values for Urinalysis Parameter: Potential of Hydrogen
Day 2
|
6.12 pH
Standard Deviation 0.452
|
6.17 pH
Standard Deviation 0.454
|
—
|
|
Part 1: Absolute Values for Urinalysis Parameter: Potential of Hydrogen
Day 5
|
6.13 pH
Standard Deviation 0.518
|
6.28 pH
Standard Deviation 0.565
|
—
|
|
Part 1: Absolute Values for Urinalysis Parameter: Potential of Hydrogen
Day 7
|
6.17 pH
Standard Deviation 0.433
|
5.94 pH
Standard Deviation 0.464
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day -1) and Days 2, 5, and 7Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
Urine samples were collected at indicated time points to analyze parameters including glucose by dipstick. Urinalysis included dipstick urine test which was used to screen for glucose. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameters of urine glucose can be read as negative in the urine sample. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period.
Outcome measures
| Measure |
Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg
n=22 Participants
Participants received a single oral dose of GSK3640254 25 mg (2 tablets), GSK3640254 100 mg (1 tablet), and DTG 50 mg (1 tablet) together under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet)
n=21 Participants
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 monolayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet)
n=20 Participants
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 bilayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
|---|---|---|---|
|
Part 1: Number of Participants With Urinalysis Dipstick Results: Glucose
Day 5, Negative
|
6 Participants
|
6 Participants
|
6 Participants
|
|
Part 1: Number of Participants With Urinalysis Dipstick Results: Glucose
Day 7, Negative
|
11 Participants
|
13 Participants
|
10 Participants
|
|
Part 1: Number of Participants With Urinalysis Dipstick Results: Glucose
Baseline (Day -1), Negative
|
22 Participants
|
21 Participants
|
20 Participants
|
|
Part 1: Number of Participants With Urinalysis Dipstick Results: Glucose
Day 2, Negative
|
22 Participants
|
21 Participants
|
20 Participants
|
SECONDARY outcome
Timeframe: Baseline (Day -1) and Days 2, 5 and 7Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
Urine samples were collected at indicated time points to analyze parameters including glucose by dipstick. Urinalysis included dipstick urine test which was used to screen for glucose. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameters of urine glucose can be read as negative in the urine sample. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period.
Outcome measures
| Measure |
Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg
n=17 Participants
Participants received a single oral dose of GSK3640254 25 mg (2 tablets), GSK3640254 100 mg (1 tablet), and DTG 50 mg (1 tablet) together under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet)
n=18 Participants
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 monolayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet)
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 bilayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
|---|---|---|---|
|
Part 2: Number of Participants With Urinalysis Dipstick Results: Glucose
Baseline (Day -1), Negative
|
17 Participants
|
18 Participants
|
—
|
|
Part 2: Number of Participants With Urinalysis Dipstick Results: Glucose
Day 2, Negative
|
17 Participants
|
18 Participants
|
—
|
|
Part 2: Number of Participants With Urinalysis Dipstick Results: Glucose
Day 5, Negative
|
8 Participants
|
9 Participants
|
—
|
|
Part 2: Number of Participants With Urinalysis Dipstick Results: Glucose
Day 7, Negative
|
9 Participants
|
9 Participants
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day -1) and Days 2, 5, and 7Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
Urine samples were collected at indicated time points to analyze parameters including protein by dipstick. Urinalysis included dipstick urine test which was used to screen for protein. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameters of urine protein can be read as negative, and trace in the urine sample. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period.
Outcome measures
| Measure |
Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg
n=22 Participants
Participants received a single oral dose of GSK3640254 25 mg (2 tablets), GSK3640254 100 mg (1 tablet), and DTG 50 mg (1 tablet) together under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet)
n=21 Participants
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 monolayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet)
n=20 Participants
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 bilayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
|---|---|---|---|
|
Part 1: Number of Participants With Urinalysis Dipstick Results: Protein
Baseline (Day -1), Negative
|
22 Participants
|
21 Participants
|
20 Participants
|
|
Part 1: Number of Participants With Urinalysis Dipstick Results: Protein
Day 2, Negative
|
22 Participants
|
21 Participants
|
20 Participants
|
|
Part 1: Number of Participants With Urinalysis Dipstick Results: Protein
Day 5, Negative
|
6 Participants
|
6 Participants
|
6 Participants
|
|
Part 1: Number of Participants With Urinalysis Dipstick Results: Protein
Day 7, Trace
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Urinalysis Dipstick Results: Protein
Day 7, Negative
|
10 Participants
|
13 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: Baseline (Day -1) and Days 2, 5 and 7Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
Urine samples were collected at indicated time points to analyze parameters including protein by dipstick. Urinalysis included dipstick urine test which was used to screen for protein. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameters of urine protein can be read as negative, and trace in the urine sample. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period.
Outcome measures
| Measure |
Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg
n=17 Participants
Participants received a single oral dose of GSK3640254 25 mg (2 tablets), GSK3640254 100 mg (1 tablet), and DTG 50 mg (1 tablet) together under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet)
n=18 Participants
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 monolayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet)
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 bilayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
|---|---|---|---|
|
Part 2: Number of Participants With Urinalysis Dipstick Results: Protein
Day 7, Trace
|
1 Participants
|
0 Participants
|
—
|
|
Part 2: Number of Participants With Urinalysis Dipstick Results: Protein
Baseline (Day -1), Negative
|
17 Participants
|
18 Participants
|
—
|
|
Part 2: Number of Participants With Urinalysis Dipstick Results: Protein
Day 2, Negative
|
17 Participants
|
18 Participants
|
—
|
|
Part 2: Number of Participants With Urinalysis Dipstick Results: Protein
Day 5, Negative
|
8 Participants
|
9 Participants
|
—
|
|
Part 2: Number of Participants With Urinalysis Dipstick Results: Protein
Day 7, Negative
|
8 Participants
|
9 Participants
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day -1) and Days 2, 5, and 7Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
Urine samples were collected at indicated time points to analyze parameters including occult blood by dipstick. Urinalysis included dipstick urine test which was used to screen for occult blood. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameters of urine occult blood can be read as negative, trace, 1+, 2+, 3+ indicating proportional concentrations in the urine sample. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period.
Outcome measures
| Measure |
Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg
n=22 Participants
Participants received a single oral dose of GSK3640254 25 mg (2 tablets), GSK3640254 100 mg (1 tablet), and DTG 50 mg (1 tablet) together under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet)
n=21 Participants
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 monolayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet)
n=20 Participants
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 bilayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
|---|---|---|---|
|
Part 1: Number of Participants With Urinalysis Dipstick Results: Occult Blood
Baseline (Day -1), Negative
|
20 Participants
|
18 Participants
|
18 Participants
|
|
Part 1: Number of Participants With Urinalysis Dipstick Results: Occult Blood
Baseline (Day -1), Trace
|
1 Participants
|
2 Participants
|
2 Participants
|
|
Part 1: Number of Participants With Urinalysis Dipstick Results: Occult Blood
Baseline (Day -1), 2+
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Urinalysis Dipstick Results: Occult Blood
Day 2, Negative
|
19 Participants
|
17 Participants
|
18 Participants
|
|
Part 1: Number of Participants With Urinalysis Dipstick Results: Occult Blood
Day 2, Trace
|
2 Participants
|
3 Participants
|
1 Participants
|
|
Part 1: Number of Participants With Urinalysis Dipstick Results: Occult Blood
Day 2, 1+
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Part 1: Number of Participants With Urinalysis Dipstick Results: Occult Blood
Day 2, 2+
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Urinalysis Dipstick Results: Occult Blood
Day 2, 3+
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Urinalysis Dipstick Results: Occult Blood
Day 5, Negative
|
4 Participants
|
5 Participants
|
6 Participants
|
|
Part 1: Number of Participants With Urinalysis Dipstick Results: Occult Blood
Day 5, 1+
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Urinalysis Dipstick Results: Occult Blood
Day 5, 2+
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Urinalysis Dipstick Results: Occult Blood
Day 7, Negative
|
10 Participants
|
11 Participants
|
9 Participants
|
|
Part 1: Number of Participants With Urinalysis Dipstick Results: Occult Blood
Day 7, Trace
|
1 Participants
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline (Day -1) and Days 2, 5 and 7Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
Urine samples were collected at indicated time points to analyze parameters including occult blood by dipstick. Urinalysis included dipstick urine test which was used to screen for occult blood. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameters of urine occult blood can be read as negative, trace, 1+, 2+, 3+ indicating proportional concentrations in the urine sample. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period.
Outcome measures
| Measure |
Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg
n=17 Participants
Participants received a single oral dose of GSK3640254 25 mg (2 tablets), GSK3640254 100 mg (1 tablet), and DTG 50 mg (1 tablet) together under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet)
n=18 Participants
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 monolayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet)
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 bilayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
|---|---|---|---|
|
Part 2: Number of Participants With Urinalysis Dipstick Results: Occult Blood
Baseline (Day -1), Trace
|
1 Participants
|
0 Participants
|
—
|
|
Part 2: Number of Participants With Urinalysis Dipstick Results: Occult Blood
Baseline (Day -1), 1+
|
0 Participants
|
1 Participants
|
—
|
|
Part 2: Number of Participants With Urinalysis Dipstick Results: Occult Blood
Baseline (Day -1), 2+
|
1 Participants
|
1 Participants
|
—
|
|
Part 2: Number of Participants With Urinalysis Dipstick Results: Occult Blood
Day 2, Negative
|
17 Participants
|
17 Participants
|
—
|
|
Part 2: Number of Participants With Urinalysis Dipstick Results: Occult Blood
Baseline (Day -1), Negative
|
15 Participants
|
16 Participants
|
—
|
|
Part 2: Number of Participants With Urinalysis Dipstick Results: Occult Blood
Day 2, 1+
|
0 Participants
|
1 Participants
|
—
|
|
Part 2: Number of Participants With Urinalysis Dipstick Results: Occult Blood
Day 5, Negative
|
8 Participants
|
8 Participants
|
—
|
|
Part 2: Number of Participants With Urinalysis Dipstick Results: Occult Blood
Day 5, Trace
|
0 Participants
|
1 Participants
|
—
|
|
Part 2: Number of Participants With Urinalysis Dipstick Results: Occult Blood
Day 7, Negative
|
7 Participants
|
9 Participants
|
—
|
|
Part 2: Number of Participants With Urinalysis Dipstick Results: Occult Blood
Day 7, 1+
|
1 Participants
|
0 Participants
|
—
|
|
Part 2: Number of Participants With Urinalysis Dipstick Results: Occult Blood
Day 7, 2+
|
1 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day -1) and Days 2, 5, and 7Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
Urine samples were collected at indicated time points to analyze parameters including ketones by dipstick. Urinalysis included dipstick urine test which was used to screen for ketones. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameters of urine ketones can be read as negative, trace, 2+ indicating proportional concentrations in the urine sample. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period.
Outcome measures
| Measure |
Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg
n=22 Participants
Participants received a single oral dose of GSK3640254 25 mg (2 tablets), GSK3640254 100 mg (1 tablet), and DTG 50 mg (1 tablet) together under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet)
n=21 Participants
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 monolayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet)
n=20 Participants
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 bilayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
|---|---|---|---|
|
Part 1: Number of Participants With Urinalysis Dipstick Results: Ketones
Baseline (Day -1), Negative
|
22 Participants
|
20 Participants
|
20 Participants
|
|
Part 1: Number of Participants With Urinalysis Dipstick Results: Ketones
Baseline (Day -1), Trace
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Urinalysis Dipstick Results: Ketones
Day 2, Negative
|
21 Participants
|
21 Participants
|
19 Participants
|
|
Part 1: Number of Participants With Urinalysis Dipstick Results: Ketones
Day 2, Trace
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Part 1: Number of Participants With Urinalysis Dipstick Results: Ketones
Day 5, Negative
|
6 Participants
|
6 Participants
|
5 Participants
|
|
Part 1: Number of Participants With Urinalysis Dipstick Results: Ketones
Day 5, 2+
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Part 1: Number of Participants With Urinalysis Dipstick Results: Ketones
Day 7, Negative
|
10 Participants
|
13 Participants
|
10 Participants
|
|
Part 1: Number of Participants With Urinalysis Dipstick Results: Ketones
Day 7, Trace
|
1 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline (Day -1) and Days 2, 5 and 7Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
Urine samples were collected at indicated time points to analyze parameters including ketones by dipstick. Urinalysis included dipstick urine test which was used to screen for ketones. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameters of urine ketones can be read as negative, trace, 1+, 2+ indicating proportional concentrations in the urine sample. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period.
Outcome measures
| Measure |
Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg
n=17 Participants
Participants received a single oral dose of GSK3640254 25 mg (2 tablets), GSK3640254 100 mg (1 tablet), and DTG 50 mg (1 tablet) together under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet)
n=18 Participants
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 monolayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet)
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 bilayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
|---|---|---|---|
|
Part 2: Number of Participants With Urinalysis Dipstick Results: Ketones
Baseline (Day -1), Negative
|
17 Participants
|
17 Participants
|
—
|
|
Part 2: Number of Participants With Urinalysis Dipstick Results: Ketones
Baseline (Day -1), Trace
|
0 Participants
|
1 Participants
|
—
|
|
Part 2: Number of Participants With Urinalysis Dipstick Results: Ketones
Day 2, Negative
|
17 Participants
|
17 Participants
|
—
|
|
Part 2: Number of Participants With Urinalysis Dipstick Results: Ketones
Day 2, 1+
|
0 Participants
|
1 Participants
|
—
|
|
Part 2: Number of Participants With Urinalysis Dipstick Results: Ketones
Day 5, Negative
|
8 Participants
|
7 Participants
|
—
|
|
Part 2: Number of Participants With Urinalysis Dipstick Results: Ketones
Day 5, Trace
|
0 Participants
|
1 Participants
|
—
|
|
Part 2: Number of Participants With Urinalysis Dipstick Results: Ketones
Day 5, 2+
|
0 Participants
|
1 Participants
|
—
|
|
Part 2: Number of Participants With Urinalysis Dipstick Results: Ketones
Day 7, Negative
|
8 Participants
|
9 Participants
|
—
|
|
Part 2: Number of Participants With Urinalysis Dipstick Results: Ketones
Day 7, Trace
|
1 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day -1) and Days 2, 5, and 7Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
Urine samples were collected at indicated time points to analyze parameters including bilirubin and nitrite by dipstick. Urinalysis included dipstick urine test which was used to screen for bilirubin and nitrite. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameters of urine bilirubin and nitrite can be read as negative in the urine sample. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period.
Outcome measures
| Measure |
Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg
n=22 Participants
Participants received a single oral dose of GSK3640254 25 mg (2 tablets), GSK3640254 100 mg (1 tablet), and DTG 50 mg (1 tablet) together under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet)
n=21 Participants
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 monolayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet)
n=20 Participants
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 bilayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
|---|---|---|---|
|
Part 1: Number of Participants With Urinalysis Dipstick Results: Bilirubin and Nitrite
Bilirubin, Baseline (Day -1), Negative
|
22 Participants
|
21 Participants
|
20 Participants
|
|
Part 1: Number of Participants With Urinalysis Dipstick Results: Bilirubin and Nitrite
Bilirubin, Day 2, Negative
|
22 Participants
|
21 Participants
|
20 Participants
|
|
Part 1: Number of Participants With Urinalysis Dipstick Results: Bilirubin and Nitrite
Bilirubin, Day 5, Negative
|
6 Participants
|
6 Participants
|
6 Participants
|
|
Part 1: Number of Participants With Urinalysis Dipstick Results: Bilirubin and Nitrite
Bilirubin, Day 7, Negative
|
11 Participants
|
13 Participants
|
10 Participants
|
|
Part 1: Number of Participants With Urinalysis Dipstick Results: Bilirubin and Nitrite
Nitrite, Baseline (Day -1), Negative
|
22 Participants
|
21 Participants
|
20 Participants
|
|
Part 1: Number of Participants With Urinalysis Dipstick Results: Bilirubin and Nitrite
Nitrite, Day 2, Negative
|
22 Participants
|
21 Participants
|
20 Participants
|
|
Part 1: Number of Participants With Urinalysis Dipstick Results: Bilirubin and Nitrite
Nitrite, Day 5, Negative
|
6 Participants
|
6 Participants
|
6 Participants
|
|
Part 1: Number of Participants With Urinalysis Dipstick Results: Bilirubin and Nitrite
Nitrite, Day 7, Negative
|
11 Participants
|
13 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: Baseline (Day -1) and Days 2, 5 and 7Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
Urine samples were collected at indicated time points to analyze parameters including bilirubin and nitrite by dipstick. Urinalysis included dipstick urine test which was used to screen for bilirubin and nitrite. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameters of urine bilirubin and nitrite can be read as negative in the urine sample. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period.
Outcome measures
| Measure |
Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg
n=17 Participants
Participants received a single oral dose of GSK3640254 25 mg (2 tablets), GSK3640254 100 mg (1 tablet), and DTG 50 mg (1 tablet) together under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet)
n=18 Participants
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 monolayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet)
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 bilayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
|---|---|---|---|
|
Part 2: Number of Participants With Urinalysis Dipstick Results: Bilirubin and Nitrite
Bilirubin, Baseline (Day -1), Negative
|
17 Participants
|
18 Participants
|
—
|
|
Part 2: Number of Participants With Urinalysis Dipstick Results: Bilirubin and Nitrite
Bilirubin, Day 2, Negative
|
17 Participants
|
18 Participants
|
—
|
|
Part 2: Number of Participants With Urinalysis Dipstick Results: Bilirubin and Nitrite
Bilirubin, Day 5, Negative
|
8 Participants
|
9 Participants
|
—
|
|
Part 2: Number of Participants With Urinalysis Dipstick Results: Bilirubin and Nitrite
Bilirubin, Day 7, Negative
|
9 Participants
|
9 Participants
|
—
|
|
Part 2: Number of Participants With Urinalysis Dipstick Results: Bilirubin and Nitrite
Nitrite, Baseline (Day -1), Negative
|
17 Participants
|
18 Participants
|
—
|
|
Part 2: Number of Participants With Urinalysis Dipstick Results: Bilirubin and Nitrite
Nitrite, Day 2, Negative
|
17 Participants
|
18 Participants
|
—
|
|
Part 2: Number of Participants With Urinalysis Dipstick Results: Bilirubin and Nitrite
Nitrite, Day 5, Negative
|
8 Participants
|
9 Participants
|
—
|
|
Part 2: Number of Participants With Urinalysis Dipstick Results: Bilirubin and Nitrite
Nitrite, Day 7, Negative
|
9 Participants
|
9 Participants
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day -1) and Days 2, 5, and 7Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
Urine samples were collected at indicated time points to analyze parameters including leukocyte esterase by dipstick. Urinalysis included dipstick urine test which was used to screen for leukocyte esterase. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameters of urine leukocyte esterase can be read as negative, trace, 1+ indicating proportional concentrations in the urine sample. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period.
Outcome measures
| Measure |
Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg
n=22 Participants
Participants received a single oral dose of GSK3640254 25 mg (2 tablets), GSK3640254 100 mg (1 tablet), and DTG 50 mg (1 tablet) together under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet)
n=21 Participants
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 monolayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet)
n=20 Participants
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 bilayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
|---|---|---|---|
|
Part 1: Number of Participants With Urinalysis Dipstick Results: Leukocyte Esterase
Baseline (Day -1), Negative
|
21 Participants
|
19 Participants
|
20 Participants
|
|
Part 1: Number of Participants With Urinalysis Dipstick Results: Leukocyte Esterase
Baseline (Day -1), Trace
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Urinalysis Dipstick Results: Leukocyte Esterase
Day 2, Negative
|
22 Participants
|
19 Participants
|
20 Participants
|
|
Part 1: Number of Participants With Urinalysis Dipstick Results: Leukocyte Esterase
Day 2, 1+
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Urinalysis Dipstick Results: Leukocyte Esterase
Day 5, Negative
|
6 Participants
|
6 Participants
|
5 Participants
|
|
Part 1: Number of Participants With Urinalysis Dipstick Results: Leukocyte Esterase
Day 5, 1+
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Part 1: Number of Participants With Urinalysis Dipstick Results: Leukocyte Esterase
Day 7, Negative
|
9 Participants
|
12 Participants
|
10 Participants
|
|
Part 1: Number of Participants With Urinalysis Dipstick Results: Leukocyte Esterase
Day 7, Trace
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Urinalysis Dipstick Results: Leukocyte Esterase
Day 7, 1+
|
0 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline (Day -1) and Days 2, 5 and 7Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
Urine samples were collected at indicated time points to analyze parameters including leukocyte esterase by dipstick. Urinalysis included dipstick urine test which was used to screen for leukocyte esterase. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameters of urine leukocyte esterase can be read as negative, trace indicating proportional concentrations in the urine sample. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period.
Outcome measures
| Measure |
Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg
n=17 Participants
Participants received a single oral dose of GSK3640254 25 mg (2 tablets), GSK3640254 100 mg (1 tablet), and DTG 50 mg (1 tablet) together under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet)
n=18 Participants
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 monolayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet)
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 bilayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
|---|---|---|---|
|
Part 2: Number of Participants With Urinalysis Dipstick Results: Leukocyte Esterase
Baseline (Day -1), Negative
|
17 Participants
|
17 Participants
|
—
|
|
Part 2: Number of Participants With Urinalysis Dipstick Results: Leukocyte Esterase
Baseline (Day -1), Trace
|
0 Participants
|
1 Participants
|
—
|
|
Part 2: Number of Participants With Urinalysis Dipstick Results: Leukocyte Esterase
Day 2, Negative
|
15 Participants
|
17 Participants
|
—
|
|
Part 2: Number of Participants With Urinalysis Dipstick Results: Leukocyte Esterase
Day 2, Trace
|
2 Participants
|
1 Participants
|
—
|
|
Part 2: Number of Participants With Urinalysis Dipstick Results: Leukocyte Esterase
Day 5, Negative
|
8 Participants
|
9 Participants
|
—
|
|
Part 2: Number of Participants With Urinalysis Dipstick Results: Leukocyte Esterase
Day 7, Negative
|
9 Participants
|
9 Participants
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day -1) and Days 2, 5, and 7Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
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 visit, prior to the first study drug administration in each treatment period. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg
n=22 Participants
Participants received a single oral dose of GSK3640254 25 mg (2 tablets), GSK3640254 100 mg (1 tablet), and DTG 50 mg (1 tablet) together under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet)
n=21 Participants
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 monolayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet)
n=20 Participants
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 bilayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
|---|---|---|---|
|
Part 1: Change From Baseline in Urinalysis Parameter: Specific Gravity
Day 2
|
0.0000 Ratio
Standard Deviation 0.00662
|
-0.0017 Ratio
Standard Deviation 0.00770
|
-0.0002 Ratio
Standard Deviation 0.00738
|
|
Part 1: Change From Baseline in Urinalysis Parameter: Specific Gravity
Day 5
|
0.0033 Ratio
Standard Deviation 0.00505
|
0.0043 Ratio
Standard Deviation 0.00524
|
0.0030 Ratio
Standard Deviation 0.00329
|
|
Part 1: Change From Baseline in Urinalysis Parameter: Specific Gravity
Day 7
|
0.0056 Ratio
Standard Deviation 0.00877
|
-0.0014 Ratio
Standard Deviation 0.00957
|
0.0010 Ratio
Standard Deviation 0.00794
|
SECONDARY outcome
Timeframe: Baseline (Day -1) and Days 2, 5 and 7Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
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 visit, prior to the first study drug administration in each treatment period. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg
n=17 Participants
Participants received a single oral dose of GSK3640254 25 mg (2 tablets), GSK3640254 100 mg (1 tablet), and DTG 50 mg (1 tablet) together under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet)
n=18 Participants
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 monolayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet)
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 bilayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
|---|---|---|---|
|
Part 2: Change From Baseline in Urinalysis Parameter: Specific Gravity
Day 2
|
0.0011 Ratio
Standard Deviation 0.00679
|
0.0018 Ratio
Standard Deviation 0.00899
|
—
|
|
Part 2: Change From Baseline in Urinalysis Parameter: Specific Gravity
Day 5
|
-0.0005 Ratio
Standard Deviation 0.00447
|
-0.0019 Ratio
Standard Deviation 0.01156
|
—
|
|
Part 2: Change From Baseline in Urinalysis Parameter: Specific Gravity
Day 7
|
-0.0001 Ratio
Standard Deviation 0.00551
|
-0.0022 Ratio
Standard Deviation 0.00748
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day -1) and Days 2, 5, and 7Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
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. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg
n=22 Participants
Participants received a single oral dose of GSK3640254 25 mg (2 tablets), GSK3640254 100 mg (1 tablet), and DTG 50 mg (1 tablet) together under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet)
n=21 Participants
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 monolayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet)
n=20 Participants
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 bilayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
|---|---|---|---|
|
Part 1: Change From Baseline for Urinalysis Parameter: Potential of Hydrogen
Day 2
|
-0.02 pH
Standard Deviation 0.545
|
0.17 pH
Standard Deviation 0.796
|
0.33 pH
Standard Deviation 0.520
|
|
Part 1: Change From Baseline for Urinalysis Parameter: Potential of Hydrogen
Day 5
|
-0.58 pH
Standard Deviation 0.665
|
-0.08 pH
Standard Deviation 0.585
|
-0.08 pH
Standard Deviation 0.204
|
|
Part 1: Change From Baseline for Urinalysis Parameter: Potential of Hydrogen
Day 7
|
-0.45 pH
Standard Deviation 0.416
|
-0.31 pH
Standard Deviation 0.723
|
0.15 pH
Standard Deviation 0.412
|
SECONDARY outcome
Timeframe: Baseline (Day -1) and Days 2, 5 and 7Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
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. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg
n=17 Participants
Participants received a single oral dose of GSK3640254 25 mg (2 tablets), GSK3640254 100 mg (1 tablet), and DTG 50 mg (1 tablet) together under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet)
n=18 Participants
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 monolayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet)
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 bilayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
|---|---|---|---|
|
Part 2: Change From Baseline for Urinalysis Parameter: Potential of Hydrogen
Day 5
|
0.13 pH
Standard Deviation 0.354
|
0.11 pH
Standard Deviation 0.333
|
—
|
|
Part 2: Change From Baseline for Urinalysis Parameter: Potential of Hydrogen
Day 7
|
-0.06 pH
Standard Deviation 0.464
|
-0.06 pH
Standard Deviation 0.635
|
—
|
|
Part 2: Change From Baseline for Urinalysis Parameter: Potential of Hydrogen
Day 2
|
0.00 pH
Standard Deviation 0.586
|
0.08 pH
Standard Deviation 0.393
|
—
|
SECONDARY outcome
Timeframe: Up to Day 17Population: Safety Population
Urine samples were collected to analyze the urine parameter: glucose. Urinalysis parameters were graded according to Division of Acquired Immune Deficiency Syndrome (DAIDS) grading for severity of laboratory toxicities and clinical adverse events, version 2.1. The grades were grade 1 (mild), 2 (moderate), 3 (severe) and 4 (potentially life-threatening). Baseline was defined as the last assessment before the first dose of the study treatment. Only those urine parameters with maximum post-Baseline grade increase (Grade 1 to Grade 4) have been presented.
Outcome measures
| Measure |
Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg
n=22 Participants
Participants received a single oral dose of GSK3640254 25 mg (2 tablets), GSK3640254 100 mg (1 tablet), and DTG 50 mg (1 tablet) together under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet)
n=21 Participants
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 monolayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet)
n=20 Participants
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 bilayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
|---|---|---|---|
|
Part 1: Number of Participants With Worst Case Urine Parameter: Glucose Results by Maximum Grade Increase Post-Baseline Relative to Baseline
Increase to Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Worst Case Urine Parameter: Glucose Results by Maximum Grade Increase Post-Baseline Relative to Baseline
Increase to Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Worst Case Urine Parameter: Glucose Results by Maximum Grade Increase Post-Baseline Relative to Baseline
Increase to Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Worst Case Urine Parameter: Glucose Results by Maximum Grade Increase Post-Baseline Relative to Baseline
Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to Day 9Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
Urine samples were collected to analyze the urine parameter: glucose. Urinalysis parameters were graded according to Division of Acquired Immune Deficiency Syndrome (DAIDS) grading for severity of laboratory toxicities and clinical adverse events, version 2.1. The grades were grade 1 (mild), 2 (moderate), 3 (severe) and 4 (potentially life-threatening). Baseline was defined as the last assessment before the first dose of the study treatment. Only those urine parameters with maximum post-Baseline grade increase (Grade 1 to Grade 4) have been presented.
Outcome measures
| Measure |
Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg
n=17 Participants
Participants received a single oral dose of GSK3640254 25 mg (2 tablets), GSK3640254 100 mg (1 tablet), and DTG 50 mg (1 tablet) together under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet)
n=18 Participants
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 monolayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet)
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 bilayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
|---|---|---|---|
|
Part 2: Number of Participants With Worst Case Urine Parameter: Glucose Results by Maximum Grade Increase Post-Baseline Relative to Baseline
Increase to Grade 1
|
0 Participants
|
0 Participants
|
—
|
|
Part 2: Number of Participants With Worst Case Urine Parameter: Glucose Results by Maximum Grade Increase Post-Baseline Relative to Baseline
Increase to Grade 2
|
0 Participants
|
0 Participants
|
—
|
|
Part 2: Number of Participants With Worst Case Urine Parameter: Glucose Results by Maximum Grade Increase Post-Baseline Relative to Baseline
Increase to Grade 3
|
0 Participants
|
0 Participants
|
—
|
|
Part 2: Number of Participants With Worst Case Urine Parameter: Glucose Results by Maximum Grade Increase Post-Baseline Relative to Baseline
Increase to Grade 4
|
0 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Up to Day 17Population: Safety Population
Urine samples were collected to analyze the urine parameter: protein. Urinalysis parameters were graded according to Division of Acquired Immune Deficiency Syndrome (DAIDS) grading for severity of laboratory toxicities and clinical adverse events, version 2.1. The grades were grade 1 (mild), 2 (moderate), 3 (severe) and 4 (potentially life-threatening). Baseline was defined as the last assessment before the first dose of the study treatment. Only those urine parameters with maximum post-Baseline grade increase (Grade 1 to Grade 4) have been presented.
Outcome measures
| Measure |
Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg
n=22 Participants
Participants received a single oral dose of GSK3640254 25 mg (2 tablets), GSK3640254 100 mg (1 tablet), and DTG 50 mg (1 tablet) together under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet)
n=21 Participants
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 monolayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet)
n=20 Participants
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 bilayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
|---|---|---|---|
|
Part 1: Number of Participants With Worst Case Urine Parameter: Protein Results by Maximum Grade Increase Post-Baseline Relative to Baseline
Increase to Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Worst Case Urine Parameter: Protein Results by Maximum Grade Increase Post-Baseline Relative to Baseline
Increase to Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Worst Case Urine Parameter: Protein Results by Maximum Grade Increase Post-Baseline Relative to Baseline
Increase to Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Worst Case Urine Parameter: Protein Results by Maximum Grade Increase Post-Baseline Relative to Baseline
Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to Day 9Population: Safety Population
Urine samples were collected to analyze the urine parameter: protein. Urinalysis parameters were graded according to Division of Acquired Immune Deficiency Syndrome (DAIDS) grading for severity of laboratory toxicities and clinical adverse events, version 2.1. The grades were grade 1 (mild), 2 (moderate), 3 (severe) and 4 (potentially life-threatening). Baseline was defined as the last assessment before the first dose of the study treatment. Only those urine parameters with maximum post-Baseline grade increase (Grade 1 to Grade 4) have been presented.
Outcome measures
| Measure |
Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg
n=17 Participants
Participants received a single oral dose of GSK3640254 25 mg (2 tablets), GSK3640254 100 mg (1 tablet), and DTG 50 mg (1 tablet) together under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet)
n=18 Participants
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 monolayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet)
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 bilayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
|---|---|---|---|
|
Part 2: Number of Participants With Worst Case Urine Parameter: Protein Results by Maximum Grade Increase Post-Baseline Relative to Baseline
Increase to Grade 1
|
0 Participants
|
0 Participants
|
—
|
|
Part 2: Number of Participants With Worst Case Urine Parameter: Protein Results by Maximum Grade Increase Post-Baseline Relative to Baseline
Increase to Grade 2
|
0 Participants
|
0 Participants
|
—
|
|
Part 2: Number of Participants With Worst Case Urine Parameter: Protein Results by Maximum Grade Increase Post-Baseline Relative to Baseline
Increase to Grade 3
|
0 Participants
|
0 Participants
|
—
|
|
Part 2: Number of Participants With Worst Case Urine Parameter: Protein Results by Maximum Grade Increase Post-Baseline Relative to Baseline
Increase to Grade 4
|
0 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Up to Day 17Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
Urine samples were collected to analyze the urine parameter: erythrocytes. Urinalysis parameters were graded according to Division of Acquired Immune Deficiency Syndrome (DAIDS) grading for severity of laboratory toxicities and clinical adverse events, version 2.1. The grades were grade 1 (mild), 2 (moderate), 3 (severe) and 4 (potentially life-threatening). Baseline was defined as the last assessment before the first dose of the study treatment. Only those urine parameters with maximum post-Baseline grade increase (Grade 1 to Grade 4) have been presented.
Outcome measures
| Measure |
Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg
n=8 Participants
Participants received a single oral dose of GSK3640254 25 mg (2 tablets), GSK3640254 100 mg (1 tablet), and DTG 50 mg (1 tablet) together under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet)
n=7 Participants
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 monolayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet)
n=4 Participants
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 bilayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
|---|---|---|---|
|
Part 1: Number of Participants With Worst Case Urine Parameter: Erythrocytes Results by Maximum Grade Increase Post-Baseline Relative to Baseline
Increase to Grade 1
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Worst Case Urine Parameter: Erythrocytes Results by Maximum Grade Increase Post-Baseline Relative to Baseline
Increase to Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Worst Case Urine Parameter: Erythrocytes Results by Maximum Grade Increase Post-Baseline Relative to Baseline
Increase to Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Worst Case Urine Parameter: Erythrocytes Results by Maximum Grade Increase Post-Baseline Relative to Baseline
Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to Day 9Population: Safety Population
Urine samples were collected to analyze the urine parameter: erythrocytes. Urinalysis parameters were graded according to Division of Acquired Immune Deficiency Syndrome (DAIDS) grading for severity of laboratory toxicities and clinical adverse events, version 2.1. The grades were grade 1 (mild), 2 (moderate), 3 (severe) and 4 (potentially life-threatening). Baseline was defined as the last assessment before the first dose of the study treatment. Only those urine parameters with maximum post-Baseline grade increase (Grade 1 to Grade 4) have been presented.
Outcome measures
| Measure |
Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg
n=17 Participants
Participants received a single oral dose of GSK3640254 25 mg (2 tablets), GSK3640254 100 mg (1 tablet), and DTG 50 mg (1 tablet) together under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet)
n=18 Participants
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 monolayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet)
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 bilayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
|---|---|---|---|
|
Part 2: Number of Participants With Worst Case Urine Parameter: Erythrocytes Results by Maximum Grade Increase Post-Baseline Relative to Baseline
Increase to Grade 1
|
0 Participants
|
0 Participants
|
—
|
|
Part 2: Number of Participants With Worst Case Urine Parameter: Erythrocytes Results by Maximum Grade Increase Post-Baseline Relative to Baseline
Increase to Grade 2
|
0 Participants
|
0 Participants
|
—
|
|
Part 2: Number of Participants With Worst Case Urine Parameter: Erythrocytes Results by Maximum Grade Increase Post-Baseline Relative to Baseline
Increase to Grade 3
|
0 Participants
|
0 Participants
|
—
|
|
Part 2: Number of Participants With Worst Case Urine Parameter: Erythrocytes Results by Maximum Grade Increase Post-Baseline Relative to Baseline
Increase to Grade 4
|
0 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1, pre-dose), and Day 1: 2, 4, 6 hours, and Day 5Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
Twelve lead ECGs were obtained to measure PR interval, QRS duration, QT interval, and QTcF interval . Twelve lead ECGs were performed with the participant in a 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
Outcome measures
| Measure |
Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg
n=22 Participants
Participants received a single oral dose of GSK3640254 25 mg (2 tablets), GSK3640254 100 mg (1 tablet), and DTG 50 mg (1 tablet) together under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet)
n=21 Participants
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 monolayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet)
n=20 Participants
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 bilayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
|---|---|---|---|
|
Part 1: Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF)
PR Interval, Baseline (Day1 pre-dose)
|
162.8 Milliseconds
Standard Deviation 17.39
|
162.8 Milliseconds
Standard Deviation 18.05
|
163.1 Milliseconds
Standard Deviation 16.90
|
|
Part 1: Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF)
PR Interval, Day 1, 2 hours
|
159.0 Milliseconds
Standard Deviation 18.13
|
158.0 Milliseconds
Standard Deviation 17.16
|
157.7 Milliseconds
Standard Deviation 17.78
|
|
Part 1: Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF)
PR Interval, Day 1, 4 hours
|
159.2 Milliseconds
Standard Deviation 17.50
|
160.0 Milliseconds
Standard Deviation 17.51
|
159.9 Milliseconds
Standard Deviation 15.79
|
|
Part 1: Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF)
PR Interval, Day 1, 6 hours
|
160.4 Milliseconds
Standard Deviation 18.70
|
158.2 Milliseconds
Standard Deviation 18.10
|
160.1 Milliseconds
Standard Deviation 16.87
|
|
Part 1: Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF)
PR Interval, Day 5
|
162.2 Milliseconds
Standard Deviation 16.02
|
170.8 Milliseconds
Standard Deviation 12.42
|
159.8 Milliseconds
Standard Deviation 31.98
|
|
Part 1: Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF)
QRS Duration, Baseline (Day 1)
|
92.0 Milliseconds
Standard Deviation 7.09
|
93.1 Milliseconds
Standard Deviation 7.83
|
93.4 Milliseconds
Standard Deviation 8.61
|
|
Part 1: Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF)
QRS Duration, Day 1, 2 hours
|
91.3 Milliseconds
Standard Deviation 7.12
|
92.8 Milliseconds
Standard Deviation 9.11
|
92.8 Milliseconds
Standard Deviation 8.15
|
|
Part 1: Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF)
QRS Duration, Day 1, 4 hours
|
90.0 Milliseconds
Standard Deviation 8.16
|
91.5 Milliseconds
Standard Deviation 8.18
|
91.7 Milliseconds
Standard Deviation 9.04
|
|
Part 1: Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF)
QRS Duration, Day 1, 6 hours
|
91.0 Milliseconds
Standard Deviation 7.67
|
91.7 Milliseconds
Standard Deviation 8.87
|
93.2 Milliseconds
Standard Deviation 8.63
|
|
Part 1: Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF)
QRS Duration, Day 5
|
92.3 Milliseconds
Standard Deviation 4.93
|
94.2 Milliseconds
Standard Deviation 6.24
|
94.8 Milliseconds
Standard Deviation 9.99
|
|
Part 1: Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF)
QT Interval, Baseline (Day 1)
|
397.0 Milliseconds
Standard Deviation 26.26
|
393.1 Milliseconds
Standard Deviation 29.10
|
394.2 Milliseconds
Standard Deviation 24.66
|
|
Part 1: Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF)
QT Interval, Day 1, 2 hours
|
381.1 Milliseconds
Standard Deviation 24.29
|
375.0 Milliseconds
Standard Deviation 24.49
|
375.6 Milliseconds
Standard Deviation 19.77
|
|
Part 1: Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF)
QT Interval, Day 1, 4 hours
|
391.2 Milliseconds
Standard Deviation 26.27
|
385.0 Milliseconds
Standard Deviation 23.31
|
386.4 Milliseconds
Standard Deviation 21.34
|
|
Part 1: Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF)
QT Interval, Day 1, 6 hours
|
387.8 Milliseconds
Standard Deviation 21.90
|
379.3 Milliseconds
Standard Deviation 23.66
|
382.2 Milliseconds
Standard Deviation 20.88
|
|
Part 1: Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF)
QT Interval, Day 5
|
389.5 Milliseconds
Standard Deviation 18.32
|
374.8 Milliseconds
Standard Deviation 29.13
|
400.5 Milliseconds
Standard Deviation 9.01
|
|
Part 1: Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF)
QTcF Interval, Baseline (Day 1)
|
404.3 Milliseconds
Standard Deviation 17.15
|
400.7 Milliseconds
Standard Deviation 19.60
|
403.7 Milliseconds
Standard Deviation 14.85
|
|
Part 1: Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF)
QTcF Interval, Day 1, 2 hours
|
397.5 Milliseconds
Standard Deviation 18.03
|
393.1 Milliseconds
Standard Deviation 19.20
|
397.0 Milliseconds
Standard Deviation 15.11
|
|
Part 1: Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF)
QTcF Interval, Day 1, 4 hours
|
399.1 Milliseconds
Standard Deviation 19.40
|
396.5 Milliseconds
Standard Deviation 399.3
|
399.3 Milliseconds
Standard Deviation 17.85
|
|
Part 1: Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF)
QTcF Interval, Day 1, 6 hours
|
401.8 Milliseconds
Standard Deviation 17.12
|
398.4 Milliseconds
Standard Deviation 19.80
|
399.0 Milliseconds
Standard Deviation 16.65
|
|
Part 1: Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF)
QTcF Interval, Day 5
|
396.5 Milliseconds
Standard Deviation 23.48
|
399.0 Milliseconds
Standard Deviation 17.93
|
395.7 Milliseconds
Standard Deviation 13.69
|
SECONDARY outcome
Timeframe: Baseline (Day 1, pre-dose), and Day 1: 2, 4, 6 hours, and Days 5, 7Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
Twelve lead ECGs were obtained to measure PR interval, QRS duration, QT interval, and QTcF interval. Twelve lead ECGs were performed with the participant in a 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.
Outcome measures
| Measure |
Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg
n=17 Participants
Participants received a single oral dose of GSK3640254 25 mg (2 tablets), GSK3640254 100 mg (1 tablet), and DTG 50 mg (1 tablet) together under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet)
n=18 Participants
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 monolayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet)
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 bilayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
|---|---|---|---|
|
Part 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF
QTcF Interval, Day 7
|
395.3 Milliseconds
Standard Deviation 12.11
|
381.1 Milliseconds
Standard Deviation 9.78
|
—
|
|
Part 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF
PR Interval, Baseline (Day 1 pre-dose)
|
168.8 Milliseconds
Standard Deviation 15.94
|
170.9 Milliseconds
Standard Deviation 14.96
|
—
|
|
Part 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF
PR Interval, Day 1, 2 hours
|
160.6 Milliseconds
Standard Deviation 14.92
|
167.0 Milliseconds
Standard Deviation 14.71
|
—
|
|
Part 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF
PR Interval, Day 1, 4 hours
|
162.6 Milliseconds
Standard Deviation 17.19
|
167.4 Milliseconds
Standard Deviation 13.84
|
—
|
|
Part 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF
PR Interval, Day 1, 6 hours
|
162.2 Milliseconds
Standard Deviation 15.23
|
160.9 Milliseconds
Standard Deviation 14.18
|
—
|
|
Part 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF
PR Interval, Day 5
|
172.1 Milliseconds
Standard Deviation 19.92
|
164.1 Milliseconds
Standard Deviation 9.69
|
—
|
|
Part 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF
PR Interval, Day 7
|
167.1 Milliseconds
Standard Deviation 9.09
|
176.2 Milliseconds
Standard Deviation 18.97
|
—
|
|
Part 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF
QRS Duration, Baseline (Day 1)
|
89.8 Milliseconds
Standard Deviation 7.17
|
89.1 Milliseconds
Standard Deviation 5.71
|
—
|
|
Part 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF
QRS Duration, Day 1, 2 hours
|
88.8 Milliseconds
Standard Deviation 6.87
|
87.9 Milliseconds
Standard Deviation 5.56
|
—
|
|
Part 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF
QRS Duration, Day 1, 4 hours
|
87.5 Milliseconds
Standard Deviation 6.74
|
89.3 Milliseconds
Standard Deviation 6.49
|
—
|
|
Part 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF
QRS Duration, Day 1, 6 hours
|
87.5 Milliseconds
Standard Deviation 6.50
|
89.7 Milliseconds
Standard Deviation 7.11
|
—
|
|
Part 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF
QRS Duration, Day 5
|
87.8 Milliseconds
Standard Deviation 4.03
|
89.2 Milliseconds
Standard Deviation 8.51
|
—
|
|
Part 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF
QRS Duration, Day 7
|
89.9 Milliseconds
Standard Deviation 6.83
|
88.8 Milliseconds
Standard Deviation 3.15
|
—
|
|
Part 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF
QT Interval, Baseline (Day 1)
|
382.8 Milliseconds
Standard Deviation 16.73
|
383.6 Milliseconds
Standard Deviation 18.49
|
—
|
|
Part 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF
QT Interval, Day 1, 2 hours
|
367.0 Milliseconds
Standard Deviation 15.73
|
385.2 Milliseconds
Standard Deviation 18.67
|
—
|
|
Part 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF
QT Interval, Day 1, 4 hours
|
373.4 Milliseconds
Standard Deviation 11.37
|
391.8 Milliseconds
Standard Deviation 16.57
|
—
|
|
Part 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF
QT Interval, Day 1, 6 hours
|
372.9 Milliseconds
Standard Deviation 16.48
|
367.8 Milliseconds
Standard Deviation 15.07
|
—
|
|
Part 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF
QT Interval, Day 5
|
367.8 Milliseconds
Standard Deviation 13.94
|
385.2 Milliseconds
Standard Deviation 25.34
|
—
|
|
Part 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF
QT Interval, Day 7
|
382.6 Milliseconds
Standard Deviation 17.92
|
378.2 Milliseconds
Standard Deviation 14.66
|
—
|
|
Part 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF
QTcF Interval, Baseline (Day 1)
|
393.3 Milliseconds
Standard Deviation 11.84
|
390.9 Milliseconds
Standard Deviation 13.13
|
—
|
|
Part 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF
QTcF Interval, Day 1, 2 hours
|
387.2 Milliseconds
Standard Deviation 12.56
|
390.3 Milliseconds
Standard Deviation 16.98
|
—
|
|
Part 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF
QTcF Interval, Day 1, 4 hours
|
388.8 Milliseconds
Standard Deviation 11.52
|
392.3 Milliseconds
Standard Deviation 14.99
|
—
|
|
Part 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF
QTcF Interval, Day 1, 6 hours
|
389.4 Milliseconds
Standard Deviation 11.52
|
390.2 Milliseconds
Standard Deviation 13.13
|
—
|
|
Part 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF
QTcF Interval, Day 5
|
388.6 Milliseconds
Standard Deviation 7.63
|
395.3 Milliseconds
Standard Deviation 14.71
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1, Pre-dose), and Day 1: 2, 4, 6 hours, and Day 5Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
Twelve lead ECGs were obtained to measure PR interval, QRS duration, QT interval, QTcF interval. Twelve lead ECGs were performed with the participant in a 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 |
Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg
n=22 Participants
Participants received a single oral dose of GSK3640254 25 mg (2 tablets), GSK3640254 100 mg (1 tablet), and DTG 50 mg (1 tablet) together under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet)
n=21 Participants
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 monolayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet)
n=20 Participants
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 bilayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
|---|---|---|---|
|
Part 1: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval
PR Interval, Day 1, 2 hours
|
-3.8 Milliseconds
Standard Deviation 10.19
|
-4.7 Milliseconds
Standard Deviation 7.79
|
-5.5 Milliseconds
Standard Deviation 11.16
|
|
Part 1: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval
PR Interval, Day 1, 4 hours
|
-3.6 Milliseconds
Standard Deviation 10.28
|
-2.8 Milliseconds
Standard Deviation 6.31
|
-3.3 Milliseconds
Standard Deviation 9.04
|
|
Part 1: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval
PR Interval, Day 1, 6 hours
|
-2.5 Milliseconds
Standard Deviation 9.65
|
-4.6 Milliseconds
Standard Deviation 11.29
|
-3.0 Milliseconds
Standard Deviation 10.31
|
|
Part 1: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval
PR Interval, Day 5
|
2.8 Milliseconds
Standard Deviation 9.13
|
-1.8 Milliseconds
Standard Deviation 8.28
|
-6.0 Milliseconds
Standard Deviation 9.44
|
|
Part 1: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval
QRS Duration, Day 1, 2 hours
|
-0.7 Milliseconds
Standard Deviation 4.22
|
-0.4 Milliseconds
Standard Deviation 4.60
|
-0.7 Milliseconds
Standard Deviation 3.12
|
|
Part 1: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval
QRS Duration, Day 1, 4 hours
|
-2.0 Milliseconds
Standard Deviation 4.40
|
-1.6 Milliseconds
Standard Deviation 5.00
|
-1.7 Milliseconds
Standard Deviation 3.54
|
|
Part 1: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval
QRS Duration, Day 1, 6 hours
|
-1.0 Milliseconds
Standard Deviation 4.55
|
-1.4 Milliseconds
Standard Deviation 3.99
|
-0.3 Milliseconds
Standard Deviation 2.45
|
|
Part 1: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval
QRS Duration, Day 5
|
2.0 Milliseconds
Standard Deviation 3.46
|
-1.3 Milliseconds
Standard Deviation 4.97
|
-0.8 Milliseconds
Standard Deviation 2.14
|
|
Part 1: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval
QT Interval, Day 1, 2 hours
|
-15.8 Milliseconds
Standard Deviation 11.54
|
-18.1 Milliseconds
Standard Deviation 10.24
|
-18.6 Milliseconds
Standard Deviation 11.71
|
|
Part 1: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval
QT Interval, Day 1, 4 hours
|
-5.8 Milliseconds
Standard Deviation 14.45
|
-8.1 Milliseconds
Standard Deviation 13.18
|
-7.9 Milliseconds
Standard Deviation 11.78
|
|
Part 1: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval
QT Interval, Day 1, 6 hours
|
-9.1 Milliseconds
Standard Deviation 12.89
|
-13.8 Milliseconds
Standard Deviation 13.51
|
-12.0 Milliseconds
Standard Deviation 13.81
|
|
Part 1: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval
QT Interval, Day 5
|
0.8 Milliseconds
Standard Deviation 14.27
|
-14.8 Milliseconds
Standard Deviation 19.54
|
-14.5 Milliseconds
Standard Deviation 9.85
|
|
Part 1: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval
QTcF Interval, Day 1, 2 hours
|
-6.8 Milliseconds
Standard Deviation 7.36
|
-7.6 Milliseconds
Standard Deviation 6.58
|
-6.8 Milliseconds
Standard Deviation 6.32
|
|
Part 1: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval
QTcF Interval, Day 1, 4 hours
|
-5.1 Milliseconds
Standard Deviation 9.07
|
-4.2 Milliseconds
Standard Deviation 8.58
|
-4.5 Milliseconds
Standard Deviation 6.88
|
|
Part 1: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval
QTcF Interval, Day 1, 6 hours
|
-2.5 Milliseconds
Standard Deviation 8.72
|
-2.2 Milliseconds
Standard Deviation 9.87
|
-4.7 Milliseconds
Standard Deviation 7.34
|
|
Part 1: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval
QTcF Interval, Day 5
|
-6.0 Milliseconds
Standard Deviation 14.04
|
-2.3 Milliseconds
Standard Deviation 14.31
|
-5.8 Milliseconds
Standard Deviation 8.16
|
SECONDARY outcome
Timeframe: Baseline (Day 1, pre-dose), and Day 1: 2, 4, 6 hours, Days 5 and 7Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
Twelve lead ECGs were obtained to measure PR interval, QRS duration, QT interval, QTcF interval. Twelve lead ECGs were performed with the participant in a 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 |
Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg
n=17 Participants
Participants received a single oral dose of GSK3640254 25 mg (2 tablets), GSK3640254 100 mg (1 tablet), and DTG 50 mg (1 tablet) together under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet)
n=18 Participants
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 monolayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet)
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 bilayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
|---|---|---|---|
|
Part 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval
PR Interval, Day 1, 2 hours
|
-8.1 Milliseconds
Standard Deviation 10.19
|
-3.9 Milliseconds
Standard Deviation 8.27
|
—
|
|
Part 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval
PR Interval, Day 1, 4 hours
|
-6.1 Milliseconds
Standard Deviation 12.06
|
-3.4 Milliseconds
Standard Deviation 9.73
|
—
|
|
Part 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval
PR Interval, Day 1, 6 hours
|
-6.5 Milliseconds
Standard Deviation 10.71
|
-9.9 Milliseconds
Standard Deviation 12.21
|
—
|
|
Part 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval
PR Interval, Day 5
|
-4.5 Milliseconds
Standard Deviation 10.94
|
-4.8 Milliseconds
Standard Deviation 8.84
|
—
|
|
Part 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval
PR Interval, Day 7
|
5.3 Milliseconds
Standard Deviation 7.89
|
3.3 Milliseconds
Standard Deviation 11.88
|
—
|
|
Part 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval
QRS Duration, Day 1, 2 hours
|
-1.0 Milliseconds
Standard Deviation 5.14
|
-1.2 Milliseconds
Standard Deviation 2.56
|
—
|
|
Part 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval
QRS Duration, Day 1, 4 hours
|
-2.3 Milliseconds
Standard Deviation 5.39
|
0.2 Milliseconds
Standard Deviation 2.21
|
—
|
|
Part 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval
QRS Duration Day 1, 6 hours
|
-2.2 Milliseconds
Standard Deviation 4.97
|
0.6 Milliseconds
Standard Deviation 2.75
|
—
|
|
Part 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval
QRS Duration, Day 5
|
-3.8 Milliseconds
Standard Deviation 7.74
|
0.0 Milliseconds
Standard Deviation 2.74
|
—
|
|
Part 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval
QRS Duration, Day 7
|
1.7 Milliseconds
Standard Deviation 3.12
|
-0.2 Milliseconds
Standard Deviation 3.93
|
—
|
|
Part 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval
QT Interval, Day 1, 2 hours
|
-15.8 Milliseconds
Standard Deviation 13.03
|
1.6 Milliseconds
Standard Deviation 11.34
|
—
|
|
Part 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval
QT Interval, Day 1, 4 hours
|
-9.5 Milliseconds
Standard Deviation 13.61
|
8.2 Milliseconds
Standard Deviation 10.80
|
—
|
|
Part 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval
QT Interval, Day 1, 6 hours
|
-9.9 Milliseconds
Standard Deviation 14.35
|
-15.7 Milliseconds
Standard Deviation 10.87
|
—
|
|
Part 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval
QT Interval, Day 5
|
-16.0 Milliseconds
Standard Deviation 17.47
|
-2.3 Milliseconds
Standard Deviation 19.62
|
—
|
|
Part 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval
QT Interval, Day 7
|
0.6 Milliseconds
Standard Deviation 8.03
|
-1.3 Milliseconds
Standard Deviation 16.72
|
—
|
|
Part 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval
QTcF Interval, Day 1, 2 hours
|
-6.1 Milliseconds
Standard Deviation 11.76
|
-0.6 Milliseconds
Standard Deviation 8.47
|
—
|
|
Part 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval
QTcF Interval, Day 1, 4 hours
|
-4.5 Milliseconds
Standard Deviation 8.52
|
1.4 Milliseconds
Standard Deviation 7.88
|
—
|
|
Part 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval
QTcF Interval, Day 1, 6 hours
|
-3.9 Milliseconds
Standard Deviation 5.96
|
-0.8 Milliseconds
Standard Deviation 8.05
|
—
|
|
Part 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval
QTcF Interval, Day 5
|
-0.5 Milliseconds
Standard Deviation 6.26
|
0.2 Milliseconds
Standard Deviation 9.56
|
—
|
|
Part 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval
QTcF Interval, Day 7
|
-1.7 Milliseconds
Standard Deviation 6.48
|
-5.7 Milliseconds
Standard Deviation 11.38
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1, pre-dose), and Day 1: 24, 48, 72 hours, Days 5 and 7Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
SBP and DBP were measured in the semi-supine position with a completely automated device after at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline is defined as the average of the triplicate predose assessments within each treatment.
Outcome measures
| Measure |
Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg
n=22 Participants
Participants received a single oral dose of GSK3640254 25 mg (2 tablets), GSK3640254 100 mg (1 tablet), and DTG 50 mg (1 tablet) together under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet)
n=21 Participants
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 monolayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet)
n=20 Participants
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 bilayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
|---|---|---|---|
|
Part 1: Absolute Values of Vital Sign Parameters: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
DBP, Baseline (Day 1)
|
61.5 Millimeters of mercury
Standard Deviation 6.39
|
63.2 Millimeters of mercury
Standard Deviation 7.21
|
63.2 Millimeters of mercury
Standard Deviation 9.05
|
|
Part 1: Absolute Values of Vital Sign Parameters: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
DBP, Day 1, 24 hours
|
60.9 Millimeters of mercury
Standard Deviation 7.34
|
63.1 Millimeters of mercury
Standard Deviation 8.18
|
63.0 Millimeters of mercury
Standard Deviation 6.40
|
|
Part 1: Absolute Values of Vital Sign Parameters: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
DBP, Day 1, 48 hours
|
59.8 Millimeters of mercury
Standard Deviation 5.89
|
61.2 Millimeters of mercury
Standard Deviation 6.68
|
59.6 Millimeters of mercury
Standard Deviation 4.72
|
|
Part 1: Absolute Values of Vital Sign Parameters: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
DBP, Day 1, 72 hours
|
58.7 Millimeters of mercury
Standard Deviation 6.19
|
63.0 Millimeters of mercury
Standard Deviation 8.69
|
61.3 Millimeters of mercury
Standard Deviation 4.08
|
|
Part 1: Absolute Values of Vital Sign Parameters: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
DBP, Day 5
|
61.7 Millimeters of mercury
Standard Deviation 5.24
|
64.2 Millimeters of mercury
Standard Deviation 6.05
|
61.5 Millimeters of mercury
Standard Deviation 4.18
|
|
Part 1: Absolute Values of Vital Sign Parameters: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
DBP Interval, Day 7
|
62.0 Millimeters of mercury
Standard Deviation 8.46
|
61.0 Millimeters of mercury
Standard Deviation 7.18
|
59.4 Millimeters of mercury
Standard Deviation 5.48
|
|
Part 1: Absolute Values of Vital Sign Parameters: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
SBP, Baseline (Day 1)
|
108.9 Millimeters of mercury
Standard Deviation 11.23
|
110.6 Millimeters of mercury
Standard Deviation 13.47
|
110.8 Millimeters of mercury
Standard Deviation 16.32
|
|
Part 1: Absolute Values of Vital Sign Parameters: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
SBP, Day 1, 24 hours
|
106.1 Millimeters of mercury
Standard Deviation 10.41
|
112.9 Millimeters of mercury
Standard Deviation 13.30
|
108.7 Millimeters of mercury
Standard Deviation 10.54
|
|
Part 1: Absolute Values of Vital Sign Parameters: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
SBP, Day 1, 48 hours
|
104.7 Millimeters of mercury
Standard Deviation 8.60
|
110.5 Millimeters of mercury
Standard Deviation 14.02
|
106.7 Millimeters of mercury
Standard Deviation 10.47
|
|
Part 1: Absolute Values of Vital Sign Parameters: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
SBP, Day 1, 72 hours
|
100.5 Millimeters of mercury
Standard Deviation 6.53
|
114.7 Millimeters of mercury
Standard Deviation 21.57
|
112.2 Millimeters of mercury
Standard Deviation 12.19
|
|
Part 1: Absolute Values of Vital Sign Parameters: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
SBP, Day 5
|
105.8 Millimeters of mercury
Standard Deviation 8.64
|
118.0 Millimeters of mercury
Standard Deviation 19.67
|
109.2 Millimeters of mercury
Standard Deviation 10.98
|
|
Part 1: Absolute Values of Vital Sign Parameters: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
SBP, Day 7
|
110.5 Millimeters of mercury
Standard Deviation 13.40
|
108.2 Millimeters of mercury
Standard Deviation 9.24
|
106.8 Millimeters of mercury
Standard Deviation 11.94
|
SECONDARY outcome
Timeframe: Baseline (Day 1, pre-dose), and Day 1: 24, 48 hours, Days 5 and 7Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
SBP and DBP were measured in the semi-supine position with a completely automated device after at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline was defined as the average of the triplicate predose assessments within each treatment.
Outcome measures
| Measure |
Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg
n=17 Participants
Participants received a single oral dose of GSK3640254 25 mg (2 tablets), GSK3640254 100 mg (1 tablet), and DTG 50 mg (1 tablet) together under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet)
n=18 Participants
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 monolayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet)
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 bilayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
|---|---|---|---|
|
Part 2: Absolute Values of Vital Signs: DBP and SBP
DBP, Baseline (Day 1 pre-dose)
|
65.1 Millimeters of mercury
Standard Deviation 8.39
|
65.7 Millimeters of mercury
Standard Deviation 9.26
|
—
|
|
Part 2: Absolute Values of Vital Signs: DBP and SBP
DBP, Day 1, 24 hours
|
64.0 Millimeters of mercury
Standard Deviation 6.44
|
62.9 Millimeters of mercury
Standard Deviation 9.09
|
—
|
|
Part 2: Absolute Values of Vital Signs: DBP and SBP
DBP, Day 1, 48 hours
|
61.8 Millimeters of mercury
Standard Deviation 7.89
|
61.1 Millimeters of mercury
Standard Deviation 9.78
|
—
|
|
Part 2: Absolute Values of Vital Signs: DBP and SBP
DBP, Day 5
|
68.1 Millimeters of mercury
Standard Deviation 4.49
|
60.0 Millimeters of mercury
Standard Deviation 4.30
|
—
|
|
Part 2: Absolute Values of Vital Signs: DBP and SBP
DBP Interval, Day 7
|
62.2 Millimeters of mercury
Standard Deviation 7.63
|
67.6 Millimeters of mercury
Standard Deviation 7.60
|
—
|
|
Part 2: Absolute Values of Vital Signs: DBP and SBP
SBP, Baseline (Day 1 pre-dose)
|
110.9 Millimeters of mercury
Standard Deviation 9.39
|
111.5 Millimeters of mercury
Standard Deviation 11.73
|
—
|
|
Part 2: Absolute Values of Vital Signs: DBP and SBP
SBP, Day 1, 24 hours
|
110.1 Millimeters of mercury
Standard Deviation 10.84
|
110.4 Millimeters of mercury
Standard Deviation 13.49
|
—
|
|
Part 2: Absolute Values of Vital Signs: DBP and SBP
SBP, Day 1, 48 hours
|
108.4 Millimeters of mercury
Standard Deviation 10.06
|
106.9 Millimeters of mercury
Standard Deviation 9.58
|
—
|
|
Part 2: Absolute Values of Vital Signs: DBP and SBP
SBP, Day 5
|
113.3 Millimeters of mercury
Standard Deviation 5.97
|
108.7 Millimeters of mercury
Standard Deviation 9.31
|
—
|
|
Part 2: Absolute Values of Vital Signs: DBP and SBP
SBP, Day 7
|
105.8 Millimeters of mercury
Standard Deviation 6.28
|
108.4 Millimeters of mercury
Standard Deviation 9.30
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1, pre-dose), and Day 1: 24, 48, 72 hours, Days 5 and 7Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
Pulse rate was measured in the semi-supine position with a completely automated device after at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline was defined as the average of the triplicate predose assessments within each treatment.
Outcome measures
| Measure |
Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg
n=22 Participants
Participants received a single oral dose of GSK3640254 25 mg (2 tablets), GSK3640254 100 mg (1 tablet), and DTG 50 mg (1 tablet) together under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet)
n=21 Participants
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 monolayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet)
n=20 Participants
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 bilayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
|---|---|---|---|
|
Part 1: Absolute Values of Vital Signs: Pulse Rate
Baseline (Day 1, Pre-dose)
|
64.9 Beats per minute
Standard Deviation 13.41
|
66.06 Beats per minute
Standard Deviation 14.53
|
67.4 Beats per minute
Standard Deviation 14.19
|
|
Part 1: Absolute Values of Vital Signs: Pulse Rate
Day 1, 24 hours
|
61.7 Beats per minute
Standard Deviation 9.05
|
68.6 Beats per minute
Standard Deviation 11.69
|
64.8 Beats per minute
Standard Deviation 11.47
|
|
Part 1: Absolute Values of Vital Signs: Pulse Rate
Day 1, 48 hours
|
61.7 Beats per minute
Standard Deviation 6.88
|
65.5 Beats per minute
Standard Deviation 11.81
|
64.9 Beats per minute
Standard Deviation 10.20
|
|
Part 1: Absolute Values of Vital Signs: Pulse Rate
Day 1, 72 hours
|
61.2 Beats per minute
Standard Deviation 10.76
|
77.7 Beats per minute
Standard Deviation 22.98
|
57.7 Beats per minute
Standard Deviation 10.76
|
|
Part 1: Absolute Values of Vital Signs: Pulse Rate
Day 5
|
62.3 Beats per minute
Standard Deviation 6.06
|
77.5 Beats per minute
Standard Deviation 20.84
|
59.7 Beats per minute
Standard Deviation 11.81
|
|
Part 1: Absolute Values of Vital Signs: Pulse Rate
Day 7
|
58.9 Beats per minute
Standard Deviation 8.29
|
60.8 Beats per minute
Standard Deviation 8.49
|
69.6 Beats per minute
Standard Deviation 9.83
|
SECONDARY outcome
Timeframe: Baseline (Day 1, pre-dose), and Day 1: 24, 48 hours, Day 5 and 7Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
Pulse rate was measured in the semi-supine position with a completely automated device after at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline was defined as the average of the triplicate predose assessments within each treatment.
Outcome measures
| Measure |
Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg
n=17 Participants
Participants received a single oral dose of GSK3640254 25 mg (2 tablets), GSK3640254 100 mg (1 tablet), and DTG 50 mg (1 tablet) together under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet)
n=18 Participants
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 monolayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet)
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 bilayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
|---|---|---|---|
|
Part 2: Absolute Values of Vital Signs: Pulse Rate
Baseline (Day 1, pre-dose)
|
64.4 Beats per minute
Standard Deviation 5.76
|
64.2 Beats per minute
Standard Deviation 7.34
|
—
|
|
Part 2: Absolute Values of Vital Signs: Pulse Rate
Day 1, 24 hours
|
65.7 Beats per minute
Standard Deviation 9.22
|
67.3 Beats per minute
Standard Deviation 8.21
|
—
|
|
Part 2: Absolute Values of Vital Signs: Pulse Rate
Day 1, 48 hours
|
66.9 Beats per minute
Standard Deviation 7.29
|
69.1 Beats per minute
Standard Deviation 8.33
|
—
|
|
Part 2: Absolute Values of Vital Signs: Pulse Rate
Day 5
|
70.0 Beats per minute
Standard Deviation 7.29
|
66.8 Beats per minute
Standard Deviation 7.10
|
—
|
|
Part 2: Absolute Values of Vital Signs: Pulse Rate
Day 7
|
65.9 Beats per minute
Standard Deviation 5.64
|
62.2 Beats per minute
Standard Deviation 7.12
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1, pre-dose), and Day 1: 24, 48, 72 hours, Days 5, 6 and 7Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
Oral temperature were measured in the semi-supine position with a completely automated device after at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline was defined as the average of the triplicate predose assessments within each treatment.
Outcome measures
| Measure |
Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg
n=22 Participants
Participants received a single oral dose of GSK3640254 25 mg (2 tablets), GSK3640254 100 mg (1 tablet), and DTG 50 mg (1 tablet) together under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet)
n=21 Participants
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 monolayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet)
n=20 Participants
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 bilayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
|---|---|---|---|
|
Part 1: Absolute Values of Vital Signs: Oral Temperature
Baseline (Day 1 pre-dose)
|
36.38 Degrees celsius
Standard Deviation 0.424
|
36.43 Degrees celsius
Standard Deviation 0.451
|
36.52 Degrees celsius
Standard Deviation 0.382
|
|
Part 1: Absolute Values of Vital Signs: Oral Temperature
Day 1, 24 hours
|
36.47 Degrees celsius
Standard Deviation 0.431
|
36.55 Degrees celsius
Standard Deviation 0.481
|
36.60 Degrees celsius
Standard Deviation 0.422
|
|
Part 1: Absolute Values of Vital Signs: Oral Temperature
Day 1, 48 hours
|
36.54 Degrees celsius
Standard Deviation 0.343
|
36.54 Degrees celsius
Standard Deviation 0.385
|
36.61 Degrees celsius
Standard Deviation 0.264
|
|
Part 1: Absolute Values of Vital Signs: Oral Temperature
Day 1, 72 hours
|
36.45 Degrees celsius
Standard Deviation 0.423
|
36.77 Degrees celsius
Standard Deviation 0.314
|
36.25 Degrees celsius
Standard Deviation 0.505
|
|
Part 1: Absolute Values of Vital Signs: Oral Temperature
Day 5
|
36.44 Degrees celsius
Standard Deviation 0.475
|
36.43 Degrees celsius
Standard Deviation 0.527
|
36.48 Degrees celsius
Standard Deviation 0.355
|
|
Part 1: Absolute Values of Vital Signs: Oral Temperature
Day 6
|
36.43 Degrees celsius
Standard Deviation 0.317
|
36.49 Degrees celsius
Standard Deviation 0.468
|
36.43 Degrees celsius
Standard Deviation 0.267
|
|
Part 1: Absolute Values of Vital Signs: Oral Temperature
Day 7
|
36.51 Degrees celsius
Standard Deviation 0.501
|
36.46 Degrees celsius
Standard Deviation 0.380
|
36.72 Degrees celsius
Standard Deviation 0.282
|
SECONDARY outcome
Timeframe: Baseline (Day 1, pre-dose), and Day 1: 24, 48 hours, Day 5 and 7Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
Oral temperature were measured in the semi-supine position with a completely automated device after at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline was defined as the average of the triplicate predose assessments within each treatment.
Outcome measures
| Measure |
Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg
n=17 Participants
Participants received a single oral dose of GSK3640254 25 mg (2 tablets), GSK3640254 100 mg (1 tablet), and DTG 50 mg (1 tablet) together under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet)
n=18 Participants
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 monolayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet)
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 bilayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
|---|---|---|---|
|
Part 2: Absolute Values of Vital Signs: Oral Temperature
Baseline (Day 1, pre-dose)
|
36.28 Degree celsius
Standard Deviation 0.366
|
36.30 Degree celsius
Standard Deviation 0.230
|
—
|
|
Part 2: Absolute Values of Vital Signs: Oral Temperature
Day 1, 24 hours
|
36.42 Degree celsius
Standard Deviation 0.325
|
36.33 Degree celsius
Standard Deviation 0.307
|
—
|
|
Part 2: Absolute Values of Vital Signs: Oral Temperature
Day 1, 48 hours
|
36.42 Degree celsius
Standard Deviation 0.321
|
36.32 Degree celsius
Standard Deviation 0.349
|
—
|
|
Part 2: Absolute Values of Vital Signs: Oral Temperature
Day 5
|
36.41 Degree celsius
Standard Deviation 0.347
|
36.31 Degree celsius
Standard Deviation 0.313
|
—
|
|
Part 2: Absolute Values of Vital Signs: Oral Temperature
Day 6
|
36.43 Degree celsius
Standard Deviation 0.339
|
36.18 Degree celsius
Standard Deviation 0.377
|
—
|
|
Part 2: Absolute Values of Vital Signs: Oral Temperature
Day 7
|
36.57 Degree celsius
Standard Deviation 0.269
|
36.38 Degree celsius
Standard Deviation 0.402
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1, pre-dose), and Day 1: 24, 48, 72 hours, Days 5 and 7Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
Respiratory rate was measured in the semi-supine position with a completely automated device after at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline was defined as the average of the triplicate predose assessments within each treatment.
Outcome measures
| Measure |
Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg
n=22 Participants
Participants received a single oral dose of GSK3640254 25 mg (2 tablets), GSK3640254 100 mg (1 tablet), and DTG 50 mg (1 tablet) together under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet)
n=21 Participants
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 monolayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet)
n=20 Participants
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 bilayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
|---|---|---|---|
|
Part 1: Absolute Values of Vital Signs: Respiratory Rate
Baseline (Day 1, pre-dose)
|
14.1 Breaths per minute
Standard Deviation 2.65
|
13.6 Breaths per minute
Standard Deviation 2.58
|
13.9 Breaths per minute
Standard Deviation 3.28
|
|
Part 1: Absolute Values of Vital Signs: Respiratory Rate
Day 1, 24 hours
|
13.8 Breaths per minute
Standard Deviation 3.26
|
13.8 Breaths per minute
Standard Deviation 3.03
|
14.8 Breaths per minute
Standard Deviation 2.93
|
|
Part 1: Absolute Values of Vital Signs: Respiratory Rate
Day 1, 48 hours
|
14.9 Breaths per minute
Standard Deviation 2.68
|
12.7 Breaths per minute
Standard Deviation 2.42
|
14.1 Breaths per minute
Standard Deviation 2.00
|
|
Part 1: Absolute Values of Vital Signs: Respiratory Rate
Day 1, 72 hours
|
14.0 Breaths per minute
Standard Deviation 2.83
|
13.0 Breaths per minute
Standard Deviation 2.45
|
14.0 Breaths per minute
Standard Deviation 1.26
|
|
Part 1: Absolute Values of Vital Signs: Respiratory Rate
Day 5
|
11.7 Breaths per minute
Standard Deviation 3.44
|
12.0 Breaths per minute
Standard Deviation 2.83
|
14.7 Breaths per minute
Standard Deviation 3.93
|
|
Part 1: Absolute Values of Vital Signs: Respiratory Rate
Day 7
|
14.0 Breaths per minute
Standard Deviation 2.97
|
14.6 Breaths per minute
Standard Deviation 1.89
|
12.9 Breaths per minute
Standard Deviation 3.78
|
SECONDARY outcome
Timeframe: Baseline (Day 1, pre-dose), and Day 1: 24, 48 hours, Days 5, and 7Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
Respiratory rate was measured in the semi-supine position with a completely automated device after at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline was defined as the average of the triplicate predose assessments within each treatment.
Outcome measures
| Measure |
Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg
n=17 Participants
Participants received a single oral dose of GSK3640254 25 mg (2 tablets), GSK3640254 100 mg (1 tablet), and DTG 50 mg (1 tablet) together under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet)
n=18 Participants
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 monolayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet)
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 bilayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
|---|---|---|---|
|
Part 2: Absolute Values of Vital Signs: Respiratory Rate
Baseline (Day 1, pre-dose)
|
12.7 Breaths per minute
Standard Deviation 2.34
|
12.9 Breaths per minute
Standard Deviation 2.49
|
—
|
|
Part 2: Absolute Values of Vital Signs: Respiratory Rate
Day 1, 24 hours
|
14.5 Breaths per minute
Standard Deviation 1.94
|
13.9 Breaths per minute
Standard Deviation 2.52
|
—
|
|
Part 2: Absolute Values of Vital Signs: Respiratory Rate
Day 1, 48 hours
|
13.1 Breaths per minute
Standard Deviation 2.84
|
13.8 Breaths per minute
Standard Deviation 2.37
|
—
|
|
Part 2: Absolute Values of Vital Signs: Respiratory Rate
Day 5
|
11.3 Breaths per minute
Standard Deviation 2.38
|
12.4 Breaths per minute
Standard Deviation 3.13
|
—
|
|
Part 2: Absolute Values of Vital Signs: Respiratory Rate
Day 7
|
13.5 Breaths per minute
Standard Deviation 2.07
|
13.1 Breaths per minute
Standard Deviation 1.45
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1, pre-dose), and Day 1: 24, 48, 72 hours, Days 5, and 7Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
SBP and DBP were measured in the semi-supine position with a completely automated device after at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline was defined as the average of the triplicate predose assessments within each treatment. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg
n=22 Participants
Participants received a single oral dose of GSK3640254 25 mg (2 tablets), GSK3640254 100 mg (1 tablet), and DTG 50 mg (1 tablet) together under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet)
n=21 Participants
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 monolayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet)
n=20 Participants
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 bilayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
|---|---|---|---|
|
Part 1: Change From Baseline in Vital Signs: DBP and SBP
DBP, Day 1, 24 hours
|
-0.6 Millimeters of mercury
Standard Deviation 5.27
|
-0.1 Millimeters of mercury
Standard Deviation 7.40
|
13.9 Millimeters of mercury
Standard Deviation 7.45
|
|
Part 1: Change From Baseline in Vital Signs: DBP and SBP
DBP, Day 1, 48 hours
|
-2.4 Millimeters of mercury
Standard Deviation 5.21
|
-2.5 Millimeters of mercury
Standard Deviation 5.25
|
-2.4 Millimeters of mercury
Standard Deviation 5.66
|
|
Part 1: Change From Baseline in Vital Signs: DBP and SBP
DBP, Day 1, 72 hours
|
-4.2 Millimeters of mercury
Standard Deviation 6.52
|
-1.3 Millimeters of mercury
Standard Deviation 6.86
|
-1.5 Millimeters of mercury
Standard Deviation 6.66
|
|
Part 1: Change From Baseline in Vital Signs: DBP and SBP
DBP, Day 5
|
-1.2 Millimeters of mercury
Standard Deviation 6.18
|
-0.2 Millimeters of mercury
Standard Deviation 7.25
|
-1.3 Millimeters of mercury
Standard Deviation 5.20
|
|
Part 1: Change From Baseline in Vital Signs: DBP and SBP
DBP, Day 7
|
-0.1 Millimeters of mercury
Standard Deviation 7.49
|
-2.3 Millimeters of mercury
Standard Deviation 5.76
|
-2.1 Millimeters of mercury
Standard Deviation 8.01
|
|
Part 1: Change From Baseline in Vital Signs: DBP and SBP
SBP, Day 1, 24 hours
|
-2.8 Millimeters of mercury
Standard Deviation 9.63
|
2.3 Millimeters of mercury
Standard Deviation 7.37
|
-2.1 Millimeters of mercury
Standard Deviation 9.95
|
|
Part 1: Change From Baseline in Vital Signs: DBP and SBP
SBP, Day 1, 48 hours
|
-4.0 Millimeters of mercury
Standard Deviation 6.08
|
-0.5 Millimeters of mercury
Standard Deviation 6.57
|
-3.8 Millimeters of mercury
Standard Deviation 10.80
|
|
Part 1: Change From Baseline in Vital Signs: DBP and SBP
SBP, Day 1, 72 hours
|
-7.8 Millimeters of mercury
Standard Deviation 9.09
|
2.8 Millimeters of mercury
Standard Deviation 8.64
|
4.2 Millimeters of mercury
Standard Deviation 6.74
|
|
Part 1: Change From Baseline in Vital Signs: DBP and SBP
SBP, Day 5
|
-2.5 Millimeters of mercury
Standard Deviation 7.06
|
6.2 Millimeters of mercury
Standard Deviation 9.13
|
1.2 Millimeters of mercury
Standard Deviation 6.52
|
|
Part 1: Change From Baseline in Vital Signs: DBP and SBP
SBP, Day 7
|
1.4 Millimeters of mercury
Standard Deviation 7.63
|
-2.4 Millimeters of mercury
Standard Deviation 10.06
|
-5.1 Millimeters of mercury
Standard Deviation 10.71
|
SECONDARY outcome
Timeframe: Baseline (Day 1, pre-dose), and Day 1: 24, 48 hours, Days 5, and 7Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
SBP and DBP were measured in the semi-supine position with a completely automated device after at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline was defined as the average of the triplicate predose assessments within each treatment. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg
n=17 Participants
Participants received a single oral dose of GSK3640254 25 mg (2 tablets), GSK3640254 100 mg (1 tablet), and DTG 50 mg (1 tablet) together under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet)
n=18 Participants
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 monolayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet)
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 bilayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
|---|---|---|---|
|
Part 2: Change From Baseline in Vital Signs: DBP and SBP
DBP, Day 1, 24 hours
|
-1.1 Millimeters of mercury
Standard Deviation 4.34
|
-2.8 Millimeters of mercury
Standard Deviation 7.18
|
—
|
|
Part 2: Change From Baseline in Vital Signs: DBP and SBP
DBP, Day 1, 48 hours
|
-3.3 Millimeters of mercury
Standard Deviation 6.30
|
-4.6 Millimeters of mercury
Standard Deviation 5.28
|
—
|
|
Part 2: Change From Baseline in Vital Signs: DBP and SBP
DBP, Day 5
|
-0.3 Millimeters of mercury
Standard Deviation 6.96
|
-1.8 Millimeters of mercury
Standard Deviation 5.54
|
—
|
|
Part 2: Change From Baseline in Vital Signs: DBP and SBP
DBP Interval, Day 7
|
0.1 Millimeters of mercury
Standard Deviation 4.48
|
-2.0 Millimeters of mercury
Standard Deviation 6.61
|
—
|
|
Part 2: Change From Baseline in Vital Signs: DBP and SBP
SBP, Day 1, 24 hours
|
-0.8 Millimeters of mercury
Standard Deviation 9.19
|
-1.1 Millimeters of mercury
Standard Deviation 10.57
|
—
|
|
Part 2: Change From Baseline in Vital Signs: DBP and SBP
SBP, Day 1, 48 hours
|
-2.5 Millimeters of mercury
Standard Deviation 5.56
|
-4.6 Millimeters of mercury
Standard Deviation 7.81
|
—
|
|
Part 2: Change From Baseline in Vital Signs: DBP and SBP
SBP, Day 5
|
1.3 Millimeters of mercury
Standard Deviation 10.10
|
1.9 Millimeters of mercury
Standard Deviation 8.22
|
—
|
|
Part 2: Change From Baseline in Vital Signs: DBP and SBP
SBP, Day 7
|
-4.1 Millimeters of mercury
Standard Deviation 4.48
|
-7.8 Millimeters of mercury
Standard Deviation 8.74
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1, pre-dose), and Day 1: 24, 48, 72 hours, Days 5, and 7Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
Pulse rate was measured in the semi-supine position with a completely automated device after at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline was defined as the average of the triplicate predose assessments within each treatment. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg
n=22 Participants
Participants received a single oral dose of GSK3640254 25 mg (2 tablets), GSK3640254 100 mg (1 tablet), and DTG 50 mg (1 tablet) together under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet)
n=21 Participants
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 monolayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet)
n=20 Participants
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 bilayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
|---|---|---|---|
|
Part 1: Change From Baseline in Vital Signs: Pulse Rate
Day 1, 24 hours
|
-3.2 Beats per minute
Standard Deviation 8.87
|
2.6 Beats per minute
Standard Deviation 8.69
|
-2.7 Beats per minute
Standard Deviation 10.80
|
|
Part 1: Change From Baseline in Vital Signs: Pulse Rate
Day 1, 48 hours
|
-0.7 Beats per minute
Standard Deviation 9.60
|
-1.4 Beats per minute
Standard Deviation 8.38
|
-2.8 Beats per minute
Standard Deviation 10.94
|
|
Part 1: Change From Baseline in Vital Signs: Pulse Rate
Day 1, 72 hours
|
-5.2 Beats per minute
Standard Deviation 14.32
|
7.2 Beats per minute
Standard Deviation 5.98
|
0.7 Beats per minute
Standard Deviation 4.41
|
|
Part 1: Change From Baseline in Vital Signs: Pulse Rate
Day 5
|
-4.0 Beats per minute
Standard Deviation 9.08
|
7.0 Beats per minute
Standard Deviation 6.32
|
2.7 Beats per minute
Standard Deviation 5.89
|
|
Part 1: Change From Baseline in Vital Signs: Pulse Rate
Day 7
|
-1.0 Beats per minute
Standard Deviation 7.33
|
-4.4 Beats per minute
Standard Deviation 9.63
|
-4.4 Beats per minute
Standard Deviation 9.42
|
SECONDARY outcome
Timeframe: Baseline (Day 1, pre-dose), and Day 1: 24, 48 hours, Days 5, and 7Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
Pulse rate was measured in the semi-supine position with a completely automated device after at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline was defined as the average of the triplicate predose assessments within each treatment. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg
n=17 Participants
Participants received a single oral dose of GSK3640254 25 mg (2 tablets), GSK3640254 100 mg (1 tablet), and DTG 50 mg (1 tablet) together under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet)
n=18 Participants
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 monolayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet)
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 bilayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
|---|---|---|---|
|
Part 2: Change From Baseline in Vital Signs: Pulse Rate
Day 1, 24 hours
|
1.3 Beats per minute
Standard Deviation 9.68
|
3.1 Beats per minute
Standard Deviation 8.32
|
—
|
|
Part 2: Change From Baseline in Vital Signs: Pulse Rate
Day 1, 48 hours
|
2.5 Beats per minute
Standard Deviation 5.37
|
4.9 Beats per minute
Standard Deviation 8.36
|
—
|
|
Part 2: Change From Baseline in Vital Signs: Pulse Rate
Day 5
|
7.0 Beats per minute
Standard Deviation 8.19
|
3.4 Beats per minute
Standard Deviation 5.32
|
—
|
|
Part 2: Change From Baseline in Vital Signs: Pulse Rate
Day 7
|
0.2 Beats per minute
Standard Deviation 4.18
|
-2.9 Beats per minute
Standard Deviation 6.51
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1, pre-dose), and Day 1: 24, 48, 72 hours, Days 5, 6 and 7Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
Oral temperature was measured in the semi-supine position with a completely automated device after at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline was defined as the average of the triplicate predose assessments within each treatment. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg
n=22 Participants
Participants received a single oral dose of GSK3640254 25 mg (2 tablets), GSK3640254 100 mg (1 tablet), and DTG 50 mg (1 tablet) together under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet)
n=21 Participants
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 monolayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet)
n=20 Participants
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 bilayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
|---|---|---|---|
|
Part 1: Change From Baseline in Vital Signs: Oral Temperature
Day 1, 24 hours
|
0.09 Degrees Celsius
Standard Deviation 0.507
|
0.11 Degrees Celsius
Standard Deviation 0.479
|
0.08 Degrees Celsius
Standard Deviation 0.443
|
|
Part 1: Change From Baseline in Vital Signs: Oral Temperature
Day 1, 48 hours
|
0.15 Degrees Celsius
Standard Deviation 0.485
|
0.05 Degrees Celsius
Standard Deviation 0.415
|
0.11 Degrees Celsius
Standard Deviation 0.274
|
|
Part 1: Change From Baseline in Vital Signs: Oral Temperature
Day 1, 72 hours
|
-0.03 Degrees Celsius
Standard Deviation 0.497
|
0.38 Degrees Celsius
Standard Deviation 0.313
|
-0.03 Degrees Celsius
Standard Deviation 0.314
|
|
Part 1: Change From Baseline in Vital Signs: Oral Temperature
Day 5
|
0.05 Degrees Celsius
Standard Deviation 0.418
|
-0.06 Degrees Celsius
Standard Deviation 0.494
|
-0.03 Degrees Celsius
Standard Deviation 0.401
|
|
Part 1: Change From Baseline in Vital Signs: Oral Temperature
Day 6
|
0.08 Degrees Celsius
Standard Deviation 0.541
|
-0.04 Degrees Celsius
Standard Deviation 0.435
|
-0.20 Degrees Celsius
Standard Deviation 0.521
|
|
Part 1: Change From Baseline in Vital Signs: Oral Temperature
Day 7
|
0.17 Degrees Celsius
Standard Deviation 0.443
|
-0.07 Degrees Celsius
Standard Deviation 0.523
|
0.09 Degrees Celsius
Standard Deviation 0.300
|
SECONDARY outcome
Timeframe: Baseline (Day 1, pre-dose), and Day 1: 24, 48 hours, Days 5, 6 and 7Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
Oral temperature was measured in the semi-supine position with a completely automated device 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. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg
n=17 Participants
Participants received a single oral dose of GSK3640254 25 mg (2 tablets), GSK3640254 100 mg (1 tablet), and DTG 50 mg (1 tablet) together under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet)
n=18 Participants
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 monolayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet)
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 bilayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
|---|---|---|---|
|
Part 2: Change From Baseline in Vital Signs: Oral Temperature
Day 1, 24 hours
|
0.14 Degrees Celsius
Standard Deviation 0.378
|
0.03 Degrees Celsius
Standard Deviation 0.341
|
—
|
|
Part 2: Change From Baseline in Vital Signs: Oral Temperature
Day 1, 48 hours
|
0.14 Degrees Celsius
Standard Deviation 0.326
|
0.02 Degrees Celsius
Standard Deviation 0.350
|
—
|
|
Part 2: Change From Baseline in Vital Signs: Oral Temperature
Day 5
|
0.12 Degrees Celsius
Standard Deviation 0.385
|
0.01 Degrees Celsius
Standard Deviation 0.356
|
—
|
|
Part 2: Change From Baseline in Vital Signs: Oral Temperature
Day 6
|
0.11 Degrees Celsius
Standard Deviation 0.314
|
-0.19 Degrees Celsius
Standard Deviation 0.481
|
—
|
|
Part 2: Change From Baseline in Vital Signs: Oral Temperature
Day 7
|
0.24 Degrees Celsius
Standard Deviation 0.167
|
0.01 Degrees Celsius
Standard Deviation 0.470
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1, pre-dose), and Day 1: 24, 48 hours, Days 5, and 7Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
Respiratory rate was measured in the semi-supine position with a completely automated device after at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline was defined as the average of the triplicate predose assessments within each treatment. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg
n=22 Participants
Participants received a single oral dose of GSK3640254 25 mg (2 tablets), GSK3640254 100 mg (1 tablet), and DTG 50 mg (1 tablet) together under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet)
n=21 Participants
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 monolayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet)
n=20 Participants
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 bilayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
|---|---|---|---|
|
Part 1: Change From Baseline in Vital Signs: Respiratory Rate
Day 1, 24 hours
|
-0.3 Breaths per minute
Standard Deviation 2.57
|
0.2 Breaths per minute
Standard Deviation 3.84
|
0.9 Breaths per minute
Standard Deviation 2.86
|
|
Part 1: Change From Baseline in Vital Signs: Respiratory Rate
Day 1, 48 hours
|
0.9 Breaths per minute
Standard Deviation 3.64
|
-0.8 Breaths per minute
Standard Deviation 3.67
|
0.5 Breaths per minute
Standard Deviation 2.58
|
|
Part 1: Change From Baseline in Vital Signs: Respiratory Rate
Day 1, 72 hours
|
-1.3 Breaths per minute
Standard Deviation 2.07
|
-1.3 Breaths per minute
Standard Deviation 3.01
|
-0.3 Breaths per minute
Standard Deviation 2.34
|
|
Part 1: Change From Baseline in Vital Signs: Respiratory Rate
Day 5
|
-3.7 Breaths per minute
Standard Deviation 2.94
|
-2.3 Breaths per minute
Standard Deviation 4.63
|
0.3 Breaths per minute
Standard Deviation 3.44
|
|
Part 1: Change From Baseline in Vital Signs: Respiratory Rate
Day 7
|
0.4 Breaths per minute
Standard Deviation 4.37
|
1.4 Breaths per minute
Standard Deviation 2.22
|
-0.3 Breaths per minute
Standard Deviation 3.40
|
SECONDARY outcome
Timeframe: Baseline (Day 1, pre-dose), and Day 1: 24, 48 hours, Days 5, and 7Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
Respiratory rate was measured in the semi-supine position with a completely automated device after at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline was defined as the average of the triplicate predose assessments within each treatment. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg
n=17 Participants
Participants received a single oral dose of GSK3640254 25 mg (2 tablets), GSK3640254 100 mg (1 tablet), and DTG 50 mg (1 tablet) together under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet)
n=18 Participants
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 monolayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet)
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 bilayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
|---|---|---|---|
|
Part 2: Change From Baseline in Vital Signs: Respiratory Rate
Day 1, 24 hours
|
1.8 Breaths per minute
Standard Deviation 2.82
|
1.0 Breaths per minute
Standard Deviation 3.01
|
—
|
|
Part 2: Change From Baseline in Vital Signs: Respiratory Rate
Day 1, 48 hours
|
0.4 Breaths per minute
Standard Deviation 3.48
|
0.9 Breaths per minute
Standard Deviation 3.01
|
—
|
|
Part 2: Change From Baseline in Vital Signs: Respiratory Rate
Day 5
|
-1.0 Breaths per minute
Standard Deviation 3.02
|
-1.3 Breaths per minute
Standard Deviation 4.24
|
—
|
|
Part 2: Change From Baseline in Vital Signs: Respiratory Rate
Day 7
|
0.0 Breaths per minute
Standard Deviation 2.83
|
1.1 Breaths per minute
Standard Deviation 3.33
|
—
|
Adverse Events
Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg
Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet)
Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet)
Part 2: Treatment D: GSK3640254/DTG, 150 mg/50 mg (Fed)
Part 2: Treatment E: GSK3640254/DTG, 150 mg/50 mg (Fasted)
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg
n=22 participants at risk
Participants received a single oral dose of GSK3640254 25 mg (2 tablets), GSK3640254 100 mg (1 tablet), and DTG 50 mg (1 tablet) together under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet)
n=21 participants at risk
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 monolayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet)
n=20 participants at risk
Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 bilayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3.
|
Part 2: Treatment D: GSK3640254/DTG, 150 mg/50 mg (Fed)
n=17 participants at risk
Participants received Treatment D a single oral dose of selected bilayer FDC from Part 1 of GSK3640254/DTG, 150 mg/50 mg under high fat and calorie conditions on Day 1 in each treatment period.
|
Part 2: Treatment E: GSK3640254/DTG, 150 mg/50 mg (Fasted)
n=18 participants at risk
Participants received Treatment E a single oral dose of selected bilayer FDC from Part 1 GSK3640254/DTG, 150 mg/50 mg administered under fasted conditions on Day 1 in each treatment period.
|
|---|---|---|---|---|---|
|
Psychiatric disorders
Anxiety
|
0.00%
0/22 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to Day 17 in Part 1 and up to Day 9 in Part 2
Safety Population consisted of all participants who received at least one dose of study intervention.
|
0.00%
0/21 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to Day 17 in Part 1 and up to Day 9 in Part 2
Safety Population consisted of all participants who received at least one dose of study intervention.
|
5.0%
1/20 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to Day 17 in Part 1 and up to Day 9 in Part 2
Safety Population consisted of all participants who received at least one dose of study intervention.
|
0.00%
0/17 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to Day 17 in Part 1 and up to Day 9 in Part 2
Safety Population consisted of all participants who received at least one dose of study intervention.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to Day 17 in Part 1 and up to Day 9 in Part 2
Safety Population consisted of all participants who received at least one dose of study intervention.
|
|
General disorders
Fatigue
|
0.00%
0/22 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to Day 17 in Part 1 and up to Day 9 in Part 2
Safety Population consisted of all participants who received at least one dose of study intervention.
|
0.00%
0/21 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to Day 17 in Part 1 and up to Day 9 in Part 2
Safety Population consisted of all participants who received at least one dose of study intervention.
|
0.00%
0/20 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to Day 17 in Part 1 and up to Day 9 in Part 2
Safety Population consisted of all participants who received at least one dose of study intervention.
|
5.9%
1/17 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to Day 17 in Part 1 and up to Day 9 in Part 2
Safety Population consisted of all participants who received at least one dose of study intervention.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to Day 17 in Part 1 and up to Day 9 in Part 2
Safety Population consisted of all participants who received at least one dose of study intervention.
|
|
Investigations
SARS-CoV-2 test positive
|
0.00%
0/22 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to Day 17 in Part 1 and up to Day 9 in Part 2
Safety Population consisted of all participants who received at least one dose of study intervention.
|
0.00%
0/21 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to Day 17 in Part 1 and up to Day 9 in Part 2
Safety Population consisted of all participants who received at least one dose of study intervention.
|
0.00%
0/20 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to Day 17 in Part 1 and up to Day 9 in Part 2
Safety Population consisted of all participants who received at least one dose of study intervention.
|
0.00%
0/17 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to Day 17 in Part 1 and up to Day 9 in Part 2
Safety Population consisted of all participants who received at least one dose of study intervention.
|
5.6%
1/18 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to Day 17 in Part 1 and up to Day 9 in Part 2
Safety Population consisted of all participants who received at least one dose of study intervention.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/22 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to Day 17 in Part 1 and up to Day 9 in Part 2
Safety Population consisted of all participants who received at least one dose of study intervention.
|
0.00%
0/21 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to Day 17 in Part 1 and up to Day 9 in Part 2
Safety Population consisted of all participants who received at least one dose of study intervention.
|
0.00%
0/20 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to Day 17 in Part 1 and up to Day 9 in Part 2
Safety Population consisted of all participants who received at least one dose of study intervention.
|
0.00%
0/17 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to Day 17 in Part 1 and up to Day 9 in Part 2
Safety Population consisted of all participants who received at least one dose of study intervention.
|
5.6%
1/18 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to Day 17 in Part 1 and up to Day 9 in Part 2
Safety Population consisted of all participants who received at least one dose of study intervention.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/22 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to Day 17 in Part 1 and up to Day 9 in Part 2
Safety Population consisted of all participants who received at least one dose of study intervention.
|
0.00%
0/21 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to Day 17 in Part 1 and up to Day 9 in Part 2
Safety Population consisted of all participants who received at least one dose of study intervention.
|
0.00%
0/20 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to Day 17 in Part 1 and up to Day 9 in Part 2
Safety Population consisted of all participants who received at least one dose of study intervention.
|
5.9%
1/17 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to Day 17 in Part 1 and up to Day 9 in Part 2
Safety Population consisted of all participants who received at least one dose of study intervention.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to Day 17 in Part 1 and up to Day 9 in Part 2
Safety Population consisted of all participants who received at least one dose of study intervention.
|
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