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.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

41 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 period

Results posted on

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

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.
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.
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.
Part 1: Period 1 (Day 1)
STARTED
9
7
7
0
0
Part 1: Period 1 (Day 1)
COMPLETED
8
7
7
0
0
Part 1: Period 1 (Day 1)
NOT COMPLETED
1
0
0
0
0
Part 1: Washout Period 1 (Up to 7 Days)
STARTED
8
7
7
0
0
Part 1: Washout Period 1 (Up to 7 Days)
COMPLETED
8
7
7
0
0
Part 1: Washout Period 1 (Up to 7 Days)
NOT COMPLETED
0
0
0
0
0
Part 1: Period 2 (Day 1)
STARTED
8
7
7
0
0
Part 1: Period 2 (Day 1)
COMPLETED
8
7
7
0
0
Part 1: Period 2 (Day 1)
NOT COMPLETED
0
0
0
0
0
Part 1: Washout Period 2 (Up to 7 Days)
STARTED
8
7
7
0
0
Part 1: Washout Period 2 (Up to 7 Days)
COMPLETED
6
6
6
0
0
Part 1: Washout Period 2 (Up to 7 Days)
NOT COMPLETED
2
1
1
0
0
Part 1: Period 3 (Day 1)
STARTED
6
6
6
0
0
Part 1: Period 3 (Day 1)
COMPLETED
6
6
6
0
0
Part 1: Period 3 (Day 1)
NOT COMPLETED
0
0
0
0
0
Part 2: Period 1 (Day 1)
STARTED
0
0
0
9
9
Part 2: Period 1 (Day 1)
COMPLETED
0
0
0
9
9
Part 2: Period 1 (Day 1)
NOT COMPLETED
0
0
0
0
0
Part 2: Washout Period 1 (Up to 7 Days)
STARTED
0
0
0
9
9
Part 2: Washout Period 1 (Up to 7 Days)
COMPLETED
0
0
0
9
8
Part 2: Washout Period 1 (Up to 7 Days)
NOT COMPLETED
0
0
0
0
1
Part 2: Period 2 (Day 1)
STARTED
0
0
0
9
8
Part 2: Period 2 (Day 1)
COMPLETED
0
0
0
9
8
Part 2: Period 2 (Day 1)
NOT COMPLETED
0
0
0
0
0

Reasons for withdrawal

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.
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.
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.
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.
Part 1: Period 1 (Day 1)
Adverse Event
1
0
0
0
0
Part 1: Washout Period 2 (Up to 7 Days)
Withdrawal by Subject
2
1
1
0
0
Part 2: Washout Period 1 (Up to 7 Days)
Protocol Violation
0
0
0
0
1

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

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.
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.
Total
n=41 Participants
Total of all reporting groups
Age, Customized
<=18 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
0 Participants
n=10 Participants
Age, Customized
19-64 years
9 Participants
n=5 Participants
7 Participants
n=7 Participants
7 Participants
n=5 Participants
9 Participants
n=4 Participants
9 Participants
n=21 Participants
41 Participants
n=10 Participants
Age, Customized
>= 65 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
0 Participants
n=10 Participants
Sex: Female, Male
Female
3 Participants
n=5 Participants
4 Participants
n=7 Participants
4 Participants
n=5 Participants
5 Participants
n=4 Participants
2 Participants
n=21 Participants
18 Participants
n=10 Participants
Sex: Female, Male
Male
6 Participants
n=5 Participants
3 Participants
n=7 Participants
3 Participants
n=5 Participants
4 Participants
n=4 Participants
7 Participants
n=21 Participants
23 Participants
n=10 Participants
Race/Ethnicity, Customized
Black or African American
3 Participants
n=5 Participants
3 Participants
n=7 Participants
3 Participants
n=5 Participants
6 Participants
n=4 Participants
3 Participants
n=21 Participants
18 Participants
n=10 Participants
Race/Ethnicity, Customized
White-White/Caucasian/European Heritage
6 Participants
n=5 Participants
3 Participants
n=7 Participants
4 Participants
n=5 Participants
3 Participants
n=4 Participants
4 Participants
n=21 Participants
20 Participants
n=10 Participants
Race/Ethnicity, Customized
Multiple
0 Participants
n=5 Participants
1 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
1 Participants
n=10 Participants
Race/Ethnicity, Customized
American Indian or Alaska Native
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
1 Participants
n=21 Participants
1 Participants
n=10 Participants
Race/Ethnicity, Customized
Asian- South East Asian Heritage
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
1 Participants
n=21 Participants
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 period

Population: 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

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.
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 period

Population: PK Parameter Population

Blood samples were collected at indicated time points for PK analysis of GSK3640254.

Outcome measures

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: 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 period

Population: PK Parameter Population

Blood samples were collected at indicated time points for PK analysis of GSK3640254.

Outcome measures

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: 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 period

Population: PK Parameter Population

Blood samples were collected at indicated time points for PK analysis of DTG.

Outcome measures

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: 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 period

Population: PK Parameter Population

Blood samples were collected at indicated time points for PK analysis of DTG.

Outcome measures

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: 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 period

Population: PK Parameter Population

Blood samples were collected at indicated time points for PK analysis of DTG.

Outcome measures

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: 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 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

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

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 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

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 period

Population: PK Parameter Population

Blood samples were collected at indicated time points for PK analysis of DTG.

Outcome measures

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 period

Population: PK Parameter Population

Blood samples were collected at indicated time points for PK analysis of DTG.

Outcome measures

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 period

Population: PK Parameter Population

Blood samples were collected at indicated time points for PK analysis of DTG.

Outcome measures

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 days

Population: 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

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 days

Population: 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

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 7

Population: 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

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 7

Population: 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

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 7

Population: 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

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 7

Population: 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

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 7

Population: 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

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 7

Population: 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

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 7

Population: 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

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 7

Population: 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

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 7

Population: 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

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 7

Population: 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

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 7

Population: 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

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 7

Population: 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

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 7

Population: 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

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 7

Population: 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

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 7

Population: 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

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 7

Population: 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

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 7

Population: 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

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 7

Population: 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

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 7

Population: 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

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 7

Population: 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

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 7

Population: 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

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 7

Population: 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

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 7

Population: 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

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 7

Population: 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

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 7

Population: 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

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 7

Population: 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

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 7

Population: 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

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 7

Population: 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

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 7

Population: 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

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 7

Population: 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

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 7

Population: 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

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 7

Population: 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

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 7

Population: 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

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 7

Population: 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

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 7

Population: 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

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 7

Population: 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

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 7

Population: 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

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 7

Population: 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

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 7

Population: 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

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 7

Population: 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

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, 7

Population: 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

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 7

Population: 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

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 7

Population: 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

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 7

Population: 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

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 7

Population: 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

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 7

Population: 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

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 7

Population: 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

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 7

Population: 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

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 7

Population: 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

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 7

Population: 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

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 7

Population: 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

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 7

Population: 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

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 7

Population: 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

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 7

Population: 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

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 7

Population: 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

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 7

Population: 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

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 7

Population: 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

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 7

Population: 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

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 7

Population: 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

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 7

Population: 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

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 7

Population: 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

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 7

Population: 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

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 7

Population: 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

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 7

Population: 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

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 17

Population: 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

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 9

Population: 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

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 17

Population: 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

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 9

Population: 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

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 17

Population: 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

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 9

Population: 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

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 5

Population: 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

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, 7

Population: 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

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 5

Population: 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

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 7

Population: 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

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 7

Population: 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

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 7

Population: 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

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 7

Population: 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

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 7

Population: 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

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 7

Population: 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

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 7

Population: 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

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 7

Population: 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

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 7

Population: 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

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 7

Population: 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

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 7

Population: 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

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 7

Population: 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

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 7

Population: 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

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 7

Population: 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

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 7

Population: 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

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 7

Population: 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

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 7

Population: 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

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

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet)

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet)

Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths

Part 2: Treatment D: GSK3640254/DTG, 150 mg/50 mg (Fed)

Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths

Part 2: Treatment E: GSK3640254/DTG, 150 mg/50 mg (Fasted)

Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

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

GSK Response Center

ViiV Healthcare

Phone: 866-435-7343

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