Trial Outcomes & Findings for To Assess the Relative Bioavailability (BA) of TRIUMEQ® and Dolutegravir and Lamivudine (DTG/3TC) Pediatric Dispersible Tablet Formulations in Healthy Volunteers (NCT NCT03441984)

NCT ID: NCT03441984

Last Updated: 2019-12-09

Results Overview

Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate pharmacokinetic (PK) parameters of DTG in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods. PK population comprised of participants in the all participants population (participants who took at least 1 dose of study medication) for whom PK sample was obtained and who had evaluable PK assay results. Statistics has been presented on geometric least square (LS) means.

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 36 participants
• Primary outcome timeframe: Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period
• Results posted on: 2019-12-09

Participant Flow

This was a 2-Part, Phase I, Single-Dose, 3-Period Crossover Relative Bioavailability Study of a Pediatric TRIUMEQ Dispersible Tablet and Pediatric Dolutegravir and Lamivudine (DTG/3TC) Fixed Dose Combination Dispersible Tablet Formulations as Compared with Adult Tablets in Healthy Participants.

A total of 36 participants were enrolled for Part 1 and 2 of the study at a single-center in the United States. Each participant received all 3 treatments according to their assignment to one of the 6 treatment sequences in Part 1 and 2.

Participant milestones

Measure	Treatment Sequence ABC-Part 1 Participants received either treatment A=Adult TRIUMEQ (Dolutegravir \[DTG\] 50 milligram \[mg\]/Abacavir \[ABC\] 600 mg/Lamivudine \[3TC\] 300 mg, one tablet) direct-to-mouth or treatment B=Pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg, 10 dispersible tablets) as a dispersion or treatment C=Pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg, 10 dispersible tablets) direct-to-mouth followed by a wash-out period of 7 days after each treatment.	Treatment Sequence BCA-Part 1 Participants received either treatment B=Pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg, 10 dispersible tablets) as a dispersion or treatment C=Pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg, 10 dispersible tablets) direct-to-mouth or treatment A=Adult TRIUMEQ (DTG 50 mg/ABC 600 mg/3TC 300 mg, one tablet) direct-to-mouth followed by a wash-out period of 7 days.	Treatment Sequence CAB-Part 1 Participants received either treatment C=Pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg, 10 dispersible tablets) direct-to-mouth or treatment A=Adult TRIUMEQ (DTG 50 mg/ABC 600 mg/3TC 300 mg, one tablet) direct-to-mouth or treatment B=Pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg, 10 dispersible tablets) as a dispersion followed by a wash-out period of 7 days.	Treatment Sequence ACB-Part 1 Participants received either treatment A=Adult TRIUMEQ (DTG 50 mg/ABC 600 mg/3TC 300 mg, one tablet) direct-to-mouth or treatment C=Pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg, 10 dispersible tablets) direct-to-mouth or treatment B=Pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg, 10 dispersible tablets) as a dispersion followed by a wash-out period of 7 days.	Treatment Sequence BAC-Part 1 Participants received either treatment B=Pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg, 10 dispersible tablets) as a dispersion or treatment A=Adult TRIUMEQ (DTG 50 mg/ABC 600 mg/3TC 300 mg, one tablet) direct-to-mouth or treatment C=Pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg, 10 dispersible tablets) direct-to-mouth followed by a wash-out period of 7 days.	Treatment Sequence CBA-Part 1 Participants received either treatment C=Pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg, 10 dispersible tablets) direct-to-mouth or treatment B=Pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg, 10 dispersible tablets) as a dispersion or treatment A=Adult TRIUMEQ (DTG 50 mg/ABC 600 mg/3TC 300 mg. one tablet) direct-to-mouth followed by a wash-out period of 7 days.	Treatment DEF-Part 2 Participants received either treatment D=Adult DTG 50 mg and 3TC 300 mg as one conventional tablet direct-to-mouth or treatment E=Pediatric DTG 5 mg/3TC 30 mg, 10 dispersible tablets as dispersion or treatment F=Pediatric DTG 5 mg/3TC 30 mg, 10 dispersible tablets direct-to-mouth followed by a wash-out period of 7 days.	Treatment EFD-Part 2 Participants received either treatment E=Pediatric DTG 5 mg/3TC 30 mg, 10 dispersible tablets as dispersion or treatment F=Pediatric DTG 5 mg/3TC 30 mg, 10 dispersible tablets direct-to-mouth or treatment D=Adult DTG 50 mg and 3TC 300 mg as one conventional tablet direct-to-mouth followed by a wash-out period of 7 days.	Treatment FDE-Part 2 Participants received either treatment F=Pediatric DTG 5 mg/3TC 30 mg, 10 dispersible tablets direct-to-mouth or treatment D=Adult DTG 50 mg and 3TC 300 mg, one conventional tablet direct-to-mouth or treatment E=Pediatric DTG 5 mg/3TC 30 mg, as 10 dispersible tablets as dispersion followed by a wash-out period of 7 days.	Treatment DFE-Part 2 Participants received either treatment D=Adult DTG 50 mg and 3TC 300 mg, as one conventional tablet direct-to-mouth or treatment F=Pediatric DTG 5 mg/3TC 30 mg, 10 dispersible tablets direct-to-mouth or treatment E=Pediatric DTG 5 mg/3TC 30 mg, 10 dispersible tablets as dispersion followed by a wash-out period of 7 days.	Treatment EDF-Part 2 Participants received either treatment E=Pediatric DTG 5 mg/3TC 30 mg, 10 dispersible tablets as dispersion or treatment D=Adult DTG 50 mg and 3TC 300 mg, one coventional tablet direct-to-mouth or treatment F=Pediatric DTG 5 mg/3TC 30 mg, 10 dispersible tablets direct-to-mouth followed by a wash-out period of 7 days.	Treatment FED-Part 2 Participants received either treatment F=Pediatric DTG 5 mg/3TC 30 mg, 10 dispersible tablets direct-to-mouth or treatment E=Pediatric DTG 5 mg/3TC 30 mg, 10 dispersible tablets as dispersion or treatment D=Adult DTG 50 mg and 3TC 300 mg, one conventional tablet direct-to-mouth followed by a wash-out period of 7 days.
Part 1: Period 1 (Up to Day 4) STARTED	3	3	3	3	3	3	0	0	0	0	0	0
Part 1: Period 1 (Up to Day 4) COMPLETED	3	3	3	3	3	3	0	0	0	0	0	0
Part 1: Period 1 (Up to Day 4) NOT COMPLETED	0	0	0	0	0	0	0	0	0	0	0	0
Part 1,Period 1: Wash-out Period: 7 Days STARTED	3	3	3	3	3	3	0	0	0	0	0	0
Part 1,Period 1: Wash-out Period: 7 Days COMPLETED	3	3	3	3	3	3	0	0	0	0	0	0
Part 1,Period 1: Wash-out Period: 7 Days NOT COMPLETED	0	0	0	0	0	0	0	0	0	0	0	0
Part 1: Period 2 (Up to Day 4 ) STARTED	3	3	3	3	3	3	0	0	0	0	0	0
Part 1: Period 2 (Up to Day 4 ) COMPLETED	3	3	2	3	3	3	0	0	0	0	0	0
Part 1: Period 2 (Up to Day 4 ) NOT COMPLETED	0	0	1	0	0	0	0	0	0	0	0	0
Part 1: Period 2,Wash-out Period: 7 Days STARTED	3	3	2	3	3	3	0	0	0	0	0	0
Part 1: Period 2,Wash-out Period: 7 Days COMPLETED	3	3	2	3	3	3	0	0	0	0	0	0
Part 1: Period 2,Wash-out Period: 7 Days NOT COMPLETED	0	0	0	0	0	0	0	0	0	0	0	0
Part 1: Period 3 (Up to Day 4 ) STARTED	3	3	2	3	3	3	0	0	0	0	0	0
Part 1: Period 3 (Up to Day 4 ) COMPLETED	3	3	2	3	3	3	0	0	0	0	0	0
Part 1: Period 3 (Up to Day 4 ) NOT COMPLETED	0	0	0	0	0	0	0	0	0	0	0	0
Part 2: Period 1(Up to Day 4) STARTED	0	0	0	0	0	0	3	3	3	3	3	3
Part 2: Period 1(Up to Day 4) COMPLETED	0	0	0	0	0	0	3	3	3	3	3	3
Part 2: Period 1(Up to Day 4) NOT COMPLETED	0	0	0	0	0	0	0	0	0	0	0	0
Part 2: Period 1, Wash-out: Up to 7 Days STARTED	0	0	0	0	0	0	3	3	3	3	3	3
Part 2: Period 1, Wash-out: Up to 7 Days COMPLETED	0	0	0	0	0	0	3	3	3	3	3	3
Part 2: Period 1, Wash-out: Up to 7 Days NOT COMPLETED	0	0	0	0	0	0	0	0	0	0	0	0
Part 2: Period 2 (Up to Day 4) STARTED	0	0	0	0	0	0	3	3	3	3	3	3
Part 2: Period 2 (Up to Day 4) COMPLETED	0	0	0	0	0	0	3	3	3	3	3	3
Part 2: Period 2 (Up to Day 4) NOT COMPLETED	0	0	0	0	0	0	0	0	0	0	0	0
Part 2: Period 2, Wash-out: Up to 7 Days STARTED	0	0	0	0	0	0	3	3	3	3	3	3
Part 2: Period 2, Wash-out: Up to 7 Days COMPLETED	0	0	0	0	0	0	3	3	3	3	3	3
Part 2: Period 2, Wash-out: Up to 7 Days NOT COMPLETED	0	0	0	0	0	0	0	0	0	0	0	0
Part 2: Period 3 (Up to Day 4) STARTED	0	0	0	0	0	0	3	3	3	3	3	3
Part 2: Period 3 (Up to Day 4) COMPLETED	0	0	0	0	0	0	3	3	3	3	3	3
Part 2: Period 3 (Up to Day 4) NOT COMPLETED	0	0	0	0	0	0	0	0	0	0	0	0

Reasons for withdrawal

Measure	Treatment Sequence ABC-Part 1 Participants received either treatment A=Adult TRIUMEQ (Dolutegravir \[DTG\] 50 milligram \[mg\]/Abacavir \[ABC\] 600 mg/Lamivudine \[3TC\] 300 mg, one tablet) direct-to-mouth or treatment B=Pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg, 10 dispersible tablets) as a dispersion or treatment C=Pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg, 10 dispersible tablets) direct-to-mouth followed by a wash-out period of 7 days after each treatment.	Treatment Sequence BCA-Part 1 Participants received either treatment B=Pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg, 10 dispersible tablets) as a dispersion or treatment C=Pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg, 10 dispersible tablets) direct-to-mouth or treatment A=Adult TRIUMEQ (DTG 50 mg/ABC 600 mg/3TC 300 mg, one tablet) direct-to-mouth followed by a wash-out period of 7 days.	Treatment Sequence CAB-Part 1 Participants received either treatment C=Pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg, 10 dispersible tablets) direct-to-mouth or treatment A=Adult TRIUMEQ (DTG 50 mg/ABC 600 mg/3TC 300 mg, one tablet) direct-to-mouth or treatment B=Pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg, 10 dispersible tablets) as a dispersion followed by a wash-out period of 7 days.	Treatment Sequence ACB-Part 1 Participants received either treatment A=Adult TRIUMEQ (DTG 50 mg/ABC 600 mg/3TC 300 mg, one tablet) direct-to-mouth or treatment C=Pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg, 10 dispersible tablets) direct-to-mouth or treatment B=Pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg, 10 dispersible tablets) as a dispersion followed by a wash-out period of 7 days.	Treatment Sequence BAC-Part 1 Participants received either treatment B=Pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg, 10 dispersible tablets) as a dispersion or treatment A=Adult TRIUMEQ (DTG 50 mg/ABC 600 mg/3TC 300 mg, one tablet) direct-to-mouth or treatment C=Pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg, 10 dispersible tablets) direct-to-mouth followed by a wash-out period of 7 days.	Treatment Sequence CBA-Part 1 Participants received either treatment C=Pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg, 10 dispersible tablets) direct-to-mouth or treatment B=Pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg, 10 dispersible tablets) as a dispersion or treatment A=Adult TRIUMEQ (DTG 50 mg/ABC 600 mg/3TC 300 mg. one tablet) direct-to-mouth followed by a wash-out period of 7 days.	Treatment DEF-Part 2 Participants received either treatment D=Adult DTG 50 mg and 3TC 300 mg as one conventional tablet direct-to-mouth or treatment E=Pediatric DTG 5 mg/3TC 30 mg, 10 dispersible tablets as dispersion or treatment F=Pediatric DTG 5 mg/3TC 30 mg, 10 dispersible tablets direct-to-mouth followed by a wash-out period of 7 days.	Treatment EFD-Part 2 Participants received either treatment E=Pediatric DTG 5 mg/3TC 30 mg, 10 dispersible tablets as dispersion or treatment F=Pediatric DTG 5 mg/3TC 30 mg, 10 dispersible tablets direct-to-mouth or treatment D=Adult DTG 50 mg and 3TC 300 mg as one conventional tablet direct-to-mouth followed by a wash-out period of 7 days.	Treatment FDE-Part 2 Participants received either treatment F=Pediatric DTG 5 mg/3TC 30 mg, 10 dispersible tablets direct-to-mouth or treatment D=Adult DTG 50 mg and 3TC 300 mg, one conventional tablet direct-to-mouth or treatment E=Pediatric DTG 5 mg/3TC 30 mg, as 10 dispersible tablets as dispersion followed by a wash-out period of 7 days.	Treatment DFE-Part 2 Participants received either treatment D=Adult DTG 50 mg and 3TC 300 mg, as one conventional tablet direct-to-mouth or treatment F=Pediatric DTG 5 mg/3TC 30 mg, 10 dispersible tablets direct-to-mouth or treatment E=Pediatric DTG 5 mg/3TC 30 mg, 10 dispersible tablets as dispersion followed by a wash-out period of 7 days.	Treatment EDF-Part 2 Participants received either treatment E=Pediatric DTG 5 mg/3TC 30 mg, 10 dispersible tablets as dispersion or treatment D=Adult DTG 50 mg and 3TC 300 mg, one coventional tablet direct-to-mouth or treatment F=Pediatric DTG 5 mg/3TC 30 mg, 10 dispersible tablets direct-to-mouth followed by a wash-out period of 7 days.	Treatment FED-Part 2 Participants received either treatment F=Pediatric DTG 5 mg/3TC 30 mg, 10 dispersible tablets direct-to-mouth or treatment E=Pediatric DTG 5 mg/3TC 30 mg, 10 dispersible tablets as dispersion or treatment D=Adult DTG 50 mg and 3TC 300 mg, one conventional tablet direct-to-mouth followed by a wash-out period of 7 days.
Part 1: Period 2 (Up to Day 4 ) Positive urine drug screen lab value	0	0	1	0	0	0	0	0	0	0	0	0

Baseline Characteristics

To Assess the Relative Bioavailability (BA) of TRIUMEQ® and Dolutegravir and Lamivudine (DTG/3TC) Pediatric Dispersible Tablet Formulations in Healthy Volunteers

Baseline characteristics by cohort

Measure	All Study Participants in Part 1 n=18 Participants All participants received either treatment A or B or C in 6 treatment sequences: ABC, BCA, CAB, ACB, CBA and BAC	All Study Participants in Part 2 n=18 Participants All participants received either treatment D or E or F in 6 treatment sequences: DEF, EFD, FDE, DFE, EDF and FED	Total n=36 Participants Total of all reporting groups
Age, Continuous	34.9 Years STANDARD_DEVIATION 10.08 • n=5 Participants	33.9 Years STANDARD_DEVIATION 8.47 • n=7 Participants	34.4 Years STANDARD_DEVIATION 9.19 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	5 Participants n=7 Participants	14 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	13 Participants n=7 Participants	22 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Asian-Central/South Asian Heritage	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Asian-Japanese/East/South-East Asian Heritage	0 Participants n=5 Participants	4 Participants n=7 Participants	4 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	5 Participants n=5 Participants	6 Participants n=7 Participants	11 Participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian or other Pacific Islander	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized White	12 Participants n=5 Participants	8 Participants n=7 Participants	20 Participants n=5 Participants

PRIMARY outcome

Timeframe: Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period

Population: PK population.

Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate pharmacokinetic (PK) parameters of DTG in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods. PK population comprised of participants in the all participants population (participants who took at least 1 dose of study medication) for whom PK sample was obtained and who had evaluable PK assay results. Statistics has been presented on geometric least square (LS) means.

Outcome measures

Measure	DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet n=17 Participants Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth.	DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets n=17 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately.	DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth n=18 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth.
Area Under the Plasma Concentration-time Curve (AUC) From Time of Dose Extrapolated to Infinity (AUC[0-inf]) in Part 1 of DTG	59.761 Hours*microgram per milliliter Geometric Coefficient of Variation 31	101.125 Hours*microgram per milliliter Geometric Coefficient of Variation 22	77.742 Hours*microgram per milliliter Geometric Coefficient of Variation 29

PRIMARY outcome

Timeframe: Pre-dose,15 and 30 minutes,1 ,1.5 ,2 ,2.5 ,3 ,4 ,5 ,6 ,8 ,12 ,16 ,24 ,48 and 72 hours post-dose of each treatment period

Population: PK population.

Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of DTG in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods. Statistics has been presented on geometric LS means.

Outcome measures

Measure	DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet n=17 Participants Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth.	DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets n=17 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately.	DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth n=18 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth.
AUC From Time of Dose to Last Measurable Concentration (AUC[0-t]) in Part 1 of DTG	57.571 Hours*microgram per milliliter Geometric Coefficient of Variation 29	97.746 Hours*microgram per milliliter Geometric Coefficient of Variation 21	75.086 Hours*microgram per milliliter Geometric Coefficient of Variation 28

PRIMARY outcome

Timeframe: Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period

Population: PK population.

Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of DTG in Part 1. PK analysis was conducted using standard non-compartmental methods. Statistics has been presented on geometric LS means.

Outcome measures

Measure	DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet n=17 Participants Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth.	DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets n=17 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately.	DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth n=18 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth.
Maximum Observed Concentration (Cmax) in Part 1 of DTG in Plasma	3.093 Micrograms per milliliter Geometric Coefficient of Variation 20	5.373 Micrograms per milliliter Geometric Coefficient of Variation 15	4.134 Micrograms per milliliter Geometric Coefficient of Variation 21

PRIMARY outcome

Timeframe: Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period

Population: PK Population

Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of ABC in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods. Statistics has been presented on geometric LS means.

Outcome measures

Measure	DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet n=17 Participants Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth.	DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets n=17 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately.	DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth n=18 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth.
AUC(0-inf) in Part 1 of ABC	16.636 Hours*microgram per milliliter Geometric Coefficient of Variation 21	17.321 Hours*microgram per milliliter Geometric Coefficient of Variation 20	16.756 Hours*microgram per milliliter Geometric Coefficient of Variation 22

PRIMARY outcome

Timeframe: Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period

Population: PK Population

Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of ABC in Part 1. PK analysis was conducted using standard non-compartmental methods. Statistics has been presented on geometric LS means.

Outcome measures

Measure	DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet n=17 Participants Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth.	DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets n=17 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately.	DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth n=18 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth.
AUC(0-t) in Part 1 of ABC	16.609 Hours*microgram per milliliter Geometric Coefficient of Variation 21	17.298 Hours*microgram per milliliter Geometric Coefficient of Variation 20	16.735 Hours*microgram per milliliter Geometric Coefficient of Variation 22

PRIMARY outcome

Timeframe: Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period

Population: PK population.

Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of ABC in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods. Statistics has been presented on geometric LS means.

Outcome measures

Measure	DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet n=17 Participants Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth.	DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets n=17 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately.	DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth n=18 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth.
Cmax in Part 1 of ABC in Plasma	5.084 Micrograms per milliliter Geometric Coefficient of Variation 19	5.351 Micrograms per milliliter Geometric Coefficient of Variation 19	4.891 Micrograms per milliliter Geometric Coefficient of Variation 23

PRIMARY outcome

Timeframe: Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period

Population: PK Population

Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of 3TC in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods. Statistics has been presented on geometric LS means.

Outcome measures

Measure	DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet n=17 Participants Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth.	DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets n=17 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately.	DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth n=18 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth.
AUC(0-inf) in Part 1 of 3TC	13.087 Hours*microgram per milliliter Geometric Coefficient of Variation 26	13.062 Hours*microgram per milliliter Geometric Coefficient of Variation 24	12.155 Hours*microgram per milliliter Geometric Coefficient of Variation 30

PRIMARY outcome

Timeframe: Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period

Population: PK population

Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of 3TC in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods. Statistics has been presented on geometric LS means.

Outcome measures

Measure	DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet n=17 Participants Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth.	DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets n=17 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately.	DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth n=18 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth.
AUC (0-t) in Part 1 of 3TC	12.857 Hours*microgram per milliliter Geometric Coefficient of Variation 26	12.829 Hours*microgram per milliliter Geometric Coefficient of Variation 24	11.893 Hours*microgram per milliliter Geometric Coefficient of Variation 29

PRIMARY outcome

Timeframe: Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period

Population: PK Population.

Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of 3TC in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods. Statistics has been presented on geometric LS means

Outcome measures

Measure	DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet n=17 Participants Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth.	DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets n=17 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately.	DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth n=18 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth.
Cmax in Part 1 of 3TC	2.194 Micrograms per milliliter Geometric Coefficient of Variation 29	2.053 Micrograms per milliliter Geometric Coefficient of Variation 35	1.947 Micrograms per milliliter Geometric Coefficient of Variation 34

PRIMARY outcome

Timeframe: Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period

Population: PK Population

Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of DTG in Part 2. PK analysis was conducted using standard non-compartmental methods. Statistics has been presented on geometric LS means.

Outcome measures

Measure	DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet n=18 Participants Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth.	DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets n=18 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately.	DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth n=18 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth.
AUC(0-inf) in Part 2 of DTG in Plasma	53.942 Hours*microgram per milliliter Geometric Coefficient of Variation 38	88.676 Hours*microgram per milliliter Geometric Coefficient of Variation 31	68.496 Hours*microgram per milliliter Geometric Coefficient of Variation 32

PRIMARY outcome

Timeframe: Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period

Population: PK Population.

Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of DTG in Part 2. PK analysis was conducted using standard non-compartmental methods. Statistics has been presented on geometric LS means.

Outcome measures

Measure	DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet n=18 Participants Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth.	DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets n=18 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately.	DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth n=18 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth.
AUC(0-t) in Part 2 of DTG	51.477 Hours*microgram per milliliter Geometric Coefficient of Variation 38	85.340 Hours*microgram per milliliter Geometric Coefficient of Variation 30	65.657 Hours*microgram per milliliter Geometric Coefficient of Variation 31

PRIMARY outcome

Timeframe: Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period

Population: PK population

Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of DTG in Part 1. PK analysis was conducted using standard non-compartmental methods. Statistics has been presented on geometric LS means.

Outcome measures

Measure	DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet n=18 Participants Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth.	DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets n=18 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately.	DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth n=18 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth.
Cmax in Part 2 of DTG in Plasma	2.764 Micrograms per milliliter Geometric Coefficient of Variation 44	5.461 Micrograms per milliliter Geometric Coefficient of Variation 18	3.558 Micrograms per milliliter Geometric Coefficient of Variation 28

PRIMARY outcome

Timeframe: Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period

Population: PK population

Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of 3TC in Part 2. Pharmacokinetic analysis was conducted using standard non-compartmental methods. Statistics has been presented on geometric LS means.

Outcome measures

Measure	DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet n=18 Participants Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth.	DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets n=18 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately.	DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth n=18 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth.
AUC(0-inf) in Part 2 of 3TC	12.245 Hours*microgram per milliliter Geometric Coefficient of Variation 17	12.149 Hours*microgram per milliliter Geometric Coefficient of Variation 21	11.910 Hours*microgram per milliliter Geometric Coefficient of Variation 20

PRIMARY outcome

Timeframe: Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period

Population: PK population

Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of 3TC in Part 2. Pharmacokinetic analysis was conducted using standard non-compartmental methods. Statistics has been presented on geometric LS means.

Outcome measures

Measure	DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet n=18 Participants Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth.	DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets n=18 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately.	DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth n=18 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth.
AUC(0-t) in Part 2 of 3TC	11.991 Hours*microgram per milliliter Geometric Coefficient of Variation 16	11.788 Hours*microgram per milliliter Geometric Coefficient of Variation 20	11.633 Hours*microgram per milliliter Geometric Coefficient of Variation 19

PRIMARY outcome

Timeframe: Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period

Population: PK population

Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of 3TC in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods. Statistics has been presented on geometric LS means.

Outcome measures

Measure	DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet n=18 Participants Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth.	DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets n=18 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately.	DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth n=18 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth.
Cmax in Part 2 of 3TC	2.276 Micrograms per milliliter Geometric Coefficient of Variation 28	2.071 Micrograms per milliliter Geometric Coefficient of Variation 27	2.093 Micrograms per milliliter Geometric Coefficient of Variation 29

SECONDARY outcome

Timeframe: Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 and 24 hours post-dose of each treatment period

Population: PK population.

Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of DTG in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods.

Outcome measures

Measure	DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet n=17 Participants Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth.	DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets n=17 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately.	DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth n=18 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth.
AUC From Time of Dose to 24 Hours (AUC[0-24]) of DTG in Part 1	40.264 Hours*microgram per milliliter Geometric Coefficient of Variation 23	69.745 Hours*microgram per milliliter Geometric Coefficient of Variation 17	53.250 Hours*microgram per milliliter Geometric Coefficient of Variation 22

SECONDARY outcome

Timeframe: Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period

Population: PK population.

Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of DTG in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods.

Outcome measures

Measure	DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet n=17 Participants Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth.	DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets n=17 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately.	DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth n=18 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth.
Time to Maximum Concentration (Tmax) of DTG in Plasma in Part 1	3.00 Hours Interval 1.5 to 4.08	2.50 Hours Interval 1.0 to 6.0	3.00 Hours Interval 1.0 to 6.0

SECONDARY outcome

Timeframe: Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period

Population: PK population.

Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of DTG in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods.

Outcome measures

Measure	DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet n=17 Participants Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth.	DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets n=17 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately.	DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth n=18 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth.
Time of Last Quantifiable Concentration (Tlast) of DTG in Part 1	72.00 Hours Interval 72.0 to 72.0	72.00 Hours Interval 72.0 to 72.3	72.00 Hours Interval 72.0 to 72.02

SECONDARY outcome

Timeframe: Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period

Population: PK population

Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of DTG in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods.

Outcome measures

Measure	DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet n=17 Participants Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth.	DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets n=17 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately.	DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth n=18 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth.
Apparent Oral Clearance (CL/F) of DTG in Plasma in Part 1	0.8367 Liters per hour Geometric Coefficient of Variation 31	0.4944 Liters per hour Geometric Coefficient of Variation 22	0.6432 Liters per hour Geometric Coefficient of Variation 29

SECONDARY outcome

Timeframe: Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period

Population: PK population

Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of DTG in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods.

Outcome measures

Measure	DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet n=17 Participants Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth.	DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets n=17 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately.	DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth n=18 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth.
Apparent Volume of Distribution (Vz/F) of DTG in Part 1	17.260 Liters Geometric Coefficient of Variation 20	10.074 Liters Geometric Coefficient of Variation 20	12.998 Liters Geometric Coefficient of Variation 21

SECONDARY outcome

Timeframe: Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 and 24 hours post-dose of each treatment period

Population: PK population

Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of DTG in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods. Statistics has been presented on geometric LS means.

Outcome measures

Measure	DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet n=17 Participants Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth.	DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets n=17 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately.	DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth n=18 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth.
Observed Concentration at 24 Hours Postdose (C24) of DTG in Plasma in Part 1	925.303 Nanograms per millilter Geometric Coefficient of Variation 34	1523.534 Nanograms per millilter Geometric Coefficient of Variation 28	1198.948 Nanograms per millilter Geometric Coefficient of Variation 33

SECONDARY outcome

Timeframe: Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period

Population: PK population

Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of DTG in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods.

Outcome measures

Measure	DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet n=17 Participants Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth.	DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets n=17 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately.	DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth n=18 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth.
Last Observed Quantifiable Concentration (Ct) of DTG in Plasma in Part 1	84.968 Nanograms per milliliter Geometric Coefficient of Variation 83	138.258 Nanograms per milliliter Geometric Coefficient of Variation 65	106.140 Nanograms per milliliter Geometric Coefficient of Variation 80

SECONDARY outcome

Timeframe: Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period

Population: PK population

Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of DTG in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods.

Outcome measures

Measure	DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet n=17 Participants Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth.	DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets n=17 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately.	DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth n=18 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth.
Terminal Elimination Phase Half-life (t½) of DTG in Plasma in Part 1	14.300 Hours Geometric Coefficient of Variation 21	14.123 Hours Geometric Coefficient of Variation 18	14.008 Hours Geometric Coefficient of Variation 20

SECONDARY outcome

Timeframe: Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period

Population: PK population

Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of DTG in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods.

Outcome measures

Measure	DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet n=17 Participants Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth.	DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets n=17 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately.	DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth n=18 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth.
Lag Time for Absorption (Tlag) of DTG in Part 1	0.00 Hours Interval 0.0 to 0.25	0.00 Hours Interval 0.0 to 0.0	0.00 Hours Interval 0.0 to 0.0

SECONDARY outcome

Timeframe: Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 and 24 hours post-dose of each treatment period

Population: PK population

Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of ABC in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods.

Outcome measures

Measure	DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet n=17 Participants Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth.	DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets n=17 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately.	DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth n=18 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth.
AUC(0-24) of ABC in Plasma in Part 1	16.619 Hours*microgram per milliliter Geometric Coefficient of Variation 21	17.300 Hours*microgram per milliliter Geometric Coefficient of Variation 20	16.743 Hours*microgram per milliliter Geometric Coefficient of Variation 22

SECONDARY outcome

Timeframe: Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period

Population: PK population

Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of ABC in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods.

Outcome measures

Measure	DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet n=17 Participants Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth.	DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets n=17 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately.	DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth n=18 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth.
Tmax of ABC in Plasma in Part 1	1.50 Hours Interval 0.5 to 2.57	1.00 Hours Interval 0.25 to 2.0	1.00 Hours Interval 0.25 to 2.0

SECONDARY outcome

Timeframe: Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period

Population: PK population

Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of ABC in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods.

Outcome measures

Measure	DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet n=17 Participants Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth.	DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets n=17 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately.	DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth n=18 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth.
Tlast of ABC in Part 1	24.00 Hours Interval 16.0 to 24.07	24.00 Hours Interval 16.0 to 24.12	24.00 Hours Interval 16.0 to 24.07

SECONDARY outcome

Timeframe: Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period

Population: PK population

Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of ABC in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods.

Outcome measures

Measure	DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet n=17 Participants Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth.	DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets n=17 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately.	DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth n=18 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth.
CL/F of ABC in Plasma in Part 1	36.0658 Liters per hour Geometric Coefficient of Variation 21	34.6391 Liters per hour Geometric Coefficient of Variation 20	35.8073 Liters per hour Geometric Coefficient of Variation 22

SECONDARY outcome

Timeframe: Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period

Population: PK population

Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of ABC in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods.

Outcome measures

Measure	DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet n=17 Participants Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth.	DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets n=17 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately.	DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth n=18 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth.
Vz/F of ABC in Part 1	120.412 Liters Geometric Coefficient of Variation 46	126.171 Liters Geometric Coefficient of Variation 39	123.076 Liters Geometric Coefficient of Variation 42

SECONDARY outcome

Timeframe: Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 and 24 hours post-dose of each treatment period

Population: PK population

Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of ABC in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods. Statistics has been presented on geometric LS means.

Outcome measures

Measure	DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet n=17 Participants Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth.	DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets n=17 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately.	DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth n=18 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth.
C24 of ABC in Plasma in Part 1	4.862 Nanograms per millilter Geometric Coefficient of Variation 45	4.491 Nanograms per millilter Geometric Coefficient of Variation 56	4.274 Nanograms per millilter Geometric Coefficient of Variation 26

SECONDARY outcome

Timeframe: Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period

Population: PK population

Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of ABC in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods.

Outcome measures

Measure	DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet n=17 Participants Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth.	DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets n=17 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately.	DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth n=18 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth.
Ct of ABC in Plasma in Part 1	6.852 Nanograms per milliliter Geometric Coefficient of Variation 74	4.788 Nanograms per milliliter Geometric Coefficient of Variation 58	5.466 Nanograms per milliliter Geometric Coefficient of Variation 55

SECONDARY outcome

Timeframe: Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period

Population: PK population

Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of ABC in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods.

Outcome measures

Measure	DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet n=17 Participants Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth.	DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets n=17 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately.	DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth n=18 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth.
T½ of ABC in Plasma in Part 1	2.314 Hours Geometric Coefficient of Variation 30	2.525 Hours Geometric Coefficient of Variation 26	2.382 Hours Geometric Coefficient of Variation 29

SECONDARY outcome

Timeframe: Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 and 24 hours post-dose of each treatment period

Population: PK population

Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of 3TC in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods.

Outcome measures

Measure	DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet n=17 Participants Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth.	DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets n=17 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately.	DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth n=18 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth.
AUC(0-24) of 3TC in Plasma in Part 1	11.968 Hours*microgram per milliliter Geometric Coefficient of Variation 26	11.927 Hours*microgram per milliliter Geometric Coefficient of Variation 26	10.952 Hours*microgram per milliliter Geometric Coefficient of Variation 30

SECONDARY outcome

Timeframe: Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period

Population: PK population

Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of 3TC in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods.

Outcome measures

Measure	DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet n=17 Participants Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth.	DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets n=17 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately.	DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth n=18 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth.
Tmax of 3TC in Part 1	2.50 Hours Interval 1.5 to 5.05	2.50 Hours Interval 1.0 to 4.0	2.50 Hours Interval 1.5 to 4.08

SECONDARY outcome

Timeframe: Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period

Population: PK population

Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of 3TC in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods.

Outcome measures

Measure	DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet n=17 Participants Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth.	DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets n=17 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately.	DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth n=18 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth.
Tlast of 3TC in Plasma in Part 1	72.00 Hours Interval 48.0 to 72.0	72.00 Hours Interval 48.0 to 72.3	72.00 Hours Interval 48.0 to 72.02

SECONDARY outcome

Timeframe: Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period

Population: PK population

Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of 3TC in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods.

Outcome measures

Measure	DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet n=17 Participants Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth.	DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets n=17 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately.	DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth n=18 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth.
CL/F of 3TC in Plasma in Part 1	22.9237 Liters per hour Geometric Coefficient of Variation 26	22.9679 Liters per hour Geometric Coefficient of Variation 24	24.6802 Liters per hour Geometric Coefficient of Variation 30

SECONDARY outcome

Timeframe: Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period

Population: PK population

Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of 3TC in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods.

Outcome measures

Measure	DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet n=17 Participants Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth.	DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets n=17 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately.	DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth n=18 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth.
Vz/F of 3TC in Plasma in Part 1	594.270 Liters Geometric Coefficient of Variation 31	591.102 Liters Geometric Coefficient of Variation 37	642.945 Liters Geometric Coefficient of Variation 38

SECONDARY outcome

Timeframe: Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 and 24 hours post-dose of each treatment period

Population: PK population

Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of 3TC in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods. Statistics has been presented on geometric LS means.

Outcome measures

Measure	DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet n=17 Participants Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth.	DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets n=17 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately.	DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth n=18 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth.
C24 of 3TC in Plasma in Part 1	37.963 Nanograms per millilter Geometric Coefficient of Variation 29	40.913 Nanograms per millilter Geometric Coefficient of Variation 24	42.434 Nanograms per millilter Geometric Coefficient of Variation 27

SECONDARY outcome

Timeframe: Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period

Population: PK population

Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of 3TC in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods.

Outcome measures

Measure	DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet n=17 Participants Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth.	DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets n=17 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately.	DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth n=18 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth.
Ct of 3TC in Plasma in Part 1	6.552 Nanograms per milliliter Geometric Coefficient of Variation 62	6.798 Nanograms per milliliter Geometric Coefficient of Variation 53	7.251 Nanograms per milliliter Geometric Coefficient of Variation 64

SECONDARY outcome

Timeframe: Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period

Population: PK population

Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of 3TC in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods.

Outcome measures

Measure	DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet n=17 Participants Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth.	DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets n=17 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately.	DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth n=18 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth.
T½ of 3TC in Plasma in Part 1	17.969 Hours Geometric Coefficient of Variation 36	17.839 Hours Geometric Coefficient of Variation 35	18.057 Hours Geometric Coefficient of Variation 39

SECONDARY outcome

Timeframe: Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 and 24 hours post-dose of each treatment period

Population: PK population

Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of DTG in Part 2. Pharmacokinetic analysis was conducted using standard non-compartmental methods.

Outcome measures

Measure	DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet n=18 Participants Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth.	DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets n=18 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately.	DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth n=18 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth.
AUC (0-24) of DTG in Plasma in Part 2	35.742 Hours*microgram per milliliter Geometric Coefficient of Variation 39	61.220 Hours*microgram per milliliter Geometric Coefficient of Variation 26	46.205 Hours*microgram per milliliter Geometric Coefficient of Variation 29

SECONDARY outcome

Timeframe: Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period

Population: PK population

Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of DTG in Part 2. Pharmacokinetic analysis was conducted using standard non-compartmental methods.

Outcome measures

Measure	DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet n=18 Participants Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth.	DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets n=18 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately.	DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth n=18 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth.
Tmax of DTG in Plasma in Part 2	2.77 Hours Interval 0.5 to 5.0	0.77 Hours Interval 0.5 to 4.0	1.79 Hours Interval 0.5 to 5.0

SECONDARY outcome

Timeframe: Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period

Population: PK population

Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of DTG in Part 2. Pharmacokinetic analysis was conducted using standard non-compartmental methods.

Outcome measures

Measure	DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet n=18 Participants Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth.	DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets n=18 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately.	DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth n=18 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth.
Tlast of DTG in Plasma in Part 2	72.00 Hours Interval 48.0 to 72.0	72.00 Hours Interval 72.0 to 72.05	72.00 Hours Interval 48.0 to 72.05

SECONDARY outcome

Timeframe: Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period

Population: PK population

Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of DTG in Part 2. Pharmacokinetic analysis was conducted using standard non-compartmental methods.

Outcome measures

Measure	DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet n=18 Participants Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth.	DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets n=18 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately.	DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth n=18 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth.
CL/F of DTG in Plasma in Part 2	0.9269 Liters per hour Geometric Coefficient of Variation 38	0.5639 Liters per hour Geometric Coefficient of Variation 31	0.7300 Liters per hour Geometric Coefficient of Variation 32

SECONDARY outcome

Timeframe: Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period

Population: PK population

Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of DTG in Part 2. Pharmacokinetic analysis was conducted using standard non-compartmental methods.

Outcome measures

Measure	DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet n=18 Participants Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth.	DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets n=18 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately.	DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth n=18 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth.
Vz/F of DTG in Plasma in Part 2	20.378 Liters Geometric Coefficient of Variation 42	11.950 Liters Geometric Coefficient of Variation 28	15.524 Liters Geometric Coefficient of Variation 30

SECONDARY outcome

Timeframe: Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 and 24 hours post-dose of each treatment period

Population: PK population

Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of DTG in Part 2. Pharmacokinetic analysis was conducted using standard non-compartmental methods. Statistics has been presented on geometric LS means.

Outcome measures

Measure	DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet n=18 Participants Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth.	DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets n=18 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately.	DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth n=18 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth.
C24 of DTG in Plasma in Part 2	825.313 Nanograms per millilter Geometric Coefficient of Variation 39	1289.044 Nanograms per millilter Geometric Coefficient of Variation 37	1034.078 Nanograms per millilter Geometric Coefficient of Variation 33

SECONDARY outcome

Timeframe: Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period

Population: PK population

Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of DTG in Part 2. Pharmacokinetic analysis was conducted using standard non-compartmental methods.

Outcome measures

Measure	DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet n=18 Participants Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth.	DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets n=18 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately.	DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth n=18 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth.
Ct of DTG in Plasma in Part 2	95.829 Nanograms per milliliter Geometric Coefficient of Variation 47	131.216 Nanograms per milliliter Geometric Coefficient of Variation 70	107.749 Nanograms per milliliter Geometric Coefficient of Variation 64

SECONDARY outcome

Timeframe: Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period

Population: PK population

Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of DTG in Part 2. Pharmacokinetic analysis was conducted using standard non-compartmental methods.

Outcome measures

Measure	DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet n=18 Participants Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth.	DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets n=18 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately.	DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth n=18 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth.
T½ of DTG in Plasma in Part 2	15.238 Hours Geometric Coefficient of Variation 21	14.690 Hours Geometric Coefficient of Variation 18	14.741 Hours Geometric Coefficient of Variation 23

SECONDARY outcome

Timeframe: Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period

Population: PK population

Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of DTG in Part 2. Pharmacokinetic analysis was conducted using standard non-compartmental methods.

Outcome measures

Measure	DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet n=18 Participants Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth.	DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets n=18 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately.	DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth n=18 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth.
Tlag of DTG in Plasma in Part 2	0.00 Hours Interval 0.0 to 0.25	0.00 Hours Interval 0.0 to 0.0	0.00 Hours Interval 0.0 to 0.0

SECONDARY outcome

Timeframe: Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 and 24 hours post-dose of each treatment period

Population: PK population

Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of 3TC in Part 2. Pharmacokinetic analysis was conducted using standard non-compartmental methods.

Outcome measures

Measure	DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet n=18 Participants Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth.	DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets n=18 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately.	DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth n=18 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth.
AUC (0-24) of 3TC in Plasma in Part 2	11.070 Hours*microgram per milliliter Geometric Coefficient of Variation 18	10.802 Hours*microgram per milliliter Geometric Coefficient of Variation 21	10.673 Hours*microgram per milliliter Geometric Coefficient of Variation 20

SECONDARY outcome

Timeframe: Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period

Population: PK population

Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of 3TC in Part 2. Pharmacokinetic analysis was conducted using standard non-compartmental methods.

Outcome measures

Measure	DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet n=18 Participants Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth.	DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets n=18 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately.	DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth n=18 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth.
Tmax of 3TC in Plasma in Part 2	1.00 Hours Interval 0.5 to 3.03	1.50 Hours Interval 0.53 to 4.0	1.50 Hours Interval 1.0 to 4.0

SECONDARY outcome

Timeframe: Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period

Population: PK population

Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of 3TC in Part 2. Pharmacokinetic analysis was conducted using standard non-compartmental methods.

Outcome measures

Measure	DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet n=18 Participants Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth.	DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets n=18 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately.	DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth n=18 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth.
Tlast of 3TC in Plasma in Part 2	72.00 Hours Interval 72.0 to 72.0	72.00 Hours Interval 72.0 to 72.05	72.00 Hours Interval 72.0 to 72.05

SECONDARY outcome

Timeframe: Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period

Population: PK population. Only those participants with data available at the specified time points were analyzed.

Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of 3TC in Part 2. Pharmacokinetic analysis was conducted using standard non-compartmental methods.

Outcome measures

Measure	DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet n=17 Participants Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth.	DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets n=18 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately.	DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth n=18 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth.
CL/F of 3TC in Plasma in Part 2	24.4998 Liters per hour Geometric Coefficient of Variation 17	24.6933 Liters per hour Geometric Coefficient of Variation 21	25.1888 Liters per hour Geometric Coefficient of Variation 20

SECONDARY outcome

Timeframe: Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period

Population: PK population

Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of 3TC in Part 2. Pharmacokinetic analysis was conducted using standard non-compartmental methods.

Outcome measures

Measure	DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet n=17 Participants Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth.	DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets n=18 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately.	DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth n=18 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth.
Vz/F of 3TC in Plasma in Part 2	730.859 Liters Geometric Coefficient of Variation 17	758.790 Liters Geometric Coefficient of Variation 28	711.280 Liters Geometric Coefficient of Variation 22

SECONDARY outcome

Timeframe: Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 and 24 hours post-dose of each treatment period

Population: PK population

Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of 3TC in Part 2. Pharmacokinetic analysis was conducted using standard non-compartmental methods. Statistics has been presented on geometric LS means.

Outcome measures

Measure	DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet n=18 Participants Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth.	DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets n=18 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately.	DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth n=18 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth.
C24 of 3TC in Plasma in Part 2	35.808 Nanograms per millilter Geometric Coefficient of Variation 21	38.475 Nanograms per millilter Geometric Coefficient of Variation 18	38.336 Nanograms per millilter Geometric Coefficient of Variation 24

SECONDARY outcome

Timeframe: Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period

Population: PK population

Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of 3TC in Part 2. Pharmacokinetic analysis was conducted using standard non-compartmental methods.

Outcome measures

Measure	DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet n=18 Participants Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth.	DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets n=18 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately.	DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth n=18 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth.
Ct of 3TC in Plasma in Part 2	7.735 Nanograms per milliliter Geometric Coefficient of Variation 62	8.417 Nanograms per milliliter Geometric Coefficient of Variation 67	7.480 Nanograms per milliliter Geometric Coefficient of Variation 64

SECONDARY outcome

Timeframe: Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period

Population: PK population

Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of 3TC in Part 2. Pharmacokinetic analysis was conducted using standard non-compartmental methods.

Outcome measures

Measure	DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet n=17 Participants Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth.	DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets n=18 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately.	DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth n=18 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth.
T½ of 3TC in Plasma in Part 2	20.677 Hours Geometric Coefficient of Variation 22	21.299 Hours Geometric Coefficient of Variation 32	19.573 Hours Geometric Coefficient of Variation 24

SECONDARY outcome

Timeframe: Up to Day 33

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 untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect, associated with liver injury and impaired liver function or any other situations as per medical or scientific judgement. Safety population comprised of all participants enrolled in the study, who took at least one dose of study treatment.

Outcome measures

Measure	DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet n=17 Participants Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth.	DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets n=17 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately.	DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth n=18 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth.
Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) in Part 1 Any AE	1 Participants	1 Participants	2 Participants
Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) in Part 1 Any SAE	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to Day 33

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 untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect, associated with liver injury and impaired liver function or any other situations as per medical or scientific judgement.

Outcome measures

Measure	DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet n=18 Participants Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth.	DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets n=18 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately.	DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth n=18 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth.
Number of Participants With AEs and Serious Adverse Events SAEs in Part 2 Any AE	1 Participants	0 Participants	1 Participants
Number of Participants With AEs and Serious Adverse Events SAEs in Part 2 Any SAE	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Day 2 of each treatment period

Population: All Participants Population.

Blood samples were collected for the analysis of clinical chemistry parameters which included glucose, calcium, potassium, sodium and urea. All participants population included all participants who received at least one dose of study medication. This population corresponded to all participants enrolled.

Outcome measures

Measure	DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet n=17 Participants Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth.	DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets n=17 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately.	DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth n=18 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth.
Absolute Values for Clinical Chemistry Parameters Measured in Part 1: Glucose, Calcium, Potassium, Sodium and Urea Urea	4.096 Millimoles per liter Standard Deviation 0.9369	4.293 Millimoles per liter Standard Deviation 1.1218	4.203 Millimoles per liter Standard Deviation 1.0572
Absolute Values for Clinical Chemistry Parameters Measured in Part 1: Glucose, Calcium, Potassium, Sodium and Urea Glucose	5.031 Millimoles per liter Standard Deviation 0.3501	4.931 Millimoles per liter Standard Deviation 0.3448	4.933 Millimoles per liter Standard Deviation 0.3709
Absolute Values for Clinical Chemistry Parameters Measured in Part 1: Glucose, Calcium, Potassium, Sodium and Urea Calcium	2.377 Millimoles per liter Standard Deviation 0.0577	2.371 Millimoles per liter Standard Deviation 0.0775	2.384 Millimoles per liter Standard Deviation 0.0704
Absolute Values for Clinical Chemistry Parameters Measured in Part 1: Glucose, Calcium, Potassium, Sodium and Urea Potassium	4.31 Millimoles per liter Standard Deviation 0.269	4.26 Millimoles per liter Standard Deviation 0.243	4.28 Millimoles per liter Standard Deviation 0.271
Absolute Values for Clinical Chemistry Parameters Measured in Part 1: Glucose, Calcium, Potassium, Sodium and Urea Sodium	138.1 Millimoles per liter Standard Deviation 2.19	138.2 Millimoles per liter Standard Deviation 1.48	138.1 Millimoles per liter Standard Deviation 1.55

SECONDARY outcome

Timeframe: Day 2 of each treatment period

Population: All Participants Population.

Blood samples were collected for the analysis of clinical chemistry parameters including ALT, ALP, AST and CPK.

Outcome measures

Measure	DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet n=17 Participants Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth.	DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets n=17 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately.	DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth n=18 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth.
Absolute Values for Clinical Chemistry Parameters Measured in Part 1: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotranferase (AST) and Creatinine Phosphokinase (CPK) ALT	15.3 International units per Liter Standard Deviation 7.20	14.8 International units per Liter Standard Deviation 5.47	15.3 International units per Liter Standard Deviation 5.80
Absolute Values for Clinical Chemistry Parameters Measured in Part 1: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotranferase (AST) and Creatinine Phosphokinase (CPK) ALP	54.4 International units per Liter Standard Deviation 16.22	55.1 International units per Liter Standard Deviation 16.89	54.4 International units per Liter Standard Deviation 16.99
Absolute Values for Clinical Chemistry Parameters Measured in Part 1: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotranferase (AST) and Creatinine Phosphokinase (CPK) AST	16.1 International units per Liter Standard Deviation 3.35	16.1 International units per Liter Standard Deviation 3.51	15.9 International units per Liter Standard Deviation 3.29
Absolute Values for Clinical Chemistry Parameters Measured in Part 1: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotranferase (AST) and Creatinine Phosphokinase (CPK) CPK	90.7 International units per Liter Standard Deviation 57.16	81.9 International units per Liter Standard Deviation 39.34	95.8 International units per Liter Standard Deviation 52.83

SECONDARY outcome

Timeframe: Day 2 of each treatment period

Population: All Participants Population.

Blood samples were collected for the analysis of clinical chemistry parameters including albumin and protein.

Outcome measures

Measure	DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet n=17 Participants Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth.	DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets n=17 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately.	DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth n=18 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth.
Absolute Values for Clinical Chemistry Parameters Measured in Part 1: Albumin and Protein Albumin	43.2 Grams per liter Standard Deviation 2.82	42.9 Grams per liter Standard Deviation 2.76	43.8 Grams per liter Standard Deviation 2.58
Absolute Values for Clinical Chemistry Parameters Measured in Part 1: Albumin and Protein Protein	70.7 Grams per liter Standard Deviation 4.55	70.8 Grams per liter Standard Deviation 4.59	71.9 Grams per liter Standard Deviation 3.73

SECONDARY outcome

Timeframe: Day 2 of each treatment period

Population: All Participants Population.

Blood samples were collected for the analysis of clinical chemistry parameters including bilirubin, creatinine and direct bilirubin.

Outcome measures

Measure	DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet n=17 Participants Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth.	DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets n=17 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately.	DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth n=18 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth.
Absolute Values for Clinical Chemistry Parameters Measured in Part 1: Bilirubin, Creatinine and Direct Bilirubin Bilirubin	9.58 Micromoles per liter Standard Deviation 3.350	9.88 Micromoles per liter Standard Deviation 3.612	9.99 Micromoles per liter Standard Deviation 4.066
Absolute Values for Clinical Chemistry Parameters Measured in Part 1: Bilirubin, Creatinine and Direct Bilirubin Creatinine	81.47 Micromoles per liter Standard Deviation 14.774	82.73 Micromoles per liter Standard Deviation 13.279	83.36 Micromoles per liter Standard Deviation 13.647
Absolute Values for Clinical Chemistry Parameters Measured in Part 1: Bilirubin, Creatinine and Direct Bilirubin Direct bilirubin	1.76 Micromoles per liter Standard Deviation 0.469	1.88 Micromoles per liter Standard Deviation 0.549	1.94 Micromoles per liter Standard Deviation 0.609

SECONDARY outcome

Timeframe: Day 2 of each treatment period

Population: All Participants Population.

Blood samples were collected for the analysis of clinical chemistry parameters including glucose, calcium, potassium, sodium and urea.

Outcome measures

Measure	DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet n=18 Participants Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth.	DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets n=18 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately.	DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth n=18 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth.
Absolute Values for Clinical Chemistry Parameters Measured in Part 2: Glucose, Calcium, Potassium, Sodium and Urea Glucose	4.938 Millimoles per liter Standard Deviation 0.2810	4.941 Millimoles per liter Standard Deviation 0.3829	4.959 Millimoles per liter Standard Deviation 0.3494
Absolute Values for Clinical Chemistry Parameters Measured in Part 2: Glucose, Calcium, Potassium, Sodium and Urea Calcium	2.378 Millimoles per liter Standard Deviation 0.0833	2.367 Millimoles per liter Standard Deviation 0.1066	2.366 Millimoles per liter Standard Deviation 0.1098
Absolute Values for Clinical Chemistry Parameters Measured in Part 2: Glucose, Calcium, Potassium, Sodium and Urea Potassium	4.20 Millimoles per liter Standard Deviation 0.252	4.10 Millimoles per liter Standard Deviation 0.188	4.09 Millimoles per liter Standard Deviation 0.240
Absolute Values for Clinical Chemistry Parameters Measured in Part 2: Glucose, Calcium, Potassium, Sodium and Urea Sodium	138.2 Millimoles per liter Standard Deviation 1.50	138.3 Millimoles per liter Standard Deviation 1.81	138.3 Millimoles per liter Standard Deviation 1.56
Absolute Values for Clinical Chemistry Parameters Measured in Part 2: Glucose, Calcium, Potassium, Sodium and Urea Urea	4.603 Millimoles per liter Standard Deviation 0.7878	4.343 Millimoles per liter Standard Deviation 0.8311	4.398 Millimoles per liter Standard Deviation 0.8430

SECONDARY outcome

Timeframe: Day 2 of each treatment period

Population: All Participants Population.

Blood samples were collected for the analysis of clinical chemistry parameters including ALT, ALP, AST and CPK.

Outcome measures

Measure	DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet n=18 Participants Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth.	DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets n=18 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately.	DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth n=18 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth.
Absolute Values for Clinical Chemistry Parameters Measured in Part 2: ALT, ALP, AST and CPK CPK	90.9 International units per liter Standard Deviation 36.86	86.4 International units per liter Standard Deviation 33.82	81.7 International units per liter Standard Deviation 25.51
Absolute Values for Clinical Chemistry Parameters Measured in Part 2: ALT, ALP, AST and CPK ALT	16.1 International units per liter Standard Deviation 11.34	15.6 International units per liter Standard Deviation 8.25	14.9 International units per liter Standard Deviation 7.44
Absolute Values for Clinical Chemistry Parameters Measured in Part 2: ALT, ALP, AST and CPK ALP	60.0 International units per liter Standard Deviation 18.87	58.8 International units per liter Standard Deviation 17.53	58.9 International units per liter Standard Deviation 17.72
Absolute Values for Clinical Chemistry Parameters Measured in Part 2: ALT, ALP, AST and CPK AST	16.5 International units per liter Standard Deviation 5.93	15.6 International units per liter Standard Deviation 3.97	15.7 International units per liter Standard Deviation 4.96

SECONDARY outcome

Timeframe: Day 2 of each treatment period

Population: All Participants Population.

Blood samples were collected for the analysis of clinical chemistry parameters including albumin and protein.

Outcome measures

Measure	DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet n=18 Participants Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth.	DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets n=18 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately.	DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth n=18 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth.
Absolute Values for Clinical Chemistry Parameters Measured in Part 2: Albumin and Protein Albumin	43.9 Grams per liter Standard Deviation 3.02	43.1 Grams per liter Standard Deviation 4.09	43.1 Grams per liter Standard Deviation 3.50
Absolute Values for Clinical Chemistry Parameters Measured in Part 2: Albumin and Protein Protein	72.1 Grams per liter Standard Deviation 3.79	70.9 Grams per liter Standard Deviation 4.11	71.2 Grams per liter Standard Deviation 5.26

SECONDARY outcome

Timeframe: Day 2 of each treatment period

Population: All Participants Population.

Blood samples were collected for the analysis of clinical chemistry parameters including bilirubin, creatinine and direct bilirubin.

Outcome measures

Measure	DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet n=18 Participants Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth.	DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets n=18 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately.	DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth n=18 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth.
Absolute Values for Clinical Chemistry Parameters Measured in Part 2: Bilirubin, Creatinine and Direct Bilirubin Bilirubin	10.71 Micromoles per liter Standard Deviation 2.872	10.60 Micromoles per liter Standard Deviation 3.275	10.58 Micromoles per liter Standard Deviation 2.869
Absolute Values for Clinical Chemistry Parameters Measured in Part 2: Bilirubin, Creatinine and Direct Bilirubin Creatinine	87.66 Micromoles per liter Standard Deviation 16.430	87.97 Micromoles per liter Standard Deviation 14.906	87.11 Micromoles per liter Standard Deviation 16.453
Absolute Values for Clinical Chemistry Parameters Measured in Part 2: Bilirubin, Creatinine and Direct Bilirubin Direct bilirubin	2.14 Micromoles per liter Standard Deviation 0.451	2.11 Micromoles per liter Standard Deviation 0.514	2.12 Micromoles per liter Standard Deviation 0.528

SECONDARY outcome

Timeframe: Baseline (Day -1) and Day 2

Population: All Participants Population.

Blood samples were collected for the analysis of clinical chemistry parameters including glucose, calcium, potassium, sodium and urea. Day -1 was defined as Baseline for clinical chemistry parameters. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.

Outcome measures

Measure	DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet n=17 Participants Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth.	DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets n=17 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately.	DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth n=18 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth.
Change From Baseline in Clinical Chemistry Parameters Measured in Part 1: Glucose, Calcium, Potassium, Sodium and Urea Glucose	0.045 Millimoles per liter Standard Deviation 0.4204	-0.068 Millimoles per liter Standard Deviation 0.3312	-0.115 Millimoles per liter Standard Deviation 0.3774
Change From Baseline in Clinical Chemistry Parameters Measured in Part 1: Glucose, Calcium, Potassium, Sodium and Urea Calcium	0.023 Millimoles per liter Standard Deviation 0.0701	0.026 Millimoles per liter Standard Deviation 0.0696	0.026 Millimoles per liter Standard Deviation 0.0535
Change From Baseline in Clinical Chemistry Parameters Measured in Part 1: Glucose, Calcium, Potassium, Sodium and Urea Potassium	0.18 Millimoles per liter Standard Deviation 0.256	0.17 Millimoles per liter Standard Deviation 0.306	0.12 Millimoles per liter Standard Deviation 0.411
Change From Baseline in Clinical Chemistry Parameters Measured in Part 1: Glucose, Calcium, Potassium, Sodium and Urea Sodium	-1.0 Millimoles per liter Standard Deviation 1.73	-1.0 Millimoles per liter Standard Deviation 1.46	-0.6 Millimoles per liter Standard Deviation 1.34
Change From Baseline in Clinical Chemistry Parameters Measured in Part 1: Glucose, Calcium, Potassium, Sodium and Urea Urea	0.361 Millimoles per liter Standard Deviation 0.8156	0.386 Millimoles per liter Standard Deviation 0.8436	0.027 Millimoles per liter Standard Deviation 1.1490

SECONDARY outcome

Timeframe: Baseline (Day -1) and Day 2

Population: All Participants Population.

Blood samples were collected for the analysis of clinical chemistry parameters including ALT, ALP, AST and CPK. Day -1 was defined as Baseline for clinical chemistry parameters. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.

Outcome measures

Measure	DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet n=17 Participants Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth.	DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets n=17 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately.	DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth n=18 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth.
Change From Baseline in Clinical Chemistry Parameters Measured in Part 1: ALT, ALP, AST and CPK ALT	-0.3 International units per Liter Standard Deviation 1.69	-0.1 International units per Liter Standard Deviation 2.05	-0.9 International units per Liter Standard Deviation 1.51
Change From Baseline in Clinical Chemistry Parameters Measured in Part 1: ALT, ALP, AST and CPK ALP	-2.6 International units per Liter Standard Deviation 6.71	-0.5 International units per Liter Standard Deviation 2.81	-0.2 International units per Liter Standard Deviation 3.84
Change From Baseline in Clinical Chemistry Parameters Measured in Part 1: ALT, ALP, AST and CPK AST	-1.4 International units per Liter Standard Deviation 1.62	-0.6 International units per Liter Standard Deviation 1.58	-1.6 International units per Liter Standard Deviation 2.93
Change From Baseline in Clinical Chemistry Parameters Measured in Part 1: ALT, ALP, AST and CPK CPK	-38.2 International units per Liter Standard Deviation 65.11	-25.1 International units per Liter Standard Deviation 31.53	-48.8 International units per Liter Standard Deviation 83.77

SECONDARY outcome

Timeframe: Baseline (Day -1) and Day 2

Population: All Participants Population.

Blood samples were collected for the analysis of clinical chemistry parameters including albumin and protein. Day -1 was defined as Baseline for clinical chemistry parameters. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.

Outcome measures

Measure	DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet n=17 Participants Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth.	DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets n=17 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately.	DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth n=18 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth.
Change From Baseline in Clinical Chemistry Parameters Measured in Part 1: Albumin and Protein Protein	1.9 Grams per liter Standard Deviation 3.31	1.6 Grams per liter Standard Deviation 3.12	2.1 Grams per liter Standard Deviation 2.96
Change From Baseline in Clinical Chemistry Parameters Measured in Part 1: Albumin and Protein Albumin	0.4 Grams per liter Standard Deviation 2.06	-0.3 Grams per liter Standard Deviation 1.61	0.4 Grams per liter Standard Deviation 1.94

SECONDARY outcome

Timeframe: Baseline (Day -1) and Day 2

Population: All Participants Population.

Blood samples were collected for the analysis of clinical chemistry parameters including bilirubin, creatinine and direct bilirubin. Day -1 was defined as Baseline for clinical chemistry parameters. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.

Outcome measures

Measure	DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet n=17 Participants Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth.	DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets n=17 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately.	DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth n=18 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth.
Change From Baseline in Clinical Chemistry Parameters Measured in Part 1: Bilirubin, Creatinine and Direct Bilirubin Bilirubin	1.95 Micromoles per liter Standard Deviation 2.482	2.20 Micromoles per liter Standard Deviation 2.313	1.63 Micromoles per liter Standard Deviation 2.479
Change From Baseline in Clinical Chemistry Parameters Measured in Part 1: Bilirubin, Creatinine and Direct Bilirubin Creatinine	13.61 Micromoles per liter Standard Deviation 5.090	13.06 Micromoles per liter Standard Deviation 4.805	13.62 Micromoles per liter Standard Deviation 3.782
Change From Baseline in Clinical Chemistry Parameters Measured in Part 1: Bilirubin, Creatinine and Direct Bilirubin Direct bilirubin	0.20 Micromoles per liter Standard Deviation 0.409	0.30 Micromoles per liter Standard Deviation 0.361	0.26 Micromoles per liter Standard Deviation 0.455

SECONDARY outcome

Timeframe: Baseline (Day -1) and Day 2

Population: All Participants Population.

Blood samples were collected for the analysis of clinical chemistry parameters including glucose, calcium, potassium, sodium and urea. Day -1 was defined as Baseline for clinical chemistry parameters. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.

Outcome measures

Measure	DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet n=18 Participants Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth.	DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets n=18 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately.	DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth n=18 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth.
Change From Baseline in Clinical Chemistry Parameters Measured in Part 2: Glucose, Calcium, Potassium, Sodium and Urea Potassium	0.06 Millimoles per liter Standard Deviation 0.268	-0.02 Millimoles per liter Standard Deviation 0.411	-0.11 Millimoles per liter Standard Deviation 0.347
Change From Baseline in Clinical Chemistry Parameters Measured in Part 2: Glucose, Calcium, Potassium, Sodium and Urea Sodium	-0.7 Millimoles per liter Standard Deviation 1.93	-1.3 Millimoles per liter Standard Deviation 1.78	-0.6 Millimoles per liter Standard Deviation 2.38
Change From Baseline in Clinical Chemistry Parameters Measured in Part 2: Glucose, Calcium, Potassium, Sodium and Urea Glucose	-0.128 Millimoles per liter Standard Deviation 0.3363	-0.107 Millimoles per liter Standard Deviation 0.3500	-0.175 Millimoles per liter Standard Deviation 0.4178
Change From Baseline in Clinical Chemistry Parameters Measured in Part 2: Glucose, Calcium, Potassium, Sodium and Urea Calcium	0.016 Millimoles per liter Standard Deviation 0.0708	0.019 Millimoles per liter Standard Deviation 0.0687	-0.004 Millimoles per liter Standard Deviation 0.0846
Change From Baseline in Clinical Chemistry Parameters Measured in Part 2: Glucose, Calcium, Potassium, Sodium and Urea Urea	0.176 Millimoles per liter Standard Deviation 1.0267	0.084 Millimoles per liter Standard Deviation 1.1918	0.414 Millimoles per liter Standard Deviation 0.8744

SECONDARY outcome

Timeframe: Baseline (Day -1) and Day 2

Population: All Participants Population.

Blood samples were collected for the analysis of clinical chemistry parameters including ALT, ALP, AST and CPK. Day -1 was defined as Baseline for clinical chemistry parameters. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.

Outcome measures

Measure	DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet n=18 Participants Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth.	DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets n=18 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately.	DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth n=18 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth.
Change From Baseline in Clinical Chemistry Parameters Measured in Part 2: ALT, ALP, AST and CPK ALP	-1.7 International units per liter Standard Deviation 5.24	-3.4 International units per liter Standard Deviation 6.06	-0.7 International units per liter Standard Deviation 4.13
Change From Baseline in Clinical Chemistry Parameters Measured in Part 2: ALT, ALP, AST and CPK ALT	-1.2 International units per liter Standard Deviation 3.26	-2.0 International units per liter Standard Deviation 3.40	-0.9 International units per liter Standard Deviation 2.85
Change From Baseline in Clinical Chemistry Parameters Measured in Part 2: ALT, ALP, AST and CPK AST	-2.1 International units per liter Standard Deviation 3.49	-2.9 International units per liter Standard Deviation 3.61	-2.2 International units per liter Standard Deviation 3.73
Change From Baseline in Clinical Chemistry Parameters Measured in Part 2: ALT, ALP, AST and CPK CPK	-34.2 International units per liter Standard Deviation 38.44	-40.3 International units per liter Standard Deviation 41.91	-33.2 International units per liter Standard Deviation 30.98

SECONDARY outcome

Timeframe: Baseline (Day -1) and Day 2

Population: All Participants Population.

Blood samples were collected for the analysis of clinical chemistry parameters including albumin and protein. Day -1 was defined as Baseline for clinical chemistry parameters. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.

Outcome measures

Measure	DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet n=18 Participants Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth.	DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets n=18 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately.	DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth n=18 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth.
Change From Baseline in Clinical Chemistry Parameters Measured in Part 2: Albumin and Protein Albumin	-0.1 Grams per liter Standard Deviation 2.15	-0.1 Grams per liter Standard Deviation 2.54	-0.6 Grams per liter Standard Deviation 2.45
Change From Baseline in Clinical Chemistry Parameters Measured in Part 2: Albumin and Protein Protein	1.1 Grams per liter Standard Deviation 4.32	1.1 Grams per liter Standard Deviation 4.30	0.6 Grams per liter Standard Deviation 4.20

SECONDARY outcome

Timeframe: Baseline (Day -1) and Day 2

Population: All Participants Population.

Blood samples were collected for the analysis of clinical chemistry parameters including bilirubin, creatinine and direct bilirubin. Day -1 was defined as Baseline for clinical chemistry parameters. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.

Outcome measures

Measure	DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet n=18 Participants Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth.	DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets n=18 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately.	DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth n=18 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth.
Change From Baseline in Clinical Chemistry Parameters Measured in Part 2: Bilirubin, Creatinine and Direct Bilirubin Bilirubin	1.84 Micromoles per liter Standard Deviation 1.974	1.56 Micromoles per liter Standard Deviation 2.848	1.91 Micromoles per liter Standard Deviation 2.563
Change From Baseline in Clinical Chemistry Parameters Measured in Part 2: Bilirubin, Creatinine and Direct Bilirubin Creatinine	10.08 Micromoles per liter Standard Deviation 7.023	10.32 Micromoles per liter Standard Deviation 6.185	10.83 Micromoles per liter Standard Deviation 6.796
Change From Baseline in Clinical Chemistry Parameters Measured in Part 2: Bilirubin, Creatinine and Direct Bilirubin Direct bilirubin	0.22 Micromoles per liter Standard Deviation 0.352	0.20 Micromoles per liter Standard Deviation 0.470	0.26 Micromoles per liter Standard Deviation 0.434

SECONDARY outcome

Timeframe: Day 2 of each treatment period

Population: All Participants Population.

Blood samples were collected for the analysis of hematology parameters including basophils, eosinophils, lymphocytes, monocytes, neutrophils, leukocytes and platelets in Part 1 at indicated time points.

Outcome measures

Measure	DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet n=17 Participants Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth.	DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets n=17 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately.	DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth n=18 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth.
Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelets in Part 1 Lymphocytes	1.709 10^9 cells per liter Standard Deviation 0.4699	1.639 10^9 cells per liter Standard Deviation 0.4326	1.672 10^9 cells per liter Standard Deviation 0.5362
Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelets in Part 1 Monocytes	0.448 10^9 cells per liter Standard Deviation 0.1305	0.436 10^9 cells per liter Standard Deviation 0.1550	0.432 10^9 cells per liter Standard Deviation 0.1002
Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelets in Part 1 Leukocytes	5.86 10^9 cells per liter Standard Deviation 1.452	5.66 10^9 cells per liter Standard Deviation 1.670	5.93 10^9 cells per liter Standard Deviation 1.410
Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelets in Part 1 Basophils	0.042 10^9 cells per liter Standard Deviation 0.0160	0.042 10^9 cells per liter Standard Deviation 0.0129	0.037 10^9 cells per liter Standard Deviation 0.0141
Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelets in Part 1 Eosinophils	0.152 10^9 cells per liter Standard Deviation 0.1202	0.145 10^9 cells per liter Standard Deviation 0.0996	0.144 10^9 cells per liter Standard Deviation 0.1151
Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelets in Part 1 Neutrophils	3.505 10^9 cells per liter Standard Deviation 1.2385	3.395 10^9 cells per liter Standard Deviation 1.5325	3.647 10^9 cells per liter Standard Deviation 1.2145
Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelets in Part 1 Platelets	248.8 10^9 cells per liter Standard Deviation 64.36	247.1 10^9 cells per liter Standard Deviation 59.94	258.5 10^9 cells per liter Standard Deviation 67.34

SECONDARY outcome

Timeframe: Day 2 of each treatment period

Population: All Participants Population.

Blood samples were collected for the analysis erythrocyte mean corpuscular hemoglobin in Part 1 at indicated time points.

Outcome measures

Measure	DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet n=17 Participants Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth.	DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets n=17 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately.	DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth n=18 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth.
Absolute Values for Erythrocyte Mean Corpuscular Hemoglobin in Part 1	28.11 Picograms Standard Deviation 2.625	27.98 Picograms Standard Deviation 2.580	28.21 Picograms Standard Deviation 2.585

SECONDARY outcome

Timeframe: Day 2 of each treatment period

Population: All Participants Population.

Blood samples were collected for the analysis erythrocyte mean corpuscular hemoglobin in Part 1 at indicated time points.

Outcome measures

Measure	DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet n=17 Participants Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth.	DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets n=17 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately.	DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth n=18 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth.
Absolute Values for Erythrocyte Mean Corpuscular Hemoglobin in Part 1	83.92 Femtoliter Standard Deviation 5.899	83.84 Femtoliter Standard Deviation 5.810	83.97 Femtoliter Standard Deviation 5.683

SECONDARY outcome

Timeframe: Day 2 of each treatment period

Population: All Participants Population.

Blood samples were collected for the analysis erythrocytes in Part 1 at indicated time points.

Outcome measures

Measure	DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet n=17 Participants Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth.	DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets n=17 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately.	DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth n=18 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth.
Absolute Values for Erythrocytes in Part 1	4.905 10^12 cells per liter Standard Deviation 0.4495	4.884 10^12 cells per liter Standard Deviation 0.4751	4.914 10^12 cells per liter Standard Deviation 0.4296

SECONDARY outcome

Timeframe: Day 2 of each treatment period

Population: All Participants Population.

Blood samples were collected for the analysis hemocrit in Part 1 at indicated time points.

Outcome measures

Measure	DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet n=17 Participants Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth.	DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets n=17 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately.	DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth n=18 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth.
Absolute Values for Hemocrit in Part 1	0.4101 Percentage of red blood cells in blood Standard Deviation 0.03195	0.4076 Percentage of red blood cells in blood Standard Deviation 0.02824	0.4114 Percentage of red blood cells in blood Standard Deviation 0.03269

SECONDARY outcome

Timeframe: Day 2 of each treatment period

Population: All Participants Population.

Blood samples were collected for the analysis hemoglobin in Part 1 at indicated time points.

Outcome measures

Measure	DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet n=17 Participants Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth.	DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets n=17 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately.	DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth n=18 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth.
Absolute Values for Hemoglobin in Part 1	137.2 Grams per liter Standard Deviation 12.51	135.9 Grams per liter Standard Deviation 11.13	138.1 Grams per liter Standard Deviation 13.20

SECONDARY outcome

Timeframe: Day 2 of each treatment period

Population: All Participants Population.

Blood samples were collected for the analysis of hematology parameters including basophils, eosinophils, lymphocytes, monocytes, neutrophils, leukocytes and platelets in Part 2 at indicated time points.

Outcome measures

Measure	DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet n=18 Participants Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth.	DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets n=18 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately.	DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth n=18 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth.
Absolute Values for Hematology Parameters Including Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelets in Part 2 Basophils	0.042 10^9 cells per liter Standard Deviation 0.0186	0.044 10^9 cells per liter Standard Deviation 0.0253	0.039 10^9 cells per liter Standard Deviation 0.0171
Absolute Values for Hematology Parameters Including Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelets in Part 2 Eosinophils	0.099 10^9 cells per liter Standard Deviation 0.0532	0.099 10^9 cells per liter Standard Deviation 0.0543	0.100 10^9 cells per liter Standard Deviation 0.0508
Absolute Values for Hematology Parameters Including Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelets in Part 2 Lymphocytes	1.555 10^9 cells per liter Standard Deviation 0.4401	1.584 10^9 cells per liter Standard Deviation 0.5536	1.553 10^9 cells per liter Standard Deviation 0.4647
Absolute Values for Hematology Parameters Including Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelets in Part 2 Monocytes	0.373 10^9 cells per liter Standard Deviation 0.1229	0.378 10^9 cells per liter Standard Deviation 0.1367	0.369 10^9 cells per liter Standard Deviation 0.1264
Absolute Values for Hematology Parameters Including Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelets in Part 2 Neutrophils	2.940 10^9 cells per liter Standard Deviation 1.2394	2.885 10^9 cells per liter Standard Deviation 0.8698	2.931 10^9 cells per liter Standard Deviation 0.9070
Absolute Values for Hematology Parameters Including Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelets in Part 2 Leukocytes	5.01 10^9 cells per liter Standard Deviation 1.513	4.98 10^9 cells per liter Standard Deviation 1.232	4.98 10^9 cells per liter Standard Deviation 1.240
Absolute Values for Hematology Parameters Including Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelets in Part 2 Platelets	242.3 10^9 cells per liter Standard Deviation 57.86	240.6 10^9 cells per liter Standard Deviation 58.34	244.2 10^9 cells per liter Standard Deviation 57.67

SECONDARY outcome

Timeframe: Day 2 of each treatment period

Population: All Participants Population.

Blood samples were collected for the analysis erythrocyte mean corpuscular hemoglobin in Part 2 at indicated time points.

Outcome measures

Measure	DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet n=18 Participants Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth.	DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets n=18 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately.	DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth n=18 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth.
Absolute Values for Erythrocyte Mean Corpuscular Hemoglobin in Part 2	29.78 Picograms Standard Deviation 1.582	29.79 Picograms Standard Deviation 1.735	29.81 Picograms Standard Deviation 1.673

SECONDARY outcome

Timeframe: Day 2 of each treatment period

Population: All Participants Population.

Blood samples were collected for the analysis erythrocyte mean corpuscular hemoglobin in Part 2 at indicated time points.

Outcome measures

Measure	DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet n=18 Participants Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth.	DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets n=18 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately.	DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth n=18 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth.
Absolute Values for Erythrocyte Mean Corpuscular Volume in Part 2	88.43 Femtoliter Standard Deviation 3.869	88.28 Femtoliter Standard Deviation 3.867	88.34 Femtoliter Standard Deviation 4.251

SECONDARY outcome

Timeframe: Day 2 of each treatment period

Population: All Participants Population.

Blood samples were collected for the analysis erythrocytes in Part 2 at indicated time points.

Outcome measures

Measure	DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet n=18 Participants Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth.	DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets n=18 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately.	DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth n=18 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth.
Absolute Values for Erythrocytes in Part 2	4.812 10^12 cells per liter Standard Deviation 0.4164	4.794 10^12 cells per liter Standard Deviation 0.4969	4.776 10^12 cells per liter Standard Deviation 0.4971

SECONDARY outcome

Timeframe: Day 2 of each treatment period

Population: All Participants Population.

Blood samples were collected for the analysis hemocrit in Part 2 at indicated time points.

Outcome measures

Measure	DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet n=18 Participants Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth.	DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets n=18 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately.	DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth n=18 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth.
Absolute Values for Hemocrit in Part 2	0.4243 Percentage of red blood cells in blood Standard Deviation 0.02589	0.4219 Percentage of red blood cells in blood Standard Deviation 0.03425	0.4206 Percentage of red blood cells in blood Standard Deviation 0.03425

SECONDARY outcome

Timeframe: Day 2 of each treatment period

Population: All Participants Population.

Blood samples were collected for the analysis hemoglobin in Part 2 at indicated time points.

Outcome measures

Measure	DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet n=18 Participants Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth.	DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets n=18 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately.	DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth n=18 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth.
Absolute Values for Hemoglobin in Part 2	143.0 Grams per liter Standard Deviation 9.57	142.3 Grams per liter Standard Deviation 11.33	141.8 Grams per liter Standard Deviation 11.79

SECONDARY outcome

Timeframe: Baseline (Day -1) and Day 2

Population: All Participants Population.

Blood samples were collected for the analysis of hematology parameters including basophils, eosinophils, lymphocytes, monocytes, neutrophils, leukocytes and platelets in Part 1 at indicated time points. Day -1 was defined as Baseline for hematology parameters. Change from Baseline is calculated as the value at specified time point minus the Baseline value.

Outcome measures

Measure	DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet n=17 Participants Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth.	DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets n=17 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately.	DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth n=18 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth.
Change From Baseline Values for Hematology Parameters Including Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelets in Part 1 Monocytes	-0.082 10^9 cells per liter Standard Deviation 0.1001	-0.066 10^9 cells per liter Standard Deviation 0.1332	-0.098 10^9 cells per liter Standard Deviation 0.0818
Change From Baseline Values for Hematology Parameters Including Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelets in Part 1 Neutrophils	-0.008 10^9 cells per liter Standard Deviation 0.5373	-0.202 10^9 cells per liter Standard Deviation 1.2690	-0.088 10^9 cells per liter Standard Deviation 0.9868
Change From Baseline Values for Hematology Parameters Including Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelets in Part 1 Leukocytes	-0.38 10^9 cells per liter Standard Deviation 0.640	-0.61 10^9 cells per liter Standard Deviation 1.356	-0.49 10^9 cells per liter Standard Deviation 0.964
Change From Baseline Values for Hematology Parameters Including Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelets in Part 1 Platelets	7.1 10^9 cells per liter Standard Deviation 12.27	-2.8 10^9 cells per liter Standard Deviation 13.14	3.7 10^9 cells per liter Standard Deviation 12.15
Change From Baseline Values for Hematology Parameters Including Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelets in Part 1 Basophils	-0.009 10^9 cells per liter Standard Deviation 0.0176	-0.009 10^9 cells per liter Standard Deviation 0.0162	-0.011 10^9 cells per liter Standard Deviation 0.0100
Change From Baseline Values for Hematology Parameters Including Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelets in Part 1 Eosinophils	-0.013 10^9 cells per liter Standard Deviation 0.0488	-0.008 10^9 cells per liter Standard Deviation 0.0323	-0.014 10^9 cells per liter Standard Deviation 0.0545
Change From Baseline Values for Hematology Parameters Including Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelets in Part 1 Lymphocytes	-0.273 10^9 cells per liter Standard Deviation 0.4366	-0.325 10^9 cells per liter Standard Deviation 0.4254	-0.286 10^9 cells per liter Standard Deviation 0.2468

SECONDARY outcome

Timeframe: Baseline (Day -1) and Day 2

Population: All Participants Population.

Blood samples were collected for the analysis erythrocyte mean corpuscular hemoglobin in Part 1 at indicated time points. Day -1 was defined as Baseline for hematology parameters. Change from Baseline is calculated as the value at specified time point minus the Baseline value.

Outcome measures

Measure	DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet n=17 Participants Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth.	DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets n=17 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately.	DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth n=18 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth.
Change From Baseline Values for Erythrocyte Mean Corpuscular Hemoglobin in Part 1	0.16 Picograms Standard Deviation 0.394	0.18 Picograms Standard Deviation 0.303	0.19 Picograms Standard Deviation 0.367

SECONDARY outcome

Timeframe: Baseline (Day -1) and Day 2

Population: All Participants Population.

Blood samples were collected for the analysis erythrocyte mean corpuscular hemoglobin in Part 1 at indicated time points. Day -1 was defined as Baseline for hematology parameters. Change from Baseline is calculated as the value at specified time point minus the Baseline value.

Outcome measures

Measure	DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet n=17 Participants Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth.	DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets n=17 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately.	DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth n=18 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth.
Change From Baseline Values for Erythrocyte Mean Corpuscular Volume in Part 1	0.09 Femtoliter Standard Deviation 0.756	0.09 Femtoliter Standard Deviation 0.634	-0.01 Femtoliter Standard Deviation 0.633

SECONDARY outcome

Timeframe: Baseline (Day -1) and Day 2

Population: All Participants Population.

Blood samples were collected for the analysis erythrocytes in Part 1 at indicated time points. Day -1 was defined as Baseline for hematology parameters. Change from Baseline is calculated as the value at specified time point minus the Baseline value.

Outcome measures

Measure	DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet n=17 Participants Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth.	DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets n=17 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately.	DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth n=18 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth.
Change From Baseline Values for Erythrocytes in Part 1	0.191 10^12 cells per liter Standard Deviation 0.1562	0.121 10^12 cells per liter Standard Deviation 0.1513	0.221 10^12 cells per liter Standard Deviation 0.1443

SECONDARY outcome

Timeframe: Baseline (Day -1) and Day 2

Population: All Participants Population.

Blood samples were collected for the analysis hemocrit in Part 1 at indicated time points. Day -1 was defined as Baseline for hematology parameters. Change from Baseline is calculated as the value at specified time point minus the Baseline value.

Outcome measures

Measure	DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet n=17 Participants Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth.	DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets n=17 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately.	DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth n=18 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth.
Change From Baseline Values for Hemocrit in Part 1	0.0164 Percentage of red blood cells in blood Standard Deviation 0.01412	0.0099 Percentage of red blood cells in blood Standard Deviation 0.01268	0.0188 Percentage of red blood cells in blood Standard Deviation 0.01373

SECONDARY outcome

Timeframe: Baseline (Day -1) and Day 2

Population: All Participants Population.

Blood samples were collected for the analysis hemoglobin in Part 1 at indicated time points. Day -1 was defined as Baseline for hematology parameters. Change from Baseline is calculated as the value at specified time point minus the Baseline value.

Outcome measures

Measure	DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet n=17 Participants Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth.	DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets n=17 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately.	DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth n=18 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth.
Change From Baseline Values for Hemoglobin in Part 1	6.1 Grams per liter Standard Deviation 4.19	4.0 Grams per liter Standard Deviation 4.46	7.2 Grams per liter Standard Deviation 4.96

SECONDARY outcome

Timeframe: Baseline (Day -1) and Day 2

Population: All Participants Population.

Blood samples were collected for the analysis of hematology parameters including basophils, eosinophils, lymphocytes, monocytes, neutrophils, leukocytes and platelets in Part 2 at indicated time points. Day -1 was defined as Baseline for hematology parameters. Change from Baseline is calculated as the value at specified time point minus the Baseline value.

Outcome measures

Measure	DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet n=18 Participants Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth.	DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets n=18 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately.	DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth n=18 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth.
Change From Baseline Values for Hematology Parameters Including Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelets in Part 2 Eosinophils	0.005 10^9 cells per liter Standard Deviation 0.0367	-0.006 10^9 cells per liter Standard Deviation 0.0315	0.004 10^9 cells per liter Standard Deviation 0.0185
Change From Baseline Values for Hematology Parameters Including Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelets in Part 2 Lymphocytes	-0.207 10^9 cells per liter Standard Deviation 0.2918	-0.219 10^9 cells per liter Standard Deviation 0.2935	-0.115 10^9 cells per liter Standard Deviation 0.2353
Change From Baseline Values for Hematology Parameters Including Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelets in Part 2 Monocytes	-0.074 10^9 cells per liter Standard Deviation 0.0668	-0.079 10^9 cells per liter Standard Deviation 0.0608	-0.049 10^9 cells per liter Standard Deviation 0.0972
Change From Baseline Values for Hematology Parameters Including Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelets in Part 2 Neutrophils	-0.602 10^9 cells per liter Standard Deviation 1.2902	-0.497 10^9 cells per liter Standard Deviation 0.6402	-0.487 10^9 cells per liter Standard Deviation 0.7496
Change From Baseline Values for Hematology Parameters Including Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelets in Part 2 Basophils	-0.004 10^9 cells per liter Standard Deviation 0.0134	-0.004 10^9 cells per liter Standard Deviation 0.0142	-0.008 10^9 cells per liter Standard Deviation 0.0142
Change From Baseline Values for Hematology Parameters Including Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelets in Part 2 Leukocytes	-0.89 10^9 cells per liter Standard Deviation 1.333	-0.81 10^9 cells per liter Standard Deviation 0.755	-0.66 10^9 cells per liter Standard Deviation 0.811
Change From Baseline Values for Hematology Parameters Including Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelets in Part 2 Platelets	-5.4 10^9 cells per liter Standard Deviation 22.31	0.3 10^9 cells per liter Standard Deviation 14.41	-2.7 10^9 cells per liter Standard Deviation 17.91

SECONDARY outcome

Timeframe: Baseline (Day -1) and Day 2

Population: All Participants Population.

Blood samples were collected for the analysis erythrocyte mean corpuscular hemoglobin in Part 2 at indicated time points. Day -1 was defined as Baseline for hematology parameters. Change from Baseline is calculated as the value at specified time point minus the Baseline value.

Outcome measures

Measure	DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet n=18 Participants Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth.	DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets n=18 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately.	DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth n=18 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth.
Change From Baseline Values for Erythrocyte Mean Corpuscular Hemoglobin in Part 2	0.16 Picograms Standard Deviation 0.403	0.07 Picograms Standard Deviation 0.353	-0.04 Picograms Standard Deviation 0.335

SECONDARY outcome

Timeframe: Baseline (Day -1) and Day 2

Population: All Participants Population.

Blood samples were collected for the analysis erythrocyte mean corpuscular hemoglobin in Part 2 at indicated time points. Day -1 was defined as Baseline for hematology parameters. Change from Baseline is calculated as the value at specified time point minus the Baseline value.

Outcome measures

Measure	DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet n=18 Participants Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth.	DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets n=18 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately.	DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth n=18 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth.
Change From Baseline Values for Erythrocyte Mean Corpuscular Volume in Part 2	0.35 Femtoliter Standard Deviation 0.678	-0.01 Femtoliter Standard Deviation 0.674	0.08 Femtoliter Standard Deviation 0.666

SECONDARY outcome

Timeframe: Baseline (Day -1) and Day 2

Population: All Participants Population.

Blood samples were collected for the analysis erythrocytes in Part 2 at indicated time points. Day -1 was defined as Baseline for hematology parameters. Change from Baseline is calculated as the value at specified time point minus the Baseline value.

Outcome measures

Measure	DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet n=18 Participants Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth.	DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets n=18 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately.	DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth n=18 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth.
Change From Baseline Values for Erythrocytes in Part 2	0.201 10^12 cells per liter Standard Deviation 0.2539	0.224 10^12 cells per liter Standard Deviation 0.2171	0.179 10^12 cells per liter Standard Deviation 0.1813

SECONDARY outcome

Timeframe: Baseline (Day -1) and Day 2

Population: All Participants Population.

Blood samples were collected for the analysis hemocrit in Part 2 at indicated time points. Day -1 was defined as Baseline for hematology parameters. Change from Baseline is calculated as the value at specified time point minus the Baseline value.

Outcome measures

Measure	DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet n=18 Participants Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth.	DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets n=18 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately.	DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth n=18 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth.
Change From Baseline Values for Hemocrit in Part 2	0.0193 Percentage of red blood cells in blood Standard Deviation 0.02273	0.0195 Percentage of red blood cells in blood Standard Deviation 0.01974	0.0159 Percentage of red blood cells in blood Standard Deviation 0.01427

SECONDARY outcome

Timeframe: Baseline (Day -1) and Day 2

Population: All Participants Population.

Blood samples were collected for the analysis hemoglobin in Part 2 at indicated time points. Day -1 was defined as Baseline for hematology parameters. Change from Baseline is calculated as the value at specified time point minus the Baseline value.

Outcome measures

Measure	DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet n=18 Participants Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth.	DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets n=18 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately.	DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth n=18 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth.
Change From Baseline Values for Hemoglobin in Part 2	6.9 Gram per liter Standard Deviation 7.70	6.8 Gram per liter Standard Deviation 5.52	5.1 Gram per liter Standard Deviation 5.63

SECONDARY outcome

Timeframe: Up to Day 33

Population: All Participants Population.

The dipstick test gives results in a semi-quantitative manner and results for urinalysis parameters can be read as increased, decreased, increase to trace, 1+ and 3+ indicating proportional concentrations in the urine sample. Only participants with abnormal findings for urinalysis at any visit has been presented.

Outcome measures

Measure	DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet n=17 Participants Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth.	DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets n=17 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately.	DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth n=18 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth.
Number of Participants With Abnormal Urinalysis Parameter in Part 1 Glucose, No change/decrease	17 Participants	17 Participants	18 Participants
Number of Participants With Abnormal Urinalysis Parameter in Part 1 Glucose, Any increase	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Urinalysis Parameter in Part 1 Ketones, No change/decrease	17 Participants	16 Participants	17 Participants
Number of Participants With Abnormal Urinalysis Parameter in Part 1 Ketones, Increase to trace	0 Participants	1 Participants	1 Participants
Number of Participants With Abnormal Urinalysis Parameter in Part 1 Occult blood, No change/decrease	16 Participants	17 Participants	16 Participants
Number of Participants With Abnormal Urinalysis Parameter in Part 1 Occult blood, Increase to trace	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Urinalysis Parameter in Part 1 Occult blood, Increase to 1+	1 Participants	0 Participants	1 Participants
Number of Participants With Abnormal Urinalysis Parameter in Part 1 Occult blood, Increase to 3+	0 Participants	0 Participants	1 Participants
Number of Participants With Abnormal Urinalysis Parameter in Part 1 Protein, No change/decrease	17 Participants	17 Participants	18 Participants
Number of Participants With Abnormal Urinalysis Parameter in Part 1 Protein, Any increase	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to Day 33

Population: All Participants Population.

Urine samples were collected for analysis of urine pH. pH is calculated on a scale of 0 to 14, values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH of less than 7 is acidic and a pH of greater than 7 is basic. Normal urine has a slightly acidic pH (5.0-6.0).

Outcome measures

Measure	DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet n=17 Participants Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth.	DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets n=17 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately.	DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth n=18 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth.
Number of Participants With Urine Potential of Hydrogen (pH)-Part 1 No change/decrease	14 Participants	14 Participants	15 Participants
Number of Participants With Urine Potential of Hydrogen (pH)-Part 1 Any increase	3 Participants	3 Participants	3 Participants
Number of Participants With Urine Potential of Hydrogen (pH)-Part 1 Increase to 5.5	1 Participants	0 Participants	1 Participants
Number of Participants With Urine Potential of Hydrogen (pH)-Part 1 Increase to 6.0	0 Participants	0 Participants	0 Participants
Number of Participants With Urine Potential of Hydrogen (pH)-Part 1 Increase to 6.5	1 Participants	1 Participants	1 Participants
Number of Participants With Urine Potential of Hydrogen (pH)-Part 1 Increase to 7.0	1 Participants	2 Participants	0 Participants
Number of Participants With Urine Potential of Hydrogen (pH)-Part 1 Increase to 7.5	0 Participants	0 Participants	0 Participants
Number of Participants With Urine Potential of Hydrogen (pH)-Part 1 Increase to 8.0	0 Participants	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Up to Day 33

Population: All Participants Population.

The dipstick test gives results in a semi-quantitative manner and results for urinalysis parameters can be read as increased, decreased, increase to trace, 1+ and 3+ indicating proportional concentrations in the urine sample. Only participants with abnormal findings for urinalysis at any visit has been presented.

Outcome measures

Measure	DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet n=18 Participants Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth.	DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets n=18 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately.	DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth n=18 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth.
Number of Participants With Abnormal Urinalysis Parameter in Part 2 Ketones, No change/decrease	17 Participants	18 Participants	18 Participants
Number of Participants With Abnormal Urinalysis Parameter in Part 2 Ketones, Increase to trace	1 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Urinalysis Parameter in Part 2 Occult blood, No change/decrease	18 Participants	17 Participants	16 Participants
Number of Participants With Abnormal Urinalysis Parameter in Part 2 Glucose, No change/decrease	18 Participants	18 Participants	18 Participants
Number of Participants With Abnormal Urinalysis Parameter in Part 2 Glucose, Any increase	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Urinalysis Parameter in Part 2 Occult blood Any increase	0 Participants	1 Participants	2 Participants
Number of Participants With Abnormal Urinalysis Parameter in Part 2 Occult blood, Increase to trace	0 Participants	0 Participants	1 Participants
Number of Participants With Abnormal Urinalysis Parameter in Part 2 Occult blood, Increase to 1+	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Urinalysis Parameter in Part 2 Occult blood, Increase to 3+	0 Participants	1 Participants	1 Participants
Number of Participants With Abnormal Urinalysis Parameter in Part 2 Protein, No change/decrease	18 Participants	18 Participants	18 Participants
Number of Participants With Abnormal Urinalysis Parameter in Part 2 Protein, Any increase	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to Day 33

Population: All Participants Population.

Urine samples were collected for analysis of urine pH. pH is calculated on a scale of 0 to 14, values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH of less than 7 is acidic and a pH of greater than 7 is basic. Normal urine has a slightly acidic pH (5.0-6.0).

Outcome measures

Measure	DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet n=18 Participants Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth.	DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets n=18 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately.	DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth n=18 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth.
Number of Participants With Urine Potential of Hydrogen (pH)-Part 2 No change/decrease	11 Participants	16 Participants	13 Participants
Number of Participants With Urine Potential of Hydrogen (pH)-Part 2 Any increase	7 Participants	2 Participants	5 Participants
Number of Participants With Urine Potential of Hydrogen (pH)-Part 2 Increase to 5.5	0 Participants	0 Participants	0 Participants
Number of Participants With Urine Potential of Hydrogen (pH)-Part 2 Increase to 6.0	1 Participants	0 Participants	1 Participants
Number of Participants With Urine Potential of Hydrogen (pH)-Part 2 Increase to 6.5	0 Participants	0 Participants	2 Participants
Number of Participants With Urine Potential of Hydrogen (pH)-Part 2 Increase to 7.0	4 Participants	2 Participants	2 Participants
Number of Participants With Urine Potential of Hydrogen (pH)-Part 2 Increase to 7.5	2 Participants	0 Participants	0 Participants
Number of Participants With Urine Potential of Hydrogen (pH)-Part 2 Increase to 8.0	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline (Day -1)

Population: All Participants Population.

Full 12-lead ECGs were recorded with the participant in a supine position. Absolute QTc Interval: >450, absolute PR Interval: <110 and Absolute QRS Interval: <75 were considered to be potential clinically significant ECG finding. The number of participants with abnormal clinically significant ECG findings are presented.

Outcome measures

Measure	DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet n=17 Participants Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth.	DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets n=17 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately.	DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth n=18 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth.
Number of Participants With Abnormal Electrocardiogram (ECG) Findings in Part 1 Not clinically significant	1 Participants	0 Participants	1 Participants
Number of Participants With Abnormal Electrocardiogram (ECG) Findings in Part 1 Clinically significant	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline (Day -1)

Population: All Participants Population.

Full 12-lead ECGs were recorded with the participant in a supine position. Absolute QTc Interval: >450, absolute PR Interval: <110 and Absolute QRS Interval: <75 were considered to be potential clinically significant ECG finding. The number of participants with abnormal clinically significant ECG findings are presented

Outcome measures

Measure	DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet n=18 Participants Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth.	DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets n=18 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately.	DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth n=18 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth.
Number of Participants With Abnormal ECG Findings in Part 2 Not clinically significant	1 Participants	1 Participants	2 Participants
Number of Participants With Abnormal ECG Findings in Part 2 Clinically significant	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Day 1 at 4 hours post intervention and Day 2 of each treatment period

Population: All Participants Population.

Blood pressure of participants were measured at indicated time points in semi-supine position after 5 minutes rest.

Outcome measures

Measure	DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet n=17 Participants Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth.	DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets n=17 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately.	DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth n=18 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth.
Absolute Values for Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) of Part 1 SBP, Day 1- 4hours	117.5 Millimeters of mercury Standard Deviation 12.25	120.7 Millimeters of mercury Standard Deviation 15.73	118.9 Millimeters of mercury Standard Deviation 10.05
Absolute Values for Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) of Part 1 SBP, Day 2	114.0 Millimeters of mercury Standard Deviation 9.50	115.2 Millimeters of mercury Standard Deviation 11.27	115.7 Millimeters of mercury Standard Deviation 9.09
Absolute Values for Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) of Part 1 DBP, Day 1- 4hours	70.9 Millimeters of mercury Standard Deviation 10.88	74.0 Millimeters of mercury Standard Deviation 11.77	71.6 Millimeters of mercury Standard Deviation 8.71
Absolute Values for Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) of Part 1 DBP, Day 2	68.1 Millimeters of mercury Standard Deviation 8.55	68.2 Millimeters of mercury Standard Deviation 7.49	68.3 Millimeters of mercury Standard Deviation 8.20

SECONDARY outcome

Timeframe: Day 1 at 4 hours post intervention and Day 2 of each treatment period

Population: All Participants Population.

Pulse rate of participants were measured at indicated time points in semi-supine position after 5 minutes rest.

Outcome measures

Measure	DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet n=17 Participants Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth.	DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets n=17 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately.	DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth n=18 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth.
Absolute Values for Pulse Rate in Part 1 Day 1- 4hours	59.5 Beats per minute Standard Deviation 8.32	61.6 Beats per minute Standard Deviation 12.02	59.7 Beats per minute Standard Deviation 9.29
Absolute Values for Pulse Rate in Part 1 Day 2	63.5 Beats per minute Standard Deviation 8.21	66.6 Beats per minute Standard Deviation 10.04	67.4 Beats per minute Standard Deviation 9.60

SECONDARY outcome

Timeframe: Day 1 at 4 hours post intervention dose and Day 2 of each treatment period

Population: All Participants Population.

Temperature of participants were measured at indicated time points in semi-supine position after 5 minutes rest.

Outcome measures

Measure	DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet n=17 Participants Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth.	DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets n=17 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately.	DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth n=18 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth.
Absolute Values for Temperature in Part 1 Day 1- 4hours	36.46 Degree celsius Standard Deviation 0.433	36.44 Degree celsius Standard Deviation 0.411	36.51 Degree celsius Standard Deviation 0.362
Absolute Values for Temperature in Part 1 Day 2	36.41 Degree celsius Standard Deviation 0.372	36.71 Degree celsius Standard Deviation 0.347	36.66 Degree celsius Standard Deviation 0.415

SECONDARY outcome

Timeframe: Day 1 at 4 hours post intervention dose and Day 2 of each treatment period

Population: All Participants Population.

Blood pressure of participants were measured at indicated time points in semi-supine position after 5 minutes rest.

Outcome measures

Measure	DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet n=18 Participants Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth.	DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets n=18 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately.	DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth n=18 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth.
Absolute Values for SBP and DBP of Part 2 SBP, Day 1- 4hours	116.2 Millimeters of mercury Standard Deviation 7.38	118.9 Millimeters of mercury Standard Deviation 13.31	119.1 Millimeters of mercury Standard Deviation 13.73
Absolute Values for SBP and DBP of Part 2 SBP, Day 2	116.0 Millimeters of mercury Standard Deviation 8.01	115.5 Millimeters of mercury Standard Deviation 9.20	113.2 Millimeters of mercury Standard Deviation 11.62
Absolute Values for SBP and DBP of Part 2 DBP, Day 1-4 hours	70.1 Millimeters of mercury Standard Deviation 9.38	70.9 Millimeters of mercury Standard Deviation 11.59	71.7 Millimeters of mercury Standard Deviation 11.02
Absolute Values for SBP and DBP of Part 2 DBP, Day 2	69.5 Millimeters of mercury Standard Deviation 6.49	71.1 Millimeters of mercury Standard Deviation 9.62	69.9 Millimeters of mercury Standard Deviation 11.46

SECONDARY outcome

Timeframe: Day 1 at 4 hours post intervention dose and Day 2 of each treatment period

Population: All Participants Population.

Pulse rate of participants were measured at indicated time points in semi-supine position after 5 minutes rest.

Outcome measures

Measure	DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet n=18 Participants Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth.	DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets n=18 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately.	DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth n=18 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth.
Absolute Values for Pulse Rate in Part 2 Day 1-4hours	63.9 Beats per minute Standard Deviation 14.95	62.6 Beats per minute Standard Deviation 11.25	63.3 Beats per minute Standard Deviation 13.64
Absolute Values for Pulse Rate in Part 2 Day 2	67.7 Beats per minute Standard Deviation 14.56	64.9 Beats per minute Standard Deviation 12.36	66.5 Beats per minute Standard Deviation 11.42

SECONDARY outcome

Timeframe: Day 1 at 4 hours post intervention dose and Day 2 of each treatment period

Population: All Participants Population.

Temperature of participants were measured at indicated time points in semi-supine position after 5 minutes rest.

Outcome measures

Measure	DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet n=18 Participants Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth.	DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets n=18 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately.	DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth n=18 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth.
Absolute Values for Temperature in Part 2 Day 1-4hours	36.31 Degree celsius Standard Deviation 0.381	36.28 Degree celsius Standard Deviation 0.373	36.39 Degree celsius Standard Deviation 0.429
Absolute Values for Temperature in Part 2 Day 2	36.33 Degree celsius Standard Deviation 0.401	36.35 Degree celsius Standard Deviation 0.228	36.45 Degree celsius Standard Deviation 0.343

SECONDARY outcome

Timeframe: Baseline (Day 1, pre-dose), Day 1- 4 hours and Day 2

Population: All Participants Population.

Blood pressure of participants were measured at indicated time points in semi-supine position after 5 minutes rest. Day 1 (Pre-dose) value was defined as Baseline for vital sign parameters. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.

Outcome measures

Measure	DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet n=17 Participants Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth.	DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets n=17 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately.	DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth n=18 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth.
Change From Baseline in SBP and DBP of Part 1 SBP, Day 1- 4hours	0.1 Millimeters of mercury Standard Deviation 9.90	3.9 Millimeters of mercury Standard Deviation 10.59	3.1 Millimeters of mercury Standard Deviation 8.54
Change From Baseline in SBP and DBP of Part 1 SBP, Day 2	-3.4 Millimeters of mercury Standard Deviation 5.94	-1.6 Millimeters of mercury Standard Deviation 7.33	-0.2 Millimeters of mercury Standard Deviation 7.74
Change From Baseline in SBP and DBP of Part 1 DBP, Day 1- 4hours	-3.2 Millimeters of mercury Standard Deviation 9.36	4.6 Millimeters of mercury Standard Deviation 8.08	1.3 Millimeters of mercury Standard Deviation 6.51
Change From Baseline in SBP and DBP of Part 1 DBP, Day 2	-6.1 Millimeters of mercury Standard Deviation 5.21	-1.2 Millimeters of mercury Standard Deviation 5.23	-1.9 Millimeters of mercury Standard Deviation 4.89

SECONDARY outcome

Timeframe: Baseline (Day 1, pre-dose), Day 1- 4 hours and Day 2

Population: All Participants Population.

Pulse rate of participants were measured at indicated time points in semi-supine position after 5 minutes rest. Day 1 (Pre-dose) value was defined as Baseline for vital sign parameters. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.

Outcome measures

Measure	DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet n=17 Participants Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth.	DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets n=17 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately.	DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth n=18 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth.
Change From Baseline in Pulse Rate of Part 1 Day 1- 4hours	-5.5 Beats per minute Standard Deviation 7.31	-4.4 Beats per minute Standard Deviation 5.91	-7.8 Beats per minute Standard Deviation 8.47
Change From Baseline in Pulse Rate of Part 1 Day 2	-1.5 Beats per minute Standard Deviation 5.97	0.5 Beats per minute Standard Deviation 7.37	-0.1 Beats per minute Standard Deviation 8.79

SECONDARY outcome

Timeframe: Baseline (Day 1, pre-dose), Day 1- 4 hours and Day 2

Population: All Participants Population.

Temperature of participants were measured at indicated time points in semi-supine position after 5 minutes rest. Day 1 (Pre-dose) value was defined as Baseline for vital sign parameters. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.

Outcome measures

Measure	DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet n=17 Participants Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth.	DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets n=17 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately.	DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth n=18 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth.
Change From Baseline in Temperature of Part 1 Day 1- 4hours	0.14 Degree celsius Standard Deviation 0.550	0.02 Degree celsius Standard Deviation 0.256	0.21 Degree celsius Standard Deviation 0.454
Change From Baseline in Temperature of Part 1 Day 2	0.09 Degree celsius Standard Deviation 0.365	0.28 Degree celsius Standard Deviation 0.251	0.36 Degree celsius Standard Deviation 0.412

SECONDARY outcome

Timeframe: Baseline (Day 1, pre-dose), Day 1- 4 hours and Day 2

Population: All Participants Population.

Blood pressure of participants were measured at indicated time points in semi-supine position after 5 minutes rest. Day 1 (Pre-dose) value was defined as Baseline for vital sign parameters. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.

Outcome measures

Measure	DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet n=18 Participants Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth.	DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets n=18 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately.	DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth n=18 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth.
Change From Baseline in SBP and DBP of Part 2 SBP, Day 1- 4hours	-4.4 Millimeters of mercury Standard Deviation 7.66	0.9 Millimeters of mercury Standard Deviation 14.51	-2.4 Millimeters of mercury Standard Deviation 8.63
Change From Baseline in SBP and DBP of Part 2 SBP, Day 2	-4.6 Millimeters of mercury Standard Deviation 11.43	-2.5 Millimeters of mercury Standard Deviation 11.95	-8.3 Millimeters of mercury Standard Deviation 9.86
Change From Baseline in SBP and DBP of Part 2 DBP, Day 1-4 hours	-0.9 Millimeters of mercury Standard Deviation 5.79	0.5 Millimeters of mercury Standard Deviation 7.73	-0.5 Millimeters of mercury Standard Deviation 7.82
Change From Baseline in SBP and DBP of Part 2 DBP, Day 2	-1.5 Millimeters of mercury Standard Deviation 6.69	0.7 Millimeters of mercury Standard Deviation 6.86	-2.2 Millimeters of mercury Standard Deviation 7.77

SECONDARY outcome

Timeframe: Baseline (Day 1, pre-dose), Day 1- 4 hours and Day 2

Population: All Participants Population.

Pulse rate of participants were measured at indicated time points in semi-supine position after 5 minutes rest. Day 1 (Pre-dose) value was defined as Baseline for vital sign parameters. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.

Outcome measures

Measure	DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet n=18 Participants Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth.	DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets n=18 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately.	DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth n=18 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth.
Change From Baseline in Pulse Rate in Part 2 Day 1-4hours	-4.7 Beats per minute Standard Deviation 7.54	-5.7 Beats per minute Standard Deviation 9.38	-8.6 Beats per minute Standard Deviation 13.61
Change From Baseline in Pulse Rate in Part 2 Day 2	-0.9 Beats per minute Standard Deviation 7.76	-3.3 Beats per minute Standard Deviation 9.98	-5.4 Beats per minute Standard Deviation 14.18

SECONDARY outcome

Timeframe: Baseline (Day 1, pre-dose), Day 1- 4 hours and Day 2

Population: All Participants Population.

Temperature of participants were measured at indicated time points in semi-supine position after 5 minutes rest. Day 1 (Pre-dose) value was defined as Baseline for vital sign parameters. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.

Outcome measures

Measure	DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet n=18 Participants Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth.	DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets n=18 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately.	DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth n=18 Participants Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth.
Change From Baseline in Temperature in Part 2 Day 1-4hours	-0.01 Degree celsius Standard Deviation 0.508	0.05 Degree celsius Standard Deviation 0.660	-0.02 Degree celsius Standard Deviation 0.514
Change From Baseline in Temperature in Part 2 Day 2	0.02 Degree celsius Standard Deviation 0.522	0.12 Degree celsius Standard Deviation 0.565	0.03 Degree celsius Standard Deviation 0.469

Adverse Events

DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet-Part 1

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets-Part 1

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

DTG5mg/ABC60mg/3TC30mgdispersible Tablet Direct to Mouth-Part1

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

DTG 50 mg/3TC 300 mg Tablet-Part 2

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

DTG 5 mg/3TC 30 mg Dispersible Tablet-Part 2

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

DTG 5 mg/3TC 30 mg Dispersible Tablet Direct to Mouth-Part 2

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet-Part 1 n=17 participants at risk Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth.	DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets-Part 1 n=17 participants at risk Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately.	DTG5mg/ABC60mg/3TC30mgdispersible Tablet Direct to Mouth-Part1 n=18 participants at risk Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth.	DTG 50 mg/3TC 300 mg Tablet-Part 2 n=18 participants at risk Participants received adult DTG and 3TC as one conventional tablet direct-to-mouth	DTG 5 mg/3TC 30 mg Dispersible Tablet-Part 2 n=18 participants at risk Participants received 10 dispersible pediatric DTG/3TC tablets as dispersion	DTG 5 mg/3TC 30 mg Dispersible Tablet Direct to Mouth-Part 2 n=18 participants at risk Participants received 10 dispersible pediatric DTG/3TC tablets direct-to-mouth
General disorders Vessel puncture site reaction	0.00% 0/17 • The SAEs and AEs were collected from Day 1 up to Day 33. AEs and SAEs were collected in the Safety Population.	0.00% 0/17 • The SAEs and AEs were collected from Day 1 up to Day 33. AEs and SAEs were collected in the Safety Population.	11.1% 2/18 • Number of events 2 • The SAEs and AEs were collected from Day 1 up to Day 33. AEs and SAEs were collected in the Safety Population.	0.00% 0/18 • The SAEs and AEs were collected from Day 1 up to Day 33. AEs and SAEs were collected in the Safety Population.	0.00% 0/18 • The SAEs and AEs were collected from Day 1 up to Day 33. AEs and SAEs were collected in the Safety Population.	0.00% 0/18 • The SAEs and AEs were collected from Day 1 up to Day 33. AEs and SAEs were collected in the Safety Population.
General disorders Vessel puncture site erythema	0.00% 0/17 • The SAEs and AEs were collected from Day 1 up to Day 33. AEs and SAEs were collected in the Safety Population.	0.00% 0/17 • The SAEs and AEs were collected from Day 1 up to Day 33. AEs and SAEs were collected in the Safety Population.	5.6% 1/18 • Number of events 1 • The SAEs and AEs were collected from Day 1 up to Day 33. AEs and SAEs were collected in the Safety Population.	0.00% 0/18 • The SAEs and AEs were collected from Day 1 up to Day 33. AEs and SAEs were collected in the Safety Population.	0.00% 0/18 • The SAEs and AEs were collected from Day 1 up to Day 33. AEs and SAEs were collected in the Safety Population.	0.00% 0/18 • The SAEs and AEs were collected from Day 1 up to Day 33. AEs and SAEs were collected in the Safety Population.
General disorders Vessel puncture site pain	0.00% 0/17 • The SAEs and AEs were collected from Day 1 up to Day 33. AEs and SAEs were collected in the Safety Population.	0.00% 0/17 • The SAEs and AEs were collected from Day 1 up to Day 33. AEs and SAEs were collected in the Safety Population.	0.00% 0/18 • The SAEs and AEs were collected from Day 1 up to Day 33. AEs and SAEs were collected in the Safety Population.	0.00% 0/18 • The SAEs and AEs were collected from Day 1 up to Day 33. AEs and SAEs were collected in the Safety Population.	0.00% 0/18 • The SAEs and AEs were collected from Day 1 up to Day 33. AEs and SAEs were collected in the Safety Population.	5.6% 1/18 • Number of events 1 • The SAEs and AEs were collected from Day 1 up to Day 33. AEs and SAEs were collected in the Safety Population.
Gastrointestinal disorders Nausea	5.9% 1/17 • Number of events 1 • The SAEs and AEs were collected from Day 1 up to Day 33. AEs and SAEs were collected in the Safety Population.	0.00% 0/17 • The SAEs and AEs were collected from Day 1 up to Day 33. AEs and SAEs were collected in the Safety Population.	0.00% 0/18 • The SAEs and AEs were collected from Day 1 up to Day 33. AEs and SAEs were collected in the Safety Population.	0.00% 0/18 • The SAEs and AEs were collected from Day 1 up to Day 33. AEs and SAEs were collected in the Safety Population.	0.00% 0/18 • The SAEs and AEs were collected from Day 1 up to Day 33. AEs and SAEs were collected in the Safety Population.	0.00% 0/18 • The SAEs and AEs were collected from Day 1 up to Day 33. AEs and SAEs were collected in the Safety Population.
Infections and infestations Urinary tract infection	0.00% 0/17 • The SAEs and AEs were collected from Day 1 up to Day 33. AEs and SAEs were collected in the Safety Population.	5.9% 1/17 • Number of events 1 • The SAEs and AEs were collected from Day 1 up to Day 33. AEs and SAEs were collected in the Safety Population.	0.00% 0/18 • The SAEs and AEs were collected from Day 1 up to Day 33. AEs and SAEs were collected in the Safety Population.	0.00% 0/18 • The SAEs and AEs were collected from Day 1 up to Day 33. AEs and SAEs were collected in the Safety Population.	0.00% 0/18 • The SAEs and AEs were collected from Day 1 up to Day 33. AEs and SAEs were collected in the Safety Population.	0.00% 0/18 • The SAEs and AEs were collected from Day 1 up to Day 33. AEs and SAEs were collected in the Safety Population.
Nervous system disorders Presyncope	0.00% 0/17 • The SAEs and AEs were collected from Day 1 up to Day 33. AEs and SAEs were collected in the Safety Population.	0.00% 0/17 • The SAEs and AEs were collected from Day 1 up to Day 33. AEs and SAEs were collected in the Safety Population.	0.00% 0/18 • The SAEs and AEs were collected from Day 1 up to Day 33. AEs and SAEs were collected in the Safety Population.	5.6% 1/18 • Number of events 1 • The SAEs and AEs were collected from Day 1 up to Day 33. AEs and SAEs were collected in the Safety Population.	0.00% 0/18 • The SAEs and AEs were collected from Day 1 up to Day 33. AEs and SAEs were collected in the Safety Population.	0.00% 0/18 • The SAEs and AEs were collected from Day 1 up to Day 33. AEs and SAEs were collected in the Safety Population.

Additional Information

GSK Reponse Center

GlaxoSmithKline

Phone: 866-435-7343

Email: GSKClinicalSupportHD@gsk.com

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