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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03441984
Recruitment Status : Completed
First Posted : February 22, 2018
Results First Posted : December 9, 2019
Last Update Posted : December 9, 2019
Sponsor:
Collaborators:
GlaxoSmithKline
Pharmaceutical Product Development (PPD), Inc
Information provided by (Responsible Party):
ViiV Healthcare

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition HIV Infections
Interventions Drug: Treatment A
Drug: Treatment B
Drug: Treatment C
Drug: Treatment D
Drug: Treatment E
Drug: Treatment F
Enrollment 36
Recruitment Details 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.
Pre-assignment Details 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.
Arm/Group Title Treatment Sequence ABC-Part 1 Treatment Sequence BCA-Part 1 Treatment Sequence CAB-Part 1 Treatment Sequence ACB-Part 1 Treatment Sequence BAC-Part 1 Treatment Sequence CBA-Part 1 Treatment DEF-Part 2 Treatment EFD-Part 2 Treatment FDE-Part 2 Treatment DFE-Part 2 Treatment EDF-Part 2 Treatment FED-Part 2
Hide Arm/Group Description 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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.
Period Title: Part 1: Period 1 (Up to Day 4)
Started 3 3 3 3 3 3 0 0 0 0 0 0
Completed 3 3 3 3 3 3 0 0 0 0 0 0
Not Completed 0 0 0 0 0 0 0 0 0 0 0 0
Period Title: Part 1,Period 1: Wash-out Period: 7 Days
Started 3 3 3 3 3 3 0 0 0 0 0 0
Completed 3 3 3 3 3 3 0 0 0 0 0 0
Not Completed 0 0 0 0 0 0 0 0 0 0 0 0
Period Title: Part 1: Period 2 (Up to Day 4 )
Started 3 3 3 3 3 3 0 0 0 0 0 0
Completed 3 3 2 3 3 3 0 0 0 0 0 0
Not Completed 0 0 1 0 0 0 0 0 0 0 0 0
Reason Not Completed
Positive urine drug screen lab value             0             0             1             0             0             0             0             0             0             0             0             0
Period Title: Part 1: Period 2,Wash-out Period: 7 Days
Started 3 3 2 3 3 3 0 0 0 0 0 0
Completed 3 3 2 3 3 3 0 0 0 0 0 0
Not Completed 0 0 0 0 0 0 0 0 0 0 0 0
Period Title: Part 1: Period 3 (Up to Day 4 )
Started 3 3 2 3 3 3 0 0 0 0 0 0
Completed 3 3 2 3 3 3 0 0 0 0 0 0
Not Completed 0 0 0 0 0 0 0 0 0 0 0 0
Period Title: Part 2: Period 1(Up to Day 4)
Started 0 0 0 0 0 0 3 3 3 3 3 3
Completed 0 0 0 0 0 0 3 3 3 3 3 3
Not Completed 0 0 0 0 0 0 0 0 0 0 0 0
Period Title: Part 2: Period 1, Wash-out: Up to 7 Days
Started 0 0 0 0 0 0 3 3 3 3 3 3
Completed 0 0 0 0 0 0 3 3 3 3 3 3
Not Completed 0 0 0 0 0 0 0 0 0 0 0 0
Period Title: Part 2: Period 2 (Up to Day 4)
Started 0 0 0 0 0 0 3 3 3 3 3 3
Completed 0 0 0 0 0 0 3 3 3 3 3 3
Not Completed 0 0 0 0 0 0 0 0 0 0 0 0
Period Title: Part 2: Period 2, Wash-out: Up to 7 Days
Started 0 0 0 0 0 0 3 3 3 3 3 3
Completed 0 0 0 0 0 0 3 3 3 3 3 3
Not Completed 0 0 0 0 0 0 0 0 0 0 0 0
Period Title: Part 2: Period 3 (Up to Day 4)
Started 0 0 0 0 0 0 3 3 3 3 3 3
Completed 0 0 0 0 0 0 3 3 3 3 3 3
Not Completed 0 0 0 0 0 0 0 0 0 0 0 0
Arm/Group Title All Study Participants in Part 1 All Study Participants in Part 2 Total
Hide Arm/Group Description All participants received either treatment A or B or C in 6 treatment sequences: ABC, BCA, CAB, ACB, CBA and BAC All participants received either treatment D or E or F in 6 treatment sequences: DEF, EFD, FDE, DFE, EDF and FED Total of all reporting groups
Overall Number of Baseline Participants 18 18 36
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 18 participants 18 participants 36 participants
34.9  (10.08) 33.9  (8.47) 34.4  (9.19)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 18 participants 36 participants
Female
9
  50.0%
5
  27.8%
14
  38.9%
Male
9
  50.0%
13
  72.2%
22
  61.1%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 18 participants 18 participants 36 participants
American Indian or Alaska Native 0 0 0
Asian-Central/South Asian Heritage 0 0 0
Asian-Japanese/East/South-East Asian Heritage 0 4 4
Black or African American 5 6 11
Native Hawaiian or other Pacific Islander 1 0 1
White 12 8 20
1.Primary Outcome
Title Area Under the Plasma Concentration-time Curve (AUC) From Time of Dose Extrapolated to Infinity (AUC[0-inf]) in Part 1 of DTG
Hide Description 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.
Time Frame 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
Hide Outcome Measure Data
Hide Analysis Population Description
PK population.
Arm/Group Title DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth
Hide Arm/Group Description:
Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth.
Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately.
Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth.
Overall Number of Participants Analyzed 17 17 18
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Hours*microgram per milliliter
59.761
(31%)
101.125
(22%)
77.742
(29%)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet, DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of geometric LS means
Estimated Value 1.6946
Confidence Interval (2-Sided) 90%
1.5690 to 1.8373
Estimation Comments Treatment comparison of pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg dispersible tablets) and adult TRIUMEQ (DTG 50 mg/ABC 600 mg/3TC 300 mg tablet) is presented
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet, DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of geometric LS means
Estimated Value 1.3512
Confidence Interval (2-Sided) 90%
1.2465 to 1.4647
Estimation Comments Treatment comparison of pediatric TRUMEQ (DTG 5 mg/ABC 60 mg/3TC 30mg dispersible tablet direct to mouth) and adult TRIUMEQ (DTG 50 mg/ABC 600 mg/3TC 300 mg tablet) is presented.
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets, DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of geometric LS means
Estimated Value 1.2541
Confidence Interval (2-Sided) 90%
1.1569 to 1.3595
Estimation Comments Treatment comparison of pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg dispersible tablets) and pediatric TRUMEQ (DTG 5 mg/ABC 60 mg/3TC 30mg dispersible tablet direct to mouth) is presented
2.Primary Outcome
Title AUC From Time of Dose to Last Measurable Concentration (AUC[0-t]) in Part 1 of DTG
Hide Description 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.
Time Frame 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
Hide Outcome Measure Data
Hide Analysis Population Description
PK population.
Arm/Group Title DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth
Hide Arm/Group Description:
Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth.
Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately.
Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth.
Overall Number of Participants Analyzed 17 17 18
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Hours*microgram per milliliter
57.571
(29%)
97.746
(21%)
75.086
(28%)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet, DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of geometric LS means
Estimated Value 1.7001
Confidence Interval (2-Sided) 90%
1.5685 to 1.8428
Estimation Comments Treatment comparison of pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg dispersible tablets) and adult TRIUMEQ (DTG 50 mg/ABC 600 mg/3TC 300 mg tablet) is presented.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet, DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of geometric LS means
Estimated Value 1.3519
Confidence Interval (2-Sided) 90%
1.2475 to 1.4650
Estimation Comments Treatment comparison of pediatric TRUMEQ (DTG 5 mg/ABC 60 mg/3TC 30mg dispersible tablet direct to mouth) and adult TRIUMEQ (DTG 50 mg/ABC 600 mg/3TC 300 mg tablet) is presented.
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets, DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of geometric LS means
Estimated Value 1.2576
Confidence Interval (2-Sided) 90%
1.1605 to 1.3629
Estimation Comments Treatment comparison of pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg dispersible tablets) and pediatric TRUMEQ (DTG 5 mg/ABC 60 mg/3TC 30mg dispersible tablet direct to mouth) is presented.
3.Primary Outcome
Title Maximum Observed Concentration (Cmax) in Part 1 of DTG in Plasma
Hide Description 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.
Time Frame 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
Hide Outcome Measure Data
Hide Analysis Population Description
PK population.
Arm/Group Title DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth
Hide Arm/Group Description:
Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth.
Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately.
Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth.
Overall Number of Participants Analyzed 17 17 18
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Micrograms per milliliter
3.093
(20%)
5.373
(15%)
4.134
(21%)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet, DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of geometric LS means
Estimated Value 1.7382
Confidence Interval (2-Sided) 90%
1.5983 to 1.8904
Estimation Comments Treatment comparison of pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg dispersible tablets) and adult TRIUMEQ (DTG 50 mg/ABC 600 mg/3TC 300 mg tablet) is presented.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet, DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of geometric LS means
Estimated Value 1.3614
Confidence Interval (2-Sided) 90%
1.2525 to 1.4798
Estimation Comments Treatment comparison of pediatric TRUMEQ (DTG 5 mg/ABC 60 mg/3TC 30mg dispersible tablet direct to mouth) and adult TRIUMEQ (DTG 50 mg/ABC 600 mg/3TC 300 mg tablet) is presented.
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets, DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of geometric LS means
Estimated Value 1.2768
Confidence Interval (2-Sided) 90%
1.1746 to 1.3878
Estimation Comments Treatment comparison of pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg dispersible tablets) and pediatric TRUMEQ (DTG 5 mg/ABC 60 mg/3TC 30mg dispersible tablet direct to mouth) is presented.
4.Primary Outcome
Title AUC(0-inf) in Part 1 of ABC
Hide Description 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.
Time Frame 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
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population
Arm/Group Title DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth
Hide Arm/Group Description:
Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth.
Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately.
Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth.
Overall Number of Participants Analyzed 17 17 18
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Hours*microgram per milliliter
16.636
(21%)
17.321
(20%)
16.756
(22%)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet, DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of geometric LS means
Estimated Value 1.0407
Confidence Interval (2-Sided) 90%
1.0118 to 1.0704
Estimation Comments Treatment comparison of pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg dispersible tablets) and adult TRIUMEQ (DTG 50 mg/ABC 600 mg/3TC 300 mg tablet) is presented.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet, DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of geometric LS means
Estimated Value 1.0228
Confidence Interval (2-Sided) 90%
0.9944 to 1.0520
Estimation Comments Treatment comparison of pediatric TRUMEQ (DTG 5 mg/ABC 60 mg/3TC 30mg dispersible tablet direct to mouth) and adult TRIUMEQ (DTG 50 mg/ABC 600 mg/3TC 300 mg tablet) is presented.
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets, DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of geometric LS means
Estimated Value 1.0175
Confidence Interval (2-Sided) 90%
0.9893 to 1.0465
Estimation Comments Treatment comparison of pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg dispersible tablets) and pediatric TRUMEQ (DTG 5 mg/ABC 60 mg/3TC 30mg dispersible tablet direct to mouth) is presented.
5.Primary Outcome
Title AUC(0-t) in Part 1 of ABC
Hide Description 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.
Time Frame 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
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population
Arm/Group Title DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth
Hide Arm/Group Description:
Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth.
Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately.
Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth.
Overall Number of Participants Analyzed 17 17 18
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Hours*microgram per milliliter
16.609
(21%)
17.298
(20%)
16.735
(22%)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet, DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of geometric LS means
Estimated Value 1.0410
Confidence Interval (2-Sided) 90%
1.0121 to 1.0708
Estimation Comments Treatment comparison of pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg dispersible tablets) and adult TRIUMEQ (DTG 50 mg/ABC 600 mg/3TC 300 mg tablet) is presented.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet, DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of geometric LS means
Estimated Value 1.0232
Confidence Interval (2-Sided) 90%
0.9948 to 1.0524
Estimation Comments Treatment comparison of pediatric TRUMEQ (DTG 5 mg/ABC 60 mg/3TC 30mg dispersible tablet direct to mouth) and adult TRIUMEQ (DTG 50 mg/ABC 600 mg/3TC 300 mg tablet) is presented.
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets, DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of geometric LS means
Estimated Value 1.0174
Confidence Interval (2-Sided) 90%
0.9892 to 1.0465
Estimation Comments Treatment comparison of pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg dispersible tablets) and pediatric TRUMEQ (DTG 5 mg/ABC 60 mg/3TC 30mg dispersible tablet direct to mouth) is presented.
6.Primary Outcome
Title Cmax in Part 1 of ABC in Plasma
Hide Description 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.
Time Frame 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
Hide Outcome Measure Data
Hide Analysis Population Description
PK population.
Arm/Group Title DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth
Hide Arm/Group Description:
Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth.
Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately.
Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth.
Overall Number of Participants Analyzed 17 17 18
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Micrograms per milliliter
5.084
(19%)
5.351
(19%)
4.891
(23%)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet, DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of geometric LS means
Estimated Value 1.0533
Confidence Interval (2-Sided) 90%
0.9885 to 1.1223
Estimation Comments Treatment comparison of pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg dispersible tablets) and adult TRIUMEQ (DTG 50 mg/ABC 600 mg/3TC 300 mg tablet) is presented.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet, DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of geometric LS means
Estimated Value 0.9766
Confidence Interval (2-Sided) 90%
0.9167 to 1.0405
Estimation Comments Treatment comparison of pediatric TRUMEQ (DTG 5 mg/ABC 60 mg/3TC 30mg dispersible tablet direct to mouth) and adult TRIUMEQ (DTG 50 mg/ABC 600 mg/3TC 300 mg tablet) is presented.
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets, DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of geometric LS means
Estimated Value 1.0785
Confidence Interval (2-Sided) 90%
1.0123 to 1.1490
Estimation Comments Treatment comparison of pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg dispersible tablets) and pediatric TRUMEQ (DTG 5 mg/ABC 60 mg/3TC 30mg dispersible tablet direct to mouth) is presented.
7.Primary Outcome
Title AUC(0-inf) in Part 1 of 3TC
Hide Description 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.
Time Frame 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
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population
Arm/Group Title DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth
Hide Arm/Group Description:
Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth.
Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately.
Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth.
Overall Number of Participants Analyzed 17 17 18
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Hours*microgram per milliliter
13.087
(26%)
13.062
(24%)
12.155
(30%)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet, DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of geometric LS means
Estimated Value 1.0000
Confidence Interval (2-Sided) 90%
0.9536 to 1.0486
Estimation Comments Treatment comparison of pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg dispersible tablets) and adult TRIUMEQ (DTG 50 mg/ABC 600 mg/3TC 300 mg tablet) is presented.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet, DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of geometric LS means
Estimated Value 0.9478
Confidence Interval (2-Sided) 90%
0.9039 to 0.9939
Estimation Comments Treatment comparison of pediatric TRUMEQ (DTG 5 mg/ABC 60 mg/3TC 30mg dispersible tablet direct to mouth) and adult TRIUMEQ (DTG 50 mg/ABC 600 mg/3TC 300 mg tablet) is presented.
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets, DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of geometric LS means
Estimated Value 1.0550
Confidence Interval (2-Sided) 90%
1.0061 to 1.1063
Estimation Comments Treatment comparison of pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg dispersible tablets) and pediatric TRUMEQ (DTG 5 mg/ABC 60 mg/3TC 30mg dispersible tablet direct to mouth) is presented.
8.Primary Outcome
Title AUC (0-t) in Part 1 of 3TC
Hide Description 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.
Time Frame 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
Hide Outcome Measure Data
Hide Analysis Population Description
PK population
Arm/Group Title DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth
Hide Arm/Group Description:
Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth.
Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately.
Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth.
Overall Number of Participants Analyzed 17 17 18
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Hours*microgram per milliliter
12.857
(26%)
12.829
(24%)
11.893
(29%)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet, DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of geometric LS means
Estimated Value 0.9994
Confidence Interval (2-Sided) 90%
0.9525 to 1.0486
Estimation Comments Treatment comparison of pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg dispersible tablets) and adult TRIUMEQ (DTG 50 mg/ABC 600 mg/3TC 300 mg tablet) is presented.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet, DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of geometric LS means
Estimated Value 0.9432
Confidence Interval (2-Sided) 90%
0.8990 to 0.9896
Estimation Comments Treatment comparison of pediatric TRUMEQ (DTG 5 mg/ABC 60 mg/3TC 30mg dispersible tablet direct to mouth) and adult TRIUMEQ (DTG 50 mg/ABC 600 mg/3TC 300 mg tablet) is presented.
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets, DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of geometric LS means
Estimated Value 1.0596
Confidence Interval (2-Sided) 90%
1.0099 to 1.1117
Estimation Comments Treatment comparison of pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg dispersible tablets) and pediatric TRUMEQ (DTG 5 mg/ABC 60 mg/3TC 30mg dispersible tablet direct to mouth) is presented.
9.Primary Outcome
Title Cmax in Part 1 of 3TC
Hide Description 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
Time Frame 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
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population.
Arm/Group Title DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth
Hide Arm/Group Description:
Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth.
Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately.
Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth.
Overall Number of Participants Analyzed 17 17 18
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Micrograms per milliliter
2.194
(29%)
2.053
(35%)
1.947
(34%)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet, DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of geometric LS means
Estimated Value 0.9362
Confidence Interval (2-Sided) 90%
0.8677 to 1.0101
Estimation Comments Treatment comparison of pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg dispersible tablets) and adult TRIUMEQ (DTG 50 mg/ABC 600 mg/3TC 300 mg tablet) is presented.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet, DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of geometric LS means
Estimated Value 0.9079
Confidence Interval (2-Sided) 90%
0.8416 to 0.9795
Estimation Comments Treatment comparison of pediatric TRUMEQ (DTG 5 mg/ABC 60 mg/3TC 30mg dispersible tablet direct to mouth) and adult TRIUMEQ (DTG 50 mg/ABC 600 mg/3TC 300 mg tablet) is presented.
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets, DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of geometric LS means
Estimated Value 1.0312
Confidence Interval (2-Sided) 90%
0.9558 to 1.1124
Estimation Comments Treatment comparison of pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg dispersible tablets) and pediatric TRUMEQ (DTG 5 mg/ABC 60 mg/3TC 30mg dispersible tablet direct to mouth) is presented.
10.Primary Outcome
Title AUC(0-inf) in Part 2 of DTG in Plasma
Hide Description 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.
Time Frame 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
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population
Arm/Group Title DTG 50 mg/3TC 300 mg Tablet DTG 5 mg/3TC 30 mg Dispersible Tablet DTG 5 mg/3TC 30 mg Dispersible Tablet Direct to Mouth
Hide Arm/Group Description:
Participants received adult DTG and 3TC as one conventional tablet direct-to-mouth
Participants received 10 dispersible pediatric DTG/3TC tablets as dispersion
Participants received 10 dispersible pediatric DTG/3TC tablets direct-to-mouth
Overall Number of Participants Analyzed 18 18 18
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Hours*microgram per milliliter
53.942
(38%)
88.676
(31%)
68.496
(32%)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection DTG 50 mg/3TC 300 mg Tablet, DTG 5 mg/3TC 30 mg Dispersible Tablet
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of geometric LS means
Estimated Value 1.6439
Confidence Interval (2-Sided) 90%
1.4649 to 1.8449
Estimation Comments Treatment comparison of pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet) and adult DTG/3TC (DTG 50 mg/3TC 300 mg tablet) is presented.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection DTG 50 mg/3TC 300 mg Tablet, DTG 5 mg/3TC 30 mg Dispersible Tablet Direct to Mouth
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of geometric LS means
Estimated Value 1.2698
Confidence Interval (2-Sided) 90%
1.1315 to 1.4250
Estimation Comments Treatment comparison of pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet direct to mouth) and pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet) is presented.
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection DTG 5 mg/3TC 30 mg Dispersible Tablet, DTG 5 mg/3TC 30 mg Dispersible Tablet Direct to Mouth
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of geometric LS means
Estimated Value 1.2946
Confidence Interval (2-Sided) 90%
1.1536 to 1.4529
Estimation Comments Treatment comparison of pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet direct to mouth) and pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet direct to mouth) is presented.
11.Primary Outcome
Title AUC(0-t) in Part 2 of DTG
Hide Description 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.
Time Frame 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
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population.
Arm/Group Title DTG 50 mg/3TC 300 mg Tablet DTG 5 mg/3TC 30 mg Dispersible Tablet DTG 5 mg/3TC 30 mg Dispersible Tablet Direct to Mouth
Hide Arm/Group Description:
Participants received adult DTG and 3TC as one conventional tablet direct-to-mouth
Participants received 10 dispersible pediatric DTG/3TC tablets as dispersion
Participants received 10 dispersible pediatric DTG/3TC tablets direct-to-mouth
Overall Number of Participants Analyzed 18 18 18
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Hours*microgram per milliliter
51.477
(38%)
85.340
(30%)
65.657
(31%)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection DTG 50 mg/3TC 300 mg Tablet, DTG 5 mg/3TC 30 mg Dispersible Tablet
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of geometric LS means
Estimated Value 1.6578
Confidence Interval (2-Sided) 90%
1.4709 to 1.8685
Estimation Comments Treatment comparison of pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet) and adult DTG/3TC (DTG 50 mg/3TC 300 mg tablet) is presented.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection DTG 50 mg/3TC 300 mg Tablet, DTG 5 mg/3TC 30 mg Dispersible Tablet Direct to Mouth
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of geometric LS means
Estimated Value 1.2755
Confidence Interval (2-Sided) 90%
1.1317 to 1.4375
Estimation Comments Treatment comparison of pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet direct to mouth) and pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet) is presented.
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection DTG 5 mg/3TC 30 mg Dispersible Tablet, DTG 5 mg/3TC 30 mg Dispersible Tablet Direct to Mouth
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of geometric LS means
Estimated Value 1.2998
Confidence Interval (2-Sided) 90%
1.1533 to 1.4650
Estimation Comments Treatment comparison of pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet direct to mouth) and pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet direct to mouth) is presented.
12.Primary Outcome
Title Cmax in Part 2 of DTG in Plasma
Hide Description 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.
Time Frame 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
Hide Outcome Measure Data
Hide Analysis Population Description
PK population
Arm/Group Title DTG 50 mg/3TC 300 mg Tablet DTG 5 mg/3TC 30 mg Dispersible Tablet DTG 5 mg/3TC 30 mg Dispersible Tablet Direct to Mouth
Hide Arm/Group Description:
Participants received adult DTG and 3TC as one conventional tablet direct-to-mouth
Participants received 10 dispersible pediatric DTG/3TC tablets as dispersion
Participants received 10 dispersible pediatric DTG/3TC tablets direct-to-mouth
Overall Number of Participants Analyzed 18 18 18
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Micrograms per milliliter
2.764
(44%)
5.461
(18%)
3.558
(28%)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection DTG 50 mg/3TC 300 mg Tablet, DTG 5 mg/3TC 30 mg Dispersible Tablet
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of geometric LS means
Estimated Value 1.9758
Confidence Interval (2-Sided) 90%
1.7585 to 2.2201
Estimation Comments Treatment comparison of pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet) and adult DTG/3TC (DTG 50 mg/3TC 300 mg tablet) is presented.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection DTG 50 mg/3TC 300 mg Tablet, DTG 5 mg/3TC 30 mg Dispersible Tablet Direct to Mouth
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of geometric LS means
Estimated Value 1.2873
Confidence Interval (2-Sided) 90%
1.1457 to 1.4465
Estimation Comments Treatment comparison of pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet direct to mouth) and pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet) is presented.
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection DTG 5 mg/3TC 30 mg Dispersible Tablet, DTG 5 mg/3TC 30 mg Dispersible Tablet Direct to Mouth
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of geometric LS means
Estimated Value 1.5348
Confidence Interval (2-Sided) 90%
1.3660 to 1.7245
Estimation Comments Treatment comparison of pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet direct to mouth) and pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet direct to mouth) is presented.
13.Primary Outcome
Title AUC(0-inf) in Part 2 of 3TC
Hide Description 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.
Time Frame 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
Hide Outcome Measure Data
Hide Analysis Population Description
PK population
Arm/Group Title DTG 50 mg/3TC 300 mg Tablet DTG 5 mg/3TC 30 mg Dispersible Tablet DTG 5 mg/3TC 30 mg Dispersible Tablet Direct to Mouth
Hide Arm/Group Description:
Participants received adult DTG and 3TC as one conventional tablet direct-to-mouth
Participants received 10 dispersible pediatric DTG/3TC tablets as dispersion
Participants received 10 dispersible pediatric DTG/3TC tablets direct-to-mouth
Overall Number of Participants Analyzed 18 18 18
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Hours*microgram per milliliter
12.245
(17%)
12.149
(21%)
11.910
(20%)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection DTG 50 mg/3TC 300 mg Tablet, DTG 5 mg/3TC 30 mg Dispersible Tablet
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of geometric LS means
Estimated Value 0.9798
Confidence Interval (2-Sided) 90%
0.9241 to 1.0389
Estimation Comments Treatment comparison of pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet) and adult DTG/3TC (DTG 50 mg/3TC 300 mg tablet) is presented.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection DTG 50 mg/3TC 300 mg Tablet, DTG 5 mg/3TC 30 mg Dispersible Tablet Direct to Mouth
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of geometric LS means
Estimated Value 0.9605
Confidence Interval (2-Sided) 90%
0.9059 to 1.0185
Estimation Comments Treatment comparison of pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet direct to mouth) and pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet) is presented.
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection DTG 5 mg/3TC 30 mg Dispersible Tablet, DTG 5 mg/3TC 30 mg Dispersible Tablet Direct to Mouth
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of geometric LS means
Estimated Value 1.0201
Confidence Interval (2-Sided) 90%
0.9633 to 1.0802
Estimation Comments Treatment comparison of pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet direct to mouth) and pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet direct to mouth) is presented.
14.Primary Outcome
Title AUC(0-t) in Part 2 of 3TC
Hide Description 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.
Time Frame 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
Hide Outcome Measure Data
Hide Analysis Population Description
PK population
Arm/Group Title DTG 50 mg/3TC 300 mg Tablet DTG 5 mg/3TC 30 mg Dispersible Tablet DTG 5 mg/3TC 30 mg Dispersible Tablet Direct to Mouth
Hide Arm/Group Description:
Participants received adult DTG and 3TC as one conventional tablet direct-to-mouth
Participants received 10 dispersible pediatric DTG/3TC tablets as dispersion
Participants received 10 dispersible pediatric DTG/3TC tablets direct-to-mouth
Overall Number of Participants Analyzed 18 18 18
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Hours*microgram per milliliter
11.991
(16%)
11.788
(20%)
11.633
(19%)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection DTG 50 mg/3TC 300 mg Tablet, DTG 5 mg/3TC 30 mg Dispersible Tablet
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of geometric LS means
Estimated Value 0.9831
Confidence Interval (2-Sided) 90%
0.9243 to 1.0457
Estimation Comments Treatment comparison of pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet) and adult DTG/3TC (DTG 50 mg/3TC 300 mg tablet) is presented.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection DTG 50 mg/3TC 300 mg Tablet, DTG 5 mg/3TC 30 mg Dispersible Tablet Direct to Mouth
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of geometric LS means
Estimated Value 0.9702
Confidence Interval (2-Sided) 90%
0.9121 to 1.0320
Estimation Comments Treatment comparison of pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet direct to mouth) and pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet) is presented.
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection DTG 5 mg/3TC 30 mg Dispersible Tablet, DTG 5 mg/3TC 30 mg Dispersible Tablet Direct to Mouth
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of geometric LS means
Estimated Value 1.0134
Confidence Interval (2-Sided) 90%
0.9527 to 1.0779
Estimation Comments Treatment comparison of pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet direct to mouth) and pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet direct to mouth) is presented.
15.Primary Outcome
Title Cmax in Part 2 of 3TC
Hide Description 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.
Time Frame 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
Hide Outcome Measure Data
Hide Analysis Population Description
PK population
Arm/Group Title DTG 50 mg/3TC 300 mg Tablet DTG 5 mg/3TC 30 mg Dispersible Tablet DTG 5 mg/3TC 30 mg Dispersible Tablet Direct to Mouth
Hide Arm/Group Description:
Participants received adult DTG and 3TC as one conventional tablet direct-to-mouth
Participants received 10 dispersible pediatric DTG/3TC tablets as dispersion
Participants received 10 dispersible pediatric DTG/3TC tablets direct-to-mouth
Overall Number of Participants Analyzed 18 18 18
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Micrograms per milliliter
2.276
(28%)
2.071
(27%)
2.093
(29%)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection DTG 50 mg/3TC 300 mg Tablet, DTG 5 mg/3TC 30 mg Dispersible Tablet
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of geometric LS means
Estimated Value 0.9100
Confidence Interval (2-Sided) 90%
0.8196 to 1.0102
Estimation Comments Treatment comparison of pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet) and adult DTG/3TC (DTG 50 mg/3TC 300 mg tablet) is presented.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection DTG 50 mg/3TC 300 mg Tablet, DTG 5 mg/3TC 30 mg Dispersible Tablet Direct to Mouth
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of geometric LS means
Estimated Value 0.9198
Confidence Interval (2-Sided) 90%
0.8285 to 1.0212
Estimation Comments Treatment comparison of pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet direct to mouth) and pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet) is presented.
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection DTG 5 mg/3TC 30 mg Dispersible Tablet, DTG 5 mg/3TC 30 mg Dispersible Tablet Direct to Mouth
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of geometric LS means
Estimated Value 0.9893
Confidence Interval (2-Sided) 90%
0.8911 to 1.0983
Estimation Comments Treatment comparison of pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet direct to mouth) and pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet direct to mouth) is presented.
16.Secondary Outcome
Title AUC From Time of Dose to 24 Hours (AUC[0-24]) of DTG in Part 1
Hide Description 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.
Time Frame 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
Hide Outcome Measure Data
Hide Analysis Population Description
PK population.
Arm/Group Title DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth
Hide Arm/Group Description:
Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth.
Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately.
Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth.
Overall Number of Participants Analyzed 17 17 18
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Hours*microgram per milliliter
40.264
(23%)
69.745
(17%)
53.250
(22%)
17.Secondary Outcome
Title Time to Maximum Concentration (Tmax) of DTG in Plasma in Part 1
Hide Description 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.
Time Frame 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
Hide Outcome Measure Data
Hide Analysis Population Description
PK population.
Arm/Group Title DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth
Hide Arm/Group Description:
Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth.
Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately.
Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth.
Overall Number of Participants Analyzed 17 17 18
Median (Full Range)
Unit of Measure: Hours
3.00
(1.50 to 4.08)
2.50
(1.00 to 6.00)
3.00
(1.00 to 6.00)
18.Secondary Outcome
Title Time of Last Quantifiable Concentration (Tlast) of DTG in Part 1
Hide Description 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.
Time Frame 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
Hide Outcome Measure Data
Hide Analysis Population Description
PK population.
Arm/Group Title DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth
Hide Arm/Group Description:
Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth.
Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately.
Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth.
Overall Number of Participants Analyzed 17 17 18
Median (Full Range)
Unit of Measure: Hours
72.00
(72.00 to 72.00)
72.00
(72.00 to 72.30)
72.00
(72.00 to 72.02)
19.Secondary Outcome
Title Apparent Oral Clearance (CL/F) of DTG in Plasma in Part 1
Hide Description 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.
Time Frame 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
Hide Outcome Measure Data
Hide Analysis Population Description
PK population
Arm/Group Title DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth
Hide Arm/Group Description:
Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth.
Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately.
Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth.
Overall Number of Participants Analyzed 17 17 18
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Liters per hour
0.8367
(31%)
0.4944
(22%)
0.6432
(29%)
20.Secondary Outcome
Title Apparent Volume of Distribution (Vz/F) of DTG in Part 1
Hide Description 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.
Time Frame 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
Hide Outcome Measure Data
Hide Analysis Population Description
PK population
Arm/Group Title DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth
Hide Arm/Group Description:
Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth.
Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately.
Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth.
Overall Number of Participants Analyzed 17 17 18
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Liters
17.260
(20%)
10.074
(20%)
12.998
(21%)
21.Secondary Outcome
Title Observed Concentration at 24 Hours Postdose (C24) of DTG in Plasma in Part 1
Hide Description 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.
Time Frame 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
Hide Outcome Measure Data
Hide Analysis Population Description
PK population
Arm/Group Title DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth
Hide Arm/Group Description:
Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth.
Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately.
Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth.
Overall Number of Participants Analyzed 17 17 18
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Nanograms per millilter
925.303
(34%)
1523.534
(28%)
1198.948
(33%)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet, DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of geometric LS means
Estimated Value 1.6503
Confidence Interval (2-Sided) 90%
1.5131 to 1.8000
Estimation Comments Treatment comparison of pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg dispersible tablets) and adult TRIUMEQ (DTG 50 mg/ABC 600 mg/3TC 300 mg tablet) is presented.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet, DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of geometric LS means
Estimated Value 1.3501
Confidence Interval (2-Sided) 90%
1.2381 to 1.4722
Estimation Comments Treatment comparison of pediatric TRUMEQ (DTG 5 mg/ABC 60 mg/3TC 30mg dispersible tablet direct to mouth) and adult TRIUMEQ (DTG 50 mg/ABC 600 mg/3TC 300 mg tablet) is presented.
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets, DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of geometric LS means
Estimated Value 1.2224
Confidence Interval (2-Sided) 90%
1.1210 to 1.3330
Estimation Comments Treatment comparison of pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg dispersible tablets) and pediatric TRUMEQ (DTG 5 mg/ABC 60 mg/3TC 30mg dispersible tablet direct to mouth) is presented.
22.Secondary Outcome
Title Last Observed Quantifiable Concentration (Ct) of DTG in Plasma in Part 1
Hide Description 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.
Time Frame 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
Hide Outcome Measure Data
Hide Analysis Population Description
PK population
Arm/Group Title DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth
Hide Arm/Group Description:
Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth.
Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately.
Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth.
Overall Number of Participants Analyzed 17 17 18
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Nanograms per milliliter
84.968
(83%)
138.258
(65%)
106.140
(80%)
23.Secondary Outcome
Title Terminal Elimination Phase Half-life (t½) of DTG in Plasma in Part 1
Hide Description 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.
Time Frame 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
Hide Outcome Measure Data
Hide Analysis Population Description
PK population
Arm/Group Title DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth
Hide Arm/Group Description:
Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth.
Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately.
Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth.
Overall Number of Participants Analyzed 17 17 18
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Hours
14.300
(21%)
14.123
(18%)
14.008
(20%)
24.Secondary Outcome
Title Lag Time for Absorption (Tlag) of DTG in Part 1
Hide Description 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.
Time Frame 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
Hide Outcome Measure Data
Hide Analysis Population Description
PK population
Arm/Group Title DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth
Hide Arm/Group Description:
Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth.
Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately.
Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth.
Overall Number of Participants Analyzed 17 17 18
Median (Full Range)
Unit of Measure: Hours
0.00
(0.00 to 0.25)
0.00
(0.00 to 0.00)
0.00
(0.00 to 0.00)
25.Secondary Outcome
Title AUC(0-24) of ABC in Plasma in Part 1
Hide Description 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.
Time Frame 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
Hide Outcome Measure Data
Hide Analysis Population Description
PK population
Arm/Group Title DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth
Hide Arm/Group Description:
Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth.
Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately.
Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth.
Overall Number of Participants Analyzed 17 17 18
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Hours*microgram per milliliter
16.619
(21%)
17.300
(20%)
16.743
(22%)
26.Secondary Outcome
Title Tmax of ABC in Plasma in Part 1
Hide Description 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.
Time Frame 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
Hide Outcome Measure Data
Hide Analysis Population Description
PK population
Arm/Group Title DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth
Hide Arm/Group Description:
Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth.
Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately.
Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth.
Overall Number of Participants Analyzed 17 17 18
Median (Full Range)
Unit of Measure: Hours
1.50
(0.50 to 2.57)
1.00
(0.25 to 2.00)
1.00
(0.25 to 2.00)
27.Secondary Outcome
Title Tlast of ABC in Part 1
Hide Description 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.
Time Frame 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
Hide Outcome Measure Data
Hide Analysis Population Description
PK population
Arm/Group Title DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth
Hide Arm/Group Description:
Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth.
Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately.
Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth.
Overall Number of Participants Analyzed 17 17 18
Median (Full Range)
Unit of Measure: Hours
24.00
(16.00 to 24.07)
24.00
(16.00 to 24.12)
24.00
(16.00 to 24.07)
28.Secondary Outcome
Title CL/F of ABC in Plasma in Part 1
Hide Description 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.
Time Frame 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
Hide Outcome Measure Data
Hide Analysis Population Description
PK population
Arm/Group Title DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth
Hide Arm/Group Description:
Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth.
Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately.
Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth.
Overall Number of Participants Analyzed 17 17 18
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Liters per hour
36.0658
(21%)
34.6391
(20%)
35.8073
(22%)
29.Secondary Outcome
Title Vz/F of ABC in Part 1
Hide Description 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.
Time Frame 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
Hide Outcome Measure Data
Hide Analysis Population Description
PK population
Arm/Group Title DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth
Hide Arm/Group Description:
Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth.
Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately.
Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth.
Overall Number of Participants Analyzed 17 17 18
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Liters
120.412
(46%)
126.171
(39%)
123.076
(42%)
30.Secondary Outcome
Title C24 of ABC in Plasma in Part 1
Hide Description 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.
Time Frame 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
Hide Outcome Measure Data
Hide Analysis Population Description
PK population
Arm/Group Title DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth
Hide Arm/Group Description:
Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth.
Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately.
Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth.
Overall Number of Participants Analyzed 17 17 18
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Nanograms per millilter
4.862
(45%)
4.491
(56%)
4.274
(26%)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet, DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of geometric LS means
Estimated Value 1.0251
Confidence Interval (2-Sided) 90%
0.8480 to 1.2392
Estimation Comments Treatment comparison between Pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg, 10 dispersible tablets) and Adult TRIUMEQ (DTG 50 mg/ABC 600 mg/3TC 300 mg, 1 conventional tablet) is presented
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet, DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of geometric LS means
Estimated Value 0.9181
Confidence Interval (2-Sided) 90%
0.7592 to 1.1103
Estimation Comments Treatment comparison between Pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg, 10 dispersible tablets) and Adult TRIUMEQ (DTG 50 mg/ABC 600 mg/3TC 300 mg, 1 conventional tablet) is presented
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets, DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of geometric LS means
Estimated Value 1.1165
Confidence Interval (2-Sided) 90%
0.9376 to 1.3295
Estimation Comments Treatment comparison between Pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg, 10 dispersible tablets) and Pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg, 10 dispersible tablets) is presented
31.Secondary Outcome
Title Ct of ABC in Plasma in Part 1
Hide Description 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.
Time Frame 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
Hide Outcome Measure Data
Hide Analysis Population Description
PK population
Arm/Group Title DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth
Hide Arm/Group Description:
Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth.
Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately.
Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth.
Overall Number of Participants Analyzed 17 17 18
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Nanograms per milliliter
6.852
(74%)
4.788
(58%)
5.466
(55%)
32.Secondary Outcome
Title T½ of ABC in Plasma in Part 1
Hide Description 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.
Time Frame 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
Hide Outcome Measure Data
Hide Analysis Population Description
PK population
Arm/Group Title DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth
Hide Arm/Group Description:
Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth.
Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately.
Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth.
Overall Number of Participants Analyzed 17 17 18
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Hours
2.314
(30%)
2.525
(26%)
2.382
(29%)
33.Secondary Outcome
Title AUC(0-24) of 3TC in Plasma in Part 1
Hide Description 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.
Time Frame 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
Hide Outcome Measure Data
Hide Analysis Population Description
PK population
Arm/Group Title DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth
Hide Arm/Group Description:
Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth.
Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately.
Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth.
Overall Number of Participants Analyzed 17 17 18
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Hours*microgram per milliliter
11.968
(26%)
11.927
(26%)
10.952
(30%)
34.Secondary Outcome
Title Tmax of 3TC in Part 1
Hide Description 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.
Time Frame 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
Hide Outcome Measure Data
Hide Analysis Population Description
PK population
Arm/Group Title DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth
Hide Arm/Group Description:
Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth.
Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately.
Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth.
Overall Number of Participants Analyzed 17 17 18
Median (Full Range)
Unit of Measure: Hours
2.50
(1.50 to 5.05)
2.50
(1.00 to 4.00)
2.50
(1.50 to 4.08)
35.Secondary Outcome
Title Tlast of 3TC in Plasma in Part 1
Hide Description 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.
Time Frame 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
Hide Outcome Measure Data
Hide Analysis Population Description
PK population
Arm/Group Title DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth
Hide Arm/Group Description:
Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth.
Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately.
Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth.
Overall Number of Participants Analyzed 17 17 18
Median (Full Range)
Unit of Measure: Hours
72.00
(48.00 to 72.00)
72.00
(48.00 to 72.30)
72.00
(48.00 to 72.02)
36.Secondary Outcome
Title CL/F of 3TC in Plasma in Part 1
Hide Description 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.
Time Frame 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
Hide Outcome Measure Data
Hide Analysis Population Description
PK population
Arm/Group Title DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth
Hide Arm/Group Description:
Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth.
Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately.
Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth.
Overall Number of Participants Analyzed 17 17 18
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Liters per hour
22.9237
(26%)
22.9679
(24%)
24.6802
(30%)
37.Secondary Outcome
Title Vz/F of 3TC in Plasma in Part 1
Hide Description 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.
Time Frame 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
Hide Outcome Measure Data
Hide Analysis Population Description
PK population
Arm/Group Title DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth
Hide Arm/Group Description:
Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth.
Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately.
Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth.
Overall Number of Participants Analyzed 17 17 18
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Liters
594.270
(31%)
591.102
(37%)
642.945
(38%)
38.Secondary Outcome
Title C24 of 3TC in Plasma in Part 1
Hide Description 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.
Time Frame 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
Hide Outcome Measure Data
Hide Analysis Population Description
PK population
Arm/Group Title DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth
Hide Arm/Group Description:
Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth.
Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately.
Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth.
Overall Number of Participants Analyzed 17 17 18
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Nanograms per millilter
37.963
(29%)
40.913
(24%)
42.434
(27%)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet, DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of geometric LS means
Estimated Value 1.0844
Confidence Interval (2-Sided) 90%
0.9904 to 1.1873
Estimation Comments Treatment comparison between Pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg, 10 dispersible tablets) and Adult TRIUMEQ (DTG 50 mg/ABC 600 mg/3TC 300 mg, 1 conventional tablet) is presented
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet, DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of geometric LS means
Estimated Value 1.1311
Confidence Interval (2-Sided) 90%
1.0334 to 1.2379
Estimation Comments Treatment comparison between Pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg, 10 dispersible tablets) and Adult TRIUMEQ (DTG 50 mg/ABC 600 mg/3TC 300 mg, 1 conventional tablet) is presented
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets, DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of geometric LS means
Estimated Value 0.9587
Confidence Interval (2-Sided) 90%
0.8760 to 1.0493
Estimation Comments Treatment comparison of pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg dispersible tablets) and pediatric TRUMEQ (DTG 5 mg/ABC 60 mg/3TC 30mg dispersible tablet direct to mouth) is presented.
39.Secondary Outcome
Title Ct of 3TC in Plasma in Part 1
Hide Description 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.
Time Frame 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
Hide Outcome Measure Data
Hide Analysis Population Description
PK population
Arm/Group Title DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth
Hide Arm/Group Description:
Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth.
Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately.
Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth.
Overall Number of Participants Analyzed 17 17 18
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Nanograms per milliliter
6.552
(62%)
6.798
(53%)
7.251
(64%)
40.Secondary Outcome
Title T½ of 3TC in Plasma in Part 1
Hide Description 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.
Time Frame 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
Hide Outcome Measure Data
Hide Analysis Population Description
PK population
Arm/Group Title DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth
Hide Arm/Group Description:
Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth.
Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately.
Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth.
Overall Number of Participants Analyzed 17 17 18
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Hours
17.969
(36%)
17.839
(35%)
18.057
(39%)
41.Secondary Outcome
Title AUC (0-24) of DTG in Plasma in Part 2
Hide Description 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.
Time Frame 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
Hide Outcome Measure Data
Hide Analysis Population Description
PK population
Arm/Group Title DTG 50 mg/3TC 300 mg Tablet DTG 5 mg/3TC 30 mg Dispersible Tablet DTG 5 mg/3TC 30mg Dispersible Tablet Direct to Mouth
Hide Arm/Group Description:
Participants received adult DTG and 3TC as one conventional tablet direct-to-mouth
Participants received 10 dispersible pediatric DTG/3TC tablets as dispersion
Participants received 10 dispersible pediatric DTG/3TC tablets direct-to-mouth
Overall Number of Participants Analyzed 18 18 18
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Hours*microgram per milliliter
35.742
(39%)
61.220
(26%)
46.205
(29%)
42.Secondary Outcome
Title Tmax of DTG in Plasma in Part 2
Hide Description 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.
Time Frame 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
Hide Outcome Measure Data
Hide Analysis Population Description
PK population
Arm/Group Title DTG 50 mg/3TC 300 mg Tablet DTG 5 mg/3TC 30 mg Dispersible Tablet DTG 5 mg/3TC 30mg Dispersible Tablet Direct to Mouth
Hide Arm/Group Description:
Participants received adult DTG and 3TC as one conventional tablet direct-to-mouth
Participants received 10 dispersible pediatric DTG/3TC tablets as dispersion
Participants received 10 dispersible pediatric DTG/3TC tablets direct-to-mouth
Overall Number of Participants Analyzed 18 18 18
Median (Full Range)
Unit of Measure: Hours
2.77
(0.50 to 5.00)
0.77
(0.50 to 4.00)
1.79
(0.50 to 5.00)
43.Secondary Outcome
Title Tlast of DTG in Plasma in Part 2
Hide Description 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.
Time Frame 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
Hide Outcome Measure Data
Hide Analysis Population Description
PK population
Arm/Group Title DTG 50 mg/3TC 300 mg Tablet DTG 5 mg/3TC 30 mg Dispersible Tablet DTG 5 mg/3TC 30mg Dispersible Tablet Direct to Mouth
Hide Arm/Group Description:
Participants received adult DTG and 3TC as one conventional tablet direct-to-mouth
Participants received 10 dispersible pediatric DTG/3TC tablets as dispersion
Participants received 10 dispersible pediatric DTG/3TC tablets direct-to-mouth
Overall Number of Participants Analyzed 18 18 18
Median (Full Range)
Unit of Measure: Hours
72.00
(48.00 to 72.00)
72.00
(72.00 to 72.05)
72.00
(48.00 to 72.05)
44.Secondary Outcome
Title CL/F of DTG in Plasma in Part 2
Hide Description 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.
Time Frame 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
Hide Outcome Measure Data
Hide Analysis Population Description
PK population
Arm/Group Title DTG 50 mg/3TC 300 mg Tablet DTG 5 mg/3TC 30 mg Dispersible Tablet DTG 5 mg/3TC 30mg Dispersible Tablet Direct to Mouth
Hide Arm/Group Description:
Participants received adult DTG and 3TC as one conventional tablet direct-to-mouth
Participants received 10 dispersible pediatric DTG/3TC tablets as dispersion
Participants received 10 dispersible pediatric DTG/3TC tablets direct-to-mouth
Overall Number of Participants Analyzed 18 18 18
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Liters per hour
0.9269
(38%)
0.5639
(31%)
0.7300
(32%)
45.Secondary Outcome
Title Vz/F of DTG in Plasma in Part 2
Hide Description 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.
Time Frame 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
Hide Outcome Measure Data
Hide Analysis Population Description
PK population
Arm/Group Title DTG 50 mg/3TC 300 mg Tablet DTG 5 mg/3TC 30 mg Dispersible Tablet DTG 5 mg/3TC 30mg Dispersible Tablet Direct to Mouth
Hide Arm/Group Description:
Participants received adult DTG and 3TC as one conventional tablet direct-to-mouth
Participants received 10 dispersible pediatric DTG/3TC tablets as dispersion
Participants received 10 dispersible pediatric DTG/3TC tablets direct-to-mouth
Overall Number of Participants Analyzed 18 18 18
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Liters
20.378
(42%)
11.950
(28%)
15.524
(30%)
46.Secondary Outcome
Title C24 of DTG in Plasma in Part 2
Hide Description 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.
Time Frame 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
Hide Outcome Measure Data
Hide Analysis Population Description
PK population
Arm/Group Title DTG 50 mg/3TC 300 mg Tablet DTG 5 mg/3TC 30 mg Dispersible Tablet DTG 5 mg/3TC 30mg Dispersible Tablet Direct to Mouth
Hide Arm/Group Description:
Participants received adult DTG and 3TC as one conventional tablet direct-to-mouth
Participants received 10 dispersible pediatric DTG/3TC tablets as dispersion
Participants received 10 dispersible pediatric DTG/3TC tablets direct-to-mouth
Overall Number of Participants Analyzed 18 18 18
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Nanograms per millilter
825.313
(39%)
1289.044
(37%)
1034.078
(33%)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection DTG 50 mg/3TC 300 mg Tablet, DTG 5 mg/3TC 30 mg Dispersible Tablet
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of geometric LS means
Estimated Value 1.5619
Confidence Interval (2-Sided) 90%
1.3678 to 1.7835
Estimation Comments Treatment comparison between Pediatric DTG/3TC (DTG 5 mg/3TC 30 mg, 10 dispersible tablets) and Adult DTG (50 mg, 1 conventional tablet) and adult 3TC (300 mg, 1 conventional tablet) is presented
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection DTG 50 mg/3TC 300 mg Tablet, DTG 5 mg/3TC 30mg Dispersible Tablet Direct to Mouth
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of geometric LS means
Estimated Value 1.2530
Confidence Interval (2-Sided) 90%
1.0973 to 1.4307
Estimation Comments Treatment comparison of pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet direct to mouth) and pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet) is presented.
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection DTG 5 mg/3TC 30 mg Dispersible Tablet, DTG 5 mg/3TC 30mg Dispersible Tablet Direct to Mouth
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of geometric LS means
Estimated Value 1.2466
Confidence Interval (2-Sided) 90%
1.0917 to 1.4234
Estimation Comments Treatment comparison of pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet direct to mouth) and pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet direct to mouth) is presented.
47.Secondary Outcome
Title Ct of DTG in Plasma in Part 2
Hide Description 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.
Time Frame 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
Hide Outcome Measure Data
Hide Analysis Population Description
PK population
Arm/Group Title DTG 50 mg/3TC 300 mg Tablet DTG 5 mg/3TC 30 mg Dispersible Tablet DTG 5 mg/3TC 30mg Dispersible Tablet Direct to Mouth
Hide Arm/Group Description:
Participants received adult DTG and 3TC as one conventional tablet direct-to-mouth
Participants received 10 dispersible pediatric DTG/3TC tablets as dispersion
Participants received 10 dispersible pediatric DTG/3TC tablets direct-to-mouth
Overall Number of Participants Analyzed 18 18 18
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Nanograms per milliliter
95.829
(47%)
131.216
(70%)
107.749
(64%)
48.Secondary Outcome
Title T½ of DTG in Plasma in Part 2
Hide Description 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.
Time Frame 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
Hide Outcome Measure Data
Hide Analysis Population Description
PK population
Arm/Group Title DTG 50 mg/3TC 300 mg Tablet DTG 5 mg/3TC 30 mg Dispersible Tablet DTG 5 mg/3TC 30mg Dispersible Tablet Direct to Mouth
Hide Arm/Group Description:
Participants received adult DTG and 3TC as one conventional tablet direct-to-mouth
Participants received 10 dispersible pediatric DTG/3TC tablets as dispersion
Participants received 10 dispersible pediatric DTG/3TC tablets direct-to-mouth
Overall Number of Participants Analyzed 18 18 18
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Hours
15.238
(21%)
14.690
(18%)
14.741
(23%)
49.Secondary Outcome
Title Tlag of DTG in Plasma in Part 2
Hide Description 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.
Time Frame 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
Hide Outcome Measure Data
Hide Analysis Population Description
PK population
Arm/Group Title DTG 50 mg/3TC 300 mg Tablet DTG 5 mg/3TC 30 mg Dispersible Tablet DTG 5 mg/3TC 30mg Dispersible Tablet Direct to Mouth
Hide Arm/Group Description:
Participants received adult DTG and 3TC as one conventional tablet direct-to-mouth
Participants received 10 dispersible pediatric DTG/3TC tablets as dispersion
Participants received 10 dispersible pediatric DTG/3TC tablets direct-to-mouth
Overall Number of Participants Analyzed 18 18 18
Median (Full Range)
Unit of Measure: Hours
0.00
(0.00 to 0.25)
0.00
(0.00 to 0.00)
0.00
(0.00 to 0.00)
50.Secondary Outcome
Title AUC (0-24) of 3TC in Plasma in Part 2
Hide Description 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.
Time Frame 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
Hide Outcome Measure Data
Hide Analysis Population Description
PK population
Arm/Group Title DTG 50 mg/3TC 300 mg Tablet DTG 5 mg/3TC 30 mg Dispersible Tablet DTG 5 mg/3TC 30mg Dispersible Tablet Direct to Mouth
Hide Arm/Group Description:
Participants received adult DTG and 3TC as one conventional tablet direct-to-mouth
Participants received 10 dispersible pediatric DTG/3TC tablets as dispersion
Participants received 10 dispersible pediatric DTG/3TC tablets direct-to-mouth
Overall Number of Participants Analyzed 18 18 18
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Hours*microgram per milliliter
11.070
(18%)
10.802
(21%)
10.673
(20%)
51.Secondary Outcome
Title Tmax of 3TC in Plasma in Part 2
Hide Description 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.
Time Frame 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
Hide Outcome Measure Data
Hide Analysis Population Description
PK population
Arm/Group Title DTG 50 mg/3TC 300 mg Tablet DTG 5 mg/3TC 30 mg Dispersible Tablet DTG 5 mg/3TC 30mg Dispersible Tablet Direct to Mouth
Hide Arm/Group Description:
Participants received adult DTG and 3TC as one conventional tablet direct-to-mouth
Participants received 10 dispersible pediatric DTG/3TC tablets as dispersion
Participants received 10 dispersible pediatric DTG/3TC tablets direct-to-mouth
Overall Number of Participants Analyzed 18 18 18
Median (Full Range)
Unit of Measure: Hours
1.00
(0.50 to 3.03)
1.50
(0.53 to 4.00)
1.50
(1.00 to 4.00)
52.Secondary Outcome
Title Tlast of 3TC in Plasma in Part 2
Hide Description 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.
Time Frame 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
Hide Outcome Measure Data
Hide Analysis Population Description
PK population
Arm/Group Title DTG 50 mg/3TC 300 mg Tablet DTG 5 mg/3TC 30 mg Dispersible Tablet DTG 5 mg/3TC 30mg Dispersible Tablet Direct to Mouth
Hide Arm/Group Description:
Participants received adult DTG and 3TC as one conventional tablet direct-to-mouth
Participants received 10 dispersible pediatric DTG/3TC tablets as dispersion
Participants received 10 dispersible pediatric DTG/3TC tablets direct-to-mouth
Overall Number of Participants Analyzed 18 18 18
Median (Full Range)
Unit of Measure: Hours
72.00
(72.00 to 72.00)
72.00
(72.00 to 72.05)
72.00
(72.00 to 72.05)
53.Secondary Outcome
Title CL/F of 3TC in Plasma in Part 2
Hide Description 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.
Time Frame 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
Hide Outcome Measure Data
Hide Analysis Population Description
PK population. Only those participants with data available at the specified time points were analyzed.
Arm/Group Title DTG 50 mg/3TC 300 mg Tablet DTG 5 mg/3TC 30 mg Dispersible Tablet DTG 5 mg/3TC 30mg Dispersible Tablet Direct to Mouth
Hide Arm/Group Description:
Participants received adult DTG and 3TC as one conventional tablet direct-to-mouth
Participants received 10 dispersible pediatric DTG/3TC tablets as dispersion
Participants received 10 dispersible pediatric DTG/3TC tablets direct-to-mouth
Overall Number of Participants Analyzed 17 18 18
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Liters per hour
24.4998
(17%)
24.6933
(21%)
25.1888
(20%)
54.Secondary Outcome
Title Vz/F of 3TC in Plasma in Part 2
Hide Description 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.
Time Frame 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
Hide Outcome Measure Data
Hide Analysis Population Description
PK population
Arm/Group Title DTG 50 mg/3TC 300 mg Tablet DTG 5 mg/3TC 30 mg Dispersible Tablet DTG 5 mg/3TC 30mg Dispersible Tablet Direct to Mouth
Hide Arm/Group Description:
Participants received adult DTG and 3TC as one conventional tablet direct-to-mouth
Participants received 10 dispersible pediatric DTG/3TC tablets as dispersion
Participants received 10 dispersible pediatric DTG/3TC tablets direct-to-mouth
Overall Number of Participants Analyzed 17 18 18
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Liters
730.859
(17%)
758.790
(28%)
711.280
(22%)
55.Secondary Outcome
Title C24 of 3TC in Plasma in Part 2
Hide Description 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.
Time Frame 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
Hide Outcome Measure Data
Hide Analysis Population Description
PK population
Arm/Group Title DTG 50 mg/3TC 300 mg Tablet DTG 5 mg/3TC 30 mg Dispersible Tablet DTG 5 mg/3TC 30mg Dispersible Tablet Direct to Mouth
Hide Arm/Group Description:
Participants received adult DTG and 3TC as one conventional tablet direct-to-mouth
Participants received 10 dispersible pediatric DTG/3TC tablets as dispersion
Participants received 10 dispersible pediatric DTG/3TC tablets direct-to-mouth
Overall Number of Participants Analyzed 18 18 18
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Nanograms per millilter
35.808
(21%)
38.475
(18%)
38.336
(24%)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection DTG 50 mg/3TC 300 mg Tablet, DTG 5 mg/3TC 30 mg Dispersible Tablet
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of geometric LS means
Estimated Value 1.0745
Confidence Interval (2-Sided) 90%
0.9997 to 1.1549
Estimation Comments Treatment comparison between Pediatric DTG/3TC (DTG 5 mg/3TC 30 mg, 10 dispersible tablets) and Adult DTG (50 mg, 1 conventional tablet) and adult 3TC (300 mg, 1 conventional tablet) is presented
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection DTG 50 mg/3TC 300 mg Tablet, DTG 5 mg/3TC 30mg Dispersible Tablet Direct to Mouth
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of geometric LS means
Estimated Value 1.0706
Confidence Interval (2-Sided) 90%
0.9961 to 1.1507
Estimation Comments Treatment comparison of pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet direct to mouth) and pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet) is presented.
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection DTG 5 mg/3TC 30 mg Dispersible Tablet, DTG 5 mg/3TC 30mg Dispersible Tablet Direct to Mouth
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of geometric LS means
Estimated Value 1.0036
Confidence Interval (2-Sided) 90%
0.9338 to 1.0787
Estimation Comments Treatment comparison of pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet direct to mouth) and pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet direct to mouth) is presented.
56.Secondary Outcome
Title Ct of 3TC in Plasma in Part 2
Hide Description 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.
Time Frame 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
Hide Outcome Measure Data
Hide Analysis Population Description
PK population
Arm/Group Title DTG 50 mg/3TC 300 mg Tablet DTG 5 mg/3TC 30 mg Dispersible Tablet DTG 5 mg/3TC 30mg Dispersible Tablet Direct to Mouth
Hide Arm/Group Description:
Participants received adult DTG and 3TC as one conventional tablet direct-to-mouth
Participants received 10 dispersible pediatric DTG/3TC tablets as dispersion
Participants received 10 dispersible pediatric DTG/3TC tablets direct-to-mouth
Overall Number of Participants Analyzed 18 18 18
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Nanograms per milliliter
7.735
(62%)
8.417
(67%)
7.480
(64%)
57.Secondary Outcome
Title T½ of 3TC in Plasma in Part 2
Hide Description 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.
Time Frame 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
Hide Outcome Measure Data
Hide Analysis Population Description
PK population
Arm/Group Title DTG 50 mg/3TC 300 mg Tablet DTG 5 mg/3TC 30 mg Dispersible Tablet DTG 5 mg/3TC 30mg Dispersible Tablet Direct to Mouth
Hide Arm/Group Description:
Participants received adult DTG and 3TC as one conventional tablet direct-to-mouth
Participants received 10 dispersible pediatric DTG/3TC tablets as dispersion
Participants received 10 dispersible pediatric DTG/3TC tablets direct-to-mouth
Overall Number of Participants Analyzed 17 18 18
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Hours
20.677
(22%)
21.299
(32%)
19.573
(24%)
58.Secondary Outcome
Title Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) in Part 1
Hide Description 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.
Time Frame Up to Day 33
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth
Hide Arm/Group Description:
Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth.
Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately.
Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth.
Overall Number of Participants Analyzed 17 17 18
Measure Type: Count of Participants
Unit of Measure: Participants
Any AE
1
   5.9%
1
   5.9%
2
  11.1%
Any SAE
0
   0.0%
0
   0.0%
0
   0.0%
59.Secondary Outcome
Title Number of Participants With AEs and Serious Adverse Events SAEs in Part 2
Hide Description 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.
Time Frame Up to Day 33
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population.
Arm/Group Title DTG 50 mg/3TC 300 mg Tablet DTG 5 mg/3TC 30 mg Dispersible Tablet DTG 5 mg/3TC 30mg Dispersible Tablet Direct to Mouth
Hide Arm/Group Description:
Participants received adult DTG and 3TC as one conventional tablet direct-to-mouth
Participants received 10 dispersible pediatric DTG/3TC tablets as dispersion
Participants received 10 dispersible pediatric DTG/3TC tablets direct-to-mouth
Overall Number of Participants Analyzed 18 18 18
Measure Type: Count of Participants
Unit of Measure: Participants
Any AE
1
   5.6%
0
   0.0%
1
   5.6%
Any SAE
0
   0.0%
0
   0.0%
0
   0.0%
60.Secondary Outcome
Title Absolute Values for Clinical Chemistry Parameters Measured in Part 1: Glucose, Calcium, Potassium, Sodium and Urea
Hide Description 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.
Time Frame Day 2 of each treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
All Participants Population.
Arm/Group Title DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth
Hide Arm/Group Description:
Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth.
Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately.
Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth.
Overall Number of Participants Analyzed 17 17 18
Mean (Standard Deviation)
Unit of Measure: Millimoles per liter
Glucose 5.031  (0.3501) 4.931  (0.3448) 4.933  (0.3709)
Calcium 2.377  (0.0577) 2.371  (0.0775) 2.384  (0.0704)
Potassium 4.31  (0.269) 4.26  (0.243) 4.28  (0.271)
Sodium 138.1  (2.19) 138.2  (1.48) 138.1  (1.55)
Urea 4.096  (0.9369) 4.293  (1.1218) 4.203  (1.0572)
61.Secondary Outcome
Title Absolute Values for Clinical Chemistry Parameters Measured in Part 1: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotranferase (AST) and Creatinine Phosphokinase (CPK)
Hide Description Blood samples were collected for the analysis of clinical chemistry parameters including ALT, ALP, AST and CPK.
Time Frame Day 2 of each treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
All Participants Population.
Arm/Group Title DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth
Hide Arm/Group Description:
Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth.
Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately.
Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth.
Overall Number of Participants Analyzed 17 17 18
Mean (Standard Deviation)
Unit of Measure: International units per Liter
ALT 15.3  (7.20) 14.8  (5.47) 15.3  (5.80)
ALP 54.4  (16.22) 55.1  (16.89) 54.4  (16.99)
AST 16.1  (3.35) 16.1  (3.51) 15.9  (3.29)
CPK 90.7  (57.16) 81.9  (39.34) 95.8  (52.83)
62.Secondary Outcome
Title Absolute Values for Clinical Chemistry Parameters Measured in Part 1: Albumin and Protein
Hide Description Blood samples were collected for the analysis of clinical chemistry parameters including albumin and protein.
Time Frame Day 2 of each treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
All Participants Population.
Arm/Group Title DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth
Hide Arm/Group Description:
Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth.
Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately.
Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth.
Overall Number of Participants Analyzed 17 17 18
Mean (Standard Deviation)
Unit of Measure: Grams per liter
Albumin 43.2  (2.82) 42.9  (2.76) 43.8  (2.58)
Protein 70.7  (4.55) 70.8  (4.59) 71.9  (3.73)
63.Secondary Outcome