Trial Outcomes & Findings for A Food-effect Study of the Pediatric Dispersible Tablet Formulations of TRIUMEQ® and DOVATO® in Healthy Adult Participants (NCT NCT04827134)
NCT ID: NCT04827134
Last Updated: 2023-06-05
Results Overview
Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis of DTG, ABC and 3TC. The PK parameters were calculated by standard non-compartmental analysis
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
33 participants
Primary outcome timeframe
Pre-dose, 0.25, 0.50, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 and 72 Hours post dose in each treatment periods 1 and 2
Results posted on
2023-06-05
Participant Flow
This study was conducted at a single center in the United States.
A total of 33 participants (16 participants in Cohort 1 and 17 participants in Cohort 2) were enrolled in the study.
Participant milestones
| Measure |
Cohort 1: TRIUMEQ Fed Followed by TRIUMEQ Fasted
Participants received TRIUMEQ (dolutegravir \[DTG\] 5 milligram \[mg\]/abacavir \[ABC\] 60 mg/lamivudine \[3TC\] 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) (Treatment A) in treatment period 1 followed by TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions (Treatment B) in treatment period 2. The treatment periods were separated by a washout period of about 7 days. All participants were followed-up for 7 to 14 days of last dose in treatment period 2.
|
Cohort 1: TRIUMEQ Fasted Followed by TRIUMEQ Fed
Participants received TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions (Treatment B) in treatment period 1 followed by TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) (Treatment A) in treatment period 2. The treatment periods were separated by a washout period of about 7 days. All participants were followed-up for 7 to 14 days of last dose in treatment period 2.
|
Cohort 2: DOVATO Fed Followed by DOVATO Fasted
Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) (Treatment C) in treatment period 1 followed by DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions (Treatment D) in treatment period 2. The treatment periods were separated by a washout period of about 7 days. All participants were followed-up for 7 to 14 days of last dose in treatment period 2.
|
Cohort 2: DOVATO Fasted Followed by DOVATO Fed
Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions (Treatment D) in treatment period 1 followed by DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) (Treatment C) in treatment period 2. The treatment periods were separated by a washout period of about 7 days. All participants were followed-up for 7 to 14 days of last dose in treatment period 2.
|
|---|---|---|---|---|
|
Treatment Period 1 (1 Day)
STARTED
|
8
|
8
|
8
|
9
|
|
Treatment Period 1 (1 Day)
COMPLETED
|
8
|
8
|
7
|
9
|
|
Treatment Period 1 (1 Day)
NOT COMPLETED
|
0
|
0
|
1
|
0
|
|
Washout Period (up to 7 Days)
STARTED
|
8
|
8
|
7
|
9
|
|
Washout Period (up to 7 Days)
COMPLETED
|
8
|
8
|
7
|
9
|
|
Washout Period (up to 7 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Treatment Period 2 (1 Day)
STARTED
|
8
|
8
|
7
|
9
|
|
Treatment Period 2 (1 Day)
COMPLETED
|
8
|
8
|
7
|
9
|
|
Treatment Period 2 (1 Day)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Cohort 1: TRIUMEQ Fed Followed by TRIUMEQ Fasted
Participants received TRIUMEQ (dolutegravir \[DTG\] 5 milligram \[mg\]/abacavir \[ABC\] 60 mg/lamivudine \[3TC\] 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) (Treatment A) in treatment period 1 followed by TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions (Treatment B) in treatment period 2. The treatment periods were separated by a washout period of about 7 days. All participants were followed-up for 7 to 14 days of last dose in treatment period 2.
|
Cohort 1: TRIUMEQ Fasted Followed by TRIUMEQ Fed
Participants received TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions (Treatment B) in treatment period 1 followed by TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) (Treatment A) in treatment period 2. The treatment periods were separated by a washout period of about 7 days. All participants were followed-up for 7 to 14 days of last dose in treatment period 2.
|
Cohort 2: DOVATO Fed Followed by DOVATO Fasted
Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) (Treatment C) in treatment period 1 followed by DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions (Treatment D) in treatment period 2. The treatment periods were separated by a washout period of about 7 days. All participants were followed-up for 7 to 14 days of last dose in treatment period 2.
|
Cohort 2: DOVATO Fasted Followed by DOVATO Fed
Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions (Treatment D) in treatment period 1 followed by DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) (Treatment C) in treatment period 2. The treatment periods were separated by a washout period of about 7 days. All participants were followed-up for 7 to 14 days of last dose in treatment period 2.
|
|---|---|---|---|---|
|
Treatment Period 1 (1 Day)
Withdrawal by Subject
|
0
|
0
|
1
|
0
|
Baseline Characteristics
A Food-effect Study of the Pediatric Dispersible Tablet Formulations of TRIUMEQ® and DOVATO® in Healthy Adult Participants
Baseline characteristics by cohort
| Measure |
Cohort 1: TRIUMEQ Fed Followed by TRIUMEQ Fasted
n=8 Participants
Participants received TRIUMEQ (dolutegravir \[DTG\] 5 milligram \[mg\]/abacavir \[ABC\] 60 mg/lamivudine \[3TC\] 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) (Treatment A) in treatment period 1 followed by TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions (Treatment B) in treatment period 2. The treatment periods were separated by a washout period of about 7 days. All participants were followed-up for 7 to 14 days of last dose in treatment period 2.
|
Cohort 1: TRIUMEQ Fasted Followed by TRIUMEQ Fed
n=8 Participants
Participants received TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions (Treatment B) in treatment period 1 followed by TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) (Treatment A) in treatment period 2. The treatment periods were separated by a washout period of about 7 days. All participants were followed-up for 7 to 14 days of last dose in treatment period 2.
|
Cohort 2: DOVATO Fed Followed by DOVATO Fasted
n=8 Participants
Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) (Treatment C) in treatment period 1 followed by DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions (Treatment D) in treatment period 2. The treatment periods were separated by a washout period of about 7 days. All participants were followed-up for 7 to 14 days of last dose in treatment period 2.
|
Cohort 2: DOVATO Fasted Followed by DOVATO Fed
n=9 Participants
Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions (Treatment D) in treatment period 1 followed by DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) (Treatment C) in treatment period 2. The treatment periods were separated by a washout period of about 7 days. All participants were followed-up for 7 to 14 days of last dose in treatment period 2.
|
Total
n=33 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Customized
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Age, Customized
19-64 years
|
8 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
9 Participants
n=7 Participants
|
33 Participants
n=31 Participants
|
|
Age, Customized
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
10 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
7 Participants
n=7 Participants
|
23 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Asian: Central/South Asian Heritage
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
2 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
11 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
White
|
6 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
20 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Multiple: Black or African American & White
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
PRIMARY outcome
Timeframe: Pre-dose, 0.25, 0.50, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 and 72 Hours post dose in each treatment periods 1 and 2Population: Pharmacokinetic Parameter Population consisted of all participants who underwent plasma PK sampling and had evaluable (non-missing) PK parameters estimated. Only those participants with data available at specified time point were analyzed.
Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis of DTG, ABC and 3TC. The PK parameters were calculated by standard non-compartmental analysis
Outcome measures
| Measure |
Cohort 2: DOVATO (DTG/3TC) Fasted
Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions during Treatment Periods 1 and 2 of Cohort 2 of study.
|
Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed
n=16 Participants
Participants received TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) during Treatment Periods 1 and 2 of Cohort 1 of study
|
Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted
n=16 Participants
Participants received TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions during Treatment Periods 1 and 2 of Cohort 1 of study.
|
Cohort 2: DOVATO (DTG/3TC) Fed
Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) during Treatment Periods 1 and 2 of Cohort 2 of study
|
|---|---|---|---|---|
|
Cohort 1: Area Under the Plasma Concentration-time Curve (AUC) From Time Zero Extrapolated to Infinity (AUC [0-inf]) of DTG, ABC and 3TC Following Administration of TRIUMEQ Under Fed and Fasted Conditions
DTG
|
—
|
59140 Hours*nanogram per milliliter
Geometric Coefficient of Variation 25.7
|
67210 Hours*nanogram per milliliter
Geometric Coefficient of Variation 24.0
|
—
|
|
Cohort 1: Area Under the Plasma Concentration-time Curve (AUC) From Time Zero Extrapolated to Infinity (AUC [0-inf]) of DTG, ABC and 3TC Following Administration of TRIUMEQ Under Fed and Fasted Conditions
ABC
|
—
|
8565 Hours*nanogram per milliliter
Geometric Coefficient of Variation 24.9
|
9986 Hours*nanogram per milliliter
Geometric Coefficient of Variation 28.8
|
—
|
|
Cohort 1: Area Under the Plasma Concentration-time Curve (AUC) From Time Zero Extrapolated to Infinity (AUC [0-inf]) of DTG, ABC and 3TC Following Administration of TRIUMEQ Under Fed and Fasted Conditions
3TC
|
—
|
6508 Hours*nanogram per milliliter
Geometric Coefficient of Variation 19.9
|
7295 Hours*nanogram per milliliter
Geometric Coefficient of Variation 23.4
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, 0.25, 0.50, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 and 72 Hours post dose in each treatment periods 1 and 2Population: Pharmacokinetic Parameter Population
Blood samples were collected at indicated time points for pharmacokinetic analysis of DTG, ABC and 3TC. The PK parameters were calculated by standard non-compartmental analysis.
Outcome measures
| Measure |
Cohort 2: DOVATO (DTG/3TC) Fasted
Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions during Treatment Periods 1 and 2 of Cohort 2 of study.
|
Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed
n=16 Participants
Participants received TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) during Treatment Periods 1 and 2 of Cohort 1 of study
|
Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted
n=16 Participants
Participants received TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions during Treatment Periods 1 and 2 of Cohort 1 of study.
|
Cohort 2: DOVATO (DTG/3TC) Fed
Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) during Treatment Periods 1 and 2 of Cohort 2 of study
|
|---|---|---|---|---|
|
Cohort 1: AUC From Time Zero to Time of Last Observed Quantifiable Concentration (AUC [0-t]) of DTG, ABC and 3TC Following Administration of TRIUMEQ Under Fed and Fasted Conditions
DTG
|
—
|
55770 Hours*nanogram per milliliter
Geometric Coefficient of Variation 23.8
|
63790 Hours*nanogram per milliliter
Geometric Coefficient of Variation 22.7
|
—
|
|
Cohort 1: AUC From Time Zero to Time of Last Observed Quantifiable Concentration (AUC [0-t]) of DTG, ABC and 3TC Following Administration of TRIUMEQ Under Fed and Fasted Conditions
ABC
|
—
|
8501 Hours*nanogram per milliliter
Geometric Coefficient of Variation 25.4
|
9923 Hours*nanogram per milliliter
Geometric Coefficient of Variation 28.9
|
—
|
|
Cohort 1: AUC From Time Zero to Time of Last Observed Quantifiable Concentration (AUC [0-t]) of DTG, ABC and 3TC Following Administration of TRIUMEQ Under Fed and Fasted Conditions
3TC
|
—
|
6319 Hours*nanogram per milliliter
Geometric Coefficient of Variation 18.9
|
7182 Hours*nanogram per milliliter
Geometric Coefficient of Variation 23.5
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, 0.25, 0.50, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 and 72 Hours post dose in each treatment periods 1 and 2Population: Pharmacokinetic Parameter Population
Blood samples were collected at indicated time points for pharmacokinetic analysis of DTG, ABC and 3TC. The PK parameters were calculated by standard non-compartmental analysis.
Outcome measures
| Measure |
Cohort 2: DOVATO (DTG/3TC) Fasted
Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions during Treatment Periods 1 and 2 of Cohort 2 of study.
|
Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed
n=16 Participants
Participants received TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) during Treatment Periods 1 and 2 of Cohort 1 of study
|
Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted
n=16 Participants
Participants received TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions during Treatment Periods 1 and 2 of Cohort 1 of study.
|
Cohort 2: DOVATO (DTG/3TC) Fed
Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) during Treatment Periods 1 and 2 of Cohort 2 of study
|
|---|---|---|---|---|
|
Cohort 1: Maximum Observed Concentration (Cmax) of DTG, ABC and 3TC Following Administration of TRIUMEQ Under Fed and Fasted Conditions
DTG
|
—
|
2359 Nanogram per milliliter
Geometric Coefficient of Variation 17.6
|
3322 Nanogram per milliliter
Geometric Coefficient of Variation 20.6
|
—
|
|
Cohort 1: Maximum Observed Concentration (Cmax) of DTG, ABC and 3TC Following Administration of TRIUMEQ Under Fed and Fasted Conditions
ABC
|
—
|
1837 Nanogram per milliliter
Geometric Coefficient of Variation 21.1
|
4080 Nanogram per milliliter
Geometric Coefficient of Variation 32.3
|
—
|
|
Cohort 1: Maximum Observed Concentration (Cmax) of DTG, ABC and 3TC Following Administration of TRIUMEQ Under Fed and Fasted Conditions
3TC
|
—
|
886.9 Nanogram per milliliter
Geometric Coefficient of Variation 18.9
|
1392 Nanogram per milliliter
Geometric Coefficient of Variation 33.3
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, 0.25, 0.50, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 and 72 Hours post dose in each treatment periods 1 and 2Population: Pharmacokinetic Parameter Population. Only those participants with data available at specified time points were analyzed.
Blood samples were collected at indicated time points for pharmacokinetic analysis of DTG and 3TC. The PK parameters were calculated by standard non-compartmental analysis.
Outcome measures
| Measure |
Cohort 2: DOVATO (DTG/3TC) Fasted
Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions during Treatment Periods 1 and 2 of Cohort 2 of study.
|
Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed
n=16 Participants
Participants received TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) during Treatment Periods 1 and 2 of Cohort 1 of study
|
Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted
n=16 Participants
Participants received TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions during Treatment Periods 1 and 2 of Cohort 1 of study.
|
Cohort 2: DOVATO (DTG/3TC) Fed
Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) during Treatment Periods 1 and 2 of Cohort 2 of study
|
|---|---|---|---|---|
|
Cohort 2: AUC (0-inf) of DTG and 3TC Following Administration of DOVATO Under Fed and Fasted Conditions
DTG
|
—
|
47830 Hours*nanogram per milliliter
Geometric Coefficient of Variation 24.2
|
51800 Hours*nanogram per milliliter
Geometric Coefficient of Variation 24.3
|
—
|
|
Cohort 2: AUC (0-inf) of DTG and 3TC Following Administration of DOVATO Under Fed and Fasted Conditions
3TC
|
—
|
6975 Hours*nanogram per milliliter
Geometric Coefficient of Variation 10.1
|
7864 Hours*nanogram per milliliter
Geometric Coefficient of Variation 13.9
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, 0.25, 0.50, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 and 72 Hours post dose in each treatment periods 1 and 2Population: Pharmacokinetic Parameter Population
Blood samples were collected at indicated time points for pharmacokinetic analysis of DTG and 3TC. The PK parameters were calculated by standard non-compartmental analysis.
Outcome measures
| Measure |
Cohort 2: DOVATO (DTG/3TC) Fasted
Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions during Treatment Periods 1 and 2 of Cohort 2 of study.
|
Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed
n=17 Participants
Participants received TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) during Treatment Periods 1 and 2 of Cohort 1 of study
|
Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted
n=16 Participants
Participants received TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions during Treatment Periods 1 and 2 of Cohort 1 of study.
|
Cohort 2: DOVATO (DTG/3TC) Fed
Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) during Treatment Periods 1 and 2 of Cohort 2 of study
|
|---|---|---|---|---|
|
Cohort 2: AUC (0-t) of DTG and 3TC Following Administration of DOVATO Under Fed and Fasted Conditions
DTG
|
—
|
46060 Hours*nanogram per milliliter
Geometric Coefficient of Variation 22.2
|
49690 Hours*nanogram per milliliter
Geometric Coefficient of Variation 22.0
|
—
|
|
Cohort 2: AUC (0-t) of DTG and 3TC Following Administration of DOVATO Under Fed and Fasted Conditions
3TC
|
—
|
6799 Hours*nanogram per milliliter
Geometric Coefficient of Variation 10.5
|
7762 Hours*nanogram per milliliter
Geometric Coefficient of Variation 14.0
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, 0.25, 0.50, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 and 72 Hours post dose in each treatment periods 1 and 2Population: Pharmacokinetic Parameter Population
Blood samples were collected at indicated time points for pharmacokinetic analysis of DTG and 3TC. The PK parameters were calculated by standard non-compartmental analysis.
Outcome measures
| Measure |
Cohort 2: DOVATO (DTG/3TC) Fasted
Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions during Treatment Periods 1 and 2 of Cohort 2 of study.
|
Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed
n=17 Participants
Participants received TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) during Treatment Periods 1 and 2 of Cohort 1 of study
|
Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted
n=16 Participants
Participants received TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions during Treatment Periods 1 and 2 of Cohort 1 of study.
|
Cohort 2: DOVATO (DTG/3TC) Fed
Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) during Treatment Periods 1 and 2 of Cohort 2 of study
|
|---|---|---|---|---|
|
Cohort 2: Cmax of DTG and 3TC Following Administration of DOVATO Under Fed and Fasted Conditions
DTG
|
—
|
2331 Nanogram per milliliter
Geometric Coefficient of Variation 15.4
|
3131 Nanogram per milliliter
Geometric Coefficient of Variation 19.8
|
—
|
|
Cohort 2: Cmax of DTG and 3TC Following Administration of DOVATO Under Fed and Fasted Conditions
3TC
|
—
|
1084 Nanogram per milliliter
Geometric Coefficient of Variation 18.6
|
2066 Nanogram per milliliter
Geometric Coefficient of Variation 28.6
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0.25, 0.50, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 and 72 Hours post dose in each treatment periods 1 and 2Population: Pharmacokinetic Parameter Population
Blood samples were collected at indicated time points for pharmacokinetic analysis of DTG, ABC and 3TC. The PK parameters were calculated by standard non-compartmental analysis.
Outcome measures
| Measure |
Cohort 2: DOVATO (DTG/3TC) Fasted
Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions during Treatment Periods 1 and 2 of Cohort 2 of study.
|
Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed
n=16 Participants
Participants received TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) during Treatment Periods 1 and 2 of Cohort 1 of study
|
Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted
n=16 Participants
Participants received TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions during Treatment Periods 1 and 2 of Cohort 1 of study.
|
Cohort 2: DOVATO (DTG/3TC) Fed
Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) during Treatment Periods 1 and 2 of Cohort 2 of study
|
|---|---|---|---|---|
|
Cohort 1: Lag Time for Absorption (Tlag) of DTG, ABC and 3TC Following Administration of TRIUMEQ Under Fed and Fasted Conditions
DTG
|
—
|
0.000 Hours
Interval 0.0 to 0.0
|
0.000 Hours
Interval 0.0 to 0.0
|
—
|
|
Cohort 1: Lag Time for Absorption (Tlag) of DTG, ABC and 3TC Following Administration of TRIUMEQ Under Fed and Fasted Conditions
ABC
|
—
|
0.000 Hours
Interval 0.0 to 0.0
|
0.000 Hours
Interval 0.0 to 0.0
|
—
|
|
Cohort 1: Lag Time for Absorption (Tlag) of DTG, ABC and 3TC Following Administration of TRIUMEQ Under Fed and Fasted Conditions
3TC
|
—
|
0.000 Hours
Interval 0.0 to 0.0
|
0.000 Hours
Interval 0.0 to 0.0
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0.25, 0.50, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 and 72 Hours post dose in each treatment periods 1 and 2Population: Pharmacokinetic Parameter Population. Only those participants with data available at specified time points were analyzed.
Blood samples were collected at indicated time points for pharmacokinetic analysis of DTG, ABC and 3TC. The PK parameters were calculated by standard non-compartmental analysis.
Outcome measures
| Measure |
Cohort 2: DOVATO (DTG/3TC) Fasted
Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions during Treatment Periods 1 and 2 of Cohort 2 of study.
|
Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed
n=16 Participants
Participants received TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) during Treatment Periods 1 and 2 of Cohort 1 of study
|
Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted
n=16 Participants
Participants received TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions during Treatment Periods 1 and 2 of Cohort 1 of study.
|
Cohort 2: DOVATO (DTG/3TC) Fed
Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) during Treatment Periods 1 and 2 of Cohort 2 of study
|
|---|---|---|---|---|
|
Cohort 1: Terminal Elimination Phase Half-life (t1/2) of DTG, ABC and 3TC Following Administration of TRIUMEQ Under Fed and Fasted Conditions
DTG
|
—
|
16.18 Hours
Geometric Coefficient of Variation 21.0
|
16.10 Hours
Geometric Coefficient of Variation 18.3
|
—
|
|
Cohort 1: Terminal Elimination Phase Half-life (t1/2) of DTG, ABC and 3TC Following Administration of TRIUMEQ Under Fed and Fasted Conditions
ABC
|
—
|
2.291 Hours
Geometric Coefficient of Variation 23.9
|
1.958 Hours
Geometric Coefficient of Variation 28.4
|
—
|
|
Cohort 1: Terminal Elimination Phase Half-life (t1/2) of DTG, ABC and 3TC Following Administration of TRIUMEQ Under Fed and Fasted Conditions
3TC
|
—
|
17.35 Hours
Geometric Coefficient of Variation 43.3
|
15.23 Hours
Geometric Coefficient of Variation 52.9
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0.25, 0.50, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12 and 24 Hours post dose in each treatment periods 1 and 2Population: Pharmacokinetic Parameter Population
Blood samples were collected at indicated time points for pharmacokinetic analysis of DTG, ABC and 3TC. The PK parameters were calculated by standard non-compartmental analysis.
Outcome measures
| Measure |
Cohort 2: DOVATO (DTG/3TC) Fasted
Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions during Treatment Periods 1 and 2 of Cohort 2 of study.
|
Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed
n=16 Participants
Participants received TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) during Treatment Periods 1 and 2 of Cohort 1 of study
|
Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted
n=16 Participants
Participants received TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions during Treatment Periods 1 and 2 of Cohort 1 of study.
|
Cohort 2: DOVATO (DTG/3TC) Fed
Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) during Treatment Periods 1 and 2 of Cohort 2 of study
|
|---|---|---|---|---|
|
Cohort 1: AUC From Time Zero to 24 Hours (AUC[0-24]) of DTG, ABC and 3TC Following Administration of TRIUMEQ Under Fed and Fasted Conditions
DTG
|
—
|
36380 Hours*nanogram per milliliter
Geometric Coefficient of Variation 19.4
|
43870 Hours*nanogram per milliliter
Geometric Coefficient of Variation 20.1
|
—
|
|
Cohort 1: AUC From Time Zero to 24 Hours (AUC[0-24]) of DTG, ABC and 3TC Following Administration of TRIUMEQ Under Fed and Fasted Conditions
ABC
|
—
|
8553 Hours*nanogram per milliliter
Geometric Coefficient of Variation 24.8
|
9980 Hours*nanogram per milliliter
Geometric Coefficient of Variation 28.8
|
—
|
|
Cohort 1: AUC From Time Zero to 24 Hours (AUC[0-24]) of DTG, ABC and 3TC Following Administration of TRIUMEQ Under Fed and Fasted Conditions
3TC
|
—
|
5817 Hours*nanogram per milliliter
Geometric Coefficient of Variation 18.1
|
6707 Hours*nanogram per milliliter
Geometric Coefficient of Variation 24.4
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0.25, 0.50, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 and 72 Hours post dose in each treatment periods 1 and 2Population: Pharmacokinetic Parameter Population
Blood samples were collected at indicated time points for pharmacokinetic analysis of DTG, ABC and 3TC. The PK parameters were calculated by standard non-compartmental analysis.
Outcome measures
| Measure |
Cohort 2: DOVATO (DTG/3TC) Fasted
Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions during Treatment Periods 1 and 2 of Cohort 2 of study.
|
Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed
n=16 Participants
Participants received TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) during Treatment Periods 1 and 2 of Cohort 1 of study
|
Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted
n=16 Participants
Participants received TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions during Treatment Periods 1 and 2 of Cohort 1 of study.
|
Cohort 2: DOVATO (DTG/3TC) Fed
Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) during Treatment Periods 1 and 2 of Cohort 2 of study
|
|---|---|---|---|---|
|
Cohort 1: Last Quantifiable Concentration (Ct) of DTG, ABC and 3TC Following Administration of TRIUMEQ Under Fed and Fasted Conditions
DTG
|
—
|
122.2 Nanogram per milliliter
Geometric Coefficient of Variation 69.6
|
128.6 Nanogram per milliliter
Geometric Coefficient of Variation 60.6
|
—
|
|
Cohort 1: Last Quantifiable Concentration (Ct) of DTG, ABC and 3TC Following Administration of TRIUMEQ Under Fed and Fasted Conditions
ABC
|
—
|
10.61 Nanogram per milliliter
Geometric Coefficient of Variation 164.7
|
17.51 Nanogram per milliliter
Geometric Coefficient of Variation 124.9
|
—
|
|
Cohort 1: Last Quantifiable Concentration (Ct) of DTG, ABC and 3TC Following Administration of TRIUMEQ Under Fed and Fasted Conditions
3TC
|
—
|
5.280 Nanogram per milliliter
Geometric Coefficient of Variation 32.3
|
4.621 Nanogram per milliliter
Geometric Coefficient of Variation 20.3
|
—
|
SECONDARY outcome
Timeframe: 24 hours post dose in treatment periods 1 and 2Population: Pharmacokinetic Parameter Population. Only those participants with data available at specified time points were analyzed.
Blood samples were collected at indicated time points for pharmacokinetic analysis of DTG, ABC and 3TC. The PK parameters were calculated by standard non-compartmental analysis.
Outcome measures
| Measure |
Cohort 2: DOVATO (DTG/3TC) Fasted
Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions during Treatment Periods 1 and 2 of Cohort 2 of study.
|
Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed
n=16 Participants
Participants received TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) during Treatment Periods 1 and 2 of Cohort 1 of study
|
Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted
n=16 Participants
Participants received TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions during Treatment Periods 1 and 2 of Cohort 1 of study.
|
Cohort 2: DOVATO (DTG/3TC) Fed
Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) during Treatment Periods 1 and 2 of Cohort 2 of study
|
|---|---|---|---|---|
|
Cohort 1: Concentration at 24 Hours Post-dose (C24) of DTG, ABC and 3TC Following Administration of TRIUMEQ Under Fed and Fasted Conditions
3TC
|
—
|
23.40 Nanogram per milliliter
Geometric Coefficient of Variation 24.4
|
21.74 Nanogram per milliliter
Geometric Coefficient of Variation 23.1
|
—
|
|
Cohort 1: Concentration at 24 Hours Post-dose (C24) of DTG, ABC and 3TC Following Administration of TRIUMEQ Under Fed and Fasted Conditions
DTG
|
—
|
958.6 Nanogram per milliliter
Geometric Coefficient of Variation 28.3
|
996.3 Nanogram per milliliter
Geometric Coefficient of Variation 26.3
|
—
|
|
Cohort 1: Concentration at 24 Hours Post-dose (C24) of DTG, ABC and 3TC Following Administration of TRIUMEQ Under Fed and Fasted Conditions
ABC
|
—
|
4.833 Nanogram per milliliter
Geometric Coefficient of Variation 52.3
|
3.814 Nanogram per milliliter
Geometric Coefficient of Variation 27.2
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0.25, 0.50, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 and 72 Hours post dose in each treatment periods 1 and 2Population: Pharmacokinetic Parameter Population
Blood samples were collected at indicated time points for pharmacokinetic analysis of DTG, ABC and 3TC. The PK parameters were calculated by standard non-compartmental analysis.
Outcome measures
| Measure |
Cohort 2: DOVATO (DTG/3TC) Fasted
Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions during Treatment Periods 1 and 2 of Cohort 2 of study.
|
Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed
n=16 Participants
Participants received TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) during Treatment Periods 1 and 2 of Cohort 1 of study
|
Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted
n=16 Participants
Participants received TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions during Treatment Periods 1 and 2 of Cohort 1 of study.
|
Cohort 2: DOVATO (DTG/3TC) Fed
Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) during Treatment Periods 1 and 2 of Cohort 2 of study
|
|---|---|---|---|---|
|
Cohort 1: Time of Maximum Observed Concentration (Tmax) of DTG, ABC and 3TC Following Administration of TRIUMEQ Under Fed and Fasted Conditions
DTG
|
—
|
5.000 Hours
Interval 3.0 to 12.0
|
1.250 Hours
Interval 0.5 to 4.0
|
—
|
|
Cohort 1: Time of Maximum Observed Concentration (Tmax) of DTG, ABC and 3TC Following Administration of TRIUMEQ Under Fed and Fasted Conditions
ABC
|
—
|
2.750 Hours
Interval 0.5 to 4.0
|
0.500 Hours
Interval 0.25 to 1.5
|
—
|
|
Cohort 1: Time of Maximum Observed Concentration (Tmax) of DTG, ABC and 3TC Following Administration of TRIUMEQ Under Fed and Fasted Conditions
3TC
|
—
|
3.500 Hours
Interval 2.0 to 4.0
|
1.508 Hours
Interval 0.5 to 3.5
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0.25, 0.50, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 and 72 Hours post dose in each treatment periods 1 and 2Population: Pharmacokinetic Parameter Population
Blood samples were collected at indicated time points for pharmacokinetic analysis of DTG and 3TC. The PK parameters were calculated by standard non-compartmental analysis.
Outcome measures
| Measure |
Cohort 2: DOVATO (DTG/3TC) Fasted
Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions during Treatment Periods 1 and 2 of Cohort 2 of study.
|
Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed
n=17 Participants
Participants received TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) during Treatment Periods 1 and 2 of Cohort 1 of study
|
Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted
n=16 Participants
Participants received TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions during Treatment Periods 1 and 2 of Cohort 1 of study.
|
Cohort 2: DOVATO (DTG/3TC) Fed
Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) during Treatment Periods 1 and 2 of Cohort 2 of study
|
|---|---|---|---|---|
|
Cohort 2: Tlag of DTG and 3TC Following Administration of DOVATO Under Fed and Fasted Conditions
DTG
|
—
|
0.000 Hours
Interval 0.0 to 0.0
|
0.000 Hours
Interval 0.0 to 0.0
|
—
|
|
Cohort 2: Tlag of DTG and 3TC Following Administration of DOVATO Under Fed and Fasted Conditions
3TC
|
—
|
0.000 Hours
Interval 0.0 to 0.0
|
0.000 Hours
Interval 0.0 to 0.0
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0.25, 0.50, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 and 72 Hours post dose in each treatment periods 1 and 2Population: Pharmacokinetic Parameter Population. Only those participants with data available at specified time points were analyzed.
Blood samples were collected at indicated time points for pharmacokinetic analysis of DTG and 3TC. The PK parameters were calculated by standard non-compartmental analysis.
Outcome measures
| Measure |
Cohort 2: DOVATO (DTG/3TC) Fasted
Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions during Treatment Periods 1 and 2 of Cohort 2 of study.
|
Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed
n=16 Participants
Participants received TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) during Treatment Periods 1 and 2 of Cohort 1 of study
|
Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted
n=16 Participants
Participants received TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions during Treatment Periods 1 and 2 of Cohort 1 of study.
|
Cohort 2: DOVATO (DTG/3TC) Fed
Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) during Treatment Periods 1 and 2 of Cohort 2 of study
|
|---|---|---|---|---|
|
Cohort 2: t1/2 of DTG and 3TC Following Administration of DOVATO Under Fed and Fasted Conditions
DTG
|
—
|
14.43 Hours
Geometric Coefficient of Variation 17.5
|
15.12 Hours
Geometric Coefficient of Variation 19.0
|
—
|
|
Cohort 2: t1/2 of DTG and 3TC Following Administration of DOVATO Under Fed and Fasted Conditions
3TC
|
—
|
18.47 Hours
Geometric Coefficient of Variation 28.8
|
18.36 Hours
Geometric Coefficient of Variation 21.0
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0.25, 0.50, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12 and 24 Hours post dose in each treatment periods 1 and 2Population: Pharmacokinetic Parameter Population
Blood samples were collected at indicated time points for pharmacokinetic analysis of DTG and 3TC. The PK parameters were calculated by standard non-compartmental analysis.
Outcome measures
| Measure |
Cohort 2: DOVATO (DTG/3TC) Fasted
Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions during Treatment Periods 1 and 2 of Cohort 2 of study.
|
Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed
n=17 Participants
Participants received TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) during Treatment Periods 1 and 2 of Cohort 1 of study
|
Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted
n=16 Participants
Participants received TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions during Treatment Periods 1 and 2 of Cohort 1 of study.
|
Cohort 2: DOVATO (DTG/3TC) Fed
Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) during Treatment Periods 1 and 2 of Cohort 2 of study
|
|---|---|---|---|---|
|
Cohort 2: AUC(0-24) of DTG and 3TC Following Administration of DOVATO Under Fed and Fasted Conditions
DTG
|
—
|
32620 Hours*nanogram per milliliter
Geometric Coefficient of Variation 19.2
|
35360 Hours*nanogram per milliliter
Geometric Coefficient of Variation 15.6
|
—
|
|
Cohort 2: AUC(0-24) of DTG and 3TC Following Administration of DOVATO Under Fed and Fasted Conditions
3TC
|
—
|
6339 Hours*nanogram per milliliter
Geometric Coefficient of Variation 10.7
|
7339 Hours*nanogram per milliliter
Geometric Coefficient of Variation 14.9
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0.25, 0.50, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 and 72 Hours post dose in each treatment periods 1 and 2Population: Pharmacokinetic Parameter Population. Only those participants with data available at specified time points were analyzed.
Blood samples were collected at indicated time points for pharmacokinetic analysis of DTG and 3TC. The PK parameters were calculated by standard non-compartmental analysis.
Outcome measures
| Measure |
Cohort 2: DOVATO (DTG/3TC) Fasted
Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions during Treatment Periods 1 and 2 of Cohort 2 of study.
|
Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed
n=16 Participants
Participants received TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) during Treatment Periods 1 and 2 of Cohort 1 of study
|
Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted
n=16 Participants
Participants received TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions during Treatment Periods 1 and 2 of Cohort 1 of study.
|
Cohort 2: DOVATO (DTG/3TC) Fed
Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) during Treatment Periods 1 and 2 of Cohort 2 of study
|
|---|---|---|---|---|
|
Cohort 2: Ct of DTG and 3TC Following Administration of DOVATO Under Fed and Fasted Conditions
DTG
|
—
|
82.37 Nanogram per milliliter
Geometric Coefficient of Variation 59.6
|
79.73 Nanogram per milliliter
Geometric Coefficient of Variation 74.5
|
—
|
|
Cohort 2: Ct of DTG and 3TC Following Administration of DOVATO Under Fed and Fasted Conditions
3TC
|
—
|
4.078 Nanogram per milliliter
Geometric Coefficient of Variation 29.6
|
3.622 Nanogram per milliliter
Geometric Coefficient of Variation 25.4
|
—
|
SECONDARY outcome
Timeframe: 24 hours post dose in treatment periods 1 and 2Population: Pharmacokinetic Parameter Population
Blood samples were collected at indicated time points for pharmacokinetic analysis of DTG and 3TC. The PK parameters were calculated by standard non-compartmental analysis.
Outcome measures
| Measure |
Cohort 2: DOVATO (DTG/3TC) Fasted
Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions during Treatment Periods 1 and 2 of Cohort 2 of study.
|
Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed
n=17 Participants
Participants received TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) during Treatment Periods 1 and 2 of Cohort 1 of study
|
Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted
n=16 Participants
Participants received TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions during Treatment Periods 1 and 2 of Cohort 1 of study.
|
Cohort 2: DOVATO (DTG/3TC) Fed
Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) during Treatment Periods 1 and 2 of Cohort 2 of study
|
|---|---|---|---|---|
|
Cohort 2: C24 of DTG and 3TC Following Administration of DOVATO Under Fed and Fasted Conditions
DTG
|
—
|
764.7 Nanogram per milliliter
Geometric Coefficient of Variation 28.5
|
715.4 Nanogram per milliliter
Geometric Coefficient of Variation 27.7
|
—
|
|
Cohort 2: C24 of DTG and 3TC Following Administration of DOVATO Under Fed and Fasted Conditions
3TC
|
—
|
22.56 Nanogram per milliliter
Geometric Coefficient of Variation 18.8
|
20.38 Nanogram per milliliter
Geometric Coefficient of Variation 18.6
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0.25, 0.50, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 and 72 Hours post dose in each treatment periods 1 and 2Population: Pharmacokinetic Parameter Population
Blood samples were collected at indicated time points for pharmacokinetic analysis of DTG and 3TC. The PK parameters were calculated by standard non-compartmental analysis.
Outcome measures
| Measure |
Cohort 2: DOVATO (DTG/3TC) Fasted
Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions during Treatment Periods 1 and 2 of Cohort 2 of study.
|
Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed
n=17 Participants
Participants received TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) during Treatment Periods 1 and 2 of Cohort 1 of study
|
Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted
n=16 Participants
Participants received TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions during Treatment Periods 1 and 2 of Cohort 1 of study.
|
Cohort 2: DOVATO (DTG/3TC) Fed
Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) during Treatment Periods 1 and 2 of Cohort 2 of study
|
|---|---|---|---|---|
|
Cohort 2: Tmax of DTG and 3TC Following Administration of DOVATO Under Fed and Fasted Conditions
DTG
|
—
|
4.000 Hours
Interval 3.5 to 8.0
|
0.875 Hours
Interval 0.5 to 3.5
|
—
|
|
Cohort 2: Tmax of DTG and 3TC Following Administration of DOVATO Under Fed and Fasted Conditions
3TC
|
—
|
3.000 Hours
Interval 0.75 to 4.0
|
0.750 Hours
Interval 0.5 to 1.0
|
—
|
SECONDARY outcome
Timeframe: Up to 23 daysPopulation: Safety Population consisted of all participants who received at least one dose of study intervention.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect or other situations as per Medical or scientific judgment.
Outcome measures
| Measure |
Cohort 2: DOVATO (DTG/3TC) Fasted
n=16 Participants
Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions during Treatment Periods 1 and 2 of Cohort 2 of study.
|
Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed
n=16 Participants
Participants received TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) during Treatment Periods 1 and 2 of Cohort 1 of study
|
Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted
n=16 Participants
Participants received TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions during Treatment Periods 1 and 2 of Cohort 1 of study.
|
Cohort 2: DOVATO (DTG/3TC) Fed
n=17 Participants
Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) during Treatment Periods 1 and 2 of Cohort 2 of study
|
|---|---|---|---|---|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
AEs
|
1 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
SAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline (Day -1) and Day 4Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
Blood samples were collected to analyze the hematology parameters: basophils, eosinophils, lymphocytes, monocytes, neutrophils and platelet count. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Cohort 2: DOVATO (DTG/3TC) Fasted
n=16 Participants
Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions during Treatment Periods 1 and 2 of Cohort 2 of study.
|
Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed
n=16 Participants
Participants received TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) during Treatment Periods 1 and 2 of Cohort 1 of study
|
Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted
n=16 Participants
Participants received TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions during Treatment Periods 1 and 2 of Cohort 1 of study.
|
Cohort 2: DOVATO (DTG/3TC) Fed
n=16 Participants
Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) during Treatment Periods 1 and 2 of Cohort 2 of study
|
|---|---|---|---|---|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count and Neutrophil
Monocytes
|
-0.021 10^9 cells per liter
Standard Deviation 0.1169
|
-0.051 10^9 cells per liter
Standard Deviation 0.0972
|
-0.048 10^9 cells per liter
Standard Deviation 0.0802
|
-0.064 10^9 cells per liter
Standard Deviation 0.1285
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count and Neutrophil
Platelet count
|
5.5 10^9 cells per liter
Standard Deviation 19.96
|
3.2 10^9 cells per liter
Standard Deviation 16.05
|
6.7 10^9 cells per liter
Standard Deviation 15.40
|
5.4 10^9 cells per liter
Standard Deviation 23.00
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count and Neutrophil
Neutrophil
|
-0.133 10^9 cells per liter
Standard Deviation 0.9317
|
0.031 10^9 cells per liter
Standard Deviation 0.5042
|
-0.159 10^9 cells per liter
Standard Deviation 0.6044
|
-0.109 10^9 cells per liter
Standard Deviation 0.9421
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count and Neutrophil
Basophils
|
0.001 10^9 cells per liter
Standard Deviation 0.0144
|
-0.002 10^9 cells per liter
Standard Deviation 0.0105
|
-0.004 10^9 cells per liter
Standard Deviation 0.0141
|
-0.003 10^9 cells per liter
Standard Deviation 0.0100
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count and Neutrophil
Eosinophils
|
0.006 10^9 cells per liter
Standard Deviation 0.0318
|
-0.002 10^9 cells per liter
Standard Deviation 0.0456
|
0.015 10^9 cells per liter
Standard Deviation 0.0755
|
-0.005 10^9 cells per liter
Standard Deviation 0.0219
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count and Neutrophil
Lymphocytes
|
-0.066 10^9 cells per liter
Standard Deviation 0.3669
|
-0.212 10^9 cells per liter
Standard Deviation 0.3773
|
-0.116 10^9 cells per liter
Standard Deviation 0.2271
|
-0.027 10^9 cells per liter
Standard Deviation 0.2865
|
SECONDARY outcome
Timeframe: Baseline (Day -1) and Day 4Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
Blood samples were collected to analyze the hematology parameter: RBC count. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Cohort 2: DOVATO (DTG/3TC) Fasted
n=16 Participants
Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions during Treatment Periods 1 and 2 of Cohort 2 of study.
|
Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed
n=16 Participants
Participants received TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) during Treatment Periods 1 and 2 of Cohort 1 of study
|
Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted
n=16 Participants
Participants received TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions during Treatment Periods 1 and 2 of Cohort 1 of study.
|
Cohort 2: DOVATO (DTG/3TC) Fed
n=16 Participants
Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) during Treatment Periods 1 and 2 of Cohort 2 of study
|
|---|---|---|---|---|
|
Change From Baseline in Hematology Parameters: Red Blood Cell (RBC) Count
|
0.018 10^12 cells per liter
Standard Deviation 0.1620
|
0.008 10^12 cells per liter
Standard Deviation 0.1891
|
-0.006 10^12 cells per liter
Standard Deviation 0.1832
|
0.024 10^12 cells per liter
Standard Deviation 0.2141
|
SECONDARY outcome
Timeframe: Baseline (Day -1) and Day 4Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
Blood samples were collected at Baseline and at Day 4 post dose of each period to analyze the hematology parameter: hemoglobin. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Cohort 2: DOVATO (DTG/3TC) Fasted
n=16 Participants
Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions during Treatment Periods 1 and 2 of Cohort 2 of study.
|
Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed
n=16 Participants
Participants received TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) during Treatment Periods 1 and 2 of Cohort 1 of study
|
Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted
n=16 Participants
Participants received TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions during Treatment Periods 1 and 2 of Cohort 1 of study.
|
Cohort 2: DOVATO (DTG/3TC) Fed
n=16 Participants
Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) during Treatment Periods 1 and 2 of Cohort 2 of study
|
|---|---|---|---|---|
|
Change From Baseline in Hematology Parameters: Hemoglobin
|
-0.1 Grams per liter
Standard Deviation 5.17
|
0.3 Grams per liter
Standard Deviation 5.66
|
-1.1 Grams per liter
Standard Deviation 4.96
|
1.2 Grams per liter
Standard Deviation 6.40
|
SECONDARY outcome
Timeframe: Baseline (Day -1) and Day 4Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
Blood samples were collected at Baseline and at Day 4 post dose of each period to analyze the hematology parameter: hematocrit. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Cohort 2: DOVATO (DTG/3TC) Fasted
n=16 Participants
Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions during Treatment Periods 1 and 2 of Cohort 2 of study.
|
Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed
n=16 Participants
Participants received TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) during Treatment Periods 1 and 2 of Cohort 1 of study
|
Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted
n=16 Participants
Participants received TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions during Treatment Periods 1 and 2 of Cohort 1 of study.
|
Cohort 2: DOVATO (DTG/3TC) Fed
n=16 Participants
Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) during Treatment Periods 1 and 2 of Cohort 2 of study
|
|---|---|---|---|---|
|
Change From Baseline in Hematology Parameters: Hematocrit
|
0.0010 Proportion of red blood cells in blood
Standard Deviation 0.01487
|
-0.0001 Proportion of red blood cells in blood
Standard Deviation 0.01647
|
0.0003 Proportion of red blood cells in blood
Standard Deviation 0.01587
|
0.0006 Proportion of red blood cells in blood
Standard Deviation 0.01950
|
SECONDARY outcome
Timeframe: Baseline (Day -1) and Day 4Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
Blood samples were collected at Baseline and at Day 4 post dose of each period to analyze the hematology parameter: erythrocytes mean corpuscular Volume. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Cohort 2: DOVATO (DTG/3TC) Fasted
n=16 Participants
Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions during Treatment Periods 1 and 2 of Cohort 2 of study.
|
Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed
n=16 Participants
Participants received TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) during Treatment Periods 1 and 2 of Cohort 1 of study
|
Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted
n=16 Participants
Participants received TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions during Treatment Periods 1 and 2 of Cohort 1 of study.
|
Cohort 2: DOVATO (DTG/3TC) Fed
n=16 Participants
Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) during Treatment Periods 1 and 2 of Cohort 2 of study
|
|---|---|---|---|---|
|
Change From Baseline in Hematology Parameters: Erythrocytes Mean Corpuscular Volume
|
-0.14 Femtoliter
Standard Deviation 0.672
|
-0.09 Femtoliter
Standard Deviation 0.665
|
0.12 Femtoliter
Standard Deviation 0.571
|
-0.28 Femtoliter
Standard Deviation 0.471
|
SECONDARY outcome
Timeframe: Baseline (Day -1) and Day 4Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
Blood samples were collected at Baseline and at Day 4 post dose of each period to analyze the hematology parameter: erythrocytes mean corpuscular hemoglobin. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Cohort 2: DOVATO (DTG/3TC) Fasted
n=16 Participants
Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions during Treatment Periods 1 and 2 of Cohort 2 of study.
|
Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed
n=16 Participants
Participants received TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) during Treatment Periods 1 and 2 of Cohort 1 of study
|
Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted
n=16 Participants
Participants received TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions during Treatment Periods 1 and 2 of Cohort 1 of study.
|
Cohort 2: DOVATO (DTG/3TC) Fed
n=16 Participants
Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) during Treatment Periods 1 and 2 of Cohort 2 of study
|
|---|---|---|---|---|
|
Change From Baseline in Hematology Parameters: Erythrocytes Mean Corpuscular Hemoglobin
|
-0.09 Picograms
Standard Deviation 0.351
|
-0.03 Picograms
Standard Deviation 0.267
|
-0.24 Picograms
Standard Deviation 0.307
|
0.13 Picograms
Standard Deviation 0.442
|
SECONDARY outcome
Timeframe: Baseline (Day -1) and Day 4Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
Blood samples were collected at Baseline and at Day 4 post dose of each period to analyze the hematology parameters: basophils, eosinophils, lymphocytes, monocytes, neutrophils and platelet count. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits.
Outcome measures
| Measure |
Cohort 2: DOVATO (DTG/3TC) Fasted
n=16 Participants
Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions during Treatment Periods 1 and 2 of Cohort 2 of study.
|
Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed
n=16 Participants
Participants received TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) during Treatment Periods 1 and 2 of Cohort 1 of study
|
Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted
n=16 Participants
Participants received TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions during Treatment Periods 1 and 2 of Cohort 1 of study.
|
Cohort 2: DOVATO (DTG/3TC) Fed
n=17 Participants
Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) during Treatment Periods 1 and 2 of Cohort 2 of study
|
|---|---|---|---|---|
|
Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count and Neutrophil
Baseline (Day -1): Basophils
|
0.041 10^9 cells per liter
Standard Deviation 0.0200
|
0.040 10^9 cells per liter
Standard Deviation 0.0210
|
0.043 10^9 cells per liter
Standard Deviation 0.0202
|
0.042 10^9 cells per liter
Standard Deviation 0.0144
|
|
Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count and Neutrophil
Day 4: Basophils
|
0.042 10^9 cells per liter
Standard Deviation 0.0176
|
0.038 10^9 cells per liter
Standard Deviation 0.0223
|
0.039 10^9 cells per liter
Standard Deviation 0.0169
|
0.039 10^9 cells per liter
Standard Deviation 0.0131
|
|
Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count and Neutrophil
Baseline (Day -1): Eosinophils
|
0.150 10^9 cells per liter
Standard Deviation 0.0922
|
0.192 10^9 cells per liter
Standard Deviation 0.0821
|
0.190 10^9 cells per liter
Standard Deviation 0.1081
|
0.147 10^9 cells per liter
Standard Deviation 0.0956
|
|
Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count and Neutrophil
Baseline (Day -1): Monocytes
|
0.469 10^9 cells per liter
Standard Deviation 0.1018
|
0.461 10^9 cells per liter
Standard Deviation 0.2078
|
0.449 10^9 cells per liter
Standard Deviation 0.1554
|
0.507 10^9 cells per liter
Standard Deviation 0.1661
|
|
Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count and Neutrophil
Day 4: Neutrophil
|
3.304 10^9 cells per liter
Standard Deviation 1.5065
|
3.329 10^9 cells per liter
Standard Deviation 0.9590
|
3.248 10^9 cells per liter
Standard Deviation 0.8036
|
3.275 10^9 cells per liter
Standard Deviation 1.4198
|
|
Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count and Neutrophil
Day 4: Eosinophils
|
0.156 10^9 cells per liter
Standard Deviation 0.1050
|
0.190 10^9 cells per liter
Standard Deviation 0.0989
|
0.205 10^9 cells per liter
Standard Deviation 0.1231
|
0.144 10^9 cells per liter
Standard Deviation 0.1022
|
|
Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count and Neutrophil
Baseline (Day -1): Lymphocytes
|
2.008 10^9 cells per liter
Standard Deviation 0.5350
|
2.002 10^9 cells per liter
Standard Deviation 0.5419
|
1.908 10^9 cells per liter
Standard Deviation 0.4189
|
2.029 10^9 cells per liter
Standard Deviation 0.5486
|
|
Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count and Neutrophil
Day 4: Lymphocytes
|
1.941 10^9 cells per liter
Standard Deviation 0.5713
|
1.790 10^9 cells per liter
Standard Deviation 0.3956
|
1.793 10^9 cells per liter
Standard Deviation 0.3677
|
1.922 10^9 cells per liter
Standard Deviation 0.5003
|
|
Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count and Neutrophil
Day 4: Monocytes
|
0.448 10^9 cells per liter
Standard Deviation 0.1222
|
0.409 10^9 cells per liter
Standard Deviation 0.1335
|
0.402 10^9 cells per liter
Standard Deviation 0.1373
|
0.435 10^9 cells per liter
Standard Deviation 0.1185
|
|
Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count and Neutrophil
Baseline (Day -1): Platelet count
|
243.1 10^9 cells per liter
Standard Deviation 54.54
|
272.4 10^9 cells per liter
Standard Deviation 66.59
|
276.8 10^9 cells per liter
Standard Deviation 69.88
|
253.9 10^9 cells per liter
Standard Deviation 56.34
|
|
Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count and Neutrophil
Day 4: Platelet count
|
248.6 10^9 cells per liter
Standard Deviation 55.33
|
275.6 10^9 cells per liter
Standard Deviation 65.27
|
283.5 10^9 cells per liter
Standard Deviation 64.14
|
249.8 10^9 cells per liter
Standard Deviation 42.35
|
|
Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count and Neutrophil
Baseline (Day -1): Neutrophil
|
3.436 10^9 cells per liter
Standard Deviation 1.0628
|
3.299 10^9 cells per liter
Standard Deviation 1.2456
|
3.407 10^9 cells per liter
Standard Deviation 1.1862
|
3.436 10^9 cells per liter
Standard Deviation 1.3351
|
SECONDARY outcome
Timeframe: Baseline (Day -1) and Day 4Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
Blood samples were collected at Baseline and at Day 4 post dose of each period to analyze the hematology parameters: RBC count. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits.
Outcome measures
| Measure |
Cohort 2: DOVATO (DTG/3TC) Fasted
n=16 Participants
Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions during Treatment Periods 1 and 2 of Cohort 2 of study.
|
Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed
n=16 Participants
Participants received TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) during Treatment Periods 1 and 2 of Cohort 1 of study
|
Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted
n=16 Participants
Participants received TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions during Treatment Periods 1 and 2 of Cohort 1 of study.
|
Cohort 2: DOVATO (DTG/3TC) Fed
n=17 Participants
Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) during Treatment Periods 1 and 2 of Cohort 2 of study
|
|---|---|---|---|---|
|
Absolute Values of Hematology Parameters: RBC Count
Baseline (Day -1)
|
4.848 10^12 cells per liter
Standard Deviation 0.3975
|
4.648 10^12 cells per liter
Standard Deviation 0.4082
|
4.684 10^12 cells per liter
Standard Deviation 0.3549
|
4.765 10^12 cells per liter
Standard Deviation 0.4251
|
|
Absolute Values of Hematology Parameters: RBC Count
Day 4
|
4.865 10^12 cells per liter
Standard Deviation 0.4051
|
4.656 10^12 cells per liter
Standard Deviation 0.4170
|
4.678 10^12 cells per liter
Standard Deviation 0.4011
|
4.839 10^12 cells per liter
Standard Deviation 0.4405
|
SECONDARY outcome
Timeframe: Baseline (Day -1) and Day 4Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
Blood samples were collected at Baseline and at Day 4 post dose of each period to analyze the hematology parameter: hemoglobin. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits.
Outcome measures
| Measure |
Cohort 2: DOVATO (DTG/3TC) Fasted
n=16 Participants
Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions during Treatment Periods 1 and 2 of Cohort 2 of study.
|
Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed
n=16 Participants
Participants received TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) during Treatment Periods 1 and 2 of Cohort 1 of study
|
Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted
n=16 Participants
Participants received TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions during Treatment Periods 1 and 2 of Cohort 1 of study.
|
Cohort 2: DOVATO (DTG/3TC) Fed
n=17 Participants
Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) during Treatment Periods 1 and 2 of Cohort 2 of study
|
|---|---|---|---|---|
|
Absolute Values of Hematology Parameters: Hemoglobin
Baseline (Day -1)
|
144.5 Grams per liter
Standard Deviation 11.25
|
133.5 Grams per liter
Standard Deviation 16.66
|
134.4 Grams per liter
Standard Deviation 15.71
|
142.0 Grams per liter
Standard Deviation 11.69
|
|
Absolute Values of Hematology Parameters: Hemoglobin
Day 4
|
144.4 Grams per liter
Standard Deviation 10.57
|
133.8 Grams per liter
Standard Deviation 16.66
|
133.3 Grams per liter
Standard Deviation 16.97
|
144.3 Grams per liter
Standard Deviation 12.06
|
SECONDARY outcome
Timeframe: Baseline (Day -1) and Day 4Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
Blood samples were collected at Baseline and at Day 4 post dose of each period to analyze the hematology parameter: hematocrit. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits.
Outcome measures
| Measure |
Cohort 2: DOVATO (DTG/3TC) Fasted
n=16 Participants
Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions during Treatment Periods 1 and 2 of Cohort 2 of study.
|
Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed
n=16 Participants
Participants received TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) during Treatment Periods 1 and 2 of Cohort 1 of study
|
Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted
n=16 Participants
Participants received TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions during Treatment Periods 1 and 2 of Cohort 1 of study.
|
Cohort 2: DOVATO (DTG/3TC) Fed
n=17 Participants
Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) during Treatment Periods 1 and 2 of Cohort 2 of study
|
|---|---|---|---|---|
|
Absolute Values of Hematology Parameters: Hematocrit
Baseline (Day -1)
|
0.4227 Proportion of red blood cells in blood
Standard Deviation 0.03075
|
0.3957 Proportion of red blood cells in blood
Standard Deviation 0.04371
|
0.3976 Proportion of red blood cells in blood
Standard Deviation 0.03892
|
0.4163 Proportion of red blood cells in blood
Standard Deviation 0.03383
|
|
Absolute Values of Hematology Parameters: Hematocrit
Day 4
|
0.4237 Proportion of red blood cells in blood
Standard Deviation 0.03137
|
0.3956 Proportion of red blood cells in blood
Standard Deviation 0.04208
|
0.3979 Proportion of red blood cells in blood
Standard Deviation 0.04358
|
0.4201 Proportion of red blood cells in blood
Standard Deviation 0.03339
|
SECONDARY outcome
Timeframe: Baseline (Day -1) and Day 4Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
Blood samples were collected at Baseline and at Day 4 post dose of each period to analyze the hematology parameter: erythrocytes mean corpuscular Volume. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits.
Outcome measures
| Measure |
Cohort 2: DOVATO (DTG/3TC) Fasted
n=16 Participants
Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions during Treatment Periods 1 and 2 of Cohort 2 of study.
|
Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed
n=16 Participants
Participants received TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) during Treatment Periods 1 and 2 of Cohort 1 of study
|
Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted
n=16 Participants
Participants received TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions during Treatment Periods 1 and 2 of Cohort 1 of study.
|
Cohort 2: DOVATO (DTG/3TC) Fed
n=17 Participants
Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) during Treatment Periods 1 and 2 of Cohort 2 of study
|
|---|---|---|---|---|
|
Absolute Values of Hematology Parameters: Erythrocytes Mean Corpuscular Volume
Day 4
|
87.31 Femtoliter
Standard Deviation 5.612
|
85.02 Femtoliter
Standard Deviation 5.470
|
85.04 Femtoliter
Standard Deviation 5.712
|
87.09 Femtoliter
Standard Deviation 5.648
|
|
Absolute Values of Hematology Parameters: Erythrocytes Mean Corpuscular Volume
Baseline (Day -1)
|
87.45 Femtoliter
Standard Deviation 5.795
|
85.11 Femtoliter
Standard Deviation 5.706
|
84.92 Femtoliter
Standard Deviation 5.749
|
87.64 Femtoliter
Standard Deviation 5.684
|
SECONDARY outcome
Timeframe: Baseline (Day -1) and Day 4Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
Blood samples were collected at Baseline and at Day 4 post dose of each period to analyze the hematology parameter: erythrocytes mean corpuscular hemoglobin. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits.
Outcome measures
| Measure |
Cohort 2: DOVATO (DTG/3TC) Fasted
n=16 Participants
Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions during Treatment Periods 1 and 2 of Cohort 2 of study.
|
Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed
n=16 Participants
Participants received TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) during Treatment Periods 1 and 2 of Cohort 1 of study
|
Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted
n=16 Participants
Participants received TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions during Treatment Periods 1 and 2 of Cohort 1 of study.
|
Cohort 2: DOVATO (DTG/3TC) Fed
n=17 Participants
Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) during Treatment Periods 1 and 2 of Cohort 2 of study
|
|---|---|---|---|---|
|
Absolute Values of Hematology Parameters: Erythrocytes Mean Corpuscular Hemoglobin
Day 4
|
29.80 Picograms
Standard Deviation 2.241
|
28.71 Picograms
Standard Deviation 2.544
|
28.48 Picograms
Standard Deviation 2.592
|
29.92 Picograms
Standard Deviation 2.260
|
|
Absolute Values of Hematology Parameters: Erythrocytes Mean Corpuscular Hemoglobin
Baseline (Day -1)
|
29.89 Picograms
Standard Deviation 2.210
|
28.74 Picograms
Standard Deviation 2.549
|
28.71 Picograms
Standard Deviation 2.655
|
29.89 Picograms
Standard Deviation 2.246
|
SECONDARY outcome
Timeframe: Baseline (Day -1) and Day 4Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
Blood samples were collected to analyze the clinical chemistry parameters: ALT, ALP and AST. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Cohort 2: DOVATO (DTG/3TC) Fasted
n=16 Participants
Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions during Treatment Periods 1 and 2 of Cohort 2 of study.
|
Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed
n=16 Participants
Participants received TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) during Treatment Periods 1 and 2 of Cohort 1 of study
|
Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted
n=16 Participants
Participants received TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions during Treatment Periods 1 and 2 of Cohort 1 of study.
|
Cohort 2: DOVATO (DTG/3TC) Fed
n=16 Participants
Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) during Treatment Periods 1 and 2 of Cohort 2 of study
|
|---|---|---|---|---|
|
Change From Baseline in Clinical Chemistry Parameters: Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Amino Transferase (AST)
ALP
|
-1.6 International units per liter
Standard Deviation 4.15
|
-2.6 International units per liter
Standard Deviation 5.71
|
-3.0 International units per liter
Standard Deviation 6.80
|
0.3 International units per liter
Standard Deviation 4.51
|
|
Change From Baseline in Clinical Chemistry Parameters: Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Amino Transferase (AST)
AST
|
-2.0 International units per liter
Standard Deviation 3.44
|
0.6 International units per liter
Standard Deviation 6.69
|
-4.0 International units per liter
Standard Deviation 4.59
|
-1.3 International units per liter
Standard Deviation 1.70
|
|
Change From Baseline in Clinical Chemistry Parameters: Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Amino Transferase (AST)
ALT
|
-3.6 International units per liter
Standard Deviation 5.06
|
4.0 International units per liter
Standard Deviation 12.63
|
-5.1 International units per liter
Standard Deviation 7.02
|
-0.4 International units per liter
Standard Deviation 4.10
|
SECONDARY outcome
Timeframe: Baseline (Day -1) and Day 4Population: Safety Population. Only those participants with data available at the specified time points were analyzed
Blood samples were collected at Baseline and at Day 4 post dose of each period to analyze the clinical chemistry parameters: calcium, glucose, potassium, sodium and BUN. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Cohort 2: DOVATO (DTG/3TC) Fasted
n=16 Participants
Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions during Treatment Periods 1 and 2 of Cohort 2 of study.
|
Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed
n=16 Participants
Participants received TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) during Treatment Periods 1 and 2 of Cohort 1 of study
|
Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted
n=16 Participants
Participants received TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions during Treatment Periods 1 and 2 of Cohort 1 of study.
|
Cohort 2: DOVATO (DTG/3TC) Fed
n=16 Participants
Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) during Treatment Periods 1 and 2 of Cohort 2 of study
|
|---|---|---|---|---|
|
Change From Baseline in Clinical Chemistry Parameters: Calcium, Glucose, Potassium, Sodium and Blood Urea Nitrogen (BUN)
Glucose
|
-0.049 Millimoles per liter
Standard Deviation 0.4082
|
-0.037 Millimoles per liter
Standard Deviation 0.2700
|
-0.169 Millimoles per liter
Standard Deviation 0.3648
|
-0.047 Millimoles per liter
Standard Deviation 0.2156
|
|
Change From Baseline in Clinical Chemistry Parameters: Calcium, Glucose, Potassium, Sodium and Blood Urea Nitrogen (BUN)
Potassium
|
-0.08 Millimoles per liter
Standard Deviation 0.434
|
0.03 Millimoles per liter
Standard Deviation 0.244
|
0.01 Millimoles per liter
Standard Deviation 0.189
|
-0.13 Millimoles per liter
Standard Deviation 0.277
|
|
Change From Baseline in Clinical Chemistry Parameters: Calcium, Glucose, Potassium, Sodium and Blood Urea Nitrogen (BUN)
Sodium
|
0.3 Millimoles per liter
Standard Deviation 1.40
|
0.4 Millimoles per liter
Standard Deviation 1.36
|
0.9 Millimoles per liter
Standard Deviation 1.29
|
-0.5 Millimoles per liter
Standard Deviation 1.41
|
|
Change From Baseline in Clinical Chemistry Parameters: Calcium, Glucose, Potassium, Sodium and Blood Urea Nitrogen (BUN)
Calcium
|
0.038 Millimoles per liter
Standard Deviation 0.0674
|
-0.003 Millimoles per liter
Standard Deviation 0.0436
|
-0.034 Millimoles per liter
Standard Deviation 0.0781
|
0.029 Millimoles per liter
Standard Deviation 0.0792
|
|
Change From Baseline in Clinical Chemistry Parameters: Calcium, Glucose, Potassium, Sodium and Blood Urea Nitrogen (BUN)
BUN
|
0.445 Millimoles per liter
Standard Deviation 0.9233
|
0.208 Millimoles per liter
Standard Deviation 0.4826
|
0.293 Millimoles per liter
Standard Deviation 0.8664
|
0.353 Millimoles per liter
Standard Deviation 0.8394
|
SECONDARY outcome
Timeframe: Baseline (Day -1) and Day 4Population: Safety Population. Only those participants with data available at the specified time points were analyzed
Blood samples were collected at Baseline and at Day 4 post dose of each period to analyze the clinical chemistry parameters: creatinine, direct bilirubin and total bilirubin. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Cohort 2: DOVATO (DTG/3TC) Fasted
n=16 Participants
Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions during Treatment Periods 1 and 2 of Cohort 2 of study.
|
Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed
n=16 Participants
Participants received TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) during Treatment Periods 1 and 2 of Cohort 1 of study
|
Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted
n=16 Participants
Participants received TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions during Treatment Periods 1 and 2 of Cohort 1 of study.
|
Cohort 2: DOVATO (DTG/3TC) Fed
n=16 Participants
Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) during Treatment Periods 1 and 2 of Cohort 2 of study
|
|---|---|---|---|---|
|
Change From Baseline in Clinical Chemistry Parameters: Creatinine, Direct Bilirubin and Total Bilirubin
Creatinine
|
2.11 Micromoles per liter
Standard Deviation 5.796
|
9.18 Micromoles per liter
Standard Deviation 2.871
|
10.76 Micromoles per liter
Standard Deviation 4.045
|
1.83 Micromoles per liter
Standard Deviation 2.931
|
|
Change From Baseline in Clinical Chemistry Parameters: Creatinine, Direct Bilirubin and Total Bilirubin
Direct Bilirubin
|
-0.06 Micromoles per liter
Standard Deviation 0.330
|
0.16 Micromoles per liter
Standard Deviation 0.541
|
0.05 Micromoles per liter
Standard Deviation 0.398
|
0.04 Micromoles per liter
Standard Deviation 0.403
|
|
Change From Baseline in Clinical Chemistry Parameters: Creatinine, Direct Bilirubin and Total Bilirubin
Total Bilirubin
|
-0.03 Micromoles per liter
Standard Deviation 1.588
|
0.16 Micromoles per liter
Standard Deviation 3.069
|
-0.74 Micromoles per liter
Standard Deviation 2.712
|
0.58 Micromoles per liter
Standard Deviation 2.377
|
SECONDARY outcome
Timeframe: Baseline (Day -1) and Day 4Population: Safety Population. Only those participants with data available at the specified time points were analyzed
Blood samples were collected at Baseline and at Day 4 post dose of each period to analyze the clinical chemistry parameters: creatine kinase. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Cohort 2: DOVATO (DTG/3TC) Fasted
n=16 Participants
Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions during Treatment Periods 1 and 2 of Cohort 2 of study.
|
Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed
n=16 Participants
Participants received TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) during Treatment Periods 1 and 2 of Cohort 1 of study
|
Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted
n=16 Participants
Participants received TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions during Treatment Periods 1 and 2 of Cohort 1 of study.
|
Cohort 2: DOVATO (DTG/3TC) Fed
n=16 Participants
Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) during Treatment Periods 1 and 2 of Cohort 2 of study
|
|---|---|---|---|---|
|
Change From Baseline in Clinical Chemistry Parameters: Creatine Kinase
|
-29.5 International units per liter
Standard Deviation 91.10
|
-17.8 International units per liter
Standard Deviation 47.62
|
-51.9 International units per liter
Standard Deviation 82.52
|
-33.9 International units per liter
Standard Deviation 44.83
|
SECONDARY outcome
Timeframe: Baseline (Day -1) and Day 4Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
Blood samples were collected at Baseline and at Day 4 post dose of each period to analyze the clinical chemistry parameters: albumin and total protein. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Cohort 2: DOVATO (DTG/3TC) Fasted
n=16 Participants
Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions during Treatment Periods 1 and 2 of Cohort 2 of study.
|
Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed
n=16 Participants
Participants received TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) during Treatment Periods 1 and 2 of Cohort 1 of study
|
Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted
n=16 Participants
Participants received TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions during Treatment Periods 1 and 2 of Cohort 1 of study.
|
Cohort 2: DOVATO (DTG/3TC) Fed
n=16 Participants
Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) during Treatment Periods 1 and 2 of Cohort 2 of study
|
|---|---|---|---|---|
|
Change From Baseline in Clinical Chemistry Parameters: Albumin and Total Protein
Albumin
|
1.1 Grams per liter
Standard Deviation 1.67
|
0.2 Grams per liter
Standard Deviation 2.32
|
-0.9 Grams per liter
Standard Deviation 3.20
|
0.9 Grams per liter
Standard Deviation 2.55
|
|
Change From Baseline in Clinical Chemistry Parameters: Albumin and Total Protein
Total Protein
|
0.7 Grams per liter
Standard Deviation 3.32
|
0.9 Grams per liter
Standard Deviation 3.07
|
-0.2 Grams per liter
Standard Deviation 4.59
|
0.8 Grams per liter
Standard Deviation 3.58
|
SECONDARY outcome
Timeframe: Baseline (Day -1) and Day 4Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
Blood samples were collected to analyze the clinical chemistry parameters: ALT, ALP and AST. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits.
Outcome measures
| Measure |
Cohort 2: DOVATO (DTG/3TC) Fasted
n=16 Participants
Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions during Treatment Periods 1 and 2 of Cohort 2 of study.
|
Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed
n=16 Participants
Participants received TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) during Treatment Periods 1 and 2 of Cohort 1 of study
|
Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted
n=16 Participants
Participants received TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions during Treatment Periods 1 and 2 of Cohort 1 of study.
|
Cohort 2: DOVATO (DTG/3TC) Fed
n=17 Participants
Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) during Treatment Periods 1 and 2 of Cohort 2 of study
|
|---|---|---|---|---|
|
Absolute Values of Clinical Chemistry Parameters: ALT, ALP and AST
Day 4: ALT
|
21.1 International units per liter
Standard Deviation 14.24
|
23.7 International units per liter
Standard Deviation 18.71
|
19.3 International units per liter
Standard Deviation 9.69
|
22.6 International units per liter
Standard Deviation 16.01
|
|
Absolute Values of Clinical Chemistry Parameters: ALT, ALP and AST
Baseline (Day -1): AST
|
18.9 International units per liter
Standard Deviation 6.57
|
18.4 International units per liter
Standard Deviation 5.26
|
20.6 International units per liter
Standard Deviation 5.77
|
18.5 International units per liter
Standard Deviation 6.97
|
|
Absolute Values of Clinical Chemistry Parameters: ALT, ALP and AST
Day 4: AST
|
16.9 International units per liter
Standard Deviation 5.11
|
19.0 International units per liter
Standard Deviation 8.82
|
16.6 International units per liter
Standard Deviation 2.94
|
17.3 International units per liter
Standard Deviation 6.04
|
|
Absolute Values of Clinical Chemistry Parameters: ALT, ALP and AST
Baseline (Day -1) ALP
|
61.8 International units per liter
Standard Deviation 14.65
|
66.8 International units per liter
Standard Deviation 15.23
|
65.6 International units per liter
Standard Deviation 17.65
|
59.3 International units per liter
Standard Deviation 13.58
|
|
Absolute Values of Clinical Chemistry Parameters: ALT, ALP and AST
Baseline (Day -1): ALT
|
24.8 International units per liter
Standard Deviation 15.45
|
19.7 International units per liter
Standard Deviation 9.16
|
24.3 International units per liter
Standard Deviation 15.10
|
23.4 International units per liter
Standard Deviation 16.38
|
|
Absolute Values of Clinical Chemistry Parameters: ALT, ALP and AST
Day 4: ALP
|
60.2 International units per liter
Standard Deviation 13.16
|
64.1 International units per liter
Standard Deviation 16.18
|
62.6 International units per liter
Standard Deviation 14.47
|
60.1 International units per liter
Standard Deviation 13.85
|
SECONDARY outcome
Timeframe: Baseline (Day -1) and Day 4Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
Blood samples were collected at Baseline and at Day 4 post dose of each period to analyze the clinical chemistry parameters: calcium, glucose, potassium, sodium and BUN. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits.
Outcome measures
| Measure |
Cohort 2: DOVATO (DTG/3TC) Fasted
n=16 Participants
Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions during Treatment Periods 1 and 2 of Cohort 2 of study.
|
Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed
n=16 Participants
Participants received TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) during Treatment Periods 1 and 2 of Cohort 1 of study
|
Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted
n=16 Participants
Participants received TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions during Treatment Periods 1 and 2 of Cohort 1 of study.
|
Cohort 2: DOVATO (DTG/3TC) Fed
n=17 Participants
Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) during Treatment Periods 1 and 2 of Cohort 2 of study
|
|---|---|---|---|---|
|
Absolute Values of Clinical Chemistry Parameters: Calcium, Glucose, Potassium, Sodium and BUN
Day 4: Calcium
|
2.371 Millimoles per liter
Standard Deviation 0.0721
|
2.347 Millimoles per liter
Standard Deviation 0.0899
|
2.342 Millimoles per liter
Standard Deviation 0.0980
|
2.368 Millimoles per liter
Standard Deviation 0.0742
|
|
Absolute Values of Clinical Chemistry Parameters: Calcium, Glucose, Potassium, Sodium and BUN
Baseline (Day -1): Glucose
|
5.068 Millimoles per liter
Standard Deviation 0.4760
|
4.821 Millimoles per liter
Standard Deviation 0.3214
|
5.016 Millimoles per liter
Standard Deviation 0.3793
|
4.974 Millimoles per liter
Standard Deviation 0.3943
|
|
Absolute Values of Clinical Chemistry Parameters: Calcium, Glucose, Potassium, Sodium and BUN
Day 4: Glucose
|
5.019 Millimoles per liter
Standard Deviation 0.3243
|
4.784 Millimoles per liter
Standard Deviation 0.2407
|
4.848 Millimoles per liter
Standard Deviation 0.2820
|
4.943 Millimoles per liter
Standard Deviation 0.4349
|
|
Absolute Values of Clinical Chemistry Parameters: Calcium, Glucose, Potassium, Sodium and BUN
Day 4: Potassium
|
4.23 Millimoles per liter
Standard Deviation 0.298
|
4.14 Millimoles per liter
Standard Deviation 0.216
|
4.18 Millimoles per liter
Standard Deviation 0.224
|
4.23 Millimoles per liter
Standard Deviation 0.235
|
|
Absolute Values of Clinical Chemistry Parameters: Calcium, Glucose, Potassium, Sodium and BUN
Baseline (Day -1): Sodium
|
138.8 Millimoles per liter
Standard Deviation 1.73
|
137.8 Millimoles per liter
Standard Deviation 0.91
|
137.9 Millimoles per liter
Standard Deviation 1.67
|
138.5 Millimoles per liter
Standard Deviation 1.59
|
|
Absolute Values of Clinical Chemistry Parameters: Calcium, Glucose, Potassium, Sodium and BUN
Day 4: Sodium
|
139.1 Millimoles per liter
Standard Deviation 1.61
|
138.3 Millimoles per liter
Standard Deviation 1.73
|
138.8 Millimoles per liter
Standard Deviation 1.17
|
138.2 Millimoles per liter
Standard Deviation 1.47
|
|
Absolute Values of Clinical Chemistry Parameters: Calcium, Glucose, Potassium, Sodium and BUN
Baseline (Day -1): BUN
|
4.592 Millimoles per liter
Standard Deviation 1.3875
|
4.531 Millimoles per liter
Standard Deviation 0.9081
|
4.333 Millimoles per liter
Standard Deviation 1.0302
|
4.633 Millimoles per liter
Standard Deviation 0.9609
|
|
Absolute Values of Clinical Chemistry Parameters: Calcium, Glucose, Potassium, Sodium and BUN
Day 4: BUN
|
5.037 Millimoles per liter
Standard Deviation 1.0406
|
4.739 Millimoles per liter
Standard Deviation 0.7250
|
4.626 Millimoles per liter
Standard Deviation 0.8416
|
5.065 Millimoles per liter
Standard Deviation 1.0791
|
|
Absolute Values of Clinical Chemistry Parameters: Calcium, Glucose, Potassium, Sodium and BUN
Baseline (Day -1): Calcium
|
2.333 Millimoles per liter
Standard Deviation 0.0981
|
2.350 Millimoles per liter
Standard Deviation 0.1030
|
2.376 Millimoles per liter
Standard Deviation 0.0975
|
2.339 Millimoles per liter
Standard Deviation 0.0793
|
|
Absolute Values of Clinical Chemistry Parameters: Calcium, Glucose, Potassium, Sodium and BUN
Baseline (Day -1): Potassium
|
4.31 Millimoles per liter
Standard Deviation 0.330
|
4.11 Millimoles per liter
Standard Deviation 0.268
|
4.16 Millimoles per liter
Standard Deviation 0.239
|
4.33 Millimoles per liter
Standard Deviation 0.335
|
SECONDARY outcome
Timeframe: Baseline (Day -1) and Day 4Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
Blood samples were collected at Baseline and at Day 4 post dose of each period to analyze the clinical chemistry parameters: creatinine, direct bilirubin and total bilirubin. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits.
Outcome measures
| Measure |
Cohort 2: DOVATO (DTG/3TC) Fasted
n=16 Participants
Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions during Treatment Periods 1 and 2 of Cohort 2 of study.
|
Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed
n=16 Participants
Participants received TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) during Treatment Periods 1 and 2 of Cohort 1 of study
|
Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted
n=16 Participants
Participants received TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions during Treatment Periods 1 and 2 of Cohort 1 of study.
|
Cohort 2: DOVATO (DTG/3TC) Fed
n=17 Participants
Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) during Treatment Periods 1 and 2 of Cohort 2 of study
|
|---|---|---|---|---|
|
Absolute Values of Clinical Chemistry Parameters: Creatinine, Direct Bilirubin and Total Bilirubin
Baseline (Day -1): Direct Bilirubin
|
1.84 Micromoles per liter
Standard Deviation 0.505
|
1.88 Micromoles per liter
Standard Deviation 0.886
|
1.88 Micromoles per liter
Standard Deviation 0.748
|
1.74 Micromoles per liter
Standard Deviation 0.271
|
|
Absolute Values of Clinical Chemistry Parameters: Creatinine, Direct Bilirubin and Total Bilirubin
Baseline (Day -1): Creatinine
|
82.54 Micromoles per liter
Standard Deviation 9.056
|
74.38 Micromoles per liter
Standard Deviation 14.598
|
75.10 Micromoles per liter
Standard Deviation 15.407
|
80.18 Micromoles per liter
Standard Deviation 12.794
|
|
Absolute Values of Clinical Chemistry Parameters: Creatinine, Direct Bilirubin and Total Bilirubin
Day 4: Creatinine
|
84.65 Micromoles per liter
Standard Deviation 10.814
|
83.55 Micromoles per liter
Standard Deviation 15.394
|
85.86 Micromoles per liter
Standard Deviation 16.173
|
83.87 Micromoles per liter
Standard Deviation 10.444
|
|
Absolute Values of Clinical Chemistry Parameters: Creatinine, Direct Bilirubin and Total Bilirubin
Day 4: Direct Bilirubin
|
1.78 Micromoles per liter
Standard Deviation 0.437
|
2.04 Micromoles per liter
Standard Deviation 0.776
|
1.93 Micromoles per liter
Standard Deviation 0.767
|
1.80 Micromoles per liter
Standard Deviation 0.539
|
|
Absolute Values of Clinical Chemistry Parameters: Creatinine, Direct Bilirubin and Total Bilirubin
Baseline (Day -1): Total Bilirubin
|
10.55 Micromoles per liter
Standard Deviation 3.109
|
10.33 Micromoles per liter
Standard Deviation 4.305
|
10.63 Micromoles per liter
Standard Deviation 4.326
|
9.90 Micromoles per liter
Standard Deviation 2.286
|
|
Absolute Values of Clinical Chemistry Parameters: Creatinine, Direct Bilirubin and Total Bilirubin
Day 4: Total Bilirubin
|
10.52 Micromoles per liter
Standard Deviation 3.040
|
10.49 Micromoles per liter
Standard Deviation 3.560
|
9.89 Micromoles per liter
Standard Deviation 3.747
|
10.73 Micromoles per liter
Standard Deviation 3.405
|
SECONDARY outcome
Timeframe: Baseline (Day -1) and Day 4Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
Blood samples were collected at Baseline and at Day 4 post dose of each period to analyze the clinical chemistry parameters: creatine kinase. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits.
Outcome measures
| Measure |
Cohort 2: DOVATO (DTG/3TC) Fasted
n=16 Participants
Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions during Treatment Periods 1 and 2 of Cohort 2 of study.
|
Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed
n=16 Participants
Participants received TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) during Treatment Periods 1 and 2 of Cohort 1 of study
|
Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted
n=16 Participants
Participants received TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions during Treatment Periods 1 and 2 of Cohort 1 of study.
|
Cohort 2: DOVATO (DTG/3TC) Fed
n=17 Participants
Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) during Treatment Periods 1 and 2 of Cohort 2 of study
|
|---|---|---|---|---|
|
Absolute Values of Clinical Chemistry Parameters: Creatine Kinase
Day 4
|
95.1 International units per liter
Standard Deviation 44.21
|
93.7 International units per liter
Standard Deviation 47.08
|
91.8 International units per liter
Standard Deviation 53.25
|
86.6 International units per liter
Standard Deviation 34.64
|
|
Absolute Values of Clinical Chemistry Parameters: Creatine Kinase
Baseline (Day -1)
|
124.6 International units per liter
Standard Deviation 117.54
|
111.5 International units per liter
Standard Deviation 66.68
|
143.8 International units per liter
Standard Deviation 110.57
|
119.7 International units per liter
Standard Deviation 59.78
|
SECONDARY outcome
Timeframe: Baseline (Day -1) and Day 4Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
Blood samples were collected at Baseline and at Day 4 post dose of each period to analyze the clinical chemistry parameters: albumin and total protein. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits.
Outcome measures
| Measure |
Cohort 2: DOVATO (DTG/3TC) Fasted
n=16 Participants
Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions during Treatment Periods 1 and 2 of Cohort 2 of study.
|
Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed
n=16 Participants
Participants received TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) during Treatment Periods 1 and 2 of Cohort 1 of study
|
Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted
n=16 Participants
Participants received TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions during Treatment Periods 1 and 2 of Cohort 1 of study.
|
Cohort 2: DOVATO (DTG/3TC) Fed
n=17 Participants
Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) during Treatment Periods 1 and 2 of Cohort 2 of study
|
|---|---|---|---|---|
|
Absolute Values of Clinical Chemistry Parameters: Albumin and Total Protein
Baseline (Day -1): Albumin
|
42.9 Grams per liter
Standard Deviation 2.59
|
44.0 Grams per liter
Standard Deviation 3.31
|
44.5 Grams per liter
Standard Deviation 3.58
|
43.0 Grams per liter
Standard Deviation 2.57
|
|
Absolute Values of Clinical Chemistry Parameters: Albumin and Total Protein
Day 4: Albumin
|
44.1 Grams per liter
Standard Deviation 2.86
|
44.2 Grams per liter
Standard Deviation 2.81
|
43.6 Grams per liter
Standard Deviation 2.83
|
43.7 Grams per liter
Standard Deviation 2.63
|
|
Absolute Values of Clinical Chemistry Parameters: Albumin and Total Protein
Baseline (Day -1): Total Protein
|
69.4 Grams per liter
Standard Deviation 4.36
|
71.3 Grams per liter
Standard Deviation 3.82
|
71.8 Grams per liter
Standard Deviation 3.64
|
69.1 Grams per liter
Standard Deviation 4.32
|
|
Absolute Values of Clinical Chemistry Parameters: Albumin and Total Protein
Day 4: Total Protein
|
70.1 Grams per liter
Standard Deviation 4.91
|
72.2 Grams per liter
Standard Deviation 3.04
|
71.6 Grams per liter
Standard Deviation 2.90
|
69.6 Grams per liter
Standard Deviation 4.08
|
SECONDARY outcome
Timeframe: Baseline (Day -1) and Day 4Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
Urine samples were collected at Baseline and at Day 4 post dose of each period to analyze the urinalysis parameter: specific gravity. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Cohort 2: DOVATO (DTG/3TC) Fasted
n=16 Participants
Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions during Treatment Periods 1 and 2 of Cohort 2 of study.
|
Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed
n=16 Participants
Participants received TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) during Treatment Periods 1 and 2 of Cohort 1 of study
|
Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted
n=16 Participants
Participants received TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions during Treatment Periods 1 and 2 of Cohort 1 of study.
|
Cohort 2: DOVATO (DTG/3TC) Fed
n=16 Participants
Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) during Treatment Periods 1 and 2 of Cohort 2 of study
|
|---|---|---|---|---|
|
Change From Baseline in Urinalysis Parameter: Specific Gravity
|
0.0019 Ratio
Standard Deviation 0.00570
|
0.0034 Ratio
Standard Deviation 0.00650
|
0.0013 Ratio
Standard Deviation 0.01116
|
0.0029 Ratio
Standard Deviation 0.00809
|
SECONDARY outcome
Timeframe: Baseline (Day -1) and Day 4Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
Urine samples were collected at Baseline and at Day 4 post dose of each period to analyze the urinalysis parameter: pH by dipstick. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acidic pH (5.0 - 6.0). Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Cohort 2: DOVATO (DTG/3TC) Fasted
n=16 Participants
Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions during Treatment Periods 1 and 2 of Cohort 2 of study.
|
Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed
n=16 Participants
Participants received TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) during Treatment Periods 1 and 2 of Cohort 1 of study
|
Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted
n=16 Participants
Participants received TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions during Treatment Periods 1 and 2 of Cohort 1 of study.
|
Cohort 2: DOVATO (DTG/3TC) Fed
n=16 Participants
Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) during Treatment Periods 1 and 2 of Cohort 2 of study
|
|---|---|---|---|---|
|
Change From Baseline in Urinalysis Parameter: Potential of Hydrogen (pH) by Dipstick
|
-0.44 pH
Standard Deviation 0.512
|
-0.34 pH
Standard Deviation 0.724
|
-0.22 pH
Standard Deviation 0.547
|
-0.13 pH
Standard Deviation 0.645
|
SECONDARY outcome
Timeframe: Baseline (Day -1) and Day 4Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
Urine samples were collected at Baseline and at Day 4 post dose of each period to analyze the urinalysis parameter: specific gravity. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits.
Outcome measures
| Measure |
Cohort 2: DOVATO (DTG/3TC) Fasted
n=16 Participants
Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions during Treatment Periods 1 and 2 of Cohort 2 of study.
|
Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed
n=16 Participants
Participants received TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) during Treatment Periods 1 and 2 of Cohort 1 of study
|
Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted
n=16 Participants
Participants received TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions during Treatment Periods 1 and 2 of Cohort 1 of study.
|
Cohort 2: DOVATO (DTG/3TC) Fed
n=17 Participants
Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) during Treatment Periods 1 and 2 of Cohort 2 of study
|
|---|---|---|---|---|
|
Absolute Values of Urinalysis Parameter: Specific Gravity
Day 4
|
1.0181 Ratio
Standard Deviation 0.00851
|
1.0162 Ratio
Standard Deviation 0.00782
|
1.0147 Ratio
Standard Deviation 0.00921
|
1.0182 Ratio
Standard Deviation 0.00727
|
|
Absolute Values of Urinalysis Parameter: Specific Gravity
Baseline (Day -1)
|
1.0163 Ratio
Standard Deviation 0.00857
|
1.0128 Ratio
Standard Deviation 0.00767
|
1.0134 Ratio
Standard Deviation 0.00766
|
1.0151 Ratio
Standard Deviation 0.00800
|
SECONDARY outcome
Timeframe: Baseline (Day -1) and Day 4Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
Urine samples were collected at Baseline and at Day 4 post dose of each period to analyze the urinalysis parameter: pH by dipstick. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acidic pH (5.0 - 6.0). Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits.
Outcome measures
| Measure |
Cohort 2: DOVATO (DTG/3TC) Fasted
n=16 Participants
Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions during Treatment Periods 1 and 2 of Cohort 2 of study.
|
Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed
n=16 Participants
Participants received TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) during Treatment Periods 1 and 2 of Cohort 1 of study
|
Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted
n=16 Participants
Participants received TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions during Treatment Periods 1 and 2 of Cohort 1 of study.
|
Cohort 2: DOVATO (DTG/3TC) Fed
n=17 Participants
Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) during Treatment Periods 1 and 2 of Cohort 2 of study
|
|---|---|---|---|---|
|
Absolute Values of Urinalysis Parameter: Potential of Hydrogen (pH) by Dipstick
Baseline (Day -1)
|
6.50 pH
Standard Deviation 0.548
|
6.38 pH
Standard Deviation 0.806
|
6.22 pH
Standard Deviation 0.515
|
6.41 pH
Standard Deviation 0.643
|
|
Absolute Values of Urinalysis Parameter: Potential of Hydrogen (pH) by Dipstick
Day 4
|
6.06 pH
Standard Deviation 0.544
|
6.03 pH
Standard Deviation 0.499
|
6.00 pH
Standard Deviation 0.577
|
6.28 pH
Standard Deviation 0.605
|
SECONDARY outcome
Timeframe: Baseline (Day -1) and Day 4Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
Urine samples were collected at indicated time points to analyze parameters including glucose, protein, blood, and ketones by dipstick. The dipstick test gives results in a semi-quantitative manner and results for urinalysis parameters can be read as Negative, Trace, 1+ (low concentrations present), 2+ (moderate concentrations present), 3+ (high concentrations present) and 4+ (very high concentrations present) indicating proportional concentrations in the urine sample.
Outcome measures
| Measure |
Cohort 2: DOVATO (DTG/3TC) Fasted
n=16 Participants
Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions during Treatment Periods 1 and 2 of Cohort 2 of study.
|
Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed
n=16 Participants
Participants received TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) during Treatment Periods 1 and 2 of Cohort 1 of study
|
Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted
n=16 Participants
Participants received TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions during Treatment Periods 1 and 2 of Cohort 1 of study.
|
Cohort 2: DOVATO (DTG/3TC) Fed
n=17 Participants
Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) during Treatment Periods 1 and 2 of Cohort 2 of study
|
|---|---|---|---|---|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick
Day 4: Urine Glucose (Negative)
|
16 Participants
|
16 Participants
|
16 Participants
|
16 Participants
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick
Baseline (Day -1): Urine Protein (Negative)
|
16 Participants
|
16 Participants
|
16 Participants
|
17 Participants
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick
Day 4: Urine Protein (Negative)
|
16 Participants
|
16 Participants
|
16 Participants
|
16 Participants
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick
Baseline (Day -1): Urine Blood (Negative)
|
15 Participants
|
16 Participants
|
15 Participants
|
16 Participants
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick
Baseline (Day -1): Urine Blood (3+)
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick
Day 4: Urine Blood (Negative)
|
15 Participants
|
15 Participants
|
14 Participants
|
16 Participants
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick
Day 4: Urine Ketones (Negative)
|
16 Participants
|
15 Participants
|
16 Participants
|
16 Participants
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick
Baseline (Day -1): Urine Glucose (Negative)
|
16 Participants
|
16 Participants
|
16 Participants
|
17 Participants
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick
Baseline (Day -1): Urine Blood (2+)
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick
Baseline (Day -1): Urine Blood (Trace)
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick
Day 4: Urine Blood (2+)
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick
Day 4: Urine Blood (3+)
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick
Baseline (Day -1): Urine Ketones (Negative)
|
16 Participants
|
16 Participants
|
16 Participants
|
17 Participants
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick
Day 4: Urine Ketones (1+)
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline (Day -1) and Day 4Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
Single 12-lead ECGs were obtained to measure PR Interval, QRS Duration, QT Interval and QTcF Interval. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Cohort 2: DOVATO (DTG/3TC) Fasted
n=16 Participants
Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions during Treatment Periods 1 and 2 of Cohort 2 of study.
|
Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed
n=16 Participants
Participants received TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) during Treatment Periods 1 and 2 of Cohort 1 of study
|
Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted
n=16 Participants
Participants received TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions during Treatment Periods 1 and 2 of Cohort 1 of study.
|
Cohort 2: DOVATO (DTG/3TC) Fed
n=16 Participants
Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) during Treatment Periods 1 and 2 of Cohort 2 of study
|
|---|---|---|---|---|
|
Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and Corrected QT Interval According to Fridericia's Formula (QTcF)
PR Interval
|
4.0 Milliseconds
Standard Deviation 5.69
|
2.2 Milliseconds
Standard Deviation 9.70
|
-0.7 Milliseconds
Standard Deviation 12.39
|
-2.7 Milliseconds
Standard Deviation 9.90
|
|
Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and Corrected QT Interval According to Fridericia's Formula (QTcF)
QT Interval
|
-2.4 Milliseconds
Standard Deviation 13.86
|
-10.5 Milliseconds
Standard Deviation 15.80
|
-6.4 Milliseconds
Standard Deviation 17.20
|
-13.1 Milliseconds
Standard Deviation 11.26
|
|
Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and Corrected QT Interval According to Fridericia's Formula (QTcF)
QRS Duration
|
0.1 Milliseconds
Standard Deviation 3.23
|
-1.2 Milliseconds
Standard Deviation 3.35
|
-2.9 Milliseconds
Standard Deviation 4.44
|
1.2 Milliseconds
Standard Deviation 2.99
|
|
Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and Corrected QT Interval According to Fridericia's Formula (QTcF)
QTcF
|
-0.8 Milliseconds
Standard Deviation 6.10
|
-4.1 Milliseconds
Standard Deviation 11.87
|
-6.9 Milliseconds
Standard Deviation 11.21
|
-2.5 Milliseconds
Standard Deviation 8.71
|
SECONDARY outcome
Timeframe: Baseline (Day -1) and Day 4Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
Single 12-lead ECGs were obtained to measure PR Interval, QRS Duration, QT Interval and QTcF Interval. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits.
Outcome measures
| Measure |
Cohort 2: DOVATO (DTG/3TC) Fasted
n=16 Participants
Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions during Treatment Periods 1 and 2 of Cohort 2 of study.
|
Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed
n=16 Participants
Participants received TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) during Treatment Periods 1 and 2 of Cohort 1 of study
|
Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted
n=16 Participants
Participants received TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions during Treatment Periods 1 and 2 of Cohort 1 of study.
|
Cohort 2: DOVATO (DTG/3TC) Fed
n=17 Participants
Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) during Treatment Periods 1 and 2 of Cohort 2 of study
|
|---|---|---|---|---|
|
Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF
Baseline (Day -1): PR Interval
|
176.1 Milliseconds
Standard Deviation 21.82
|
163.4 Milliseconds
Standard Deviation 24.29
|
161.6 Milliseconds
Standard Deviation 23.91
|
174.6 Milliseconds
Standard Deviation 25.55
|
|
Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF
Day 4: PR Interval
|
180.1 Milliseconds
Standard Deviation 19.48
|
165.6 Milliseconds
Standard Deviation 23.35
|
160.9 Milliseconds
Standard Deviation 24.82
|
174.8 Milliseconds
Standard Deviation 17.72
|
|
Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF
Day 4: QT Interval
|
399.8 Milliseconds
Standard Deviation 25.41
|
391.3 Milliseconds
Standard Deviation 15.10
|
394.3 Milliseconds
Standard Deviation 19.00
|
392.9 Milliseconds
Standard Deviation 20.51
|
|
Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF
Baseline (Day -1): QRS Duration
|
93.1 Milliseconds
Standard Deviation 7.27
|
95.6 Milliseconds
Standard Deviation 8.66
|
96.7 Milliseconds
Standard Deviation 10.62
|
93.4 Milliseconds
Standard Deviation 8.12
|
|
Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF
Day 4: QRS Duration
|
93.2 Milliseconds
Standard Deviation 7.53
|
94.4 Milliseconds
Standard Deviation 8.38
|
93.8 Milliseconds
Standard Deviation 10.36
|
93.8 Milliseconds
Standard Deviation 7.48
|
|
Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF
Baseline (Day -1): QT Interval
|
402.2 Milliseconds
Standard Deviation 25.69
|
401.8 Milliseconds
Standard Deviation 21.90
|
400.7 Milliseconds
Standard Deviation 21.35
|
407.5 Milliseconds
Standard Deviation 23.85
|
|
Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF
Baseline (Day -1)
|
401.3 Milliseconds
Standard Deviation 16.99
|
400.1 Milliseconds
Standard Deviation 14.30
|
403.6 Milliseconds
Standard Deviation 14.51
|
400.1 Milliseconds
Standard Deviation 17.84
|
|
Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF
Day 4: QTcF
|
400.4 Milliseconds
Standard Deviation 18.54
|
395.9 Milliseconds
Standard Deviation 14.26
|
396.6 Milliseconds
Standard Deviation 13.34
|
395.6 Milliseconds
Standard Deviation 19.23
|
SECONDARY outcome
Timeframe: Baseline (Day -1) and Day 4Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
SBP and DBP were measured in the supine or semi-supine position with a completely automated device after at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Cohort 2: DOVATO (DTG/3TC) Fasted
n=16 Participants
Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions during Treatment Periods 1 and 2 of Cohort 2 of study.
|
Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed
n=16 Participants
Participants received TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) during Treatment Periods 1 and 2 of Cohort 1 of study
|
Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted
n=16 Participants
Participants received TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions during Treatment Periods 1 and 2 of Cohort 1 of study.
|
Cohort 2: DOVATO (DTG/3TC) Fed
n=16 Participants
Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) during Treatment Periods 1 and 2 of Cohort 2 of study
|
|---|---|---|---|---|
|
Change From Baseline in Vital Signs Measurements: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SBP
|
0.6 Millimeters of mercury
Standard Deviation 8.54
|
-1.1 Millimeters of mercury
Standard Deviation 4.32
|
-4.2 Millimeters of mercury
Standard Deviation 6.71
|
1.9 Millimeters of mercury
Standard Deviation 8.14
|
|
Change From Baseline in Vital Signs Measurements: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
DBP
|
-1.1 Millimeters of mercury
Standard Deviation 8.71
|
0.0 Millimeters of mercury
Standard Deviation 7.27
|
0.3 Millimeters of mercury
Standard Deviation 5.20
|
3.0 Millimeters of mercury
Standard Deviation 6.46
|
SECONDARY outcome
Timeframe: Baseline (Day -1) and Day 4Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
SBP and DBP were measured in the supine or semi-supine position with a completely automated device after at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits.
Outcome measures
| Measure |
Cohort 2: DOVATO (DTG/3TC) Fasted
n=16 Participants
Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions during Treatment Periods 1 and 2 of Cohort 2 of study.
|
Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed
n=16 Participants
Participants received TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) during Treatment Periods 1 and 2 of Cohort 1 of study
|
Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted
n=16 Participants
Participants received TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions during Treatment Periods 1 and 2 of Cohort 1 of study.
|
Cohort 2: DOVATO (DTG/3TC) Fed
n=17 Participants
Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) during Treatment Periods 1 and 2 of Cohort 2 of study
|
|---|---|---|---|---|
|
Absolute Values of Vital Signs Measurements: SBP and DBP
Baseline (Day -1): SBP
|
113.5 Millimeters of mercury
Standard Deviation 8.65
|
110.6 Millimeters of mercury
Standard Deviation 10.61
|
113.0 Millimeters of mercury
Standard Deviation 10.04
|
112.5 Millimeters of mercury
Standard Deviation 9.37
|
|
Absolute Values of Vital Signs Measurements: SBP and DBP
Day 4: SBP
|
114.1 Millimeters of mercury
Standard Deviation 10.67
|
109.5 Millimeters of mercury
Standard Deviation 10.93
|
108.8 Millimeters of mercury
Standard Deviation 9.07
|
114.7 Millimeters of mercury
Standard Deviation 9.14
|
|
Absolute Values of Vital Signs Measurements: SBP and DBP
Day 4: DBP
|
65.3 Millimeters of mercury
Standard Deviation 8.20
|
64.0 Millimeters of mercury
Standard Deviation 9.12
|
64.3 Millimeters of mercury
Standard Deviation 8.99
|
66.4 Millimeters of mercury
Standard Deviation 8.06
|
|
Absolute Values of Vital Signs Measurements: SBP and DBP
Baseline (Day -1): DBP
|
66.4 Millimeters of mercury
Standard Deviation 6.55
|
64.0 Millimeters of mercury
Standard Deviation 7.68
|
64.0 Millimeters of mercury
Standard Deviation 7.69
|
63.0 Millimeters of mercury
Standard Deviation 7.37
|
SECONDARY outcome
Timeframe: Baseline (Day -1) and Day 4Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
Pulse rate were measured in the supine or semi-supine position with a completely automated device after at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Cohort 2: DOVATO (DTG/3TC) Fasted
n=16 Participants
Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions during Treatment Periods 1 and 2 of Cohort 2 of study.
|
Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed
n=16 Participants
Participants received TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) during Treatment Periods 1 and 2 of Cohort 1 of study
|
Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted
n=16 Participants
Participants received TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions during Treatment Periods 1 and 2 of Cohort 1 of study.
|
Cohort 2: DOVATO (DTG/3TC) Fed
n=16 Participants
Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) during Treatment Periods 1 and 2 of Cohort 2 of study
|
|---|---|---|---|---|
|
Change From Baseline in Vital Signs Measurements: Pulse Rate
|
-0.1 Beats per minute
Standard Deviation 7.04
|
3.0 Beats per minute
Standard Deviation 5.18
|
-0.3 Beats per minute
Standard Deviation 5.87
|
1.1 Beats per minute
Standard Deviation 10.12
|
SECONDARY outcome
Timeframe: Baseline (Day -1) and Day 4Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
Pulse rate were measured in the supine or semi-supine position with a completely automated device after at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits.
Outcome measures
| Measure |
Cohort 2: DOVATO (DTG/3TC) Fasted
n=16 Participants
Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions during Treatment Periods 1 and 2 of Cohort 2 of study.
|
Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed
n=16 Participants
Participants received TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) during Treatment Periods 1 and 2 of Cohort 1 of study
|
Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted
n=16 Participants
Participants received TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions during Treatment Periods 1 and 2 of Cohort 1 of study.
|
Cohort 2: DOVATO (DTG/3TC) Fed
n=17 Participants
Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) during Treatment Periods 1 and 2 of Cohort 2 of study
|
|---|---|---|---|---|
|
Absolute Values of Vital Signs Measurements: Pulse Rate
Baseline (Day -1)
|
60.1 Beats per minute
Standard Deviation 8.44
|
59.9 Beats per minute
Standard Deviation 9.07
|
62.3 Beats per minute
Standard Deviation 7.49
|
59.9 Beats per minute
Standard Deviation 10.82
|
|
Absolute Values of Vital Signs Measurements: Pulse Rate
Day 4
|
59.9 Beats per minute
Standard Deviation 6.68
|
62.9 Beats per minute
Standard Deviation 8.47
|
62.0 Beats per minute
Standard Deviation 9.89
|
61.4 Beats per minute
Standard Deviation 3.86
|
Adverse Events
Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort 2: DOVATO (DTG/3TC) Fed
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Cohort 2: DOVATO (DTG/3TC) Fasted
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed
n=16 participants at risk
Participants received TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) during Treatment Periods 1 and 2 of Cohort 1 of study
|
Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted
n=16 participants at risk
Participants received TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions during Treatment Periods 1 and 2 of Cohort 1 of study.
|
Cohort 2: DOVATO (DTG/3TC) Fed
n=17 participants at risk
Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) during Treatment Periods 1 and 2 of Cohort 2 of study.
|
Cohort 2: DOVATO (DTG/3TC) Fasted
n=16 participants at risk
Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions during Treatment Periods 1 and 2 of Cohort 2 of study.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/16 • All-cause mortality, Serious Adverse Events (SAEs) and non-SAEs were collected up to 23 days.
All-cause mortality, SAEs and non-SAEs were reported for Safety Population that consisted of all participants who received at least one dose of study intervention. Adverse events were presented treatment-wise.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, Serious Adverse Events (SAEs) and non-SAEs were collected up to 23 days.
All-cause mortality, SAEs and non-SAEs were reported for Safety Population that consisted of all participants who received at least one dose of study intervention. Adverse events were presented treatment-wise.
|
0.00%
0/17 • All-cause mortality, Serious Adverse Events (SAEs) and non-SAEs were collected up to 23 days.
All-cause mortality, SAEs and non-SAEs were reported for Safety Population that consisted of all participants who received at least one dose of study intervention. Adverse events were presented treatment-wise.
|
0.00%
0/16 • All-cause mortality, Serious Adverse Events (SAEs) and non-SAEs were collected up to 23 days.
All-cause mortality, SAEs and non-SAEs were reported for Safety Population that consisted of all participants who received at least one dose of study intervention. Adverse events were presented treatment-wise.
|
|
Nervous system disorders
Headache
|
0.00%
0/16 • All-cause mortality, Serious Adverse Events (SAEs) and non-SAEs were collected up to 23 days.
All-cause mortality, SAEs and non-SAEs were reported for Safety Population that consisted of all participants who received at least one dose of study intervention. Adverse events were presented treatment-wise.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, Serious Adverse Events (SAEs) and non-SAEs were collected up to 23 days.
All-cause mortality, SAEs and non-SAEs were reported for Safety Population that consisted of all participants who received at least one dose of study intervention. Adverse events were presented treatment-wise.
|
0.00%
0/17 • All-cause mortality, Serious Adverse Events (SAEs) and non-SAEs were collected up to 23 days.
All-cause mortality, SAEs and non-SAEs were reported for Safety Population that consisted of all participants who received at least one dose of study intervention. Adverse events were presented treatment-wise.
|
0.00%
0/16 • All-cause mortality, Serious Adverse Events (SAEs) and non-SAEs were collected up to 23 days.
All-cause mortality, SAEs and non-SAEs were reported for Safety Population that consisted of all participants who received at least one dose of study intervention. Adverse events were presented treatment-wise.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/16 • All-cause mortality, Serious Adverse Events (SAEs) and non-SAEs were collected up to 23 days.
All-cause mortality, SAEs and non-SAEs were reported for Safety Population that consisted of all participants who received at least one dose of study intervention. Adverse events were presented treatment-wise.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, Serious Adverse Events (SAEs) and non-SAEs were collected up to 23 days.
All-cause mortality, SAEs and non-SAEs were reported for Safety Population that consisted of all participants who received at least one dose of study intervention. Adverse events were presented treatment-wise.
|
0.00%
0/17 • All-cause mortality, Serious Adverse Events (SAEs) and non-SAEs were collected up to 23 days.
All-cause mortality, SAEs and non-SAEs were reported for Safety Population that consisted of all participants who received at least one dose of study intervention. Adverse events were presented treatment-wise.
|
0.00%
0/16 • All-cause mortality, Serious Adverse Events (SAEs) and non-SAEs were collected up to 23 days.
All-cause mortality, SAEs and non-SAEs were reported for Safety Population that consisted of all participants who received at least one dose of study intervention. Adverse events were presented treatment-wise.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/16 • All-cause mortality, Serious Adverse Events (SAEs) and non-SAEs were collected up to 23 days.
All-cause mortality, SAEs and non-SAEs were reported for Safety Population that consisted of all participants who received at least one dose of study intervention. Adverse events were presented treatment-wise.
|
0.00%
0/16 • All-cause mortality, Serious Adverse Events (SAEs) and non-SAEs were collected up to 23 days.
All-cause mortality, SAEs and non-SAEs were reported for Safety Population that consisted of all participants who received at least one dose of study intervention. Adverse events were presented treatment-wise.
|
0.00%
0/17 • All-cause mortality, Serious Adverse Events (SAEs) and non-SAEs were collected up to 23 days.
All-cause mortality, SAEs and non-SAEs were reported for Safety Population that consisted of all participants who received at least one dose of study intervention. Adverse events were presented treatment-wise.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, Serious Adverse Events (SAEs) and non-SAEs were collected up to 23 days.
All-cause mortality, SAEs and non-SAEs were reported for Safety Population that consisted of all participants who received at least one dose of study intervention. Adverse events were presented treatment-wise.
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
0.00%
0/16 • All-cause mortality, Serious Adverse Events (SAEs) and non-SAEs were collected up to 23 days.
All-cause mortality, SAEs and non-SAEs were reported for Safety Population that consisted of all participants who received at least one dose of study intervention. Adverse events were presented treatment-wise.
|
0.00%
0/16 • All-cause mortality, Serious Adverse Events (SAEs) and non-SAEs were collected up to 23 days.
All-cause mortality, SAEs and non-SAEs were reported for Safety Population that consisted of all participants who received at least one dose of study intervention. Adverse events were presented treatment-wise.
|
5.9%
1/17 • Number of events 1 • All-cause mortality, Serious Adverse Events (SAEs) and non-SAEs were collected up to 23 days.
All-cause mortality, SAEs and non-SAEs were reported for Safety Population that consisted of all participants who received at least one dose of study intervention. Adverse events were presented treatment-wise.
|
0.00%
0/16 • All-cause mortality, Serious Adverse Events (SAEs) and non-SAEs were collected up to 23 days.
All-cause mortality, SAEs and non-SAEs were reported for Safety Population that consisted of all participants who received at least one dose of study intervention. Adverse events were presented treatment-wise.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
6.2%
1/16 • Number of events 1 • All-cause mortality, Serious Adverse Events (SAEs) and non-SAEs were collected up to 23 days.
All-cause mortality, SAEs and non-SAEs were reported for Safety Population that consisted of all participants who received at least one dose of study intervention. Adverse events were presented treatment-wise.
|
0.00%
0/16 • All-cause mortality, Serious Adverse Events (SAEs) and non-SAEs were collected up to 23 days.
All-cause mortality, SAEs and non-SAEs were reported for Safety Population that consisted of all participants who received at least one dose of study intervention. Adverse events were presented treatment-wise.
|
0.00%
0/17 • All-cause mortality, Serious Adverse Events (SAEs) and non-SAEs were collected up to 23 days.
All-cause mortality, SAEs and non-SAEs were reported for Safety Population that consisted of all participants who received at least one dose of study intervention. Adverse events were presented treatment-wise.
|
0.00%
0/16 • All-cause mortality, Serious Adverse Events (SAEs) and non-SAEs were collected up to 23 days.
All-cause mortality, SAEs and non-SAEs were reported for Safety Population that consisted of all participants who received at least one dose of study intervention. Adverse events were presented treatment-wise.
|
|
Gastrointestinal disorders
Angular cheilitis
|
0.00%
0/16 • All-cause mortality, Serious Adverse Events (SAEs) and non-SAEs were collected up to 23 days.
All-cause mortality, SAEs and non-SAEs were reported for Safety Population that consisted of all participants who received at least one dose of study intervention. Adverse events were presented treatment-wise.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, Serious Adverse Events (SAEs) and non-SAEs were collected up to 23 days.
All-cause mortality, SAEs and non-SAEs were reported for Safety Population that consisted of all participants who received at least one dose of study intervention. Adverse events were presented treatment-wise.
|
0.00%
0/17 • All-cause mortality, Serious Adverse Events (SAEs) and non-SAEs were collected up to 23 days.
All-cause mortality, SAEs and non-SAEs were reported for Safety Population that consisted of all participants who received at least one dose of study intervention. Adverse events were presented treatment-wise.
|
0.00%
0/16 • All-cause mortality, Serious Adverse Events (SAEs) and non-SAEs were collected up to 23 days.
All-cause mortality, SAEs and non-SAEs were reported for Safety Population that consisted of all participants who received at least one dose of study intervention. Adverse events were presented treatment-wise.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER