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This study will assess the effect of food on the pharmacokinetics (PK) of pediatric formulations of TRIUMEQ (dolutegravir [DTG] 5 milligrams [mg]/abacavir [ABC] 60 mg/lamivudine [3TC] 30 mg) dispersible tablets and DOVATO (DTG 5 mg/3TC 30 mg) dispersible tablets in healthy adult participants. Additionally, safety and tolerability of these formulations will also be assessed. TRIUMEQ and DOVATO are registered trademarks of GlaxoSmithKline group of companies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1: TRIUMEQ Fed followed by TRIUMEQ Fasted | Experimental | 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. |
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| Cohort 1: TRIUMEQ Fasted followed by TRIUMEQ Fed | Experimental | 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. |
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| Cohort 2: DOVATO Fed followed by DOVATO Fasted | Experimental | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TRIUMEQ | Drug | TRIUMEQ will be available as fixed dose combination (FDC) dispersible tablets to be administered orally as a dispersion. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | 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 |
| 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 | 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. | 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 |
| Cohort 1: Maximum Observed Concentration (Cmax) of DTG, ABC and 3TC Following Administration of TRIUMEQ Under Fed and Fasted Conditions | 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. | 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 |
| Cohort 2: AUC (0-inf) of DTG and 3TC Following Administration of DOVATO Under Fed and Fasted Conditions | 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. | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Cohort 1: Lag Time for Absorption (Tlag) of DTG, ABC and 3TC Following Administration of TRIUMEQ Under Fed and Fasted Conditions | 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. | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | ViiV Healthcare | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Austin | Texas | 78744 | United States |
IPD for this study will be made available via the Clinical Study Data Request site.
IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study.
Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
A total of 33 participants (16 participants in Cohort 1 and 17 participants in Cohort 2) were enrolled in the study.
This study was conducted at a single center in the United States.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | 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. |
| FG003 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Treatment Period 1 (1 Day) |
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| Washout Period (up to 7 Days) |
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| Treatment Period 2 (1 Day) |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | 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 | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | Hours*nanogram per milliliter | 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 |
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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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed | 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 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | ViiV Healthcare | 866-435-7343 | GSKClinicalSupportHD@gsk.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 4, 2021 | Jun 8, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 7, 2021 | Jun 30, 2022 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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| ID | Term |
|---|---|
| C000631408 | abacavir, dolutegravir, and lamivudine drug combination |
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This is a randomized, single-dose, 2-cohort, 2-period crossover study.
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This is an open-label study
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|
| Cohort 2: DOVATO Fasted followed by DOVATO Fed | Experimental | 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. |
|
| DOVATO | Drug | DOVATO will be available as FDC dispersible tablets to be administered orally as a dispersion. |
|
| Cohort 2: AUC (0-t) of DTG and 3TC Following Administration of DOVATO Under Fed and Fasted Conditions |
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. |
| 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 |
| Cohort 2: Cmax of DTG and 3TC Following Administration of DOVATO Under Fed and Fasted Conditions | 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. | 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 |
| Cohort 1: Terminal Elimination Phase Half-life (t1/2) of DTG, ABC and 3TC Following Administration of TRIUMEQ Under Fed and Fasted Conditions | 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. | 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 |
| 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 | 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. | 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 2 |
| Cohort 1: Last Quantifiable Concentration (Ct) of DTG, ABC and 3TC Following Administration of TRIUMEQ Under Fed and Fasted Conditions | 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. | 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 |
| Cohort 1: Concentration at 24 Hours Post-dose (C24) of DTG, ABC and 3TC Following Administration of TRIUMEQ Under Fed and Fasted Conditions | 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. | 24 hours post dose in treatment periods 1 and 2 |
| Cohort 1: Time of Maximum Observed Concentration (Tmax) of DTG, ABC and 3TC Following Administration of TRIUMEQ Under Fed and Fasted Conditions | 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. | 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 |
| Cohort 2: Tlag of DTG and 3TC Following Administration of DOVATO Under Fed and Fasted Conditions | 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. | 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 |
| Cohort 2: t1/2 of DTG and 3TC Following Administration of DOVATO Under Fed and Fasted Conditions | 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. | 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 |
| Cohort 2: AUC(0-24) of DTG and 3TC Following Administration of DOVATO Under Fed and Fasted Conditions | 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. | 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 2 |
| Cohort 2: Ct of DTG and 3TC Following Administration of DOVATO Under Fed and Fasted Conditions | 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. | 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 |
| Cohort 2: C24 of DTG and 3TC Following Administration of DOVATO Under Fed and Fasted Conditions | 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. | 24 hours post dose in treatment periods 1 and 2 |
| Cohort 2: Tmax of DTG and 3TC Following Administration of DOVATO Under Fed and Fasted Conditions | 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. | 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 |
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | 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. | Up to 23 days |
| Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count and Neutrophil | 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. | Baseline (Day -1) and Day 4 |
| Change From Baseline in Hematology Parameters: Red Blood Cell (RBC) Count | 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. | Baseline (Day -1) and Day 4 |
| Change From Baseline in Hematology Parameters: Hemoglobin | 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. | Baseline (Day -1) and Day 4 |
| Change From Baseline in Hematology Parameters: Hematocrit | 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. | Baseline (Day -1) and Day 4 |
| Change From Baseline in Hematology Parameters: Erythrocytes Mean Corpuscular Volume | 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. | Baseline (Day -1) and Day 4 |
| Change From Baseline in Hematology Parameters: Erythrocytes Mean Corpuscular Hemoglobin | 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. | Baseline (Day -1) and Day 4 |
| Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count and Neutrophil | 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. | Baseline (Day -1) and Day 4 |
| Absolute Values of Hematology Parameters: RBC Count | 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. | Baseline (Day -1) and Day 4 |
| Absolute Values of Hematology Parameters: Hemoglobin | 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. | Baseline (Day -1) and Day 4 |
| Absolute Values of Hematology Parameters: Hematocrit | 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. | Baseline (Day -1) and Day 4 |
| Absolute Values of Hematology Parameters: Erythrocytes Mean Corpuscular Volume | 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. | Baseline (Day -1) and Day 4 |
| Absolute Values of Hematology Parameters: Erythrocytes Mean Corpuscular Hemoglobin | 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. | Baseline (Day -1) and Day 4 |
| Change From Baseline in Clinical Chemistry Parameters: Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Amino Transferase (AST) | 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. | Baseline (Day -1) and Day 4 |
| Change From Baseline in Clinical Chemistry Parameters: Calcium, Glucose, Potassium, Sodium and Blood Urea Nitrogen (BUN) | 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. | Baseline (Day -1) and Day 4 |
| Change From Baseline in Clinical Chemistry Parameters: Creatinine, Direct Bilirubin and Total Bilirubin | 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. | Baseline (Day -1) and Day 4 |
| Change From Baseline in Clinical Chemistry Parameters: Creatine Kinase | 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. | Baseline (Day -1) and Day 4 |
| Change From Baseline in Clinical Chemistry Parameters: Albumin and Total Protein | 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. | Baseline (Day -1) and Day 4 |
| Absolute Values of Clinical Chemistry Parameters: ALT, ALP and AST | 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. | Baseline (Day -1) and Day 4 |
| Absolute Values of Clinical Chemistry Parameters: Calcium, Glucose, Potassium, Sodium and BUN | 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. | Baseline (Day -1) and Day 4 |
| Absolute Values of Clinical Chemistry Parameters: Creatinine, Direct Bilirubin and Total Bilirubin | 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. | Baseline (Day -1) and Day 4 |
| Absolute Values of Clinical Chemistry Parameters: Creatine Kinase | 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. | Baseline (Day -1) and Day 4 |
| Absolute Values of Clinical Chemistry Parameters: Albumin and Total Protein | 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. | Baseline (Day -1) and Day 4 |
| Change From Baseline in Urinalysis Parameter: Specific Gravity | 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. | Baseline (Day -1) and Day 4 |
| Change From Baseline in Urinalysis Parameter: Potential of Hydrogen (pH) by Dipstick | 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. | Baseline (Day -1) and Day 4 |
| Absolute Values of Urinalysis Parameter: Specific Gravity | 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. | Baseline (Day -1) and Day 4 |
| Absolute Values of Urinalysis Parameter: Potential of Hydrogen (pH) by Dipstick | 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. | Baseline (Day -1) and Day 4 |
| Number of Participants With Abnormal Values on Urinalysis by Dipstick | 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. | Baseline (Day -1) and Day 4 |
| Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and Corrected QT Interval According to Fridericia's Formula (QTcF) | 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. | Baseline (Day -1) and Day 4 |
| Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF | 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. | Baseline (Day -1) and Day 4 |
| Change From Baseline in Vital Signs Measurements: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | 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. | Baseline (Day -1) and Day 4 |
| Absolute Values of Vital Signs Measurements: SBP and DBP | 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. | Baseline (Day -1) and Day 4 |
| Change From Baseline in Vital Signs Measurements: Pulse Rate | 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. | Baseline (Day -1) and Day 4 |
| Absolute Values of Vital Signs Measurements: Pulse Rate | 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. | Baseline (Day -1) and Day 4 |
| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| BG001 | 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. |
| BG002 | 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. |
| BG003 | 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. |
| BG004 | Total | Total of all reporting groups |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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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
| OG001 | Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted | 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. |
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| Primary | 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 | 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. | Pharmacokinetic Parameter Population | Posted | Geometric Mean | Geometric Coefficient of Variation | Hours*nanogram per milliliter | 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 |
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| Primary | Cohort 1: Maximum Observed Concentration (Cmax) of DTG, ABC and 3TC Following Administration of TRIUMEQ Under Fed and Fasted Conditions | 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. | Pharmacokinetic Parameter Population | Posted | Geometric Mean | Geometric Coefficient of Variation | Nanogram per milliliter | 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 |
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| Primary | Cohort 2: AUC (0-inf) of DTG and 3TC Following Administration of DOVATO Under Fed and Fasted Conditions | 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. | Pharmacokinetic Parameter Population. Only those participants with data available at specified time points were analyzed. | Posted | Geometric Mean | Geometric Coefficient of Variation | Hours*nanogram per milliliter | 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 |
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| Primary | Cohort 2: AUC (0-t) of DTG and 3TC Following Administration of DOVATO Under Fed and Fasted Conditions | 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. | Pharmacokinetic Parameter Population | Posted | Geometric Mean | Geometric Coefficient of Variation | Hours*nanogram per milliliter | 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 |
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| Primary | Cohort 2: Cmax of DTG and 3TC Following Administration of DOVATO Under Fed and Fasted Conditions | 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. | Pharmacokinetic Parameter Population | Posted | Geometric Mean | Geometric Coefficient of Variation | Nanogram per milliliter | 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 |
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| Secondary | Cohort 1: Lag Time for Absorption (Tlag) of DTG, ABC and 3TC Following Administration of TRIUMEQ Under Fed and Fasted Conditions | 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. | Pharmacokinetic Parameter Population | Posted | Median | Full Range | Hours | 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 |
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| Secondary | Cohort 1: Terminal Elimination Phase Half-life (t1/2) of DTG, ABC and 3TC Following Administration of TRIUMEQ Under Fed and Fasted Conditions | 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. | Pharmacokinetic Parameter Population. Only those participants with data available at specified time points were analyzed. | Posted | Geometric Mean | Geometric Coefficient of Variation | Hours | 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 |
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| Secondary | 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 | 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. | Pharmacokinetic Parameter Population | Posted | Geometric Mean | Geometric Coefficient of Variation | Hours*nanogram per milliliter | 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 2 |
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| Secondary | Cohort 1: Last Quantifiable Concentration (Ct) of DTG, ABC and 3TC Following Administration of TRIUMEQ Under Fed and Fasted Conditions | 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. | Pharmacokinetic Parameter Population | Posted | Geometric Mean | Geometric Coefficient of Variation | Nanogram per milliliter | 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 |
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| Secondary | Cohort 1: Concentration at 24 Hours Post-dose (C24) of DTG, ABC and 3TC Following Administration of TRIUMEQ Under Fed and Fasted Conditions | 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. | Pharmacokinetic Parameter Population. Only those participants with data available at specified time points were analyzed. | Posted | Geometric Mean | Geometric Coefficient of Variation | Nanogram per milliliter | 24 hours post dose in treatment periods 1 and 2 |
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| Secondary | Cohort 1: Time of Maximum Observed Concentration (Tmax) of DTG, ABC and 3TC Following Administration of TRIUMEQ Under Fed and Fasted Conditions | 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. | Pharmacokinetic Parameter Population | Posted | Median | Full Range | Hours | 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 |
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| Secondary | Cohort 2: Tlag of DTG and 3TC Following Administration of DOVATO Under Fed and Fasted Conditions | 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. | Pharmacokinetic Parameter Population | Posted | Median | Full Range | Hours | 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 |
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| Secondary | Cohort 2: t1/2 of DTG and 3TC Following Administration of DOVATO Under Fed and Fasted Conditions | 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. | Pharmacokinetic Parameter Population. Only those participants with data available at specified time points were analyzed. | Posted | Geometric Mean | Geometric Coefficient of Variation | Hours | 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 |
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| Secondary | Cohort 2: AUC(0-24) of DTG and 3TC Following Administration of DOVATO Under Fed and Fasted Conditions | 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. | Pharmacokinetic Parameter Population | Posted | Geometric Mean | Geometric Coefficient of Variation | Hours*nanogram per milliliter | 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 2 |
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| Secondary | Cohort 2: Ct of DTG and 3TC Following Administration of DOVATO Under Fed and Fasted Conditions | 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. | Pharmacokinetic Parameter Population. Only those participants with data available at specified time points were analyzed. | Posted | Geometric Mean | Geometric Coefficient of Variation | Nanogram per milliliter | 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 |
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| Secondary | Cohort 2: C24 of DTG and 3TC Following Administration of DOVATO Under Fed and Fasted Conditions | 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. | Pharmacokinetic Parameter Population | Posted | Geometric Mean | Geometric Coefficient of Variation | Nanogram per milliliter | 24 hours post dose in treatment periods 1 and 2 |
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| Secondary | Cohort 2: Tmax of DTG and 3TC Following Administration of DOVATO Under Fed and Fasted Conditions | 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. | Pharmacokinetic Parameter Population | Posted | Median | Full Range | Hours | 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 |
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| Secondary | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | 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. | Safety Population consisted of all participants who received at least one dose of study intervention. | Posted | Count of Participants | Participants | Up to 23 days |
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| Secondary | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count and Neutrophil | 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. | Safety Population. Only those participants with data available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | 10^9 cells per liter | Baseline (Day -1) and Day 4 |
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| Secondary | Change From Baseline in Hematology Parameters: Red Blood Cell (RBC) Count | 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. | Safety Population. Only those participants with data available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | 10^12 cells per liter | Baseline (Day -1) and Day 4 |
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| Secondary | Change From Baseline in Hematology Parameters: Hemoglobin | 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. | Safety Population. Only those participants with data available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | Grams per liter | Baseline (Day -1) and Day 4 |
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| Secondary | Change From Baseline in Hematology Parameters: Hematocrit | 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. | Safety Population. Only those participants with data available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | Proportion of red blood cells in blood | Baseline (Day -1) and Day 4 |
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| Secondary | Change From Baseline in Hematology Parameters: Erythrocytes Mean Corpuscular Volume | 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. | Safety Population. Only those participants with data available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | Femtoliter | Baseline (Day -1) and Day 4 |
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| Secondary | Change From Baseline in Hematology Parameters: Erythrocytes Mean Corpuscular Hemoglobin | 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. | Safety Population. Only those participants with data available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | Picograms | Baseline (Day -1) and Day 4 |
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| Secondary | Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count and Neutrophil | 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. | Safety Population. Only those participants with data available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | 10^9 cells per liter | Baseline (Day -1) and Day 4 |
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| Secondary | Absolute Values of Hematology Parameters: RBC Count | 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. | Safety Population. Only those participants with data available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | 10^12 cells per liter | Baseline (Day -1) and Day 4 |
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| Secondary | Absolute Values of Hematology Parameters: Hemoglobin | 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. | Safety Population. Only those participants with data available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | Grams per liter | Baseline (Day -1) and Day 4 |
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| Secondary | Absolute Values of Hematology Parameters: Hematocrit | 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. | Safety Population. Only those participants with data available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | Proportion of red blood cells in blood | Baseline (Day -1) and Day 4 |
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| Secondary | Absolute Values of Hematology Parameters: Erythrocytes Mean Corpuscular Volume | 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. | Safety Population. Only those participants with data available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | Femtoliter | Baseline (Day -1) and Day 4 |
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| Secondary | Absolute Values of Hematology Parameters: Erythrocytes Mean Corpuscular Hemoglobin | 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. | Safety Population. Only those participants with data available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | Picograms | Baseline (Day -1) and Day 4 |
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| Secondary | Change From Baseline in Clinical Chemistry Parameters: Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Amino Transferase (AST) | 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. | Safety Population. Only those participants with data available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | International units per liter | Baseline (Day -1) and Day 4 |
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| Secondary | Change From Baseline in Clinical Chemistry Parameters: Calcium, Glucose, Potassium, Sodium and Blood Urea Nitrogen (BUN) | 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. | Safety Population. Only those participants with data available at the specified time points were analyzed | Posted | Mean | Standard Deviation | Millimoles per liter | Baseline (Day -1) and Day 4 |
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| Secondary | Change From Baseline in Clinical Chemistry Parameters: Creatinine, Direct Bilirubin and Total Bilirubin | 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. | Safety Population. Only those participants with data available at the specified time points were analyzed | Posted | Mean | Standard Deviation | Micromoles per liter | Baseline (Day -1) and Day 4 |
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| Secondary | Change From Baseline in Clinical Chemistry Parameters: Creatine Kinase | 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. | Safety Population. Only those participants with data available at the specified time points were analyzed | Posted | Mean | Standard Deviation | International units per liter | Baseline (Day -1) and Day 4 |
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| Secondary | Change From Baseline in Clinical Chemistry Parameters: Albumin and Total Protein | 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. | Safety Population. Only those participants with data available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | Grams per liter | Baseline (Day -1) and Day 4 |
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| Secondary | Absolute Values of Clinical Chemistry Parameters: ALT, ALP and AST | 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. | Safety Population. Only those participants with data available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | International units per liter | Baseline (Day -1) and Day 4 |
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| Secondary | Absolute Values of Clinical Chemistry Parameters: Calcium, Glucose, Potassium, Sodium and BUN | 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. | Safety Population. Only those participants with data available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | Millimoles per liter | Baseline (Day -1) and Day 4 |
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| Secondary | Absolute Values of Clinical Chemistry Parameters: Creatinine, Direct Bilirubin and Total Bilirubin | 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. | Safety Population. Only those participants with data available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | Micromoles per liter | Baseline (Day -1) and Day 4 |
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| Secondary | Absolute Values of Clinical Chemistry Parameters: Creatine Kinase | 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. | Safety Population. Only those participants with data available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | International units per liter | Baseline (Day -1) and Day 4 |
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| Secondary | Absolute Values of Clinical Chemistry Parameters: Albumin and Total Protein | 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. | Safety Population. Only those participants with data available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | Grams per liter | Baseline (Day -1) and Day 4 |
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| Secondary | Change From Baseline in Urinalysis Parameter: Specific Gravity | 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. | Safety Population. Only those participants with data available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | Ratio | Baseline (Day -1) and Day 4 |
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| Secondary | Change From Baseline in Urinalysis Parameter: Potential of Hydrogen (pH) by Dipstick | 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. | Safety Population. Only those participants with data available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | pH | Baseline (Day -1) and Day 4 |
|
|
|
| Secondary | Absolute Values of Urinalysis Parameter: Specific Gravity | 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. | Safety Population. Only those participants with data available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | Ratio | Baseline (Day -1) and Day 4 |
|
|
|
| Secondary | Absolute Values of Urinalysis Parameter: Potential of Hydrogen (pH) by Dipstick | 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. | Safety Population. Only those participants with data available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | pH | Baseline (Day -1) and Day 4 |
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| Secondary | Number of Participants With Abnormal Values on Urinalysis by Dipstick | 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. | Safety Population. Only those participants with data available at the specified time points were analyzed. | Posted | Count of Participants | Participants | Baseline (Day -1) and Day 4 |
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|
|
| Secondary | Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and Corrected QT Interval According to Fridericia's Formula (QTcF) | 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. | Safety Population. Only those participants with data available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | Milliseconds | Baseline (Day -1) and Day 4 |
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| Secondary | Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF | 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. | Safety Population. Only those participants with data available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | Milliseconds | Baseline (Day -1) and Day 4 |
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| Secondary | Change From Baseline in Vital Signs Measurements: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | 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. | Safety Population. Only those participants with data available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | Millimeters of mercury | Baseline (Day -1) and Day 4 |
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| Secondary | Absolute Values of Vital Signs Measurements: SBP and DBP | 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. | Safety Population. Only those participants with data available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | Millimeters of mercury | Baseline (Day -1) and Day 4 |
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| Secondary | Change From Baseline in Vital Signs Measurements: Pulse Rate | 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. | Safety Population. Only those participants with data available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | Beats per minute | Baseline (Day -1) and Day 4 |
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| Secondary | Absolute Values of Vital Signs Measurements: Pulse Rate | 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. | Safety Population. Only those participants with data available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | Beats per minute | Baseline (Day -1) and Day 4 |
|
|
|
| 0 |
| 16 |
| 0 |
| 16 |
| 1 |
| 16 |
| EG001 | Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted | 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. | 0 | 16 | 0 | 16 | 3 | 16 |
| EG002 | 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. | 0 | 17 | 0 | 17 | 1 | 17 |
| EG003 | 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. | 0 | 16 | 0 | 16 | 1 | 16 |
| Angular cheilitis | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
|
| Skin irritation | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
|
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.
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| 3TC |
|
| Ratio of Geometric Least Square Means |
| 0.8567 |
| 2-Sided |
| 90 |
| 0.8159 |
| 0.8995 |
An analysis of variance was performed on parameter AUC(0-t) for Analyte ABC to compare treatment arms Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed with Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted. |
| Other |
| Ratio of Geometric Least Square Means | 0.8798 | 2-Sided | 90 | 0.8202 | 0.9438 | An analysis of variance was performed on parameter AUC(0-t) for Analyte 3TC to compare treatment arms Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed with Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted. | Other |
| 3TC |
|
| Ratio of Geometric Least Square Means |
| 0.4503 |
| 2-Sided |
| 90 |
| 0.3976 |
| 0.5100 |
An analysis of variance was performed on parameter Cmax for Analyte ABC to compare treatment arms Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed with Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted. |
| Other |
| Ratio of Geometric Least Square Means | 0.6373 | 2-Sided | 90 | 0.5594 | 0.7260 | An analysis of variance was performed on parameter Cmax for Analyte 3TC to compare treatment arms Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed with Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted. | Other |
| Ratio of Geometric Least Square Means |
| 0.8847 |
| 2-Sided |
| 90 |
| 0.8303 |
| 0.9426 |
An analysis of variance was performed on parameter AUC(0-inf) for Analyte 3TC to compare treatment arms Cohort 2: DOVATO (DTG/3TC) Fed with Cohort 2: DOVATO (DTG/3TC) Fasted. |
| Other |
| Ratio of Geometric Least Square Means |
| 0.8806 |
| 2-Sided |
| 90 |
| 0.8251 |
| 0.9398 |
An analysis of variance was performed on parameter AUC(0-t) for Analyte 3TC to compare treatment arms Cohort 2: DOVATO (DTG/3TC) Fed with Cohort 2: DOVATO (DTG/3TC) Fasted. |
| Other |
| Ratio of Geometric Least Square Means |
| 0.5191 |
| 2-Sided |
| 90 |
| 0.4535 |
| 0.5943 |
An analysis of variance was performed on parameter Cmax for Analyte 3TC to compare treatment arms Cohort 2: DOVATO (DTG/3TC) Fed with Cohort 2: DOVATO (DTG/3TC) Fasted. |
| Other |
| 3TC |
|
| ABC |
|
|
| 3TC |
|
|
| 3TC |
|
| 3TC |
|
| ABC |
|
|
| 3TC |
|
|
| 3TC |
|
| SAEs |
|
| Eosinophils |
|
| Lymphocytes |
|
| Monocytes |
|
| Platelet count |
|
| Neutrophil |
|
|
| Day 4: Basophils |
|
|
| Baseline (Day -1): Eosinophils |
|
|
| Day 4: Eosinophils |
|
|
| Baseline (Day -1): Lymphocytes |
|
|
| Day 4: Lymphocytes |
|
|
| Baseline (Day -1): Monocytes |
|
|
| Day 4: Monocytes |
|
|
| Baseline (Day -1): Platelet count |
|
|
| Day 4: Platelet count |
|
|
| Baseline (Day -1): Neutrophil |
|
|
| Day 4: Neutrophil |
|
|
|
| Day 4 |
|
|
|
| Day 4 |
|
|
|
| Day 4 |
|
|
|
| Day 4 |
|
|
|
| Day 4 |
|
|
| ALP |
|
| AST |
|
| Glucose |
|
| Potassium |
|
| Sodium |
|
| BUN |
|
| Direct Bilirubin |
|
| Total Bilirubin |
|
| Total Protein |
|
|
| Day 4: ALT |
|
|
| Baseline (Day -1) ALP |
|
|
| Day 4: ALP |
|
|
| Baseline (Day -1): AST |
|
|
| Day 4: AST |
|
|
|
| Day 4: Calcium |
|
|
| Baseline (Day -1): Glucose |
|
|
| Day 4: Glucose |
|
|
| Baseline (Day -1): Potassium |
|
|
| Day 4: Potassium |
|
|
| Baseline (Day -1): Sodium |
|
|
| Day 4: Sodium |
|
|
| Baseline (Day -1): BUN |
|
|
| Day 4: BUN |
|
|
|
| Day 4: Creatinine |
|
|
| Baseline (Day -1): Direct Bilirubin |
|
|
| Day 4: Direct Bilirubin |
|
|
| Baseline (Day -1): Total Bilirubin |
|
|
| Day 4: Total Bilirubin |
|
|
|
| Day 4 |
|
|
|
| Day 4: Albumin |
|
|
| Baseline (Day -1): Total Protein |
|
|
| Day 4: Total Protein |
|
|
|
| Day 4 |
|
|
|
| Day 4 |
|
|
|
| Day 4: Urine Glucose (Negative) |
|
|
| Baseline (Day -1): Urine Protein (Negative) |
|
|
| Day 4: Urine Protein (Negative) |
|
|
| Baseline (Day -1): Urine Blood (Negative) |
|
|
| Baseline (Day -1): Urine Blood (3+) |
|
|
| Baseline (Day -1): Urine Blood (2+) |
|
|
| Baseline (Day -1): Urine Blood (Trace) |
|
|
| Day 4: Urine Blood (Negative) |
|
|
| Day 4: Urine Blood (2+) |
|
|
| Day 4: Urine Blood (3+) |
|
|
| Baseline (Day -1): Urine Ketones (Negative) |
|
|
| Day 4: Urine Ketones (Negative) |
|
|
| Day 4: Urine Ketones (1+) |
|
|
| QRS Duration |
|
| QT Interval |
|
| QTcF |
|
|
| Day 4: PR Interval |
|
|
| Baseline (Day -1): QRS Duration |
|
|
| Day 4: QRS Duration |
|
|
| Baseline (Day -1): QT Interval |
|
|
| Day 4: QT Interval |
|
|
| Baseline (Day -1) |
|
|
| Day 4: QTcF |
|
|
| DBP |
|
|
| Day 4: SBP |
|
|
| Baseline (Day -1): DBP |
|
|
| Day 4: DBP |
|
|
|
| Day 4 |
|
|