HIV Infections
Conditions
Keywords
TRIUMEQ, DOVATO, Pharmacokinetics, Food effect, Dolutegravir, Abacavir, Lamivudine
Brief summary
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.
Interventions
Sponsors
ViiV Healthcare
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Masking description
This is an open-label study
Intervention model description
This is a randomized, single-dose, 2-cohort, 2-period crossover study.
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Participant must be 18 to 50 years of age inclusive, at the time of signing the informed consent. * Participants who are healthy as determined by the investigator or medically qualified designee based on a medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring (history and ECG). * Body weight \>=50.0 kilograms (kg) (110 pounds \[lbs.\]) for males and \>=45 kg (99 lbs.) for females and body mass index within the range 18.5 to 31.0 kilogram per meter square (kg/m\^2, inclusive). * A male participant is eligible to participate if they agree to use contraceptive methods. * A female participant is eligible to participate if she is not pregnant (, not lactating or breastfeeding, and at least 1 of the following conditions applies: Is not a woman of childbearing potential (WOCBP) OR Is a WOCBP and using a non-hormonal contraceptive method that is highly effective * Capable of giving signed informed consent * Documentation that the participant is negative for the human leukocyte antigen (HLA) B\*5701 allele.
Exclusion criteria
* Current or chronic history of liver disease or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones). * Medical history of cardiac arrhythmias, prior myocardial infarction in the past 3 months, or cardiac disease or a family or personal history of long QT syndrome. * A pre-existing condition interfering with normal gastrointestinal anatomy or motility (e.g., gastroesophageal reflux disease, gastric ulcers, gastritis), hepatic and/or renal function, that could interfere with the absorption, metabolism, and/or excretion of the study intervention. * QT interval corrected for heart rate according to Fridericia's formula (QTcF) \>450 milliseconds (msec). * A participant with known or suspected active coronavirus disease (COVID-19) infection OR contact with an individual with known COVID-19, within 14 days of study enrollment. * Presence of hepatitis B surface antigen at screening or within 3 months prior to starting study intervention. * Positive hepatitis C antibody test result at screening or within 3 months prior to starting study intervention AND positive on reflex to hepatitis C ribonucleic acid (RNA). * Positive human immunodeficiency virus (HIV)-1 and -2 antigen/antibody immunoassay at screening. * Alanine aminotransferase (ALT) \>1.5 × upper limit of normal (ULN). A single repeat of ALT is allowed within a single screening period to determine eligibility. * Bilirubin \>1.5 × ULN (isolated bilirubin \>1.5 × ULN is acceptable if bilirubin is fractionated and direct bilirubin \<35%). A single repeat of any laboratory abnormality is allowed within a single screening period to determine eligibility. * Any acute laboratory abnormality at screening which, in the opinion of the investigator, should preclude participation in the study of an investigational compound. * Any Grade 2 to 4 laboratory abnormality at screening, with the exception of creatine phosphokinase (CPK) and lipid abnormalities (e.g., total cholesterol, triglycerides), and ALT (described above), will exclude a participant from the study unless the investigator can provide a compelling explanation for the laboratory result(s) and has the assent of the sponsor. A single repeat of any laboratory abnormality is allowed within a single screening period to determine eligibility. * A positive test result for drugs of abuse (including marijuana), alcohol, or cotinine (indicating active current smoking) at screening or before the first dose of study intervention. * Unable to refrain from the use of prescription or non-prescription drugs including vitamins, herbal and dietary supplements (including St. John's wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the first dose of study intervention and for the duration of the study until completion of the follow-up visit, unless, in the opinion of the investigator and ViiV Healthcare (VH)/GlaxoSmithKline medical monitor, the medication will not interfere with the study procedures or compromise participant safety. * Unwillingness to abstain from excessive consumption of any food or drink containing grapefruit and grapefruit juice, Seville oranges, blood oranges, or pomelos or their fruit juices within 7 days prior to the first dose of study intervention(s) until the end of the study. * Participation in another concurrent clinical study or prior clinical study (with the exception of imaging trials) prior to Day 1 of Period 1 in the current study: 30 days, 5 half-lives, or twice the duration of the biological effect of the study intervention (whichever is longer). * Where participation in the study would result in donation of blood or blood products in excess of 500 milliliter (mL) within 60 days. * Estimated serum creatinine clearance (Chronic Kidney Disease Epidemiology Collaboration \[CKD-EPI\]) \<90 milliliter per minute (mL/min). * History of regular alcohol consumption within 6 months of the study, defined as an average weekly intake of \>14 units for males or \>7 drinks for females. * Unable to refrain from tobacco or nicotine-containing products within 1 month prior to screening. * History of sensitivity, prior intolerance or hypersensitivity to any of the study interventions, or components thereof, or a history of drug or other allergy that, in the opinion of the investigator or medical monitor, contraindicates their participation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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 | 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 |
| 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 | 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 | 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. |
| Cohort 1: Maximum Observed Concentration (Cmax) of DTG, ABC and 3TC Following Administration of TRIUMEQ Under Fed and Fasted Conditions | 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 | 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. |
| Cohort 2: AUC (0-inf) of DTG and 3TC Following Administration of DOVATO Under Fed and Fasted Conditions | 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 | 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. |
| Cohort 2: AUC (0-t) of DTG and 3TC Following Administration of DOVATO Under Fed and Fasted Conditions | 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 | 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. |
| Cohort 2: Cmax of DTG and 3TC Following Administration of DOVATO Under Fed and Fasted Conditions | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cohort 2: Tlag of DTG and 3TC Following Administration of DOVATO Under Fed and Fasted Conditions | 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 | 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. |
| Cohort 2: t1/2 of DTG and 3TC Following Administration of DOVATO Under Fed and Fasted Conditions | 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 | 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. |
| Cohort 2: AUC(0-24) of DTG and 3TC Following Administration of DOVATO Under Fed and Fasted Conditions | 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 | 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. |
| Cohort 2: Ct of DTG and 3TC Following Administration of DOVATO Under Fed and Fasted Conditions | 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 | 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. |
| Cohort 2: C24 of DTG and 3TC Following Administration of DOVATO Under Fed and Fasted Conditions | 24 hours post dose in treatment periods 1 and 2 | 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. |
| Cohort 2: Tmax of DTG and 3TC Following Administration of DOVATO Under Fed and Fasted Conditions | 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 | 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. |
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Up to 23 days | 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. |
| Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count and Neutrophil | Baseline (Day -1) and Day 4 | 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. |
| Change From Baseline in Hematology Parameters: Red Blood Cell (RBC) Count | Baseline (Day -1) and Day 4 | 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. |
| Change From Baseline in Hematology Parameters: Hemoglobin | Baseline (Day -1) and Day 4 | 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. |
| Change From Baseline in Hematology Parameters: Hematocrit | Baseline (Day -1) and Day 4 | 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. |
| Change From Baseline in Hematology Parameters: Erythrocytes Mean Corpuscular Volume | Baseline (Day -1) and Day 4 | 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. |
| Change From Baseline in Hematology Parameters: Erythrocytes Mean Corpuscular Hemoglobin | Baseline (Day -1) and Day 4 | 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. |
| Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count and Neutrophil | Baseline (Day -1) and Day 4 | 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. |
| Absolute Values of Hematology Parameters: RBC Count | Baseline (Day -1) and Day 4 | 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. |
| Absolute Values of Hematology Parameters: Hemoglobin | Baseline (Day -1) and Day 4 | 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. |
| Absolute Values of Hematology Parameters: Hematocrit | Baseline (Day -1) and Day 4 | 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. |
| Absolute Values of Hematology Parameters: Erythrocytes Mean Corpuscular Volume | Baseline (Day -1) and Day 4 | 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. |
| Absolute Values of Hematology Parameters: Erythrocytes Mean Corpuscular Hemoglobin | Baseline (Day -1) and Day 4 | 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 in Clinical Chemistry Parameters: Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Amino Transferase (AST) | Baseline (Day -1) and Day 4 | 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. |
| Change From Baseline in Clinical Chemistry Parameters: Calcium, Glucose, Potassium, Sodium and Blood Urea Nitrogen (BUN) | Baseline (Day -1) and Day 4 | 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. |
| Change From Baseline in Clinical Chemistry Parameters: Creatinine, Direct Bilirubin and Total Bilirubin | Baseline (Day -1) and Day 4 | 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. |
| Change From Baseline in Clinical Chemistry Parameters: Creatine Kinase | Baseline (Day -1) and Day 4 | 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. |
| Change From Baseline in Clinical Chemistry Parameters: Albumin and Total Protein | Baseline (Day -1) and Day 4 | 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. |
| Absolute Values of Clinical Chemistry Parameters: ALT, ALP and AST | Baseline (Day -1) and Day 4 | 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. |
| Absolute Values of Clinical Chemistry Parameters: Calcium, Glucose, Potassium, Sodium and BUN | Baseline (Day -1) and Day 4 | 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. |
| Absolute Values of Clinical Chemistry Parameters: Creatinine, Direct Bilirubin and Total Bilirubin | Baseline (Day -1) and Day 4 | 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. |
| Absolute Values of Clinical Chemistry Parameters: Creatine Kinase | Baseline (Day -1) and Day 4 | 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. |
| Absolute Values of Clinical Chemistry Parameters: Albumin and Total Protein | Baseline (Day -1) and Day 4 | 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 in Urinalysis Parameter: Specific Gravity | Baseline (Day -1) and Day 4 | 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. |
| Change From Baseline in Urinalysis Parameter: Potential of Hydrogen (pH) by Dipstick | Baseline (Day -1) and Day 4 | 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. |
| Absolute Values of Urinalysis Parameter: Specific Gravity | Baseline (Day -1) and Day 4 | 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. |
| Absolute Values of Urinalysis Parameter: Potential of Hydrogen (pH) by Dipstick | Baseline (Day -1) and Day 4 | 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. |
| Number of Participants With Abnormal Values on Urinalysis by Dipstick | Baseline (Day -1) and Day 4 | 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. |
| Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and Corrected QT Interval According to Fridericia's Formula (QTcF) | Baseline (Day -1) and Day 4 | 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. |
| Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF | Baseline (Day -1) and Day 4 | 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 in Vital Signs Measurements: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Baseline (Day -1) and Day 4 | 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. |
| Absolute Values of Vital Signs Measurements: SBP and DBP | Baseline (Day -1) and Day 4 | 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 in Vital Signs Measurements: Pulse Rate | Baseline (Day -1) and Day 4 | 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. |
| Cohort 1: Lag Time for Absorption (Tlag) of DTG, ABC and 3TC Following Administration of TRIUMEQ Under Fed and Fasted Conditions | 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 | 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. |
| Absolute Values of Vital Signs Measurements: Pulse Rate | Baseline (Day -1) and Day 4 | 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. |
| Cohort 1: Terminal Elimination Phase Half-life (t1/2) of DTG, ABC and 3TC Following Administration of TRIUMEQ Under Fed and Fasted Conditions | 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 | 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. |
| 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 | 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 | 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. |
| Cohort 1: Last Quantifiable Concentration (Ct) of DTG, ABC and 3TC Following Administration of TRIUMEQ Under Fed and Fasted Conditions | 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 | 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. |
| Cohort 1: Concentration at 24 Hours Post-dose (C24) of DTG, ABC and 3TC Following Administration of TRIUMEQ Under Fed and Fasted Conditions | 24 hours post dose in treatment periods 1 and 2 | 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. |
| Cohort 1: Time of Maximum Observed Concentration (Tmax) of DTG, ABC and 3TC Following Administration of TRIUMEQ Under Fed and Fasted Conditions | 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 | 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. |
Countries
United States
Participant flow
Recruitment details
This study was conducted at a single center in the United States.
Pre-assignment details
A total of 33 participants (16 participants in Cohort 1 and 17 participants in Cohort 2) were enrolled in the study.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 8 |
| 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. | 8 |
| 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. | 8 |
| 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. | 9 |
| Total | 33 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Treatment Period 1 (1 Day) | Withdrawal by Subject | 0 | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | Cohort 1: TRIUMEQ Fed Followed by TRIUMEQ Fasted | Cohort 1: TRIUMEQ Fasted Followed by TRIUMEQ Fed | Cohort 2: DOVATO Fed Followed by DOVATO Fasted | Cohort 2: DOVATO Fasted Followed by DOVATO Fed | Total |
|---|---|---|---|---|---|
| Age, Customized <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Customized 19-64 years | 8 Participants | 8 Participants | 8 Participants | 9 Participants | 33 Participants |
| Age, Customized >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian: Central/South Asian Heritage | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Black or African American | 2 Participants | 3 Participants | 2 Participants | 4 Participants | 11 Participants |
| Race/Ethnicity, Customized Multiple: Black or African American & White | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized White | 6 Participants | 4 Participants | 5 Participants | 5 Participants | 20 Participants |
| Sex: Female, Male Female | 2 Participants | 4 Participants | 2 Participants | 2 Participants | 10 Participants |
| Sex: Female, Male Male | 6 Participants | 4 Participants | 6 Participants | 7 Participants | 23 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 16 | 0 / 16 | 0 / 17 | 0 / 16 |
| other Total, other adverse events | 1 / 16 | 3 / 16 | 1 / 17 | 1 / 16 |
| serious Total, serious adverse events | 0 / 16 | 0 / 16 | 0 / 17 | 0 / 16 |
Outcome results
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
Time frame: 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
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed | 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 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed | 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 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed | 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 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted | 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 | 67210 Hours*nanogram per milliliter | Geometric Coefficient of Variation 24 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted | 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 | 9986 Hours*nanogram per milliliter | Geometric Coefficient of Variation 28.8 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted | 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 | 7295 Hours*nanogram per milliliter | Geometric Coefficient of Variation 23.4 |
90% CI: [0.8344, 0.9282]
90% CI: [0.8168, 0.9007]
90% CI: [0.8316, 0.9566]
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.
Time frame: 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
Population: Pharmacokinetic Parameter Population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed | 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 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed | 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 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed | 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 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted | 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 | 63790 Hours*nanogram per milliliter | Geometric Coefficient of Variation 22.7 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted | 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 | 9923 Hours*nanogram per milliliter | Geometric Coefficient of Variation 28.9 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted | 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 | 7182 Hours*nanogram per milliliter | Geometric Coefficient of Variation 23.5 |
90% CI: [0.8293, 0.9219]
90% CI: [0.8159, 0.8995]
90% CI: [0.8202, 0.9438]
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.
Time frame: 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
Population: Pharmacokinetic Parameter Population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed | 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 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed | 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 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed | 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 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted | Cohort 1: Maximum Observed Concentration (Cmax) of DTG, ABC and 3TC Following Administration of TRIUMEQ Under Fed and Fasted Conditions | DTG | 3322 Nanogram per milliliter | Geometric Coefficient of Variation 20.6 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted | Cohort 1: Maximum Observed Concentration (Cmax) of DTG, ABC and 3TC Following Administration of TRIUMEQ Under Fed and Fasted Conditions | ABC | 4080 Nanogram per milliliter | Geometric Coefficient of Variation 32.3 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted | Cohort 1: Maximum Observed Concentration (Cmax) of DTG, ABC and 3TC Following Administration of TRIUMEQ Under Fed and Fasted Conditions | 3TC | 1392 Nanogram per milliliter | Geometric Coefficient of Variation 33.3 |
90% CI: [0.6598, 0.7643]
90% CI: [0.3976, 0.51]
90% CI: [0.5594, 0.726]
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.
Time frame: 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
Population: Pharmacokinetic Parameter Population. Only those participants with data available at specified time points were analyzed.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed | 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 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed | 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 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted | Cohort 2: AUC (0-inf) of DTG and 3TC Following Administration of DOVATO Under Fed and Fasted Conditions | DTG | 51800 Hours*nanogram per milliliter | Geometric Coefficient of Variation 24.3 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted | Cohort 2: AUC (0-inf) of DTG and 3TC Following Administration of DOVATO Under Fed and Fasted Conditions | 3TC | 7864 Hours*nanogram per milliliter | Geometric Coefficient of Variation 13.9 |
90% CI: [0.8834, 0.9472]
90% CI: [0.8303, 0.9426]
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.
Time frame: 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
Population: Pharmacokinetic Parameter Population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed | 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 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed | 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 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted | Cohort 2: AUC (0-t) of DTG and 3TC Following Administration of DOVATO Under Fed and Fasted Conditions | DTG | 49690 Hours*nanogram per milliliter | Geometric Coefficient of Variation 22 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted | Cohort 2: AUC (0-t) of DTG and 3TC Following Administration of DOVATO Under Fed and Fasted Conditions | 3TC | 7762 Hours*nanogram per milliliter | Geometric Coefficient of Variation 14 |
90% CI: [0.8862, 0.9475]
90% CI: [0.8251, 0.9398]
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.
Time frame: 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
Population: Pharmacokinetic Parameter Population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed | 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 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed | 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 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted | Cohort 2: Cmax of DTG and 3TC Following Administration of DOVATO Under Fed and Fasted Conditions | DTG | 3131 Nanogram per milliliter | Geometric Coefficient of Variation 19.8 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted | Cohort 2: Cmax of DTG and 3TC Following Administration of DOVATO Under Fed and Fasted Conditions | 3TC | 2066 Nanogram per milliliter | Geometric Coefficient of Variation 28.6 |
90% CI: [0.6576, 0.8068]
90% CI: [0.4535, 0.5943]
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.
Time frame: Baseline (Day -1) and Day 4
Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed | Absolute Values of Clinical Chemistry Parameters: Albumin and Total Protein | Baseline (Day -1): Total Protein | 71.3 Grams per liter | Standard Deviation 3.82 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed | Absolute Values of Clinical Chemistry Parameters: Albumin and Total Protein | Day 4: Albumin | 44.2 Grams per liter | Standard Deviation 2.81 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed | Absolute Values of Clinical Chemistry Parameters: Albumin and Total Protein | Day 4: Total Protein | 72.2 Grams per liter | Standard Deviation 3.04 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed | Absolute Values of Clinical Chemistry Parameters: Albumin and Total Protein | Baseline (Day -1): Albumin | 44.0 Grams per liter | Standard Deviation 3.31 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted | Absolute Values of Clinical Chemistry Parameters: Albumin and Total Protein | Baseline (Day -1): Albumin | 44.5 Grams per liter | Standard Deviation 3.58 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted | Absolute Values of Clinical Chemistry Parameters: Albumin and Total Protein | Day 4: Albumin | 43.6 Grams per liter | Standard Deviation 2.83 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted | Absolute Values of Clinical Chemistry Parameters: Albumin and Total Protein | Day 4: Total Protein | 71.6 Grams per liter | Standard Deviation 2.9 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted | Absolute Values of Clinical Chemistry Parameters: Albumin and Total Protein | Baseline (Day -1): Total Protein | 71.8 Grams per liter | Standard Deviation 3.64 |
| Cohort 2: DOVATO (DTG/3TC) Fed | Absolute Values of Clinical Chemistry Parameters: Albumin and Total Protein | Baseline (Day -1): Total Protein | 69.1 Grams per liter | Standard Deviation 4.32 |
| Cohort 2: DOVATO (DTG/3TC) Fed | Absolute Values of Clinical Chemistry Parameters: Albumin and Total Protein | Day 4: Total Protein | 69.6 Grams per liter | Standard Deviation 4.08 |
| Cohort 2: DOVATO (DTG/3TC) Fed | Absolute Values of Clinical Chemistry Parameters: Albumin and Total Protein | Baseline (Day -1): Albumin | 43.0 Grams per liter | Standard Deviation 2.57 |
| Cohort 2: DOVATO (DTG/3TC) Fed | Absolute Values of Clinical Chemistry Parameters: Albumin and Total Protein | Day 4: Albumin | 43.7 Grams per liter | Standard Deviation 2.63 |
| Cohort 2: DOVATO (DTG/3TC) Fasted | Absolute Values of Clinical Chemistry Parameters: Albumin and Total Protein | Day 4: Albumin | 44.1 Grams per liter | Standard Deviation 2.86 |
| Cohort 2: DOVATO (DTG/3TC) Fasted | Absolute Values of Clinical Chemistry Parameters: Albumin and Total Protein | Baseline (Day -1): Albumin | 42.9 Grams per liter | Standard Deviation 2.59 |
| Cohort 2: DOVATO (DTG/3TC) Fasted | Absolute Values of Clinical Chemistry Parameters: Albumin and Total Protein | Day 4: Total Protein | 70.1 Grams per liter | Standard Deviation 4.91 |
| Cohort 2: DOVATO (DTG/3TC) Fasted | Absolute Values of Clinical Chemistry Parameters: Albumin and Total Protein | Baseline (Day -1): Total Protein | 69.4 Grams per liter | Standard Deviation 4.36 |
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.
Time frame: Baseline (Day -1) and Day 4
Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed | Absolute Values of Clinical Chemistry Parameters: ALT, ALP and AST | Day 4: AST | 19.0 International units per liter | Standard Deviation 8.82 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed | Absolute Values of Clinical Chemistry Parameters: ALT, ALP and AST | Baseline (Day -1) ALP | 66.8 International units per liter | Standard Deviation 15.23 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed | Absolute Values of Clinical Chemistry Parameters: ALT, ALP and AST | Baseline (Day -1): ALT | 19.7 International units per liter | Standard Deviation 9.16 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed | Absolute Values of Clinical Chemistry Parameters: ALT, ALP and AST | Baseline (Day -1): AST | 18.4 International units per liter | Standard Deviation 5.26 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed | Absolute Values of Clinical Chemistry Parameters: ALT, ALP and AST | Day 4: ALT | 23.7 International units per liter | Standard Deviation 18.71 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed | Absolute Values of Clinical Chemistry Parameters: ALT, ALP and AST | Day 4: ALP | 64.1 International units per liter | Standard Deviation 16.18 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted | Absolute Values of Clinical Chemistry Parameters: ALT, ALP and AST | Day 4: ALT | 19.3 International units per liter | Standard Deviation 9.69 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted | Absolute Values of Clinical Chemistry Parameters: ALT, ALP and AST | Day 4: ALP | 62.6 International units per liter | Standard Deviation 14.47 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted | Absolute Values of Clinical Chemistry Parameters: ALT, ALP and AST | Baseline (Day -1): AST | 20.6 International units per liter | Standard Deviation 5.77 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted | Absolute Values of Clinical Chemistry Parameters: ALT, ALP and AST | Baseline (Day -1) ALP | 65.6 International units per liter | Standard Deviation 17.65 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted | Absolute Values of Clinical Chemistry Parameters: ALT, ALP and AST | Day 4: AST | 16.6 International units per liter | Standard Deviation 2.94 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted | Absolute Values of Clinical Chemistry Parameters: ALT, ALP and AST | Baseline (Day -1): ALT | 24.3 International units per liter | Standard Deviation 15.1 |
| Cohort 2: DOVATO (DTG/3TC) Fed | Absolute Values of Clinical Chemistry Parameters: ALT, ALP and AST | Day 4: ALT | 22.6 International units per liter | Standard Deviation 16.01 |
| Cohort 2: DOVATO (DTG/3TC) Fed | Absolute Values of Clinical Chemistry Parameters: ALT, ALP and AST | Baseline (Day -1): ALT | 23.4 International units per liter | Standard Deviation 16.38 |
| Cohort 2: DOVATO (DTG/3TC) Fed | Absolute Values of Clinical Chemistry Parameters: ALT, ALP and AST | Baseline (Day -1) ALP | 59.3 International units per liter | Standard Deviation 13.58 |
| Cohort 2: DOVATO (DTG/3TC) Fed | Absolute Values of Clinical Chemistry Parameters: ALT, ALP and AST | Baseline (Day -1): AST | 18.5 International units per liter | Standard Deviation 6.97 |
| Cohort 2: DOVATO (DTG/3TC) Fed | Absolute Values of Clinical Chemistry Parameters: ALT, ALP and AST | Day 4: ALP | 60.1 International units per liter | Standard Deviation 13.85 |
| Cohort 2: DOVATO (DTG/3TC) Fed | Absolute Values of Clinical Chemistry Parameters: ALT, ALP and AST | Day 4: AST | 17.3 International units per liter | Standard Deviation 6.04 |
| Cohort 2: DOVATO (DTG/3TC) Fasted | Absolute Values of Clinical Chemistry Parameters: ALT, ALP and AST | Day 4: AST | 16.9 International units per liter | Standard Deviation 5.11 |
| Cohort 2: DOVATO (DTG/3TC) Fasted | Absolute Values of Clinical Chemistry Parameters: ALT, ALP and AST | Day 4: ALP | 60.2 International units per liter | Standard Deviation 13.16 |
| Cohort 2: DOVATO (DTG/3TC) Fasted | Absolute Values of Clinical Chemistry Parameters: ALT, ALP and AST | Baseline (Day -1): ALT | 24.8 International units per liter | Standard Deviation 15.45 |
| Cohort 2: DOVATO (DTG/3TC) Fasted | Absolute Values of Clinical Chemistry Parameters: ALT, ALP and AST | Baseline (Day -1): AST | 18.9 International units per liter | Standard Deviation 6.57 |
| Cohort 2: DOVATO (DTG/3TC) Fasted | Absolute Values of Clinical Chemistry Parameters: ALT, ALP and AST | Baseline (Day -1) ALP | 61.8 International units per liter | Standard Deviation 14.65 |
| Cohort 2: DOVATO (DTG/3TC) Fasted | Absolute Values of Clinical Chemistry Parameters: ALT, ALP and AST | Day 4: ALT | 21.1 International units per liter | Standard Deviation 14.24 |
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.
Time frame: Baseline (Day -1) and Day 4
Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed | Absolute Values of Clinical Chemistry Parameters: Calcium, Glucose, Potassium, Sodium and BUN | Day 4: BUN | 4.739 Millimoles per liter | Standard Deviation 0.725 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed | Absolute Values of Clinical Chemistry Parameters: Calcium, Glucose, Potassium, Sodium and BUN | Day 4: Glucose | 4.784 Millimoles per liter | Standard Deviation 0.2407 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed | Absolute Values of Clinical Chemistry Parameters: Calcium, Glucose, Potassium, Sodium and BUN | Baseline (Day -1): Calcium | 2.350 Millimoles per liter | Standard Deviation 0.103 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed | Absolute Values of Clinical Chemistry Parameters: Calcium, Glucose, Potassium, Sodium and BUN | Baseline (Day -1): BUN | 4.531 Millimoles per liter | Standard Deviation 0.9081 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed | Absolute Values of Clinical Chemistry Parameters: Calcium, Glucose, Potassium, Sodium and BUN | Baseline (Day -1): Sodium | 137.8 Millimoles per liter | Standard Deviation 0.91 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed | Absolute Values of Clinical Chemistry Parameters: Calcium, Glucose, Potassium, Sodium and BUN | Baseline (Day -1): Glucose | 4.821 Millimoles per liter | Standard Deviation 0.3214 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed | Absolute Values of Clinical Chemistry Parameters: Calcium, Glucose, Potassium, Sodium and BUN | Day 4: Calcium | 2.347 Millimoles per liter | Standard Deviation 0.0899 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed | Absolute Values of Clinical Chemistry Parameters: Calcium, Glucose, Potassium, Sodium and BUN | Day 4: Potassium | 4.14 Millimoles per liter | Standard Deviation 0.216 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed | Absolute Values of Clinical Chemistry Parameters: Calcium, Glucose, Potassium, Sodium and BUN | Baseline (Day -1): Potassium | 4.11 Millimoles per liter | Standard Deviation 0.268 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed | Absolute Values of Clinical Chemistry Parameters: Calcium, Glucose, Potassium, Sodium and BUN | Day 4: Sodium | 138.3 Millimoles per liter | Standard Deviation 1.73 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted | Absolute Values of Clinical Chemistry Parameters: Calcium, Glucose, Potassium, Sodium and BUN | Day 4: BUN | 4.626 Millimoles per liter | Standard Deviation 0.8416 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted | Absolute Values of Clinical Chemistry Parameters: Calcium, Glucose, Potassium, Sodium and BUN | Day 4: Calcium | 2.342 Millimoles per liter | Standard Deviation 0.098 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted | Absolute Values of Clinical Chemistry Parameters: Calcium, Glucose, Potassium, Sodium and BUN | Baseline (Day -1): Glucose | 5.016 Millimoles per liter | Standard Deviation 0.3793 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted | Absolute Values of Clinical Chemistry Parameters: Calcium, Glucose, Potassium, Sodium and BUN | Day 4: Sodium | 138.8 Millimoles per liter | Standard Deviation 1.17 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted | Absolute Values of Clinical Chemistry Parameters: Calcium, Glucose, Potassium, Sodium and BUN | Baseline (Day -1): BUN | 4.333 Millimoles per liter | Standard Deviation 1.0302 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted | Absolute Values of Clinical Chemistry Parameters: Calcium, Glucose, Potassium, Sodium and BUN | Baseline (Day -1): Calcium | 2.376 Millimoles per liter | Standard Deviation 0.0975 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted | Absolute Values of Clinical Chemistry Parameters: Calcium, Glucose, Potassium, Sodium and BUN | Day 4: Glucose | 4.848 Millimoles per liter | Standard Deviation 0.282 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted | Absolute Values of Clinical Chemistry Parameters: Calcium, Glucose, Potassium, Sodium and BUN | Baseline (Day -1): Potassium | 4.16 Millimoles per liter | Standard Deviation 0.239 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted | Absolute Values of Clinical Chemistry Parameters: Calcium, Glucose, Potassium, Sodium and BUN | Day 4: Potassium | 4.18 Millimoles per liter | Standard Deviation 0.224 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted | Absolute Values of Clinical Chemistry Parameters: Calcium, Glucose, Potassium, Sodium and BUN | Baseline (Day -1): Sodium | 137.9 Millimoles per liter | Standard Deviation 1.67 |
| Cohort 2: DOVATO (DTG/3TC) Fed | Absolute Values of Clinical Chemistry Parameters: Calcium, Glucose, Potassium, Sodium and BUN | Baseline (Day -1): Calcium | 2.339 Millimoles per liter | Standard Deviation 0.0793 |
| Cohort 2: DOVATO (DTG/3TC) Fed | Absolute Values of Clinical Chemistry Parameters: Calcium, Glucose, Potassium, Sodium and BUN | Baseline (Day -1): BUN | 4.633 Millimoles per liter | Standard Deviation 0.9609 |
| Cohort 2: DOVATO (DTG/3TC) Fed | Absolute Values of Clinical Chemistry Parameters: Calcium, Glucose, Potassium, Sodium and BUN | Day 4: Glucose | 4.943 Millimoles per liter | Standard Deviation 0.4349 |
| Cohort 2: DOVATO (DTG/3TC) Fed | Absolute Values of Clinical Chemistry Parameters: Calcium, Glucose, Potassium, Sodium and BUN | Baseline (Day -1): Potassium | 4.33 Millimoles per liter | Standard Deviation 0.335 |
| Cohort 2: DOVATO (DTG/3TC) Fed | Absolute Values of Clinical Chemistry Parameters: Calcium, Glucose, Potassium, Sodium and BUN | Baseline (Day -1): Glucose | 4.974 Millimoles per liter | Standard Deviation 0.3943 |
| Cohort 2: DOVATO (DTG/3TC) Fed | Absolute Values of Clinical Chemistry Parameters: Calcium, Glucose, Potassium, Sodium and BUN | Day 4: Calcium | 2.368 Millimoles per liter | Standard Deviation 0.0742 |
| Cohort 2: DOVATO (DTG/3TC) Fed | Absolute Values of Clinical Chemistry Parameters: Calcium, Glucose, Potassium, Sodium and BUN | Day 4: Potassium | 4.23 Millimoles per liter | Standard Deviation 0.235 |
| Cohort 2: DOVATO (DTG/3TC) Fed | Absolute Values of Clinical Chemistry Parameters: Calcium, Glucose, Potassium, Sodium and BUN | Baseline (Day -1): Sodium | 138.5 Millimoles per liter | Standard Deviation 1.59 |
| Cohort 2: DOVATO (DTG/3TC) Fed | Absolute Values of Clinical Chemistry Parameters: Calcium, Glucose, Potassium, Sodium and BUN | Day 4: BUN | 5.065 Millimoles per liter | Standard Deviation 1.0791 |
| Cohort 2: DOVATO (DTG/3TC) Fed | Absolute Values of Clinical Chemistry Parameters: Calcium, Glucose, Potassium, Sodium and BUN | Day 4: Sodium | 138.2 Millimoles per liter | Standard Deviation 1.47 |
| Cohort 2: DOVATO (DTG/3TC) Fasted | Absolute Values of Clinical Chemistry Parameters: Calcium, Glucose, Potassium, Sodium and BUN | Day 4: BUN | 5.037 Millimoles per liter | Standard Deviation 1.0406 |
| Cohort 2: DOVATO (DTG/3TC) Fasted | Absolute Values of Clinical Chemistry Parameters: Calcium, Glucose, Potassium, Sodium and BUN | Day 4: Potassium | 4.23 Millimoles per liter | Standard Deviation 0.298 |
| Cohort 2: DOVATO (DTG/3TC) Fasted | Absolute Values of Clinical Chemistry Parameters: Calcium, Glucose, Potassium, Sodium and BUN | Day 4: Calcium | 2.371 Millimoles per liter | Standard Deviation 0.0721 |
| Cohort 2: DOVATO (DTG/3TC) Fasted | Absolute Values of Clinical Chemistry Parameters: Calcium, Glucose, Potassium, Sodium and BUN | Day 4: Glucose | 5.019 Millimoles per liter | Standard Deviation 0.3243 |
| Cohort 2: DOVATO (DTG/3TC) Fasted | Absolute Values of Clinical Chemistry Parameters: Calcium, Glucose, Potassium, Sodium and BUN | Baseline (Day -1): Glucose | 5.068 Millimoles per liter | Standard Deviation 0.476 |
| Cohort 2: DOVATO (DTG/3TC) Fasted | 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 |
| Cohort 2: DOVATO (DTG/3TC) Fasted | 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 |
| Cohort 2: DOVATO (DTG/3TC) Fasted | Absolute Values of Clinical Chemistry Parameters: Calcium, Glucose, Potassium, Sodium and BUN | Baseline (Day -1): Potassium | 4.31 Millimoles per liter | Standard Deviation 0.33 |
| Cohort 2: DOVATO (DTG/3TC) Fasted | Absolute Values of Clinical Chemistry Parameters: Calcium, Glucose, Potassium, Sodium and BUN | Day 4: Sodium | 139.1 Millimoles per liter | Standard Deviation 1.61 |
| Cohort 2: DOVATO (DTG/3TC) Fasted | 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 |
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.
Time frame: Baseline (Day -1) and Day 4
Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed | Absolute Values of Clinical Chemistry Parameters: Creatine Kinase | Day 4 | 93.7 International units per liter | Standard Deviation 47.08 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed | Absolute Values of Clinical Chemistry Parameters: Creatine Kinase | Baseline (Day -1) | 111.5 International units per liter | Standard Deviation 66.68 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted | Absolute Values of Clinical Chemistry Parameters: Creatine Kinase | Day 4 | 91.8 International units per liter | Standard Deviation 53.25 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted | Absolute Values of Clinical Chemistry Parameters: Creatine Kinase | Baseline (Day -1) | 143.8 International units per liter | Standard Deviation 110.57 |
| Cohort 2: DOVATO (DTG/3TC) Fed | Absolute Values of Clinical Chemistry Parameters: Creatine Kinase | Baseline (Day -1) | 119.7 International units per liter | Standard Deviation 59.78 |
| Cohort 2: DOVATO (DTG/3TC) Fed | Absolute Values of Clinical Chemistry Parameters: Creatine Kinase | Day 4 | 86.6 International units per liter | Standard Deviation 34.64 |
| Cohort 2: DOVATO (DTG/3TC) Fasted | Absolute Values of Clinical Chemistry Parameters: Creatine Kinase | Baseline (Day -1) | 124.6 International units per liter | Standard Deviation 117.54 |
| Cohort 2: DOVATO (DTG/3TC) Fasted | Absolute Values of Clinical Chemistry Parameters: Creatine Kinase | Day 4 | 95.1 International units per liter | Standard Deviation 44.21 |
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.
Time frame: Baseline (Day -1) and Day 4
Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed | Absolute Values of Clinical Chemistry Parameters: Creatinine, Direct Bilirubin and Total Bilirubin | Baseline (Day -1): Creatinine | 74.38 Micromoles per liter | Standard Deviation 14.598 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed | Absolute Values of Clinical Chemistry Parameters: Creatinine, Direct Bilirubin and Total Bilirubin | Baseline (Day -1): Direct Bilirubin | 1.88 Micromoles per liter | Standard Deviation 0.886 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed | Absolute Values of Clinical Chemistry Parameters: Creatinine, Direct Bilirubin and Total Bilirubin | Day 4: Direct Bilirubin | 2.04 Micromoles per liter | Standard Deviation 0.776 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed | Absolute Values of Clinical Chemistry Parameters: Creatinine, Direct Bilirubin and Total Bilirubin | Day 4: Total Bilirubin | 10.49 Micromoles per liter | Standard Deviation 3.56 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed | Absolute Values of Clinical Chemistry Parameters: Creatinine, Direct Bilirubin and Total Bilirubin | Day 4: Creatinine | 83.55 Micromoles per liter | Standard Deviation 15.394 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed | Absolute Values of Clinical Chemistry Parameters: Creatinine, Direct Bilirubin and Total Bilirubin | Baseline (Day -1): Total Bilirubin | 10.33 Micromoles per liter | Standard Deviation 4.305 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted | Absolute Values of Clinical Chemistry Parameters: Creatinine, Direct Bilirubin and Total Bilirubin | Day 4: Direct Bilirubin | 1.93 Micromoles per liter | Standard Deviation 0.767 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted | Absolute Values of Clinical Chemistry Parameters: Creatinine, Direct Bilirubin and Total Bilirubin | Baseline (Day -1): Creatinine | 75.10 Micromoles per liter | Standard Deviation 15.407 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted | Absolute Values of Clinical Chemistry Parameters: Creatinine, Direct Bilirubin and Total Bilirubin | Baseline (Day -1): Total Bilirubin | 10.63 Micromoles per liter | Standard Deviation 4.326 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted | Absolute Values of Clinical Chemistry Parameters: Creatinine, Direct Bilirubin and Total Bilirubin | Baseline (Day -1): Direct Bilirubin | 1.88 Micromoles per liter | Standard Deviation 0.748 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted | Absolute Values of Clinical Chemistry Parameters: Creatinine, Direct Bilirubin and Total Bilirubin | Day 4: Creatinine | 85.86 Micromoles per liter | Standard Deviation 16.173 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted | Absolute Values of Clinical Chemistry Parameters: Creatinine, Direct Bilirubin and Total Bilirubin | Day 4: Total Bilirubin | 9.89 Micromoles per liter | Standard Deviation 3.747 |
| Cohort 2: DOVATO (DTG/3TC) Fed | Absolute Values of Clinical Chemistry Parameters: Creatinine, Direct Bilirubin and Total Bilirubin | Day 4: Total Bilirubin | 10.73 Micromoles per liter | Standard Deviation 3.405 |
| Cohort 2: DOVATO (DTG/3TC) Fed | Absolute Values of Clinical Chemistry Parameters: Creatinine, Direct Bilirubin and Total Bilirubin | Day 4: Direct Bilirubin | 1.80 Micromoles per liter | Standard Deviation 0.539 |
| Cohort 2: DOVATO (DTG/3TC) Fed | Absolute Values of Clinical Chemistry Parameters: Creatinine, Direct Bilirubin and Total Bilirubin | Baseline (Day -1): Creatinine | 80.18 Micromoles per liter | Standard Deviation 12.794 |
| Cohort 2: DOVATO (DTG/3TC) Fed | Absolute Values of Clinical Chemistry Parameters: Creatinine, Direct Bilirubin and Total Bilirubin | Day 4: Creatinine | 83.87 Micromoles per liter | Standard Deviation 10.444 |
| Cohort 2: DOVATO (DTG/3TC) Fed | Absolute Values of Clinical Chemistry Parameters: Creatinine, Direct Bilirubin and Total Bilirubin | Baseline (Day -1): Total Bilirubin | 9.90 Micromoles per liter | Standard Deviation 2.286 |
| Cohort 2: DOVATO (DTG/3TC) Fed | Absolute Values of Clinical Chemistry Parameters: Creatinine, Direct Bilirubin and Total Bilirubin | Baseline (Day -1): Direct Bilirubin | 1.74 Micromoles per liter | Standard Deviation 0.271 |
| Cohort 2: DOVATO (DTG/3TC) Fasted | Absolute Values of Clinical Chemistry Parameters: Creatinine, Direct Bilirubin and Total Bilirubin | Day 4: Creatinine | 84.65 Micromoles per liter | Standard Deviation 10.814 |
| Cohort 2: DOVATO (DTG/3TC) Fasted | 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 |
| Cohort 2: DOVATO (DTG/3TC) Fasted | 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 |
| Cohort 2: DOVATO (DTG/3TC) Fasted | 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 |
| Cohort 2: DOVATO (DTG/3TC) Fasted | 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 |
| Cohort 2: DOVATO (DTG/3TC) Fasted | Absolute Values of Clinical Chemistry Parameters: Creatinine, Direct Bilirubin and Total Bilirubin | Day 4: Total Bilirubin | 10.52 Micromoles per liter | Standard Deviation 3.04 |
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.
Time frame: Baseline (Day -1) and Day 4
Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed | Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF | Baseline (Day -1): PR Interval | 163.4 Milliseconds | Standard Deviation 24.29 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed | Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF | Day 4: PR Interval | 165.6 Milliseconds | Standard Deviation 23.35 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed | Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF | Baseline (Day -1): QRS Duration | 95.6 Milliseconds | Standard Deviation 8.66 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed | Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF | Day 4: QRS Duration | 94.4 Milliseconds | Standard Deviation 8.38 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed | Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF | Baseline (Day -1): QT Interval | 401.8 Milliseconds | Standard Deviation 21.9 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed | Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF | Day 4: QT Interval | 391.3 Milliseconds | Standard Deviation 15.1 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed | Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF | Baseline (Day -1) | 400.1 Milliseconds | Standard Deviation 14.3 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed | Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF | Day 4: QTcF | 395.9 Milliseconds | Standard Deviation 14.26 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted | Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF | Day 4: QTcF | 396.6 Milliseconds | Standard Deviation 13.34 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted | Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF | Day 4: QT Interval | 394.3 Milliseconds | Standard Deviation 19 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted | Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF | Baseline (Day -1): QRS Duration | 96.7 Milliseconds | Standard Deviation 10.62 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted | Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF | Day 4: PR Interval | 160.9 Milliseconds | Standard Deviation 24.82 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted | Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF | Baseline (Day -1) | 403.6 Milliseconds | Standard Deviation 14.51 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted | Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF | Day 4: QRS Duration | 93.8 Milliseconds | Standard Deviation 10.36 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted | Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF | Baseline (Day -1): PR Interval | 161.6 Milliseconds | Standard Deviation 23.91 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted | Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF | Baseline (Day -1): QT Interval | 400.7 Milliseconds | Standard Deviation 21.35 |
| Cohort 2: DOVATO (DTG/3TC) Fed | Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF | Baseline (Day -1) | 400.1 Milliseconds | Standard Deviation 17.84 |
| Cohort 2: DOVATO (DTG/3TC) Fed | Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF | Baseline (Day -1): QRS Duration | 93.4 Milliseconds | Standard Deviation 8.12 |
| Cohort 2: DOVATO (DTG/3TC) Fed | Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF | Day 4: QT Interval | 392.9 Milliseconds | Standard Deviation 20.51 |
| Cohort 2: DOVATO (DTG/3TC) Fed | Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF | Day 4: QRS Duration | 93.8 Milliseconds | Standard Deviation 7.48 |
| Cohort 2: DOVATO (DTG/3TC) Fed | Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF | Baseline (Day -1): QT Interval | 407.5 Milliseconds | Standard Deviation 23.85 |
| Cohort 2: DOVATO (DTG/3TC) Fed | Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF | Day 4: QTcF | 395.6 Milliseconds | Standard Deviation 19.23 |
| Cohort 2: DOVATO (DTG/3TC) Fed | Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF | Baseline (Day -1): PR Interval | 174.6 Milliseconds | Standard Deviation 25.55 |
| Cohort 2: DOVATO (DTG/3TC) Fed | Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF | Day 4: PR Interval | 174.8 Milliseconds | Standard Deviation 17.72 |
| Cohort 2: DOVATO (DTG/3TC) Fasted | 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 |
| Cohort 2: DOVATO (DTG/3TC) Fasted | Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF | Day 4: QRS Duration | 93.2 Milliseconds | Standard Deviation 7.53 |
| Cohort 2: DOVATO (DTG/3TC) Fasted | Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF | Day 4: PR Interval | 180.1 Milliseconds | Standard Deviation 19.48 |
| Cohort 2: DOVATO (DTG/3TC) Fasted | 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 |
| Cohort 2: DOVATO (DTG/3TC) Fasted | Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF | Day 4: QTcF | 400.4 Milliseconds | Standard Deviation 18.54 |
| Cohort 2: DOVATO (DTG/3TC) Fasted | Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF | Baseline (Day -1) | 401.3 Milliseconds | Standard Deviation 16.99 |
| Cohort 2: DOVATO (DTG/3TC) Fasted | 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 |
| Cohort 2: DOVATO (DTG/3TC) Fasted | Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF | Day 4: QT Interval | 399.8 Milliseconds | Standard Deviation 25.41 |
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.
Time frame: Baseline (Day -1) and Day 4
Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed | Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count and Neutrophil | Baseline (Day -1): Lymphocytes | 2.002 10^9 cells per liter | Standard Deviation 0.5419 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed | Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count and Neutrophil | Baseline (Day -1): Eosinophils | 0.192 10^9 cells per liter | Standard Deviation 0.0821 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed | Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count and Neutrophil | Baseline (Day -1): Platelet count | 272.4 10^9 cells per liter | Standard Deviation 66.59 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed | Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count and Neutrophil | Day 4: Eosinophils | 0.190 10^9 cells per liter | Standard Deviation 0.0989 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed | Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count and Neutrophil | Day 4: Platelet count | 275.6 10^9 cells per liter | Standard Deviation 65.27 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed | Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count and Neutrophil | Baseline (Day -1): Basophils | 0.040 10^9 cells per liter | Standard Deviation 0.021 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed | Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count and Neutrophil | Day 4: Neutrophil | 3.329 10^9 cells per liter | Standard Deviation 0.959 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed | Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count and Neutrophil | Day 4: Monocytes | 0.409 10^9 cells per liter | Standard Deviation 0.1335 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed | Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count and Neutrophil | Baseline (Day -1): Monocytes | 0.461 10^9 cells per liter | Standard Deviation 0.2078 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed | Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count and Neutrophil | Day 4: Basophils | 0.038 10^9 cells per liter | Standard Deviation 0.0223 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed | Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count and Neutrophil | Baseline (Day -1): Neutrophil | 3.299 10^9 cells per liter | Standard Deviation 1.2456 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed | Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count and Neutrophil | Day 4: Lymphocytes | 1.790 10^9 cells per liter | Standard Deviation 0.3956 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted | Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count and Neutrophil | Baseline (Day -1): Platelet count | 276.8 10^9 cells per liter | Standard Deviation 69.88 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted | Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count and Neutrophil | Baseline (Day -1): Basophils | 0.043 10^9 cells per liter | Standard Deviation 0.0202 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted | Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count and Neutrophil | Day 4: Basophils | 0.039 10^9 cells per liter | Standard Deviation 0.0169 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted | Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count and Neutrophil | Baseline (Day -1): Eosinophils | 0.190 10^9 cells per liter | Standard Deviation 0.1081 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted | Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count and Neutrophil | Day 4: Eosinophils | 0.205 10^9 cells per liter | Standard Deviation 0.1231 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted | Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count and Neutrophil | Baseline (Day -1): Lymphocytes | 1.908 10^9 cells per liter | Standard Deviation 0.4189 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted | Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count and Neutrophil | Baseline (Day -1): Monocytes | 0.449 10^9 cells per liter | Standard Deviation 0.1554 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted | Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count and Neutrophil | Day 4: Monocytes | 0.402 10^9 cells per liter | Standard Deviation 0.1373 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted | Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count and Neutrophil | Day 4: Lymphocytes | 1.793 10^9 cells per liter | Standard Deviation 0.3677 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted | Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count and Neutrophil | Day 4: Platelet count | 283.5 10^9 cells per liter | Standard Deviation 64.14 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted | Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count and Neutrophil | Baseline (Day -1): Neutrophil | 3.407 10^9 cells per liter | Standard Deviation 1.1862 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted | Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count and Neutrophil | Day 4: Neutrophil | 3.248 10^9 cells per liter | Standard Deviation 0.8036 |
| Cohort 2: DOVATO (DTG/3TC) Fed | Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count and Neutrophil | Baseline (Day -1): Lymphocytes | 2.029 10^9 cells per liter | Standard Deviation 0.5486 |
| Cohort 2: DOVATO (DTG/3TC) Fed | Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count and Neutrophil | Day 4: Basophils | 0.039 10^9 cells per liter | Standard Deviation 0.0131 |
| Cohort 2: DOVATO (DTG/3TC) Fed | 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 1.3351 |
| Cohort 2: DOVATO (DTG/3TC) Fed | Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count and Neutrophil | Baseline (Day -1): Basophils | 0.042 10^9 cells per liter | Standard Deviation 0.0144 |
| Cohort 2: DOVATO (DTG/3TC) Fed | Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count and Neutrophil | Day 4: Monocytes | 0.435 10^9 cells per liter | Standard Deviation 0.1185 |
| Cohort 2: DOVATO (DTG/3TC) Fed | Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count and Neutrophil | Day 4: Lymphocytes | 1.922 10^9 cells per liter | Standard Deviation 0.5003 |
| Cohort 2: DOVATO (DTG/3TC) Fed | Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count and Neutrophil | Baseline (Day -1): Platelet count | 253.9 10^9 cells per liter | Standard Deviation 56.34 |
| Cohort 2: DOVATO (DTG/3TC) Fed | Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count and Neutrophil | Day 4: Platelet count | 249.8 10^9 cells per liter | Standard Deviation 42.35 |
| Cohort 2: DOVATO (DTG/3TC) Fed | Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count and Neutrophil | Baseline (Day -1): Eosinophils | 0.147 10^9 cells per liter | Standard Deviation 0.0956 |
| Cohort 2: DOVATO (DTG/3TC) Fed | Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count and Neutrophil | Baseline (Day -1): Monocytes | 0.507 10^9 cells per liter | Standard Deviation 0.1661 |
| Cohort 2: DOVATO (DTG/3TC) Fed | Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count and Neutrophil | Day 4: Eosinophils | 0.144 10^9 cells per liter | Standard Deviation 0.1022 |
| Cohort 2: DOVATO (DTG/3TC) Fed | Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count and Neutrophil | Day 4: Neutrophil | 3.275 10^9 cells per liter | Standard Deviation 1.4198 |
| Cohort 2: DOVATO (DTG/3TC) Fasted | 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 |
| Cohort 2: DOVATO (DTG/3TC) Fasted | 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 |
| Cohort 2: DOVATO (DTG/3TC) Fasted | 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 |
| Cohort 2: DOVATO (DTG/3TC) Fasted | 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 0.02 |
| Cohort 2: DOVATO (DTG/3TC) Fasted | 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 0.535 |
| Cohort 2: DOVATO (DTG/3TC) Fasted | 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 |
| Cohort 2: DOVATO (DTG/3TC) Fasted | 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 |
| Cohort 2: DOVATO (DTG/3TC) Fasted | 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 |
| Cohort 2: DOVATO (DTG/3TC) Fasted | 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 |
| Cohort 2: DOVATO (DTG/3TC) Fasted | 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 |
| Cohort 2: DOVATO (DTG/3TC) Fasted | 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 |
| Cohort 2: DOVATO (DTG/3TC) Fasted | 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 0.105 |
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.
Time frame: Baseline (Day -1) and Day 4
Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed | Absolute Values of Hematology Parameters: Erythrocytes Mean Corpuscular Hemoglobin | Baseline (Day -1) | 28.74 Picograms | Standard Deviation 2.549 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed | Absolute Values of Hematology Parameters: Erythrocytes Mean Corpuscular Hemoglobin | Day 4 | 28.71 Picograms | Standard Deviation 2.544 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted | Absolute Values of Hematology Parameters: Erythrocytes Mean Corpuscular Hemoglobin | Day 4 | 28.48 Picograms | Standard Deviation 2.592 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted | Absolute Values of Hematology Parameters: Erythrocytes Mean Corpuscular Hemoglobin | Baseline (Day -1) | 28.71 Picograms | Standard Deviation 2.655 |
| Cohort 2: DOVATO (DTG/3TC) Fed | Absolute Values of Hematology Parameters: Erythrocytes Mean Corpuscular Hemoglobin | Baseline (Day -1) | 29.89 Picograms | Standard Deviation 2.246 |
| Cohort 2: DOVATO (DTG/3TC) Fed | Absolute Values of Hematology Parameters: Erythrocytes Mean Corpuscular Hemoglobin | Day 4 | 29.92 Picograms | Standard Deviation 2.26 |
| Cohort 2: DOVATO (DTG/3TC) Fasted | Absolute Values of Hematology Parameters: Erythrocytes Mean Corpuscular Hemoglobin | Baseline (Day -1) | 29.89 Picograms | Standard Deviation 2.21 |
| Cohort 2: DOVATO (DTG/3TC) Fasted | Absolute Values of Hematology Parameters: Erythrocytes Mean Corpuscular Hemoglobin | Day 4 | 29.80 Picograms | Standard Deviation 2.241 |
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.
Time frame: Baseline (Day -1) and Day 4
Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed | Absolute Values of Hematology Parameters: Erythrocytes Mean Corpuscular Volume | Baseline (Day -1) | 85.11 Femtoliter | Standard Deviation 5.706 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed | Absolute Values of Hematology Parameters: Erythrocytes Mean Corpuscular Volume | Day 4 | 85.02 Femtoliter | Standard Deviation 5.47 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted | Absolute Values of Hematology Parameters: Erythrocytes Mean Corpuscular Volume | Day 4 | 85.04 Femtoliter | Standard Deviation 5.712 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted | Absolute Values of Hematology Parameters: Erythrocytes Mean Corpuscular Volume | Baseline (Day -1) | 84.92 Femtoliter | Standard Deviation 5.749 |
| Cohort 2: DOVATO (DTG/3TC) Fed | Absolute Values of Hematology Parameters: Erythrocytes Mean Corpuscular Volume | Baseline (Day -1) | 87.64 Femtoliter | Standard Deviation 5.684 |
| Cohort 2: DOVATO (DTG/3TC) Fed | Absolute Values of Hematology Parameters: Erythrocytes Mean Corpuscular Volume | Day 4 | 87.09 Femtoliter | Standard Deviation 5.648 |
| Cohort 2: DOVATO (DTG/3TC) Fasted | Absolute Values of Hematology Parameters: Erythrocytes Mean Corpuscular Volume | Baseline (Day -1) | 87.45 Femtoliter | Standard Deviation 5.795 |
| Cohort 2: DOVATO (DTG/3TC) Fasted | Absolute Values of Hematology Parameters: Erythrocytes Mean Corpuscular Volume | Day 4 | 87.31 Femtoliter | Standard Deviation 5.612 |
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.
Time frame: Baseline (Day -1) and Day 4
Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed | Absolute Values of Hematology Parameters: Hematocrit | Baseline (Day -1) | 0.3957 Proportion of red blood cells in blood | Standard Deviation 0.04371 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed | Absolute Values of Hematology Parameters: Hematocrit | Day 4 | 0.3956 Proportion of red blood cells in blood | Standard Deviation 0.04208 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted | Absolute Values of Hematology Parameters: Hematocrit | Day 4 | 0.3979 Proportion of red blood cells in blood | Standard Deviation 0.04358 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted | Absolute Values of Hematology Parameters: Hematocrit | Baseline (Day -1) | 0.3976 Proportion of red blood cells in blood | Standard Deviation 0.03892 |
| Cohort 2: DOVATO (DTG/3TC) Fed | Absolute Values of Hematology Parameters: Hematocrit | Baseline (Day -1) | 0.4163 Proportion of red blood cells in blood | Standard Deviation 0.03383 |
| Cohort 2: DOVATO (DTG/3TC) Fed | Absolute Values of Hematology Parameters: Hematocrit | Day 4 | 0.4201 Proportion of red blood cells in blood | Standard Deviation 0.03339 |
| Cohort 2: DOVATO (DTG/3TC) Fasted | Absolute Values of Hematology Parameters: Hematocrit | Baseline (Day -1) | 0.4227 Proportion of red blood cells in blood | Standard Deviation 0.03075 |
| Cohort 2: DOVATO (DTG/3TC) Fasted | Absolute Values of Hematology Parameters: Hematocrit | Day 4 | 0.4237 Proportion of red blood cells in blood | Standard Deviation 0.03137 |
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.
Time frame: Baseline (Day -1) and Day 4
Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed | Absolute Values of Hematology Parameters: Hemoglobin | Baseline (Day -1) | 133.5 Grams per liter | Standard Deviation 16.66 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed | Absolute Values of Hematology Parameters: Hemoglobin | Day 4 | 133.8 Grams per liter | Standard Deviation 16.66 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted | Absolute Values of Hematology Parameters: Hemoglobin | Day 4 | 133.3 Grams per liter | Standard Deviation 16.97 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted | Absolute Values of Hematology Parameters: Hemoglobin | Baseline (Day -1) | 134.4 Grams per liter | Standard Deviation 15.71 |
| Cohort 2: DOVATO (DTG/3TC) Fed | Absolute Values of Hematology Parameters: Hemoglobin | Day 4 | 144.3 Grams per liter | Standard Deviation 12.06 |
| Cohort 2: DOVATO (DTG/3TC) Fed | Absolute Values of Hematology Parameters: Hemoglobin | Baseline (Day -1) | 142.0 Grams per liter | Standard Deviation 11.69 |
| Cohort 2: DOVATO (DTG/3TC) Fasted | Absolute Values of Hematology Parameters: Hemoglobin | Baseline (Day -1) | 144.5 Grams per liter | Standard Deviation 11.25 |
| Cohort 2: DOVATO (DTG/3TC) Fasted | Absolute Values of Hematology Parameters: Hemoglobin | Day 4 | 144.4 Grams per liter | Standard Deviation 10.57 |
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.
Time frame: Baseline (Day -1) and Day 4
Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed | Absolute Values of Hematology Parameters: RBC Count | Baseline (Day -1) | 4.648 10^12 cells per liter | Standard Deviation 0.4082 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed | Absolute Values of Hematology Parameters: RBC Count | Day 4 | 4.656 10^12 cells per liter | Standard Deviation 0.417 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted | Absolute Values of Hematology Parameters: RBC Count | Day 4 | 4.678 10^12 cells per liter | Standard Deviation 0.4011 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted | Absolute Values of Hematology Parameters: RBC Count | Baseline (Day -1) | 4.684 10^12 cells per liter | Standard Deviation 0.3549 |
| Cohort 2: DOVATO (DTG/3TC) Fed | Absolute Values of Hematology Parameters: RBC Count | Day 4 | 4.839 10^12 cells per liter | Standard Deviation 0.4405 |
| Cohort 2: DOVATO (DTG/3TC) Fed | Absolute Values of Hematology Parameters: RBC Count | Baseline (Day -1) | 4.765 10^12 cells per liter | Standard Deviation 0.4251 |
| Cohort 2: DOVATO (DTG/3TC) Fasted | Absolute Values of Hematology Parameters: RBC Count | Baseline (Day -1) | 4.848 10^12 cells per liter | Standard Deviation 0.3975 |
| Cohort 2: DOVATO (DTG/3TC) Fasted | Absolute Values of Hematology Parameters: RBC Count | Day 4 | 4.865 10^12 cells per liter | Standard Deviation 0.4051 |
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.
Time frame: Baseline (Day -1) and Day 4
Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed | Absolute Values of Urinalysis Parameter: Potential of Hydrogen (pH) by Dipstick | Baseline (Day -1) | 6.38 pH | Standard Deviation 0.806 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed | Absolute Values of Urinalysis Parameter: Potential of Hydrogen (pH) by Dipstick | Day 4 | 6.03 pH | Standard Deviation 0.499 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted | Absolute Values of Urinalysis Parameter: Potential of Hydrogen (pH) by Dipstick | Baseline (Day -1) | 6.22 pH | Standard Deviation 0.515 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted | Absolute Values of Urinalysis Parameter: Potential of Hydrogen (pH) by Dipstick | Day 4 | 6.00 pH | Standard Deviation 0.577 |
| Cohort 2: DOVATO (DTG/3TC) Fed | Absolute Values of Urinalysis Parameter: Potential of Hydrogen (pH) by Dipstick | Day 4 | 6.28 pH | Standard Deviation 0.605 |
| Cohort 2: DOVATO (DTG/3TC) Fed | Absolute Values of Urinalysis Parameter: Potential of Hydrogen (pH) by Dipstick | Baseline (Day -1) | 6.41 pH | Standard Deviation 0.643 |
| Cohort 2: DOVATO (DTG/3TC) Fasted | Absolute Values of Urinalysis Parameter: Potential of Hydrogen (pH) by Dipstick | Baseline (Day -1) | 6.50 pH | Standard Deviation 0.548 |
| Cohort 2: DOVATO (DTG/3TC) Fasted | Absolute Values of Urinalysis Parameter: Potential of Hydrogen (pH) by Dipstick | Day 4 | 6.06 pH | Standard Deviation 0.544 |
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.
Time frame: Baseline (Day -1) and Day 4
Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed | Absolute Values of Urinalysis Parameter: Specific Gravity | Day 4 | 1.0162 Ratio | Standard Deviation 0.00782 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed | Absolute Values of Urinalysis Parameter: Specific Gravity | Baseline (Day -1) | 1.0128 Ratio | Standard Deviation 0.00767 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted | Absolute Values of Urinalysis Parameter: Specific Gravity | Baseline (Day -1) | 1.0134 Ratio | Standard Deviation 0.00766 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted | Absolute Values of Urinalysis Parameter: Specific Gravity | Day 4 | 1.0147 Ratio | Standard Deviation 0.00921 |
| Cohort 2: DOVATO (DTG/3TC) Fed | Absolute Values of Urinalysis Parameter: Specific Gravity | Baseline (Day -1) | 1.0151 Ratio | Standard Deviation 0.008 |
| Cohort 2: DOVATO (DTG/3TC) Fed | Absolute Values of Urinalysis Parameter: Specific Gravity | Day 4 | 1.0182 Ratio | Standard Deviation 0.00727 |
| Cohort 2: DOVATO (DTG/3TC) Fasted | Absolute Values of Urinalysis Parameter: Specific Gravity | Day 4 | 1.0181 Ratio | Standard Deviation 0.00851 |
| Cohort 2: DOVATO (DTG/3TC) Fasted | Absolute Values of Urinalysis Parameter: Specific Gravity | Baseline (Day -1) | 1.0163 Ratio | Standard Deviation 0.00857 |
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.
Time frame: Baseline (Day -1) and Day 4
Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed | Absolute Values of Vital Signs Measurements: Pulse Rate | Day 4 | 62.9 Beats per minute | Standard Deviation 8.47 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed | Absolute Values of Vital Signs Measurements: Pulse Rate | Baseline (Day -1) | 59.9 Beats per minute | Standard Deviation 9.07 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted | Absolute Values of Vital Signs Measurements: Pulse Rate | Day 4 | 62.0 Beats per minute | Standard Deviation 9.89 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted | Absolute Values of Vital Signs Measurements: Pulse Rate | Baseline (Day -1) | 62.3 Beats per minute | Standard Deviation 7.49 |
| Cohort 2: DOVATO (DTG/3TC) Fed | Absolute Values of Vital Signs Measurements: Pulse Rate | Baseline (Day -1) | 59.9 Beats per minute | Standard Deviation 10.82 |
| Cohort 2: DOVATO (DTG/3TC) Fed | Absolute Values of Vital Signs Measurements: Pulse Rate | Day 4 | 61.4 Beats per minute | Standard Deviation 3.86 |
| Cohort 2: DOVATO (DTG/3TC) Fasted | Absolute Values of Vital Signs Measurements: Pulse Rate | Baseline (Day -1) | 60.1 Beats per minute | Standard Deviation 8.44 |
| Cohort 2: DOVATO (DTG/3TC) Fasted | Absolute Values of Vital Signs Measurements: Pulse Rate | Day 4 | 59.9 Beats per minute | Standard Deviation 6.68 |
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.
Time frame: Baseline (Day -1) and Day 4
Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed | Absolute Values of Vital Signs Measurements: SBP and DBP | Baseline (Day -1): SBP | 110.6 Millimeters of mercury | Standard Deviation 10.61 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed | Absolute Values of Vital Signs Measurements: SBP and DBP | Day 4: SBP | 109.5 Millimeters of mercury | Standard Deviation 10.93 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed | Absolute Values of Vital Signs Measurements: SBP and DBP | Baseline (Day -1): DBP | 64.0 Millimeters of mercury | Standard Deviation 7.68 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed | Absolute Values of Vital Signs Measurements: SBP and DBP | Day 4: DBP | 64.0 Millimeters of mercury | Standard Deviation 9.12 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted | Absolute Values of Vital Signs Measurements: SBP and DBP | Day 4: SBP | 108.8 Millimeters of mercury | Standard Deviation 9.07 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted | Absolute Values of Vital Signs Measurements: SBP and DBP | Baseline (Day -1): DBP | 64.0 Millimeters of mercury | Standard Deviation 7.69 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted | Absolute Values of Vital Signs Measurements: SBP and DBP | Day 4: DBP | 64.3 Millimeters of mercury | Standard Deviation 8.99 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted | Absolute Values of Vital Signs Measurements: SBP and DBP | Baseline (Day -1): SBP | 113.0 Millimeters of mercury | Standard Deviation 10.04 |
| Cohort 2: DOVATO (DTG/3TC) Fed | Absolute Values of Vital Signs Measurements: SBP and DBP | Baseline (Day -1): DBP | 63.0 Millimeters of mercury | Standard Deviation 7.37 |
| Cohort 2: DOVATO (DTG/3TC) Fed | Absolute Values of Vital Signs Measurements: SBP and DBP | Day 4: SBP | 114.7 Millimeters of mercury | Standard Deviation 9.14 |
| Cohort 2: DOVATO (DTG/3TC) Fed | Absolute Values of Vital Signs Measurements: SBP and DBP | Day 4: DBP | 66.4 Millimeters of mercury | Standard Deviation 8.06 |
| Cohort 2: DOVATO (DTG/3TC) Fed | Absolute Values of Vital Signs Measurements: SBP and DBP | Baseline (Day -1): SBP | 112.5 Millimeters of mercury | Standard Deviation 9.37 |
| Cohort 2: DOVATO (DTG/3TC) Fasted | Absolute Values of Vital Signs Measurements: SBP and DBP | Day 4: DBP | 65.3 Millimeters of mercury | Standard Deviation 8.2 |
| Cohort 2: DOVATO (DTG/3TC) Fasted | Absolute Values of Vital Signs Measurements: SBP and DBP | Day 4: SBP | 114.1 Millimeters of mercury | Standard Deviation 10.67 |
| Cohort 2: DOVATO (DTG/3TC) Fasted | Absolute Values of Vital Signs Measurements: SBP and DBP | Baseline (Day -1): SBP | 113.5 Millimeters of mercury | Standard Deviation 8.65 |
| Cohort 2: DOVATO (DTG/3TC) Fasted | Absolute Values of Vital Signs Measurements: SBP and DBP | Baseline (Day -1): DBP | 66.4 Millimeters of mercury | Standard Deviation 6.55 |
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.
Time frame: Baseline (Day -1) and Day 4
Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed | Change From Baseline in Clinical Chemistry Parameters: Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Amino Transferase (AST) | ALT | 4.0 International units per liter | Standard Deviation 12.63 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed | Change From Baseline in Clinical Chemistry Parameters: Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Amino Transferase (AST) | AST | 0.6 International units per liter | Standard Deviation 6.69 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed | Change From Baseline in Clinical Chemistry Parameters: Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Amino Transferase (AST) | ALP | -2.6 International units per liter | Standard Deviation 5.71 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted | Change From Baseline in Clinical Chemistry Parameters: Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Amino Transferase (AST) | ALT | -5.1 International units per liter | Standard Deviation 7.02 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted | Change From Baseline in Clinical Chemistry Parameters: Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Amino Transferase (AST) | AST | -4.0 International units per liter | Standard Deviation 4.59 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted | Change From Baseline in Clinical Chemistry Parameters: Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Amino Transferase (AST) | ALP | -3.0 International units per liter | Standard Deviation 6.8 |
| Cohort 2: DOVATO (DTG/3TC) Fed | Change From Baseline in Clinical Chemistry Parameters: Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Amino Transferase (AST) | ALP | 0.3 International units per liter | Standard Deviation 4.51 |
| Cohort 2: DOVATO (DTG/3TC) Fed | Change From Baseline in Clinical Chemistry Parameters: Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Amino Transferase (AST) | ALT | -0.4 International units per liter | Standard Deviation 4.1 |
| Cohort 2: DOVATO (DTG/3TC) Fed | Change From Baseline in Clinical Chemistry Parameters: Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Amino Transferase (AST) | AST | -1.3 International units per liter | Standard Deviation 1.7 |
| Cohort 2: DOVATO (DTG/3TC) Fasted | 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 |
| Cohort 2: DOVATO (DTG/3TC) Fasted | 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 |
| Cohort 2: DOVATO (DTG/3TC) Fasted | 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 |
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.
Time frame: Baseline (Day -1) and Day 4
Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed | Change From Baseline in Clinical Chemistry Parameters: Albumin and Total Protein | Total Protein | 0.9 Grams per liter | Standard Deviation 3.07 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed | Change From Baseline in Clinical Chemistry Parameters: Albumin and Total Protein | Albumin | 0.2 Grams per liter | Standard Deviation 2.32 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted | Change From Baseline in Clinical Chemistry Parameters: Albumin and Total Protein | Albumin | -0.9 Grams per liter | Standard Deviation 3.2 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted | Change From Baseline in Clinical Chemistry Parameters: Albumin and Total Protein | Total Protein | -0.2 Grams per liter | Standard Deviation 4.59 |
| Cohort 2: DOVATO (DTG/3TC) Fed | Change From Baseline in Clinical Chemistry Parameters: Albumin and Total Protein | Albumin | 0.9 Grams per liter | Standard Deviation 2.55 |
| Cohort 2: DOVATO (DTG/3TC) Fed | Change From Baseline in Clinical Chemistry Parameters: Albumin and Total Protein | Total Protein | 0.8 Grams per liter | Standard Deviation 3.58 |
| Cohort 2: DOVATO (DTG/3TC) Fasted | Change From Baseline in Clinical Chemistry Parameters: Albumin and Total Protein | Total Protein | 0.7 Grams per liter | Standard Deviation 3.32 |
| Cohort 2: DOVATO (DTG/3TC) Fasted | Change From Baseline in Clinical Chemistry Parameters: Albumin and Total Protein | Albumin | 1.1 Grams per liter | Standard Deviation 1.67 |
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.
Time frame: Baseline (Day -1) and Day 4
Population: Safety Population. Only those participants with data available at the specified time points were analyzed
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed | Change From Baseline in Clinical Chemistry Parameters: Calcium, Glucose, Potassium, Sodium and Blood Urea Nitrogen (BUN) | Potassium | 0.03 Millimoles per liter | Standard Deviation 0.244 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed | Change From Baseline in Clinical Chemistry Parameters: Calcium, Glucose, Potassium, Sodium and Blood Urea Nitrogen (BUN) | Calcium | -0.003 Millimoles per liter | Standard Deviation 0.0436 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed | Change From Baseline in Clinical Chemistry Parameters: Calcium, Glucose, Potassium, Sodium and Blood Urea Nitrogen (BUN) | Sodium | 0.4 Millimoles per liter | Standard Deviation 1.36 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed | Change From Baseline in Clinical Chemistry Parameters: Calcium, Glucose, Potassium, Sodium and Blood Urea Nitrogen (BUN) | Glucose | -0.037 Millimoles per liter | Standard Deviation 0.27 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed | Change From Baseline in Clinical Chemistry Parameters: Calcium, Glucose, Potassium, Sodium and Blood Urea Nitrogen (BUN) | BUN | 0.208 Millimoles per liter | Standard Deviation 0.4826 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted | Change From Baseline in Clinical Chemistry Parameters: Calcium, Glucose, Potassium, Sodium and Blood Urea Nitrogen (BUN) | Sodium | 0.9 Millimoles per liter | Standard Deviation 1.29 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted | Change From Baseline in Clinical Chemistry Parameters: Calcium, Glucose, Potassium, Sodium and Blood Urea Nitrogen (BUN) | BUN | 0.293 Millimoles per liter | Standard Deviation 0.8664 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted | Change From Baseline in Clinical Chemistry Parameters: Calcium, Glucose, Potassium, Sodium and Blood Urea Nitrogen (BUN) | Calcium | -0.034 Millimoles per liter | Standard Deviation 0.0781 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted | Change From Baseline in Clinical Chemistry Parameters: Calcium, Glucose, Potassium, Sodium and Blood Urea Nitrogen (BUN) | Glucose | -0.169 Millimoles per liter | Standard Deviation 0.3648 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted | Change From Baseline in Clinical Chemistry Parameters: Calcium, Glucose, Potassium, Sodium and Blood Urea Nitrogen (BUN) | Potassium | 0.01 Millimoles per liter | Standard Deviation 0.189 |
| Cohort 2: DOVATO (DTG/3TC) Fed | Change From Baseline in Clinical Chemistry Parameters: Calcium, Glucose, Potassium, Sodium and Blood Urea Nitrogen (BUN) | Sodium | -0.5 Millimoles per liter | Standard Deviation 1.41 |
| Cohort 2: DOVATO (DTG/3TC) Fed | Change From Baseline in Clinical Chemistry Parameters: Calcium, Glucose, Potassium, Sodium and Blood Urea Nitrogen (BUN) | Potassium | -0.13 Millimoles per liter | Standard Deviation 0.277 |
| Cohort 2: DOVATO (DTG/3TC) Fed | Change From Baseline in Clinical Chemistry Parameters: Calcium, Glucose, Potassium, Sodium and Blood Urea Nitrogen (BUN) | Glucose | -0.047 Millimoles per liter | Standard Deviation 0.2156 |
| Cohort 2: DOVATO (DTG/3TC) Fed | Change From Baseline in Clinical Chemistry Parameters: Calcium, Glucose, Potassium, Sodium and Blood Urea Nitrogen (BUN) | BUN | 0.353 Millimoles per liter | Standard Deviation 0.8394 |
| Cohort 2: DOVATO (DTG/3TC) Fed | Change From Baseline in Clinical Chemistry Parameters: Calcium, Glucose, Potassium, Sodium and Blood Urea Nitrogen (BUN) | Calcium | 0.029 Millimoles per liter | Standard Deviation 0.0792 |
| Cohort 2: DOVATO (DTG/3TC) Fasted | 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 |
| Cohort 2: DOVATO (DTG/3TC) Fasted | 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 |
| Cohort 2: DOVATO (DTG/3TC) Fasted | Change From Baseline in Clinical Chemistry Parameters: Calcium, Glucose, Potassium, Sodium and Blood Urea Nitrogen (BUN) | Sodium | 0.3 Millimoles per liter | Standard Deviation 1.4 |
| Cohort 2: DOVATO (DTG/3TC) Fasted | 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 |
| Cohort 2: DOVATO (DTG/3TC) Fasted | 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 |
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.
Time frame: Baseline (Day -1) and Day 4
Population: Safety Population. Only those participants with data available at the specified time points were analyzed
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed | Change From Baseline in Clinical Chemistry Parameters: Creatine Kinase | -17.8 International units per liter | Standard Deviation 47.62 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted | Change From Baseline in Clinical Chemistry Parameters: Creatine Kinase | -51.9 International units per liter | Standard Deviation 82.52 |
| Cohort 2: DOVATO (DTG/3TC) Fed | Change From Baseline in Clinical Chemistry Parameters: Creatine Kinase | -33.9 International units per liter | Standard Deviation 44.83 |
| Cohort 2: DOVATO (DTG/3TC) Fasted | Change From Baseline in Clinical Chemistry Parameters: Creatine Kinase | -29.5 International units per liter | Standard Deviation 91.1 |
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.
Time frame: Baseline (Day -1) and Day 4
Population: Safety Population. Only those participants with data available at the specified time points were analyzed
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed | Change From Baseline in Clinical Chemistry Parameters: Creatinine, Direct Bilirubin and Total Bilirubin | Creatinine | 9.18 Micromoles per liter | Standard Deviation 2.871 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed | Change From Baseline in Clinical Chemistry Parameters: Creatinine, Direct Bilirubin and Total Bilirubin | Total Bilirubin | 0.16 Micromoles per liter | Standard Deviation 3.069 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed | Change From Baseline in Clinical Chemistry Parameters: Creatinine, Direct Bilirubin and Total Bilirubin | Direct Bilirubin | 0.16 Micromoles per liter | Standard Deviation 0.541 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted | Change From Baseline in Clinical Chemistry Parameters: Creatinine, Direct Bilirubin and Total Bilirubin | Creatinine | 10.76 Micromoles per liter | Standard Deviation 4.045 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted | Change From Baseline in Clinical Chemistry Parameters: Creatinine, Direct Bilirubin and Total Bilirubin | Total Bilirubin | -0.74 Micromoles per liter | Standard Deviation 2.712 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted | Change From Baseline in Clinical Chemistry Parameters: Creatinine, Direct Bilirubin and Total Bilirubin | Direct Bilirubin | 0.05 Micromoles per liter | Standard Deviation 0.398 |
| Cohort 2: DOVATO (DTG/3TC) Fed | Change From Baseline in Clinical Chemistry Parameters: Creatinine, Direct Bilirubin and Total Bilirubin | Direct Bilirubin | 0.04 Micromoles per liter | Standard Deviation 0.403 |
| Cohort 2: DOVATO (DTG/3TC) Fed | Change From Baseline in Clinical Chemistry Parameters: Creatinine, Direct Bilirubin and Total Bilirubin | Creatinine | 1.83 Micromoles per liter | Standard Deviation 2.931 |
| Cohort 2: DOVATO (DTG/3TC) Fed | Change From Baseline in Clinical Chemistry Parameters: Creatinine, Direct Bilirubin and Total Bilirubin | Total Bilirubin | 0.58 Micromoles per liter | Standard Deviation 2.377 |
| Cohort 2: DOVATO (DTG/3TC) Fasted | Change From Baseline in Clinical Chemistry Parameters: Creatinine, Direct Bilirubin and Total Bilirubin | Creatinine | 2.11 Micromoles per liter | Standard Deviation 5.796 |
| Cohort 2: DOVATO (DTG/3TC) Fasted | Change From Baseline in Clinical Chemistry Parameters: Creatinine, Direct Bilirubin and Total Bilirubin | Total Bilirubin | -0.03 Micromoles per liter | Standard Deviation 1.588 |
| Cohort 2: DOVATO (DTG/3TC) Fasted | Change From Baseline in Clinical Chemistry Parameters: Creatinine, Direct Bilirubin and Total Bilirubin | Direct Bilirubin | -0.06 Micromoles per liter | Standard Deviation 0.33 |
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.
Time frame: Baseline (Day -1) and Day 4
Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed | 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 | -1.2 Milliseconds | Standard Deviation 3.35 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed | Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and Corrected QT Interval According to Fridericia's Formula (QTcF) | QTcF | -4.1 Milliseconds | Standard Deviation 11.87 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed | 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 | -10.5 Milliseconds | Standard Deviation 15.8 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed | 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 | 2.2 Milliseconds | Standard Deviation 9.7 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted | 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 | -6.4 Milliseconds | Standard Deviation 17.2 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted | 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 | -0.7 Milliseconds | Standard Deviation 12.39 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted | 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 | -2.9 Milliseconds | Standard Deviation 4.44 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted | Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and Corrected QT Interval According to Fridericia's Formula (QTcF) | QTcF | -6.9 Milliseconds | Standard Deviation 11.21 |
| Cohort 2: DOVATO (DTG/3TC) Fed | 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 | 1.2 Milliseconds | Standard Deviation 2.99 |
| Cohort 2: DOVATO (DTG/3TC) Fed | Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and Corrected QT Interval According to Fridericia's Formula (QTcF) | QTcF | -2.5 Milliseconds | Standard Deviation 8.71 |
| Cohort 2: DOVATO (DTG/3TC) Fed | 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 | -13.1 Milliseconds | Standard Deviation 11.26 |
| Cohort 2: DOVATO (DTG/3TC) Fed | 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 | -2.7 Milliseconds | Standard Deviation 9.9 |
| Cohort 2: DOVATO (DTG/3TC) Fasted | 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 |
| Cohort 2: DOVATO (DTG/3TC) Fasted | 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 |
| Cohort 2: DOVATO (DTG/3TC) Fasted | 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 6.1 |
| Cohort 2: DOVATO (DTG/3TC) Fasted | 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 |
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.
Time frame: Baseline (Day -1) and Day 4
Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count and Neutrophil | Basophils | -0.002 10^9 cells per liter | Standard Deviation 0.0105 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count and Neutrophil | Eosinophils | -0.002 10^9 cells per liter | Standard Deviation 0.0456 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count and Neutrophil | Lymphocytes | -0.212 10^9 cells per liter | Standard Deviation 0.3773 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count and Neutrophil | Monocytes | -0.051 10^9 cells per liter | Standard Deviation 0.0972 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count and Neutrophil | Platelet count | 3.2 10^9 cells per liter | Standard Deviation 16.05 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count and Neutrophil | Neutrophil | 0.031 10^9 cells per liter | Standard Deviation 0.5042 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count and Neutrophil | Neutrophil | -0.159 10^9 cells per liter | Standard Deviation 0.6044 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count and Neutrophil | Monocytes | -0.048 10^9 cells per liter | Standard Deviation 0.0802 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count and Neutrophil | Basophils | -0.004 10^9 cells per liter | Standard Deviation 0.0141 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count and Neutrophil | Lymphocytes | -0.116 10^9 cells per liter | Standard Deviation 0.2271 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count and Neutrophil | Eosinophils | 0.015 10^9 cells per liter | Standard Deviation 0.0755 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count and Neutrophil | Platelet count | 6.7 10^9 cells per liter | Standard Deviation 15.4 |
| Cohort 2: DOVATO (DTG/3TC) Fed | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count and Neutrophil | Eosinophils | -0.005 10^9 cells per liter | Standard Deviation 0.0219 |
| Cohort 2: DOVATO (DTG/3TC) Fed | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count and Neutrophil | Lymphocytes | -0.027 10^9 cells per liter | Standard Deviation 0.2865 |
| Cohort 2: DOVATO (DTG/3TC) Fed | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count and Neutrophil | Monocytes | -0.064 10^9 cells per liter | Standard Deviation 0.1285 |
| Cohort 2: DOVATO (DTG/3TC) Fed | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count and Neutrophil | Neutrophil | -0.109 10^9 cells per liter | Standard Deviation 0.9421 |
| Cohort 2: DOVATO (DTG/3TC) Fed | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count and Neutrophil | Platelet count | 5.4 10^9 cells per liter | Standard Deviation 23 |
| Cohort 2: DOVATO (DTG/3TC) Fed | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count and Neutrophil | Basophils | -0.003 10^9 cells per liter | Standard Deviation 0.01 |
| Cohort 2: DOVATO (DTG/3TC) Fasted | 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 |
| Cohort 2: DOVATO (DTG/3TC) Fasted | 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 |
| Cohort 2: DOVATO (DTG/3TC) Fasted | 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 |
| Cohort 2: DOVATO (DTG/3TC) Fasted | 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 |
| Cohort 2: DOVATO (DTG/3TC) Fasted | 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 |
| Cohort 2: DOVATO (DTG/3TC) Fasted | 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 |
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.
Time frame: Baseline (Day -1) and Day 4
Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed | Change From Baseline in Hematology Parameters: Erythrocytes Mean Corpuscular Hemoglobin | -0.03 Picograms | Standard Deviation 0.267 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted | Change From Baseline in Hematology Parameters: Erythrocytes Mean Corpuscular Hemoglobin | -0.24 Picograms | Standard Deviation 0.307 |
| Cohort 2: DOVATO (DTG/3TC) Fed | Change From Baseline in Hematology Parameters: Erythrocytes Mean Corpuscular Hemoglobin | 0.13 Picograms | Standard Deviation 0.442 |
| Cohort 2: DOVATO (DTG/3TC) Fasted | Change From Baseline in Hematology Parameters: Erythrocytes Mean Corpuscular Hemoglobin | -0.09 Picograms | Standard Deviation 0.351 |
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.
Time frame: Baseline (Day -1) and Day 4
Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed | Change From Baseline in Hematology Parameters: Erythrocytes Mean Corpuscular Volume | -0.09 Femtoliter | Standard Deviation 0.665 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted | Change From Baseline in Hematology Parameters: Erythrocytes Mean Corpuscular Volume | 0.12 Femtoliter | Standard Deviation 0.571 |
| Cohort 2: DOVATO (DTG/3TC) Fed | Change From Baseline in Hematology Parameters: Erythrocytes Mean Corpuscular Volume | -0.28 Femtoliter | Standard Deviation 0.471 |
| Cohort 2: DOVATO (DTG/3TC) Fasted | Change From Baseline in Hematology Parameters: Erythrocytes Mean Corpuscular Volume | -0.14 Femtoliter | Standard Deviation 0.672 |
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.
Time frame: Baseline (Day -1) and Day 4
Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed | Change From Baseline in Hematology Parameters: Hematocrit | -0.0001 Proportion of red blood cells in blood | Standard Deviation 0.01647 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted | Change From Baseline in Hematology Parameters: Hematocrit | 0.0003 Proportion of red blood cells in blood | Standard Deviation 0.01587 |
| Cohort 2: DOVATO (DTG/3TC) Fed | Change From Baseline in Hematology Parameters: Hematocrit | 0.0006 Proportion of red blood cells in blood | Standard Deviation 0.0195 |
| Cohort 2: DOVATO (DTG/3TC) Fasted | Change From Baseline in Hematology Parameters: Hematocrit | 0.0010 Proportion of red blood cells in blood | Standard Deviation 0.01487 |
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.
Time frame: Baseline (Day -1) and Day 4
Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed | Change From Baseline in Hematology Parameters: Hemoglobin | 0.3 Grams per liter | Standard Deviation 5.66 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted | Change From Baseline in Hematology Parameters: Hemoglobin | -1.1 Grams per liter | Standard Deviation 4.96 |
| Cohort 2: DOVATO (DTG/3TC) Fed | Change From Baseline in Hematology Parameters: Hemoglobin | 1.2 Grams per liter | Standard Deviation 6.4 |
| Cohort 2: DOVATO (DTG/3TC) Fasted | Change From Baseline in Hematology Parameters: Hemoglobin | -0.1 Grams per liter | Standard Deviation 5.17 |
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.
Time frame: Baseline (Day -1) and Day 4
Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed | Change From Baseline in Hematology Parameters: Red Blood Cell (RBC) Count | 0.008 10^12 cells per liter | Standard Deviation 0.1891 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted | Change From Baseline in Hematology Parameters: Red Blood Cell (RBC) Count | -0.006 10^12 cells per liter | Standard Deviation 0.1832 |
| Cohort 2: DOVATO (DTG/3TC) Fed | Change From Baseline in Hematology Parameters: Red Blood Cell (RBC) Count | 0.024 10^12 cells per liter | Standard Deviation 0.2141 |
| Cohort 2: DOVATO (DTG/3TC) Fasted | Change From Baseline in Hematology Parameters: Red Blood Cell (RBC) Count | 0.018 10^12 cells per liter | Standard Deviation 0.162 |
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.
Time frame: Baseline (Day -1) and Day 4
Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed | Change From Baseline in Urinalysis Parameter: Potential of Hydrogen (pH) by Dipstick | -0.34 pH | Standard Deviation 0.724 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted | Change From Baseline in Urinalysis Parameter: Potential of Hydrogen (pH) by Dipstick | -0.22 pH | Standard Deviation 0.547 |
| Cohort 2: DOVATO (DTG/3TC) Fed | Change From Baseline in Urinalysis Parameter: Potential of Hydrogen (pH) by Dipstick | -0.13 pH | Standard Deviation 0.645 |
| Cohort 2: DOVATO (DTG/3TC) Fasted | Change From Baseline in Urinalysis Parameter: Potential of Hydrogen (pH) by Dipstick | -0.44 pH | Standard Deviation 0.512 |
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.
Time frame: Baseline (Day -1) and Day 4
Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed | Change From Baseline in Urinalysis Parameter: Specific Gravity | 0.0034 Ratio | Standard Deviation 0.0065 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted | Change From Baseline in Urinalysis Parameter: Specific Gravity | 0.0013 Ratio | Standard Deviation 0.01116 |
| Cohort 2: DOVATO (DTG/3TC) Fed | Change From Baseline in Urinalysis Parameter: Specific Gravity | 0.0029 Ratio | Standard Deviation 0.00809 |
| Cohort 2: DOVATO (DTG/3TC) Fasted | Change From Baseline in Urinalysis Parameter: Specific Gravity | 0.0019 Ratio | Standard Deviation 0.0057 |
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.
Time frame: Baseline (Day -1) and Day 4
Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed | Change From Baseline in Vital Signs Measurements: Pulse Rate | 3.0 Beats per minute | Standard Deviation 5.18 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted | Change From Baseline in Vital Signs Measurements: Pulse Rate | -0.3 Beats per minute | Standard Deviation 5.87 |
| Cohort 2: DOVATO (DTG/3TC) Fed | Change From Baseline in Vital Signs Measurements: Pulse Rate | 1.1 Beats per minute | Standard Deviation 10.12 |
| Cohort 2: DOVATO (DTG/3TC) Fasted | Change From Baseline in Vital Signs Measurements: Pulse Rate | -0.1 Beats per minute | Standard Deviation 7.04 |
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.
Time frame: Baseline (Day -1) and Day 4
Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed | Change From Baseline in Vital Signs Measurements: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP | -1.1 Millimeters of mercury | Standard Deviation 4.32 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed | Change From Baseline in Vital Signs Measurements: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP | 0.0 Millimeters of mercury | Standard Deviation 7.27 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted | Change From Baseline in Vital Signs Measurements: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP | 0.3 Millimeters of mercury | Standard Deviation 5.2 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted | Change From Baseline in Vital Signs Measurements: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP | -4.2 Millimeters of mercury | Standard Deviation 6.71 |
| Cohort 2: DOVATO (DTG/3TC) Fed | Change From Baseline in Vital Signs Measurements: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP | 1.9 Millimeters of mercury | Standard Deviation 8.14 |
| Cohort 2: DOVATO (DTG/3TC) Fed | Change From Baseline in Vital Signs Measurements: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP | 3.0 Millimeters of mercury | Standard Deviation 6.46 |
| Cohort 2: DOVATO (DTG/3TC) Fasted | 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 |
| Cohort 2: DOVATO (DTG/3TC) Fasted | 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 |
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.
Time frame: 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
Population: Pharmacokinetic Parameter Population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed | 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 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed | 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 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed | 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 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted | 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 | 43870 Hours*nanogram per milliliter | Geometric Coefficient of Variation 20.1 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted | 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 | 9980 Hours*nanogram per milliliter | Geometric Coefficient of Variation 28.8 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted | 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 | 6707 Hours*nanogram per milliliter | Geometric Coefficient of Variation 24.4 |
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.
Time frame: 24 hours post dose in treatment periods 1 and 2
Population: Pharmacokinetic Parameter Population. Only those participants with data available at specified time points were analyzed.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed | 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 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed | 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 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed | 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 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted | Cohort 1: Concentration at 24 Hours Post-dose (C24) of DTG, ABC and 3TC Following Administration of TRIUMEQ Under Fed and Fasted Conditions | DTG | 996.3 Nanogram per milliliter | Geometric Coefficient of Variation 26.3 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted | Cohort 1: Concentration at 24 Hours Post-dose (C24) of DTG, ABC and 3TC Following Administration of TRIUMEQ Under Fed and Fasted Conditions | ABC | 3.814 Nanogram per milliliter | Geometric Coefficient of Variation 27.2 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted | Cohort 1: Concentration at 24 Hours Post-dose (C24) of DTG, ABC and 3TC Following Administration of TRIUMEQ Under Fed and Fasted Conditions | 3TC | 21.74 Nanogram per milliliter | Geometric Coefficient of Variation 23.1 |
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.
Time frame: 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
Population: Pharmacokinetic Parameter Population
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed | 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 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed | 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 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed | 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 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted | 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 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted | 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 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted | 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 |
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.
Time frame: 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
Population: Pharmacokinetic Parameter Population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed | 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 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed | 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 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed | 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 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted | Cohort 1: Last Quantifiable Concentration (Ct) of DTG, ABC and 3TC Following Administration of TRIUMEQ Under Fed and Fasted Conditions | DTG | 128.6 Nanogram per milliliter | Geometric Coefficient of Variation 60.6 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted | Cohort 1: Last Quantifiable Concentration (Ct) of DTG, ABC and 3TC Following Administration of TRIUMEQ Under Fed and Fasted Conditions | ABC | 17.51 Nanogram per milliliter | Geometric Coefficient of Variation 124.9 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted | Cohort 1: Last Quantifiable Concentration (Ct) of DTG, ABC and 3TC Following Administration of TRIUMEQ Under Fed and Fasted Conditions | 3TC | 4.621 Nanogram per milliliter | Geometric Coefficient of Variation 20.3 |
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.
Time frame: 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
Population: Pharmacokinetic Parameter Population. Only those participants with data available at specified time points were analyzed.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed | 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 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed | 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 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed | 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 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted | Cohort 1: Terminal Elimination Phase Half-life (t1/2) of DTG, ABC and 3TC Following Administration of TRIUMEQ Under Fed and Fasted Conditions | DTG | 16.10 Hours | Geometric Coefficient of Variation 18.3 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted | Cohort 1: Terminal Elimination Phase Half-life (t1/2) of DTG, ABC and 3TC Following Administration of TRIUMEQ Under Fed and Fasted Conditions | ABC | 1.958 Hours | Geometric Coefficient of Variation 28.4 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted | Cohort 1: Terminal Elimination Phase Half-life (t1/2) of DTG, ABC and 3TC Following Administration of TRIUMEQ Under Fed and Fasted Conditions | 3TC | 15.23 Hours | Geometric Coefficient of Variation 52.9 |
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.
Time frame: 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
Population: Pharmacokinetic Parameter Population
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed | 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 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed | 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 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed | 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 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted | Cohort 1: Time of Maximum Observed Concentration (Tmax) of DTG, ABC and 3TC Following Administration of TRIUMEQ Under Fed and Fasted Conditions | DTG | 1.250 Hours |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted | Cohort 1: Time of Maximum Observed Concentration (Tmax) of DTG, ABC and 3TC Following Administration of TRIUMEQ Under Fed and Fasted Conditions | ABC | 0.500 Hours |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted | Cohort 1: Time of Maximum Observed Concentration (Tmax) of DTG, ABC and 3TC Following Administration of TRIUMEQ Under Fed and Fasted Conditions | 3TC | 1.508 Hours |
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.
Time frame: 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
Population: Pharmacokinetic Parameter Population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed | 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 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed | 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 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted | Cohort 2: AUC(0-24) of DTG and 3TC Following Administration of DOVATO Under Fed and Fasted Conditions | DTG | 35360 Hours*nanogram per milliliter | Geometric Coefficient of Variation 15.6 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted | Cohort 2: AUC(0-24) of DTG and 3TC Following Administration of DOVATO Under Fed and Fasted Conditions | 3TC | 7339 Hours*nanogram per milliliter | Geometric Coefficient of Variation 14.9 |
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.
Time frame: 24 hours post dose in treatment periods 1 and 2
Population: Pharmacokinetic Parameter Population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed | 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 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed | 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 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted | Cohort 2: C24 of DTG and 3TC Following Administration of DOVATO Under Fed and Fasted Conditions | DTG | 715.4 Nanogram per milliliter | Geometric Coefficient of Variation 27.7 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted | Cohort 2: C24 of DTG and 3TC Following Administration of DOVATO Under Fed and Fasted Conditions | 3TC | 20.38 Nanogram per milliliter | Geometric Coefficient of Variation 18.6 |
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.
Time frame: 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
Population: Pharmacokinetic Parameter Population. Only those participants with data available at specified time points were analyzed.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed | 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 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed | 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 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted | Cohort 2: Ct of DTG and 3TC Following Administration of DOVATO Under Fed and Fasted Conditions | DTG | 79.73 Nanogram per milliliter | Geometric Coefficient of Variation 74.5 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted | Cohort 2: Ct of DTG and 3TC Following Administration of DOVATO Under Fed and Fasted Conditions | 3TC | 3.622 Nanogram per milliliter | Geometric Coefficient of Variation 25.4 |
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.
Time frame: 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
Population: Pharmacokinetic Parameter Population. Only those participants with data available at specified time points were analyzed.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed | 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 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed | 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 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted | Cohort 2: t1/2 of DTG and 3TC Following Administration of DOVATO Under Fed and Fasted Conditions | DTG | 15.12 Hours | Geometric Coefficient of Variation 19 |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted | Cohort 2: t1/2 of DTG and 3TC Following Administration of DOVATO Under Fed and Fasted Conditions | 3TC | 18.36 Hours | Geometric Coefficient of Variation 21 |
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.
Time frame: 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
Population: Pharmacokinetic Parameter Population
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed | Cohort 2: Tlag of DTG and 3TC Following Administration of DOVATO Under Fed and Fasted Conditions | DTG | 0.000 Hours |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed | Cohort 2: Tlag of DTG and 3TC Following Administration of DOVATO Under Fed and Fasted Conditions | 3TC | 0.000 Hours |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted | Cohort 2: Tlag of DTG and 3TC Following Administration of DOVATO Under Fed and Fasted Conditions | DTG | 0.000 Hours |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted | Cohort 2: Tlag of DTG and 3TC Following Administration of DOVATO Under Fed and Fasted Conditions | 3TC | 0.000 Hours |
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.
Time frame: 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
Population: Pharmacokinetic Parameter Population
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed | Cohort 2: Tmax of DTG and 3TC Following Administration of DOVATO Under Fed and Fasted Conditions | DTG | 4.000 Hours |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed | Cohort 2: Tmax of DTG and 3TC Following Administration of DOVATO Under Fed and Fasted Conditions | 3TC | 3.000 Hours |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted | Cohort 2: Tmax of DTG and 3TC Following Administration of DOVATO Under Fed and Fasted Conditions | DTG | 0.875 Hours |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted | Cohort 2: Tmax of DTG and 3TC Following Administration of DOVATO Under Fed and Fasted Conditions | 3TC | 0.750 Hours |
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.
Time frame: Baseline (Day -1) and Day 4
Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed | Number of Participants With Abnormal Values on Urinalysis by Dipstick | Baseline (Day -1): Urine Glucose (Negative) | 16 Participants |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed | Number of Participants With Abnormal Values on Urinalysis by Dipstick | Day 4: Urine Glucose (Negative) | 16 Participants |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed | Number of Participants With Abnormal Values on Urinalysis by Dipstick | Baseline (Day -1): Urine Protein (Negative) | 16 Participants |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed | Number of Participants With Abnormal Values on Urinalysis by Dipstick | Baseline (Day -1): Urine Blood (3+) | 0 Participants |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed | Number of Participants With Abnormal Values on Urinalysis by Dipstick | Baseline (Day -1): Urine Blood (2+) | 0 Participants |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed | Number of Participants With Abnormal Values on Urinalysis by Dipstick | Baseline (Day -1): Urine Blood (Trace) | 0 Participants |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed | Number of Participants With Abnormal Values on Urinalysis by Dipstick | Day 4: Urine Blood (Negative) | 15 Participants |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed | Number of Participants With Abnormal Values on Urinalysis by Dipstick | Day 4: Urine Blood (3+) | 0 Participants |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed | Number of Participants With Abnormal Values on Urinalysis by Dipstick | Baseline (Day -1): Urine Ketones (Negative) | 16 Participants |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed | Number of Participants With Abnormal Values on Urinalysis by Dipstick | Day 4: Urine Ketones (Negative) | 15 Participants |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed | Number of Participants With Abnormal Values on Urinalysis by Dipstick | Day 4: Urine Ketones (1+) | 1 Participants |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed | Number of Participants With Abnormal Values on Urinalysis by Dipstick | Day 4: Urine Protein (Negative) | 16 Participants |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed | Number of Participants With Abnormal Values on Urinalysis by Dipstick | Baseline (Day -1): Urine Blood (Negative) | 16 Participants |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed | Number of Participants With Abnormal Values on Urinalysis by Dipstick | Day 4: Urine Blood (2+) | 1 Participants |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted | Number of Participants With Abnormal Values on Urinalysis by Dipstick | Baseline (Day -1): Urine Protein (Negative) | 16 Participants |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted | Number of Participants With Abnormal Values on Urinalysis by Dipstick | Day 4: Urine Blood (2+) | 2 Participants |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted | Number of Participants With Abnormal Values on Urinalysis by Dipstick | Day 4: Urine Blood (3+) | 0 Participants |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted | Number of Participants With Abnormal Values on Urinalysis by Dipstick | Baseline (Day -1): Urine Blood (Negative) | 15 Participants |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted | Number of Participants With Abnormal Values on Urinalysis by Dipstick | Day 4: Urine Ketones (Negative) | 16 Participants |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted | Number of Participants With Abnormal Values on Urinalysis by Dipstick | Baseline (Day -1): Urine Blood (2+) | 0 Participants |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted | Number of Participants With Abnormal Values on Urinalysis by Dipstick | Baseline (Day -1): Urine Blood (3+) | 1 Participants |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted | Number of Participants With Abnormal Values on Urinalysis by Dipstick | Day 4: Urine Glucose (Negative) | 16 Participants |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted | Number of Participants With Abnormal Values on Urinalysis by Dipstick | Baseline (Day -1): Urine Glucose (Negative) | 16 Participants |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted | Number of Participants With Abnormal Values on Urinalysis by Dipstick | Baseline (Day -1): Urine Blood (Trace) | 0 Participants |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted | Number of Participants With Abnormal Values on Urinalysis by Dipstick | Day 4: Urine Protein (Negative) | 16 Participants |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted | Number of Participants With Abnormal Values on Urinalysis by Dipstick | Baseline (Day -1): Urine Ketones (Negative) | 16 Participants |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted | Number of Participants With Abnormal Values on Urinalysis by Dipstick | Day 4: Urine Ketones (1+) | 0 Participants |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted | Number of Participants With Abnormal Values on Urinalysis by Dipstick | Day 4: Urine Blood (Negative) | 14 Participants |
| Cohort 2: DOVATO (DTG/3TC) Fed | Number of Participants With Abnormal Values on Urinalysis by Dipstick | Baseline (Day -1): Urine Blood (Trace) | 1 Participants |
| Cohort 2: DOVATO (DTG/3TC) Fed | Number of Participants With Abnormal Values on Urinalysis by Dipstick | Baseline (Day -1): Urine Blood (3+) | 0 Participants |
| Cohort 2: DOVATO (DTG/3TC) Fed | Number of Participants With Abnormal Values on Urinalysis by Dipstick | Baseline (Day -1): Urine Blood (2+) | 0 Participants |
| Cohort 2: DOVATO (DTG/3TC) Fed | Number of Participants With Abnormal Values on Urinalysis by Dipstick | Day 4: Urine Blood (Negative) | 16 Participants |
| Cohort 2: DOVATO (DTG/3TC) Fed | Number of Participants With Abnormal Values on Urinalysis by Dipstick | Day 4: Urine Blood (3+) | 0 Participants |
| Cohort 2: DOVATO (DTG/3TC) Fed | Number of Participants With Abnormal Values on Urinalysis by Dipstick | Day 4: Urine Blood (2+) | 0 Participants |
| Cohort 2: DOVATO (DTG/3TC) Fed | Number of Participants With Abnormal Values on Urinalysis by Dipstick | Day 4: Urine Ketones (Negative) | 16 Participants |
| Cohort 2: DOVATO (DTG/3TC) Fed | Number of Participants With Abnormal Values on Urinalysis by Dipstick | Day 4: Urine Ketones (1+) | 0 Participants |
| Cohort 2: DOVATO (DTG/3TC) Fed | Number of Participants With Abnormal Values on Urinalysis by Dipstick | Baseline (Day -1): Urine Ketones (Negative) | 17 Participants |
| Cohort 2: DOVATO (DTG/3TC) Fed | Number of Participants With Abnormal Values on Urinalysis by Dipstick | Baseline (Day -1): Urine Glucose (Negative) | 17 Participants |
| Cohort 2: DOVATO (DTG/3TC) Fed | Number of Participants With Abnormal Values on Urinalysis by Dipstick | Day 4: Urine Protein (Negative) | 16 Participants |
| Cohort 2: DOVATO (DTG/3TC) Fed | Number of Participants With Abnormal Values on Urinalysis by Dipstick | Day 4: Urine Glucose (Negative) | 16 Participants |
| Cohort 2: DOVATO (DTG/3TC) Fed | Number of Participants With Abnormal Values on Urinalysis by Dipstick | Baseline (Day -1): Urine Protein (Negative) | 17 Participants |
| Cohort 2: DOVATO (DTG/3TC) Fed | Number of Participants With Abnormal Values on Urinalysis by Dipstick | Baseline (Day -1): Urine Blood (Negative) | 16 Participants |
| Cohort 2: DOVATO (DTG/3TC) Fasted | Number of Participants With Abnormal Values on Urinalysis by Dipstick | Baseline (Day -1): Urine Ketones (Negative) | 16 Participants |
| Cohort 2: DOVATO (DTG/3TC) Fasted | Number of Participants With Abnormal Values on Urinalysis by Dipstick | Day 4: Urine Blood (Negative) | 15 Participants |
| Cohort 2: DOVATO (DTG/3TC) Fasted | Number of Participants With Abnormal Values on Urinalysis by Dipstick | Baseline (Day -1): Urine Blood (3+) | 0 Participants |
| Cohort 2: DOVATO (DTG/3TC) Fasted | Number of Participants With Abnormal Values on Urinalysis by Dipstick | Baseline (Day -1): Urine Glucose (Negative) | 16 Participants |
| Cohort 2: DOVATO (DTG/3TC) Fasted | Number of Participants With Abnormal Values on Urinalysis by Dipstick | Baseline (Day -1): Urine Blood (Negative) | 15 Participants |
| Cohort 2: DOVATO (DTG/3TC) Fasted | Number of Participants With Abnormal Values on Urinalysis by Dipstick | Baseline (Day -1): Urine Blood (2+) | 1 Participants |
| Cohort 2: DOVATO (DTG/3TC) Fasted | Number of Participants With Abnormal Values on Urinalysis by Dipstick | Day 4: Urine Blood (2+) | 0 Participants |
| Cohort 2: DOVATO (DTG/3TC) Fasted | Number of Participants With Abnormal Values on Urinalysis by Dipstick | Day 4: Urine Blood (3+) | 1 Participants |
| Cohort 2: DOVATO (DTG/3TC) Fasted | Number of Participants With Abnormal Values on Urinalysis by Dipstick | Baseline (Day -1): Urine Protein (Negative) | 16 Participants |
| Cohort 2: DOVATO (DTG/3TC) Fasted | Number of Participants With Abnormal Values on Urinalysis by Dipstick | Day 4: Urine Ketones (Negative) | 16 Participants |
| Cohort 2: DOVATO (DTG/3TC) Fasted | Number of Participants With Abnormal Values on Urinalysis by Dipstick | Baseline (Day -1): Urine Blood (Trace) | 0 Participants |
| Cohort 2: DOVATO (DTG/3TC) Fasted | Number of Participants With Abnormal Values on Urinalysis by Dipstick | Day 4: Urine Glucose (Negative) | 16 Participants |
| Cohort 2: DOVATO (DTG/3TC) Fasted | Number of Participants With Abnormal Values on Urinalysis by Dipstick | Day 4: Urine Ketones (1+) | 0 Participants |
| Cohort 2: DOVATO (DTG/3TC) Fasted | Number of Participants With Abnormal Values on Urinalysis by Dipstick | Day 4: Urine Protein (Negative) | 16 Participants |
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.
Time frame: Up to 23 days
Population: Safety Population consisted of all participants who received at least one dose of study intervention.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 1 Participants |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 0 Participants |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 0 Participants |
| Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 3 Participants |
| Cohort 2: DOVATO (DTG/3TC) Fed | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 1 Participants |
| Cohort 2: DOVATO (DTG/3TC) Fed | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 0 Participants |
| Cohort 2: DOVATO (DTG/3TC) Fasted | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 1 Participants |
| Cohort 2: DOVATO (DTG/3TC) Fasted | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 0 Participants |