HIV Infections
Conditions
Keywords
Dolutegravir, Rilpivirine, HIV infection, Fixed-dose combination, Japanese, Pharmacokinetics
Brief summary
Dolutegravir (DTG), a human immunodeficiency virus (HIV)-1 integrase inhibitor (INI), and Rilpivirine (RPV), a non-nucleoside HIV-1 reverse transcriptase inhibitor (NNRTI), are each approved in the United States (US), European Union, and other countries for the treatment of HIV-1 infection. JULUCA is a combination of Dolutegravir and Rilpivirine indicated for the treatment of HIV-1 infection in antiretroviral (ARV) experienced adult subjects who are switching from their current antiretroviral treatment to the 2-drug combination. Although, the pharmacokinetics (PK), safety and tolerability of DTG/RPV (50 milligram \[mg\]/25mg) fixed-dose combination (FDC) tablets have been extensively studied, these parameters have not been assessed exclusively in Japanese subjects. This study will evaluate the pharmacokinetics, safety and tolerability of a single dose DTG/RPV 50 mg/25 mg FDC in a healthy adult Japanese population to support a post-approval commitment for DTG/RPV 50 mg/25 mg FDC in Japan.
Interventions
DRUGJULUCA (Dolutegravir and Rilpivirine) 50mg/25mg FDC tablet
JULUCA tablets will be administered orally once daily with a meal. It will be available as a fixed dose combination of Dolutegravir 50mg and Rilpivirine 25mg.
Sponsors
Janssen, LP
ViiV Healthcare
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Subject must be 18 to 55 years of age, at the time of signing the informed consent * Subjects who were born in Japan with 4 ethnic Japanese grandparents. Subjects who have not lived outside Japan for more than 10 years and who are Japanese passport holders (current or expired) * Subjects who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring (history and electrocardiogram \[ECG\]) * Subjects with body weight \>=50 kilogram (kg) (110 pounds) for men and \>=45kg (99 pounds) for women and body mass index (BMI) within the range 18.5-31.0 kg per square meter (kg/m\^2) * Male or female subjects; Male subjects with no specific restrictions * A female subject is eligible to participate if she is not pregnant or breastfeeding, and not a woman of childbearing potential (WOCBP) * The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy * Subjects capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol
Exclusion criteria
* Subjects with history of current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention or interfering with the interpretation of data * Subjects with abnormal blood pressure (as determined by the investigator) * Subjects with alanine transaminase (ALT) \>1.5 times upper limit of normal (ULN) * Subjects with bilirubin \>1.5 times ULN (isolated bilirubin \>1.5 times ULN is acceptable if bilirubin is fractionated and direct bilirubin \<35%) * Subjects with current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones) * Subjects with QTcF \>460 millisecond (msec)(Based on the average of the 12-Lead-electrocardiogram (ECG) triplicate readings obtained at Screening) (Note: The QTc is the QT interval corrected for heart rate according to Fridericia's formula (QTcF), and/or another method, machine-read or manually over-read. The specific formula that will be used to determine eligibility and discontinuation for an individual subject should be determined prior to initiation of the study. In other words, several different formulae cannot be used to calculate the QTc for an individual subject and then the lowest QTc value used to include or discontinue the subject from the trial) * Subjects with past or intended use of over-the-counter or prescription medication including herbal medications within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to dosing. Acetaminophen, at doses of \<=2 grams per day, is allowed for use any time during the study * Participation in the study would result in loss of blood or blood products in excess of 500 milliliter (mL) within 56 days * Exposure to more than 4 new chemical entities within 12 months prior to the first dosing day * Current enrollment or past participation within the last 30 days before signing of consent in any other clinical study involving an investigational study intervention or any other type of medical research * Subjects with presence of Hepatitis B surface antigen (HBsAg) at screening or within 3 months prior to first dose of study intervention * Subjects with positive Hepatitis C antibody test result at screening or within 3 months prior to first dose of study intervention (Note: Subjects with positive Hepatitis C antibody due to prior resolved disease can be enrolled, only if a confirmatory negative Hepatitis C RNA test is obtained) * Subjects with positive Hepatitis C RNA test result at screening or within 3 months prior to first dose of study intervention (Note: Test is optional and subjects with negative Hepatitis C antibody test are not required to also undergo Hepatitis C RNA testing) * Subjects with positive pre-study drug or alcohol screen * Subjects with positive human immunodeficiency virus (HIV) antibody test * Subjects with regular use of known drugs of abuse * Subjects with creatinine clearance (CrCL) \<60 milliliter per minute * Employment with Janssen, ViiV, GlaxoSmithKline(GSK), or with the Investigator or study site, with direct involvement in the proposed study or other studies under the direction of that Investigator or study site, as well as family members of the employees or the Investigator * Subjects with urinary cotinine levels indicative of smoking or history or regular use of tobacco- or nicotine-containing products (e.g. nicotine patches or vaporizing devices) within 6 months prior to screening * Subjects with regular alcohol consumption within 6 months prior to the study defined as: An average weekly intake of \>14 units for males or \>7 units for females. One unit is equivalent to 8 gram of alcohol: a half-pint (approximately 240mL) of beer, 1 glass (125mL) of wine or 1 (25mL) measure of spirits * Subjects with sensitivity to heparin or heparin-induced thrombocytopenia * Subjects with sensitivity to any of the study interventions, or components thereof, or drug or other allergy that, in the opinion of the investigator or medical monitor, contraindicates participation in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area Under the Concentration (AUC) Time Curve From Time Zero Extrapolated to Infinite Time (AUC [0-infinity]) of DTG | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 12, 16, 24, 48, 72, and 120 hours post-dose | Blood samples were collected at indicated time-points for analysis of AUC (0-infinity) of DTG. PK parameters were calculated by standard non-compartmental analysis. |
| AUC (0-infinity) of RPV | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 12, 16, 24, 48, 72, 120, 168, 216, and 264 hours post-dose | Blood samples were collected at indicated time-points for analysis of AUC (0-infinity) of RPV. PK parameters were calculated by standard non-compartmental analysis. |
| Area Under the Concentration Time Curve From Time Zero to Last Time of Quantifiable Concentration (AUC [0-t]) of DTG | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 12, 16, 24, 48, 72, and 120 hours post-dose | Blood samples were collected at indicated time-points for analysis of AUC (0-t) of DTG. PK parameters were calculated by standard non-compartmental analysis. |
| AUC (0-t) of RPV | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 12, 16, 24, 48, 72, 120, 168, 216, and 264 hours post-dose | Blood samples were collected at indicated time-points for analysis of AUC (0-t) of RPV. PK parameters were calculated by standard non-compartmental analysis. |
| Maximum Observed Plasma Concentration (Cmax) of DTG | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 12, 16, 24, 48, 72, and 120 hours post-dose | Blood samples were collected at indicated time-points for analysis of Cmax of DTG. PK parameters were calculated by standard non-compartmental analysis. |
| Cmax of RPV | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 12, 16, 24, 48, 72, 120, 168, 216, and 264 hours post-dose | Blood samples were collected at indicated time-points for analysis of Cmax of RPV. PK parameters were calculated by standard non-compartmental analysis. |
| Absorption Lag Time (Tlag) of DTG | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 12, 16, 24, 48, 72, and 120 hours post-dose | Blood samples were collected at indicated time-points for analysis of tlag of DTG. PK parameters were calculated by standard non-compartmental analysis. |
| Tlag of RPV | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 12, 16, 24, 48, 72, 120, 168, 216, and 264 hours post-dose | Blood samples were collected at indicated time-points for analysis of tlag of RPV. PK parameters were calculated by standard non-compartmental analysis. |
| Time to Reach Maximum Observed Concentration (Tmax) of DTG | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 12, 16, 24, 48, 72, and 120 hours post-dose | Blood samples were collected at indicated time-points for analysis of tmax of DTG. PK parameters were calculated by standard non-compartmental analysis. |
| Tmax of RPV | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 12, 16, 24, 48, 72, 120, 168, 216, and 264 hours post-dose | Blood samples were collected at indicated time-points for analysis of tmax of RPV. PK parameters were calculated by standard non-compartmental analysis. |
| Time of Last Quantifiable Concentration (Tlast) of DTG | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 12, 16, 24, 48, 72, and 120 hours post-dose | Blood samples were collected at indicated time-points for analysis of tlast of DTG. PK parameters were calculated by standard non-compartmental analysis. |
| Tlast of RPV | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 12, 16, 24, 48, 72, 120, 168, 216, and 264 hours post-dose | Blood samples were collected at indicated time-points for analysis of tlast of RPV. PK parameters were calculated by standard non-compartmental analysis. |
| Elimination Half-life (t1/2) of DTG | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 12, 16, 24, 48, 72, and 120 hours post-dose | Blood samples were collected at indicated time-points for analysis of t1/2 of DTG. PK parameters were calculated by standard non-compartmental analysis. |
| T1/2 of RPV | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 12, 16, 24, 48, 72, 120, 168, 216, and 264 hours post-dose | Blood samples were collected at indicated time-points for analysis of t1/2 of RPV. PK parameters were calculated by standard non-compartmental analysis. |
| Apparent Elimination Rate Constant (Lambda z) of DTG | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 12, 16, 24, 48, 72, and 120 hours post-dose | Blood samples were collected at indicated time-points for analysis of lambda z of DTG. PK parameters were calculated by standard non-compartmental analysis. |
| Lambda z of RPV | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 12, 16, 24, 48, 72, 120, 168, 216, and 264 hours post-dose | Blood samples were collected at indicated time-points for analysis of lambda z of RPV. PK parameters were calculated by standard non-compartmental analysis. |
| Percentage of AUC(0-infinity) That Was Extrapolated (%AUCex) of DTG | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 12, 16, 24, 48, 72, and 120 hours post-dose | Blood samples were collected at indicated time-points for analysis of percentage AUCex of DTG. PK parameters were calculated by standard non-compartmental analysis. |
| Percentage AUCex of RPV | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 12, 16, 24, 48, 72, 120, 168, 216, and 264 hours post-dose | Blood samples were collected at indicated time-points for analysis of percentage AUCex of RPV. PK parameters were calculated by standard non-compartmental analysis. |
| Area Under the Plasma Concentration Time Curve From Time Zero to 24 Hours (AUC[0-24]) of DTG | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 12, 16, and 24 hours post-dose | Blood samples were collected at indicated time-points for analysis of AUC(0-24) of DTG. PK parameters were calculated by standard non-compartmental analysis. |
| AUC (0-24) of RPV | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 12, 16, and 24 hours post-dose | Blood samples were collected at indicated time-points for analysis of AUC (0-24) of RPV. PK parameters were calculated by standard non-compartmental analysis. |
| C24 of RPV | At 24 hours post-dose | Blood samples were collected at indicated time-points for analysis of C24 of RPV. PK parameters were calculated by standard non-compartmental analysis. |
| Area Under the Plasma Concentration Time Curve From Time Zero to 72 Hours (AUC[0-72]) of DTG | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 12, 16, 24, 48, and 72 hours post-dose | Blood samples were collected at indicated time-points for analysis of AUC(0-72) of DTG. PK parameters were calculated by standard non-compartmental analysis. |
| AUC (0-72) of RPV | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 12, 16, 24, 48 and 72 hours post-dose | Blood samples were collected at indicated time-points for analysis of AUC (0-72) of RPV. PK parameters were calculated by standard non-compartmental analysis. |
| Apparent Oral Clearance (CL/F) of DTG | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 12, 16, 24, 48, 72, and 120 hours post-dose | Blood samples were collected at indicated time-points for analysis of CL/F of DTG. PK parameters were calculated by standard non-compartmental analysis. |
| CL/F of RPV | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 12, 16, 24, 48, 72, 120, 168, 216, 264 hours post-dose | Blood samples were collected at indicated time-points for analysis of CL/F of RPV. PK parameters were calculated by standard non-compartmental analysis. |
| Apparent Oral Volume of Distribution (Vz/F) of DTG | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 12, 16, 24, 48, 72, and 120 hours post-dose | Blood samples were collected at indicated time-points for analysis of Vz/F of DTG. PK parameters were calculated by standard non-compartmental analysis. |
| Vz/F of RPV | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 12, 16, 24, 48, 72, 120, 168, 216, and 264 hours post-dose | Blood samples were collected at indicated time-points for analysis of Vz/F of RPV. PK parameters were calculated by standard non-compartmental analysis. |
| Last Quantifiable Concentration (Ct) of DTG | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 12, 16, 24, 48, 72, and 120 hours post-dose | Blood samples were collected at indicated time-points for analysis of Ct of DTG. PK parameters were calculated by standard non-compartmental analysis. |
| Ct of RPV | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 12, 16, 24, 48, 72, 120, 168, 216, and 264 hours post-dose | Blood samples were collected at indicated time-points for analysis of Ct of RPV. PK parameters were calculated by standard non-compartmental analysis. |
| Concentration at 24-hour Post-dose (C24) of DTG | At 24 hours post-dose | Blood samples were collected at indicated time-points for analysis of C24 of DTG. PK parameters were calculated by standard non-compartmental analysis. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) | Up to Day 18 | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. A SAE is defined as any untoward medical occurrence that, at any dose: results in death and is life-threatening; which requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent disability or incapacity and birth defect or congenital anomaly, or any other situation that require medical or scientific judgment. |
| Change From Baseline in Neutrophil, Lymphocyte, Leukocyte, Monocyte, Eosinophil, Basophil and Platelet Count | Baseline (Day -1) and Day 3 | Blood samples were collected at indicated time-points for analysis of hematology parameters like platelet count, neutrophils, lymphocytes, leukocyte, monocytes, eosinophils and basophils. Baseline was defined as Day -1. Change from Baseline was defined as post-dose visit value minus Baseline value. |
| Absolute Values of Neutrophil, Lymphocyte, Leukocyte, Monocyte, Eosinophil, Basophil and Platelet Count | Baseline (Day -1) and Day 3 | Blood samples were collected at indicated time-points for analysis of hematology parameters like platelet count, neutrophils, lymphocytes, monocytes, leukocyte, eosinophils and basophils. Baseline was defined as Day -1. |
| Change From Baseline in Hemoglobin Level | Baseline (Day -1) and Day 3 | Blood samples were collected at indicated timepoints for analysis of hematology parameter like hemoglobin. Baseline was defined as Day -1. Change from Baseline was defined as post-dose visit value minus Baseline value. |
| Absolute Values of Hemoglobin Level | Baseline (Day -1) and Day 3 | Blood samples were collected at indicated timepoints for analysis of hematology parameter like hemoglobin. Baseline was defined as Day -1. |
| Change From Baseline in Hematocrit Level | Baseline (Day -1) and Day 3 | Blood samples were collected at indicated timepoints for analysis of hematology parameter like hematocrit. Baseline was defined as Day -1. Change from Baseline was defined as post-dose visit value minus Baseline value. |
| Absolute Values of Hematocrit Level | Baseline (Day -1) and Day 3 | Blood samples were collected at indicated timepoints for analysis of hematology parameter like hematocrit. Baseline was defined as Day -1. |
| Change From Baseline in Erythrocytes | Baseline (Day -1) and Day 3 | Blood samples were collected at indicated timepoints for analysis of hematology parameter like erythrocytes. Baseline was defined as Day -1. Change from Baseline was defined as post-dose visit value minus Baseline value. |
| Absolute Values of Erythrocytes | Baseline (Day -1) and Day 3 | Blood samples were collected at indicated timepoints for analysis of hematology parameter like erythrocytes. Baseline was defined as Day -1. |
| Change From Baseline in Mean Corpuscular Hemoglobin (MCH) | Baseline (Day -1) and Day 3 | Blood samples were collected at indicated timepoints for analysis of hematology parameter like MCH. Baseline was defined as Day -1. Change from Baseline was defined as post-dose visit value minus Baseline value. |
| Absolute Values of MCH | Baseline (Day -1) and Day 3 | Blood samples were collected at indicated timepoints for analysis of hematology parameter like MCH. Baseline was defined as Day -1. |
| Change From Baseline in Mean Corpuscular Volume (MCV) | Baseline (Day -1) and Day 3 | Blood samples were collected at indicated timepoints for analysis of hematology parameter like MCV. Baseline was defined as Day -1. Change from Baseline was defined as post-dose visit value minus Baseline value. |
| Absolute Values of MCV | Baseline (Day -1) and Day 3 | Blood samples were collected at indicated timepoints for analysis of hematology parameter like MCV. Baseline was defined as Day -1. |
| Change From Baseline in Reticulocytes | Baseline (Day -1) and Day 3 | Blood samples were collected at indicated timepoints for analysis of hematology parameter like reticulocytes. Baseline was defined as Day -1. Change from Baseline was defined as post-dose visit value minus Baseline value. |
| Absolute Values of Reticulocytes | Baseline (Day -1) and Day 3 | Blood samples were collected at indicated timepoints for analysis of hematology parameter like reticulocytes. Baseline was defined as Day -1. |
| Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Sodium, and Potassium Levels | Baseline (Day -1) and Day 3 | Blood samples were collected at indicated time-points for analysis of clinical chemistry parameters like (BUN), glucose, sodium, calcium, and potassium levels. Baseline was defined as Day -1. Change from Baseline was defined as post-dose visit value minus Baseline value. |
| Absolute Values of BUN, Glucose, Calcium, Sodium, and Potassium Levels | Baseline (Day -1) and Day 3 | Blood samples were collected at indicated time-points for analysis of clinical chemistry parameters like (BUN), glucose, sodium, calcium, and potassium levels. Baseline was defined as Day -1. |
| Change From Baseline in Total and Direct Bilirubin, Creatinine and Protein Levels | Baseline (Day -1) and Day 3 | Blood samples were collected at indicated time-points for analysis of clinical chemistry parameters like total and direct bilirubin, creatinine and protein levels. Baseline was defined as Day -1. Change from Baseline was defined as post-dose visit value minus Baseline value. |
| Absolute Values of Total and Direct Bilirubin, Creatinine and Protein Levels | Baseline (Day -1) and Day 3 | Blood samples were collected at indicated time-points for analysis of clinical chemistry parameters like total and direct bilirubin, creatinine and protein levels. Baseline was defined as Day -1. |
| Change From Baseline in Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Alkaline Phosphatase (ALP) Levels | Baseline (Day -1) and Day 3 | Blood samples were collected at indicated time-points for analysis of clinical chemistry parameters like AST, ALT and ALP levels. Baseline was defined as Day -1. Change from Baseline was defined as post-dose visit value minus Baseline value. |
| Absolute Values of AST, ALT and ALP Levels | Baseline (Day -1) and Day 3 | Blood samples were collected at indicated time-points for analysis of clinical chemistry parameters like AST, ALT and ALP levels. Baseline was defined as Day -1. |
| Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Baseline (Day 1, Pre-dose) and at Day 12 | SBP and DBP were assessed in the supine position with a completely automated device. Day 1 (Pre-dose) was defined as Baseline. Change from Baseline was defined as post-dose visit value minus Baseline value. |
| Absolute Values of SBP and DBP | Baseline (Day 1, Pre-dose) and at Day 12 | SBP and DBP were assessed in the supine position with a completely automated device. Day 1 (Pre-dose) was defined as Baseline. |
| Change From Baseline in Pulse Rate | Baseline (Day 1, Pre-dose) and at Day 12 | Pulse rate was assessed in the supine position with a completely automated device. Day 1 (Pre-dose) was defined as Baseline. Change from Baseline was defined as post-dose visit value minus Baseline value. |
| Absolute Values of Pulse Rate | Baseline (Day 1, Pre-dose) and at Day 12 | Pulse rate was assessed in the supine position with a completely automated device. Day 1 (Pre-dose) was defined as Baseline. |
| Change From Baseline in Body Temperature | Baseline (Day 1, Pre-dose) and at Day 12 | Body temperature were assessed at indicated time-points. Day 1 (Pre-dose) was defined as Baseline. Change from Baseline was defined as post-dose visit value minus Baseline value. |
| Absolute Values of Body Temperature | Baseline (Day 1, Pre-dose) and at Day 12 | Body temperature were assessed at indicated time-points. Day 1 (Pre-dose) was defined as Baseline. |
Countries
United States
Participant flow
Recruitment details
The was a single dose, open-label study in healthy Japanese participants for the evaluation of pharmacokinetics (PK), safety and tolerability of fixed dose combination (FDC) tablet of Dolutegravir (DTG)/Rilpivirine (RPV) 50 milligrams (mg)/ 25 mg
Pre-assignment details
A total of 16 participants were enrolled in the study
Participants by arm
| Arm | Count |
|---|---|
| DTG/RPV 50mg/25mg FDC Healthy participants were administered single oral FDC tablet of DTG/RPV 50mg/25mg on Day 1 in fed state | 16 |
| Total | 16 |
Baseline characteristics
| Characteristic | DTG/RPV 50mg/25mg FDC |
|---|---|
| Age, Continuous | 41.6 Years STANDARD_DEVIATION 9.69 |
| Race/Ethnicity, Customized Japanese Heritage/East Asian | 16 Participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 16 |
| other Total, other adverse events | 2 / 16 |
| serious Total, serious adverse events | 0 / 16 |
Outcome results
Primary
Absorption Lag Time (Tlag) of DTG
Blood samples were collected at indicated time-points for analysis of tlag of DTG. PK parameters were calculated by standard non-compartmental analysis.
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 12, 16, 24, 48, 72, and 120 hours post-dose
Population: PK Population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| DTG/RPV 50mg/25mg FDC | Absorption Lag Time (Tlag) of DTG | 0.0 Hours |
Primary
Apparent Elimination Rate Constant (Lambda z) of DTG
Blood samples were collected at indicated time-points for analysis of lambda z of DTG. PK parameters were calculated by standard non-compartmental analysis.
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 12, 16, 24, 48, 72, and 120 hours post-dose
Population: PK Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DTG/RPV 50mg/25mg FDC | Apparent Elimination Rate Constant (Lambda z) of DTG | 0.0405 Per hour | Standard Deviation 0.00604 |
Primary
Apparent Oral Clearance (CL/F) of DTG
Blood samples were collected at indicated time-points for analysis of CL/F of DTG. PK parameters were calculated by standard non-compartmental analysis.
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 12, 16, 24, 48, 72, and 120 hours post-dose
Population: PK Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| DTG/RPV 50mg/25mg FDC | Apparent Oral Clearance (CL/F) of DTG | 0.5498 Liters per hour | Geometric Coefficient of Variation 26.2 |
Primary
Apparent Oral Volume of Distribution (Vz/F) of DTG
Blood samples were collected at indicated time-points for analysis of Vz/F of DTG. PK parameters were calculated by standard non-compartmental analysis.
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 12, 16, 24, 48, 72, and 120 hours post-dose
Population: PK Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DTG/RPV 50mg/25mg FDC | Apparent Oral Volume of Distribution (Vz/F) of DTG | 14.0079 Liters | Standard Deviation 2.8138 |
Primary
Area Under the Concentration (AUC) Time Curve From Time Zero Extrapolated to Infinite Time (AUC [0-infinity]) of DTG
Blood samples were collected at indicated time-points for analysis of AUC (0-infinity) of DTG. PK parameters were calculated by standard non-compartmental analysis.
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 12, 16, 24, 48, 72, and 120 hours post-dose
Population: PK Population included all participants in the Safety Population (participants who were enrolled in the study and received at least one dose of study drug) for whom a PK sample was obtained and had evaluable PK assay results.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| DTG/RPV 50mg/25mg FDC | Area Under the Concentration (AUC) Time Curve From Time Zero Extrapolated to Infinite Time (AUC [0-infinity]) of DTG | 90.9402 Hours*micrograms per milliliter | Geometric Coefficient of Variation 26.2 |
Primary
Area Under the Concentration Time Curve From Time Zero to Last Time of Quantifiable Concentration (AUC [0-t]) of DTG
Blood samples were collected at indicated time-points for analysis of AUC (0-t) of DTG. PK parameters were calculated by standard non-compartmental analysis.
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 12, 16, 24, 48, 72, and 120 hours post-dose
Population: PK Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| DTG/RPV 50mg/25mg FDC | Area Under the Concentration Time Curve From Time Zero to Last Time of Quantifiable Concentration (AUC [0-t]) of DTG | 89.1993 Hours*micrograms per milliliter | Geometric Coefficient of Variation 26.8 |
Primary
Area Under the Plasma Concentration Time Curve From Time Zero to 24 Hours (AUC[0-24]) of DTG
Blood samples were collected at indicated time-points for analysis of AUC(0-24) of DTG. PK parameters were calculated by standard non-compartmental analysis.
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 12, 16, and 24 hours post-dose
Population: PK Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| DTG/RPV 50mg/25mg FDC | Area Under the Plasma Concentration Time Curve From Time Zero to 24 Hours (AUC[0-24]) of DTG | 54.9466 Hours*micrograms per milliliter | Geometric Coefficient of Variation 20.4 |
Primary
Area Under the Plasma Concentration Time Curve From Time Zero to 72 Hours (AUC[0-72]) of DTG
Blood samples were collected at indicated time-points for analysis of AUC(0-72) of DTG. PK parameters were calculated by standard non-compartmental analysis.
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 12, 16, 24, 48, and 72 hours post-dose
Population: PK Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| DTG/RPV 50mg/25mg FDC | Area Under the Plasma Concentration Time Curve From Time Zero to 72 Hours (AUC[0-72]) of DTG | 85.3534 Hours*micrograms per milliliter | Geometric Coefficient of Variation 24.3 |
Primary
AUC (0-24) of RPV
Blood samples were collected at indicated time-points for analysis of AUC (0-24) of RPV. PK parameters were calculated by standard non-compartmental analysis.
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 12, 16, and 24 hours post-dose
Population: PK Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| DTG/RPV 50mg/25mg FDC | AUC (0-24) of RPV | 1420.2525 Hours*nanograms per milliliter | Geometric Coefficient of Variation 24.8 |
Primary
AUC (0-72) of RPV
Blood samples were collected at indicated time-points for analysis of AUC (0-72) of RPV. PK parameters were calculated by standard non-compartmental analysis.
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 12, 16, 24, 48 and 72 hours post-dose
Population: PK Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| DTG/RPV 50mg/25mg FDC | AUC (0-72) of RPV | 2886.6035 Hours*nanograms per milliliter | Geometric Coefficient of Variation 22.7 |
Primary
AUC (0-infinity) of RPV
Blood samples were collected at indicated time-points for analysis of AUC (0-infinity) of RPV. PK parameters were calculated by standard non-compartmental analysis.
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 12, 16, 24, 48, 72, 120, 168, 216, and 264 hours post-dose
Population: PK Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| DTG/RPV 50mg/25mg FDC | AUC (0-infinity) of RPV | 4027.9415 Hours*nanogram per milliliter | Geometric Coefficient of Variation 29 |
Primary
AUC (0-t) of RPV
Blood samples were collected at indicated time-points for analysis of AUC (0-t) of RPV. PK parameters were calculated by standard non-compartmental analysis.
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 12, 16, 24, 48, 72, 120, 168, 216, and 264 hours post-dose
Population: PK Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| DTG/RPV 50mg/25mg FDC | AUC (0-t) of RPV | 3920.9404 Hours*nanogram per milliliter | Geometric Coefficient of Variation 29.1 |
Primary
C24 of RPV
Blood samples were collected at indicated time-points for analysis of C24 of RPV. PK parameters were calculated by standard non-compartmental analysis.
Time frame: At 24 hours post-dose
Population: PK Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| DTG/RPV 50mg/25mg FDC | C24 of RPV | 43.35 Nanograms per milliliter | Geometric Coefficient of Variation 22.1 |
Primary
CL/F of RPV
Blood samples were collected at indicated time-points for analysis of CL/F of RPV. PK parameters were calculated by standard non-compartmental analysis.
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 12, 16, 24, 48, 72, 120, 168, 216, 264 hours post-dose
Population: PK Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| DTG/RPV 50mg/25mg FDC | CL/F of RPV | 6.2066 Liters per hour | Geometric Coefficient of Variation 29 |
Primary
Cmax of RPV
Blood samples were collected at indicated time-points for analysis of Cmax of RPV. PK parameters were calculated by standard non-compartmental analysis.
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 12, 16, 24, 48, 72, 120, 168, 216, and 264 hours post-dose
Population: PK Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| DTG/RPV 50mg/25mg FDC | Cmax of RPV | 136.10 Nanogram per milliliter | Geometric Coefficient of Variation 34.3 |
Primary
Concentration at 24-hour Post-dose (C24) of DTG
Blood samples were collected at indicated time-points for analysis of C24 of DTG. PK parameters were calculated by standard non-compartmental analysis.
Time frame: At 24 hours post-dose
Population: PK Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| DTG/RPV 50mg/25mg FDC | Concentration at 24-hour Post-dose (C24) of DTG | 1453.6 Nanograms per milliliter | Geometric Coefficient of Variation 25.6 |
Primary
Ct of RPV
Blood samples were collected at indicated time-points for analysis of Ct of RPV. PK parameters were calculated by standard non-compartmental analysis.
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 12, 16, 24, 48, 72, 120, 168, 216, and 264 hours post-dose
Population: PK Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| DTG/RPV 50mg/25mg FDC | Ct of RPV | 1.836 Nanograms per milliliter | Geometric Coefficient of Variation 30.4 |
Primary
Elimination Half-life (t1/2) of DTG
Blood samples were collected at indicated time-points for analysis of t1/2 of DTG. PK parameters were calculated by standard non-compartmental analysis.
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 12, 16, 24, 48, 72, and 120 hours post-dose
Population: PK Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| DTG/RPV 50mg/25mg FDC | Elimination Half-life (t1/2) of DTG | 17.3135 Hours | Geometric Coefficient of Variation 15.6 |
Primary
Lambda z of RPV
Blood samples were collected at indicated time-points for analysis of lambda z of RPV. PK parameters were calculated by standard non-compartmental analysis.
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 12, 16, 24, 48, 72, 120, 168, 216, and 264 hours post-dose
Population: PK Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DTG/RPV 50mg/25mg FDC | Lambda z of RPV | 0.0196 Per hour | Standard Deviation 0.00674 |
Primary
Last Quantifiable Concentration (Ct) of DTG
Blood samples were collected at indicated time-points for analysis of Ct of DTG. PK parameters were calculated by standard non-compartmental analysis.
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 12, 16, 24, 48, 72, and 120 hours post-dose
Population: PK Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| DTG/RPV 50mg/25mg FDC | Last Quantifiable Concentration (Ct) of DTG | 54.59 Nanograms per milliliter | Geometric Coefficient of Variation 82.1 |
Primary
Maximum Observed Plasma Concentration (Cmax) of DTG
Blood samples were collected at indicated time-points for analysis of Cmax of DTG. PK parameters were calculated by standard non-compartmental analysis.
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 12, 16, 24, 48, 72, and 120 hours post-dose
Population: PK Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| DTG/RPV 50mg/25mg FDC | Maximum Observed Plasma Concentration (Cmax) of DTG | 4108.5 Nanograms per milliliter | Geometric Coefficient of Variation 15 |
Primary
Percentage AUCex of RPV
Blood samples were collected at indicated time-points for analysis of percentage AUCex of RPV. PK parameters were calculated by standard non-compartmental analysis.
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 12, 16, 24, 48, 72, 120, 168, 216, and 264 hours post-dose
Population: PK Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DTG/RPV 50mg/25mg FDC | Percentage AUCex of RPV | 2.6501 Percentage of AUCex | Standard Deviation 1.14962 |
Primary
Percentage of AUC(0-infinity) That Was Extrapolated (%AUCex) of DTG
Blood samples were collected at indicated time-points for analysis of percentage AUCex of DTG. PK parameters were calculated by standard non-compartmental analysis.
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 12, 16, 24, 48, 72, and 120 hours post-dose
Population: PK Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DTG/RPV 50mg/25mg FDC | Percentage of AUC(0-infinity) That Was Extrapolated (%AUCex) of DTG | 1.9065 Percentage of AUCex | Standard Deviation 1.28407 |
Primary
T1/2 of RPV
Blood samples were collected at indicated time-points for analysis of t1/2 of RPV. PK parameters were calculated by standard non-compartmental analysis.
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 12, 16, 24, 48, 72, 120, 168, 216, and 264 hours post-dose
Population: PK Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| DTG/RPV 50mg/25mg FDC | T1/2 of RPV | 37.2571 Hours | Geometric Coefficient of Variation 33.7 |
Primary
Time of Last Quantifiable Concentration (Tlast) of DTG
Blood samples were collected at indicated time-points for analysis of tlast of DTG. PK parameters were calculated by standard non-compartmental analysis.
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 12, 16, 24, 48, 72, and 120 hours post-dose
Population: PK Population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| DTG/RPV 50mg/25mg FDC | Time of Last Quantifiable Concentration (Tlast) of DTG | 120.0854 Hours |
Primary
Time to Reach Maximum Observed Concentration (Tmax) of DTG
Blood samples were collected at indicated time-points for analysis of tmax of DTG. PK parameters were calculated by standard non-compartmental analysis.
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 12, 16, 24, 48, 72, and 120 hours post-dose
Population: PK Population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| DTG/RPV 50mg/25mg FDC | Time to Reach Maximum Observed Concentration (Tmax) of DTG | 3.0085 Hours |
Primary
Tlag of RPV
Blood samples were collected at indicated time-points for analysis of tlag of RPV. PK parameters were calculated by standard non-compartmental analysis.
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 12, 16, 24, 48, 72, 120, 168, 216, and 264 hours post-dose
Population: PK Population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| DTG/RPV 50mg/25mg FDC | Tlag of RPV | 0.5 Hours |
Primary
Tlast of RPV
Blood samples were collected at indicated time-points for analysis of tlast of RPV. PK parameters were calculated by standard non-compartmental analysis.
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 12, 16, 24, 48, 72, 120, 168, 216, and 264 hours post-dose
Population: PK Population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| DTG/RPV 50mg/25mg FDC | Tlast of RPV | 214.5819 Hours |
Primary
Tmax of RPV
Blood samples were collected at indicated time-points for analysis of tmax of RPV. PK parameters were calculated by standard non-compartmental analysis.
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 12, 16, 24, 48, 72, 120, 168, 216, and 264 hours post-dose
Population: PK Population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| DTG/RPV 50mg/25mg FDC | Tmax of RPV | 4.4976 Hours |
Primary
Vz/F of RPV
Blood samples were collected at indicated time-points for analysis of Vz/F of RPV. PK parameters were calculated by standard non-compartmental analysis.
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 12, 16, 24, 48, 72, 120, 168, 216, and 264 hours post-dose
Population: PK Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DTG/RPV 50mg/25mg FDC | Vz/F of RPV | 347.3276 Liters | Standard Deviation 99.96058 |
Secondary
Absolute Values of AST, ALT and ALP Levels
Blood samples were collected at indicated time-points for analysis of clinical chemistry parameters like AST, ALT and ALP levels. Baseline was defined as Day -1.
Time frame: Baseline (Day -1) and Day 3
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DTG/RPV 50mg/25mg FDC | Absolute Values of AST, ALT and ALP Levels | ALP, Day 3 | 53.1 International units per Liter | Standard Deviation 11.24 |
| DTG/RPV 50mg/25mg FDC | Absolute Values of AST, ALT and ALP Levels | ALT, Baseline (Day -1) | 19.4 International units per Liter | Standard Deviation 7.2 |
| DTG/RPV 50mg/25mg FDC | Absolute Values of AST, ALT and ALP Levels | ALT, Day 3 | 22.6 International units per Liter | Standard Deviation 11.51 |
| DTG/RPV 50mg/25mg FDC | Absolute Values of AST, ALT and ALP Levels | AST, Baseline (Day -1) | 17.9 International units per Liter | Standard Deviation 3.72 |
| DTG/RPV 50mg/25mg FDC | Absolute Values of AST, ALT and ALP Levels | AST, Day 3 | 18.5 International units per Liter | Standard Deviation 4.41 |
| DTG/RPV 50mg/25mg FDC | Absolute Values of AST, ALT and ALP Levels | ALP, Baseline (Day -1) | 52.3 International units per Liter | Standard Deviation 11.57 |
Secondary
Absolute Values of Body Temperature
Body temperature were assessed at indicated time-points. Day 1 (Pre-dose) was defined as Baseline.
Time frame: Baseline (Day 1, Pre-dose) and at Day 12
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DTG/RPV 50mg/25mg FDC | Absolute Values of Body Temperature | Day 1, Pre-dose | 36.16 Degree Celsius | Standard Deviation 0.271 |
| DTG/RPV 50mg/25mg FDC | Absolute Values of Body Temperature | Day 12 | 36.21 Degree Celsius | Standard Deviation 0.443 |
Secondary
Absolute Values of BUN, Glucose, Calcium, Sodium, and Potassium Levels
Blood samples were collected at indicated time-points for analysis of clinical chemistry parameters like (BUN), glucose, sodium, calcium, and potassium levels. Baseline was defined as Day -1.
Time frame: Baseline (Day -1) and Day 3
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DTG/RPV 50mg/25mg FDC | Absolute Values of BUN, Glucose, Calcium, Sodium, and Potassium Levels | BUN, Baseline (Day -1) | 4.1948 Millimoles per Liter | Standard Deviation 1.01395 |
| DTG/RPV 50mg/25mg FDC | Absolute Values of BUN, Glucose, Calcium, Sodium, and Potassium Levels | BUN, Day 3 | 4.4848 Millimoles per Liter | Standard Deviation 0.99251 |
| DTG/RPV 50mg/25mg FDC | Absolute Values of BUN, Glucose, Calcium, Sodium, and Potassium Levels | Calcium, Baseline (Day -1) | 2.3079 Millimoles per Liter | Standard Deviation 0.08098 |
| DTG/RPV 50mg/25mg FDC | Absolute Values of BUN, Glucose, Calcium, Sodium, and Potassium Levels | Potassium, Baseline (Day -1) | 4.18 Millimoles per Liter | Standard Deviation 0.284 |
| DTG/RPV 50mg/25mg FDC | Absolute Values of BUN, Glucose, Calcium, Sodium, and Potassium Levels | Calcium, Day 3 | 2.3562 Millimoles per Liter | Standard Deviation 0.0644 |
| DTG/RPV 50mg/25mg FDC | Absolute Values of BUN, Glucose, Calcium, Sodium, and Potassium Levels | Glucose, Baseline (Day -1) | 5.5163 Millimoles per Liter | Standard Deviation 0.40684 |
| DTG/RPV 50mg/25mg FDC | Absolute Values of BUN, Glucose, Calcium, Sodium, and Potassium Levels | Glucose, Day 3 | 5.3255 Millimoles per Liter | Standard Deviation 0.39014 |
| DTG/RPV 50mg/25mg FDC | Absolute Values of BUN, Glucose, Calcium, Sodium, and Potassium Levels | Potassium, Day 3 | 4.19 Millimoles per Liter | Standard Deviation 0.124 |
| DTG/RPV 50mg/25mg FDC | Absolute Values of BUN, Glucose, Calcium, Sodium, and Potassium Levels | Sodium, Baseline (Day -1) | 137.1 Millimoles per Liter | Standard Deviation 1.88 |
| DTG/RPV 50mg/25mg FDC | Absolute Values of BUN, Glucose, Calcium, Sodium, and Potassium Levels | Sodium, Day 3 | 139.8 Millimoles per Liter | Standard Deviation 2.37 |
Secondary
Absolute Values of Erythrocytes
Blood samples were collected at indicated timepoints for analysis of hematology parameter like erythrocytes. Baseline was defined as Day -1.
Time frame: Baseline (Day -1) and Day 3
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DTG/RPV 50mg/25mg FDC | Absolute Values of Erythrocytes | Baseline (Day -1) | 4.688 Trillion cells per liter | Standard Deviation 0.5299 |
| DTG/RPV 50mg/25mg FDC | Absolute Values of Erythrocytes | Day 3 | 5.046 Trillion cells per liter | Standard Deviation 0.4994 |
Secondary
Absolute Values of Hematocrit Level
Blood samples were collected at indicated timepoints for analysis of hematology parameter like hematocrit. Baseline was defined as Day -1.
Time frame: Baseline (Day -1) and Day 3
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DTG/RPV 50mg/25mg FDC | Absolute Values of Hematocrit Level | Baseline (Day -1) | 0.4248 Proportion of red blood cells in blood | Standard Deviation 0.0406 |
| DTG/RPV 50mg/25mg FDC | Absolute Values of Hematocrit Level | Day 3 | 0.4556 Proportion of red blood cells in blood | Standard Deviation 0.04087 |
Secondary
Absolute Values of Hemoglobin Level
Blood samples were collected at indicated timepoints for analysis of hematology parameter like hemoglobin. Baseline was defined as Day -1.
Time frame: Baseline (Day -1) and Day 3
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DTG/RPV 50mg/25mg FDC | Absolute Values of Hemoglobin Level | Baseline (Day -1) | 140.9 Grams per liter | Standard Deviation 15.92 |
| DTG/RPV 50mg/25mg FDC | Absolute Values of Hemoglobin Level | Day 3 | 151.0 Grams per liter | Standard Deviation 15.19 |
Secondary
Absolute Values of MCH
Blood samples were collected at indicated timepoints for analysis of hematology parameter like MCH. Baseline was defined as Day -1.
Time frame: Baseline (Day -1) and Day 3
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DTG/RPV 50mg/25mg FDC | Absolute Values of MCH | Baseline (Day -1) | 30.04 Picograms | Standard Deviation 1.288 |
| DTG/RPV 50mg/25mg FDC | Absolute Values of MCH | Day 3 | 29.94 Picograms | Standard Deviation 1.275 |
Secondary
Absolute Values of MCV
Blood samples were collected at indicated timepoints for analysis of hematology parameter like MCV. Baseline was defined as Day -1.
Time frame: Baseline (Day -1) and Day 3
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DTG/RPV 50mg/25mg FDC | Absolute Values of MCV | Baseline (Day -1) | 90.87 Femtoliters | Standard Deviation 3.593 |
| DTG/RPV 50mg/25mg FDC | Absolute Values of MCV | Day 3 | 90.44 Femtoliters | Standard Deviation 3.522 |
Secondary
Absolute Values of Neutrophil, Lymphocyte, Leukocyte, Monocyte, Eosinophil, Basophil and Platelet Count
Blood samples were collected at indicated time-points for analysis of hematology parameters like platelet count, neutrophils, lymphocytes, monocytes, leukocyte, eosinophils and basophils. Baseline was defined as Day -1.
Time frame: Baseline (Day -1) and Day 3
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DTG/RPV 50mg/25mg FDC | Absolute Values of Neutrophil, Lymphocyte, Leukocyte, Monocyte, Eosinophil, Basophil and Platelet Count | Basophils, Day 3 | 0.01 Giga cells per liter | Standard Deviation 0.034 |
| DTG/RPV 50mg/25mg FDC | Absolute Values of Neutrophil, Lymphocyte, Leukocyte, Monocyte, Eosinophil, Basophil and Platelet Count | Eosinophils, Baseline (Day -1) | 0.20 Giga cells per liter | Standard Deviation 0.11 |
| DTG/RPV 50mg/25mg FDC | Absolute Values of Neutrophil, Lymphocyte, Leukocyte, Monocyte, Eosinophil, Basophil and Platelet Count | Basophils, Baseline (Day -1) | 0.04 Giga cells per liter | Standard Deviation 0.05 |
| DTG/RPV 50mg/25mg FDC | Absolute Values of Neutrophil, Lymphocyte, Leukocyte, Monocyte, Eosinophil, Basophil and Platelet Count | Eosinophils, Day 3 | 0.16 Giga cells per liter | Standard Deviation 0.063 |
| DTG/RPV 50mg/25mg FDC | Absolute Values of Neutrophil, Lymphocyte, Leukocyte, Monocyte, Eosinophil, Basophil and Platelet Count | Leukocytes, Baseline (Day -1) | 5.76 Giga cells per liter | Standard Deviation 1.238 |
| DTG/RPV 50mg/25mg FDC | Absolute Values of Neutrophil, Lymphocyte, Leukocyte, Monocyte, Eosinophil, Basophil and Platelet Count | Leukocytes, Day 3 | 5.59 Giga cells per liter | Standard Deviation 1.433 |
| DTG/RPV 50mg/25mg FDC | Absolute Values of Neutrophil, Lymphocyte, Leukocyte, Monocyte, Eosinophil, Basophil and Platelet Count | Lymphocytes, Baseline (Day -1) | 1.84 Giga cells per liter | Standard Deviation 0.407 |
| DTG/RPV 50mg/25mg FDC | Absolute Values of Neutrophil, Lymphocyte, Leukocyte, Monocyte, Eosinophil, Basophil and Platelet Count | Lymphocytes, Day 3 | 1.82 Giga cells per liter | Standard Deviation 0.565 |
| DTG/RPV 50mg/25mg FDC | Absolute Values of Neutrophil, Lymphocyte, Leukocyte, Monocyte, Eosinophil, Basophil and Platelet Count | Monocytes, Baseline (Day -1) | 0.45 Giga cells per liter | Standard Deviation 0.126 |
| DTG/RPV 50mg/25mg FDC | Absolute Values of Neutrophil, Lymphocyte, Leukocyte, Monocyte, Eosinophil, Basophil and Platelet Count | Monocytes, Day 3 | 0.41 Giga cells per liter | Standard Deviation 0.141 |
| DTG/RPV 50mg/25mg FDC | Absolute Values of Neutrophil, Lymphocyte, Leukocyte, Monocyte, Eosinophil, Basophil and Platelet Count | Platelets, Baseline (Day -1) | 233.3 Giga cells per liter | Standard Deviation 43.24 |
| DTG/RPV 50mg/25mg FDC | Absolute Values of Neutrophil, Lymphocyte, Leukocyte, Monocyte, Eosinophil, Basophil and Platelet Count | Platelets, Day 3 | 238.6 Giga cells per liter | Standard Deviation 47.88 |
| DTG/RPV 50mg/25mg FDC | Absolute Values of Neutrophil, Lymphocyte, Leukocyte, Monocyte, Eosinophil, Basophil and Platelet Count | Neutrophils, Baseline (Day -1) | 3.21 Giga cells per liter | Standard Deviation 0.973 |
| DTG/RPV 50mg/25mg FDC | Absolute Values of Neutrophil, Lymphocyte, Leukocyte, Monocyte, Eosinophil, Basophil and Platelet Count | Neutrophils, Day 3 | 3.16 Giga cells per liter | Standard Deviation 1.001 |
Secondary
Absolute Values of Pulse Rate
Pulse rate was assessed in the supine position with a completely automated device. Day 1 (Pre-dose) was defined as Baseline.
Time frame: Baseline (Day 1, Pre-dose) and at Day 12
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DTG/RPV 50mg/25mg FDC | Absolute Values of Pulse Rate | Day 1, Pre-dose | 58.0 Beats per minute | Standard Deviation 9.87 |
| DTG/RPV 50mg/25mg FDC | Absolute Values of Pulse Rate | Day 12 | 66.7 Beats per minute | Standard Deviation 10 |
Secondary
Absolute Values of Reticulocytes
Blood samples were collected at indicated timepoints for analysis of hematology parameter like reticulocytes. Baseline was defined as Day -1.
Time frame: Baseline (Day -1) and Day 3
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DTG/RPV 50mg/25mg FDC | Absolute Values of Reticulocytes | Baseline (Day -1) | 1.47 Percentage of reticulocytes | Standard Deviation 0.46 |
| DTG/RPV 50mg/25mg FDC | Absolute Values of Reticulocytes | Day 3 | 1.59 Percentage of reticulocytes | Standard Deviation 0.491 |
Secondary
Absolute Values of SBP and DBP
SBP and DBP were assessed in the supine position with a completely automated device. Day 1 (Pre-dose) was defined as Baseline.
Time frame: Baseline (Day 1, Pre-dose) and at Day 12
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DTG/RPV 50mg/25mg FDC | Absolute Values of SBP and DBP | SBP, Day 1, Pre-dose | 107.0 Millimeters of mercury | Standard Deviation 7.43 |
| DTG/RPV 50mg/25mg FDC | Absolute Values of SBP and DBP | DBP, Day 1, Pre-dose | 70.1 Millimeters of mercury | Standard Deviation 7.58 |
| DTG/RPV 50mg/25mg FDC | Absolute Values of SBP and DBP | SBP, Day 12 | 113.2 Millimeters of mercury | Standard Deviation 10.89 |
| DTG/RPV 50mg/25mg FDC | Absolute Values of SBP and DBP | DBP, Day 12 | 71.7 Millimeters of mercury | Standard Deviation 11.29 |
Secondary
Absolute Values of Total and Direct Bilirubin, Creatinine and Protein Levels
Blood samples were collected at indicated time-points for analysis of clinical chemistry parameters like total and direct bilirubin, creatinine and protein levels. Baseline was defined as Day -1.
Time frame: Baseline (Day -1) and Day 3
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DTG/RPV 50mg/25mg FDC | Absolute Values of Total and Direct Bilirubin, Creatinine and Protein Levels | Creatinine, Day 3 | 83.0408 Micromoles per liter | Standard Deviation 13.2087 |
| DTG/RPV 50mg/25mg FDC | Absolute Values of Total and Direct Bilirubin, Creatinine and Protein Levels | Protein, Baseline (Day -1) | 66.6 Micromoles per liter | Standard Deviation 3.63 |
| DTG/RPV 50mg/25mg FDC | Absolute Values of Total and Direct Bilirubin, Creatinine and Protein Levels | Total bilirubin, Baseline (Day -1) | 11.008 Micromoles per liter | Standard Deviation 4.3694 |
| DTG/RPV 50mg/25mg FDC | Absolute Values of Total and Direct Bilirubin, Creatinine and Protein Levels | Total bilirubin, Day 3 | 14.963 Micromoles per liter | Standard Deviation 5.2054 |
| DTG/RPV 50mg/25mg FDC | Absolute Values of Total and Direct Bilirubin, Creatinine and Protein Levels | Direct bilirubin, Baseline (Day -1) | 2.565 Micromoles per liter | Standard Deviation 1.2488 |
| DTG/RPV 50mg/25mg FDC | Absolute Values of Total and Direct Bilirubin, Creatinine and Protein Levels | Direct bilirubin, Day 3 | 2.993 Micromoles per liter | Standard Deviation 1.1682 |
| DTG/RPV 50mg/25mg FDC | Absolute Values of Total and Direct Bilirubin, Creatinine and Protein Levels | Creatinine, Baseline (Day -1) | 80.3335 Micromoles per liter | Standard Deviation 13.8833 |
| DTG/RPV 50mg/25mg FDC | Absolute Values of Total and Direct Bilirubin, Creatinine and Protein Levels | Protein, Day 3 | 70.8 Micromoles per liter | Standard Deviation 4.57 |
Secondary
Change From Baseline in Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Alkaline Phosphatase (ALP) Levels
Blood samples were collected at indicated time-points for analysis of clinical chemistry parameters like AST, ALT and ALP levels. Baseline was defined as Day -1. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time frame: Baseline (Day -1) and Day 3
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DTG/RPV 50mg/25mg FDC | Change From Baseline in Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Alkaline Phosphatase (ALP) Levels | ALT | 3.2 International units per Liter | Standard Deviation 7.46 |
| DTG/RPV 50mg/25mg FDC | Change From Baseline in Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Alkaline Phosphatase (ALP) Levels | AST | 0.6 International units per Liter | Standard Deviation 3.42 |
| DTG/RPV 50mg/25mg FDC | Change From Baseline in Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Alkaline Phosphatase (ALP) Levels | ALP | 0.9 International units per Liter | Standard Deviation 2.87 |
Secondary
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Sodium, and Potassium Levels
Blood samples were collected at indicated time-points for analysis of clinical chemistry parameters like (BUN), glucose, sodium, calcium, and potassium levels. Baseline was defined as Day -1. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time frame: Baseline (Day -1) and Day 3
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DTG/RPV 50mg/25mg FDC | Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Sodium, and Potassium Levels | BUN | 0.2901 Millimoles per Liter | Standard Deviation 0.942 |
| DTG/RPV 50mg/25mg FDC | Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Sodium, and Potassium Levels | Calcium | 0.0483 Millimoles per Liter | Standard Deviation 0.07315 |
| DTG/RPV 50mg/25mg FDC | Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Sodium, and Potassium Levels | Glucose | -0.1908 Millimoles per Liter | Standard Deviation 0.30738 |
| DTG/RPV 50mg/25mg FDC | Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Sodium, and Potassium Levels | Potassium | 0.02 Millimoles per Liter | Standard Deviation 0.288 |
| DTG/RPV 50mg/25mg FDC | Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Sodium, and Potassium Levels | Sodium | 2.8 Millimoles per Liter | Standard Deviation 2.46 |
Secondary
Change From Baseline in Body Temperature
Body temperature were assessed at indicated time-points. Day 1 (Pre-dose) was defined as Baseline. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time frame: Baseline (Day 1, Pre-dose) and at Day 12
Population: Safety Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DTG/RPV 50mg/25mg FDC | Change From Baseline in Body Temperature | 0.06 Degree Celsius | Standard Deviation 0.453 |
Secondary
Change From Baseline in Erythrocytes
Blood samples were collected at indicated timepoints for analysis of hematology parameter like erythrocytes. Baseline was defined as Day -1. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time frame: Baseline (Day -1) and Day 3
Population: Safety Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DTG/RPV 50mg/25mg FDC | Change From Baseline in Erythrocytes | 0.358 Trillion cells per liter | Standard Deviation 0.2112 |
Secondary
Change From Baseline in Hematocrit Level
Blood samples were collected at indicated timepoints for analysis of hematology parameter like hematocrit. Baseline was defined as Day -1. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time frame: Baseline (Day -1) and Day 3
Population: Safety Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DTG/RPV 50mg/25mg FDC | Change From Baseline in Hematocrit Level | 0.0308 Proportion of red blood cells in blood | Standard Deviation 0.01967 |
Secondary
Change From Baseline in Hemoglobin Level
Blood samples were collected at indicated timepoints for analysis of hematology parameter like hemoglobin. Baseline was defined as Day -1. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time frame: Baseline (Day -1) and Day 3
Population: Safety Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DTG/RPV 50mg/25mg FDC | Change From Baseline in Hemoglobin Level | 10.1 Grams per liter | Standard Deviation 7.33 |
Secondary
Change From Baseline in Mean Corpuscular Hemoglobin (MCH)
Blood samples were collected at indicated timepoints for analysis of hematology parameter like MCH. Baseline was defined as Day -1. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time frame: Baseline (Day -1) and Day 3
Population: Safety Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DTG/RPV 50mg/25mg FDC | Change From Baseline in Mean Corpuscular Hemoglobin (MCH) | -0.10 Picograms | Standard Deviation 0.303 |
Secondary
Change From Baseline in Mean Corpuscular Volume (MCV)
Blood samples were collected at indicated timepoints for analysis of hematology parameter like MCV. Baseline was defined as Day -1. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time frame: Baseline (Day -1) and Day 3
Population: Safety Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DTG/RPV 50mg/25mg FDC | Change From Baseline in Mean Corpuscular Volume (MCV) | -0.43 Femtoliters | Standard Deviation 0.849 |
Secondary
Change From Baseline in Neutrophil, Lymphocyte, Leukocyte, Monocyte, Eosinophil, Basophil and Platelet Count
Blood samples were collected at indicated time-points for analysis of hematology parameters like platelet count, neutrophils, lymphocytes, leukocyte, monocytes, eosinophils and basophils. Baseline was defined as Day -1. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time frame: Baseline (Day -1) and Day 3
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DTG/RPV 50mg/25mg FDC | Change From Baseline in Neutrophil, Lymphocyte, Leukocyte, Monocyte, Eosinophil, Basophil and Platelet Count | Basophils | -0.03 Giga cells per liter | Standard Deviation 0.045 |
| DTG/RPV 50mg/25mg FDC | Change From Baseline in Neutrophil, Lymphocyte, Leukocyte, Monocyte, Eosinophil, Basophil and Platelet Count | Eosinophils | -0.04 Giga cells per liter | Standard Deviation 0.089 |
| DTG/RPV 50mg/25mg FDC | Change From Baseline in Neutrophil, Lymphocyte, Leukocyte, Monocyte, Eosinophil, Basophil and Platelet Count | Leukocytes | -0.16 Giga cells per liter | Standard Deviation 1.016 |
| DTG/RPV 50mg/25mg FDC | Change From Baseline in Neutrophil, Lymphocyte, Leukocyte, Monocyte, Eosinophil, Basophil and Platelet Count | Lymphocytes | -0.03 Giga cells per liter | Standard Deviation 0.445 |
| DTG/RPV 50mg/25mg FDC | Change From Baseline in Neutrophil, Lymphocyte, Leukocyte, Monocyte, Eosinophil, Basophil and Platelet Count | Monocytes | -0.04 Giga cells per liter | Standard Deviation 0.081 |
| DTG/RPV 50mg/25mg FDC | Change From Baseline in Neutrophil, Lymphocyte, Leukocyte, Monocyte, Eosinophil, Basophil and Platelet Count | Platelets | 5.4 Giga cells per liter | Standard Deviation 18.85 |
| DTG/RPV 50mg/25mg FDC | Change From Baseline in Neutrophil, Lymphocyte, Leukocyte, Monocyte, Eosinophil, Basophil and Platelet Count | Neutrophils | -0.06 Giga cells per liter | Standard Deviation 0.788 |
Secondary
Change From Baseline in Pulse Rate
Pulse rate was assessed in the supine position with a completely automated device. Day 1 (Pre-dose) was defined as Baseline. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time frame: Baseline (Day 1, Pre-dose) and at Day 12
Population: Safety Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DTG/RPV 50mg/25mg FDC | Change From Baseline in Pulse Rate | 8.7 Beats per minute | Standard Deviation 10.32 |
Secondary
Change From Baseline in Reticulocytes
Blood samples were collected at indicated timepoints for analysis of hematology parameter like reticulocytes. Baseline was defined as Day -1. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time frame: Baseline (Day -1) and Day 3
Population: Safety Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DTG/RPV 50mg/25mg FDC | Change From Baseline in Reticulocytes | 0.13 Percentage of reticulocytes | Standard Deviation 0.211 |
Secondary
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SBP and DBP were assessed in the supine position with a completely automated device. Day 1 (Pre-dose) was defined as Baseline. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time frame: Baseline (Day 1, Pre-dose) and at Day 12
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DTG/RPV 50mg/25mg FDC | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP | 6.2 Millimeters of mercury | Standard Deviation 9.35 |
| DTG/RPV 50mg/25mg FDC | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP | 1.6 Millimeters of mercury | Standard Deviation 9.61 |
Secondary
Change From Baseline in Total and Direct Bilirubin, Creatinine and Protein Levels
Blood samples were collected at indicated time-points for analysis of clinical chemistry parameters like total and direct bilirubin, creatinine and protein levels. Baseline was defined as Day -1. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time frame: Baseline (Day -1) and Day 3
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DTG/RPV 50mg/25mg FDC | Change From Baseline in Total and Direct Bilirubin, Creatinine and Protein Levels | Total bilirubin | 3.954 Micromoles per liter | Standard Deviation 4.6188 |
| DTG/RPV 50mg/25mg FDC | Change From Baseline in Total and Direct Bilirubin, Creatinine and Protein Levels | Direct bilirubin | 0.428 Micromoles per liter | Standard Deviation 0.7647 |
| DTG/RPV 50mg/25mg FDC | Change From Baseline in Total and Direct Bilirubin, Creatinine and Protein Levels | Creatinine | 2.7072 Micromoles per liter | Standard Deviation 6.15397 |
| DTG/RPV 50mg/25mg FDC | Change From Baseline in Total and Direct Bilirubin, Creatinine and Protein Levels | Protein | 4.2 Micromoles per liter | Standard Deviation 3.73 |
Secondary
Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. A SAE is defined as any untoward medical occurrence that, at any dose: results in death and is life-threatening; which requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent disability or incapacity and birth defect or congenital anomaly, or any other situation that require medical or scientific judgment.
Time frame: Up to Day 18
Population: Safety Population included participants who were enrolled in the study and received at least one dose of study drug.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| DTG/RPV 50mg/25mg FDC | Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) | AE | 2 Participants |
| DTG/RPV 50mg/25mg FDC | Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) | SAE | 0 Participants |