HIV Infections
Conditions
Keywords
Dolutegravir, GSK3640254, Fixed Dose Combinations, Bioavailability
Brief summary
This is a two part study to compare the relative bioavailability (BA) of 2 fixed dose combinations (FDCs) of GSK3640254/DTG with GSK3640254 and DTG administered together as single agents (Part 1) and to assess the effect of food on the pharmacokinetic (PK) of the selected FDC of GSK3640254/DTG (Part 2).
Interventions
DRUGGSK3640254
GSK3640254 will be administered via oral route.
DRUGDTG
DTG will be administered via oral route.
DRUGGSK3640254/DTG
GSK3640254/DTG will be administered via oral route.
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 2-part crossover study.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Participant must be 18 to 65 years of age inclusive, at the time of signing the informed consent. * Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring (history and ECG). * Participants capable of giving signed informed consent.
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). * A pre-existing condition interfering with normal gastro intestinal anatomy or motility (for example \[e.g.\], gastroesophageal reflux disease, gastric ulcers, gastritis) or hepatic and/or renal function that could interfere with the absorption, metabolism, and/or excretion of the study intervention or render the participant unable to take oral study intervention. * Prior cholecystectomy surgery (prior appendectomy is acceptable). * Clinically significant illness, including viral syndromes within 3 weeks of dosing. * 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. * Current enrollment or past participation within the last 30 days before signing of consent in any other clinical study involving an investigational study intervention (including an investigational COVID vaccine) or any other type of medical research. * Prior exposure to GSK3640254 or prior intolerance to DTG in this or another clinical study. * Any positive (abnormal) response confirmed by the investigator on a screening clinician- or qualified designee-administered Columbia Suicide Severity Rating Scale (C-SSRS). * Any significant arrhythmia or ECG finding (e.g., prior myocardial infarction in the past 3 months, symptomatic bradycardia, non-sustained or sustained atrial arrhythmias, non-sustained or sustained ventricular tachycardia, any degree of atrioventricular block, or conduction abnormality) which, in the opinion of the investigator or ViiV Healthcare (VH)/GlaxoSmithKline (GSK) medical monitor, will interfere with the safety for the individual participant.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Part 1: Area Under the Plasma Concentration-time Curve From Time 0 Extrapolated to Infinity (AUC[0-inf]) of GSK3640254 | Pre-dose, 30 minutes, 1 hour, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72, 96 hours post dose in each treatment period | Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis of GSK3640254. |
| Part 1: Area Under the Plasma Concentration-time Curve From Time 0 to Time t (AUC[0-t]) of GSK3640254 | Pre-dose, 30 minutes, 1 hour, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72, 96 hours post dose in each treatment period | Blood samples were collected at indicated time points for PK analysis of GSK3640254. |
| Part 1: Maximum Observed Concentration (Cmax) of GSK3640254 | Pre-dose, 30 minutes, 1 hour, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72, 96 hours post dose in each treatment period | Blood samples were collected at indicated time points for PK analysis of GSK3640254. |
| Part 1: AUC(0-inf) of DTG | Pre-dose, 30 minutes, 1 hour, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72, 96 hours post dose in each treatment period | Blood samples were collected at indicated time points for PK analysis of DTG. |
| Part 1: AUC(0-t) of DTG | Pre-dose, 30 minutes, 1 hour, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72, 96 hours post dose in each treatment period | Blood samples were collected at indicated time points for PK analysis of DTG. |
| Part 1: Cmax of DTG | Pre-dose, 30 minutes, 1 hour, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72, 96 hours post dose in each treatment period | Blood samples were collected at indicated time points for PK analysis of DTG. |
| Part 2: AUC(0-inf) of GSK3640254 | Pre-dose, 30 minutes, 1 hour, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72, 96 hours post dose in each treatment period | Blood samples were collected at indicated time points for PK analysis of GSK3640254. |
| Part 2: AUC(0-t) of GSK3640254 | Pre-dose, 30 minutes, 1 hour, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72, 96 hours post dose in each treatment period. | Blood samples were collected at indicated time points for PK analysis of GSK3640254. |
| Part 2: Cmax of GSK3640254 | Pre-dose, 30 minutes, 1 hour, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72, 96 hours post dose in each treatment period | Blood samples were collected at indicated time points for PK analysis of GSK3640254. |
| Part 2: AUC(0-inf) of DTG | Pre-dose, 30 minutes, 1 hour, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72, 96 hours post dose in each treatment period | Blood samples were collected at indicated time points for PK analysis of DTG. |
| Part 2: AUC(0-t) of DTG | Pre-dose, 30 minutes, 1 hour, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72, 96 hours post dose in each treatment period | Blood samples were collected at indicated time points for PK analysis of DTG. |
| Part 2: Cmax of DTG | Pre-dose, 30 minutes, 1 hour, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72, 96 hours post dose in each treatment period | Blood samples were collected at indicated time points for PK analysis of DTG. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Part 1: Absolute Values for Hematology Parameters: Erythrocytes Mean Corpuscular Hemoglobin | Baseline (Day -1) and Days 2, 5 and 7 | Blood samples were collected to analyze the hematology parameter: erythrocytes mean corpuscular hemoglobin. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period. |
| Part 2: Absolute Values for Hematology Parameters: Erythrocytes Mean Corpuscular Hemoglobin | Baseline (Day -1) and Days 2, 5 and 7 | Blood samples were collected to analyze the hematology parameter: erythrocytes mean corpuscular hemoglobin. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period. |
| Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Baseline (Day -1) and Days 2, 5 and 7 | Blood samples were collected to analyze the hematology parameters: basophils, eosinophils, lymphocytes, monocytes, neutrophils, and platelets. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. |
| Part 2: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Baseline (Day -1) and Days 2, 5 and 7 | Blood samples were collected to analyze the hematology parameters: basophils, eosinophils, lymphocytes, monocytes, neutrophils, and platelets. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. |
| Part 1: Change From Baseline in Hematology Parameter: Hemoglobin | Baseline (Day -1) and Days 2, 5 and 7 | Blood samples were collected to analyze the hematology parameter: hemoglobin. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. |
| Part 2: Change From Baseline in Hematology Parameter: Hemoglobin | Baseline (Day -1) and Days 2, 5 and 7 | Blood samples were collected to analyze the hematology parameter: hemoglobin. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. |
| Part 1: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume | Baseline (Day -1) and Days 2, 5 and 7 | Blood samples were collected to analyze the hematology parameter: erythrocytes mean corpuscular volume. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. |
| Part 2: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume | Baseline (Day -1) and Days 2, 5 and 7 | Blood samples were collected to analyze the hematology parameter: erythrocytes mean corpuscular volume. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. |
| Part 1: Change From Baseline in Hematology Parameter: Erythrocytes | Baseline (Day -1) and Days 2, 5 and 7 | Blood samples were collected to analyze the hematology parameter: erythrocytes. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. |
| Part 2: Change From Baseline in Hematology Parameter: Erythrocytes | Baseline (Day -1) and Days 2, 5 and 7 | Blood samples were collected to analyze the hematology parameter: erythrocytes. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. |
| Part 1: Change From Baseline in Hematology Parameter: Hematocrit | Baseline (Day -1) and Days 2, 5 and 7 | Blood samples were collected to analyze the hematology parameter: hemotocrit. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. |
| Part 2: Change From Baseline in Hematology Parameter: Hematocrit | Baseline (Day -1) and Days 2, 5 and 7 | Blood samples were collected to analyze the hematology parameters: hemotocrit. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. |
| Part 1: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin | Baseline (Day -1) and Days 2, 5, and 7 | Blood samples were collected to analyze the hematology parameter: erythrocytes mean corpuscular hemoglobin. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. |
| Part 2: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin | Baseline (Day -1) and Days 2, 5 and 7 | Blood samples were collected to analyze the hematology parameter: erythrocytes mean corpuscular hemoglobin. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. |
| Part 1: Absolute Values for Clinical Chemistry Parameters: Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH), Creatinine Kinase (CK) | Baseline (Day -1), and Days 2, 5, and 7 | Blood samples were collected to analyze the chemistry parameters: ALT, ALP, AST, GGT, LDH, CK. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period. |
| Part 2: Absolute Values of Clinical Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK | Baseline (Day -1) and Days 2, 5 and 7 | Blood samples were collected to analyze the chemistry parameters: ALT, ALP, AST, GGT, LDH, CK. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period. |
| Part 1: Absolute Values of Clinical Chemistry Parameters: Calcium, Carbon-dioxide (CO2), Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Baseline (Day -1), and Days 2, 5, and 7 | Blood samples were collected to analyze the chemistry parameters: calcium, CO2, chloride, glucose, potassium, sodium, urea nitrogen, phosphorus, triglycerides, cholesterol, and anion gap. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period. |
| Part 2: Absolute Values of Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Baseline (Day -1) and Days 2, 5 and 7 | Blood samples were collected to analyze the chemistry parameters: calcium, CO2, chloride, glucose, potassium, sodium, urea nitrogen, phosphorus, triglycerides, cholesterol, and anion gap. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period. |
| Part 1: Absolute Values for Chemistry Parameters: Serum Lipase, Serum Amylase | Baseline (Day -1), and Days 2, 5, and 7 | Blood samples were collected to analyze the chemistry parameters: serum lipase and serum amylase. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period. |
| Part 2: Absolute Values for Chemistry Parameters: Serum Lipase, Serum Amylase | Baseline (Day -1) and Days 2, 5 and 7 | Blood samples were collected to analyze the chemistry parameters: serum lipase, serum amylase. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period. |
| Part 1: Absolute Values of Clinical Chemistry Parameters: Albumin, Globulin and Protein | Baseline (Day -1), and Days 2, 5, and 7 | Blood samples were collected to analyze the chemistry parameters: albumin, globulin and protein. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period. |
| Part 2: Absolute Values of Clinical Chemistry Parameters: Albumin, Globulin and Protein | Baseline (Day -1) and Days 2, 5 and 7 | Blood samples were collected to analyze the chemistry parameters: albumin, globulin and protein. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period. |
| Part 1: Absolute Values of Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate | Baseline (Day -1), and Days 2, 5, and 7 | Blood samples were collected to analyze the chemistry parameters: creatinine, direct bilirubin, bilirubin, urate. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period. |
| Part 2: Absolute Values of Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate | Baseline (Day -1) and Days 2, 5 and 7 | Blood samples were collected to analyze the chemistry parameters: creatinine, direct bilirubin, bilirubin, and urate. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period. |
| Part 1: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK | Baseline (Day -1) and Days 2, 5, and 7 | Blood samples were collected to analyze the chemistry parameters: ALT, ALP, AST, GGT, LDH, CK. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. |
| Part 2: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK | Baseline (Day -1) and Days 2, 5 and 7 | Blood samples were collected to analyze the chemistry parameters: ALT, ALP, AST, GGT, LDH, CK. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. |
| Part 1: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Baseline (Day -1) and Days 2, 5, and 7 | Blood samples were collected to analyze the chemistry parameters: calcium, CO2, chloride, glucose, potassium, sodium, urea nitrogen, phosphorus, triglycerides, cholesterol, and anion gap. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. |
| Part 2: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Baseline (Day -1) and Days 2, 5 and 7 | Blood samples were collected to analyze the chemistry parameters: calcium, CO2, chloride, glucose, potassium, sodium, urea nitrogen, phosphorus, triglycerides, cholesterol, and anion gap. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. |
| Part 1: Change From Baseline in Clinical Chemistry Parameters: Lipase and Amylase | Baseline (Day -1) and Days 2, 5, and 7 | Blood samples were collected to analyze the chemistry parameters: lipase and amylase. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. |
| Part 2: Change From Baseline in Clinical Chemistry Parameters: Lipase and Amylase | Baseline (Day -1) and Days 2, 5 and 7 | Blood samples were collected to analyze the chemistry parameters: lipase and amylase. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. |
| Part 1: Change From Baseline in Clinical Chemistry Parameters: Albumin, Globulin and Protein | Baseline (Day -1) and Days 2, 5, 7 | Blood samples were collected to analyze the chemistry parameters: albumin, globulin and protein. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. |
| Part 2: Change From Baseline in Clinical Chemistry Parameters: Albumin, Globulin and Protein | Baseline (Day -1) and Days 2, 5 and 7 | Blood samples were collected to analyze the chemistry parameters: albumin, globulin and protein. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. |
| Part 1: Change From Baseline in Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate | Baseline (Day -1) and Days 2, 5, and 7 | Blood samples were collected to analyze the chemistry parameters: creatinine, direct bilirubin, bilirubin, and urate. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. |
| Part 2: Change From Baseline in Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate | Baseline (Day -1) and Days 2, 5 and 7 | Blood samples were collected to analyze the chemistry parameters: Creatinine, direct bilirubin, bilirubin, and urate. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. |
| Part 1: Absolute Values for Urinalysis Parameter: Specific Gravity | Baseline (Day -1) and Days 2, 5, and 7 | Urine samples were collected 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, including those from unscheduled visit, prior to the first study drug administration in each treatment period. |
| Part 2 : Absolute Values for Urinalysis Parameter: Specific Gravity | Baseline (Day -1) and Days 2, 5 and 7 | Urine samples were collected 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, including those from unscheduled visit, prior to the first study drug administration in each treatment period. |
| Part 1: Absolute Values for Urinalysis Parameters: Potential of Hydrogen (pH) | Baseline (Day -1) and Days 2, 5, and 7 | Urine samples were collected to analyze the urinalysis parameter: pH. 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. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period. |
| Part 1: Absolute Values for Urinalysis Parameter: Potential of Hydrogen | Baseline (Day -1) and Days 2, 5 and 7 | Urine samples were collected to analyze the urinalysis parameter: pH. 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. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period. |
| Part 1: Number of Participants With Urinalysis Dipstick Results: Glucose | Baseline (Day -1) and Days 2, 5, and 7 | Urine samples were collected at indicated time points to analyze parameters including glucose by dipstick. Urinalysis included dipstick urine test which was used to screen for glucose. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameters of urine glucose can be read as negative in the urine sample. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period. |
| Part 2: Number of Participants With Urinalysis Dipstick Results: Glucose | Baseline (Day -1) and Days 2, 5 and 7 | Urine samples were collected at indicated time points to analyze parameters including glucose by dipstick. Urinalysis included dipstick urine test which was used to screen for glucose. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameters of urine glucose can be read as negative in the urine sample. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period. |
| Part 1: Number of Participants With Urinalysis Dipstick Results: Protein | Baseline (Day -1) and Days 2, 5, and 7 | Urine samples were collected at indicated time points to analyze parameters including protein by dipstick. Urinalysis included dipstick urine test which was used to screen for protein. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameters of urine protein can be read as negative, and trace in the urine sample. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period. |
| Part 2: Number of Participants With Urinalysis Dipstick Results: Protein | Baseline (Day -1) and Days 2, 5 and 7 | Urine samples were collected at indicated time points to analyze parameters including protein by dipstick. Urinalysis included dipstick urine test which was used to screen for protein. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameters of urine protein can be read as negative, and trace in the urine sample. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period. |
| Part 1: Number of Participants With Urinalysis Dipstick Results: Occult Blood | Baseline (Day -1) and Days 2, 5, and 7 | Urine samples were collected at indicated time points to analyze parameters including occult blood by dipstick. Urinalysis included dipstick urine test which was used to screen for occult blood. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameters of urine occult blood can be read as negative, trace, 1+, 2+, 3+ indicating proportional concentrations in the urine sample. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period. |
| Part 2: Number of Participants With Urinalysis Dipstick Results: Occult Blood | Baseline (Day -1) and Days 2, 5 and 7 | Urine samples were collected at indicated time points to analyze parameters including occult blood by dipstick. Urinalysis included dipstick urine test which was used to screen for occult blood. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameters of urine occult blood can be read as negative, trace, 1+, 2+, 3+ indicating proportional concentrations in the urine sample. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period. |
| Part 1: Number of Participants With Urinalysis Dipstick Results: Ketones | Baseline (Day -1) and Days 2, 5, and 7 | Urine samples were collected at indicated time points to analyze parameters including ketones by dipstick. Urinalysis included dipstick urine test which was used to screen for ketones. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameters of urine ketones can be read as negative, trace, 2+ indicating proportional concentrations in the urine sample. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period. |
| Part 2: Number of Participants With Urinalysis Dipstick Results: Ketones | Baseline (Day -1) and Days 2, 5 and 7 | Urine samples were collected at indicated time points to analyze parameters including ketones by dipstick. Urinalysis included dipstick urine test which was used to screen for ketones. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameters of urine ketones can be read as negative, trace, 1+, 2+ indicating proportional concentrations in the urine sample. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period. |
| Part 1: Number of Participants With Urinalysis Dipstick Results: Bilirubin and Nitrite | Baseline (Day -1) and Days 2, 5, and 7 | Urine samples were collected at indicated time points to analyze parameters including bilirubin and nitrite by dipstick. Urinalysis included dipstick urine test which was used to screen for bilirubin and nitrite. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameters of urine bilirubin and nitrite can be read as negative in the urine sample. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period. |
| Part 2: Number of Participants With Urinalysis Dipstick Results: Bilirubin and Nitrite | Baseline (Day -1) and Days 2, 5 and 7 | Urine samples were collected at indicated time points to analyze parameters including bilirubin and nitrite by dipstick. Urinalysis included dipstick urine test which was used to screen for bilirubin and nitrite. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameters of urine bilirubin and nitrite can be read as negative in the urine sample. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period. |
| Part 1: Number of Participants With Urinalysis Dipstick Results: Leukocyte Esterase | Baseline (Day -1) and Days 2, 5, and 7 | Urine samples were collected at indicated time points to analyze parameters including leukocyte esterase by dipstick. Urinalysis included dipstick urine test which was used to screen for leukocyte esterase. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameters of urine leukocyte esterase can be read as negative, trace, 1+ indicating proportional concentrations in the urine sample. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period. |
| Part 2: Number of Participants With Urinalysis Dipstick Results: Leukocyte Esterase | Baseline (Day -1) and Days 2, 5 and 7 | Urine samples were collected at indicated time points to analyze parameters including leukocyte esterase by dipstick. Urinalysis included dipstick urine test which was used to screen for leukocyte esterase. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameters of urine leukocyte esterase can be read as negative, trace indicating proportional concentrations in the urine sample. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period. |
| Part 1: Change From Baseline in Urinalysis Parameter: Specific Gravity | Baseline (Day -1) and Days 2, 5, and 7 | Urine samples were collected 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, including those from unscheduled visit, prior to the first study drug administration in each treatment period. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. |
| Part 2: Change From Baseline in Urinalysis Parameter: Specific Gravity | Baseline (Day -1) and Days 2, 5 and 7 | Urine samples were collected 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, including those from unscheduled visit, prior to the first study drug administration in each treatment period. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. |
| Part 1: Change From Baseline for Urinalysis Parameter: Potential of Hydrogen | Baseline (Day -1) and Days 2, 5, and 7 | Urine samples were collected to analyze the urinalysis parameter: pH. 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. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. |
| Part 2: Change From Baseline for Urinalysis Parameter: Potential of Hydrogen | Baseline (Day -1) and Days 2, 5 and 7 | Urine samples were collected to analyze the urinalysis parameter: pH. 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. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. |
| Part 1: Number of Participants With Worst Case Urine Parameter: Glucose Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Up to Day 17 | Urine samples were collected to analyze the urine parameter: glucose. Urinalysis parameters were graded according to Division of Acquired Immune Deficiency Syndrome (DAIDS) grading for severity of laboratory toxicities and clinical adverse events, version 2.1. The grades were grade 1 (mild), 2 (moderate), 3 (severe) and 4 (potentially life-threatening). Baseline was defined as the last assessment before the first dose of the study treatment. Only those urine parameters with maximum post-Baseline grade increase (Grade 1 to Grade 4) have been presented. |
| Part 2: Number of Participants With Worst Case Urine Parameter: Glucose Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Up to Day 9 | Urine samples were collected to analyze the urine parameter: glucose. Urinalysis parameters were graded according to Division of Acquired Immune Deficiency Syndrome (DAIDS) grading for severity of laboratory toxicities and clinical adverse events, version 2.1. The grades were grade 1 (mild), 2 (moderate), 3 (severe) and 4 (potentially life-threatening). Baseline was defined as the last assessment before the first dose of the study treatment. Only those urine parameters with maximum post-Baseline grade increase (Grade 1 to Grade 4) have been presented. |
| Part 1: Number of Participants With Worst Case Urine Parameter: Protein Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Up to Day 17 | Urine samples were collected to analyze the urine parameter: protein. Urinalysis parameters were graded according to Division of Acquired Immune Deficiency Syndrome (DAIDS) grading for severity of laboratory toxicities and clinical adverse events, version 2.1. The grades were grade 1 (mild), 2 (moderate), 3 (severe) and 4 (potentially life-threatening). Baseline was defined as the last assessment before the first dose of the study treatment. Only those urine parameters with maximum post-Baseline grade increase (Grade 1 to Grade 4) have been presented. |
| Part 2: Number of Participants With Worst Case Urine Parameter: Protein Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Up to Day 9 | Urine samples were collected to analyze the urine parameter: protein. Urinalysis parameters were graded according to Division of Acquired Immune Deficiency Syndrome (DAIDS) grading for severity of laboratory toxicities and clinical adverse events, version 2.1. The grades were grade 1 (mild), 2 (moderate), 3 (severe) and 4 (potentially life-threatening). Baseline was defined as the last assessment before the first dose of the study treatment. Only those urine parameters with maximum post-Baseline grade increase (Grade 1 to Grade 4) have been presented. |
| Part 1: Number of Participants With Worst Case Urine Parameter: Erythrocytes Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Up to Day 17 | Urine samples were collected to analyze the urine parameter: erythrocytes. Urinalysis parameters were graded according to Division of Acquired Immune Deficiency Syndrome (DAIDS) grading for severity of laboratory toxicities and clinical adverse events, version 2.1. The grades were grade 1 (mild), 2 (moderate), 3 (severe) and 4 (potentially life-threatening). Baseline was defined as the last assessment before the first dose of the study treatment. Only those urine parameters with maximum post-Baseline grade increase (Grade 1 to Grade 4) have been presented. |
| Part 2: Number of Participants With Worst Case Urine Parameter: Erythrocytes Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Up to Day 9 | Urine samples were collected to analyze the urine parameter: erythrocytes. Urinalysis parameters were graded according to Division of Acquired Immune Deficiency Syndrome (DAIDS) grading for severity of laboratory toxicities and clinical adverse events, version 2.1. The grades were grade 1 (mild), 2 (moderate), 3 (severe) and 4 (potentially life-threatening). Baseline was defined as the last assessment before the first dose of the study treatment. Only those urine parameters with maximum post-Baseline grade increase (Grade 1 to Grade 4) have been presented. |
| Part 1: Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF) | Baseline (Day 1, pre-dose), and Day 1: 2, 4, 6 hours, and Day 5 | Twelve lead ECGs were obtained to measure PR interval, QRS duration, QT interval, and QTcF interval . Twelve lead ECGs were performed with the participant in a supine position after a rest of at least 10 minutes. Baseline was defined as the average of the triplicate pre-dose assessments within each treatment |
| Part 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF | Baseline (Day 1, pre-dose), and Day 1: 2, 4, 6 hours, and Days 5, 7 | Twelve lead ECGs were obtained to measure PR interval, QRS duration, QT interval, and QTcF interval. Twelve lead ECGs were performed with the participant in a supine position after a rest of at least 10 minutes. Baseline was defined as the average of the triplicate pre-dose assessments within each treatment. |
| Part 1: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval | Baseline (Day 1, Pre-dose), and Day 1: 2, 4, 6 hours, and Day 5 | Twelve lead ECGs were obtained to measure PR interval, QRS duration, QT interval, QTcF interval. Twelve lead ECGs were performed with the participant in a supine position after a rest of at least 10 minutes. Baseline was defined as the average of the triplicate pre-dose assessments within each treatment. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. |
| Part 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval | Baseline (Day 1, pre-dose), and Day 1: 2, 4, 6 hours, Days 5 and 7 | Twelve lead ECGs were obtained to measure PR interval, QRS duration, QT interval, QTcF interval. Twelve lead ECGs were performed with the participant in a supine position after a rest of at least 10 minutes. Baseline was defined as the average of the triplicate pre-dose assessments within each treatment. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. |
| Part 1: Absolute Values of Vital Sign Parameters: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | Baseline (Day 1, pre-dose), and Day 1: 24, 48, 72 hours, Days 5 and 7 | SBP and DBP were measured in the 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 is defined as the average of the triplicate predose assessments within each treatment. |
| Part 2: Absolute Values of Vital Signs: DBP and SBP | Baseline (Day 1, pre-dose), and Day 1: 24, 48 hours, Days 5 and 7 | SBP and DBP were measured in the 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 average of the triplicate predose assessments within each treatment. |
| Part 1: Absolute Values of Vital Signs: Pulse Rate | Baseline (Day 1, pre-dose), and Day 1: 24, 48, 72 hours, Days 5 and 7 | Pulse rate was measured in the 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 average of the triplicate predose assessments within each treatment. |
| Part 2: Absolute Values of Vital Signs: Pulse Rate | Baseline (Day 1, pre-dose), and Day 1: 24, 48 hours, Day 5 and 7 | Pulse rate was measured in the 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 average of the triplicate predose assessments within each treatment. |
| Part 1: Absolute Values of Vital Signs: Oral Temperature | Baseline (Day 1, pre-dose), and Day 1: 24, 48, 72 hours, Days 5, 6 and 7 | Oral temperature were measured in the 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 average of the triplicate predose assessments within each treatment. |
| Part 2: Absolute Values of Vital Signs: Oral Temperature | Baseline (Day 1, pre-dose), and Day 1: 24, 48 hours, Day 5 and 7 | Oral temperature were measured in the 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 average of the triplicate predose assessments within each treatment. |
| Part 1: Absolute Values of Vital Signs: Respiratory Rate | Baseline (Day 1, pre-dose), and Day 1: 24, 48, 72 hours, Days 5 and 7 | Respiratory rate was measured in the 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 average of the triplicate predose assessments within each treatment. |
| Part 2: Absolute Values of Vital Signs: Respiratory Rate | Baseline (Day 1, pre-dose), and Day 1: 24, 48 hours, Days 5, and 7 | Respiratory rate was measured in the 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 average of the triplicate predose assessments within each treatment. |
| Part 1: Change From Baseline in Vital Signs: DBP and SBP | Baseline (Day 1, pre-dose), and Day 1: 24, 48, 72 hours, Days 5, and 7 | SBP and DBP were measured in the 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 average of the triplicate predose assessments within each treatment. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. |
| Part 2: Change From Baseline in Vital Signs: DBP and SBP | Baseline (Day 1, pre-dose), and Day 1: 24, 48 hours, Days 5, and 7 | SBP and DBP were measured in the 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 average of the triplicate predose assessments within each treatment. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. |
| Part 1: Change From Baseline in Vital Signs: Pulse Rate | Baseline (Day 1, pre-dose), and Day 1: 24, 48, 72 hours, Days 5, and 7 | Pulse rate was measured in the 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 average of the triplicate predose assessments within each treatment. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. |
| Part 2: Change From Baseline in Vital Signs: Pulse Rate | Baseline (Day 1, pre-dose), and Day 1: 24, 48 hours, Days 5, and 7 | Pulse rate was measured in the 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 average of the triplicate predose assessments within each treatment. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. |
| Part 1: Change From Baseline in Vital Signs: Oral Temperature | Baseline (Day 1, pre-dose), and Day 1: 24, 48, 72 hours, Days 5, 6 and 7 | Oral temperature was measured in the 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 average of the triplicate predose assessments within each treatment. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. |
| Part 2: Change From Baseline in Vital Signs: Oral Temperature | Baseline (Day 1, pre-dose), and Day 1: 24, 48 hours, Days 5, 6 and 7 | Oral temperature was measured in the 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, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. |
| Part 1: Number of Participants With Non-Serious Adverse Events (Non-SAEs) and Serious Adverse Events (SAEs) | Up to 17 days | An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. A SAE is defined as any serious adverse event that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or other situations as per medical or scientific judgment. Adverse events which were not Serious Adverse Events were considered as Non-Serious adverse events. |
| Part 2: Change From Baseline in Vital Signs: Respiratory Rate | Baseline (Day 1, pre-dose), and Day 1: 24, 48 hours, Days 5, and 7 | Respiratory rate was measured in the 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 average of the triplicate predose assessments within each treatment. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. |
| Part 1: Change From Baseline in Vital Signs: Respiratory Rate | Baseline (Day 1, pre-dose), and Day 1: 24, 48 hours, Days 5, and 7 | Respiratory rate was measured in the 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 average of the triplicate predose assessments within each treatment. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. |
| Part 2: Number of Participants With Non-SAEs and SAEs | Up to 9 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. A SAE is defined as any serious adverse event that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or other situations as per medical or scientific judgment. Adverse events which were not Serious Adverse Events were considered as Non-Serious adverse events. |
| Part 1: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Baseline (Day -1) and Days 2, 5 and 7 | Blood samples were collected to analyze the hematology parameters: basophils, eosinophils, lymphocytes, monocytes, neutrophils, and platelets. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period. |
| Part 2: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Baseline (Day -1) and Days 2, 5 and 7 | Blood samples were collected to analyze the hematology parameters: basophils, eosinophils, lymphocytes, monocytes, neutrophils, leukocytes and platelets. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period. |
| Part 1: Absolute Values for Hematology Parameter: Hemoglobin | Baseline (Day -1) and Days 2, 5 and 7 | Blood samples were collected to analyze the hematology parameter: hemoglobin. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period. |
| Part 2: Absolute Values for Hematology Parameter: Hemoglobin | Baseline (Day -1) and Days 2, 5 and 7 | Blood samples were collected to analyze the hematology parameter: hemoglobin. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period. |
| Part 1: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Volume | Baseline (Day -1) and Days 2, 5 and 7 | Blood samples were collected to analyze the hematology parameter: erythrocytes mean corpuscular volume. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period. |
| Part 2: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Volume | Baseline (Day -1) and Days 2, 5 and 7 | Blood samples were collected to analyze the hematology parameter: erythrocytes mean corpuscular volume. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period. |
| Part 1: Absolute Values for Hematology Parameter: Erythrocytes | Baseline (Day -1) and Days 2, 5 and 7 | Blood samples were collected to analyze the hematology parameter: erythrocytes. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period. |
| Part 2: Absolute Values for Hematology Parameter: Erythrocytes | Baseline (Day -1) and Days 2, 5 and 7 | Blood samples were collected to analyze the hematology parameter: erythrocytes. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period. |
| Part 1: Absolute Values for Hematology Parameters: Hematocrit | Baseline (Day -1) and Days 2, 5 and 7 | Blood samples were collected to analyze the hematology parameter: hematocrit. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period. |
| Part 2: Absolute Values for Hematology Parameters: Hematocrit | Baseline (Day -1) and Days 2, 5 and 7 | Blood samples were collected to analyze the hematology parameter: hematocrit. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period. |
Countries
United States
Participant flow
Recruitment details
This was a randomized, open-label, single dose, crossover clinical study to assess relative bioavailability and food-effect of the fixed dose combination (FDC) of GSK3640254 and Dolutegravir (DTG) in healthy participants.
Pre-assignment details
A total of 41 participants (23 participants in Part 1 and 18 participants in Part 2) were enrolled in the study.
Participants by arm
| Arm | Count |
|---|---|
| Part 1: Cohort 1: Sequence ABC Participants received Treatment A as a single oral dose of GSK3640254 25 milligrams (mg) (2 tablets), GSK3640254 100 mg (1 tablet)/dolutegravir (DTG) 50 mg (1 tablet) administered together under moderate fat and calorie conditions on Day 1 in treatment period 1 followed by Treatment B as a single oral dose of GSK3640254/DTG, 150 mg/50 mg (1 monolayer tablet) FDC administered under moderate fat and calorie conditions on Day 1 in treatment period 2, further followed by Treatment C as a single oral dose of GSK3640254/DTG, 150 mg/50 mg (1 bilayer tablet) FDC administered under moderate fat and calorie conditions on Day 1 in treatment period 3. There was washout period of 7 days between each treatment period. | 9 |
| Part 1: Cohort 2: Sequence BCA Participants received Treatment B as a single oral dose of GSK3640254/DTG, 150 mg/50 mg (1 monolayer tablet) FDC administered under moderate fat and calorie conditions on Day 1 in treatment period 1 followed by Treatment C as a single oral dose of GSK3640254/DTG, 150 mg/50 mg (1 bilayer tablet) FDC administered under moderate fat and calorie conditions on Day 1 in treatment period 2, further followed by Treatment A as a single oral dose of GSK3640254 25 mg (2 tablets), GSK3640254 100 mg (1 tablet), and DTG 50 mg (1 tablet) administered together under moderate fat and calorie conditions on Day 1 on treatment period 3. There was washout period of 7 days between each treatment period. | 7 |
| Part 1: Cohort 3: Sequence CAB Participants received Treatment C as a single oral dose of GSK3640254/DTG, 150 mg/50 mg (1 bilayer tablet) FDC administered under moderate fat and calorie conditions on Day 1 in treatment period 1 followed by Treatment A as a single oral dose of GSK3640254 25 mg (2 tablets), GSK3640254 100 mg (1 tablet) and DTG 50 mg (1 tablet) administered together under moderate fat and calorie conditions (reference) on Day 1 in treatment period 2, further followed by Treatment B as a single oral dose of GSK3640254/DTG, 150 mg/50 mg (1 monolayer tablet) FDC administered under moderate fat and calorie conditions on Day 1 in treatment period 3. There was washout period of 7 days between each treatment period. | 7 |
| Part 2: Cohort 1: Sequence DE Participants received Treatment D as a single oral dose of selected bilayer FDC from Part 1 of GSK3640254/DTG, 150 mg/50 mg administered under high fat and calorie conditions on Day 1 in treatment Period 1, followed by Treatment E as a single oral dose of selected FDC of GSK3640254/DTG, 150 mg/50 mg administered under fasted conditions on Day 1 in treatment Period 2. There was washout period of 7 days between each treatment period. | 9 |
| Part 2: Cohort 2: Sequence ED Participants received Treatment E as a single oral dose of selected bilayer FDC from Part 1 of GSK3640254/DTG, 150 mg/50 mg administered under fasted conditions on Day 1 in treatment Period 1, followed by Treatment D as a single oral dose of selected FDC of GSK3640254/DTG, 150 mg/50 mg administered under high fat and calorie conditions on Day 1 in treatment Period 2. There was washout period of 7 days between each treatment period. | 9 |
| Total | 41 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Part 1: Period 1 (Day 1) | Adverse Event | 1 | 0 | 0 | 0 | 0 |
| Part 1: Washout Period 2 (Up to 7 Days) | Withdrawal by Subject | 2 | 1 | 1 | 0 | 0 |
| Part 2: Washout Period 1 (Up to 7 Days) | Protocol Violation | 0 | 0 | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | Part 1: Cohort 1: Sequence ABC | Part 1: Cohort 2: Sequence BCA | Part 1: Cohort 3: Sequence CAB | Part 2: Cohort 1: Sequence DE | Part 2: Cohort 2: Sequence ED | Total |
|---|---|---|---|---|---|---|
| Age, Customized <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Customized 19-64 years | 9 Participants | 7 Participants | 7 Participants | 9 Participants | 9 Participants | 41 Participants |
| Age, Customized >= 65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Asian- South East Asian Heritage | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Black or African American | 3 Participants | 3 Participants | 3 Participants | 6 Participants | 3 Participants | 18 Participants |
| Race/Ethnicity, Customized Multiple | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized White-White/Caucasian/European Heritage | 6 Participants | 3 Participants | 4 Participants | 3 Participants | 4 Participants | 20 Participants |
| Sex: Female, Male Female | 3 Participants | 4 Participants | 4 Participants | 5 Participants | 2 Participants | 18 Participants |
| Sex: Female, Male Male | 6 Participants | 3 Participants | 3 Participants | 4 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 | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 22 | 0 / 21 | 0 / 20 | 0 / 17 | 0 / 18 |
| other Total, other adverse events | 0 / 22 | 0 / 21 | 1 / 20 | 1 / 17 | 2 / 18 |
| serious Total, serious adverse events | 0 / 22 | 0 / 21 | 0 / 20 | 0 / 17 | 0 / 18 |
Outcome results
Primary
Part 1: Area Under the Plasma Concentration-time Curve From Time 0 Extrapolated to Infinity (AUC[0-inf]) of GSK3640254
Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis of GSK3640254.
Time frame: Pre-dose, 30 minutes, 1 hour, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72, 96 hours post dose in each treatment period
Population: PK Parameter Population consisted of all participants who underwent plasma PK sampling and had evaluable PK parameters estimated. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Area Under the Plasma Concentration-time Curve From Time 0 Extrapolated to Infinity (AUC[0-inf]) of GSK3640254 | 22.13 Hours*microgram per milliliter | Geometric Coefficient of Variation 46.8 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Area Under the Plasma Concentration-time Curve From Time 0 Extrapolated to Infinity (AUC[0-inf]) of GSK3640254 | 21.93 Hours*microgram per milliliter | Geometric Coefficient of Variation 36.6 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Area Under the Plasma Concentration-time Curve From Time 0 Extrapolated to Infinity (AUC[0-inf]) of GSK3640254 | 22.63 Hours*microgram per milliliter | Geometric Coefficient of Variation 38 |
90% CI: [0.9335, 1.126]
90% CI: [0.9693, 1.185]
Primary
Part 1: Area Under the Plasma Concentration-time Curve From Time 0 to Time t (AUC[0-t]) of GSK3640254
Blood samples were collected at indicated time points for PK analysis of GSK3640254.
Time frame: Pre-dose, 30 minutes, 1 hour, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72, 96 hours post dose in each treatment period
Population: PK Parameter Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Area Under the Plasma Concentration-time Curve From Time 0 to Time t (AUC[0-t]) of GSK3640254 | 17.62 Hours*microgram per milliliter | Geometric Coefficient of Variation 55.4 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Area Under the Plasma Concentration-time Curve From Time 0 to Time t (AUC[0-t]) of GSK3640254 | 19.14 Hours*microgram per milliliter | Geometric Coefficient of Variation 42.9 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Area Under the Plasma Concentration-time Curve From Time 0 to Time t (AUC[0-t]) of GSK3640254 | 18.69 Hours*microgram per milliliter | Geometric Coefficient of Variation 42.4 |
90% CI: [0.9918, 1.278]
90% CI: [0.9278, 1.201]
Primary
Part 1: AUC(0-inf) of DTG
Blood samples were collected at indicated time points for PK analysis of DTG.
Time frame: Pre-dose, 30 minutes, 1 hour, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72, 96 hours post dose in each treatment period
Population: PK Parameter Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: AUC(0-inf) of DTG | 74.18 Hours*microgram per milliliter | Geometric Coefficient of Variation 30.7 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: AUC(0-inf) of DTG | 82.13 Hours*microgram per milliliter | Geometric Coefficient of Variation 26.1 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: AUC(0-inf) of DTG | 80.53 Hours*microgram per milliliter | Geometric Coefficient of Variation 34.7 |
90% CI: [1.067, 1.195]
90% CI: [1.05, 1.178]
Primary
Part 1: AUC(0-t) of DTG
Blood samples were collected at indicated time points for PK analysis of DTG.
Time frame: Pre-dose, 30 minutes, 1 hour, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72, 96 hours post dose in each treatment period
Population: PK Parameter Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: AUC(0-t) of DTG | 68.91 Hours*microgram per milliliter | Geometric Coefficient of Variation 32.5 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: AUC(0-t) of DTG | 77.89 Hours*microgram per milliliter | Geometric Coefficient of Variation 29 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: AUC(0-t) of DTG | 73.44 Hours*microgram per milliliter | Geometric Coefficient of Variation 37 |
90% CI: [1.07, 1.267]
90% CI: [0.9975, 1.184]
Primary
Part 1: Cmax of DTG
Blood samples were collected at indicated time points for PK analysis of DTG.
Time frame: Pre-dose, 30 minutes, 1 hour, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72, 96 hours post dose in each treatment period
Population: PK Parameter Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Cmax of DTG | 4.182 Microgram per milliliter | Geometric Coefficient of Variation 18.5 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Cmax of DTG | 4.432 Microgram per milliliter | Geometric Coefficient of Variation 17.8 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Cmax of DTG | 4.264 Microgram per milliliter | Geometric Coefficient of Variation 23.2 |
90% CI: [1.036, 1.122]
90% CI: [0.9914, 1.075]
Primary
Part 1: Maximum Observed Concentration (Cmax) of GSK3640254
Blood samples were collected at indicated time points for PK analysis of GSK3640254.
Time frame: Pre-dose, 30 minutes, 1 hour, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72, 96 hours post dose in each treatment period
Population: PK Parameter Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Maximum Observed Concentration (Cmax) of GSK3640254 | 0.7382 Microgram per milliliter | Geometric Coefficient of Variation 40.3 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Maximum Observed Concentration (Cmax) of GSK3640254 | 0.7610 Microgram per milliliter | Geometric Coefficient of Variation 33.5 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Maximum Observed Concentration (Cmax) of GSK3640254 | 0.7579 Microgram per milliliter | Geometric Coefficient of Variation 40.1 |
90% CI: [0.9209, 1.166]
90% CI: [0.9049, 1.151]
Primary
Part 2: AUC(0-inf) of DTG
Blood samples were collected at indicated time points for PK analysis of DTG.
Time frame: Pre-dose, 30 minutes, 1 hour, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72, 96 hours post dose in each treatment period
Population: PK Parameter Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: AUC(0-inf) of DTG | 85.07 Hours*microgram per milliliter | Geometric Coefficient of Variation 29 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: AUC(0-inf) of DTG | 64.61 Hours*microgram per milliliter | Geometric Coefficient of Variation 31.5 |
90% CI: [1.193, 1.451]
Primary
Part 2: AUC(0-inf) of GSK3640254
Blood samples were collected at indicated time points for PK analysis of GSK3640254.
Time frame: Pre-dose, 30 minutes, 1 hour, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72, 96 hours post dose in each treatment period
Population: PK Parameter Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: AUC(0-inf) of GSK3640254 | 21.39 Hours*microgram per milliliter | Geometric Coefficient of Variation 38 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: AUC(0-inf) of GSK3640254 | 6.622 Hours*microgram per milliliter | Geometric Coefficient of Variation 77.4 |
90% CI: [2.135, 3.427]
Primary
Part 2: AUC(0-t) of DTG
Blood samples were collected at indicated time points for PK analysis of DTG.
Time frame: Pre-dose, 30 minutes, 1 hour, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72, 96 hours post dose in each treatment period
Population: PK Parameter Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: AUC(0-t) of DTG | 83.18 Hours*microgram per milliliter | Geometric Coefficient of Variation 28.2 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: AUC(0-t) of DTG | 63.17 Hours*microgram per milliliter | Geometric Coefficient of Variation 31 |
90% CI: [1.193, 1.452]
Primary
Part 2: AUC(0-t) of GSK3640254
Blood samples were collected at indicated time points for PK analysis of GSK3640254.
Time frame: Pre-dose, 30 minutes, 1 hour, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72, 96 hours post dose in each treatment period.
Population: PK Parameter Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: AUC(0-t) of GSK3640254 | 19.33 Hours*microgram per milliliter | Geometric Coefficient of Variation 36.6 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: AUC(0-t) of GSK3640254 | 6.027 Hours*microgram per milliliter | Geometric Coefficient of Variation 78.8 |
90% CI: [2.16, 3.527]
Primary
Part 2: Cmax of DTG
Blood samples were collected at indicated time points for PK analysis of DTG.
Time frame: Pre-dose, 30 minutes, 1 hour, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72, 96 hours post dose in each treatment period
Population: PK Parameter Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Cmax of DTG | 4.000 Microgram per milliliter | Geometric Coefficient of Variation 21.1 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Cmax of DTG | 3.273 Microgram per milliliter | Geometric Coefficient of Variation 28.4 |
90% CI: [1.138, 1.333]
Primary
Part 2: Cmax of GSK3640254
Blood samples were collected at indicated time points for PK analysis of GSK3640254.
Time frame: Pre-dose, 30 minutes, 1 hour, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72, 96 hours post dose in each treatment period
Population: PK Parameter Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Cmax of GSK3640254 | 0.6093 Microgram per milliliter | Geometric Coefficient of Variation 41.3 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Cmax of GSK3640254 | 0.2193 Microgram per milliliter | Geometric Coefficient of Variation 92.1 |
90% CI: [1.821, 3.425]
Secondary
Part 1: Absolute Values for Chemistry Parameters: Serum Lipase, Serum Amylase
Blood samples were collected to analyze the chemistry parameters: serum lipase and serum amylase. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period.
Time frame: Baseline (Day -1), and Days 2, 5, and 7
Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values for Chemistry Parameters: Serum Lipase, Serum Amylase | Serum lipase, Baseline (Day -1) | 32.5 Units per Liter | Standard Deviation 12.77 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values for Chemistry Parameters: Serum Lipase, Serum Amylase | Serum lipase, Day 2 | 32.1 Units per Liter | Standard Deviation 13.07 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values for Chemistry Parameters: Serum Lipase, Serum Amylase | Serum lipase, Day 5 | 34.3 Units per Liter | Standard Deviation 15.08 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values for Chemistry Parameters: Serum Lipase, Serum Amylase | Serum lipase, Day 7 | 33.1 Units per Liter | Standard Deviation 17.23 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values for Chemistry Parameters: Serum Lipase, Serum Amylase | Serum amylase, Baseline (Day -1) | 54.9 Units per Liter | Standard Deviation 13.67 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values for Chemistry Parameters: Serum Lipase, Serum Amylase | Serum amylase, Day 2 | 58.9 Units per Liter | Standard Deviation 15.47 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values for Chemistry Parameters: Serum Lipase, Serum Amylase | Serum amylase, Day 5 | 63.3 Units per Liter | Standard Deviation 9.91 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values for Chemistry Parameters: Serum Lipase, Serum Amylase | Serum amylase, Day 7 | 62.0 Units per Liter | Standard Deviation 19.18 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values for Chemistry Parameters: Serum Lipase, Serum Amylase | Serum lipase, Day 5 | 40.2 Units per Liter | Standard Deviation 19.87 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values for Chemistry Parameters: Serum Lipase, Serum Amylase | Serum amylase, Day 5 | 55.2 Units per Liter | Standard Deviation 15.47 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values for Chemistry Parameters: Serum Lipase, Serum Amylase | Serum lipase, Day 7 | 28.8 Units per Liter | Standard Deviation 11.77 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values for Chemistry Parameters: Serum Lipase, Serum Amylase | Serum amylase, Baseline (Day -1) | 58.9 Units per Liter | Standard Deviation 16.72 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values for Chemistry Parameters: Serum Lipase, Serum Amylase | Serum amylase, Day 2 | 62.8 Units per Liter | Standard Deviation 18.88 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values for Chemistry Parameters: Serum Lipase, Serum Amylase | Serum lipase, Baseline (Day -1) | 34.6 Units per Liter | Standard Deviation 17.45 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values for Chemistry Parameters: Serum Lipase, Serum Amylase | Serum lipase, Day 2 | 40.4 Units per Liter | Standard Deviation 27.76 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values for Chemistry Parameters: Serum Lipase, Serum Amylase | Serum amylase, Day 7 | 62.2 Units per Liter | Standard Deviation 14.71 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values for Chemistry Parameters: Serum Lipase, Serum Amylase | Serum lipase, Day 5 | 27.7 Units per Liter | Standard Deviation 5.61 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values for Chemistry Parameters: Serum Lipase, Serum Amylase | Serum lipase, Day 2 | 34.2 Units per Liter | Standard Deviation 13.5 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values for Chemistry Parameters: Serum Lipase, Serum Amylase | Serum lipase, Baseline (Day -1) | 31.1 Units per Liter | Standard Deviation 13.95 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values for Chemistry Parameters: Serum Lipase, Serum Amylase | Serum lipase, Day 7 | 35.0 Units per Liter | Standard Deviation 17.18 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values for Chemistry Parameters: Serum Lipase, Serum Amylase | Serum amylase, Day 5 | 62.2 Units per Liter | Standard Deviation 23.16 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values for Chemistry Parameters: Serum Lipase, Serum Amylase | Serum amylase, Day 2 | 61.7 Units per Liter | Standard Deviation 16.92 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values for Chemistry Parameters: Serum Lipase, Serum Amylase | Serum amylase, Baseline (Day -1) | 58.4 Units per Liter | Standard Deviation 14.51 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values for Chemistry Parameters: Serum Lipase, Serum Amylase | Serum amylase, Day 7 | 56.2 Units per Liter | Standard Deviation 13.57 |
Secondary
Part 1: Absolute Values for Clinical Chemistry Parameters: Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH), Creatinine Kinase (CK)
Blood samples were collected to analyze the chemistry parameters: ALT, ALP, AST, GGT, LDH, CK. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period.
Time frame: Baseline (Day -1), and Days 2, 5, and 7
Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values for Clinical Chemistry Parameters: Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH), Creatinine Kinase (CK) | AST, Day 5 | 14.8 International units per Liter | Standard Deviation 4.26 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values for Clinical Chemistry Parameters: Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH), Creatinine Kinase (CK) | GGT, Day 7 | 21.4 International units per Liter | Standard Deviation 10.08 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values for Clinical Chemistry Parameters: Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH), Creatinine Kinase (CK) | ALP, Day 5 | 49.8 International units per Liter | Standard Deviation 13.69 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values for Clinical Chemistry Parameters: Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH), Creatinine Kinase (CK) | ALT, Baseline (Day -1) | 16.4 International units per Liter | Standard Deviation 9.44 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values for Clinical Chemistry Parameters: Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH), Creatinine Kinase (CK) | GGT, Day 5 | 22.3 International units per Liter | Standard Deviation 19.38 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values for Clinical Chemistry Parameters: Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH), Creatinine Kinase (CK) | ALP, Day 7 | 55.1 International units per Liter | Standard Deviation 14.74 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values for Clinical Chemistry Parameters: Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH), Creatinine Kinase (CK) | CK, Day 7 | 90.8 International units per Liter | Standard Deviation 51.77 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values for Clinical Chemistry Parameters: Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH), Creatinine Kinase (CK) | CK, Day 2 | 89.7 International units per Liter | Standard Deviation 51.73 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values for Clinical Chemistry Parameters: Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH), Creatinine Kinase (CK) | GGT, Day 2 | 22.0 International units per Liter | Standard Deviation 14.57 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values for Clinical Chemistry Parameters: Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH), Creatinine Kinase (CK) | AST, Day 7 | 16.5 International units per Liter | Standard Deviation 5.13 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values for Clinical Chemistry Parameters: Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH), Creatinine Kinase (CK) | ALT, Day 2 | 16.3 International units per Liter | Standard Deviation 9.32 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values for Clinical Chemistry Parameters: Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH), Creatinine Kinase (CK) | GGT, Baseline (Day -1) | 22.1 International units per Liter | Standard Deviation 15.68 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values for Clinical Chemistry Parameters: Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH), Creatinine Kinase (CK) | AST, Day 2 | 15.8 International units per Liter | Standard Deviation 4.02 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values for Clinical Chemistry Parameters: Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH), Creatinine Kinase (CK) | CK, Baseline (Day -1) | 101.0 International units per Liter | Standard Deviation 49.01 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values for Clinical Chemistry Parameters: Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH), Creatinine Kinase (CK) | ALT, Day 5 | 14.0 International units per Liter | Standard Deviation 4.56 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values for Clinical Chemistry Parameters: Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH), Creatinine Kinase (CK) | AST, Baseline (Day -1) | 16.3 International units per Liter | Standard Deviation 4.84 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values for Clinical Chemistry Parameters: Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH), Creatinine Kinase (CK) | LDH, Day 7 | 105.3 International units per Liter | Standard Deviation 12.41 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values for Clinical Chemistry Parameters: Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH), Creatinine Kinase (CK) | ALT, Day 7 | 20.5 International units per Liter | Standard Deviation 14.81 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values for Clinical Chemistry Parameters: Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH), Creatinine Kinase (CK) | LDH, Day 5 | 119.5 International units per Liter | Standard Deviation 15.54 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values for Clinical Chemistry Parameters: Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH), Creatinine Kinase (CK) | LDH, Day 2 | 119.1 International units per Liter | Standard Deviation 16.92 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values for Clinical Chemistry Parameters: Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH), Creatinine Kinase (CK) | ALP, Baseline (Day -1) | 54.6 International units per Liter | Standard Deviation 14.9 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values for Clinical Chemistry Parameters: Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH), Creatinine Kinase (CK) | CK, Day 5 | 69.0 International units per Liter | Standard Deviation 33 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values for Clinical Chemistry Parameters: Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH), Creatinine Kinase (CK) | LDH, Baseline (Day -1) | 121.7 International units per Liter | Standard Deviation 19.59 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values for Clinical Chemistry Parameters: Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH), Creatinine Kinase (CK) | ALP, Day 2 | 56.5 International units per Liter | Standard Deviation 14.72 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values for Clinical Chemistry Parameters: Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH), Creatinine Kinase (CK) | ALT, Day 7 | 20.8 International units per Liter | Standard Deviation 18.34 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values for Clinical Chemistry Parameters: Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH), Creatinine Kinase (CK) | AST, Baseline (Day -1) | 17.0 International units per Liter | Standard Deviation 5.63 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values for Clinical Chemistry Parameters: Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH), Creatinine Kinase (CK) | AST, Day 2 | 16.1 International units per Liter | Standard Deviation 4.57 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values for Clinical Chemistry Parameters: Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH), Creatinine Kinase (CK) | ALT, Baseline (Day -1) | 19.1 International units per Liter | Standard Deviation 13.65 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values for Clinical Chemistry Parameters: Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH), Creatinine Kinase (CK) | ALT, Day 2 | 17.4 International units per Liter | Standard Deviation 9.99 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values for Clinical Chemistry Parameters: Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH), Creatinine Kinase (CK) | ALT, Day 5 | 16.7 International units per Liter | Standard Deviation 8.64 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values for Clinical Chemistry Parameters: Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH), Creatinine Kinase (CK) | ALP, Baseline (Day -1) | 55.6 International units per Liter | Standard Deviation 15.14 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values for Clinical Chemistry Parameters: Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH), Creatinine Kinase (CK) | ALP, Day 2 | 57.6 International units per Liter | Standard Deviation 14.03 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values for Clinical Chemistry Parameters: Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH), Creatinine Kinase (CK) | ALP, Day 5 | 60.8 International units per Liter | Standard Deviation 12.62 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values for Clinical Chemistry Parameters: Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH), Creatinine Kinase (CK) | ALP, Day 7 | 52.8 International units per Liter | Standard Deviation 16.34 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values for Clinical Chemistry Parameters: Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH), Creatinine Kinase (CK) | AST, Day 5 | 16.2 International units per Liter | Standard Deviation 4.92 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values for Clinical Chemistry Parameters: Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH), Creatinine Kinase (CK) | AST, Day 7 | 17.5 International units per Liter | Standard Deviation 7.31 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values for Clinical Chemistry Parameters: Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH), Creatinine Kinase (CK) | GGT, Baseline (Day -1) | 22.9 International units per Liter | Standard Deviation 16.21 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values for Clinical Chemistry Parameters: Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH), Creatinine Kinase (CK) | GGT, Day 2 | 22.8 International units per Liter | Standard Deviation 15.45 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values for Clinical Chemistry Parameters: Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH), Creatinine Kinase (CK) | GGT, Day 5 | 21.8 International units per Liter | Standard Deviation 6.11 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values for Clinical Chemistry Parameters: Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH), Creatinine Kinase (CK) | GGT, Day 7 | 22.9 International units per Liter | Standard Deviation 18.6 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values for Clinical Chemistry Parameters: Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH), Creatinine Kinase (CK) | LDH, Baseline (Day -1) | 121.0 International units per Liter | Standard Deviation 24.41 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values for Clinical Chemistry Parameters: Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH), Creatinine Kinase (CK) | LDH, Day 2 | 120.1 International units per Liter | Standard Deviation 23.02 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values for Clinical Chemistry Parameters: Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH), Creatinine Kinase (CK) | LDH, Day 5 | 114.0 International units per Liter | Standard Deviation 21.22 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values for Clinical Chemistry Parameters: Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH), Creatinine Kinase (CK) | LDH, Day 7 | 118.1 International units per Liter | Standard Deviation 22.72 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values for Clinical Chemistry Parameters: Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH), Creatinine Kinase (CK) | CK, Baseline (Day -1) | 115.1 International units per Liter | Standard Deviation 114.93 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values for Clinical Chemistry Parameters: Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH), Creatinine Kinase (CK) | CK, Day 2 | 104.8 International units per Liter | Standard Deviation 109.7 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values for Clinical Chemistry Parameters: Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH), Creatinine Kinase (CK) | CK, Day 5 | 96.5 International units per Liter | Standard Deviation 63.32 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values for Clinical Chemistry Parameters: Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH), Creatinine Kinase (CK) | CK, Day 7 | 104.6 International units per Liter | Standard Deviation 109.85 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values for Clinical Chemistry Parameters: Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH), Creatinine Kinase (CK) | ALP, Baseline (Day -1) | 53.4 International units per Liter | Standard Deviation 15.34 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values for Clinical Chemistry Parameters: Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH), Creatinine Kinase (CK) | AST, Baseline (Day -1) | 17.1 International units per Liter | Standard Deviation 6.23 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values for Clinical Chemistry Parameters: Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH), Creatinine Kinase (CK) | LDH, Baseline (Day -1) | 119.5 International units per Liter | Standard Deviation 22.3 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values for Clinical Chemistry Parameters: Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH), Creatinine Kinase (CK) | ALT, Day 7 | 17.2 International units per Liter | Standard Deviation 9.6 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values for Clinical Chemistry Parameters: Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH), Creatinine Kinase (CK) | CK, Day 2 | 107.0 International units per Liter | Standard Deviation 114.66 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values for Clinical Chemistry Parameters: Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH), Creatinine Kinase (CK) | LDH, Day 2 | 123.5 International units per Liter | Standard Deviation 25.15 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values for Clinical Chemistry Parameters: Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH), Creatinine Kinase (CK) | ALP, Day 7 | 59.3 International units per Liter | Standard Deviation 16.35 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values for Clinical Chemistry Parameters: Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH), Creatinine Kinase (CK) | AST, Day 2 | 17.1 International units per Liter | Standard Deviation 5.92 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values for Clinical Chemistry Parameters: Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH), Creatinine Kinase (CK) | LDH, Day 5 | 107.5 International units per Liter | Standard Deviation 16.08 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values for Clinical Chemistry Parameters: Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH), Creatinine Kinase (CK) | ALT, Day 5 | 19.5 International units per Liter | Standard Deviation 16.67 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values for Clinical Chemistry Parameters: Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH), Creatinine Kinase (CK) | CK, Day 7 | 88.2 International units per Liter | Standard Deviation 46.19 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values for Clinical Chemistry Parameters: Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH), Creatinine Kinase (CK) | LDH, Day 7 | 116.0 International units per Liter | Standard Deviation 20.23 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values for Clinical Chemistry Parameters: Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH), Creatinine Kinase (CK) | AST, Day 7 | 17.5 International units per Liter | Standard Deviation 6.19 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values for Clinical Chemistry Parameters: Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH), Creatinine Kinase (CK) | ALT, Day 2 | 18.4 International units per Liter | Standard Deviation 12.29 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values for Clinical Chemistry Parameters: Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH), Creatinine Kinase (CK) | GGT, Baseline (Day -1) | 22.2 International units per Liter | Standard Deviation 15.53 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values for Clinical Chemistry Parameters: Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH), Creatinine Kinase (CK) | AST, Day 5 | 16.3 International units per Liter | Standard Deviation 2.07 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values for Clinical Chemistry Parameters: Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH), Creatinine Kinase (CK) | CK, Day 5 | 85.8 International units per Liter | Standard Deviation 40.74 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values for Clinical Chemistry Parameters: Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH), Creatinine Kinase (CK) | GGT, Day 2 | 22.7 International units per Liter | Standard Deviation 13.77 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values for Clinical Chemistry Parameters: Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH), Creatinine Kinase (CK) | ALP, Day 5 | 53.8 International units per Liter | Standard Deviation 17.62 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values for Clinical Chemistry Parameters: Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH), Creatinine Kinase (CK) | CK, Baseline (Day -1) | 106.8 International units per Liter | Standard Deviation 93.82 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values for Clinical Chemistry Parameters: Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH), Creatinine Kinase (CK) | GGT, Day 5 | 20.5 International units per Liter | Standard Deviation 12.36 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values for Clinical Chemistry Parameters: Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH), Creatinine Kinase (CK) | ALP, Day 2 | 55.2 International units per Liter | Standard Deviation 15.58 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values for Clinical Chemistry Parameters: Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH), Creatinine Kinase (CK) | ALT, Baseline (Day -1) | 18.9 International units per Liter | Standard Deviation 15.33 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values for Clinical Chemistry Parameters: Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH), Creatinine Kinase (CK) | GGT, Day 7 | 26.8 International units per Liter | Standard Deviation 20.97 |
Secondary
Part 1: Absolute Values for Hematology Parameter: Erythrocytes
Blood samples were collected to analyze the hematology parameter: erythrocytes. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period.
Time frame: Baseline (Day -1) and Days 2, 5 and 7
Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values for Hematology Parameter: Erythrocytes | Baseline (Day -1) | 4.757 10^12 cells per liter | Standard Deviation 0.4773 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values for Hematology Parameter: Erythrocytes | Day 2 | 4.822 10^12 cells per liter | Standard Deviation 0.4863 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values for Hematology Parameter: Erythrocytes | Day 5 | 4.658 10^12 cells per liter | Standard Deviation 0.4331 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values for Hematology Parameter: Erythrocytes | Day 7 | 4.939 10^12 cells per liter | Standard Deviation 0.5032 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values for Hematology Parameter: Erythrocytes | Day 7 | 4.752 10^12 cells per liter | Standard Deviation 0.5521 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values for Hematology Parameter: Erythrocytes | Baseline (Day -1) | 4.850 10^12 cells per liter | Standard Deviation 0.519 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values for Hematology Parameter: Erythrocytes | Day 5 | 4.558 10^12 cells per liter | Standard Deviation 0.3547 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values for Hematology Parameter: Erythrocytes | Day 2 | 4.855 10^12 cells per liter | Standard Deviation 0.474 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values for Hematology Parameter: Erythrocytes | Day 7 | 4.700 10^12 cells per liter | Standard Deviation 0.4412 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values for Hematology Parameter: Erythrocytes | Day 2 | 4.700 10^12 cells per liter | Standard Deviation 0.4353 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values for Hematology Parameter: Erythrocytes | Day 5 | 4.710 10^12 cells per liter | Standard Deviation 0.5284 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values for Hematology Parameter: Erythrocytes | Baseline (Day -1) | 4.686 10^12 cells per liter | Standard Deviation 0.4967 |
Secondary
Part 1: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Volume
Blood samples were collected to analyze the hematology parameter: erythrocytes mean corpuscular volume. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period.
Time frame: Baseline (Day -1) and Days 2, 5 and 7
Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Volume | Baseline (Day -1) | 86.45 Femtoliter | Standard Deviation 4.446 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Volume | Day 2 | 86.26 Femtoliter | Standard Deviation 4.324 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Volume | Day 5 | 86.48 Femtoliter | Standard Deviation 4.642 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Volume | Day 7 | 86.12 Femtoliter | Standard Deviation 4.256 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Volume | Day 7 | 87.28 Femtoliter | Standard Deviation 4.12 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Volume | Baseline (Day -1) | 86.33 Femtoliter | Standard Deviation 4.376 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Volume | Day 5 | 86.08 Femtoliter | Standard Deviation 4.923 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Volume | Day 2 | 86.51 Femtoliter | Standard Deviation 4.392 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Volume | Day 7 | 86.09 Femtoliter | Standard Deviation 4.703 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Volume | Day 2 | 86.99 Femtoliter | Standard Deviation 4.171 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Volume | Day 5 | 87.58 Femtoliter | Standard Deviation 4.668 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Volume | Baseline (Day -1) | 86.94 Femtoliter | Standard Deviation 4.244 |
Secondary
Part 1: Absolute Values for Hematology Parameter: Hemoglobin
Blood samples were collected to analyze the hematology parameter: hemoglobin. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period.
Time frame: Baseline (Day -1) and Days 2, 5 and 7
Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values for Hematology Parameter: Hemoglobin | Baseline (Day -1) | 139.8 Grams per liter | Standard Deviation 16.04 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values for Hematology Parameter: Hemoglobin | Day 2 | 141.1 Grams per liter | Standard Deviation 15.57 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values for Hematology Parameter: Hemoglobin | Day 5 | 134.8 Grams per liter | Standard Deviation 14.74 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values for Hematology Parameter: Hemoglobin | Day 7 | 145.8 Grams per liter | Standard Deviation 14.97 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values for Hematology Parameter: Hemoglobin | Day 7 | 140.6 Grams per liter | Standard Deviation 18.11 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values for Hematology Parameter: Hemoglobin | Baseline (Day -1) | 142.7 Grams per liter | Standard Deviation 16.64 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values for Hematology Parameter: Hemoglobin | Day 5 | 135.0 Grams per liter | Standard Deviation 15.19 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values for Hematology Parameter: Hemoglobin | Day 2 | 143.1 Grams per liter | Standard Deviation 15.14 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values for Hematology Parameter: Hemoglobin | Day 7 | 138.1 Grams per liter | Standard Deviation 16.11 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values for Hematology Parameter: Hemoglobin | Day 2 | 139.2 Grams per liter | Standard Deviation 16.11 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values for Hematology Parameter: Hemoglobin | Day 5 | 141.8 Grams per liter | Standard Deviation 14.89 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values for Hematology Parameter: Hemoglobin | Baseline (Day -1) | 138.8 Grams per liter | Standard Deviation 16.55 |
Secondary
Part 1: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets
Blood samples were collected to analyze the hematology parameters: basophils, eosinophils, lymphocytes, monocytes, neutrophils, and platelets. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period.
Time frame: Baseline (Day -1) and Days 2, 5 and 7
Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Eosinophils, Day 5 | 0.197 10^9 cells per liter | Standard Deviation 0.1481 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Lymphocytes, Baseline (Day -1) | 1.683 10^9 cells per liter | Standard Deviation 0.3691 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Platelets, Baseline (Day -1) | 247.8 10^9 cells per liter | Standard Deviation 45.94 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Basophils, Baseline (Day -1) | 0.035 10^9 cells per liter | Standard Deviation 0.0144 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Lymphocytes, Day 2 | 1.647 10^9 cells per liter | Standard Deviation 0.3715 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Neutrophils, Day 5 | 2.967 10^9 cells per liter | Standard Deviation 0.8932 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Basophils, Day 7 | 0.033 10^9 cells per liter | Standard Deviation 0.0142 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Lymphocytes, Day 5 | 1.835 10^9 cells per liter | Standard Deviation 0.4113 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Neutrophils, Day 2 | 2.756 10^9 cells per liter | Standard Deviation 0.8228 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Platelets, Day 2 | 254.6 10^9 cells per liter | Standard Deviation 46.26 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Lymphocytes, Day 7 | 1.630 10^9 cells per liter | Standard Deviation 0.3049 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Neutrophils, Baseline (Day -1) | 2.729 10^9 cells per liter | Standard Deviation 0.851 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Basophils, Day 2 | 0.036 10^9 cells per liter | Standard Deviation 0.0133 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Monocytes, Baseline (Day -1) | 0.396 10^9 cells per liter | Standard Deviation 0.0834 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Basophils, Day 5 | 0.045 10^9 cells per liter | Standard Deviation 0.0138 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Eosinophils, Baseline (Day -1) | 0.157 10^9 cells per liter | Standard Deviation 0.1455 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Monocytes, Day 2 | 0.395 10^9 cells per liter | Standard Deviation 0.0803 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Platelets, Day 5 | 277.8 10^9 cells per liter | Standard Deviation 35.13 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Neutrophils, Day 7 | 2.462 10^9 cells per liter | Standard Deviation 0.9607 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Monocytes, Day 5 | 0.422 10^9 cells per liter | Standard Deviation 0.0987 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Eosinophils, Day 7 | 0.141 10^9 cells per liter | Standard Deviation 0.1272 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Platelets, Day 7 | 237.9 10^9 cells per liter | Standard Deviation 40.4 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Monocytes, Day 7 | 0.380 10^9 cells per liter | Standard Deviation 0.0587 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Eosinophils, Day 2 | 0.157 10^9 cells per liter | Standard Deviation 0.1382 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Monocytes, Day 7 | 0.398 10^9 cells per liter | Standard Deviation 0.1162 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Neutrophils, Baseline (Day -1) | 2.691 10^9 cells per liter | Standard Deviation 1.0455 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Neutrophils, Day 2 | 2.589 10^9 cells per liter | Standard Deviation 0.9598 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Eosinophils, Day 2 | 0.146 10^9 cells per liter | Standard Deviation 0.1229 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Neutrophils, Day 5 | 2.648 10^9 cells per liter | Standard Deviation 0.8738 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Basophils, Baseline (Day -1) | 0.036 10^9 cells per liter | Standard Deviation 0.014 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Neutrophils, Day 7 | 2.594 10^9 cells per liter | Standard Deviation 1.1921 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Platelets, Baseline (Day -1) | 252.5 10^9 cells per liter | Standard Deviation 52.73 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Eosinophils, Day 5 | 0.182 10^9 cells per liter | Standard Deviation 0.1512 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Platelets, Day 2 | 257.0 10^9 cells per liter | Standard Deviation 54.66 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Platelets, Day 5 | 268.7 10^9 cells per liter | Standard Deviation 52.38 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Eosinophils, Day 7 | 0.152 10^9 cells per liter | Standard Deviation 0.1194 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Basophils, Day 5 | 0.035 10^9 cells per liter | Standard Deviation 0.0187 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Lymphocytes, Baseline (Day -1) | 1.674 10^9 cells per liter | Standard Deviation 0.2885 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Lymphocytes, Day 2 | 1.735 10^9 cells per liter | Standard Deviation 0.3019 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Lymphocytes, Day 5 | 1.663 10^9 cells per liter | Standard Deviation 0.4034 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Basophils, Day 7 | 0.040 10^9 cells per liter | Standard Deviation 0.0108 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Lymphocytes, Day 7 | 1.675 10^9 cells per liter | Standard Deviation 0.3398 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Monocytes, Baseline (Day -1) | 0.396 10^9 cells per liter | Standard Deviation 0.0878 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Monocytes, Day 2 | 0.389 10^9 cells per liter | Standard Deviation 0.0861 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Eosinophils, Baseline (Day -1) | 0.150 10^9 cells per liter | Standard Deviation 0.13 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Monocytes, Day 5 | 0.387 10^9 cells per liter | Standard Deviation 0.0497 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Platelets, Day 7 | 257.1 10^9 cells per liter | Standard Deviation 55.49 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Basophils, Day 2 | 0.036 10^9 cells per liter | Standard Deviation 0.012 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Monocytes, Day 5 | 0.380 10^9 cells per liter | Standard Deviation 0.1243 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Basophils, Baseline (Day -1) | 0.036 10^9 cells per liter | Standard Deviation 0.0132 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Basophils, Day 2 | 0.037 10^9 cells per liter | Standard Deviation 0.0184 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Basophils, Day 5 | 0.028 10^9 cells per liter | Standard Deviation 0.0117 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Basophils, Day 7 | 0.038 10^9 cells per liter | Standard Deviation 0.0169 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Eosinophils, Baseline (Day -1) | 0.171 10^9 cells per liter | Standard Deviation 0.1559 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Eosinophils, Day 2 | 0.170 10^9 cells per liter | Standard Deviation 0.1482 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Eosinophils, Day 5 | 0.120 10^9 cells per liter | Standard Deviation 0.121 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Eosinophils, Day 7 | 0.189 10^9 cells per liter | Standard Deviation 0.1613 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Lymphocytes, Baseline (Day -1) | 1.646 10^9 cells per liter | Standard Deviation 0.3375 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Lymphocytes, Day 2 | 1.711 10^9 cells per liter | Standard Deviation 0.395 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Lymphocytes, Day 5 | 1.705 10^9 cells per liter | Standard Deviation 0.4574 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Lymphocytes, Day 7 | 1.592 10^9 cells per liter | Standard Deviation 0.3674 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Monocytes, Baseline (Day -1) | 0.419 10^9 cells per liter | Standard Deviation 0.1464 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Monocytes, Day 2 | 0.410 10^9 cells per liter | Standard Deviation 0.0932 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Monocytes, Day 7 | 0.410 10^9 cells per liter | Standard Deviation 0.0903 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Neutrophils, Baseline (Day -1) | 2.906 10^9 cells per liter | Standard Deviation 1.3028 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Neutrophils, Day 2 | 2.573 10^9 cells per liter | Standard Deviation 0.9203 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Neutrophils, Day 5 | 2.703 10^9 cells per liter | Standard Deviation 2.0389 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Neutrophils, Day 7 | 2.812 10^9 cells per liter | Standard Deviation 0.9202 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Platelets, Baseline (Day -1) | 256.5 10^9 cells per liter | Standard Deviation 50.02 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Platelets, Day 2 | 260.4 10^9 cells per liter | Standard Deviation 52.24 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Platelets, Day 5 | 212.2 10^9 cells per liter | Standard Deviation 44.62 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Platelets, Day 7 | 271.4 10^9 cells per liter | Standard Deviation 44.96 |
Secondary
Part 1: Absolute Values for Hematology Parameters: Erythrocytes Mean Corpuscular Hemoglobin
Blood samples were collected to analyze the hematology parameter: erythrocytes mean corpuscular hemoglobin. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period.
Time frame: Baseline (Day -1) and Days 2, 5 and 7
Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values for Hematology Parameters: Erythrocytes Mean Corpuscular Hemoglobin | Baseline (Day -1) | 29.37 Picograms | Standard Deviation 1.743 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values for Hematology Parameters: Erythrocytes Mean Corpuscular Hemoglobin | Day 2 | 29.28 Picograms | Standard Deviation 1.811 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values for Hematology Parameters: Erythrocytes Mean Corpuscular Hemoglobin | Day 5 | 28.95 Picograms | Standard Deviation 2.117 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values for Hematology Parameters: Erythrocytes Mean Corpuscular Hemoglobin | Day 7 | 29.61 Picograms | Standard Deviation 1.924 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values for Hematology Parameters: Erythrocytes Mean Corpuscular Hemoglobin | Day 7 | 29.61 Picograms | Standard Deviation 1.853 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values for Hematology Parameters: Erythrocytes Mean Corpuscular Hemoglobin | Baseline (Day -1) | 29.47 Picograms | Standard Deviation 1.859 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values for Hematology Parameters: Erythrocytes Mean Corpuscular Hemoglobin | Day 5 | 29.63 Picograms | Standard Deviation 2.113 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values for Hematology Parameters: Erythrocytes Mean Corpuscular Hemoglobin | Day 2 | 29.51 Picograms | Standard Deviation 1.834 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values for Hematology Parameters: Erythrocytes Mean Corpuscular Hemoglobin | Day 7 | 29.34 Picograms | Standard Deviation 1.735 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values for Hematology Parameters: Erythrocytes Mean Corpuscular Hemoglobin | Day 2 | 29.63 Picograms | Standard Deviation 1.823 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values for Hematology Parameters: Erythrocytes Mean Corpuscular Hemoglobin | Day 5 | 30.23 Picograms | Standard Deviation 2.111 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values for Hematology Parameters: Erythrocytes Mean Corpuscular Hemoglobin | Baseline (Day -1) | 29.65 Picograms | Standard Deviation 1.819 |
Secondary
Part 1: Absolute Values for Hematology Parameters: Hematocrit
Blood samples were collected to analyze the hematology parameter: hematocrit. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period.
Time frame: Baseline (Day -1) and Days 2, 5 and 7
Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values for Hematology Parameters: Hematocrit | Baseline (Day -1) | 0.4110 Proportion of red blood cells in blood | Standard Deviation 0.04343 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values for Hematology Parameters: Hematocrit | Day 2 | 0.4156 Proportion of red blood cells in blood | Standard Deviation 0.04297 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values for Hematology Parameters: Hematocrit | Day 5 | 0.4025 Proportion of red blood cells in blood | Standard Deviation 0.0393 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values for Hematology Parameters: Hematocrit | Day 7 | 0.4246 Proportion of red blood cells in blood | Standard Deviation 0.04202 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values for Hematology Parameters: Hematocrit | Day 7 | 0.4144 Proportion of red blood cells in blood | Standard Deviation 0.04936 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values for Hematology Parameters: Hematocrit | Baseline (Day -1) | 0.4181 Proportion of red blood cells in blood | Standard Deviation 0.04561 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values for Hematology Parameters: Hematocrit | Day 5 | 0.3922 Proportion of red blood cells in blood | Standard Deviation 0.03854 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values for Hematology Parameters: Hematocrit | Day 2 | 0.4195 Proportion of red blood cells in blood | Standard Deviation 0.04087 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values for Hematology Parameters: Hematocrit | Day 7 | 0.4047 Proportion of red blood cells in blood | Standard Deviation 0.04553 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values for Hematology Parameters: Hematocrit | Day 2 | 0.4087 Proportion of red blood cells in blood | Standard Deviation 0.0426 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values for Hematology Parameters: Hematocrit | Day 5 | 0.4117 Proportion of red blood cells in blood | Standard Deviation 0.04206 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values for Hematology Parameters: Hematocrit | Baseline (Day -1) | 0.4070 Proportion of red blood cells in blood | Standard Deviation 0.0449 |
Secondary
Part 1: Absolute Values for Urinalysis Parameter: Potential of Hydrogen
Urine samples were collected to analyze the urinalysis parameter: pH. 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. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period.
Time frame: Baseline (Day -1) and Days 2, 5 and 7
Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values for Urinalysis Parameter: Potential of Hydrogen | Baseline (Day -1) | 6.12 pH | Standard Deviation 0.574 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values for Urinalysis Parameter: Potential of Hydrogen | Day 2 | 6.12 pH | Standard Deviation 0.452 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values for Urinalysis Parameter: Potential of Hydrogen | Day 5 | 6.13 pH | Standard Deviation 0.518 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values for Urinalysis Parameter: Potential of Hydrogen | Day 7 | 6.17 pH | Standard Deviation 0.433 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values for Urinalysis Parameter: Potential of Hydrogen | Day 7 | 5.94 pH | Standard Deviation 0.464 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values for Urinalysis Parameter: Potential of Hydrogen | Baseline (Day -1) | 6.08 pH | Standard Deviation 0.354 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values for Urinalysis Parameter: Potential of Hydrogen | Day 5 | 6.28 pH | Standard Deviation 0.565 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values for Urinalysis Parameter: Potential of Hydrogen | Day 2 | 6.17 pH | Standard Deviation 0.454 |
Secondary
Part 1: Absolute Values for Urinalysis Parameter: Specific Gravity
Urine samples were collected 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, including those from unscheduled visit, prior to the first study drug administration in each treatment period.
Time frame: Baseline (Day -1) and Days 2, 5, and 7
Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values for Urinalysis Parameter: Specific Gravity | Baseline (Day -1) | 1.0138 Ratio | Standard Deviation 0.00654 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values for Urinalysis Parameter: Specific Gravity | Day 2 | 1.0137 Ratio | Standard Deviation 0.00683 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values for Urinalysis Parameter: Specific Gravity | Day 5 | 1.0143 Ratio | Standard Deviation 0.00543 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values for Urinalysis Parameter: Specific Gravity | Day 7 | 1.0202 Ratio | Standard Deviation 0.00569 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values for Urinalysis Parameter: Specific Gravity | Day 7 | 1.0159 Ratio | Standard Deviation 0.0076 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values for Urinalysis Parameter: Specific Gravity | Baseline (Day -1) | 1.0168 Ratio | Standard Deviation 0.00685 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values for Urinalysis Parameter: Specific Gravity | Day 5 | 1.0197 Ratio | Standard Deviation 0.00638 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values for Urinalysis Parameter: Specific Gravity | Day 2 | 1.0150 Ratio | Standard Deviation 0.00766 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values for Urinalysis Parameter: Specific Gravity | Day 7 | 1.0160 Ratio | Standard Deviation 0.00733 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values for Urinalysis Parameter: Specific Gravity | Day 2 | 1.0151 Ratio | Standard Deviation 0.00763 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values for Urinalysis Parameter: Specific Gravity | Day 5 | 1.0197 Ratio | Standard Deviation 0.00799 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values for Urinalysis Parameter: Specific Gravity | Baseline (Day -1) | 1.0153 Ratio | Standard Deviation 0.00693 |
Secondary
Part 1: Absolute Values for Urinalysis Parameters: Potential of Hydrogen (pH)
Urine samples were collected to analyze the urinalysis parameter: pH. 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. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period.
Time frame: Baseline (Day -1) and Days 2, 5, and 7
Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values for Urinalysis Parameters: Potential of Hydrogen (pH) | Baseline (Day -1) | 6.18 pH | Standard Deviation 0.733 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values for Urinalysis Parameters: Potential of Hydrogen (pH) | Day 2 | 6.16 pH | Standard Deviation 0.585 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values for Urinalysis Parameters: Potential of Hydrogen (pH) | Day 5 | 5.83 pH | Standard Deviation 0.408 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values for Urinalysis Parameters: Potential of Hydrogen (pH) | Day 7 | 5.82 pH | Standard Deviation 0.603 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values for Urinalysis Parameters: Potential of Hydrogen (pH) | Day 7 | 5.81 pH | Standard Deviation 0.596 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values for Urinalysis Parameters: Potential of Hydrogen (pH) | Baseline (Day -1) | 5.95 pH | Standard Deviation 0.631 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values for Urinalysis Parameters: Potential of Hydrogen (pH) | Day 5 | 5.83 pH | Standard Deviation 0.258 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values for Urinalysis Parameters: Potential of Hydrogen (pH) | Day 2 | 6.12 pH | Standard Deviation 0.723 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values for Urinalysis Parameters: Potential of Hydrogen (pH) | Day 7 | 6.15 pH | Standard Deviation 0.914 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values for Urinalysis Parameters: Potential of Hydrogen (pH) | Day 2 | 6.20 pH | Standard Deviation 0.785 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values for Urinalysis Parameters: Potential of Hydrogen (pH) | Day 5 | 5.75 pH | Standard Deviation 0.274 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values for Urinalysis Parameters: Potential of Hydrogen (pH) | Baseline (Day -1) | 5.88 pH | Standard Deviation 0.582 |
Secondary
Part 1: Absolute Values of Clinical Chemistry Parameters: Albumin, Globulin and Protein
Blood samples were collected to analyze the chemistry parameters: albumin, globulin and protein. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period.
Time frame: Baseline (Day -1), and Days 2, 5, and 7
Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values of Clinical Chemistry Parameters: Albumin, Globulin and Protein | Albumin, Day 5 | 43.8 Grams per liter | Standard Deviation 2.23 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values of Clinical Chemistry Parameters: Albumin, Globulin and Protein | Albumin, Baseline (Day -1) | 43.8 Grams per liter | Standard Deviation 2.91 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values of Clinical Chemistry Parameters: Albumin, Globulin and Protein | Albumin, Day 2 | 44.6 Grams per liter | Standard Deviation 2.61 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values of Clinical Chemistry Parameters: Albumin, Globulin and Protein | Albumin, Day 7 | 43.6 Grams per liter | Standard Deviation 2.66 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values of Clinical Chemistry Parameters: Albumin, Globulin and Protein | Globulin, Baseline (Day -1) | 26.4 Grams per liter | Standard Deviation 4.04 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values of Clinical Chemistry Parameters: Albumin, Globulin and Protein | Globulin, Day 2 | 27.3 Grams per liter | Standard Deviation 3.85 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values of Clinical Chemistry Parameters: Albumin, Globulin and Protein | Globulin, Day 5 | 26.0 Grams per liter | Standard Deviation 2.61 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values of Clinical Chemistry Parameters: Albumin, Globulin and Protein | Globulin, Day 7 | 27.1 Grams per liter | Standard Deviation 3.78 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values of Clinical Chemistry Parameters: Albumin, Globulin and Protein | Protein, Baseline (Day -1) | 70.1 Grams per liter | Standard Deviation 5.1 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values of Clinical Chemistry Parameters: Albumin, Globulin and Protein | Protein, Day 2 | 71.9 Grams per liter | Standard Deviation 4.86 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values of Clinical Chemistry Parameters: Albumin, Globulin and Protein | Protein, Day 5 | 69.8 Grams per liter | Standard Deviation 1.94 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values of Clinical Chemistry Parameters: Albumin, Globulin and Protein | Protein, Day 7 | 70.7 Grams per liter | Standard Deviation 4.9 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values of Clinical Chemistry Parameters: Albumin, Globulin and Protein | Protein, Day 7 | 69.8 Grams per liter | Standard Deviation 4.17 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values of Clinical Chemistry Parameters: Albumin, Globulin and Protein | Albumin, Day 5 | 43.8 Grams per liter | Standard Deviation 2.32 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values of Clinical Chemistry Parameters: Albumin, Globulin and Protein | Protein, Baseline (Day -1) | 70.8 Grams per liter | Standard Deviation 4.12 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values of Clinical Chemistry Parameters: Albumin, Globulin and Protein | Albumin, Baseline (Day -1) | 43.8 Grams per liter | Standard Deviation 3.12 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values of Clinical Chemistry Parameters: Albumin, Globulin and Protein | Globulin, Day 5 | 28.0 Grams per liter | Standard Deviation 3.52 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values of Clinical Chemistry Parameters: Albumin, Globulin and Protein | Globulin, Day 2 | 27.4 Grams per liter | Standard Deviation 3.72 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values of Clinical Chemistry Parameters: Albumin, Globulin and Protein | Albumin, Day 2 | 44.5 Grams per liter | Standard Deviation 2.29 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values of Clinical Chemistry Parameters: Albumin, Globulin and Protein | Protein, Day 5 | 71.8 Grams per liter | Standard Deviation 4.71 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values of Clinical Chemistry Parameters: Albumin, Globulin and Protein | Globulin, Day 7 | 25.8 Grams per liter | Standard Deviation 3.6 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values of Clinical Chemistry Parameters: Albumin, Globulin and Protein | Globulin, Baseline (Day -1) | 27.0 Grams per liter | Standard Deviation 3.25 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values of Clinical Chemistry Parameters: Albumin, Globulin and Protein | Albumin, Day 7 | 43.9 Grams per liter | Standard Deviation 2.22 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values of Clinical Chemistry Parameters: Albumin, Globulin and Protein | Protein, Day 2 | 71.9 Grams per liter | Standard Deviation 4.03 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values of Clinical Chemistry Parameters: Albumin, Globulin and Protein | Albumin, Day 7 | 45.3 Grams per liter | Standard Deviation 2.16 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values of Clinical Chemistry Parameters: Albumin, Globulin and Protein | Globulin, Baseline (Day -1) | 26.0 Grams per liter | Standard Deviation 3.63 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values of Clinical Chemistry Parameters: Albumin, Globulin and Protein | Protein, Day 2 | 71.6 Grams per liter | Standard Deviation 5.6 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values of Clinical Chemistry Parameters: Albumin, Globulin and Protein | Globulin, Day 2 | 27.1 Grams per liter | Standard Deviation 4.51 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values of Clinical Chemistry Parameters: Albumin, Globulin and Protein | Globulin, Day 5 | 26.2 Grams per liter | Standard Deviation 3.37 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values of Clinical Chemistry Parameters: Albumin, Globulin and Protein | Globulin, Day 7 | 25.9 Grams per liter | Standard Deviation 4.31 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values of Clinical Chemistry Parameters: Albumin, Globulin and Protein | Protein, Day 5 | 69.3 Grams per liter | Standard Deviation 5.28 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values of Clinical Chemistry Parameters: Albumin, Globulin and Protein | Albumin, Baseline (Day -1) | 43.8 Grams per liter | Standard Deviation 2.38 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values of Clinical Chemistry Parameters: Albumin, Globulin and Protein | Protein, Baseline (Day -1) | 69.7 Grams per liter | Standard Deviation 4.46 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values of Clinical Chemistry Parameters: Albumin, Globulin and Protein | Albumin, Day 2 | 44.5 Grams per liter | Standard Deviation 2.46 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values of Clinical Chemistry Parameters: Albumin, Globulin and Protein | Albumin, Day 5 | 43.2 Grams per liter | Standard Deviation 4.12 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values of Clinical Chemistry Parameters: Albumin, Globulin and Protein | Protein, Day 7 | 71.2 Grams per liter | Standard Deviation 4.71 |
Secondary
Part 1: Absolute Values of Clinical Chemistry Parameters: Calcium, Carbon-dioxide (CO2), Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap
Blood samples were collected to analyze the chemistry parameters: calcium, CO2, chloride, glucose, potassium, sodium, urea nitrogen, phosphorus, triglycerides, cholesterol, and anion gap. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period.
Time frame: Baseline (Day -1), and Days 2, 5, and 7
Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values of Clinical Chemistry Parameters: Calcium, Carbon-dioxide (CO2), Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Phosphate, Day 2 | 1.195 Millimoles per liter | Standard Deviation 0.1672 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values of Clinical Chemistry Parameters: Calcium, Carbon-dioxide (CO2), Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Glucose, Day 7 | 5.207 Millimoles per liter | Standard Deviation 0.3982 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values of Clinical Chemistry Parameters: Calcium, Carbon-dioxide (CO2), Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Cholesterol, Day 7 | 4.415 Millimoles per liter | Standard Deviation 0.5871 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values of Clinical Chemistry Parameters: Calcium, Carbon-dioxide (CO2), Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Phosphate, Baseline (Day -1) | 1.126 Millimoles per liter | Standard Deviation 0.1429 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values of Clinical Chemistry Parameters: Calcium, Carbon-dioxide (CO2), Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Potassium, Baseline (Day -1) | 4.20 Millimoles per liter | Standard Deviation 0.233 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values of Clinical Chemistry Parameters: Calcium, Carbon-dioxide (CO2), Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | CO2, Day 2 | 29.4 Millimoles per liter | Standard Deviation 2.24 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values of Clinical Chemistry Parameters: Calcium, Carbon-dioxide (CO2), Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Urea nitrogen, Day 7 | 4.810 Millimoles per liter | Standard Deviation 1.017 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values of Clinical Chemistry Parameters: Calcium, Carbon-dioxide (CO2), Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Potassium, Day 2 | 4.22 Millimoles per liter | Standard Deviation 0.246 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values of Clinical Chemistry Parameters: Calcium, Carbon-dioxide (CO2), Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Anion gap, Day 5 | 10.8 Millimoles per liter | Standard Deviation 1.72 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values of Clinical Chemistry Parameters: Calcium, Carbon-dioxide (CO2), Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Urea nitrogen, Day 5 | 3.980 Millimoles per liter | Standard Deviation 0.4246 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values of Clinical Chemistry Parameters: Calcium, Carbon-dioxide (CO2), Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Potassium, Day 5 | 4.18 Millimoles per liter | Standard Deviation 0.147 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values of Clinical Chemistry Parameters: Calcium, Carbon-dioxide (CO2), Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Cholesterol, Day 5 | 4.863 Millimoles per liter | Standard Deviation 0.6029 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values of Clinical Chemistry Parameters: Calcium, Carbon-dioxide (CO2), Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Urea nitrogen, Day 2 | 4.625 Millimoles per liter | Standard Deviation 0.8713 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values of Clinical Chemistry Parameters: Calcium, Carbon-dioxide (CO2), Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Potassium, Day 7 | 4.35 Millimoles per liter | Standard Deviation 0.383 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values of Clinical Chemistry Parameters: Calcium, Carbon-dioxide (CO2), Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | CO2, Day 5 | 28.2 Millimoles per liter | Standard Deviation 1.94 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values of Clinical Chemistry Parameters: Calcium, Carbon-dioxide (CO2), Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Urea nitrogen, Baseline (Day -1) | 4.105 Millimoles per liter | Standard Deviation 0.9931 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values of Clinical Chemistry Parameters: Calcium, Carbon-dioxide (CO2), Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Sodium, Baseline (Day -1) | 137.5 Millimoles per liter | Standard Deviation 2.48 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values of Clinical Chemistry Parameters: Calcium, Carbon-dioxide (CO2), Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Calcium, Day 5 | 2.345 Millimoles per liter | Standard Deviation 0.0948 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values of Clinical Chemistry Parameters: Calcium, Carbon-dioxide (CO2), Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Sodium, Day 7 | 138.2 Millimoles per liter | Standard Deviation 1.99 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values of Clinical Chemistry Parameters: Calcium, Carbon-dioxide (CO2), Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Sodium, Day 2 | 137.5 Millimoles per liter | Standard Deviation 2.22 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values of Clinical Chemistry Parameters: Calcium, Carbon-dioxide (CO2), Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Cholesterol, Day 2 | 4.783 Millimoles per liter | Standard Deviation 0.6972 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values of Clinical Chemistry Parameters: Calcium, Carbon-dioxide (CO2), Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Sodium, Day 5 | 137.8 Millimoles per liter | Standard Deviation 1.83 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values of Clinical Chemistry Parameters: Calcium, Carbon-dioxide (CO2), Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | CO2, Day 7 | 30.5 Millimoles per liter | Standard Deviation 2.5 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values of Clinical Chemistry Parameters: Calcium, Carbon-dioxide (CO2), Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Anion gap, Day 7 | 10.2 Millimoles per liter | Standard Deviation 1.25 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values of Clinical Chemistry Parameters: Calcium, Carbon-dioxide (CO2), Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Cholesterol, Baseline (Day -1) | 4.666 Millimoles per liter | Standard Deviation 0.6505 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values of Clinical Chemistry Parameters: Calcium, Carbon-dioxide (CO2), Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Chloride, Baseline (Day -1) | 101.7 Millimoles per liter | Standard Deviation 1.49 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values of Clinical Chemistry Parameters: Calcium, Carbon-dioxide (CO2), Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Anion gap, Day 2 | 10.3 Millimoles per liter | Standard Deviation 1.94 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values of Clinical Chemistry Parameters: Calcium, Carbon-dioxide (CO2), Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Triglycerides Day 7 | 1.316 Millimoles per liter | Standard Deviation 0.6488 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values of Clinical Chemistry Parameters: Calcium, Carbon-dioxide (CO2), Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Chloride, Day 2 | 102.0 Millimoles per liter | Standard Deviation 2.53 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values of Clinical Chemistry Parameters: Calcium, Carbon-dioxide (CO2), Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Calcium, Day 7 | 2.380 Millimoles per liter | Standard Deviation 0.0949 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values of Clinical Chemistry Parameters: Calcium, Carbon-dioxide (CO2), Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Triglycerides, Day 5 | 0.907 Millimoles per liter | Standard Deviation 0.2482 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values of Clinical Chemistry Parameters: Calcium, Carbon-dioxide (CO2), Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Chloride, Day 5 | 102.8 Millimoles per liter | Standard Deviation 1.47 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values of Clinical Chemistry Parameters: Calcium, Carbon-dioxide (CO2), Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Calcium, Day 2 | 2.371 Millimoles per liter | Standard Deviation 0.0986 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values of Clinical Chemistry Parameters: Calcium, Carbon-dioxide (CO2), Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Triglycerides, Day 2 | 1.255 Millimoles per liter | Standard Deviation 0.54 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values of Clinical Chemistry Parameters: Calcium, Carbon-dioxide (CO2), Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Chloride, Day 7 | 101.9 Millimoles per liter | Standard Deviation 1.92 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values of Clinical Chemistry Parameters: Calcium, Carbon-dioxide (CO2), Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Anion gap, Baseline (Day -1) | 9.5 Millimoles per liter | Standard Deviation 1.3 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values of Clinical Chemistry Parameters: Calcium, Carbon-dioxide (CO2), Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Triglycerides, Baseline (Day -1) | 1.161 Millimoles per liter | Standard Deviation 0.3495 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values of Clinical Chemistry Parameters: Calcium, Carbon-dioxide (CO2), Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Glucose, Baseline (Day -1) | 5.125 Millimoles per liter | Standard Deviation 0.4472 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values of Clinical Chemistry Parameters: Calcium, Carbon-dioxide (CO2), Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | CO2, Baseline (Day -1) | 30.5 Millimoles per liter | Standard Deviation 1.9 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values of Clinical Chemistry Parameters: Calcium, Carbon-dioxide (CO2), Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Phosphate, Day 7 | 1.114 Millimoles per liter | Standard Deviation 0.0886 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values of Clinical Chemistry Parameters: Calcium, Carbon-dioxide (CO2), Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Glucose, Day 2 | 4.927 Millimoles per liter | Standard Deviation 0.4659 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values of Clinical Chemistry Parameters: Calcium, Carbon-dioxide (CO2), Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Calcium, Baseline (Day -1) | 2.357 Millimoles per liter | Standard Deviation 0.0999 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values of Clinical Chemistry Parameters: Calcium, Carbon-dioxide (CO2), Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Phosphate, Day 5 | 1.267 Millimoles per liter | Standard Deviation 0.1007 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values of Clinical Chemistry Parameters: Calcium, Carbon-dioxide (CO2), Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Glucose, Day 5 | 4.643 Millimoles per liter | Standard Deviation 0.3725 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values of Clinical Chemistry Parameters: Calcium, Carbon-dioxide (CO2), Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Cholesterol, Day 5 | 4.507 Millimoles per liter | Standard Deviation 1.2255 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values of Clinical Chemistry Parameters: Calcium, Carbon-dioxide (CO2), Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Calcium, Baseline (Day -1) | 2.366 Millimoles per liter | Standard Deviation 0.1034 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values of Clinical Chemistry Parameters: Calcium, Carbon-dioxide (CO2), Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Calcium, Day 2 | 2.377 Millimoles per liter | Standard Deviation 0.0868 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values of Clinical Chemistry Parameters: Calcium, Carbon-dioxide (CO2), Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Calcium, Day 5 | 2.407 Millimoles per liter | Standard Deviation 0.0509 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values of Clinical Chemistry Parameters: Calcium, Carbon-dioxide (CO2), Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Calcium, Day 7 | 2.348 Millimoles per liter | Standard Deviation 0.1014 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values of Clinical Chemistry Parameters: Calcium, Carbon-dioxide (CO2), Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | CO2, Baseline (Day -1) | 30.2 Millimoles per liter | Standard Deviation 2.14 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values of Clinical Chemistry Parameters: Calcium, Carbon-dioxide (CO2), Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | CO2, Day 2 | 29.8 Millimoles per liter | Standard Deviation 2.12 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values of Clinical Chemistry Parameters: Calcium, Carbon-dioxide (CO2), Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | CO2, Day 5 | 29.3 Millimoles per liter | Standard Deviation 2.34 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values of Clinical Chemistry Parameters: Calcium, Carbon-dioxide (CO2), Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | CO2, Day 7 | 30.5 Millimoles per liter | Standard Deviation 1.98 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values of Clinical Chemistry Parameters: Calcium, Carbon-dioxide (CO2), Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Chloride, Baseline (Day -1) | 101.8 Millimoles per liter | Standard Deviation 2.07 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values of Clinical Chemistry Parameters: Calcium, Carbon-dioxide (CO2), Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Chloride, Day 2 | 101.6 Millimoles per liter | Standard Deviation 2.11 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values of Clinical Chemistry Parameters: Calcium, Carbon-dioxide (CO2), Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Chloride, Day 5 | 101.3 Millimoles per liter | Standard Deviation 2.16 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values of Clinical Chemistry Parameters: Calcium, Carbon-dioxide (CO2), Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Chloride, Day 7 | 102.4 Millimoles per liter | Standard Deviation 2.02 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values of Clinical Chemistry Parameters: Calcium, Carbon-dioxide (CO2), Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Glucose, Baseline (Day -1) | 5.114 Millimoles per liter | Standard Deviation 0.3745 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values of Clinical Chemistry Parameters: Calcium, Carbon-dioxide (CO2), Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Glucose, Day 2 | 4.979 Millimoles per liter | Standard Deviation 0.496 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values of Clinical Chemistry Parameters: Calcium, Carbon-dioxide (CO2), Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Glucose, Day 7 | 4.980 Millimoles per liter | Standard Deviation 0.4112 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values of Clinical Chemistry Parameters: Calcium, Carbon-dioxide (CO2), Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Potassium, Baseline (Day -1) | 4.30 Millimoles per liter | Standard Deviation 4.24 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values of Clinical Chemistry Parameters: Calcium, Carbon-dioxide (CO2), Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Potassium, Day 2 | 4.12 Millimoles per liter | Standard Deviation 0.266 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values of Clinical Chemistry Parameters: Calcium, Carbon-dioxide (CO2), Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Potassium, Day 5 | 4.08 Millimoles per liter | Standard Deviation 0.271 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values of Clinical Chemistry Parameters: Calcium, Carbon-dioxide (CO2), Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Potassium, Day 7 | 4.24 Millimoles per liter | Standard Deviation 0.331 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values of Clinical Chemistry Parameters: Calcium, Carbon-dioxide (CO2), Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Sodium, Baseline (Day -1) | 137.9 Millimoles per liter | Standard Deviation 2.15 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values of Clinical Chemistry Parameters: Calcium, Carbon-dioxide (CO2), Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Sodium, Day 2 | 137.8 Millimoles per liter | Standard Deviation 1.73 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values of Clinical Chemistry Parameters: Calcium, Carbon-dioxide (CO2), Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Sodium, Day 5 | 137.2 Millimoles per liter | Standard Deviation 2.14 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values of Clinical Chemistry Parameters: Calcium, Carbon-dioxide (CO2), Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Sodium, Day 7 | 138.2 Millimoles per liter | Standard Deviation 2.2 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values of Clinical Chemistry Parameters: Calcium, Carbon-dioxide (CO2), Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Urea nitrogen, Baseline (Day -1) | 4.398 Millimoles per liter | Standard Deviation 0.926 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values of Clinical Chemistry Parameters: Calcium, Carbon-dioxide (CO2), Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Urea nitrogen, Day 2 | 4.731 Millimoles per liter | Standard Deviation 0.8265 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values of Clinical Chemistry Parameters: Calcium, Carbon-dioxide (CO2), Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Urea nitrogen, Day 5 | 4.378 Millimoles per liter | Standard Deviation 0.6674 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values of Clinical Chemistry Parameters: Calcium, Carbon-dioxide (CO2), Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Urea nitrogen, Day 7 | 4.220 Millimoles per liter | Standard Deviation 0.5511 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values of Clinical Chemistry Parameters: Calcium, Carbon-dioxide (CO2), Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Phosphate, Baseline (Day -1) | 1.095 Millimoles per liter | Standard Deviation 0.1602 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values of Clinical Chemistry Parameters: Calcium, Carbon-dioxide (CO2), Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Phosphate, Day 2 | 1.173 Millimoles per liter | Standard Deviation 0.1474 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values of Clinical Chemistry Parameters: Calcium, Carbon-dioxide (CO2), Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Phosphate, Day 5 | 1.142 Millimoles per liter | Standard Deviation 0.2344 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values of Clinical Chemistry Parameters: Calcium, Carbon-dioxide (CO2), Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Phosphate, Day 7 | 1.198 Millimoles per liter | Standard Deviation 0.1058 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values of Clinical Chemistry Parameters: Calcium, Carbon-dioxide (CO2), Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Triglycerides, Baseline (Day -1) | 1.284 Millimoles per liter | Standard Deviation 0.6031 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values of Clinical Chemistry Parameters: Calcium, Carbon-dioxide (CO2), Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Triglycerides, Day 2 | 1.271 Millimoles per liter | Standard Deviation 0.6676 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values of Clinical Chemistry Parameters: Calcium, Carbon-dioxide (CO2), Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Triglycerides, Day 5 | 1.020 Millimoles per liter | Standard Deviation 0.4494 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values of Clinical Chemistry Parameters: Calcium, Carbon-dioxide (CO2), Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Triglycerides Day 7 | 0.972 Millimoles per liter | Standard Deviation 0.3031 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values of Clinical Chemistry Parameters: Calcium, Carbon-dioxide (CO2), Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Cholesterol, Baseline (Day -1) | 4.737 Millimoles per liter | Standard Deviation 0.7591 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values of Clinical Chemistry Parameters: Calcium, Carbon-dioxide (CO2), Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Cholesterol, Day 2 | 4.795 Millimoles per liter | Standard Deviation 0.7617 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values of Clinical Chemistry Parameters: Calcium, Carbon-dioxide (CO2), Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Glucose, Day 5 | 5.153 Millimoles per liter | Standard Deviation 0.3527 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values of Clinical Chemistry Parameters: Calcium, Carbon-dioxide (CO2), Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Cholesterol, Day 7 | 4.776 Millimoles per liter | Standard Deviation 0.6017 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values of Clinical Chemistry Parameters: Calcium, Carbon-dioxide (CO2), Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Anion gap, Baseline (Day -1) | 10.1 Millimoles per liter | Standard Deviation 1.62 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values of Clinical Chemistry Parameters: Calcium, Carbon-dioxide (CO2), Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Anion gap, Day 2 | 10.5 Millimoles per liter | Standard Deviation 1.29 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values of Clinical Chemistry Parameters: Calcium, Carbon-dioxide (CO2), Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Anion gap, Day 5 | 10.7 Millimoles per liter | Standard Deviation 1.63 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values of Clinical Chemistry Parameters: Calcium, Carbon-dioxide (CO2), Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Anion gap, Day 7 | 9.7 Millimoles per liter | Standard Deviation 1.38 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values of Clinical Chemistry Parameters: Calcium, Carbon-dioxide (CO2), Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | CO2, Baseline (Day -1) | 30.3 Millimoles per liter | Standard Deviation 1.83 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values of Clinical Chemistry Parameters: Calcium, Carbon-dioxide (CO2), Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Phosphate, Day 2 | 1.238 Millimoles per liter | Standard Deviation 0.1306 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values of Clinical Chemistry Parameters: Calcium, Carbon-dioxide (CO2), Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Glucose, Day 2 | 4.813 Millimoles per liter | Standard Deviation 0.4044 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values of Clinical Chemistry Parameters: Calcium, Carbon-dioxide (CO2), Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Anion gap, Day 7 | 9.4 Millimoles per liter | Standard Deviation 1.65 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values of Clinical Chemistry Parameters: Calcium, Carbon-dioxide (CO2), Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Phosphate, Day 5 | 1.178 Millimoles per liter | Standard Deviation 0.1574 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values of Clinical Chemistry Parameters: Calcium, Carbon-dioxide (CO2), Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Glucose, Baseline (Day -1) | 5.074 Millimoles per liter | Standard Deviation 0.3816 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values of Clinical Chemistry Parameters: Calcium, Carbon-dioxide (CO2), Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Cholesterol, Day 7 | 4.590 Millimoles per liter | Standard Deviation 0.7417 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values of Clinical Chemistry Parameters: Calcium, Carbon-dioxide (CO2), Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Phosphate, Day 7 | 1.172 Millimoles per liter | Standard Deviation 0.1494 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values of Clinical Chemistry Parameters: Calcium, Carbon-dioxide (CO2), Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Chloride, Day 7 | 101.8 Millimoles per liter | Standard Deviation 1.03 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values of Clinical Chemistry Parameters: Calcium, Carbon-dioxide (CO2), Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Calcium, Day 7 | 2.371 Millimoles per liter | Standard Deviation 0.1201 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values of Clinical Chemistry Parameters: Calcium, Carbon-dioxide (CO2), Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Triglycerides, Baseline (Day -1) | 1.011 Millimoles per liter | Standard Deviation 0.3381 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values of Clinical Chemistry Parameters: Calcium, Carbon-dioxide (CO2), Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Chloride, Day 5 | 101.7 Millimoles per liter | Standard Deviation 1.86 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values of Clinical Chemistry Parameters: Calcium, Carbon-dioxide (CO2), Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Anion gap, Day 5 | 10.8 Millimoles per liter | Standard Deviation 1.72 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values of Clinical Chemistry Parameters: Calcium, Carbon-dioxide (CO2), Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Triglycerides, Day 2 | 1.022 Millimoles per liter | Standard Deviation 0.3455 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values of Clinical Chemistry Parameters: Calcium, Carbon-dioxide (CO2), Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Chloride, Day 2 | 102.0 Millimoles per liter | Standard Deviation 2.32 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values of Clinical Chemistry Parameters: Calcium, Carbon-dioxide (CO2), Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Anion gap, Baseline (Day -1) | 9.6 Millimoles per liter | Standard Deviation 1.43 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values of Clinical Chemistry Parameters: Calcium, Carbon-dioxide (CO2), Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Triglycerides, Day 5 | 0.827 Millimoles per liter | Standard Deviation 0.2523 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values of Clinical Chemistry Parameters: Calcium, Carbon-dioxide (CO2), Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Chloride, Baseline (Day -1) | 102.1 Millimoles per liter | Standard Deviation 2.21 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values of Clinical Chemistry Parameters: Calcium, Carbon-dioxide (CO2), Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Calcium, Day 5 | 2.393 Millimoles per liter | Standard Deviation 0.1171 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values of Clinical Chemistry Parameters: Calcium, Carbon-dioxide (CO2), Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Triglycerides Day 7 | 1.048 Millimoles per liter | Standard Deviation 0.3121 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values of Clinical Chemistry Parameters: Calcium, Carbon-dioxide (CO2), Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | CO2, Day 7 | 30.0 Millimoles per liter | Standard Deviation 2.05 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values of Clinical Chemistry Parameters: Calcium, Carbon-dioxide (CO2), Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Calcium, Baseline (Day -1) | 2.347 Millimoles per liter | Standard Deviation 0.0839 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values of Clinical Chemistry Parameters: Calcium, Carbon-dioxide (CO2), Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Sodium, Day 2 | 137.9 Millimoles per liter | Standard Deviation 1.76 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values of Clinical Chemistry Parameters: Calcium, Carbon-dioxide (CO2), Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Cholesterol, Baseline (Day -1) | 4.674 Millimoles per liter | Standard Deviation 0.6908 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values of Clinical Chemistry Parameters: Calcium, Carbon-dioxide (CO2), Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Sodium, Day 5 | 137.8 Millimoles per liter | Standard Deviation 2.64 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values of Clinical Chemistry Parameters: Calcium, Carbon-dioxide (CO2), Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Sodium, Baseline (Day -1) | 137.6 Millimoles per liter | Standard Deviation 2.37 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values of Clinical Chemistry Parameters: Calcium, Carbon-dioxide (CO2), Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | CO2, Day 5 | 29.7 Millimoles per liter | Standard Deviation 2.5 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values of Clinical Chemistry Parameters: Calcium, Carbon-dioxide (CO2), Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Sodium, Day 7 | 137.2 Millimoles per liter | Standard Deviation 2.39 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values of Clinical Chemistry Parameters: Calcium, Carbon-dioxide (CO2), Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Potassium, Day 7 | 4.16 Millimoles per liter | Standard Deviation 0.165 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values of Clinical Chemistry Parameters: Calcium, Carbon-dioxide (CO2), Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Anion gap, Day 2 | 10.3 Millimoles per liter | Standard Deviation 2.23 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values of Clinical Chemistry Parameters: Calcium, Carbon-dioxide (CO2), Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Urea nitrogen, Baseline (Day -1) | 4.216 Millimoles per liter | Standard Deviation 0.5976 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values of Clinical Chemistry Parameters: Calcium, Carbon-dioxide (CO2), Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Potassium, Day 5 | 4.15 Millimoles per liter | Standard Deviation 0.513 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values of Clinical Chemistry Parameters: Calcium, Carbon-dioxide (CO2), Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Cholesterol, Day 2 | 4.726 Millimoles per liter | Standard Deviation 0.7404 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values of Clinical Chemistry Parameters: Calcium, Carbon-dioxide (CO2), Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Urea nitrogen, Day 2 | 4.491 Millimoles per liter | Standard Deviation 0.8115 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values of Clinical Chemistry Parameters: Calcium, Carbon-dioxide (CO2), Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Potassium, Day 2 | 4.27 Millimoles per liter | Standard Deviation 0.334 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values of Clinical Chemistry Parameters: Calcium, Carbon-dioxide (CO2), Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | CO2, Day 2 | 29.8 Millimoles per liter | Standard Deviation 2.36 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values of Clinical Chemistry Parameters: Calcium, Carbon-dioxide (CO2), Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Urea nitrogen, Day 5 | 4.368 Millimoles per liter | Standard Deviation 0.6707 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values of Clinical Chemistry Parameters: Calcium, Carbon-dioxide (CO2), Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Potassium, Baseline (Day -1) | 4.24 Millimoles per liter | Standard Deviation 0.315 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values of Clinical Chemistry Parameters: Calcium, Carbon-dioxide (CO2), Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Calcium, Day 2 | 2.379 Millimoles per liter | Standard Deviation 0.1009 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values of Clinical Chemistry Parameters: Calcium, Carbon-dioxide (CO2), Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Urea nitrogen, Day 7 | 4.439 Millimoles per liter | Standard Deviation 1.0769 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values of Clinical Chemistry Parameters: Calcium, Carbon-dioxide (CO2), Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Glucose, Day 7 | 4.946 Millimoles per liter | Standard Deviation 0.3303 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values of Clinical Chemistry Parameters: Calcium, Carbon-dioxide (CO2), Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Cholesterol, Day 5 | 4.292 Millimoles per liter | Standard Deviation 0.4032 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values of Clinical Chemistry Parameters: Calcium, Carbon-dioxide (CO2), Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Phosphate, Baseline (Day -1) | 1.156 Millimoles per liter | Standard Deviation 0.1414 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values of Clinical Chemistry Parameters: Calcium, Carbon-dioxide (CO2), Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Glucose, Day 5 | 5.123 Millimoles per liter | Standard Deviation 0.4912 |
Secondary
Part 1: Absolute Values of Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate
Blood samples were collected to analyze the chemistry parameters: creatinine, direct bilirubin, bilirubin, urate. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period.
Time frame: Baseline (Day -1), and Days 2, 5, and 7
Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values of Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate | Direct bilirubin, Baseline (Day -1) | 1.93 Micromoles per liter | Standard Deviation 0.54 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values of Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate | Creatinine, Day 2 | 82.89 Micromoles per liter | Standard Deviation 15.88 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values of Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate | Creatinine, Day 5 | 76.77 Micromoles per liter | Standard Deviation 9.046 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values of Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate | Creatinine, Day 7 | 82.05 Micromoles per liter | Standard Deviation 14.136 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values of Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate | Creatinine, Baseline (Day -1) | 74.58 Micromoles per liter | Standard Deviation 13.77 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values of Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate | Direct bilirubin, Day 2 | 1.80 Micromoles per liter | Standard Deviation 0.532 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values of Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate | Direct bilirubin, Day 5 | 1.67 Micromoles per liter | Standard Deviation 0.437 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values of Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate | Direct bilirubin, Day 7 | 2.00 Micromoles per liter | Standard Deviation 0.548 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values of Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate | Bilirubin, Baseline (Day -1) | 10.38 Micromoles per liter | Standard Deviation 3.283 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values of Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate | Bilirubin, Day 2 | 9.70 Micromoles per liter | Standard Deviation 2.714 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values of Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate | Bilirubin, Day 5 | 8.38 Micromoles per liter | Standard Deviation 3.021 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values of Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate | Bilirubin, Day 7 | 10.92 Micromoles per liter | Standard Deviation 2.975 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values of Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate | Urate, Baseline (Day -1) | 287.0 Micromoles per liter | Standard Deviation 67.2 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values of Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate | Urate, Day 2 | 280.1 Micromoles per liter | Standard Deviation 64.07 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values of Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate | Urate, Day 5 | 235.0 Micromoles per liter | Standard Deviation 40.83 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values of Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate | Urate, Day 7 | 305.1 Micromoles per liter | Standard Deviation 55.55 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values of Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate | Direct bilirubin, Day 2 | 1.97 Micromoles per liter | Standard Deviation 0.678 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values of Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate | Direct bilirubin, Day 5 | 2.08 Micromoles per liter | Standard Deviation 0.694 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values of Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate | Direct bilirubin, Day 7 | 1.88 Micromoles per liter | Standard Deviation 0.577 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values of Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate | Urate, Day 2 | 283.9 Micromoles per liter | Standard Deviation 62.39 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values of Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate | Bilirubin, Baseline (Day -1) | 11.43 Micromoles per liter | Standard Deviation 3.51 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values of Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate | Bilirubin, Day 2 | 11.04 Micromoles per liter | Standard Deviation 3.619 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values of Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate | Urate, Day 7 | 271.8 Micromoles per liter | Standard Deviation 58.66 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values of Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate | Bilirubin, Day 5 | 9.95 Micromoles per liter | Standard Deviation 3.605 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values of Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate | Creatinine, Baseline (Day -1) | 77.79 Micromoles per liter | Standard Deviation 14.328 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values of Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate | Urate, Day 5 | 290.5 Micromoles per liter | Standard Deviation 53.91 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values of Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate | Creatinine, Day 2 | 84.90 Micromoles per liter | Standard Deviation 17.025 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values of Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate | Bilirubin, Day 7 | 10.34 Micromoles per liter | Standard Deviation 3.51 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values of Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate | Creatinine, Day 5 | 77.20 Micromoles per liter | Standard Deviation 17.447 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values of Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate | Creatinine, Day 7 | 78.55 Micromoles per liter | Standard Deviation 15.613 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values of Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate | Direct bilirubin, Baseline (Day -1) | 2.03 Micromoles per liter | Standard Deviation 0.597 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values of Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate | Urate, Baseline (Day -1) | 291.8 Micromoles per liter | Standard Deviation 58.22 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values of Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate | Bilirubin, Day 5 | 11.05 Micromoles per liter | Standard Deviation 3.553 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values of Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate | Direct bilirubin, Day 2 | 2.03 Micromoles per liter | Standard Deviation 0.687 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values of Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate | Urate, Baseline (Day -1) | 276.0 Micromoles per liter | Standard Deviation 58.76 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values of Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate | Creatinine, Day 5 | 79.57 Micromoles per liter | Standard Deviation 18.646 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values of Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate | Direct bilirubin, Day 5 | 2.28 Micromoles per liter | Standard Deviation 0.778 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values of Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate | Urate, Day 7 | 280.0 Micromoles per liter | Standard Deviation 53.36 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values of Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate | Creatinine, Baseline (Day -1) | 75.32 Micromoles per liter | Standard Deviation 15.25 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values of Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate | Direct bilirubin, Day 7 | 2.04 Micromoles per liter | Standard Deviation 0.648 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values of Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate | Bilirubin, Day 7 | 10.11 Micromoles per liter | Standard Deviation 3.473 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values of Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate | Direct bilirubin, Baseline (Day -1) | 2.03 Micromoles per liter | Standard Deviation 0.634 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values of Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate | Bilirubin, Baseline (Day -1) | 10.93 Micromoles per liter | Standard Deviation 3.805 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values of Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate | Urate, Day 2 | 271.9 Micromoles per liter | Standard Deviation 54.52 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values of Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate | Creatinine, Day 2 | 81.47 Micromoles per liter | Standard Deviation 15.445 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values of Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate | Bilirubin, Day 2 | 10.72 Micromoles per liter | Standard Deviation 3.862 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values of Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate | Creatinine, Day 7 | 74.53 Micromoles per liter | Standard Deviation 13.793 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values of Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate | Urate, Day 5 | 292.3 Micromoles per liter | Standard Deviation 53.16 |
Secondary
Part 1: Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF)
Twelve lead ECGs were obtained to measure PR interval, QRS duration, QT interval, and QTcF interval . Twelve lead ECGs were performed with the participant in a supine position after a rest of at least 10 minutes. Baseline was defined as the average of the triplicate pre-dose assessments within each treatment
Time frame: Baseline (Day 1, pre-dose), and Day 1: 2, 4, 6 hours, and Day 5
Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF) | QTcF Interval, Day 1, 2 hours | 397.5 Milliseconds | Standard Deviation 18.03 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF) | PR Interval, Baseline (Day1 pre-dose) | 162.8 Milliseconds | Standard Deviation 17.39 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF) | QRS Duration, Day 1, 2 hours | 91.3 Milliseconds | Standard Deviation 7.12 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF) | PR Interval, Day 1, 6 hours | 160.4 Milliseconds | Standard Deviation 18.7 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF) | PR Interval, Day 5 | 162.2 Milliseconds | Standard Deviation 16.02 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF) | QRS Duration, Day 1, 4 hours | 90.0 Milliseconds | Standard Deviation 8.16 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF) | QTcF Interval, Day 1, 4 hours | 399.1 Milliseconds | Standard Deviation 19.4 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF) | PR Interval, Day 1, 4 hours | 159.2 Milliseconds | Standard Deviation 17.5 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF) | QRS Duration, Day 1, 6 hours | 91.0 Milliseconds | Standard Deviation 7.67 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF) | QTcF Interval, Baseline (Day 1) | 404.3 Milliseconds | Standard Deviation 17.15 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF) | PR Interval, Day 1, 2 hours | 159.0 Milliseconds | Standard Deviation 18.13 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF) | QRS Duration, Day 5 | 92.3 Milliseconds | Standard Deviation 4.93 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF) | QT Interval, Day 5 | 389.5 Milliseconds | Standard Deviation 18.32 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF) | QTcF Interval, Day 1, 6 hours | 401.8 Milliseconds | Standard Deviation 17.12 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF) | QT Interval, Baseline (Day 1) | 397.0 Milliseconds | Standard Deviation 26.26 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF) | QTcF Interval, Day 5 | 396.5 Milliseconds | Standard Deviation 23.48 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF) | QT Interval, Day 1, 6 hours | 387.8 Milliseconds | Standard Deviation 21.9 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF) | QRS Duration, Baseline (Day 1) | 92.0 Milliseconds | Standard Deviation 7.09 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF) | QT Interval, Day 1, 4 hours | 391.2 Milliseconds | Standard Deviation 26.27 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF) | QT Interval, Day 1, 2 hours | 381.1 Milliseconds | Standard Deviation 24.29 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF) | QT Interval, Day 1, 4 hours | 385.0 Milliseconds | Standard Deviation 23.31 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF) | QT Interval, Day 1, 6 hours | 379.3 Milliseconds | Standard Deviation 23.66 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF) | QT Interval, Day 5 | 374.8 Milliseconds | Standard Deviation 29.13 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF) | PR Interval, Day 1, 6 hours | 158.2 Milliseconds | Standard Deviation 18.1 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF) | QTcF Interval, Baseline (Day 1) | 400.7 Milliseconds | Standard Deviation 19.6 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF) | QTcF Interval, Day 1, 6 hours | 398.4 Milliseconds | Standard Deviation 19.8 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF) | QTcF Interval, Day 1, 2 hours | 393.1 Milliseconds | Standard Deviation 19.2 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF) | QTcF Interval, Day 1, 4 hours | 396.5 Milliseconds | Standard Deviation 399.3 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF) | PR Interval, Day 5 | 170.8 Milliseconds | Standard Deviation 12.42 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF) | QTcF Interval, Day 5 | 399.0 Milliseconds | Standard Deviation 17.93 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF) | QRS Duration, Baseline (Day 1) | 93.1 Milliseconds | Standard Deviation 7.83 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF) | QRS Duration, Day 1, 2 hours | 92.8 Milliseconds | Standard Deviation 9.11 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF) | PR Interval, Baseline (Day1 pre-dose) | 162.8 Milliseconds | Standard Deviation 18.05 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF) | QRS Duration, Day 1, 4 hours | 91.5 Milliseconds | Standard Deviation 8.18 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF) | QRS Duration, Day 1, 6 hours | 91.7 Milliseconds | Standard Deviation 8.87 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF) | QRS Duration, Day 5 | 94.2 Milliseconds | Standard Deviation 6.24 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF) | PR Interval, Day 1, 2 hours | 158.0 Milliseconds | Standard Deviation 17.16 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF) | QT Interval, Baseline (Day 1) | 393.1 Milliseconds | Standard Deviation 29.1 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF) | QT Interval, Day 1, 2 hours | 375.0 Milliseconds | Standard Deviation 24.49 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF) | PR Interval, Day 1, 4 hours | 160.0 Milliseconds | Standard Deviation 17.51 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF) | QTcF Interval, Day 5 | 395.7 Milliseconds | Standard Deviation 13.69 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF) | QT Interval, Baseline (Day 1) | 394.2 Milliseconds | Standard Deviation 24.66 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF) | QTcF Interval, Day 1, 6 hours | 399.0 Milliseconds | Standard Deviation 16.65 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF) | PR Interval, Baseline (Day1 pre-dose) | 163.1 Milliseconds | Standard Deviation 16.9 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF) | PR Interval, Day 1, 4 hours | 159.9 Milliseconds | Standard Deviation 15.79 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF) | PR Interval, Day 1, 6 hours | 160.1 Milliseconds | Standard Deviation 16.87 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF) | PR Interval, Day 5 | 159.8 Milliseconds | Standard Deviation 31.98 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF) | QRS Duration, Baseline (Day 1) | 93.4 Milliseconds | Standard Deviation 8.61 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF) | QRS Duration, Day 1, 2 hours | 92.8 Milliseconds | Standard Deviation 8.15 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF) | QRS Duration, Day 1, 4 hours | 91.7 Milliseconds | Standard Deviation 9.04 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF) | QRS Duration, Day 1, 6 hours | 93.2 Milliseconds | Standard Deviation 8.63 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF) | QRS Duration, Day 5 | 94.8 Milliseconds | Standard Deviation 9.99 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF) | QT Interval, Day 1, 2 hours | 375.6 Milliseconds | Standard Deviation 19.77 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF) | QT Interval, Day 1, 4 hours | 386.4 Milliseconds | Standard Deviation 21.34 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF) | QT Interval, Day 1, 6 hours | 382.2 Milliseconds | Standard Deviation 20.88 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF) | QT Interval, Day 5 | 400.5 Milliseconds | Standard Deviation 9.01 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF) | QTcF Interval, Baseline (Day 1) | 403.7 Milliseconds | Standard Deviation 14.85 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF) | QTcF Interval, Day 1, 2 hours | 397.0 Milliseconds | Standard Deviation 15.11 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF) | QTcF Interval, Day 1, 4 hours | 399.3 Milliseconds | Standard Deviation 17.85 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF) | PR Interval, Day 1, 2 hours | 157.7 Milliseconds | Standard Deviation 17.78 |
Secondary
Part 1: Absolute Values of Vital Sign Parameters: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
SBP and DBP were measured in the 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 is defined as the average of the triplicate predose assessments within each treatment.
Time frame: Baseline (Day 1, pre-dose), and Day 1: 24, 48, 72 hours, Days 5 and 7
Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values of Vital Sign Parameters: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP, Day 1, 24 hours | 60.9 Millimeters of mercury | Standard Deviation 7.34 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values of Vital Sign Parameters: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP, Day 1, 72 hours | 58.7 Millimeters of mercury | Standard Deviation 6.19 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values of Vital Sign Parameters: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP, Day 5 | 61.7 Millimeters of mercury | Standard Deviation 5.24 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values of Vital Sign Parameters: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP, Baseline (Day 1) | 61.5 Millimeters of mercury | Standard Deviation 6.39 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values of Vital Sign Parameters: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP, Day 1, 48 hours | 59.8 Millimeters of mercury | Standard Deviation 5.89 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values of Vital Sign Parameters: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP Interval, Day 7 | 62.0 Millimeters of mercury | Standard Deviation 8.46 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values of Vital Sign Parameters: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP, Baseline (Day 1) | 108.9 Millimeters of mercury | Standard Deviation 11.23 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values of Vital Sign Parameters: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP, Day 1, 24 hours | 106.1 Millimeters of mercury | Standard Deviation 10.41 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values of Vital Sign Parameters: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP, Day 1, 48 hours | 104.7 Millimeters of mercury | Standard Deviation 8.6 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values of Vital Sign Parameters: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP, Day 1, 72 hours | 100.5 Millimeters of mercury | Standard Deviation 6.53 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values of Vital Sign Parameters: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP, Day 5 | 105.8 Millimeters of mercury | Standard Deviation 8.64 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values of Vital Sign Parameters: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP, Day 7 | 110.5 Millimeters of mercury | Standard Deviation 13.4 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values of Vital Sign Parameters: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP Interval, Day 7 | 61.0 Millimeters of mercury | Standard Deviation 7.18 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values of Vital Sign Parameters: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP, Day 5 | 118.0 Millimeters of mercury | Standard Deviation 19.67 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values of Vital Sign Parameters: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP, Day 1, 72 hours | 63.0 Millimeters of mercury | Standard Deviation 8.69 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values of Vital Sign Parameters: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP, Day 1, 48 hours | 61.2 Millimeters of mercury | Standard Deviation 6.68 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values of Vital Sign Parameters: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP, Day 1, 48 hours | 110.5 Millimeters of mercury | Standard Deviation 14.02 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values of Vital Sign Parameters: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP, Day 5 | 64.2 Millimeters of mercury | Standard Deviation 6.05 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values of Vital Sign Parameters: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP, Baseline (Day 1) | 110.6 Millimeters of mercury | Standard Deviation 13.47 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values of Vital Sign Parameters: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP, Day 1, 72 hours | 114.7 Millimeters of mercury | Standard Deviation 21.57 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values of Vital Sign Parameters: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP, Day 7 | 108.2 Millimeters of mercury | Standard Deviation 9.24 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values of Vital Sign Parameters: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP, Day 1, 24 hours | 112.9 Millimeters of mercury | Standard Deviation 13.3 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values of Vital Sign Parameters: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP, Baseline (Day 1) | 63.2 Millimeters of mercury | Standard Deviation 7.21 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values of Vital Sign Parameters: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP, Day 1, 24 hours | 63.1 Millimeters of mercury | Standard Deviation 8.18 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values of Vital Sign Parameters: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP, Baseline (Day 1) | 63.2 Millimeters of mercury | Standard Deviation 9.05 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values of Vital Sign Parameters: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP, Day 1, 24 hours | 63.0 Millimeters of mercury | Standard Deviation 6.4 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values of Vital Sign Parameters: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP, Day 5 | 109.2 Millimeters of mercury | Standard Deviation 10.98 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values of Vital Sign Parameters: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP, Day 1, 48 hours | 59.6 Millimeters of mercury | Standard Deviation 4.72 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values of Vital Sign Parameters: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP, Day 5 | 61.5 Millimeters of mercury | Standard Deviation 4.18 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values of Vital Sign Parameters: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP Interval, Day 7 | 59.4 Millimeters of mercury | Standard Deviation 5.48 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values of Vital Sign Parameters: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP, Day 1, 72 hours | 112.2 Millimeters of mercury | Standard Deviation 12.19 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values of Vital Sign Parameters: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP, Day 1, 24 hours | 108.7 Millimeters of mercury | Standard Deviation 10.54 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values of Vital Sign Parameters: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP, Day 1, 72 hours | 61.3 Millimeters of mercury | Standard Deviation 4.08 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values of Vital Sign Parameters: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP, Baseline (Day 1) | 110.8 Millimeters of mercury | Standard Deviation 16.32 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values of Vital Sign Parameters: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP, Day 7 | 106.8 Millimeters of mercury | Standard Deviation 11.94 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values of Vital Sign Parameters: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP, Day 1, 48 hours | 106.7 Millimeters of mercury | Standard Deviation 10.47 |
Secondary
Part 1: Absolute Values of Vital Signs: Oral Temperature
Oral temperature were measured in the 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 average of the triplicate predose assessments within each treatment.
Time frame: Baseline (Day 1, pre-dose), and Day 1: 24, 48, 72 hours, Days 5, 6 and 7
Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values of Vital Signs: Oral Temperature | Day 6 | 36.43 Degrees celsius | Standard Deviation 0.317 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values of Vital Signs: Oral Temperature | Day 5 | 36.44 Degrees celsius | Standard Deviation 0.475 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values of Vital Signs: Oral Temperature | Day 1, 72 hours | 36.45 Degrees celsius | Standard Deviation 0.423 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values of Vital Signs: Oral Temperature | Baseline (Day 1 pre-dose) | 36.38 Degrees celsius | Standard Deviation 0.424 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values of Vital Signs: Oral Temperature | Day 7 | 36.51 Degrees celsius | Standard Deviation 0.501 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values of Vital Signs: Oral Temperature | Day 1, 24 hours | 36.47 Degrees celsius | Standard Deviation 0.431 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values of Vital Signs: Oral Temperature | Day 1, 48 hours | 36.54 Degrees celsius | Standard Deviation 0.343 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values of Vital Signs: Oral Temperature | Day 1, 72 hours | 36.77 Degrees celsius | Standard Deviation 0.314 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values of Vital Signs: Oral Temperature | Day 1, 48 hours | 36.54 Degrees celsius | Standard Deviation 0.385 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values of Vital Signs: Oral Temperature | Baseline (Day 1 pre-dose) | 36.43 Degrees celsius | Standard Deviation 0.451 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values of Vital Signs: Oral Temperature | Day 1, 24 hours | 36.55 Degrees celsius | Standard Deviation 0.481 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values of Vital Signs: Oral Temperature | Day 5 | 36.43 Degrees celsius | Standard Deviation 0.527 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values of Vital Signs: Oral Temperature | Day 6 | 36.49 Degrees celsius | Standard Deviation 0.468 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values of Vital Signs: Oral Temperature | Day 7 | 36.46 Degrees celsius | Standard Deviation 0.38 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values of Vital Signs: Oral Temperature | Day 5 | 36.48 Degrees celsius | Standard Deviation 0.355 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values of Vital Signs: Oral Temperature | Day 1, 24 hours | 36.60 Degrees celsius | Standard Deviation 0.422 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values of Vital Signs: Oral Temperature | Day 7 | 36.72 Degrees celsius | Standard Deviation 0.282 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values of Vital Signs: Oral Temperature | Day 6 | 36.43 Degrees celsius | Standard Deviation 0.267 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values of Vital Signs: Oral Temperature | Day 1, 72 hours | 36.25 Degrees celsius | Standard Deviation 0.505 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values of Vital Signs: Oral Temperature | Day 1, 48 hours | 36.61 Degrees celsius | Standard Deviation 0.264 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values of Vital Signs: Oral Temperature | Baseline (Day 1 pre-dose) | 36.52 Degrees celsius | Standard Deviation 0.382 |
Secondary
Part 1: Absolute Values of Vital Signs: Pulse Rate
Pulse rate was measured in the 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 average of the triplicate predose assessments within each treatment.
Time frame: Baseline (Day 1, pre-dose), and Day 1: 24, 48, 72 hours, Days 5 and 7
Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values of Vital Signs: Pulse Rate | Baseline (Day 1, Pre-dose) | 64.9 Beats per minute | Standard Deviation 13.41 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values of Vital Signs: Pulse Rate | Day 1, 24 hours | 61.7 Beats per minute | Standard Deviation 9.05 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values of Vital Signs: Pulse Rate | Day 1, 48 hours | 61.7 Beats per minute | Standard Deviation 6.88 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values of Vital Signs: Pulse Rate | Day 1, 72 hours | 61.2 Beats per minute | Standard Deviation 10.76 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values of Vital Signs: Pulse Rate | Day 5 | 62.3 Beats per minute | Standard Deviation 6.06 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values of Vital Signs: Pulse Rate | Day 7 | 58.9 Beats per minute | Standard Deviation 8.29 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values of Vital Signs: Pulse Rate | Day 7 | 60.8 Beats per minute | Standard Deviation 8.49 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values of Vital Signs: Pulse Rate | Baseline (Day 1, Pre-dose) | 66.06 Beats per minute | Standard Deviation 14.53 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values of Vital Signs: Pulse Rate | Day 1, 72 hours | 77.7 Beats per minute | Standard Deviation 22.98 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values of Vital Signs: Pulse Rate | Day 5 | 77.5 Beats per minute | Standard Deviation 20.84 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values of Vital Signs: Pulse Rate | Day 1, 24 hours | 68.6 Beats per minute | Standard Deviation 11.69 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values of Vital Signs: Pulse Rate | Day 1, 48 hours | 65.5 Beats per minute | Standard Deviation 11.81 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values of Vital Signs: Pulse Rate | Day 1, 24 hours | 64.8 Beats per minute | Standard Deviation 11.47 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values of Vital Signs: Pulse Rate | Day 1, 48 hours | 64.9 Beats per minute | Standard Deviation 10.2 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values of Vital Signs: Pulse Rate | Day 7 | 69.6 Beats per minute | Standard Deviation 9.83 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values of Vital Signs: Pulse Rate | Day 1, 72 hours | 57.7 Beats per minute | Standard Deviation 10.76 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values of Vital Signs: Pulse Rate | Baseline (Day 1, Pre-dose) | 67.4 Beats per minute | Standard Deviation 14.19 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values of Vital Signs: Pulse Rate | Day 5 | 59.7 Beats per minute | Standard Deviation 11.81 |
Secondary
Part 1: Absolute Values of Vital Signs: Respiratory Rate
Respiratory rate was measured in the 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 average of the triplicate predose assessments within each treatment.
Time frame: Baseline (Day 1, pre-dose), and Day 1: 24, 48, 72 hours, Days 5 and 7
Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values of Vital Signs: Respiratory Rate | Baseline (Day 1, pre-dose) | 14.1 Breaths per minute | Standard Deviation 2.65 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values of Vital Signs: Respiratory Rate | Day 1, 24 hours | 13.8 Breaths per minute | Standard Deviation 3.26 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values of Vital Signs: Respiratory Rate | Day 1, 48 hours | 14.9 Breaths per minute | Standard Deviation 2.68 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values of Vital Signs: Respiratory Rate | Day 1, 72 hours | 14.0 Breaths per minute | Standard Deviation 2.83 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values of Vital Signs: Respiratory Rate | Day 5 | 11.7 Breaths per minute | Standard Deviation 3.44 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Absolute Values of Vital Signs: Respiratory Rate | Day 7 | 14.0 Breaths per minute | Standard Deviation 2.97 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values of Vital Signs: Respiratory Rate | Day 7 | 14.6 Breaths per minute | Standard Deviation 1.89 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values of Vital Signs: Respiratory Rate | Baseline (Day 1, pre-dose) | 13.6 Breaths per minute | Standard Deviation 2.58 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values of Vital Signs: Respiratory Rate | Day 1, 72 hours | 13.0 Breaths per minute | Standard Deviation 2.45 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values of Vital Signs: Respiratory Rate | Day 5 | 12.0 Breaths per minute | Standard Deviation 2.83 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values of Vital Signs: Respiratory Rate | Day 1, 24 hours | 13.8 Breaths per minute | Standard Deviation 3.03 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Absolute Values of Vital Signs: Respiratory Rate | Day 1, 48 hours | 12.7 Breaths per minute | Standard Deviation 2.42 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values of Vital Signs: Respiratory Rate | Day 1, 24 hours | 14.8 Breaths per minute | Standard Deviation 2.93 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values of Vital Signs: Respiratory Rate | Day 1, 48 hours | 14.1 Breaths per minute | Standard Deviation 2 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values of Vital Signs: Respiratory Rate | Day 7 | 12.9 Breaths per minute | Standard Deviation 3.78 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values of Vital Signs: Respiratory Rate | Day 1, 72 hours | 14.0 Breaths per minute | Standard Deviation 1.26 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values of Vital Signs: Respiratory Rate | Baseline (Day 1, pre-dose) | 13.9 Breaths per minute | Standard Deviation 3.28 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Absolute Values of Vital Signs: Respiratory Rate | Day 5 | 14.7 Breaths per minute | Standard Deviation 3.93 |
Secondary
Part 1: Change From Baseline for Urinalysis Parameter: Potential of Hydrogen
Urine samples were collected to analyze the urinalysis parameter: pH. 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. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time frame: Baseline (Day -1) and Days 2, 5, and 7
Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Change From Baseline for Urinalysis Parameter: Potential of Hydrogen | Day 5 | -0.58 pH | Standard Deviation 0.665 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Change From Baseline for Urinalysis Parameter: Potential of Hydrogen | Day 2 | -0.02 pH | Standard Deviation 0.545 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Change From Baseline for Urinalysis Parameter: Potential of Hydrogen | Day 7 | -0.45 pH | Standard Deviation 0.416 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Change From Baseline for Urinalysis Parameter: Potential of Hydrogen | Day 5 | -0.08 pH | Standard Deviation 0.585 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Change From Baseline for Urinalysis Parameter: Potential of Hydrogen | Day 2 | 0.17 pH | Standard Deviation 0.796 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Change From Baseline for Urinalysis Parameter: Potential of Hydrogen | Day 7 | -0.31 pH | Standard Deviation 0.723 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Change From Baseline for Urinalysis Parameter: Potential of Hydrogen | Day 2 | 0.33 pH | Standard Deviation 0.52 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Change From Baseline for Urinalysis Parameter: Potential of Hydrogen | Day 7 | 0.15 pH | Standard Deviation 0.412 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Change From Baseline for Urinalysis Parameter: Potential of Hydrogen | Day 5 | -0.08 pH | Standard Deviation 0.204 |
Secondary
Part 1: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK
Blood samples were collected to analyze the chemistry parameters: ALT, ALP, AST, GGT, LDH, CK. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time frame: Baseline (Day -1) and Days 2, 5, and 7
Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK | ALP, Day 5 | -1.8 International units per Liter | Standard Deviation 3.25 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK | ALT, Day 5 | -1.7 International units per Liter | Standard Deviation 4.37 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK | ALT, Day 7 | 1.1 International units per Liter | Standard Deviation 5.97 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK | ALP, Day 2 | 1.8 International units per Liter | Standard Deviation 5.14 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK | ALT, Day 2 | -0.1 International units per Liter | Standard Deviation 2.49 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK | ALP, Day 7 | 1.4 International units per Liter | Standard Deviation 3.67 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK | AST, Day 2 | -0.5 International units per Liter | Standard Deviation 1.65 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK | AST, Day 5 | -2.0 International units per Liter | Standard Deviation 2.9 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK | AST, Day 7 | -0.4 International units per Liter | Standard Deviation 2.06 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK | GGT, Day 2 | -0.1 International units per Liter | Standard Deviation 2.24 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK | GGT, Day 5 | -3.0 International units per Liter | Standard Deviation 4.2 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK | GGT, Day 7 | -0.1 International units per Liter | Standard Deviation 3.11 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK | LDH, Day 2 | -2.6 International units per Liter | Standard Deviation 11.67 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK | LDH, Day 5 | -16.5 International units per Liter | Standard Deviation 14.9 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK | LDH, Day 7 | -8.8 International units per Liter | Standard Deviation 10.09 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK | CK, Day 2 | -11.4 International units per Liter | Standard Deviation 33.22 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK | CK, Day 5 | -18.5 International units per Liter | Standard Deviation 20.66 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK | CK, Day 7 | -26.2 International units per Liter | Standard Deviation 43.88 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK | CK, Day 7 | -27.3 International units per Liter | Standard Deviation 43.24 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK | ALT, Day 2 | -1.7 International units per Liter | Standard Deviation 4.74 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK | GGT, Day 2 | 0.0 International units per Liter | Standard Deviation 1.43 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK | LDH, Day 2 | -0.9 International units per Liter | Standard Deviation 10.41 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK | ALT, Day 5 | -0.2 International units per Liter | Standard Deviation 2.23 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK | LDH, Day 7 | -10.2 International units per Liter | Standard Deviation 9.54 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK | CK, Day 2 | -10.3 International units per Liter | Standard Deviation 20.22 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK | ALT, Day 7 | -0.3 International units per Liter | Standard Deviation 9.32 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK | GGT, Day 5 | -1.3 International units per Liter | Standard Deviation 1.86 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK | CK, Day 5 | -1.8 International units per Liter | Standard Deviation 11.58 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK | ALP, Day 2 | 2.0 International units per Liter | Standard Deviation 3.76 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK | AST, Day 7 | -0.9 International units per Liter | Standard Deviation 3.62 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK | LDH, Day 5 | 0.3 International units per Liter | Standard Deviation 7.26 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK | ALP, Day 5 | -1.0 International units per Liter | Standard Deviation 5.66 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK | AST, Day 5 | 0.3 International units per Liter | Standard Deviation 1.63 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK | GGT, Day 7 | -1.2 International units per Liter | Standard Deviation 2.48 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK | ALP, Day 7 | 0.8 International units per Liter | Standard Deviation 3.75 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK | AST, Day 2 | -0.9 International units per Liter | Standard Deviation 2.32 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK | ALP, Day 7 | 3.9 International units per Liter | Standard Deviation 5.55 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK | AST, Day 2 | 0.0 International units per Liter | Standard Deviation 3.08 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK | AST, Day 5 | 0.0 International units per Liter | Standard Deviation 3.58 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK | LDH, Day 7 | -5.3 International units per Liter | Standard Deviation 15.43 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK | AST, Day 7 | 0.6 International units per Liter | Standard Deviation 2.76 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK | CK, Day 7 | -9.3 International units per Liter | Standard Deviation 22.62 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK | GGT, Day 2 | 0.6 International units per Liter | Standard Deviation 3.76 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK | GGT, Day 5 | -1.0 International units per Liter | Standard Deviation 2.28 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK | CK, Day 2 | 0.2 International units per Liter | Standard Deviation 27.16 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK | GGT, Day 7 | 2.4 International units per Liter | Standard Deviation 8.13 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK | ALT, Day 2 | -0.5 International units per Liter | Standard Deviation 5.5 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK | ALT, Day 5 | -3.0 International units per Liter | Standard Deviation 8.39 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK | LDH, Day 2 | 4.0 International units per Liter | Standard Deviation 9.89 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK | ALT, Day 7 | 0.5 International units per Liter | Standard Deviation 7.93 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK | ALP, Day 2 | 1.8 International units per Liter | Standard Deviation 4.66 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK | ALP, Day 5 | -2.7 International units per Liter | Standard Deviation 6.74 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK | LDH, Day 5 | 2.2 International units per Liter | Standard Deviation 14.15 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK | CK, Day 5 | 8.8 International units per Liter | Standard Deviation 13.75 |
Secondary
Part 1: Change From Baseline in Clinical Chemistry Parameters: Albumin, Globulin and Protein
Blood samples were collected to analyze the chemistry parameters: albumin, globulin and protein. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time frame: Baseline (Day -1) and Days 2, 5, 7
Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters: Albumin, Globulin and Protein | Globulin, Day 2 | 1.0 Grams per liter | Standard Deviation 2.44 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters: Albumin, Globulin and Protein | Protein, Day 7 | 0.2 Grams per liter | Standard Deviation 3.49 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters: Albumin, Globulin and Protein | Globulin, Day 7 | 0.0 Grams per liter | Standard Deviation 1.67 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters: Albumin, Globulin and Protein | Globulin, Day 5 | 0.2 Grams per liter | Standard Deviation 2.4 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters: Albumin, Globulin and Protein | Albumin, Day 2 | 0.8 Grams per liter | Standard Deviation 2.65 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters: Albumin, Globulin and Protein | Protein, Day 5 | -0.7 Grams per liter | Standard Deviation 2.8 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters: Albumin, Globulin and Protein | Albumin, Day 7 | 0.2 Grams per liter | Standard Deviation 2.14 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters: Albumin, Globulin and Protein | Albumin, Day 5 | -0.8 Grams per liter | Standard Deviation 1.72 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters: Albumin, Globulin and Protein | Protein, Day 2 | 1.8 Grams per liter | Standard Deviation 4.69 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Change From Baseline in Clinical Chemistry Parameters: Albumin, Globulin and Protein | Globulin, Day 5 | 0.2 Grams per liter | Standard Deviation 1.17 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Change From Baseline in Clinical Chemistry Parameters: Albumin, Globulin and Protein | Albumin, Day 2 | 0.7 Grams per liter | Standard Deviation 2.08 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Change From Baseline in Clinical Chemistry Parameters: Albumin, Globulin and Protein | Albumin, Day 5 | 0.2 Grams per liter | Standard Deviation 2.32 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Change From Baseline in Clinical Chemistry Parameters: Albumin, Globulin and Protein | Albumin, Day 7 | 0.0 Grams per liter | Standard Deviation 2.68 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Change From Baseline in Clinical Chemistry Parameters: Albumin, Globulin and Protein | Globulin, Day 2 | 0.4 Grams per liter | Standard Deviation 1.8 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Change From Baseline in Clinical Chemistry Parameters: Albumin, Globulin and Protein | Globulin, Day 7 | -0.5 Grams per liter | Standard Deviation 2.33 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Change From Baseline in Clinical Chemistry Parameters: Albumin, Globulin and Protein | Protein, Day 2 | 1.1 Grams per liter | Standard Deviation 3.65 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Change From Baseline in Clinical Chemistry Parameters: Albumin, Globulin and Protein | Protein, Day 5 | 0.3 Grams per liter | Standard Deviation 2.58 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Change From Baseline in Clinical Chemistry Parameters: Albumin, Globulin and Protein | Protein, Day 7 | -0.5 Grams per liter | Standard Deviation 4.56 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Change From Baseline in Clinical Chemistry Parameters: Albumin, Globulin and Protein | Albumin, Day 7 | 1.3 Grams per liter | Standard Deviation 1.49 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Change From Baseline in Clinical Chemistry Parameters: Albumin, Globulin and Protein | Albumin, Day 2 | 0.7 Grams per liter | Standard Deviation 1.49 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Change From Baseline in Clinical Chemistry Parameters: Albumin, Globulin and Protein | Protein, Day 2 | 1.9 Grams per liter | Standard Deviation 3.54 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Change From Baseline in Clinical Chemistry Parameters: Albumin, Globulin and Protein | Albumin, Day 5 | -0.2 Grams per liter | Standard Deviation 2.32 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Change From Baseline in Clinical Chemistry Parameters: Albumin, Globulin and Protein | Protein, Day 7 | 1.9 Grams per liter | Standard Deviation 2.81 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Change From Baseline in Clinical Chemistry Parameters: Albumin, Globulin and Protein | Globulin, Day 5 | 1.0 Grams per liter | Standard Deviation 2.1 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Change From Baseline in Clinical Chemistry Parameters: Albumin, Globulin and Protein | Globulin, Day 2 | 1.2 Grams per liter | Standard Deviation 2.23 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Change From Baseline in Clinical Chemistry Parameters: Albumin, Globulin and Protein | Protein, Day 5 | 0.8 Grams per liter | Standard Deviation 3.13 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Change From Baseline in Clinical Chemistry Parameters: Albumin, Globulin and Protein | Globulin, Day 7 | 0.6 Grams per liter | Standard Deviation 1.84 |
Secondary
Part 1: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap
Blood samples were collected to analyze the chemistry parameters: calcium, CO2, chloride, glucose, potassium, sodium, urea nitrogen, phosphorus, triglycerides, cholesterol, and anion gap. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time frame: Baseline (Day -1) and Days 2, 5, and 7
Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Glucose, Day 7 | -0.086 Millimoles per liter | Standard Deviation 0.3962 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | CO2, Day 5 | -1.7 Millimoles per liter | Standard Deviation 1.37 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Phosphate, Day 2 | 0.069 Millimoles per liter | Standard Deviation 0.1242 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Potassium, Day 2 | 0.02 Millimoles per liter | Standard Deviation 0.234 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Anion gap, Day 5 | 1.0 Millimoles per liter | Standard Deviation 1.41 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Calcium, Day 2 | 0.014 Millimoles per liter | Standard Deviation 0.0547 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Potassium, Day 5 | 0.10 Millimoles per liter | Standard Deviation 0.29 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Cholesterol, Day 5 | -0.098 Millimoles per liter | Standard Deviation 0.5254 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Urea nitrogen, Day 7 | 0.618 Millimoles per liter | Standard Deviation 0.7434 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Potassium, Day 7 | 0.10 Millimoles per liter | Standard Deviation 0.31 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | CO2, Day 7 | -0.5 Millimoles per liter | Standard Deviation 1.69 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Urea nitrogen, Day 5 | 0.857 Millimoles per liter | Standard Deviation 0.4584 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Sodium, Day 2 | 0.0 Millimoles per liter | Standard Deviation 1.95 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Calcium, Day 7 | 0.011 Millimoles per liter | Standard Deviation 0.065 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Urea nitrogen, Day 2 | 0.520 Millimoles per liter | Standard Deviation 0.7073 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Sodium, Day 5 | 1.0 Millimoles per liter | Standard Deviation 1.79 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Cholesterol, Day 2 | 0.117 Millimoles per liter | Standard Deviation 0.3551 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Sodium, Day 7 | -0.2 Millimoles per liter | Standard Deviation 2.36 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Chloride, Day 2 | 0.3 Millimoles per liter | Standard Deviation 1.94 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Calcium, Day 5 | -0.007 Millimoles per liter | Standard Deviation 0.0333 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Triglycerides, Day 7 | 0.160 Millimoles per liter | Standard Deviation 0.429 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Chloride, Day 5 | 1.7 Millimoles per liter | Standard Deviation 2.25 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Anion gap, Day 2 | 0.8 Millimoles per liter | Standard Deviation 2.07 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Triglycerides, Day 5 | -0.192 Millimoles per liter | Standard Deviation 0.1338 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Chloride, Day 7 | 0.2 Millimoles per liter | Standard Deviation 1.89 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | CO2, Day 2 | -1.1 Millimoles per liter | Standard Deviation 1.41 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Triglycerides, Day 2 | 0.095 Millimoles per liter | Standard Deviation 0.3467 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Glucose, Day 2 | -0.197 Millimoles per liter | Standard Deviation 0.2209 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Anion gap, Day 7 | 0.4 Millimoles per liter | Standard Deviation 1.29 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Phosphate, Day 7 | 0.036 Millimoles per liter | Standard Deviation 0.1218 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Glucose, Day 5 | -0.093 Millimoles per liter | Standard Deviation 0.255 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Cholesterol, Day 7 | -0.033 Millimoles per liter | Standard Deviation 0.4137 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Phosphate, Day 5 | 0.082 Millimoles per liter | Standard Deviation 0.1232 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Urea nitrogen, Day 7 | -0.035 Millimoles per liter | Standard Deviation 0.5511 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Calcium, Day 2 | 0.011 Millimoles per liter | Standard Deviation 0.0599 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Calcium, Day 5 | 0.013 Millimoles per liter | Standard Deviation 0.0432 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Calcium, Day 7 | -0.002 Millimoles per liter | Standard Deviation 0.0867 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | CO2, Day 2 | -0.5 Millimoles per liter | Standard Deviation 1.33 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | CO2, Day 5 | -0.8 Millimoles per liter | Standard Deviation 1.17 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | CO2, Day 7 | 0.4 Millimoles per liter | Standard Deviation 2.22 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Chloride, Day 2 | -0.1 Millimoles per liter | Standard Deviation 1.15 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Chloride, Day 5 | -0.3 Millimoles per liter | Standard Deviation 1.03 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Chloride, Day 7 | 0.8 Millimoles per liter | Standard Deviation 2.17 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Glucose, Day 2 | -0.135 Millimoles per liter | Standard Deviation 0.2856 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Glucose, Day 5 | -0.035 Millimoles per liter | Standard Deviation 0.1792 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Glucose, Day 7 | -0.066 Millimoles per liter | Standard Deviation 0.3024 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Potassium, Day 2 | -0.18 Millimoles per liter | Standard Deviation 0.274 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Potassium, Day 5 | -0.05 Millimoles per liter | Standard Deviation 0.226 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Potassium, Day 7 | -0.06 Millimoles per liter | Standard Deviation 0.198 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Sodium, Day 2 | 1.64 Millimoles per liter | Standard Deviation 0.3 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Sodium, Day 5 | -0.2 Millimoles per liter | Standard Deviation 1.17 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Sodium, Day 7 | 0.4 Millimoles per liter | Standard Deviation 2.14 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Urea nitrogen, Day 2 | 0.333 Millimoles per liter | Standard Deviation 0.4752 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Urea nitrogen, Day 5 | 0.143 Millimoles per liter | Standard Deviation 0.5844 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Phosphate, Day 2 | 0.078 Millimoles per liter | Standard Deviation 0.0972 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Phosphate, Day 5 | 0.048 Millimoles per liter | Standard Deviation 0.0952 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Phosphate, Day 7 | 0.099 Millimoles per liter | Standard Deviation 0.1245 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Triglycerides, Day 2 | -0.013 Millimoles per liter | Standard Deviation 0.2499 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Triglycerides, Day 5 | -0.223 Millimoles per liter | Standard Deviation 0.3551 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Triglycerides, Day 7 | -0.149 Millimoles per liter | Standard Deviation 0.2656 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Cholesterol, Day 2 | 0.058 Millimoles per liter | Standard Deviation 0.3115 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Cholesterol, Day 5 | -0.022 Millimoles per liter | Standard Deviation 0.4323 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Cholesterol, Day 7 | -0.137 Millimoles per liter | Standard Deviation 0.4751 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Anion gap, Day 2 | 0.3 Millimoles per liter | Standard Deviation 1.59 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Anion gap, Day 5 | 1.2 Millimoles per liter | Standard Deviation 1.17 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Anion gap, Day 7 | -0.8 Millimoles per liter | Standard Deviation 1.88 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Glucose, Day 5 | -0.105 Millimoles per liter | Standard Deviation 0.1735 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Anion gap, Day 5 | 1.7 Millimoles per liter | Standard Deviation 1.37 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Phosphate, Day 5 | -0.002 Millimoles per liter | Standard Deviation 0.0964 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Glucose, Day 2 | -0.262 Millimoles per liter | Standard Deviation 0.1809 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Cholesterol, Day 7 | 0.056 Millimoles per liter | Standard Deviation 0.3841 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Phosphate, Day 7 | 0.052 Millimoles per liter | Standard Deviation 0.0487 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Chloride, Day 7 | -0.1 Millimoles per liter | Standard Deviation 2.23 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Calcium, Day 7 | 0.018 Millimoles per liter | Standard Deviation 0.0875 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Triglycerides, Day 2 | 0.011 Millimoles per liter | Standard Deviation 0.228 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Chloride, Day 5 | -1.5 Millimoles per liter | Standard Deviation 2.51 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Calcium, Day 2 | 0.033 Millimoles per liter | Standard Deviation 0.0838 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Triglycerides, Day 5 | -0.185 Millimoles per liter | Standard Deviation 0.1778 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Chloride, Day 2 | -0.1 Millimoles per liter | Standard Deviation 1.47 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Anion gap, Day 2 | 0.8 Millimoles per liter | Standard Deviation 2.36 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Triglycerides, Day 7 | -0.016 Millimoles per liter | Standard Deviation 0.1888 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | CO2, Day 7 | 0.0 Millimoles per liter | Standard Deviation 1.05 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Calcium, Day 5 | 0.007 Millimoles per liter | Standard Deviation 0.0535 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Cholesterol, Day 2 | 0.052 Millimoles per liter | Standard Deviation 0.2865 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Sodium, Day 5 | -1.3 Millimoles per liter | Standard Deviation 2.66 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | CO2, Day 5 | -1.7 Millimoles per liter | Standard Deviation 1.63 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Sodium, Day 7 | -0.3 Millimoles per liter | Standard Deviation 2.31 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Sodium, Day 2 | 0.3 Millimoles per liter | Standard Deviation 2.24 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Anion gap, Day 7 | -0.4 Millimoles per liter | Standard Deviation 1.35 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Urea nitrogen, Day 2 | 0.4553 Millimoles per liter | Standard Deviation 0.4553 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Potassium, Day 7 | -0.08 Millimoles per liter | Standard Deviation 0.361 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Cholesterol, Day 5 | -0.252 Millimoles per liter | Standard Deviation 0.3485 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Urea nitrogen, Day 5 | -0.017 Millimoles per liter | Standard Deviation 0.6301 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Potassium, Day 5 | -0.20 Millimoles per liter | Standard Deviation 0.369 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Potassium, Day 2 | 0.03 Millimoles per liter | Standard Deviation 0.281 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Urea nitrogen, Day 7 | 0.309 Millimoles per liter | Standard Deviation 0.7935 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Glucose, Day 7 | -0.171 Millimoles per liter | Standard Deviation 0.192 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | CO2, Day 2 | -0.5 Millimoles per liter | Standard Deviation 1.57 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Phosphate, Day 2 | 0.082 Millimoles per liter | Standard Deviation 0.0716 |
Secondary
Part 1: Change From Baseline in Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate
Blood samples were collected to analyze the chemistry parameters: creatinine, direct bilirubin, bilirubin, and urate. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time frame: Baseline (Day -1) and Days 2, 5, and 7
Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate | Creatinine, Day 2 | 8.31 Micromoles per liter | Standard Deviation 4.422 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate | Creatinine, Day 5 | 3.10 Micromoles per liter | Standard Deviation 2.44 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate | Creatinine, Day 7 | 2.18 Micromoles per liter | Standard Deviation 5.799 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate | Direct bilirubin, Day 2 | -0.12 Micromoles per liter | Standard Deviation 0.267 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate | Direct bilirubin, Day 5 | -0.20 Micromoles per liter | Standard Deviation 0.261 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate | Direct bilirubin, Day 7 | -0.03 Micromoles per liter | Standard Deviation 0.39 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate | Bilirubin, Day 2 | -0.68 Micromoles per liter | Standard Deviation 1.327 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate | Bilirubin, Day 5 | -1.85 Micromoles per liter | Standard Deviation 1.958 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate | Bilirubin, Day 7 | 0.10 Micromoles per liter | Standard Deviation 1.638 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate | Urate, Day 2 | -7.0 Micromoles per liter | Standard Deviation 17.31 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate | Urate, Day 5 | -11.7 Micromoles per liter | Standard Deviation 8.36 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate | Urate, Day 7 | -6.4 Micromoles per liter | Standard Deviation 28.61 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Change From Baseline in Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate | Urate, Day 7 | -6.8 Micromoles per liter | Standard Deviation 13.36 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Change From Baseline in Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate | Creatinine, Day 2 | 7.12 Micromoles per liter | Standard Deviation 5.636 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Change From Baseline in Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate | Bilirubin, Day 2 | -0.39 Micromoles per liter | Standard Deviation 1.742 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Change From Baseline in Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate | Bilirubin, Day 7 | -1.06 Micromoles per liter | Standard Deviation 1.34 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Change From Baseline in Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate | Creatinine, Day 5 | 3.38 Micromoles per liter | Standard Deviation 3.026 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Change From Baseline in Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate | Direct bilirubin, Day 7 | -0.11 Micromoles per liter | Standard Deviation 0.33 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Change From Baseline in Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate | Urate, Day 5 | -7.0 Micromoles per liter | Standard Deviation 17.15 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Change From Baseline in Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate | Creatinine, Day 7 | 0.97 Micromoles per liter | Standard Deviation 5.027 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Change From Baseline in Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate | Bilirubin, Day 5 | -1.12 Micromoles per liter | Standard Deviation 1.306 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Change From Baseline in Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate | Direct bilirubin, Day 5 | 0.02 Micromoles per liter | Standard Deviation 0.354 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Change From Baseline in Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate | Direct bilirubin, Day 2 | -0.06 Micromoles per liter | Standard Deviation 0.329 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Change From Baseline in Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate | Urate, Day 2 | -7.9 Micromoles per liter | Standard Deviation 15.31 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Change From Baseline in Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate | Direct bilirubin, Day 2 | -0.01 Micromoles per liter | Standard Deviation 0.324 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Change From Baseline in Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate | Direct bilirubin, Day 5 | 0.35 Micromoles per liter | Standard Deviation 0.138 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Change From Baseline in Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate | Urate, Day 2 | -4.2 Micromoles per liter | Standard Deviation 21.77 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Change From Baseline in Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate | Direct bilirubin, Day 7 | -0.11 Micromoles per liter | Standard Deviation 0.502 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Change From Baseline in Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate | Bilirubin, Day 2 | -0.21 Micromoles per liter | Standard Deviation 1.236 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Change From Baseline in Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate | Bilirubin, Day 5 | 0.55 Micromoles per liter | Standard Deviation 0.602 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Change From Baseline in Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate | Urate, Day 5 | 6.7 Micromoles per liter | Standard Deviation 30.59 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Change From Baseline in Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate | Creatinine, Day 2 | 6.15 Micromoles per liter | Standard Deviation 4.228 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Change From Baseline in Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate | Creatinine, Day 5 | 1.92 Micromoles per liter | Standard Deviation 2.671 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Change From Baseline in Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate | Bilirubin, Day 7 | -1.40 Micromoles per liter | Standard Deviation 2.078 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Change From Baseline in Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate | Creatinine, Day 7 | 1.34 Micromoles per liter | Standard Deviation 6.215 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Change From Baseline in Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate | Urate, Day 7 | 2.3 Micromoles per liter | Standard Deviation 20.74 |
Secondary
Part 1: Change From Baseline in Clinical Chemistry Parameters: Lipase and Amylase
Blood samples were collected to analyze the chemistry parameters: lipase and amylase. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time frame: Baseline (Day -1) and Days 2, 5, and 7
Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters: Lipase and Amylase | Lipase, Day 2 | -0.4 Units per Liter | Standard Deviation 5.21 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters: Lipase and Amylase | Lipase, Day 5 | 3.3 Units per Liter | Standard Deviation 3.33 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters: Lipase and Amylase | Lipase, Day 7 | 4.5 Units per Liter | Standard Deviation 15.61 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters: Lipase and Amylase | Amylase, Day 2 | 4.0 Units per Liter | Standard Deviation 5.54 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters: Lipase and Amylase | Amylase, Day 5 | 5.5 Units per Liter | Standard Deviation 4.23 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters: Lipase and Amylase | Amylase, Day 7 | 5.0 Units per Liter | Standard Deviation 9.08 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Change From Baseline in Clinical Chemistry Parameters: Lipase and Amylase | Amylase, Day 7 | -0.7 Units per Liter | Standard Deviation 10.27 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Change From Baseline in Clinical Chemistry Parameters: Lipase and Amylase | Lipase, Day 2 | 5.8 Units per Liter | Standard Deviation 13.57 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Change From Baseline in Clinical Chemistry Parameters: Lipase and Amylase | Amylase, Day 2 | 3.9 Units per Liter | Standard Deviation 5.21 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Change From Baseline in Clinical Chemistry Parameters: Lipase and Amylase | Amylase, Day 5 | 0.5 Units per Liter | Standard Deviation 4.32 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Change From Baseline in Clinical Chemistry Parameters: Lipase and Amylase | Lipase, Day 5 | 1.3 Units per Liter | Standard Deviation 3.98 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Change From Baseline in Clinical Chemistry Parameters: Lipase and Amylase | Lipase, Day 7 | -3.6 Units per Liter | Standard Deviation 19.59 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Change From Baseline in Clinical Chemistry Parameters: Lipase and Amylase | Lipase, Day 5 | 2.0 Units per Liter | Standard Deviation 9.92 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Change From Baseline in Clinical Chemistry Parameters: Lipase and Amylase | Lipase, Day 7 | 2.1 Units per Liter | Standard Deviation 5.49 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Change From Baseline in Clinical Chemistry Parameters: Lipase and Amylase | Amylase, Day 7 | 3.5 Units per Liter | Standard Deviation 9.23 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Change From Baseline in Clinical Chemistry Parameters: Lipase and Amylase | Amylase, Day 2 | 3.3 Units per Liter | Standard Deviation 8.7 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Change From Baseline in Clinical Chemistry Parameters: Lipase and Amylase | Lipase, Day 2 | 3.2 Units per Liter | Standard Deviation 10.59 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Change From Baseline in Clinical Chemistry Parameters: Lipase and Amylase | Amylase, Day 5 | -1.2 Units per Liter | Standard Deviation 7.94 |
Secondary
Part 1: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval
Twelve lead ECGs were obtained to measure PR interval, QRS duration, QT interval, QTcF interval. Twelve lead ECGs were performed with the participant in a supine position after a rest of at least 10 minutes. Baseline was defined as the average of the triplicate pre-dose assessments within each treatment. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time frame: Baseline (Day 1, Pre-dose), and Day 1: 2, 4, 6 hours, and Day 5
Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval | PR Interval, Day 1, 4 hours | -3.6 Milliseconds | Standard Deviation 10.28 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval | QTcF Interval, Day 1, 4 hours | -5.1 Milliseconds | Standard Deviation 9.07 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval | PR Interval, Day 1, 2 hours | -3.8 Milliseconds | Standard Deviation 10.19 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval | PR Interval, Day 1, 6 hours | -2.5 Milliseconds | Standard Deviation 9.65 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval | PR Interval, Day 5 | 2.8 Milliseconds | Standard Deviation 9.13 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval | QRS Duration, Day 1, 2 hours | -0.7 Milliseconds | Standard Deviation 4.22 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval | QRS Duration, Day 1, 4 hours | -2.0 Milliseconds | Standard Deviation 4.4 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval | QRS Duration, Day 1, 6 hours | -1.0 Milliseconds | Standard Deviation 4.55 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval | QRS Duration, Day 5 | 2.0 Milliseconds | Standard Deviation 3.46 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval | QT Interval, Day 1, 2 hours | -15.8 Milliseconds | Standard Deviation 11.54 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval | QT Interval, Day 1, 4 hours | -5.8 Milliseconds | Standard Deviation 14.45 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval | QT Interval, Day 1, 6 hours | -9.1 Milliseconds | Standard Deviation 12.89 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval | QT Interval, Day 5 | 0.8 Milliseconds | Standard Deviation 14.27 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval | QTcF Interval, Day 1, 2 hours | -6.8 Milliseconds | Standard Deviation 7.36 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval | QTcF Interval, Day 1, 6 hours | -2.5 Milliseconds | Standard Deviation 8.72 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval | QTcF Interval, Day 5 | -6.0 Milliseconds | Standard Deviation 14.04 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval | QRS Duration, Day 1, 2 hours | -0.4 Milliseconds | Standard Deviation 4.6 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval | QRS Duration, Day 1, 4 hours | -1.6 Milliseconds | Standard Deviation 5 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval | QRS Duration, Day 1, 6 hours | -1.4 Milliseconds | Standard Deviation 3.99 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval | QTcF Interval, Day 1, 2 hours | -7.6 Milliseconds | Standard Deviation 6.58 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval | QRS Duration, Day 5 | -1.3 Milliseconds | Standard Deviation 4.97 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval | QT Interval, Day 1, 2 hours | -18.1 Milliseconds | Standard Deviation 10.24 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval | QTcF Interval, Day 5 | -2.3 Milliseconds | Standard Deviation 14.31 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval | QT Interval, Day 1, 4 hours | -8.1 Milliseconds | Standard Deviation 13.18 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval | PR Interval, Day 1, 4 hours | -2.8 Milliseconds | Standard Deviation 6.31 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval | QTcF Interval, Day 1, 6 hours | -2.2 Milliseconds | Standard Deviation 9.87 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval | QTcF Interval, Day 1, 4 hours | -4.2 Milliseconds | Standard Deviation 8.58 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval | QT Interval, Day 1, 6 hours | -13.8 Milliseconds | Standard Deviation 13.51 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval | PR Interval, Day 1, 2 hours | -4.7 Milliseconds | Standard Deviation 7.79 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval | PR Interval, Day 1, 6 hours | -4.6 Milliseconds | Standard Deviation 11.29 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval | PR Interval, Day 5 | -1.8 Milliseconds | Standard Deviation 8.28 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval | QT Interval, Day 5 | -14.8 Milliseconds | Standard Deviation 19.54 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval | QT Interval, Day 1, 4 hours | -7.9 Milliseconds | Standard Deviation 11.78 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval | QRS Duration, Day 1, 2 hours | -0.7 Milliseconds | Standard Deviation 3.12 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval | QT Interval, Day 5 | -14.5 Milliseconds | Standard Deviation 9.85 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval | PR Interval, Day 1, 4 hours | -3.3 Milliseconds | Standard Deviation 9.04 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval | QRS Duration, Day 1, 4 hours | -1.7 Milliseconds | Standard Deviation 3.54 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval | QTcF Interval, Day 5 | -5.8 Milliseconds | Standard Deviation 8.16 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval | QT Interval, Day 1, 6 hours | -12.0 Milliseconds | Standard Deviation 13.81 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval | QRS Duration, Day 1, 6 hours | -0.3 Milliseconds | Standard Deviation 2.45 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval | PR Interval, Day 5 | -6.0 Milliseconds | Standard Deviation 9.44 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval | QTcF Interval, Day 1, 4 hours | -4.5 Milliseconds | Standard Deviation 6.88 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval | QRS Duration, Day 5 | -0.8 Milliseconds | Standard Deviation 2.14 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval | QTcF Interval, Day 1, 2 hours | -6.8 Milliseconds | Standard Deviation 6.32 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval | PR Interval, Day 1, 6 hours | -3.0 Milliseconds | Standard Deviation 10.31 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval | QT Interval, Day 1, 2 hours | -18.6 Milliseconds | Standard Deviation 11.71 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval | QTcF Interval, Day 1, 6 hours | -4.7 Milliseconds | Standard Deviation 7.34 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval | PR Interval, Day 1, 2 hours | -5.5 Milliseconds | Standard Deviation 11.16 |
Secondary
Part 1: Change From Baseline in Hematology Parameter: Erythrocytes
Blood samples were collected to analyze the hematology parameter: erythrocytes. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time frame: Baseline (Day -1) and Days 2, 5 and 7
Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Change From Baseline in Hematology Parameter: Erythrocytes | Day 5 | 0.020 10^12 cells per liter | Standard Deviation 0.1642 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Change From Baseline in Hematology Parameter: Erythrocytes | Day 2 | 0.052 10^12 cells per liter | Standard Deviation 0.1937 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Change From Baseline in Hematology Parameter: Erythrocytes | Day 7 | -0.043 10^12 cells per liter | Standard Deviation 0.1286 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Change From Baseline in Hematology Parameter: Erythrocytes | Day 5 | -0.097 10^12 cells per liter | Standard Deviation 0.1592 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Change From Baseline in Hematology Parameter: Erythrocytes | Day 2 | 0.005 10^12 cells per liter | Standard Deviation 0.1651 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Change From Baseline in Hematology Parameter: Erythrocytes | Day 7 | -0.115 10^12 cells per liter | Standard Deviation 0.2308 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Change From Baseline in Hematology Parameter: Erythrocytes | Day 2 | 0.014 10^12 cells per liter | Standard Deviation 0.1672 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Change From Baseline in Hematology Parameter: Erythrocytes | Day 7 | 0.010 10^12 cells per liter | Standard Deviation 0.2011 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Change From Baseline in Hematology Parameter: Erythrocytes | Day 5 | -0.062 10^12 cells per liter | Standard Deviation 0.1297 |
Secondary
Part 1: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin
Blood samples were collected to analyze the hematology parameter: erythrocytes mean corpuscular hemoglobin. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time frame: Baseline (Day -1) and Days 2, 5, and 7
Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin | Day 5 | 0.05 Picograms | Standard Deviation 0.138 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin | Day 2 | -0.02 Picograms | Standard Deviation 0.319 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin | Day 7 | -0.05 Picograms | Standard Deviation 0.372 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin | Day 5 | 0.07 Picograms | Standard Deviation 0.28 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin | Day 2 | 0.04 Picograms | Standard Deviation 0.368 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin | Day 7 | 0.01 Picograms | Standard Deviation 0.423 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin | Day 2 | -0.02 Picograms | Standard Deviation 0.233 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin | Day 7 | -0.16 Picograms | Standard Deviation 0.32 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin | Day 5 | 0.17 Picograms | Standard Deviation 0.301 |
Secondary
Part 1: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume
Blood samples were collected to analyze the hematology parameter: erythrocytes mean corpuscular volume. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time frame: Baseline (Day -1) and Days 2, 5 and 7
Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume | Day 5 | 0.32 Femtoliter | Standard Deviation 0.615 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume | Day 2 | -0.06 Femtoliter | Standard Deviation 0.576 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume | Day 7 | -0.58 Femtoliter | Standard Deviation 0.456 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume | Day 5 | 0.42 Femtoliter | Standard Deviation 0.611 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume | Day 2 | 0.18 Femtoliter | Standard Deviation 0.658 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume | Day 7 | 0.10 Femtoliter | Standard Deviation 0.663 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume | Day 2 | 0.05 Femtoliter | Standard Deviation 0.664 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume | Day 7 | -0.09 Femtoliter | Standard Deviation 0.78 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume | Day 5 | 0.13 Femtoliter | Standard Deviation 0.423 |
Secondary
Part 1: Change From Baseline in Hematology Parameter: Hematocrit
Blood samples were collected to analyze the hematology parameter: hemotocrit. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time frame: Baseline (Day -1) and Days 2, 5 and 7
Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Change From Baseline in Hematology Parameter: Hematocrit | Day 5 | 0.0027 Proportion of red blood cells in blood | Standard Deviation 0.01253 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Change From Baseline in Hematology Parameter: Hematocrit | Day 2 | 0.0042 Proportion of red blood cells in blood | Standard Deviation 0.01656 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Change From Baseline in Hematology Parameter: Hematocrit | Day 7 | -0.0066 Proportion of red blood cells in blood | Standard Deviation 0.01184 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Change From Baseline in Hematology Parameter: Hematocrit | Day 5 | -0.0067 Proportion of red blood cells in blood | Standard Deviation 0.01369 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Change From Baseline in Hematology Parameter: Hematocrit | Day 2 | 0.0013 Proportion of red blood cells in blood | Standard Deviation 0.01405 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Change From Baseline in Hematology Parameter: Hematocrit | Day 7 | -0.0092 Proportion of red blood cells in blood | Standard Deviation 0.01971 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Change From Baseline in Hematology Parameter: Hematocrit | Day 2 | 0.0017 Proportion of red blood cells in blood | Standard Deviation 0.01477 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Change From Baseline in Hematology Parameter: Hematocrit | Day 7 | 0.0011 Proportion of red blood cells in blood | Standard Deviation 0.0193 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Change From Baseline in Hematology Parameter: Hematocrit | Day 5 | -0.0048 Proportion of red blood cells in blood | Standard Deviation 0.01148 |
Secondary
Part 1: Change From Baseline in Hematology Parameter: Hemoglobin
Blood samples were collected to analyze the hematology parameter: hemoglobin. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time frame: Baseline (Day -1) and Days 2, 5 and 7
Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Change From Baseline in Hematology Parameter: Hemoglobin | Day 5 | 0.5 Grams per liter | Standard Deviation 4.46 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Change From Baseline in Hematology Parameter: Hemoglobin | Day 2 | 1.2 Grams per liter | Standard Deviation 5.98 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Change From Baseline in Hematology Parameter: Hemoglobin | Day 7 | -1.8 Grams per liter | Standard Deviation 3.16 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Change From Baseline in Hematology Parameter: Hemoglobin | Day 5 | -2.7 Grams per liter | Standard Deviation 4.59 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Change From Baseline in Hematology Parameter: Hemoglobin | Day 2 | 0.4 Grams per liter | Standard Deviation 5.44 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Change From Baseline in Hematology Parameter: Hemoglobin | Day 7 | -3.2 Grams per liter | Standard Deviation 7.57 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Change From Baseline in Hematology Parameter: Hemoglobin | Day 2 | 0.4 Grams per liter | Standard Deviation 5.09 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Change From Baseline in Hematology Parameter: Hemoglobin | Day 7 | 0.0 Grams per liter | Standard Deviation 5.1 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Change From Baseline in Hematology Parameter: Hemoglobin | Day 5 | -1.3 Grams per liter | Standard Deviation 5.01 |
Secondary
Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets
Blood samples were collected to analyze the hematology parameters: basophils, eosinophils, lymphocytes, monocytes, neutrophils, and platelets. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time frame: Baseline (Day -1) and Days 2, 5 and 7
Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Eosinophils, Day 5 | 0.012 10^9 cells per liter | Standard Deviation 0.0722 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Basophils, Day 5 | 0.003 10^9 cells per liter | Standard Deviation 0.0137 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Basophils, Day 7 | 0.002 10^9 cells per liter | Standard Deviation 0.0075 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Eosinophils, Day 2 | -0.005 10^9 cells per liter | Standard Deviation 0.034 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Basophils, Day 2 | 0.000 10^9 cells per liter | Standard Deviation 0.0112 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Eosinophils, Day 7 | 0.006 10^9 cells per liter | Standard Deviation 0.0437 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Lymphocytes, Day 2 | -0.006 10^9 cells per liter | Standard Deviation 0.2568 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Lymphocytes, Day 5 | 0.012 10^9 cells per liter | Standard Deviation 0.267 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Lymphocytes, Day 7 | -0.023 10^9 cells per liter | Standard Deviation 0.1443 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Monocytes, Day 2 | 0.000 10^9 cells per liter | Standard Deviation 0.0662 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Monocytes, Day 5 | -0.022 10^9 cells per liter | Standard Deviation 0.0679 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Monocytes, Day 7 | -0.006 10^9 cells per liter | Standard Deviation 0.0585 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Neutrophils, Day 2 | 0.000 10^9 cells per liter | Standard Deviation 0.6401 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Neutrophils, Day 5 | 0.092 10^9 cells per liter | Standard Deviation 0.4511 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Neutrophils, Day 7 | -0.269 10^9 cells per liter | Standard Deviation 0.677 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Platelets, Day 2 | 4.4 10^9 cells per liter | Standard Deviation 9.28 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Platelets, Day 5 | 5.2 10^9 cells per liter | Standard Deviation 13.27 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Platelets, Day 7 | -2.2 10^9 cells per liter | Standard Deviation 20.03 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Platelets, Day 7 | 7.9 10^9 cells per liter | Standard Deviation 26.01 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Basophils, Day 2 | 0.000 10^9 cells per liter | Standard Deviation 0.0128 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Monocytes, Day 2 | -0.008 10^9 cells per liter | Standard Deviation 0.065 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Neutrophils, Day 2 | -0.103 10^9 cells per liter | Standard Deviation 0.6015 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Basophils, Day 5 | 0.002 10^9 cells per liter | Standard Deviation 0.0117 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Neutrophils, Day 7 | -0.066 10^9 cells per liter | Standard Deviation 0.6836 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Platelets, Day 2 | 4.5 10^9 cells per liter | Standard Deviation 15.78 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Basophils, Day 7 | 0.002 10^9 cells per liter | Standard Deviation 0.0109 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Monocytes, Day 5 | 0.000 10^9 cells per liter | Standard Deviation 0.0672 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Platelets, Day 5 | -1.5 10^9 cells per liter | Standard Deviation 15.06 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Eosinophils, Day 2 | -0.004 10^9 cells per liter | Standard Deviation 0.0393 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Lymphocytes, Day 7 | 0.069 10^9 cells per liter | Standard Deviation 0.2843 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Neutrophils, Day 5 | 0.007 10^9 cells per liter | Standard Deviation 0.1939 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Eosinophils, Day 5 | -0.020 10^9 cells per liter | Standard Deviation 0.0379 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Lymphocytes, Day 5 | -0.103 10^9 cells per liter | Standard Deviation 0.2293 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Monocytes, Day 7 | -0.005 10^9 cells per liter | Standard Deviation 0.0901 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Eosinophils, Day 7 | 0.013 10^9 cells per liter | Standard Deviation 0.0632 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Lymphocytes, Day 2 | 0.061 10^9 cells per liter | Standard Deviation 0.1626 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Eosinophils, Day 7 | -0.015 10^9 cells per liter | Standard Deviation 0.045 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Lymphocytes, Day 2 | 0.065 10^9 cells per liter | Standard Deviation 0.1831 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Lymphocytes, Day 5 | 0.053 10^9 cells per liter | Standard Deviation 0.5253 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Neutrophils, Day 7 | -0.642 10^9 cells per liter | Standard Deviation 1.3252 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Lymphocytes, Day 7 | 0.031 10^9 cells per liter | Standard Deviation 0.2409 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Platelets, Day 7 | 3.1 10^9 cells per liter | Standard Deviation 32.56 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Monocytes, Day 2 | -0.009 10^9 cells per liter | Standard Deviation 0.1268 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Monocytes, Day 5 | 0.012 10^9 cells per liter | Standard Deviation 0.0286 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Platelets, Day 2 | 4.0 10^9 cells per liter | Standard Deviation 14.96 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Monocytes, Day 7 | -0.044 10^9 cells per liter | Standard Deviation 0.1607 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Basophils, Day 2 | 0.002 10^9 cells per liter | Standard Deviation 0.0114 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Basophils, Day 5 | -0.007 10^9 cells per liter | Standard Deviation 0.0121 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Neutrophils, Day 2 | -0.334 10^9 cells per liter | Standard Deviation 0.9923 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Basophils, Day 7 | 0.006 10^9 cells per liter | Standard Deviation 0.0117 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Eosinophils, Day 2 | -0.001 10^9 cells per liter | Standard Deviation 0.0253 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Eosinophils, Day 5 | -0.022 10^9 cells per liter | Standard Deviation 0.0739 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Neutrophils, Day 5 | 0.222 10^9 cells per liter | Standard Deviation 1.1719 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Platelets, Day 5 | -7.5 10^9 cells per liter | Standard Deviation 16.21 |
Secondary
Part 1: Change From Baseline in Urinalysis Parameter: Specific Gravity
Urine samples were collected 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, including those from unscheduled visit, prior to the first study drug administration in each treatment period. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time frame: Baseline (Day -1) and Days 2, 5, and 7
Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Change From Baseline in Urinalysis Parameter: Specific Gravity | Day 5 | 0.0033 Ratio | Standard Deviation 0.00505 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Change From Baseline in Urinalysis Parameter: Specific Gravity | Day 2 | 0.0000 Ratio | Standard Deviation 0.00662 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Change From Baseline in Urinalysis Parameter: Specific Gravity | Day 7 | 0.0056 Ratio | Standard Deviation 0.00877 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Change From Baseline in Urinalysis Parameter: Specific Gravity | Day 5 | 0.0043 Ratio | Standard Deviation 0.00524 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Change From Baseline in Urinalysis Parameter: Specific Gravity | Day 2 | -0.0017 Ratio | Standard Deviation 0.0077 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Change From Baseline in Urinalysis Parameter: Specific Gravity | Day 7 | -0.0014 Ratio | Standard Deviation 0.00957 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Change From Baseline in Urinalysis Parameter: Specific Gravity | Day 2 | -0.0002 Ratio | Standard Deviation 0.00738 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Change From Baseline in Urinalysis Parameter: Specific Gravity | Day 7 | 0.0010 Ratio | Standard Deviation 0.00794 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Change From Baseline in Urinalysis Parameter: Specific Gravity | Day 5 | 0.0030 Ratio | Standard Deviation 0.00329 |
Secondary
Part 1: Change From Baseline in Vital Signs: DBP and SBP
SBP and DBP were measured in the 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 average of the triplicate predose assessments within each treatment. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time frame: Baseline (Day 1, pre-dose), and Day 1: 24, 48, 72 hours, Days 5, and 7
Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Change From Baseline in Vital Signs: DBP and SBP | DBP, Day 1, 24 hours | -0.6 Millimeters of mercury | Standard Deviation 5.27 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Change From Baseline in Vital Signs: DBP and SBP | DBP, Day 1, 48 hours | -2.4 Millimeters of mercury | Standard Deviation 5.21 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Change From Baseline in Vital Signs: DBP and SBP | DBP, Day 1, 72 hours | -4.2 Millimeters of mercury | Standard Deviation 6.52 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Change From Baseline in Vital Signs: DBP and SBP | DBP, Day 5 | -1.2 Millimeters of mercury | Standard Deviation 6.18 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Change From Baseline in Vital Signs: DBP and SBP | DBP, Day 7 | -0.1 Millimeters of mercury | Standard Deviation 7.49 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Change From Baseline in Vital Signs: DBP and SBP | SBP, Day 1, 24 hours | -2.8 Millimeters of mercury | Standard Deviation 9.63 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Change From Baseline in Vital Signs: DBP and SBP | SBP, Day 1, 48 hours | -4.0 Millimeters of mercury | Standard Deviation 6.08 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Change From Baseline in Vital Signs: DBP and SBP | SBP, Day 1, 72 hours | -7.8 Millimeters of mercury | Standard Deviation 9.09 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Change From Baseline in Vital Signs: DBP and SBP | SBP, Day 5 | -2.5 Millimeters of mercury | Standard Deviation 7.06 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Change From Baseline in Vital Signs: DBP and SBP | SBP, Day 7 | 1.4 Millimeters of mercury | Standard Deviation 7.63 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Change From Baseline in Vital Signs: DBP and SBP | SBP, Day 5 | 6.2 Millimeters of mercury | Standard Deviation 9.13 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Change From Baseline in Vital Signs: DBP and SBP | DBP, Day 1, 24 hours | -0.1 Millimeters of mercury | Standard Deviation 7.4 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Change From Baseline in Vital Signs: DBP and SBP | SBP, Day 1, 24 hours | 2.3 Millimeters of mercury | Standard Deviation 7.37 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Change From Baseline in Vital Signs: DBP and SBP | DBP, Day 7 | -2.3 Millimeters of mercury | Standard Deviation 5.76 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Change From Baseline in Vital Signs: DBP and SBP | DBP, Day 1, 48 hours | -2.5 Millimeters of mercury | Standard Deviation 5.25 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Change From Baseline in Vital Signs: DBP and SBP | SBP, Day 7 | -2.4 Millimeters of mercury | Standard Deviation 10.06 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Change From Baseline in Vital Signs: DBP and SBP | SBP, Day 1, 72 hours | 2.8 Millimeters of mercury | Standard Deviation 8.64 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Change From Baseline in Vital Signs: DBP and SBP | DBP, Day 1, 72 hours | -1.3 Millimeters of mercury | Standard Deviation 6.86 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Change From Baseline in Vital Signs: DBP and SBP | SBP, Day 1, 48 hours | -0.5 Millimeters of mercury | Standard Deviation 6.57 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Change From Baseline in Vital Signs: DBP and SBP | DBP, Day 5 | -0.2 Millimeters of mercury | Standard Deviation 7.25 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Change From Baseline in Vital Signs: DBP and SBP | SBP, Day 1, 72 hours | 4.2 Millimeters of mercury | Standard Deviation 6.74 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Change From Baseline in Vital Signs: DBP and SBP | DBP, Day 5 | -1.3 Millimeters of mercury | Standard Deviation 5.2 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Change From Baseline in Vital Signs: DBP and SBP | DBP, Day 7 | -2.1 Millimeters of mercury | Standard Deviation 8.01 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Change From Baseline in Vital Signs: DBP and SBP | SBP, Day 1, 24 hours | -2.1 Millimeters of mercury | Standard Deviation 9.95 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Change From Baseline in Vital Signs: DBP and SBP | SBP, Day 5 | 1.2 Millimeters of mercury | Standard Deviation 6.52 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Change From Baseline in Vital Signs: DBP and SBP | SBP, Day 1, 48 hours | -3.8 Millimeters of mercury | Standard Deviation 10.8 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Change From Baseline in Vital Signs: DBP and SBP | DBP, Day 1, 24 hours | 13.9 Millimeters of mercury | Standard Deviation 7.45 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Change From Baseline in Vital Signs: DBP and SBP | SBP, Day 7 | -5.1 Millimeters of mercury | Standard Deviation 10.71 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Change From Baseline in Vital Signs: DBP and SBP | DBP, Day 1, 48 hours | -2.4 Millimeters of mercury | Standard Deviation 5.66 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Change From Baseline in Vital Signs: DBP and SBP | DBP, Day 1, 72 hours | -1.5 Millimeters of mercury | Standard Deviation 6.66 |
Secondary
Part 1: Change From Baseline in Vital Signs: Oral Temperature
Oral temperature was measured in the 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 average of the triplicate predose assessments within each treatment. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time frame: Baseline (Day 1, pre-dose), and Day 1: 24, 48, 72 hours, Days 5, 6 and 7
Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Change From Baseline in Vital Signs: Oral Temperature | Day 6 | 0.08 Degrees Celsius | Standard Deviation 0.541 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Change From Baseline in Vital Signs: Oral Temperature | Day 7 | 0.17 Degrees Celsius | Standard Deviation 0.443 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Change From Baseline in Vital Signs: Oral Temperature | Day 1, 72 hours | -0.03 Degrees Celsius | Standard Deviation 0.497 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Change From Baseline in Vital Signs: Oral Temperature | Day 1, 24 hours | 0.09 Degrees Celsius | Standard Deviation 0.507 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Change From Baseline in Vital Signs: Oral Temperature | Day 5 | 0.05 Degrees Celsius | Standard Deviation 0.418 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Change From Baseline in Vital Signs: Oral Temperature | Day 1, 48 hours | 0.15 Degrees Celsius | Standard Deviation 0.485 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Change From Baseline in Vital Signs: Oral Temperature | Day 1, 24 hours | 0.11 Degrees Celsius | Standard Deviation 0.479 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Change From Baseline in Vital Signs: Oral Temperature | Day 6 | -0.04 Degrees Celsius | Standard Deviation 0.435 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Change From Baseline in Vital Signs: Oral Temperature | Day 1, 48 hours | 0.05 Degrees Celsius | Standard Deviation 0.415 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Change From Baseline in Vital Signs: Oral Temperature | Day 1, 72 hours | 0.38 Degrees Celsius | Standard Deviation 0.313 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Change From Baseline in Vital Signs: Oral Temperature | Day 7 | -0.07 Degrees Celsius | Standard Deviation 0.523 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Change From Baseline in Vital Signs: Oral Temperature | Day 5 | -0.06 Degrees Celsius | Standard Deviation 0.494 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Change From Baseline in Vital Signs: Oral Temperature | Day 7 | 0.09 Degrees Celsius | Standard Deviation 0.3 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Change From Baseline in Vital Signs: Oral Temperature | Day 1, 24 hours | 0.08 Degrees Celsius | Standard Deviation 0.443 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Change From Baseline in Vital Signs: Oral Temperature | Day 1, 48 hours | 0.11 Degrees Celsius | Standard Deviation 0.274 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Change From Baseline in Vital Signs: Oral Temperature | Day 1, 72 hours | -0.03 Degrees Celsius | Standard Deviation 0.314 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Change From Baseline in Vital Signs: Oral Temperature | Day 5 | -0.03 Degrees Celsius | Standard Deviation 0.401 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Change From Baseline in Vital Signs: Oral Temperature | Day 6 | -0.20 Degrees Celsius | Standard Deviation 0.521 |
Secondary
Part 1: Change From Baseline in Vital Signs: Pulse Rate
Pulse rate was measured in the 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 average of the triplicate predose assessments within each treatment. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time frame: Baseline (Day 1, pre-dose), and Day 1: 24, 48, 72 hours, Days 5, and 7
Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Change From Baseline in Vital Signs: Pulse Rate | Day 5 | -4.0 Beats per minute | Standard Deviation 9.08 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Change From Baseline in Vital Signs: Pulse Rate | Day 1, 72 hours | -5.2 Beats per minute | Standard Deviation 14.32 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Change From Baseline in Vital Signs: Pulse Rate | Day 1, 24 hours | -3.2 Beats per minute | Standard Deviation 8.87 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Change From Baseline in Vital Signs: Pulse Rate | Day 1, 48 hours | -0.7 Beats per minute | Standard Deviation 9.6 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Change From Baseline in Vital Signs: Pulse Rate | Day 7 | -1.0 Beats per minute | Standard Deviation 7.33 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Change From Baseline in Vital Signs: Pulse Rate | Day 1, 72 hours | 7.2 Beats per minute | Standard Deviation 5.98 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Change From Baseline in Vital Signs: Pulse Rate | Day 1, 24 hours | 2.6 Beats per minute | Standard Deviation 8.69 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Change From Baseline in Vital Signs: Pulse Rate | Day 1, 48 hours | -1.4 Beats per minute | Standard Deviation 8.38 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Change From Baseline in Vital Signs: Pulse Rate | Day 5 | 7.0 Beats per minute | Standard Deviation 6.32 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Change From Baseline in Vital Signs: Pulse Rate | Day 7 | -4.4 Beats per minute | Standard Deviation 9.63 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Change From Baseline in Vital Signs: Pulse Rate | Day 7 | -4.4 Beats per minute | Standard Deviation 9.42 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Change From Baseline in Vital Signs: Pulse Rate | Day 5 | 2.7 Beats per minute | Standard Deviation 5.89 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Change From Baseline in Vital Signs: Pulse Rate | Day 1, 24 hours | -2.7 Beats per minute | Standard Deviation 10.8 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Change From Baseline in Vital Signs: Pulse Rate | Day 1, 72 hours | 0.7 Beats per minute | Standard Deviation 4.41 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Change From Baseline in Vital Signs: Pulse Rate | Day 1, 48 hours | -2.8 Beats per minute | Standard Deviation 10.94 |
Secondary
Part 1: Change From Baseline in Vital Signs: Respiratory Rate
Respiratory rate was measured in the 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 average of the triplicate predose assessments within each treatment. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time frame: Baseline (Day 1, pre-dose), and Day 1: 24, 48 hours, Days 5, and 7
Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Change From Baseline in Vital Signs: Respiratory Rate | Day 5 | -3.7 Breaths per minute | Standard Deviation 2.94 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Change From Baseline in Vital Signs: Respiratory Rate | Day 1, 72 hours | -1.3 Breaths per minute | Standard Deviation 2.07 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Change From Baseline in Vital Signs: Respiratory Rate | Day 1, 24 hours | -0.3 Breaths per minute | Standard Deviation 2.57 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Change From Baseline in Vital Signs: Respiratory Rate | Day 1, 48 hours | 0.9 Breaths per minute | Standard Deviation 3.64 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Change From Baseline in Vital Signs: Respiratory Rate | Day 7 | 0.4 Breaths per minute | Standard Deviation 4.37 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Change From Baseline in Vital Signs: Respiratory Rate | Day 1, 72 hours | -1.3 Breaths per minute | Standard Deviation 3.01 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Change From Baseline in Vital Signs: Respiratory Rate | Day 1, 24 hours | 0.2 Breaths per minute | Standard Deviation 3.84 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Change From Baseline in Vital Signs: Respiratory Rate | Day 1, 48 hours | -0.8 Breaths per minute | Standard Deviation 3.67 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Change From Baseline in Vital Signs: Respiratory Rate | Day 5 | -2.3 Breaths per minute | Standard Deviation 4.63 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Change From Baseline in Vital Signs: Respiratory Rate | Day 7 | 1.4 Breaths per minute | Standard Deviation 2.22 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Change From Baseline in Vital Signs: Respiratory Rate | Day 7 | -0.3 Breaths per minute | Standard Deviation 3.4 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Change From Baseline in Vital Signs: Respiratory Rate | Day 5 | 0.3 Breaths per minute | Standard Deviation 3.44 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Change From Baseline in Vital Signs: Respiratory Rate | Day 1, 24 hours | 0.9 Breaths per minute | Standard Deviation 2.86 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Change From Baseline in Vital Signs: Respiratory Rate | Day 1, 72 hours | -0.3 Breaths per minute | Standard Deviation 2.34 |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Change From Baseline in Vital Signs: Respiratory Rate | Day 1, 48 hours | 0.5 Breaths per minute | Standard Deviation 2.58 |
Secondary
Part 1: Number of Participants With Non-Serious Adverse Events (Non-SAEs) and Serious Adverse Events (SAEs)
An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. A SAE is defined as any serious adverse event that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or other situations as per medical or scientific judgment. Adverse events which were not Serious Adverse Events were considered as Non-Serious adverse events.
Time frame: Up to 17 days
Population: Safety Population consisted of all participants who received at least one dose of study intervention.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Number of Participants With Non-Serious Adverse Events (Non-SAEs) and Serious Adverse Events (SAEs) | Non-SAEs | 0 Participants |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Number of Participants With Non-Serious Adverse Events (Non-SAEs) and Serious Adverse Events (SAEs) | SAEs | 0 Participants |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Number of Participants With Non-Serious Adverse Events (Non-SAEs) and Serious Adverse Events (SAEs) | Non-SAEs | 0 Participants |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Number of Participants With Non-Serious Adverse Events (Non-SAEs) and Serious Adverse Events (SAEs) | SAEs | 0 Participants |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Number of Participants With Non-Serious Adverse Events (Non-SAEs) and Serious Adverse Events (SAEs) | Non-SAEs | 1 Participants |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Number of Participants With Non-Serious Adverse Events (Non-SAEs) and Serious Adverse Events (SAEs) | SAEs | 0 Participants |
Secondary
Part 1: Number of Participants With Urinalysis Dipstick Results: Bilirubin and Nitrite
Urine samples were collected at indicated time points to analyze parameters including bilirubin and nitrite by dipstick. Urinalysis included dipstick urine test which was used to screen for bilirubin and nitrite. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameters of urine bilirubin and nitrite can be read as negative in the urine sample. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period.
Time frame: Baseline (Day -1) and Days 2, 5, and 7
Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Number of Participants With Urinalysis Dipstick Results: Bilirubin and Nitrite | Bilirubin, Day 5, Negative | 6 Participants |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Number of Participants With Urinalysis Dipstick Results: Bilirubin and Nitrite | Nitrite, Day 5, Negative | 6 Participants |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Number of Participants With Urinalysis Dipstick Results: Bilirubin and Nitrite | Nitrite, Day 7, Negative | 11 Participants |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Number of Participants With Urinalysis Dipstick Results: Bilirubin and Nitrite | Bilirubin, Day 7, Negative | 11 Participants |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Number of Participants With Urinalysis Dipstick Results: Bilirubin and Nitrite | Bilirubin, Day 2, Negative | 22 Participants |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Number of Participants With Urinalysis Dipstick Results: Bilirubin and Nitrite | Nitrite, Day 2, Negative | 22 Participants |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Number of Participants With Urinalysis Dipstick Results: Bilirubin and Nitrite | Nitrite, Baseline (Day -1), Negative | 22 Participants |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Number of Participants With Urinalysis Dipstick Results: Bilirubin and Nitrite | Bilirubin, Baseline (Day -1), Negative | 22 Participants |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Number of Participants With Urinalysis Dipstick Results: Bilirubin and Nitrite | Nitrite, Baseline (Day -1), Negative | 21 Participants |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Number of Participants With Urinalysis Dipstick Results: Bilirubin and Nitrite | Nitrite, Day 5, Negative | 6 Participants |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Number of Participants With Urinalysis Dipstick Results: Bilirubin and Nitrite | Bilirubin, Day 2, Negative | 21 Participants |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Number of Participants With Urinalysis Dipstick Results: Bilirubin and Nitrite | Nitrite, Day 7, Negative | 13 Participants |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Number of Participants With Urinalysis Dipstick Results: Bilirubin and Nitrite | Bilirubin, Day 5, Negative | 6 Participants |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Number of Participants With Urinalysis Dipstick Results: Bilirubin and Nitrite | Bilirubin, Baseline (Day -1), Negative | 21 Participants |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Number of Participants With Urinalysis Dipstick Results: Bilirubin and Nitrite | Bilirubin, Day 7, Negative | 13 Participants |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Number of Participants With Urinalysis Dipstick Results: Bilirubin and Nitrite | Nitrite, Day 2, Negative | 21 Participants |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Number of Participants With Urinalysis Dipstick Results: Bilirubin and Nitrite | Nitrite, Day 7, Negative | 10 Participants |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Number of Participants With Urinalysis Dipstick Results: Bilirubin and Nitrite | Bilirubin, Baseline (Day -1), Negative | 20 Participants |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Number of Participants With Urinalysis Dipstick Results: Bilirubin and Nitrite | Bilirubin, Day 2, Negative | 20 Participants |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Number of Participants With Urinalysis Dipstick Results: Bilirubin and Nitrite | Bilirubin, Day 5, Negative | 6 Participants |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Number of Participants With Urinalysis Dipstick Results: Bilirubin and Nitrite | Bilirubin, Day 7, Negative | 10 Participants |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Number of Participants With Urinalysis Dipstick Results: Bilirubin and Nitrite | Nitrite, Day 2, Negative | 20 Participants |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Number of Participants With Urinalysis Dipstick Results: Bilirubin and Nitrite | Nitrite, Day 5, Negative | 6 Participants |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Number of Participants With Urinalysis Dipstick Results: Bilirubin and Nitrite | Nitrite, Baseline (Day -1), Negative | 20 Participants |
Secondary
Part 1: Number of Participants With Urinalysis Dipstick Results: Glucose
Urine samples were collected at indicated time points to analyze parameters including glucose by dipstick. Urinalysis included dipstick urine test which was used to screen for glucose. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameters of urine glucose can be read as negative in the urine sample. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period.
Time frame: Baseline (Day -1) and Days 2, 5, and 7
Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Number of Participants With Urinalysis Dipstick Results: Glucose | Baseline (Day -1), Negative | 22 Participants |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Number of Participants With Urinalysis Dipstick Results: Glucose | Day 2, Negative | 22 Participants |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Number of Participants With Urinalysis Dipstick Results: Glucose | Day 5, Negative | 6 Participants |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Number of Participants With Urinalysis Dipstick Results: Glucose | Day 7, Negative | 11 Participants |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Number of Participants With Urinalysis Dipstick Results: Glucose | Day 7, Negative | 13 Participants |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Number of Participants With Urinalysis Dipstick Results: Glucose | Baseline (Day -1), Negative | 21 Participants |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Number of Participants With Urinalysis Dipstick Results: Glucose | Day 5, Negative | 6 Participants |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Number of Participants With Urinalysis Dipstick Results: Glucose | Day 2, Negative | 21 Participants |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Number of Participants With Urinalysis Dipstick Results: Glucose | Day 7, Negative | 10 Participants |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Number of Participants With Urinalysis Dipstick Results: Glucose | Day 2, Negative | 20 Participants |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Number of Participants With Urinalysis Dipstick Results: Glucose | Day 5, Negative | 6 Participants |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Number of Participants With Urinalysis Dipstick Results: Glucose | Baseline (Day -1), Negative | 20 Participants |
Secondary
Part 1: Number of Participants With Urinalysis Dipstick Results: Ketones
Urine samples were collected at indicated time points to analyze parameters including ketones by dipstick. Urinalysis included dipstick urine test which was used to screen for ketones. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameters of urine ketones can be read as negative, trace, 2+ indicating proportional concentrations in the urine sample. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period.
Time frame: Baseline (Day -1) and Days 2, 5, and 7
Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Number of Participants With Urinalysis Dipstick Results: Ketones | Baseline (Day -1), Negative | 22 Participants |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Number of Participants With Urinalysis Dipstick Results: Ketones | Baseline (Day -1), Trace | 0 Participants |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Number of Participants With Urinalysis Dipstick Results: Ketones | Day 2, Negative | 21 Participants |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Number of Participants With Urinalysis Dipstick Results: Ketones | Day 2, Trace | 1 Participants |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Number of Participants With Urinalysis Dipstick Results: Ketones | Day 5, Negative | 6 Participants |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Number of Participants With Urinalysis Dipstick Results: Ketones | Day 5, 2+ | 0 Participants |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Number of Participants With Urinalysis Dipstick Results: Ketones | Day 7, Negative | 10 Participants |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Number of Participants With Urinalysis Dipstick Results: Ketones | Day 7, Trace | 1 Participants |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Number of Participants With Urinalysis Dipstick Results: Ketones | Day 2, Negative | 21 Participants |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Number of Participants With Urinalysis Dipstick Results: Ketones | Day 7, Negative | 13 Participants |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Number of Participants With Urinalysis Dipstick Results: Ketones | Day 2, Trace | 0 Participants |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Number of Participants With Urinalysis Dipstick Results: Ketones | Day 5, Negative | 6 Participants |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Number of Participants With Urinalysis Dipstick Results: Ketones | Day 5, 2+ | 0 Participants |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Number of Participants With Urinalysis Dipstick Results: Ketones | Baseline (Day -1), Negative | 20 Participants |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Number of Participants With Urinalysis Dipstick Results: Ketones | Baseline (Day -1), Trace | 1 Participants |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Number of Participants With Urinalysis Dipstick Results: Ketones | Day 7, Trace | 0 Participants |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Number of Participants With Urinalysis Dipstick Results: Ketones | Day 2, Negative | 19 Participants |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Number of Participants With Urinalysis Dipstick Results: Ketones | Baseline (Day -1), Trace | 0 Participants |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Number of Participants With Urinalysis Dipstick Results: Ketones | Baseline (Day -1), Negative | 20 Participants |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Number of Participants With Urinalysis Dipstick Results: Ketones | Day 2, Trace | 1 Participants |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Number of Participants With Urinalysis Dipstick Results: Ketones | Day 7, Negative | 10 Participants |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Number of Participants With Urinalysis Dipstick Results: Ketones | Day 5, 2+ | 1 Participants |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Number of Participants With Urinalysis Dipstick Results: Ketones | Day 5, Negative | 5 Participants |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Number of Participants With Urinalysis Dipstick Results: Ketones | Day 7, Trace | 0 Participants |
Secondary
Part 1: Number of Participants With Urinalysis Dipstick Results: Leukocyte Esterase
Urine samples were collected at indicated time points to analyze parameters including leukocyte esterase by dipstick. Urinalysis included dipstick urine test which was used to screen for leukocyte esterase. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameters of urine leukocyte esterase can be read as negative, trace, 1+ indicating proportional concentrations in the urine sample. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period.
Time frame: Baseline (Day -1) and Days 2, 5, and 7
Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Number of Participants With Urinalysis Dipstick Results: Leukocyte Esterase | Day 7, Negative | 9 Participants |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Number of Participants With Urinalysis Dipstick Results: Leukocyte Esterase | Day 2, 1+ | 0 Participants |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Number of Participants With Urinalysis Dipstick Results: Leukocyte Esterase | Baseline (Day -1), Trace | 1 Participants |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Number of Participants With Urinalysis Dipstick Results: Leukocyte Esterase | Day 5, 1+ | 0 Participants |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Number of Participants With Urinalysis Dipstick Results: Leukocyte Esterase | Day 5, Negative | 6 Participants |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Number of Participants With Urinalysis Dipstick Results: Leukocyte Esterase | Baseline (Day -1), Negative | 21 Participants |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Number of Participants With Urinalysis Dipstick Results: Leukocyte Esterase | Day 7, Trace | 2 Participants |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Number of Participants With Urinalysis Dipstick Results: Leukocyte Esterase | Day 2, Negative | 22 Participants |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Number of Participants With Urinalysis Dipstick Results: Leukocyte Esterase | Day 7, 1+ | 0 Participants |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Number of Participants With Urinalysis Dipstick Results: Leukocyte Esterase | Day 5, Negative | 6 Participants |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Number of Participants With Urinalysis Dipstick Results: Leukocyte Esterase | Baseline (Day -1), Negative | 19 Participants |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Number of Participants With Urinalysis Dipstick Results: Leukocyte Esterase | Baseline (Day -1), Trace | 2 Participants |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Number of Participants With Urinalysis Dipstick Results: Leukocyte Esterase | Day 2, Negative | 19 Participants |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Number of Participants With Urinalysis Dipstick Results: Leukocyte Esterase | Day 2, 1+ | 2 Participants |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Number of Participants With Urinalysis Dipstick Results: Leukocyte Esterase | Day 5, 1+ | 0 Participants |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Number of Participants With Urinalysis Dipstick Results: Leukocyte Esterase | Day 7, Negative | 12 Participants |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Number of Participants With Urinalysis Dipstick Results: Leukocyte Esterase | Day 7, Trace | 0 Participants |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Number of Participants With Urinalysis Dipstick Results: Leukocyte Esterase | Day 7, 1+ | 1 Participants |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Number of Participants With Urinalysis Dipstick Results: Leukocyte Esterase | Day 2, Negative | 20 Participants |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Number of Participants With Urinalysis Dipstick Results: Leukocyte Esterase | Baseline (Day -1), Negative | 20 Participants |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Number of Participants With Urinalysis Dipstick Results: Leukocyte Esterase | Day 7, Negative | 10 Participants |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Number of Participants With Urinalysis Dipstick Results: Leukocyte Esterase | Baseline (Day -1), Trace | 0 Participants |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Number of Participants With Urinalysis Dipstick Results: Leukocyte Esterase | Day 7, 1+ | 0 Participants |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Number of Participants With Urinalysis Dipstick Results: Leukocyte Esterase | Day 5, Negative | 5 Participants |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Number of Participants With Urinalysis Dipstick Results: Leukocyte Esterase | Day 2, 1+ | 0 Participants |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Number of Participants With Urinalysis Dipstick Results: Leukocyte Esterase | Day 7, Trace | 0 Participants |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Number of Participants With Urinalysis Dipstick Results: Leukocyte Esterase | Day 5, 1+ | 1 Participants |
Secondary
Part 1: Number of Participants With Urinalysis Dipstick Results: Occult Blood
Urine samples were collected at indicated time points to analyze parameters including occult blood by dipstick. Urinalysis included dipstick urine test which was used to screen for occult blood. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameters of urine occult blood can be read as negative, trace, 1+, 2+, 3+ indicating proportional concentrations in the urine sample. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period.
Time frame: Baseline (Day -1) and Days 2, 5, and 7
Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Number of Participants With Urinalysis Dipstick Results: Occult Blood | Day 7, Negative | 10 Participants |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Number of Participants With Urinalysis Dipstick Results: Occult Blood | Day 5, Negative | 4 Participants |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Number of Participants With Urinalysis Dipstick Results: Occult Blood | Day 2, 1+ | 0 Participants |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Number of Participants With Urinalysis Dipstick Results: Occult Blood | Baseline (Day -1), 2+ | 1 Participants |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Number of Participants With Urinalysis Dipstick Results: Occult Blood | Day 2, 3+ | 0 Participants |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Number of Participants With Urinalysis Dipstick Results: Occult Blood | Day 2, 2+ | 1 Participants |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Number of Participants With Urinalysis Dipstick Results: Occult Blood | Baseline (Day -1), Negative | 20 Participants |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Number of Participants With Urinalysis Dipstick Results: Occult Blood | Baseline (Day -1), Trace | 1 Participants |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Number of Participants With Urinalysis Dipstick Results: Occult Blood | Day 5, 2+ | 1 Participants |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Number of Participants With Urinalysis Dipstick Results: Occult Blood | Day 2, Negative | 19 Participants |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Number of Participants With Urinalysis Dipstick Results: Occult Blood | Day 7, Trace | 1 Participants |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Number of Participants With Urinalysis Dipstick Results: Occult Blood | Day 5, 1+ | 1 Participants |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Number of Participants With Urinalysis Dipstick Results: Occult Blood | Day 2, Trace | 2 Participants |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Number of Participants With Urinalysis Dipstick Results: Occult Blood | Day 2, 2+ | 0 Participants |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Number of Participants With Urinalysis Dipstick Results: Occult Blood | Baseline (Day -1), Negative | 18 Participants |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Number of Participants With Urinalysis Dipstick Results: Occult Blood | Baseline (Day -1), Trace | 2 Participants |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Number of Participants With Urinalysis Dipstick Results: Occult Blood | Baseline (Day -1), 2+ | 1 Participants |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Number of Participants With Urinalysis Dipstick Results: Occult Blood | Day 2, Negative | 17 Participants |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Number of Participants With Urinalysis Dipstick Results: Occult Blood | Day 2, Trace | 3 Participants |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Number of Participants With Urinalysis Dipstick Results: Occult Blood | Day 2, 1+ | 0 Participants |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Number of Participants With Urinalysis Dipstick Results: Occult Blood | Day 2, 3+ | 1 Participants |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Number of Participants With Urinalysis Dipstick Results: Occult Blood | Day 5, Negative | 5 Participants |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Number of Participants With Urinalysis Dipstick Results: Occult Blood | Day 5, 1+ | 1 Participants |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Number of Participants With Urinalysis Dipstick Results: Occult Blood | Day 5, 2+ | 0 Participants |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Number of Participants With Urinalysis Dipstick Results: Occult Blood | Day 7, Negative | 11 Participants |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Number of Participants With Urinalysis Dipstick Results: Occult Blood | Day 7, Trace | 2 Participants |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Number of Participants With Urinalysis Dipstick Results: Occult Blood | Day 5, Negative | 6 Participants |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Number of Participants With Urinalysis Dipstick Results: Occult Blood | Day 2, Negative | 18 Participants |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Number of Participants With Urinalysis Dipstick Results: Occult Blood | Day 7, Negative | 9 Participants |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Number of Participants With Urinalysis Dipstick Results: Occult Blood | Day 5, 1+ | 0 Participants |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Number of Participants With Urinalysis Dipstick Results: Occult Blood | Baseline (Day -1), 2+ | 0 Participants |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Number of Participants With Urinalysis Dipstick Results: Occult Blood | Baseline (Day -1), Negative | 18 Participants |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Number of Participants With Urinalysis Dipstick Results: Occult Blood | Day 5, 2+ | 0 Participants |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Number of Participants With Urinalysis Dipstick Results: Occult Blood | Day 2, 2+ | 0 Participants |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Number of Participants With Urinalysis Dipstick Results: Occult Blood | Day 2, 1+ | 1 Participants |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Number of Participants With Urinalysis Dipstick Results: Occult Blood | Baseline (Day -1), Trace | 2 Participants |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Number of Participants With Urinalysis Dipstick Results: Occult Blood | Day 2, 3+ | 0 Participants |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Number of Participants With Urinalysis Dipstick Results: Occult Blood | Day 2, Trace | 1 Participants |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Number of Participants With Urinalysis Dipstick Results: Occult Blood | Day 7, Trace | 1 Participants |
Secondary
Part 1: Number of Participants With Urinalysis Dipstick Results: Protein
Urine samples were collected at indicated time points to analyze parameters including protein by dipstick. Urinalysis included dipstick urine test which was used to screen for protein. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameters of urine protein can be read as negative, and trace in the urine sample. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period.
Time frame: Baseline (Day -1) and Days 2, 5, and 7
Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Number of Participants With Urinalysis Dipstick Results: Protein | Day 7, Negative | 10 Participants |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Number of Participants With Urinalysis Dipstick Results: Protein | Day 5, Negative | 6 Participants |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Number of Participants With Urinalysis Dipstick Results: Protein | Baseline (Day -1), Negative | 22 Participants |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Number of Participants With Urinalysis Dipstick Results: Protein | Day 2, Negative | 22 Participants |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Number of Participants With Urinalysis Dipstick Results: Protein | Day 7, Trace | 1 Participants |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Number of Participants With Urinalysis Dipstick Results: Protein | Day 5, Negative | 6 Participants |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Number of Participants With Urinalysis Dipstick Results: Protein | Baseline (Day -1), Negative | 21 Participants |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Number of Participants With Urinalysis Dipstick Results: Protein | Day 2, Negative | 21 Participants |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Number of Participants With Urinalysis Dipstick Results: Protein | Day 7, Negative | 13 Participants |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Number of Participants With Urinalysis Dipstick Results: Protein | Day 7, Trace | 0 Participants |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Number of Participants With Urinalysis Dipstick Results: Protein | Day 7, Trace | 0 Participants |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Number of Participants With Urinalysis Dipstick Results: Protein | Day 7, Negative | 10 Participants |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Number of Participants With Urinalysis Dipstick Results: Protein | Baseline (Day -1), Negative | 20 Participants |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Number of Participants With Urinalysis Dipstick Results: Protein | Day 5, Negative | 6 Participants |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Number of Participants With Urinalysis Dipstick Results: Protein | Day 2, Negative | 20 Participants |
Secondary
Part 1: Number of Participants With Worst Case Urine Parameter: Erythrocytes Results by Maximum Grade Increase Post-Baseline Relative to Baseline
Urine samples were collected to analyze the urine parameter: erythrocytes. Urinalysis parameters were graded according to Division of Acquired Immune Deficiency Syndrome (DAIDS) grading for severity of laboratory toxicities and clinical adverse events, version 2.1. The grades were grade 1 (mild), 2 (moderate), 3 (severe) and 4 (potentially life-threatening). Baseline was defined as the last assessment before the first dose of the study treatment. Only those urine parameters with maximum post-Baseline grade increase (Grade 1 to Grade 4) have been presented.
Time frame: Up to Day 17
Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Number of Participants With Worst Case Urine Parameter: Erythrocytes Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Increase to Grade 1 | 1 Participants |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Number of Participants With Worst Case Urine Parameter: Erythrocytes Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Increase to Grade 2 | 0 Participants |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Number of Participants With Worst Case Urine Parameter: Erythrocytes Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Increase to Grade 3 | 0 Participants |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Number of Participants With Worst Case Urine Parameter: Erythrocytes Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Increase to Grade 4 | 0 Participants |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Number of Participants With Worst Case Urine Parameter: Erythrocytes Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Increase to Grade 4 | 0 Participants |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Number of Participants With Worst Case Urine Parameter: Erythrocytes Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Increase to Grade 1 | 0 Participants |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Number of Participants With Worst Case Urine Parameter: Erythrocytes Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Increase to Grade 3 | 0 Participants |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Number of Participants With Worst Case Urine Parameter: Erythrocytes Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Increase to Grade 2 | 0 Participants |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Number of Participants With Worst Case Urine Parameter: Erythrocytes Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Increase to Grade 4 | 0 Participants |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Number of Participants With Worst Case Urine Parameter: Erythrocytes Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Increase to Grade 2 | 0 Participants |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Number of Participants With Worst Case Urine Parameter: Erythrocytes Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Increase to Grade 3 | 0 Participants |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Number of Participants With Worst Case Urine Parameter: Erythrocytes Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Increase to Grade 1 | 0 Participants |
Secondary
Part 1: Number of Participants With Worst Case Urine Parameter: Glucose Results by Maximum Grade Increase Post-Baseline Relative to Baseline
Urine samples were collected to analyze the urine parameter: glucose. Urinalysis parameters were graded according to Division of Acquired Immune Deficiency Syndrome (DAIDS) grading for severity of laboratory toxicities and clinical adverse events, version 2.1. The grades were grade 1 (mild), 2 (moderate), 3 (severe) and 4 (potentially life-threatening). Baseline was defined as the last assessment before the first dose of the study treatment. Only those urine parameters with maximum post-Baseline grade increase (Grade 1 to Grade 4) have been presented.
Time frame: Up to Day 17
Population: Safety Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Number of Participants With Worst Case Urine Parameter: Glucose Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Increase to Grade 3 | 0 Participants |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Number of Participants With Worst Case Urine Parameter: Glucose Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Increase to Grade 2 | 0 Participants |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Number of Participants With Worst Case Urine Parameter: Glucose Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Increase to Grade 4 | 0 Participants |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Number of Participants With Worst Case Urine Parameter: Glucose Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Increase to Grade 1 | 0 Participants |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Number of Participants With Worst Case Urine Parameter: Glucose Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Increase to Grade 2 | 0 Participants |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Number of Participants With Worst Case Urine Parameter: Glucose Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Increase to Grade 4 | 0 Participants |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Number of Participants With Worst Case Urine Parameter: Glucose Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Increase to Grade 1 | 0 Participants |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Number of Participants With Worst Case Urine Parameter: Glucose Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Increase to Grade 3 | 0 Participants |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Number of Participants With Worst Case Urine Parameter: Glucose Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Increase to Grade 1 | 0 Participants |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Number of Participants With Worst Case Urine Parameter: Glucose Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Increase to Grade 4 | 0 Participants |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Number of Participants With Worst Case Urine Parameter: Glucose Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Increase to Grade 3 | 0 Participants |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Number of Participants With Worst Case Urine Parameter: Glucose Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Increase to Grade 2 | 0 Participants |
Secondary
Part 1: Number of Participants With Worst Case Urine Parameter: Protein Results by Maximum Grade Increase Post-Baseline Relative to Baseline
Urine samples were collected to analyze the urine parameter: protein. Urinalysis parameters were graded according to Division of Acquired Immune Deficiency Syndrome (DAIDS) grading for severity of laboratory toxicities and clinical adverse events, version 2.1. The grades were grade 1 (mild), 2 (moderate), 3 (severe) and 4 (potentially life-threatening). Baseline was defined as the last assessment before the first dose of the study treatment. Only those urine parameters with maximum post-Baseline grade increase (Grade 1 to Grade 4) have been presented.
Time frame: Up to Day 17
Population: Safety Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Number of Participants With Worst Case Urine Parameter: Protein Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Increase to Grade 2 | 0 Participants |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Number of Participants With Worst Case Urine Parameter: Protein Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Increase to Grade 1 | 0 Participants |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Number of Participants With Worst Case Urine Parameter: Protein Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Increase to Grade 3 | 0 Participants |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 1: Number of Participants With Worst Case Urine Parameter: Protein Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Increase to Grade 4 | 0 Participants |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Number of Participants With Worst Case Urine Parameter: Protein Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Increase to Grade 4 | 0 Participants |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Number of Participants With Worst Case Urine Parameter: Protein Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Increase to Grade 3 | 0 Participants |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Number of Participants With Worst Case Urine Parameter: Protein Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Increase to Grade 1 | 0 Participants |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 1: Number of Participants With Worst Case Urine Parameter: Protein Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Increase to Grade 2 | 0 Participants |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Number of Participants With Worst Case Urine Parameter: Protein Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Increase to Grade 1 | 0 Participants |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Number of Participants With Worst Case Urine Parameter: Protein Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Increase to Grade 2 | 0 Participants |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Number of Participants With Worst Case Urine Parameter: Protein Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Increase to Grade 3 | 0 Participants |
| Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Part 1: Number of Participants With Worst Case Urine Parameter: Protein Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Increase to Grade 4 | 0 Participants |
Secondary
Part 2: Absolute Values for Chemistry Parameters: Serum Lipase, Serum Amylase
Blood samples were collected to analyze the chemistry parameters: serum lipase, serum amylase. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period.
Time frame: Baseline (Day -1) and Days 2, 5 and 7
Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Absolute Values for Chemistry Parameters: Serum Lipase, Serum Amylase | Serum lipase, Baseline (Day -1) | 32.1 Units per Liter | Standard Deviation 11.73 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Absolute Values for Chemistry Parameters: Serum Lipase, Serum Amylase | Serum lipase, Day 2 | 30.5 Units per Liter | Standard Deviation 11.6 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Absolute Values for Chemistry Parameters: Serum Lipase, Serum Amylase | Serum lipase, Day 5 | 28.6 Units per Liter | Standard Deviation 19.28 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Absolute Values for Chemistry Parameters: Serum Lipase, Serum Amylase | Serum lipase, Day 7 | 35.0 Units per Liter | Standard Deviation 6.22 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Absolute Values for Chemistry Parameters: Serum Lipase, Serum Amylase | Serum amylase, Baseline (Day -1) | 58.7 Units per Liter | Standard Deviation 17.33 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Absolute Values for Chemistry Parameters: Serum Lipase, Serum Amylase | Serum amylase, Day 2 | 58.3 Units per Liter | Standard Deviation 17.08 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Absolute Values for Chemistry Parameters: Serum Lipase, Serum Amylase | Serum amylase, Day 5 | 53.9 Units per Liter | Standard Deviation 16.4 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Absolute Values for Chemistry Parameters: Serum Lipase, Serum Amylase | Serum amylase, Day 7 | 63.3 Units per Liter | Standard Deviation 15.98 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Absolute Values for Chemistry Parameters: Serum Lipase, Serum Amylase | Serum amylase, Day 7 | 51.7 Units per Liter | Standard Deviation 14.27 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Absolute Values for Chemistry Parameters: Serum Lipase, Serum Amylase | Serum lipase, Baseline (Day -1) | 30.2 Units per Liter | Standard Deviation 10.22 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Absolute Values for Chemistry Parameters: Serum Lipase, Serum Amylase | Serum amylase, Baseline (Day -1) | 56.7 Units per Liter | Standard Deviation 15.19 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Absolute Values for Chemistry Parameters: Serum Lipase, Serum Amylase | Serum lipase, Day 2 | 30.4 Units per Liter | Standard Deviation 11.12 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Absolute Values for Chemistry Parameters: Serum Lipase, Serum Amylase | Serum amylase, Day 5 | 62.7 Units per Liter | Standard Deviation 14.06 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Absolute Values for Chemistry Parameters: Serum Lipase, Serum Amylase | Serum lipase, Day 5 | 40.3 Units per Liter | Standard Deviation 15.17 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Absolute Values for Chemistry Parameters: Serum Lipase, Serum Amylase | Serum amylase, Day 2 | 58.8 Units per Liter | Standard Deviation 15.21 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Absolute Values for Chemistry Parameters: Serum Lipase, Serum Amylase | Serum lipase, Day 7 | 25.2 Units per Liter | Standard Deviation 12.59 |
Secondary
Part 2: Absolute Values for Hematology Parameter: Erythrocytes
Blood samples were collected to analyze the hematology parameter: erythrocytes. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period.
Time frame: Baseline (Day -1) and Days 2, 5 and 7
Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Absolute Values for Hematology Parameter: Erythrocytes | Baseline (Day -1) | 4.914 10^12 cells per liter | Standard Deviation 0.507 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Absolute Values for Hematology Parameter: Erythrocytes | Day 2 | 4.958 10^12 cells per liter | Standard Deviation 0.493 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Absolute Values for Hematology Parameter: Erythrocytes | Day 5 | 4.976 10^12 cells per liter | Standard Deviation 0.4861 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Absolute Values for Hematology Parameter: Erythrocytes | Day 7 | 4.760 10^12 cells per liter | Standard Deviation 0.5021 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Absolute Values for Hematology Parameter: Erythrocytes | Day 7 | 4.942 10^12 cells per liter | Standard Deviation 0.5117 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Absolute Values for Hematology Parameter: Erythrocytes | Baseline (Day -1) | 4.853 10^12 cells per liter | Standard Deviation 0.506 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Absolute Values for Hematology Parameter: Erythrocytes | Day 5 | 4.787 10^12 cells per liter | Standard Deviation 0.4171 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Absolute Values for Hematology Parameter: Erythrocytes | Day 2 | 4.913 10^12 cells per liter | Standard Deviation 0.5727 |
Secondary
Part 2: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Volume
Blood samples were collected to analyze the hematology parameter: erythrocytes mean corpuscular volume. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period.
Time frame: Baseline (Day -1) and Days 2, 5 and 7
Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Volume | Baseline (Day -1) | 84.55 Femtoliter | Standard Deviation 5.141 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Volume | Day 2 | 84.30 Femtoliter | Standard Deviation 4.926 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Volume | Day 5 | 84.33 Femtoliter | Standard Deviation 3.593 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Volume | Day 7 | 84.37 Femtoliter | Standard Deviation 5.841 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Volume | Day 7 | 85.29 Femtoliter | Standard Deviation 4.042 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Volume | Baseline (Day -1) | 84.89 Femtoliter | Standard Deviation 4.925 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Volume | Day 5 | 84.50 Femtoliter | Standard Deviation 6.116 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Volume | Day 2 | 84.74 Femtoliter | Standard Deviation 5.146 |
Secondary
Part 2: Absolute Values for Hematology Parameter: Hemoglobin
Blood samples were collected to analyze the hematology parameter: hemoglobin. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period.
Time frame: Baseline (Day -1) and Days 2, 5 and 7
Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Absolute Values for Hematology Parameter: Hemoglobin | Baseline (Day -1) | 139.8 Grams per liter | Standard Deviation 15.66 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Absolute Values for Hematology Parameter: Hemoglobin | Day 2 | 141.0 Grams per liter | Standard Deviation 15.86 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Absolute Values for Hematology Parameter: Hemoglobin | Day 5 | 143.1 Grams per liter | Standard Deviation 11.22 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Absolute Values for Hematology Parameter: Hemoglobin | Day 7 | 134.3 Grams per liter | Standard Deviation 15.82 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Absolute Values for Hematology Parameter: Hemoglobin | Day 7 | 144.2 Grams per liter | Standard Deviation 11.11 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Absolute Values for Hematology Parameter: Hemoglobin | Baseline (Day -1) | 138.4 Grams per liter | Standard Deviation 14.09 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Absolute Values for Hematology Parameter: Hemoglobin | Day 5 | 135.6 Grams per liter | Standard Deviation 18.04 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Absolute Values for Hematology Parameter: Hemoglobin | Day 2 | 140.7 Grams per liter | Standard Deviation 16.62 |
Secondary
Part 2: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets
Blood samples were collected to analyze the hematology parameters: basophils, eosinophils, lymphocytes, monocytes, neutrophils, leukocytes and platelets. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period.
Time frame: Baseline (Day -1) and Days 2, 5 and 7
Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Eosinophils, Day 5 | 0.131 10^9 cells per liter | Standard Deviation 0.0869 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Basophils, Day 2 | 0.038 10^9 cells per liter | Standard Deviation 0.0183 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Basophils, Day 5 | 0.051 10^9 cells per liter | Standard Deviation 0.0253 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Basophils, Day 7 | 0.033 10^9 cells per liter | Standard Deviation 0.0141 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Eosinophils, Baseline (Day -1) | 0.128 10^9 cells per liter | Standard Deviation 0.0688 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Eosinophils, Day 2 | 0.125 10^9 cells per liter | Standard Deviation 0.07 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Basophils, Baseline (Day -1) | 0.046 10^9 cells per liter | Standard Deviation 0.0289 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Eosinophils, Day 7 | 0.123 10^9 cells per liter | Standard Deviation 0.0726 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Lymphocytes, Baseline (Day -1) | 1.786 10^9 cells per liter | Standard Deviation 0.4445 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Lymphocytes, Day 2 | 1.884 10^9 cells per liter | Standard Deviation 0.4805 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Lymphocytes, Day 5 | 1.663 10^9 cells per liter | Standard Deviation 0.5135 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Lymphocytes, Day 7 | 1.827 10^9 cells per liter | Standard Deviation 0.3937 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Monocytes, Baseline (Day -1) | 0.466 10^9 cells per liter | Standard Deviation 0.1086 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Monocytes, Day 2 | 0.452 10^9 cells per liter | Standard Deviation 0.1114 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Monocytes, Day 5 | 0.479 10^9 cells per liter | Standard Deviation 0.1512 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Monocytes, Day 7 | 0.452 10^9 cells per liter | Standard Deviation 0.0987 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Neutrophils, Baseline (Day -1) | 3.094 10^9 cells per liter | Standard Deviation 1.1911 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Neutrophils, Day 2 | 2.999 10^9 cells per liter | Standard Deviation 1.1184 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Neutrophils, Day 5 | 3.891 10^9 cells per liter | Standard Deviation 2.1672 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Neutrophils, Day 7 | 2.967 10^9 cells per liter | Standard Deviation 1.0973 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Platelets, Baseline (Day -1) | 291.6 10^9 cells per liter | Standard Deviation 53.57 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Platelets, Day 2 | 302.0 10^9 cells per liter | Standard Deviation 56.3 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Platelets, Day 5 | 278.6 10^9 cells per liter | Standard Deviation 61.63 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Platelets, Day 7 | 307.4 10^9 cells per liter | Standard Deviation 55.38 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Platelets, Day 5 | 314.1 10^9 cells per liter | Standard Deviation 53.97 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Basophils, Baseline (Day -1) | 0.041 10^9 cells per liter | Standard Deviation 0.0242 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Monocytes, Baseline (Day -1) | 0.443 10^9 cells per liter | Standard Deviation 0.11 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Basophils, Day 2 | 0.041 10^9 cells per liter | Standard Deviation 0.0192 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Neutrophils, Day 5 | 3.234 10^9 cells per liter | Standard Deviation 1.3698 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Basophils, Day 5 | 0.037 10^9 cells per liter | Standard Deviation 0.0141 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Monocytes, Day 2 | 0.458 10^9 cells per liter | Standard Deviation 0.107 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Basophils, Day 7 | 0.057 10^9 cells per liter | Standard Deviation 0.0354 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Platelets, Day 2 | 299.7 10^9 cells per liter | Standard Deviation 62.53 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Eosinophils, Baseline (Day -1) | 0.138 10^9 cells per liter | Standard Deviation 0.088 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Monocytes, Day 5 | 0.430 10^9 cells per liter | Standard Deviation 0.1021 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Eosinophils, Day 2 | 0.136 10^9 cells per liter | Standard Deviation 0.0786 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Neutrophils, Day 7 | 3.083 10^9 cells per liter | Standard Deviation 1.1599 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Eosinophils, Day 5 | 0.111 10^9 cells per liter | Standard Deviation 0.0601 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Monocytes, Day 7 | 0.469 10^9 cells per liter | Standard Deviation 0.1102 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Eosinophils, Day 7 | 0.133 10^9 cells per liter | Standard Deviation 0.0652 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Platelets, Day 7 | 274.4 10^9 cells per liter | Standard Deviation 61.27 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Lymphocytes, Baseline (Day -1) | 1.771 10^9 cells per liter | Standard Deviation 0.4902 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Neutrophils, Baseline (Day -1) | 3.138 10^9 cells per liter | Standard Deviation 1.1817 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Lymphocytes, Day 2 | 1.838 10^9 cells per liter | Standard Deviation 0.4761 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Platelets, Baseline (Day -1) | 292.7 10^9 cells per liter | Standard Deviation 59.84 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Lymphocytes, Day 5 | 1.750 10^9 cells per liter | Standard Deviation 0.3384 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Neutrophils, Day 2 | 3.122 10^9 cells per liter | Standard Deviation 1.122 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Lymphocytes, Day 7 | 1.730 10^9 cells per liter | Standard Deviation 0.508 |
Secondary
Part 2: Absolute Values for Hematology Parameters: Erythrocytes Mean Corpuscular Hemoglobin
Blood samples were collected to analyze the hematology parameter: erythrocytes mean corpuscular hemoglobin. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period.
Time frame: Baseline (Day -1) and Days 2, 5 and 7
Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Absolute Values for Hematology Parameters: Erythrocytes Mean Corpuscular Hemoglobin | Baseline (Day -1) | 28.51 Picograms | Standard Deviation 2.271 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Absolute Values for Hematology Parameters: Erythrocytes Mean Corpuscular Hemoglobin | Day 2 | 28.49 Picograms | Standard Deviation 2.208 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Absolute Values for Hematology Parameters: Erythrocytes Mean Corpuscular Hemoglobin | Day 5 | 28.84 Picograms | Standard Deviation 1.508 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Absolute Values for Hematology Parameters: Erythrocytes Mean Corpuscular Hemoglobin | Day 7 | 28.32 Picograms | Standard Deviation 2.878 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Absolute Values for Hematology Parameters: Erythrocytes Mean Corpuscular Hemoglobin | Day 7 | 29.27 Picograms | Standard Deviation 1.665 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Absolute Values for Hematology Parameters: Erythrocytes Mean Corpuscular Hemoglobin | Baseline (Day -1) | 28.62 Picograms | Standard Deviation 2.379 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Absolute Values for Hematology Parameters: Erythrocytes Mean Corpuscular Hemoglobin | Day 5 | 28.32 Picograms | Standard Deviation 2.81 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Absolute Values for Hematology Parameters: Erythrocytes Mean Corpuscular Hemoglobin | Day 2 | 28.68 Picograms | Standard Deviation 2.266 |
Secondary
Part 2: Absolute Values for Hematology Parameters: Hematocrit
Blood samples were collected to analyze the hematology parameter: hematocrit. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period.
Time frame: Baseline (Day -1) and Days 2, 5 and 7
Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Absolute Values for Hematology Parameters: Hematocrit | Baseline (Day -1) | 0.4145 Proportion of red blood cells in blood | Standard Deviation 0.04184 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Absolute Values for Hematology Parameters: Hematocrit | Day 2 | 0.4173 Proportion of red blood cells in blood | Standard Deviation 0.04269 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Absolute Values for Hematology Parameters: Hematocrit | Day 5 | 0.4183 Proportion of red blood cells in blood | Standard Deviation 0.03167 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Absolute Values for Hematology Parameters: Hematocrit | Day 7 | 0.4004 Proportion of red blood cells in blood | Standard Deviation 0.04078 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Absolute Values for Hematology Parameters: Hematocrit | Day 7 | 0.4201 Proportion of red blood cells in blood | Standard Deviation 0.03113 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Absolute Values for Hematology Parameters: Hematocrit | Baseline (Day -1) | 0.4106 Proportion of red blood cells in blood | Standard Deviation 0.03687 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Absolute Values for Hematology Parameters: Hematocrit | Day 5 | 0.4044 Proportion of red blood cells in blood | Standard Deviation 0.04641 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Absolute Values for Hematology Parameters: Hematocrit | Day 2 | 0.4153 Proportion of red blood cells in blood | Standard Deviation 0.0451 |
Secondary
Part 2 : Absolute Values for Urinalysis Parameter: Specific Gravity
Urine samples were collected 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, including those from unscheduled visit, prior to the first study drug administration in each treatment period.
Time frame: Baseline (Day -1) and Days 2, 5 and 7
Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2 : Absolute Values for Urinalysis Parameter: Specific Gravity | Baseline (Day -1) | 1.0146 Ratio | Standard Deviation 0.00742 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2 : Absolute Values for Urinalysis Parameter: Specific Gravity | Day 2 | 1.0157 Ratio | Standard Deviation 0.00778 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2 : Absolute Values for Urinalysis Parameter: Specific Gravity | Day 5 | 1.0123 Ratio | Standard Deviation 0.00715 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2 : Absolute Values for Urinalysis Parameter: Specific Gravity | Day 7 | 1.0161 Ratio | Standard Deviation 0.01129 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2 : Absolute Values for Urinalysis Parameter: Specific Gravity | Day 7 | 1.0144 Ratio | Standard Deviation 0.00735 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2 : Absolute Values for Urinalysis Parameter: Specific Gravity | Baseline (Day -1) | 1.0164 Ratio | Standard Deviation 0.00834 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2 : Absolute Values for Urinalysis Parameter: Specific Gravity | Day 5 | 1.0142 Ratio | Standard Deviation 0.01284 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2 : Absolute Values for Urinalysis Parameter: Specific Gravity | Day 2 | 1.0182 Ratio | Standard Deviation 0.00906 |
Secondary
Part 2: Absolute Values of Clinical Chemistry Parameters: Albumin, Globulin and Protein
Blood samples were collected to analyze the chemistry parameters: albumin, globulin and protein. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period.
Time frame: Baseline (Day -1) and Days 2, 5 and 7
Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Absolute Values of Clinical Chemistry Parameters: Albumin, Globulin and Protein | Albumin, Baseline (Day -1) | 42.9 Grams per liter | Standard Deviation 3.72 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Absolute Values of Clinical Chemistry Parameters: Albumin, Globulin and Protein | Albumin, Day 2 | 43.3 Grams per liter | Standard Deviation 2.91 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Absolute Values of Clinical Chemistry Parameters: Albumin, Globulin and Protein | Albumin, Day 5 | 44.4 Grams per liter | Standard Deviation 2.56 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Absolute Values of Clinical Chemistry Parameters: Albumin, Globulin and Protein | Albumin, Day 7 | 43.3 Grams per liter | Standard Deviation 4.33 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Absolute Values of Clinical Chemistry Parameters: Albumin, Globulin and Protein | Globulin, Baseline (Day -1) | 28.0 Grams per liter | Standard Deviation 3.39 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Absolute Values of Clinical Chemistry Parameters: Albumin, Globulin and Protein | Globulin, Day 2 | 28.5 Grams per liter | Standard Deviation 3.27 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Absolute Values of Clinical Chemistry Parameters: Albumin, Globulin and Protein | Globulin, Day 5 | 27.1 Grams per liter | Standard Deviation 3.94 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Absolute Values of Clinical Chemistry Parameters: Albumin, Globulin and Protein | Globulin, Day 7 | 28.4 Grams per liter | Standard Deviation 3.64 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Absolute Values of Clinical Chemistry Parameters: Albumin, Globulin and Protein | Protein, Baseline (Day -1) | 70.9 Grams per liter | Standard Deviation 4.83 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Absolute Values of Clinical Chemistry Parameters: Albumin, Globulin and Protein | Protein, Day 2 | 71.8 Grams per liter | Standard Deviation 3.6 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Absolute Values of Clinical Chemistry Parameters: Albumin, Globulin and Protein | Protein, Day 5 | 71.5 Grams per liter | Standard Deviation 3.96 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Absolute Values of Clinical Chemistry Parameters: Albumin, Globulin and Protein | Protein, Day 7 | 71.8 Grams per liter | Standard Deviation 6.04 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Absolute Values of Clinical Chemistry Parameters: Albumin, Globulin and Protein | Protein, Day 5 | 75.3 Grams per liter | Standard Deviation 5 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Absolute Values of Clinical Chemistry Parameters: Albumin, Globulin and Protein | Albumin, Baseline (Day -1) | 43.1 Grams per liter | Standard Deviation 3.4 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Absolute Values of Clinical Chemistry Parameters: Albumin, Globulin and Protein | Globulin, Day 5 | 30.4 Grams per liter | Standard Deviation 3.78 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Absolute Values of Clinical Chemistry Parameters: Albumin, Globulin and Protein | Albumin, Day 2 | 43.2 Grams per liter | Standard Deviation 3.26 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Absolute Values of Clinical Chemistry Parameters: Albumin, Globulin and Protein | Protein, Day 2 | 71.3 Grams per liter | Standard Deviation 4.6 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Absolute Values of Clinical Chemistry Parameters: Albumin, Globulin and Protein | Albumin, Day 5 | 44.9 Grams per liter | Standard Deviation 4.04 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Absolute Values of Clinical Chemistry Parameters: Albumin, Globulin and Protein | Globulin, Day 7 | 25.9 Grams per liter | Standard Deviation 3.48 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Absolute Values of Clinical Chemistry Parameters: Albumin, Globulin and Protein | Albumin, Day 7 | 43.2 Grams per liter | Standard Deviation 2.39 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Absolute Values of Clinical Chemistry Parameters: Albumin, Globulin and Protein | Protein, Day 7 | 69.1 Grams per liter | Standard Deviation 4.23 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Absolute Values of Clinical Chemistry Parameters: Albumin, Globulin and Protein | Globulin, Baseline (Day -1) | 27.2 Grams per liter | Standard Deviation 3.64 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Absolute Values of Clinical Chemistry Parameters: Albumin, Globulin and Protein | Protein, Baseline (Day -1) | 70.3 Grams per liter | Standard Deviation 4.69 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Absolute Values of Clinical Chemistry Parameters: Albumin, Globulin and Protein | Globulin, Day 2 | 28.1 Grams per liter | Standard Deviation 3.47 |
Secondary
Part 2: Absolute Values of Clinical Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK
Blood samples were collected to analyze the chemistry parameters: ALT, ALP, AST, GGT, LDH, CK. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period.
Time frame: Baseline (Day -1) and Days 2, 5 and 7
Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Absolute Values of Clinical Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK | ALP, Day 5 | 61.6 International units per Liter | Standard Deviation 18.18 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Absolute Values of Clinical Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK | ALT, Day 2 | 18.6 International units per Liter | Standard Deviation 11.57 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Absolute Values of Clinical Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK | ALT, Day 5 | 18.5 International units per Liter | Standard Deviation 11.82 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Absolute Values of Clinical Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK | ALT, Day 7 | 21.8 International units per Liter | Standard Deviation 16.34 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Absolute Values of Clinical Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK | ALP Baseline (Day -1) | 63.2 International units per Liter | Standard Deviation 18.86 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Absolute Values of Clinical Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK | ALP, Day 2 | 62.1 International units per Liter | Standard Deviation 18.43 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Absolute Values of Clinical Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK | ALT, Baseline (Day -1) | 18.9 International units per Liter | Standard Deviation 12.42 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Absolute Values of Clinical Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK | ALP, Day 7 | 66.6 International units per Liter | Standard Deviation 17.59 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Absolute Values of Clinical Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK | AST, Baseline (Day -1) | 16.4 International units per Liter | Standard Deviation 4.15 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Absolute Values of Clinical Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK | AST, Day 2 | 15.6 International units per Liter | Standard Deviation 3.36 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Absolute Values of Clinical Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK | AST, Day 5 | 17.0 International units per Liter | Standard Deviation 2.88 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Absolute Values of Clinical Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK | AST, Day 7 | 17.7 International units per Liter | Standard Deviation 6.56 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Absolute Values of Clinical Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK | GGT, Baseline (Day -1) | 21.6 International units per Liter | Standard Deviation 8.81 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Absolute Values of Clinical Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK | GGT, Day 2 | 20.9 International units per Liter | Standard Deviation 8.62 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Absolute Values of Clinical Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK | GGT, Day 5 | 21.6 International units per Liter | Standard Deviation 8.33 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Absolute Values of Clinical Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK | GGT, Day 7 | 20.8 International units per Liter | Standard Deviation 9.65 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Absolute Values of Clinical Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK | LDH, Baseline (Day -1) | 125.5 International units per Liter | Standard Deviation 14.23 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Absolute Values of Clinical Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK | LDH, Day 2 | 117.8 International units per Liter | Standard Deviation 13.32 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Absolute Values of Clinical Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK | LDH, Day 5 | 122.6 International units per Liter | Standard Deviation 16.59 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Absolute Values of Clinical Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK | LDH, Day 7 | 119.2 International units per Liter | Standard Deviation 14.92 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Absolute Values of Clinical Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK | CK, Baseline (Day -1) | 101.8 International units per Liter | Standard Deviation 52.32 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Absolute Values of Clinical Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK | CK, Day 2 | 89.5 International units per Liter | Standard Deviation 45.43 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Absolute Values of Clinical Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK | CK, Day 5 | 95.8 International units per Liter | Standard Deviation 38.31 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Absolute Values of Clinical Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK | CK, Day 7 | 97.7 International units per Liter | Standard Deviation 65.84 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Absolute Values of Clinical Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK | CK, Day 5 | 99.8 International units per Liter | Standard Deviation 65.97 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Absolute Values of Clinical Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK | ALT, Baseline (Day -1) | 18.8 International units per Liter | Standard Deviation 13.37 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Absolute Values of Clinical Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK | GGT, Baseline (Day -1) | 21.7 International units per Liter | Standard Deviation 9.34 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Absolute Values of Clinical Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK | ALT, Day 2 | 18.9 International units per Liter | Standard Deviation 12.65 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Absolute Values of Clinical Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK | LDH, Day 5 | 122.6 International units per Liter | Standard Deviation 14.56 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Absolute Values of Clinical Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK | ALT, Day 5 | 25.2 International units per Liter | Standard Deviation 20.47 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Absolute Values of Clinical Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK | GGT, Day 2 | 22.2 International units per Liter | Standard Deviation 9.67 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Absolute Values of Clinical Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK | ALT, Day 7 | 18.1 International units per Liter | Standard Deviation 9.97 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Absolute Values of Clinical Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK | CK, Day 2 | 89.9 International units per Liter | Standard Deviation 41.11 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Absolute Values of Clinical Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK | ALP Baseline (Day -1) | 61.6 International units per Liter | Standard Deviation 18.57 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Absolute Values of Clinical Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK | GGT, Day 5 | 22.8 International units per Liter | Standard Deviation 11.91 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Absolute Values of Clinical Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK | ALP, Day 2 | 62.1 International units per Liter | Standard Deviation 18.75 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Absolute Values of Clinical Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK | LDH, Day 7 | 124.9 International units per Liter | Standard Deviation 17.95 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Absolute Values of Clinical Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK | ALP, Day 5 | 70.4 International units per Liter | Standard Deviation 21.18 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Absolute Values of Clinical Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK | GGT, Day 7 | 21.8 International units per Liter | Standard Deviation 8.3 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Absolute Values of Clinical Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK | ALP, Day 7 | 58.8 International units per Liter | Standard Deviation 19.73 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Absolute Values of Clinical Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK | CK, Day 7 | 85.9 International units per Liter | Standard Deviation 31.47 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Absolute Values of Clinical Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK | AST, Baseline (Day -1) | 16.7 International units per Liter | Standard Deviation 4.92 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Absolute Values of Clinical Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK | LDH, Baseline (Day -1) | 123.4 International units per Liter | Standard Deviation 14.62 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Absolute Values of Clinical Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK | AST, Day 2 | 16.1 International units per Liter | Standard Deviation 4.3 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Absolute Values of Clinical Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK | CK, Baseline (Day -1) | 103.3 International units per Liter | Standard Deviation 56.84 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Absolute Values of Clinical Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK | AST, Day 5 | 20.1 International units per Liter | Standard Deviation 7.79 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Absolute Values of Clinical Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK | LDH, Day 2 | 118.4 International units per Liter | Standard Deviation 11.64 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Absolute Values of Clinical Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK | AST, Day 7 | 15.9 International units per Liter | Standard Deviation 2.71 |
Secondary
Part 2: Absolute Values of Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap
Blood samples were collected to analyze the chemistry parameters: calcium, CO2, chloride, glucose, potassium, sodium, urea nitrogen, phosphorus, triglycerides, cholesterol, and anion gap. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period.
Time frame: Baseline (Day -1) and Days 2, 5 and 7
Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Absolute Values of Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Sodium, Day 5 | 137.4 Millimoles per liter | Standard Deviation 1.69 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Absolute Values of Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | CO2, Day 5 | 30.1 Millimoles per liter | Standard Deviation 1.64 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Absolute Values of Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Sodium, Day 7 | 138.9 Millimoles per liter | Standard Deviation 1.17 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Absolute Values of Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Glucose, Baseline (Day -1) | 4.872 Millimoles per liter | Standard Deviation 0.3107 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Absolute Values of Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Urea nitrogen, Baseline (Day -1) | 4.193 Millimoles per liter | Standard Deviation 0.9707 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Absolute Values of Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Calcium, Day 5 | 2.315 Millimoles per liter | Standard Deviation 0.0991 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Absolute Values of Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Urea nitrogen, Day 2 | 4.511 Millimoles per liter | Standard Deviation 0.8025 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Absolute Values of Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Glucose, Day 2 | 4.784 Millimoles per liter | Standard Deviation 0.347 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Absolute Values of Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Urea nitrogen, Day 5 | 4.488 Millimoles per liter | Standard Deviation 0.784 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Absolute Values of Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | CO2, Day 7 | 31.3 Millimoles per liter | Standard Deviation 1.87 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Absolute Values of Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Urea nitrogen, Day 7 | 4.130 Millimoles per liter | Standard Deviation 0.985 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Absolute Values of Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Glucose, Day 5 | 4.606 Millimoles per liter | Standard Deviation 0.3351 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Absolute Values of Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Phosphate, Baseline (Day -1) | 1.129 Millimoles per liter | Standard Deviation 0.1711 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Absolute Values of Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | CO2, Baseline (Day -1) | 31.2 Millimoles per liter | Standard Deviation 1.42 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Absolute Values of Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Phosphate, Day 2 | 1.163 Millimoles per liter | Standard Deviation 0.1414 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Absolute Values of Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Glucose, Day 7 | 4.984 Millimoles per liter | Standard Deviation 0.3691 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Absolute Values of Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Phosphate, Day 5 | 1.149 Millimoles per liter | Standard Deviation 0.1183 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Absolute Values of Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Chloride, Baseline (Day -1) | 101.8 Millimoles per liter | Standard Deviation 2.11 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Absolute Values of Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Phosphate, Day 7 | 1.147 Millimoles per liter | Standard Deviation 0.1777 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Absolute Values of Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Potassium, Baseline (Day -1) | 4.29 Millimoles per liter | Standard Deviation 0.183 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Absolute Values of Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Triglycerides, Baseline (Day -1) | 1.380 Millimoles per liter | Standard Deviation 0.5675 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Absolute Values of Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Calcium, Day 2 | 2.343 Millimoles per liter | Standard Deviation 0.0922 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Absolute Values of Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Triglycerides, Day 2 | 1.255 Millimoles per liter | Standard Deviation 0.5644 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Absolute Values of Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Potassium, Day 2 | 4.30 Millimoles per liter | Standard Deviation 0.193 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Absolute Values of Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Triglycerides, Day 5 | 1.268 Millimoles per liter | Standard Deviation 0.6846 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Absolute Values of Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Chloride, Day 2 | 102.3 Millimoles per liter | Standard Deviation 1.34 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Absolute Values of Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Triglycerides, Day 7 | 1.200 Millimoles per liter | Standard Deviation 0.5402 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Absolute Values of Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Potassium, Day 5 | 4.33 Millimoles per liter | Standard Deviation 0.369 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Absolute Values of Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Cholesterol, Baseline (Day -1) | 4.477 Millimoles per liter | Standard Deviation 0.8449 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Absolute Values of Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | CO2, Day 2 | 29.8 Millimoles per liter | Standard Deviation 2.1 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Absolute Values of Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Cholesterol, Day 2 | 4.603 Millimoles per liter | Standard Deviation 0.7998 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Absolute Values of Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Potassium, Day 7 | 4.26 Millimoles per liter | Standard Deviation 0.133 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Absolute Values of Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Cholesterol, Day 5 | 4.591 Millimoles per liter | Standard Deviation 0.8199 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Absolute Values of Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Chloride, Day 5 | 102.0 Millimoles per liter | Standard Deviation 1.93 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Absolute Values of Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Cholesterol, Day 7 | 4.173 Millimoles per liter | Standard Deviation 0.774 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Absolute Values of Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Sodium, Baseline (Day -1) | 138.2 Millimoles per liter | Standard Deviation 2.02 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Absolute Values of Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Anion Gap, Baseline (Day -1) | 9.5 Millimoles per liter | Standard Deviation 0.87 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Absolute Values of Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Calcium, Day 7 | 2.362 Millimoles per liter | Standard Deviation 0.1049 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Absolute Values of Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Anion Gap, Day 2 | 9.9 Millimoles per liter | Standard Deviation 0.85 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Absolute Values of Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Sodium, Day 2 | 137.8 Millimoles per liter | Standard Deviation 1.83 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Absolute Values of Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Anion Gap, Day 5 | 9.6 Millimoles per liter | Standard Deviation 0.92 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Absolute Values of Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Chloride, Day 7 | 102.3 Millimoles per liter | Standard Deviation 1.87 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Absolute Values of Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Anion Gap, Day 7 | 9.3 Millimoles per liter | Standard Deviation 0.87 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Absolute Values of Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Calcium, Baseline (Day -1) | 2.356 Millimoles per liter | Standard Deviation 0.0947 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Absolute Values of Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Anion Gap, Day 7 | 9.6 Millimoles per liter | Standard Deviation 0.88 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Absolute Values of Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Calcium, Baseline (Day -1) | 2.354 Millimoles per liter | Standard Deviation 0.0833 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Absolute Values of Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Calcium, Day 2 | 2.362 Millimoles per liter | Standard Deviation 0.0854 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Absolute Values of Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Calcium, Day 5 | 2.381 Millimoles per liter | Standard Deviation 0.0764 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Absolute Values of Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Calcium, Day 7 | 2.340 Millimoles per liter | Standard Deviation 0.0616 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Absolute Values of Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | CO2, Baseline (Day -1) | 31.1 Millimoles per liter | Standard Deviation 1.51 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Absolute Values of Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | CO2, Day 2 | 30.1 Millimoles per liter | Standard Deviation 2.1 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Absolute Values of Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | CO2, Day 5 | 30.8 Millimoles per liter | Standard Deviation 1.86 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Absolute Values of Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | CO2, Day 7 | 31.1 Millimoles per liter | Standard Deviation 1.17 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Absolute Values of Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Chloride, Baseline (Day -1) | 102.1 Millimoles per liter | Standard Deviation 1.45 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Absolute Values of Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Chloride, Day 2 | 101.7 Millimoles per liter | Standard Deviation 1.64 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Absolute Values of Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Chloride, Day 5 | 101.4 Millimoles per liter | Standard Deviation 1.01 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Absolute Values of Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Chloride, Day 7 | 102.1 Millimoles per liter | Standard Deviation 2.2 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Absolute Values of Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Glucose, Baseline (Day -1) | 4.913 Millimoles per liter | Standard Deviation 0.3252 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Absolute Values of Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Glucose, Day 2 | 4.989 Millimoles per liter | Standard Deviation 0.3379 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Absolute Values of Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Glucose, Day 5 | 4.729 Millimoles per liter | Standard Deviation 0.1985 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Absolute Values of Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Glucose, Day 7 | 4.754 Millimoles per liter | Standard Deviation 0.3304 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Absolute Values of Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Potassium, Baseline (Day -1) | 4.27 Millimoles per liter | Standard Deviation 0.225 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Absolute Values of Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Potassium, Day 2 | 4.36 Millimoles per liter | Standard Deviation 0.35 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Absolute Values of Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Potassium, Day 5 | 4.18 Millimoles per liter | Standard Deviation 0.222 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Absolute Values of Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Potassium, Day 7 | 4.46 Millimoles per liter | Standard Deviation 0.364 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Absolute Values of Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Sodium, Baseline (Day -1) | 138.1 Millimoles per liter | Standard Deviation 1.55 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Absolute Values of Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Sodium, Day 2 | 137.8 Millimoles per liter | Standard Deviation 2.39 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Absolute Values of Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Sodium, Day 5 | 138.1 Millimoles per liter | Standard Deviation 1.9 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Absolute Values of Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Sodium, Day 7 | 138.4 Millimoles per liter | Standard Deviation 2.4 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Absolute Values of Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Urea nitrogen, Baseline (Day -1) | 4.289 Millimoles per liter | Standard Deviation 0.8517 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Absolute Values of Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Urea nitrogen, Day 2 | 4.917 Millimoles per liter | Standard Deviation 1.2215 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Absolute Values of Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Urea nitrogen, Day 5 | 4.197 Millimoles per liter | Standard Deviation 0.9577 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Absolute Values of Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Urea nitrogen, Day 7 | 4.889 Millimoles per liter | Standard Deviation 1.2618 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Absolute Values of Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Phosphate, Baseline (Day -1) | 1.137 Millimoles per liter | Standard Deviation 0.1644 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Absolute Values of Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Phosphate, Day 2 | 1.181 Millimoles per liter | Standard Deviation 0.1402 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Absolute Values of Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Phosphate, Day 5 | 1.159 Millimoles per liter | Standard Deviation 0.1837 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Absolute Values of Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Phosphate, Day 7 | 1.146 Millimoles per liter | Standard Deviation 0.1261 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Absolute Values of Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Triglycerides, Baseline (Day -1) | 1.346 Millimoles per liter | Standard Deviation 0.6796 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Absolute Values of Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Triglycerides, Day 2 | 1.226 Millimoles per liter | Standard Deviation 0.4816 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Absolute Values of Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Triglycerides, Day 5 | 1.044 Millimoles per liter | Standard Deviation 0.4087 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Absolute Values of Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Triglycerides, Day 7 | 1.461 Millimoles per liter | Standard Deviation 0.7119 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Absolute Values of Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Cholesterol, Baseline (Day -1) | 4.454 Millimoles per liter | Standard Deviation 0.7606 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Absolute Values of Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Cholesterol, Day 2 | 4.531 Millimoles per liter | Standard Deviation 0.8227 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Absolute Values of Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Cholesterol, Day 5 | 4.287 Millimoles per liter | Standard Deviation 0.9845 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Absolute Values of Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Cholesterol, Day 7 | 4.617 Millimoles per liter | Standard Deviation 0.8221 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Absolute Values of Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Anion Gap, Baseline (Day -1) | 9.2 Millimoles per liter | Standard Deviation 0.92 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Absolute Values of Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Anion Gap, Day 2 | 10.4 Millimoles per liter | Standard Deviation 0.98 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Absolute Values of Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Anion Gap, Day 5 | 9.0 Millimoles per liter | Standard Deviation 2.83 |
Secondary
Part 2: Absolute Values of Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate
Blood samples were collected to analyze the chemistry parameters: creatinine, direct bilirubin, bilirubin, and urate. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period.
Time frame: Baseline (Day -1) and Days 2, 5 and 7
Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Absolute Values of Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate | Creatinine, Day 5 | 85.31 Micromoles per liter | Standard Deviation 13.191 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Absolute Values of Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate | Urate, Day 2 | 307.0 Micromoles per liter | Standard Deviation 64.72 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Absolute Values of Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate | Urate, Day 5 | 330.1 Micromoles per liter | Standard Deviation 68.86 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Absolute Values of Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate | Urate, Day 7 | 308.0 Micromoles per liter | Standard Deviation 74.35 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Absolute Values of Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate | Creatinine, Baseline (Day -1) | 81.02 Micromoles per liter | Standard Deviation 17.857 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Absolute Values of Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate | Creatinine, Day 2 | 88.29 Micromoles per liter | Standard Deviation 21.603 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Absolute Values of Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate | Creatinine, Day 7 | 82.51 Micromoles per liter | Standard Deviation 25.513 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Absolute Values of Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate | Direct bilirubin, Baseline (Day -1) | 1.71 Micromoles per liter | Standard Deviation 0.506 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Absolute Values of Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate | Direct bilirubin, Day 2 | 1.69 Micromoles per liter | Standard Deviation 0.431 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Absolute Values of Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate | Direct bilirubin, Day 5 | 1.89 Micromoles per liter | Standard Deviation 0.295 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Absolute Values of Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate | Direct bilirubin, Day 7 | 1.62 Micromoles per liter | Standard Deviation 0.565 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Absolute Values of Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate | Bilirubin, Baseline (Day -1) | 9.64 Micromoles per liter | Standard Deviation 3.401 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Absolute Values of Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate | Bilirubin, Day 2 | 8.98 Micromoles per liter | Standard Deviation 1.548 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Absolute Values of Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate | Bilirubin, Day 5 | 9.55 Micromoles per liter | Standard Deviation 1.125 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Absolute Values of Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate | Bilirubin, Day 7 | 8.57 Micromoles per liter | Standard Deviation 3.324 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Absolute Values of Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate | Urate, Baseline (Day -1) | 324.4 Micromoles per liter | Standard Deviation 66.68 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Absolute Values of Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate | Urate, Baseline (Day -1) | 329.2 Micromoles per liter | Standard Deviation 73.48 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Absolute Values of Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate | Direct bilirubin, Day 2 | 1.77 Micromoles per liter | Standard Deviation 0.621 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Absolute Values of Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate | Urate, Day 2 | 331.8 Micromoles per liter | Standard Deviation 81.7 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Absolute Values of Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate | Bilirubin, Day 2 | 9.58 Micromoles per liter | Standard Deviation 3.048 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Absolute Values of Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate | Urate, Day 5 | 306.0 Micromoles per liter | Standard Deviation 73.64 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Absolute Values of Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate | Direct bilirubin, Day 5 | 1.99 Micromoles per liter | Standard Deviation 0.851 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Absolute Values of Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate | Urate, Day 7 | 332.3 Micromoles per liter | Standard Deviation 62.07 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Absolute Values of Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate | Bilirubin, Day 7 | 9.90 Micromoles per liter | Standard Deviation 0.758 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Absolute Values of Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate | Creatinine, Baseline (Day -1) | 83.19 Micromoles per liter | Standard Deviation 19.817 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Absolute Values of Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate | Direct bilirubin, Day 7 | 1.72 Micromoles per liter | Standard Deviation 0.286 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Absolute Values of Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate | Creatinine, Day 2 | 90.17 Micromoles per liter | Standard Deviation 22.148 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Absolute Values of Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate | Creatinine, Day 5 | 83.79 Micromoles per liter | Standard Deviation 24.894 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Absolute Values of Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate | Bilirubin, Day 5 | 10.50 Micromoles per liter | Standard Deviation 5.312 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Absolute Values of Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate | Creatinine, Day 7 | 82.90 Micromoles per liter | Standard Deviation 12.663 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Absolute Values of Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate | Bilirubin, Baseline (Day -1) | 9.27 Micromoles per liter | Standard Deviation 2.548 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Absolute Values of Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate | Direct bilirubin, Baseline (Day -1) | 1.73 Micromoles per liter | Standard Deviation 0.47 |
Secondary
Part 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF
Twelve lead ECGs were obtained to measure PR interval, QRS duration, QT interval, and QTcF interval. Twelve lead ECGs were performed with the participant in a supine position after a rest of at least 10 minutes. Baseline was defined as the average of the triplicate pre-dose assessments within each treatment.
Time frame: Baseline (Day 1, pre-dose), and Day 1: 2, 4, 6 hours, and Days 5, 7
Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF | PR Interval, Day 7 | 167.1 Milliseconds | Standard Deviation 9.09 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF | QTcF Interval, Day 7 | 395.3 Milliseconds | Standard Deviation 12.11 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF | PR Interval, Baseline (Day 1 pre-dose) | 168.8 Milliseconds | Standard Deviation 15.94 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF | PR Interval, Day 1, 2 hours | 160.6 Milliseconds | Standard Deviation 14.92 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF | PR Interval, Day 1, 4 hours | 162.6 Milliseconds | Standard Deviation 17.19 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF | PR Interval, Day 1, 6 hours | 162.2 Milliseconds | Standard Deviation 15.23 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF | PR Interval, Day 5 | 172.1 Milliseconds | Standard Deviation 19.92 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF | QRS Duration, Baseline (Day 1) | 89.8 Milliseconds | Standard Deviation 7.17 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF | QRS Duration, Day 1, 2 hours | 88.8 Milliseconds | Standard Deviation 6.87 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF | QRS Duration, Day 1, 4 hours | 87.5 Milliseconds | Standard Deviation 6.74 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF | QRS Duration, Day 1, 6 hours | 87.5 Milliseconds | Standard Deviation 6.5 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF | QRS Duration, Day 5 | 87.8 Milliseconds | Standard Deviation 4.03 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF | QRS Duration, Day 7 | 89.9 Milliseconds | Standard Deviation 6.83 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF | QT Interval, Baseline (Day 1) | 382.8 Milliseconds | Standard Deviation 16.73 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF | QT Interval, Day 1, 2 hours | 367.0 Milliseconds | Standard Deviation 15.73 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF | QT Interval, Day 1, 4 hours | 373.4 Milliseconds | Standard Deviation 11.37 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF | QT Interval, Day 1, 6 hours | 372.9 Milliseconds | Standard Deviation 16.48 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF | QT Interval, Day 5 | 367.8 Milliseconds | Standard Deviation 13.94 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF | QT Interval, Day 7 | 382.6 Milliseconds | Standard Deviation 17.92 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF | QTcF Interval, Baseline (Day 1) | 393.3 Milliseconds | Standard Deviation 11.84 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF | QTcF Interval, Day 1, 2 hours | 387.2 Milliseconds | Standard Deviation 12.56 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF | QTcF Interval, Day 1, 4 hours | 388.8 Milliseconds | Standard Deviation 11.52 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF | QTcF Interval, Day 1, 6 hours | 389.4 Milliseconds | Standard Deviation 11.52 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF | QTcF Interval, Day 5 | 388.6 Milliseconds | Standard Deviation 7.63 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF | QRS Duration, Day 7 | 88.8 Milliseconds | Standard Deviation 3.15 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF | QTcF Interval, Day 5 | 395.3 Milliseconds | Standard Deviation 14.71 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF | QT Interval, Baseline (Day 1) | 383.6 Milliseconds | Standard Deviation 18.49 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF | PR Interval, Baseline (Day 1 pre-dose) | 170.9 Milliseconds | Standard Deviation 14.96 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF | QTcF Interval, Baseline (Day 1) | 390.9 Milliseconds | Standard Deviation 13.13 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF | PR Interval, Day 1, 2 hours | 167.0 Milliseconds | Standard Deviation 14.71 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF | QT Interval, Day 1, 2 hours | 385.2 Milliseconds | Standard Deviation 18.67 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF | PR Interval, Day 1, 4 hours | 167.4 Milliseconds | Standard Deviation 13.84 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF | QTcF Interval, Day 1, 6 hours | 390.2 Milliseconds | Standard Deviation 13.13 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF | PR Interval, Day 1, 6 hours | 160.9 Milliseconds | Standard Deviation 14.18 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF | QT Interval, Day 1, 4 hours | 391.8 Milliseconds | Standard Deviation 16.57 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF | PR Interval, Day 5 | 164.1 Milliseconds | Standard Deviation 9.69 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF | QRS Duration, Baseline (Day 1) | 89.1 Milliseconds | Standard Deviation 5.71 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF | PR Interval, Day 7 | 176.2 Milliseconds | Standard Deviation 18.97 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF | QTcF Interval, Day 1, 2 hours | 390.3 Milliseconds | Standard Deviation 16.98 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF | QT Interval, Day 1, 6 hours | 367.8 Milliseconds | Standard Deviation 15.07 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF | QRS Duration, Day 1, 2 hours | 87.9 Milliseconds | Standard Deviation 5.56 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF | QTcF Interval, Day 7 | 381.1 Milliseconds | Standard Deviation 9.78 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF | QRS Duration, Day 1, 4 hours | 89.3 Milliseconds | Standard Deviation 6.49 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF | QT Interval, Day 5 | 385.2 Milliseconds | Standard Deviation 25.34 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF | QRS Duration, Day 1, 6 hours | 89.7 Milliseconds | Standard Deviation 7.11 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF | QTcF Interval, Day 1, 4 hours | 392.3 Milliseconds | Standard Deviation 14.99 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF | QRS Duration, Day 5 | 89.2 Milliseconds | Standard Deviation 8.51 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF | QT Interval, Day 7 | 378.2 Milliseconds | Standard Deviation 14.66 |
Secondary
Part 2: Absolute Values of Vital Signs: DBP and SBP
SBP and DBP were measured in the 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 average of the triplicate predose assessments within each treatment.
Time frame: Baseline (Day 1, pre-dose), and Day 1: 24, 48 hours, Days 5 and 7
Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Absolute Values of Vital Signs: DBP and SBP | SBP, Baseline (Day 1 pre-dose) | 110.9 Millimeters of mercury | Standard Deviation 9.39 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Absolute Values of Vital Signs: DBP and SBP | DBP, Baseline (Day 1 pre-dose) | 65.1 Millimeters of mercury | Standard Deviation 8.39 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Absolute Values of Vital Signs: DBP and SBP | SBP, Day 1, 24 hours | 110.1 Millimeters of mercury | Standard Deviation 10.84 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Absolute Values of Vital Signs: DBP and SBP | DBP, Day 1, 48 hours | 61.8 Millimeters of mercury | Standard Deviation 7.89 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Absolute Values of Vital Signs: DBP and SBP | SBP, Day 1, 48 hours | 108.4 Millimeters of mercury | Standard Deviation 10.06 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Absolute Values of Vital Signs: DBP and SBP | DBP, Day 5 | 68.1 Millimeters of mercury | Standard Deviation 4.49 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Absolute Values of Vital Signs: DBP and SBP | SBP, Day 5 | 113.3 Millimeters of mercury | Standard Deviation 5.97 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Absolute Values of Vital Signs: DBP and SBP | DBP Interval, Day 7 | 62.2 Millimeters of mercury | Standard Deviation 7.63 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Absolute Values of Vital Signs: DBP and SBP | SBP, Day 7 | 105.8 Millimeters of mercury | Standard Deviation 6.28 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Absolute Values of Vital Signs: DBP and SBP | DBP, Day 1, 24 hours | 64.0 Millimeters of mercury | Standard Deviation 6.44 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Absolute Values of Vital Signs: DBP and SBP | SBP, Day 7 | 108.4 Millimeters of mercury | Standard Deviation 9.3 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Absolute Values of Vital Signs: DBP and SBP | DBP, Baseline (Day 1 pre-dose) | 65.7 Millimeters of mercury | Standard Deviation 9.26 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Absolute Values of Vital Signs: DBP and SBP | DBP, Day 1, 24 hours | 62.9 Millimeters of mercury | Standard Deviation 9.09 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Absolute Values of Vital Signs: DBP and SBP | DBP, Day 5 | 60.0 Millimeters of mercury | Standard Deviation 4.3 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Absolute Values of Vital Signs: DBP and SBP | DBP Interval, Day 7 | 67.6 Millimeters of mercury | Standard Deviation 7.6 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Absolute Values of Vital Signs: DBP and SBP | SBP, Baseline (Day 1 pre-dose) | 111.5 Millimeters of mercury | Standard Deviation 11.73 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Absolute Values of Vital Signs: DBP and SBP | SBP, Day 1, 24 hours | 110.4 Millimeters of mercury | Standard Deviation 13.49 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Absolute Values of Vital Signs: DBP and SBP | SBP, Day 1, 48 hours | 106.9 Millimeters of mercury | Standard Deviation 9.58 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Absolute Values of Vital Signs: DBP and SBP | SBP, Day 5 | 108.7 Millimeters of mercury | Standard Deviation 9.31 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Absolute Values of Vital Signs: DBP and SBP | DBP, Day 1, 48 hours | 61.1 Millimeters of mercury | Standard Deviation 9.78 |
Secondary
Part 2: Absolute Values of Vital Signs: Oral Temperature
Oral temperature were measured in the 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 average of the triplicate predose assessments within each treatment.
Time frame: Baseline (Day 1, pre-dose), and Day 1: 24, 48 hours, Day 5 and 7
Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Absolute Values of Vital Signs: Oral Temperature | Baseline (Day 1, pre-dose) | 36.28 Degree celsius | Standard Deviation 0.366 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Absolute Values of Vital Signs: Oral Temperature | Day 1, 24 hours | 36.42 Degree celsius | Standard Deviation 0.325 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Absolute Values of Vital Signs: Oral Temperature | Day 1, 48 hours | 36.42 Degree celsius | Standard Deviation 0.321 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Absolute Values of Vital Signs: Oral Temperature | Day 5 | 36.41 Degree celsius | Standard Deviation 0.347 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Absolute Values of Vital Signs: Oral Temperature | Day 6 | 36.43 Degree celsius | Standard Deviation 0.339 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Absolute Values of Vital Signs: Oral Temperature | Day 7 | 36.57 Degree celsius | Standard Deviation 0.269 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Absolute Values of Vital Signs: Oral Temperature | Day 6 | 36.18 Degree celsius | Standard Deviation 0.377 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Absolute Values of Vital Signs: Oral Temperature | Baseline (Day 1, pre-dose) | 36.30 Degree celsius | Standard Deviation 0.23 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Absolute Values of Vital Signs: Oral Temperature | Day 5 | 36.31 Degree celsius | Standard Deviation 0.313 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Absolute Values of Vital Signs: Oral Temperature | Day 1, 24 hours | 36.33 Degree celsius | Standard Deviation 0.307 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Absolute Values of Vital Signs: Oral Temperature | Day 7 | 36.38 Degree celsius | Standard Deviation 0.402 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Absolute Values of Vital Signs: Oral Temperature | Day 1, 48 hours | 36.32 Degree celsius | Standard Deviation 0.349 |
Secondary
Part 2: Absolute Values of Vital Signs: Pulse Rate
Pulse rate was measured in the 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 average of the triplicate predose assessments within each treatment.
Time frame: Baseline (Day 1, pre-dose), and Day 1: 24, 48 hours, Day 5 and 7
Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Absolute Values of Vital Signs: Pulse Rate | Baseline (Day 1, pre-dose) | 64.4 Beats per minute | Standard Deviation 5.76 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Absolute Values of Vital Signs: Pulse Rate | Day 5 | 70.0 Beats per minute | Standard Deviation 7.29 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Absolute Values of Vital Signs: Pulse Rate | Day 1, 24 hours | 65.7 Beats per minute | Standard Deviation 9.22 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Absolute Values of Vital Signs: Pulse Rate | Day 1, 48 hours | 66.9 Beats per minute | Standard Deviation 7.29 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Absolute Values of Vital Signs: Pulse Rate | Day 7 | 65.9 Beats per minute | Standard Deviation 5.64 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Absolute Values of Vital Signs: Pulse Rate | Day 1, 24 hours | 67.3 Beats per minute | Standard Deviation 8.21 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Absolute Values of Vital Signs: Pulse Rate | Day 5 | 66.8 Beats per minute | Standard Deviation 7.1 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Absolute Values of Vital Signs: Pulse Rate | Day 7 | 62.2 Beats per minute | Standard Deviation 7.12 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Absolute Values of Vital Signs: Pulse Rate | Baseline (Day 1, pre-dose) | 64.2 Beats per minute | Standard Deviation 7.34 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Absolute Values of Vital Signs: Pulse Rate | Day 1, 48 hours | 69.1 Beats per minute | Standard Deviation 8.33 |
Secondary
Part 2: Absolute Values of Vital Signs: Respiratory Rate
Respiratory rate was measured in the 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 average of the triplicate predose assessments within each treatment.
Time frame: Baseline (Day 1, pre-dose), and Day 1: 24, 48 hours, Days 5, and 7
Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Absolute Values of Vital Signs: Respiratory Rate | Day 5 | 11.3 Breaths per minute | Standard Deviation 2.38 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Absolute Values of Vital Signs: Respiratory Rate | Baseline (Day 1, pre-dose) | 12.7 Breaths per minute | Standard Deviation 2.34 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Absolute Values of Vital Signs: Respiratory Rate | Day 1, 24 hours | 14.5 Breaths per minute | Standard Deviation 1.94 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Absolute Values of Vital Signs: Respiratory Rate | Day 1, 48 hours | 13.1 Breaths per minute | Standard Deviation 2.84 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Absolute Values of Vital Signs: Respiratory Rate | Day 7 | 13.5 Breaths per minute | Standard Deviation 2.07 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Absolute Values of Vital Signs: Respiratory Rate | Day 7 | 13.1 Breaths per minute | Standard Deviation 1.45 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Absolute Values of Vital Signs: Respiratory Rate | Day 1, 48 hours | 13.8 Breaths per minute | Standard Deviation 2.37 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Absolute Values of Vital Signs: Respiratory Rate | Baseline (Day 1, pre-dose) | 12.9 Breaths per minute | Standard Deviation 2.49 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Absolute Values of Vital Signs: Respiratory Rate | Day 5 | 12.4 Breaths per minute | Standard Deviation 3.13 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Absolute Values of Vital Signs: Respiratory Rate | Day 1, 24 hours | 13.9 Breaths per minute | Standard Deviation 2.52 |
Secondary
Part 2: Change From Baseline for Urinalysis Parameter: Potential of Hydrogen
Urine samples were collected to analyze the urinalysis parameter: pH. 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. Baseline was defined as the latest pre-dose assessment with a non-missing value, 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 Days 2, 5 and 7
Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Change From Baseline for Urinalysis Parameter: Potential of Hydrogen | Day 5 | 0.13 pH | Standard Deviation 0.354 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Change From Baseline for Urinalysis Parameter: Potential of Hydrogen | Day 2 | 0.00 pH | Standard Deviation 0.586 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Change From Baseline for Urinalysis Parameter: Potential of Hydrogen | Day 7 | -0.06 pH | Standard Deviation 0.464 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Change From Baseline for Urinalysis Parameter: Potential of Hydrogen | Day 5 | 0.11 pH | Standard Deviation 0.333 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Change From Baseline for Urinalysis Parameter: Potential of Hydrogen | Day 2 | 0.08 pH | Standard Deviation 0.393 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Change From Baseline for Urinalysis Parameter: Potential of Hydrogen | Day 7 | -0.06 pH | Standard Deviation 0.635 |
Secondary
Part 2: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK
Blood samples were collected to analyze the chemistry parameters: ALT, ALP, AST, GGT, LDH, CK. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time frame: Baseline (Day -1) and Days 2, 5 and 7
Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK | ALT, Day 2 | -0.7 International units per Liter | Standard Deviation 3.48 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK | ALT, Day 5 | 1.1 International units per Liter | Standard Deviation 2.64 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK | ALT, Day 7 | 1.6 International units per Liter | Standard Deviation 5.77 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK | ALP, Day 2 | -0.1 International units per Liter | Standard Deviation 4.22 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK | ALP, Day 5 | 1.1 International units per Liter | Standard Deviation 3.56 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK | ALP, Day 7 | 1.0 International units per Liter | Standard Deviation 3.81 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK | AST, Day 2 | -0.8 International units per Liter | Standard Deviation 2.32 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK | AST, Day 5 | 1.4 International units per Liter | Standard Deviation 1.06 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK | AST, Day 7 | 0.7 International units per Liter | Standard Deviation 2.55 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK | GGT, Day 2 | -0.3 International units per Liter | Standard Deviation 1.08 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK | GGT, Day 5 | 0.9 International units per Liter | Standard Deviation 0.83 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK | GGT, Day 7 | -1.6 International units per Liter | Standard Deviation 3.09 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK | LDH, Day 2 | -7.1 International units per Liter | Standard Deviation 11.65 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK | LDH, Day 5 | -4.6 International units per Liter | Standard Deviation 10.89 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK | LDH, Day 7 | -4.8 International units per Liter | Standard Deviation 12.02 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK | CK, Day 2 | -6.9 International units per Liter | Standard Deviation 12.25 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK | CK, Day 5 | 7.6 International units per Liter | Standard Deviation 11.56 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK | CK, Day 7 | -16.3 International units per Liter | Standard Deviation 34.3 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK | LDH, Day 5 | 3.3 International units per Liter | Standard Deviation 16.9 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK | ALT, Day 2 | 0.1 International units per Liter | Standard Deviation 3.3 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK | GGT, Day 2 | 0.5 International units per Liter | Standard Deviation 1.38 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK | ALT, Day 5 | 3.4 International units per Liter | Standard Deviation 7.21 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK | CK, Day 7 | -23.1 International units per Liter | Standard Deviation 36.97 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK | ALT, Day 7 | 2.2 International units per Liter | Standard Deviation 3.67 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK | GGT, Day 5 | 2.0 International units per Liter | Standard Deviation 3.67 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK | ALP, Day 2 | 0.4 International units per Liter | Standard Deviation 3.65 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK | LDH, Day 7 | -2.7 International units per Liter | Standard Deviation 11.92 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK | ALP, Day 5 | 3.9 International units per Liter | Standard Deviation 9.2 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK | GGT, Day 7 | -0.9 International units per Liter | Standard Deviation 2.71 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK | ALP, Day 7 | 2.1 International units per Liter | Standard Deviation 4.26 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK | CK, Day 5 | 2.1 International units per Liter | Standard Deviation 13.7 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK | AST, Day 2 | -0.7 International units per Liter | Standard Deviation 1.81 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK | LDH, Day 2 | -4.9 International units per Liter | Standard Deviation 8.68 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK | AST, Day 5 | 2.4 International units per Liter | Standard Deviation 3.32 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK | CK, Day 2 | -13.4 International units per Liter | Standard Deviation 20.32 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK | AST, Day 7 | 0.1 International units per Liter | Standard Deviation 1.69 |
Secondary
Part 2: Change From Baseline in Clinical Chemistry Parameters: Albumin, Globulin and Protein
Blood samples were collected to analyze the chemistry parameters: albumin, globulin and protein. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time frame: Baseline (Day -1) and Days 2, 5 and 7
Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Change From Baseline in Clinical Chemistry Parameters: Albumin, Globulin and Protein | Albumin, Day 5 | 0.9 Grams per liter | Standard Deviation 3 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Change From Baseline in Clinical Chemistry Parameters: Albumin, Globulin and Protein | Globulin, Day 7 | -1.0 Grams per liter | Standard Deviation 3.08 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Change From Baseline in Clinical Chemistry Parameters: Albumin, Globulin and Protein | Globulin, Day 2 | 0.3 Grams per liter | Standard Deviation 1.98 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Change From Baseline in Clinical Chemistry Parameters: Albumin, Globulin and Protein | Protein, Day 2 | 0.9 Grams per liter | Standard Deviation 3.95 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Change From Baseline in Clinical Chemistry Parameters: Albumin, Globulin and Protein | Albumin, Day 7 | 0.9 Grams per liter | Standard Deviation 2.47 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Change From Baseline in Clinical Chemistry Parameters: Albumin, Globulin and Protein | Protein, Day 5 | 1.6 Grams per liter | Standard Deviation 3.85 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Change From Baseline in Clinical Chemistry Parameters: Albumin, Globulin and Protein | Globulin, Day 5 | 0.8 Grams per liter | Standard Deviation 1.67 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Change From Baseline in Clinical Chemistry Parameters: Albumin, Globulin and Protein | Protein, Day 7 | -0.1 Grams per liter | Standard Deviation 4.04 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Change From Baseline in Clinical Chemistry Parameters: Albumin, Globulin and Protein | Albumin, Day 2 | 0.6 Grams per liter | Standard Deviation 2.78 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Change From Baseline in Clinical Chemistry Parameters: Albumin, Globulin and Protein | Protein, Day 7 | 0.3 Grams per liter | Standard Deviation 4.58 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Change From Baseline in Clinical Chemistry Parameters: Albumin, Globulin and Protein | Albumin, Day 2 | 0.2 Grams per liter | Standard Deviation 2.18 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Change From Baseline in Clinical Chemistry Parameters: Albumin, Globulin and Protein | Albumin, Day 5 | 1.6 Grams per liter | Standard Deviation 4.36 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Change From Baseline in Clinical Chemistry Parameters: Albumin, Globulin and Protein | Albumin, Day 7 | 0.4 Grams per liter | Standard Deviation 3.17 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Change From Baseline in Clinical Chemistry Parameters: Albumin, Globulin and Protein | Globulin, Day 2 | 0.8 Grams per liter | Standard Deviation 2.28 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Change From Baseline in Clinical Chemistry Parameters: Albumin, Globulin and Protein | Globulin, Day 5 | 2.0 Grams per liter | Standard Deviation 2.78 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Change From Baseline in Clinical Chemistry Parameters: Albumin, Globulin and Protein | Globulin, Day 7 | -0.1 Grams per liter | Standard Deviation 2.42 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Change From Baseline in Clinical Chemistry Parameters: Albumin, Globulin and Protein | Protein, Day 2 | 1.0 Grams per liter | Standard Deviation 3.33 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Change From Baseline in Clinical Chemistry Parameters: Albumin, Globulin and Protein | Protein, Day 5 | 3.6 Grams per liter | Standard Deviation 6.27 |
Secondary
Part 2: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap
Blood samples were collected to analyze the chemistry parameters: calcium, CO2, chloride, glucose, potassium, sodium, urea nitrogen, phosphorus, triglycerides, cholesterol, and anion gap. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time frame: Baseline (Day -1) and Days 2, 5 and 7
Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Calcium, Day 5 | -0.033 Millimoles per liter | Standard Deviation 0.0812 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Sodium, Day 7 | 0.6 Millimoles per liter | Standard Deviation 1.33 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Glucose, Day 2 | -0.084 Millimoles per liter | Standard Deviation 0.148 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Urea nitrogen, Day 2 | 0.228 Millimoles per liter | Standard Deviation 0.4467 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | CO2, Day 7 | 0.2 Millimoles per liter | Standard Deviation 1.48 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Urea nitrogen, Day 5 | -0.138 Millimoles per liter | Standard Deviation 0.695 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Glucose, Day 5 | -0.160 Millimoles per liter | Standard Deviation 0.2754 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Urea nitrogen, Day 7 | 0.321 Millimoles per liter | Standard Deviation 0.7415 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | CO2, Day 2 | -1.3 Millimoles per liter | Standard Deviation 1.49 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Phosphate, Day 2 | 0.041 Millimoles per liter | Standard Deviation 0.0842 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Glucose, Day 7 | 0.019 Millimoles per liter | Standard Deviation 0.3691 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Phosphate, Day 5 | 0.014 Millimoles per liter | Standard Deviation 0.0983 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Chloride, Day 2 | 0.3 Millimoles per liter | Standard Deviation 1.85 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Phosphate, Day 7 | 0.023 Millimoles per liter | Standard Deviation 0.0854 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Potassium, Day 2 | 0.01 Millimoles per liter | Standard Deviation 0.247 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Triglycerides, Day 2 | -0.111 Millimoles per liter | Standard Deviation 0.3084 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Calcium, Day 7 | -0.002 Millimoles per liter | Standard Deviation 0.0814 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Triglycerides, Day 5 | -0.215 Millimoles per liter | Standard Deviation 0.3208 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Potassium, Day 5 | -0.01 Millimoles per liter | Standard Deviation 0.476 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Triglycerides, Day 7 | -0.089 Millimoles per liter | Standard Deviation 0.4124 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Chloride, Day 5 | 0.4 Millimoles per liter | Standard Deviation 2 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Cholesterol, Day 2 | 0.121 Millimoles per liter | Standard Deviation 0.4047 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Potassium, Day 7 | 0.01 Millimoles per liter | Standard Deviation 0.145 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Cholesterol, Day 5 | -0.036 Millimoles per liter | Standard Deviation 0.3 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | CO2, Day 5 | -1.1 Millimoles per liter | Standard Deviation 0.99 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Cholesterol, Day 7 | -0.170 Millimoles per liter | Standard Deviation 0.4438 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Sodium, Day 2 | -0.4 Millimoles per liter | Standard Deviation 1.41 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Anion gap, Day 2 | 0.5 Millimoles per liter | Standard Deviation 0.82 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Chloride, Day 7 | 0.4 Millimoles per liter | Standard Deviation 1.88 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Anion gap, Day 5 | 0.0 Millimoles per liter | Standard Deviation 1.41 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Sodium, Day 5 | -0.8 Millimoles per liter | Standard Deviation 1.49 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Anion gap, Day 7 | -0.1 Millimoles per liter | Standard Deviation 0.78 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Calcium, Day 2 | -0.008 Millimoles per liter | Standard Deviation 0.0764 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Anion gap, Day 7 | 0.6 Millimoles per liter | Standard Deviation 1.42 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Calcium, Day 2 | 0.007 Millimoles per liter | Standard Deviation 0.0585 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Calcium, Day 5 | 0.019 Millimoles per liter | Standard Deviation 0.0971 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Calcium, Day 7 | -0.007 Millimoles per liter | Standard Deviation 0.0779 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | CO2, Day 2 | -1.0 Millimoles per liter | Standard Deviation 1.37 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | CO2, Day 5 | -0.6 Millimoles per liter | Standard Deviation 0.73 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | CO2, Day 7 | 0.3 Millimoles per liter | Standard Deviation 1.41 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Chloride, Day 2 | -0.4 Millimoles per liter | Standard Deviation 1.89 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Chloride, Day 5 | -0.9 Millimoles per liter | Standard Deviation 1.9 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Chloride, Day 7 | 0.2 Millimoles per liter | Standard Deviation 2.33 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Glucose, Day 2 | 0.077 Millimoles per liter | Standard Deviation 0.2392 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Glucose, Day 5 | -0.256 Millimoles per liter | Standard Deviation 0.3867 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Glucose, Day 7 | -0.087 Millimoles per liter | Standard Deviation 0.2601 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Potassium, Day 2 | 0.09 Millimoles per liter | Standard Deviation 0.289 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Potassium, Day 5 | -0.08 Millimoles per liter | Standard Deviation 0.192 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Potassium, Day 7 | 0.18 Millimoles per liter | Standard Deviation 0.393 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Sodium, Day 2 | -0.3 Millimoles per liter | Standard Deviation 2.24 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Sodium, Day 5 | -0.8 Millimoles per liter | Standard Deviation 1.86 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Sodium, Day 7 | 1.2 Millimoles per liter | Standard Deviation 2.22 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Urea nitrogen, Day 2 | 0.628 Millimoles per liter | Standard Deviation 0.7585 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Urea nitrogen, Day 5 | 0.067 Millimoles per liter | Standard Deviation 0.8951 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Urea nitrogen, Day 7 | 0.441 Millimoles per liter | Standard Deviation 0.7504 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Phosphate, Day 2 | 0.044 Millimoles per liter | Standard Deviation 0.0902 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Phosphate, Day 5 | 0.012 Millimoles per liter | Standard Deviation 0.0349 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Phosphate, Day 7 | 0.019 Millimoles per liter | Standard Deviation 0.0862 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Triglycerides, Day 2 | -0.121 Millimoles per liter | Standard Deviation 0.2674 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Triglycerides, Day 5 | -0.156 Millimoles per liter | Standard Deviation 0.2584 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Triglycerides, Day 7 | -0.031 Millimoles per liter | Standard Deviation 0.2996 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Cholesterol, Day 2 | 0.076 Millimoles per liter | Standard Deviation 0.2377 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Cholesterol, Day 5 | 0.113 Millimoles per liter | Standard Deviation 0.4685 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Cholesterol, Day 7 | -0.119 Millimoles per liter | Standard Deviation 0.4662 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Anion gap, Day 2 | 1.3 Millimoles per liter | Standard Deviation 0.96 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | Anion gap, Day 5 | -0.3 Millimoles per liter | Standard Deviation 3.08 |
Secondary
Part 2: Change From Baseline in Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate
Blood samples were collected to analyze the chemistry parameters: Creatinine, direct bilirubin, bilirubin, and urate. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time frame: Baseline (Day -1) and Days 2, 5 and 7
Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Change From Baseline in Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate | Creatinine, Day 2 | 7.73 Micromoles per liter | Standard Deviation 4.766 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Change From Baseline in Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate | Creatinine, Day 5 | 3.54 Micromoles per liter | Standard Deviation 6.065 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Change From Baseline in Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate | Creatinine, Day 7 | 2.16 Micromoles per liter | Standard Deviation 3.83 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Change From Baseline in Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate | Direct bilirubin, Day 2 | 0.07 Micromoles per liter | Standard Deviation 0.328 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Change From Baseline in Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate | Direct bilirubin, Day 5 | 0.13 Micromoles per liter | Standard Deviation 0.212 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Change From Baseline in Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate | Direct bilirubin, Day 7 | -0.04 Micromoles per liter | Standard Deviation 0.3 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Change From Baseline in Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate | Bilirubin, Day 2 | 0.02 Micromoles per liter | Standard Deviation 1.518 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Change From Baseline in Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate | Bilirubin, Day 5 | -0.41 Micromoles per liter | Standard Deviation 1.635 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Change From Baseline in Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate | Bilirubin, Day 7 | -0.78 Micromoles per liter | Standard Deviation 2.499 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Change From Baseline in Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate | Urate, Day 2 | -12.4 Micromoles per liter | Standard Deviation 19.25 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Change From Baseline in Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate | Urate, Day 5 | -5.9 Micromoles per liter | Standard Deviation 12.97 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Change From Baseline in Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate | Urate, Day 7 | -6.0 Micromoles per liter | Standard Deviation 19.21 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Change From Baseline in Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate | Urate, Day 5 | -2.0 Micromoles per liter | Standard Deviation 13.42 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Change From Baseline in Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate | Creatinine, Day 2 | 6.97 Micromoles per liter | Standard Deviation 5.419 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Change From Baseline in Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate | Bilirubin, Day 2 | 0.31 Micromoles per liter | Standard Deviation 1.101 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Change From Baseline in Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate | Creatinine, Day 5 | 1.28 Micromoles per liter | Standard Deviation 6.361 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Change From Baseline in Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate | Urate, Day 2 | 2.6 Micromoles per liter | Standard Deviation 15.74 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Change From Baseline in Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate | Creatinine, Day 7 | -0.98 Micromoles per liter | Standard Deviation 3.061 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Change From Baseline in Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate | Bilirubin, Day 5 | 1.93 Micromoles per liter | Standard Deviation 2.272 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Change From Baseline in Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate | Direct bilirubin, Day 2 | 0.04 Micromoles per liter | Standard Deviation 0.405 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Change From Baseline in Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate | Urate, Day 7 | -18.0 Micromoles per liter | Standard Deviation 22.32 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Change From Baseline in Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate | Direct bilirubin, Day 5 | 0.37 Micromoles per liter | Standard Deviation 0.374 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Change From Baseline in Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate | Bilirubin, Day 7 | -0.08 Micromoles per liter | Standard Deviation 1.358 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Change From Baseline in Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate | Direct bilirubin, Day 7 | -0.12 Micromoles per liter | Standard Deviation 0.307 |
Secondary
Part 2: Change From Baseline in Clinical Chemistry Parameters: Lipase and Amylase
Blood samples were collected to analyze the chemistry parameters: lipase and amylase. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time frame: Baseline (Day -1) and Days 2, 5 and 7
Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Change From Baseline in Clinical Chemistry Parameters: Lipase and Amylase | Lipase, Day 2 | -1.6 Units per Liter | Standard Deviation 5.77 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Change From Baseline in Clinical Chemistry Parameters: Lipase and Amylase | Lipase, Day 5 | 2.3 Units per Liter | Standard Deviation 20.1 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Change From Baseline in Clinical Chemistry Parameters: Lipase and Amylase | Lipase, Day 7 | -2.2 Units per Liter | Standard Deviation 8.77 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Change From Baseline in Clinical Chemistry Parameters: Lipase and Amylase | Amylase, Day 2 | 0.8 Units per Liter | Standard Deviation 4.11 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Change From Baseline in Clinical Chemistry Parameters: Lipase and Amylase | Amylase, Day 5 | 0.8 Units per Liter | Standard Deviation 7.42 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Change From Baseline in Clinical Chemistry Parameters: Lipase and Amylase | Amylase, Day 7 | -0.3 Units per Liter | Standard Deviation 6.28 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Change From Baseline in Clinical Chemistry Parameters: Lipase and Amylase | Amylase, Day 5 | -0.7 Units per Liter | Standard Deviation 6.84 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Change From Baseline in Clinical Chemistry Parameters: Lipase and Amylase | Lipase, Day 2 | 0.3 Units per Liter | Standard Deviation 3.51 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Change From Baseline in Clinical Chemistry Parameters: Lipase and Amylase | Amylase, Day 2 | 2.1 Units per Liter | Standard Deviation 3.83 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Change From Baseline in Clinical Chemistry Parameters: Lipase and Amylase | Lipase, Day 5 | 5.3 Units per Liter | Standard Deviation 13.17 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Change From Baseline in Clinical Chemistry Parameters: Lipase and Amylase | Amylase, Day 7 | 1.6 Units per Liter | Standard Deviation 4.39 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Change From Baseline in Clinical Chemistry Parameters: Lipase and Amylase | Lipase, Day 7 | -0.1 Units per Liter | Standard Deviation 4.65 |
Secondary
Part 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval
Twelve lead ECGs were obtained to measure PR interval, QRS duration, QT interval, QTcF interval. Twelve lead ECGs were performed with the participant in a supine position after a rest of at least 10 minutes. Baseline was defined as the average of the triplicate pre-dose assessments within each treatment. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time frame: Baseline (Day 1, pre-dose), and Day 1: 2, 4, 6 hours, Days 5 and 7
Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval | QT Interval, Day 7 | 0.6 Milliseconds | Standard Deviation 8.03 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval | QTcF Interval, Day 1, 6 hours | -3.9 Milliseconds | Standard Deviation 5.96 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval | QTcF Interval, Day 7 | -1.7 Milliseconds | Standard Deviation 6.48 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval | PR Interval, Day 1, 2 hours | -8.1 Milliseconds | Standard Deviation 10.19 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval | PR Interval, Day 1, 4 hours | -6.1 Milliseconds | Standard Deviation 12.06 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval | PR Interval, Day 1, 6 hours | -6.5 Milliseconds | Standard Deviation 10.71 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval | PR Interval, Day 5 | -4.5 Milliseconds | Standard Deviation 10.94 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval | PR Interval, Day 7 | 5.3 Milliseconds | Standard Deviation 7.89 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval | QRS Duration, Day 1, 2 hours | -1.0 Milliseconds | Standard Deviation 5.14 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval | QRS Duration, Day 1, 4 hours | -2.3 Milliseconds | Standard Deviation 5.39 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval | QRS Duration Day 1, 6 hours | -2.2 Milliseconds | Standard Deviation 4.97 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval | QRS Duration, Day 5 | -3.8 Milliseconds | Standard Deviation 7.74 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval | QRS Duration, Day 7 | 1.7 Milliseconds | Standard Deviation 3.12 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval | QT Interval, Day 1, 2 hours | -15.8 Milliseconds | Standard Deviation 13.03 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval | QT Interval, Day 1, 4 hours | -9.5 Milliseconds | Standard Deviation 13.61 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval | QT Interval, Day 1, 6 hours | -9.9 Milliseconds | Standard Deviation 14.35 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval | QT Interval, Day 5 | -16.0 Milliseconds | Standard Deviation 17.47 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval | QTcF Interval, Day 1, 2 hours | -6.1 Milliseconds | Standard Deviation 11.76 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval | QTcF Interval, Day 1, 4 hours | -4.5 Milliseconds | Standard Deviation 8.52 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval | QTcF Interval, Day 5 | -0.5 Milliseconds | Standard Deviation 6.26 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval | QT Interval, Day 5 | -2.3 Milliseconds | Standard Deviation 19.62 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval | QRS Duration, Day 5 | 0.0 Milliseconds | Standard Deviation 2.74 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval | QTcF Interval, Day 5 | 0.2 Milliseconds | Standard Deviation 9.56 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval | QT Interval, Day 7 | -1.3 Milliseconds | Standard Deviation 16.72 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval | QRS Duration, Day 7 | -0.2 Milliseconds | Standard Deviation 3.93 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval | PR Interval, Day 1, 2 hours | -3.9 Milliseconds | Standard Deviation 8.27 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval | QTcF Interval, Day 1, 6 hours | -0.8 Milliseconds | Standard Deviation 8.05 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval | PR Interval, Day 1, 4 hours | -3.4 Milliseconds | Standard Deviation 9.73 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval | QT Interval, Day 1, 2 hours | 1.6 Milliseconds | Standard Deviation 11.34 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval | PR Interval, Day 1, 6 hours | -9.9 Milliseconds | Standard Deviation 12.21 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval | QTcF Interval, Day 1, 2 hours | -0.6 Milliseconds | Standard Deviation 8.47 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval | PR Interval, Day 5 | -4.8 Milliseconds | Standard Deviation 8.84 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval | QT Interval, Day 1, 4 hours | 8.2 Milliseconds | Standard Deviation 10.8 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval | PR Interval, Day 7 | 3.3 Milliseconds | Standard Deviation 11.88 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval | QTcF Interval, Day 7 | -5.7 Milliseconds | Standard Deviation 11.38 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval | QRS Duration, Day 1, 2 hours | -1.2 Milliseconds | Standard Deviation 2.56 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval | QT Interval, Day 1, 6 hours | -15.7 Milliseconds | Standard Deviation 10.87 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval | QRS Duration, Day 1, 4 hours | 0.2 Milliseconds | Standard Deviation 2.21 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval | QTcF Interval, Day 1, 4 hours | 1.4 Milliseconds | Standard Deviation 7.88 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval | QRS Duration Day 1, 6 hours | 0.6 Milliseconds | Standard Deviation 2.75 |
Secondary
Part 2: Change From Baseline in Hematology Parameter: Erythrocytes
Blood samples were collected to analyze the hematology parameter: erythrocytes. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time frame: Baseline (Day -1) and Days 2, 5 and 7
Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes | Day 2 | 0.034 10^12 cells per liter | Standard Deviation 0.1628 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes | Day 5 | -0.024 10^12 cells per liter | Standard Deviation 0.1464 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes | Day 7 | -0.077 10^12 cells per liter | Standard Deviation 0.1875 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes | Day 2 | 0.061 10^12 cells per liter | Standard Deviation 0.1886 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes | Day 5 | 0.027 10^12 cells per liter | Standard Deviation 0.2285 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes | Day 7 | -0.003 10^12 cells per liter | Standard Deviation 0.1151 |
Secondary
Part 2: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin
Blood samples were collected to analyze the hematology parameter: erythrocytes mean corpuscular hemoglobin. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time frame: Baseline (Day -1) and Days 2, 5 and 7
Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin | Day 2 | 0.07 Picograms | Standard Deviation 0.451 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin | Day 5 | -0.13 Picograms | Standard Deviation 0.255 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin | Day 7 | 0.21 Picograms | Standard Deviation 0.483 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin | Day 2 | 0.06 Picograms | Standard Deviation 0.463 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin | Day 5 | 0.00 Picograms | Standard Deviation 0.387 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin | Day 7 | 0.34 Picograms | Standard Deviation 0.445 |
Secondary
Part 2: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume
Blood samples were collected to analyze the hematology parameter: erythrocytes mean corpuscular volume. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time frame: Baseline (Day -1) and Days 2, 5 and 7
Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume | Day 2 | -0.05 Femtoliter | Standard Deviation 0.629 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume | Day 5 | -0.31 Femtoliter | Standard Deviation 0.479 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume | Day 7 | -0.11 Femtoliter | Standard Deviation 0.992 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume | Day 2 | -0.16 Femtoliter | Standard Deviation 0.444 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume | Day 5 | 0.13 Femtoliter | Standard Deviation 0.552 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume | Day 7 | -0.13 Femtoliter | Standard Deviation 0.418 |
Secondary
Part 2: Change From Baseline in Hematology Parameter: Hematocrit
Blood samples were collected to analyze the hematology parameters: hemotocrit. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time frame: Baseline (Day -1) and Days 2, 5 and 7
Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Change From Baseline in Hematology Parameter: Hematocrit | Day 2 | 0.0029 Proportion of red blood cells in blood | Standard Deviation 0.01474 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Change From Baseline in Hematology Parameter: Hematocrit | Day 5 | -0.0038 Proportion of red blood cells in blood | Standard Deviation 0.01403 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Change From Baseline in Hematology Parameter: Hematocrit | Day 7 | -0.0074 Proportion of red blood cells in blood | Standard Deviation 0.01795 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Change From Baseline in Hematology Parameter: Hematocrit | Day 5 | 0.0040 Proportion of red blood cells in blood | Standard Deviation 0.0206 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Change From Baseline in Hematology Parameter: Hematocrit | Day 2 | 0.0047 Proportion of red blood cells in blood | Standard Deviation 0.01576 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Change From Baseline in Hematology Parameter: Hematocrit | Day 7 | -0.0007 Proportion of red blood cells in blood | Standard Deviation 0.01093 |
Secondary
Part 2: Change From Baseline in Hematology Parameter: Hemoglobin
Blood samples were collected to analyze the hematology parameter: hemoglobin. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time frame: Baseline (Day -1) and Days 2, 5 and 7
Population: Safety Population. Only those participants with data available at the specified time points were analyzed
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Change From Baseline in Hematology Parameter: Hemoglobin | Day 2 | 1.4 Grams per liter | Standard Deviation 4.86 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Change From Baseline in Hematology Parameter: Hemoglobin | Day 5 | -1.4 Grams per liter | Standard Deviation 4 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Change From Baseline in Hematology Parameter: Hemoglobin | Day 7 | -1.2 Grams per liter | Standard Deviation 4.35 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Change From Baseline in Hematology Parameter: Hemoglobin | Day 2 | 2.2 Grams per liter | Standard Deviation 4.66 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Change From Baseline in Hematology Parameter: Hemoglobin | Day 5 | 1.2 Grams per liter | Standard Deviation 5.52 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Change From Baseline in Hematology Parameter: Hemoglobin | Day 7 | 1.7 Grams per liter | Standard Deviation 3.84 |
Secondary
Part 2: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets
Blood samples were collected to analyze the hematology parameters: basophils, eosinophils, lymphocytes, monocytes, neutrophils, and platelets. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time frame: Baseline (Day -1) and Days 2, 5 and 7
Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Basophils, Day 2 | -0.004 10^9 cells per liter | Standard Deviation 0.0121 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Basophils, Day 5 | -0.010 10^9 cells per liter | Standard Deviation 0.02 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Basophils, Day 7 | 0.000 10^9 cells per liter | Standard Deviation 0.01 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Eosinophils, Day 2 | -0.006 10^9 cells per liter | Standard Deviation 0.0234 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Eosinophils, Day 5 | -0.001 10^9 cells per liter | Standard Deviation 0.0236 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Eosinophils, Day 7 | 0.000 10^9 cells per liter | Standard Deviation 0.026 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Lymphocytes, Day 2 | 0.068 10^9 cells per liter | Standard Deviation 0.2198 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Lymphocytes, Day 5 | -0.075 10^9 cells per liter | Standard Deviation 0.1507 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Lymphocytes, Day 7 | -0.003 10^9 cells per liter | Standard Deviation 0.2733 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Monocytes, Day 2 | -0.023 10^9 cells per liter | Standard Deviation 0.0422 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Monocytes, Day 5 | -0.009 10^9 cells per liter | Standard Deviation 0.104 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Monocytes, Day 7 | 0.006 10^9 cells per liter | Standard Deviation 0.0923 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Neutrophils, Day 2 | -0.077 10^9 cells per liter | Standard Deviation 0.4373 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Neutrophils, Day 5 | 0.719 10^9 cells per liter | Standard Deviation 1.2615 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Neutrophils, Day 7 | -0.058 10^9 cells per liter | Standard Deviation 0.6203 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Platelets, Day 2 | 6.1 10^9 cells per liter | Standard Deviation 16.69 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Platelets, Day 5 | 0.0 10^9 cells per liter | Standard Deviation 7.19 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Platelets, Day 7 | 4.2 10^9 cells per liter | Standard Deviation 29.94 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Neutrophils, Day 5 | 0.268 10^9 cells per liter | Standard Deviation 0.8053 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Basophils, Day 2 | -0.001 10^9 cells per liter | Standard Deviation 0.0111 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Monocytes, Day 2 | 0.014 10^9 cells per liter | Standard Deviation 0.0497 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Basophils, Day 5 | 0.003 10^9 cells per liter | Standard Deviation 0.0071 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Platelets, Day 7 | -3.4 10^9 cells per liter | Standard Deviation 30.53 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Basophils, Day 7 | 0.008 10^9 cells per liter | Standard Deviation 0.0273 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Monocytes, Day 5 | -0.022 10^9 cells per liter | Standard Deviation 0.0851 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Eosinophils, Day 2 | -0.002 10^9 cells per liter | Standard Deviation 0.0342 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Neutrophils, Day 7 | -0.226 10^9 cells per liter | Standard Deviation 0.4835 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Eosinophils, Day 5 | -0.012 10^9 cells per liter | Standard Deviation 0.0205 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Monocytes, Day 7 | 0.034 10^9 cells per liter | Standard Deviation 0.0706 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Eosinophils, Day 7 | -0.020 10^9 cells per liter | Standard Deviation 0.04 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Platelets, Day 5 | 6.7 10^9 cells per liter | Standard Deviation 11.32 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Lymphocytes, Day 2 | 0.067 10^9 cells per liter | Standard Deviation 0.1895 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Neutrophils, Day 2 | -0.016 10^9 cells per liter | Standard Deviation 0.4117 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Lymphocytes, Day 5 | -0.077 10^9 cells per liter | Standard Deviation 0.1678 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Platelets, Day 2 | 7.1 10^9 cells per liter | Standard Deviation 12.62 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Lymphocytes, Day 7 | 0.016 10^9 cells per liter | Standard Deviation 0.1068 |
Secondary
Part 2: Change From Baseline in Urinalysis Parameter: Specific Gravity
Urine samples were collected 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, including those from unscheduled visit, prior to the first study drug administration in each treatment period. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time frame: Baseline (Day -1) and Days 2, 5 and 7
Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Change From Baseline in Urinalysis Parameter: Specific Gravity | Day 2 | 0.0011 Ratio | Standard Deviation 0.00679 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Change From Baseline in Urinalysis Parameter: Specific Gravity | Day 5 | -0.0005 Ratio | Standard Deviation 0.00447 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Change From Baseline in Urinalysis Parameter: Specific Gravity | Day 7 | -0.0001 Ratio | Standard Deviation 0.00551 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Change From Baseline in Urinalysis Parameter: Specific Gravity | Day 2 | 0.0018 Ratio | Standard Deviation 0.00899 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Change From Baseline in Urinalysis Parameter: Specific Gravity | Day 5 | -0.0019 Ratio | Standard Deviation 0.01156 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Change From Baseline in Urinalysis Parameter: Specific Gravity | Day 7 | -0.0022 Ratio | Standard Deviation 0.00748 |
Secondary
Part 2: Change From Baseline in Vital Signs: DBP and SBP
SBP and DBP were measured in the 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 average of the triplicate predose assessments within each treatment. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time frame: Baseline (Day 1, pre-dose), and Day 1: 24, 48 hours, Days 5, and 7
Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Change From Baseline in Vital Signs: DBP and SBP | DBP, Day 1, 24 hours | -1.1 Millimeters of mercury | Standard Deviation 4.34 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Change From Baseline in Vital Signs: DBP and SBP | DBP, Day 1, 48 hours | -3.3 Millimeters of mercury | Standard Deviation 6.3 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Change From Baseline in Vital Signs: DBP and SBP | DBP, Day 5 | -0.3 Millimeters of mercury | Standard Deviation 6.96 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Change From Baseline in Vital Signs: DBP and SBP | DBP Interval, Day 7 | 0.1 Millimeters of mercury | Standard Deviation 4.48 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Change From Baseline in Vital Signs: DBP and SBP | SBP, Day 1, 24 hours | -0.8 Millimeters of mercury | Standard Deviation 9.19 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Change From Baseline in Vital Signs: DBP and SBP | SBP, Day 1, 48 hours | -2.5 Millimeters of mercury | Standard Deviation 5.56 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Change From Baseline in Vital Signs: DBP and SBP | SBP, Day 5 | 1.3 Millimeters of mercury | Standard Deviation 10.1 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Change From Baseline in Vital Signs: DBP and SBP | SBP, Day 7 | -4.1 Millimeters of mercury | Standard Deviation 4.48 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Change From Baseline in Vital Signs: DBP and SBP | SBP, Day 7 | -7.8 Millimeters of mercury | Standard Deviation 8.74 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Change From Baseline in Vital Signs: DBP and SBP | DBP, Day 1, 24 hours | -2.8 Millimeters of mercury | Standard Deviation 7.18 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Change From Baseline in Vital Signs: DBP and SBP | SBP, Day 1, 24 hours | -1.1 Millimeters of mercury | Standard Deviation 10.57 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Change From Baseline in Vital Signs: DBP and SBP | DBP, Day 1, 48 hours | -4.6 Millimeters of mercury | Standard Deviation 5.28 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Change From Baseline in Vital Signs: DBP and SBP | SBP, Day 5 | 1.9 Millimeters of mercury | Standard Deviation 8.22 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Change From Baseline in Vital Signs: DBP and SBP | DBP, Day 5 | -1.8 Millimeters of mercury | Standard Deviation 5.54 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Change From Baseline in Vital Signs: DBP and SBP | SBP, Day 1, 48 hours | -4.6 Millimeters of mercury | Standard Deviation 7.81 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Change From Baseline in Vital Signs: DBP and SBP | DBP Interval, Day 7 | -2.0 Millimeters of mercury | Standard Deviation 6.61 |
Secondary
Part 2: Change From Baseline in Vital Signs: Oral Temperature
Oral temperature was measured in the 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, 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, pre-dose), and Day 1: 24, 48 hours, Days 5, 6 and 7
Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Change From Baseline in Vital Signs: Oral Temperature | Day 6 | 0.11 Degrees Celsius | Standard Deviation 0.314 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Change From Baseline in Vital Signs: Oral Temperature | Day 1, 24 hours | 0.14 Degrees Celsius | Standard Deviation 0.378 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Change From Baseline in Vital Signs: Oral Temperature | Day 1, 48 hours | 0.14 Degrees Celsius | Standard Deviation 0.326 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Change From Baseline in Vital Signs: Oral Temperature | Day 5 | 0.12 Degrees Celsius | Standard Deviation 0.385 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Change From Baseline in Vital Signs: Oral Temperature | Day 7 | 0.24 Degrees Celsius | Standard Deviation 0.167 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Change From Baseline in Vital Signs: Oral Temperature | Day 7 | 0.01 Degrees Celsius | Standard Deviation 0.47 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Change From Baseline in Vital Signs: Oral Temperature | Day 5 | 0.01 Degrees Celsius | Standard Deviation 0.356 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Change From Baseline in Vital Signs: Oral Temperature | Day 1, 24 hours | 0.03 Degrees Celsius | Standard Deviation 0.341 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Change From Baseline in Vital Signs: Oral Temperature | Day 6 | -0.19 Degrees Celsius | Standard Deviation 0.481 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Change From Baseline in Vital Signs: Oral Temperature | Day 1, 48 hours | 0.02 Degrees Celsius | Standard Deviation 0.35 |
Secondary
Part 2: Change From Baseline in Vital Signs: Pulse Rate
Pulse rate was measured in the 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 average of the triplicate predose assessments within each treatment. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time frame: Baseline (Day 1, pre-dose), and Day 1: 24, 48 hours, Days 5, and 7
Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Change From Baseline in Vital Signs: Pulse Rate | Day 1, 24 hours | 1.3 Beats per minute | Standard Deviation 9.68 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Change From Baseline in Vital Signs: Pulse Rate | Day 1, 48 hours | 2.5 Beats per minute | Standard Deviation 5.37 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Change From Baseline in Vital Signs: Pulse Rate | Day 5 | 7.0 Beats per minute | Standard Deviation 8.19 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Change From Baseline in Vital Signs: Pulse Rate | Day 7 | 0.2 Beats per minute | Standard Deviation 4.18 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Change From Baseline in Vital Signs: Pulse Rate | Day 7 | -2.9 Beats per minute | Standard Deviation 6.51 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Change From Baseline in Vital Signs: Pulse Rate | Day 1, 24 hours | 3.1 Beats per minute | Standard Deviation 8.32 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Change From Baseline in Vital Signs: Pulse Rate | Day 5 | 3.4 Beats per minute | Standard Deviation 5.32 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Change From Baseline in Vital Signs: Pulse Rate | Day 1, 48 hours | 4.9 Beats per minute | Standard Deviation 8.36 |
Secondary
Part 2: Change From Baseline in Vital Signs: Respiratory Rate
Respiratory rate was measured in the 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 average of the triplicate predose assessments within each treatment. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time frame: Baseline (Day 1, pre-dose), and Day 1: 24, 48 hours, Days 5, and 7
Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Change From Baseline in Vital Signs: Respiratory Rate | Day 1, 24 hours | 1.8 Breaths per minute | Standard Deviation 2.82 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Change From Baseline in Vital Signs: Respiratory Rate | Day 1, 48 hours | 0.4 Breaths per minute | Standard Deviation 3.48 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Change From Baseline in Vital Signs: Respiratory Rate | Day 5 | -1.0 Breaths per minute | Standard Deviation 3.02 |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Change From Baseline in Vital Signs: Respiratory Rate | Day 7 | 0.0 Breaths per minute | Standard Deviation 2.83 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Change From Baseline in Vital Signs: Respiratory Rate | Day 7 | 1.1 Breaths per minute | Standard Deviation 3.33 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Change From Baseline in Vital Signs: Respiratory Rate | Day 1, 24 hours | 1.0 Breaths per minute | Standard Deviation 3.01 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Change From Baseline in Vital Signs: Respiratory Rate | Day 5 | -1.3 Breaths per minute | Standard Deviation 4.24 |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Change From Baseline in Vital Signs: Respiratory Rate | Day 1, 48 hours | 0.9 Breaths per minute | Standard Deviation 3.01 |
Secondary
Part 2: Number of Participants With Non-SAEs and 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. A SAE is defined as any serious adverse event that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or other situations as per medical or scientific judgment. Adverse events which were not Serious Adverse Events were considered as Non-Serious adverse events.
Time frame: Up to 9 days
Population: Safety Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Number of Participants With Non-SAEs and SAEs | Non-SAEs | 1 Participants |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Number of Participants With Non-SAEs and SAEs | SAEs | 0 Participants |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Number of Participants With Non-SAEs and SAEs | Non-SAEs | 2 Participants |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Number of Participants With Non-SAEs and SAEs | SAEs | 0 Participants |
Secondary
Part 2: Number of Participants With Urinalysis Dipstick Results: Bilirubin and Nitrite
Urine samples were collected at indicated time points to analyze parameters including bilirubin and nitrite by dipstick. Urinalysis included dipstick urine test which was used to screen for bilirubin and nitrite. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameters of urine bilirubin and nitrite can be read as negative in the urine sample. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period.
Time frame: Baseline (Day -1) and Days 2, 5 and 7
Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Number of Participants With Urinalysis Dipstick Results: Bilirubin and Nitrite | Bilirubin, Baseline (Day -1), Negative | 17 Participants |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Number of Participants With Urinalysis Dipstick Results: Bilirubin and Nitrite | Bilirubin, Day 2, Negative | 17 Participants |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Number of Participants With Urinalysis Dipstick Results: Bilirubin and Nitrite | Bilirubin, Day 5, Negative | 8 Participants |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Number of Participants With Urinalysis Dipstick Results: Bilirubin and Nitrite | Bilirubin, Day 7, Negative | 9 Participants |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Number of Participants With Urinalysis Dipstick Results: Bilirubin and Nitrite | Nitrite, Baseline (Day -1), Negative | 17 Participants |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Number of Participants With Urinalysis Dipstick Results: Bilirubin and Nitrite | Nitrite, Day 2, Negative | 17 Participants |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Number of Participants With Urinalysis Dipstick Results: Bilirubin and Nitrite | Nitrite, Day 5, Negative | 8 Participants |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Number of Participants With Urinalysis Dipstick Results: Bilirubin and Nitrite | Nitrite, Day 7, Negative | 9 Participants |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Number of Participants With Urinalysis Dipstick Results: Bilirubin and Nitrite | Nitrite, Day 7, Negative | 9 Participants |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Number of Participants With Urinalysis Dipstick Results: Bilirubin and Nitrite | Bilirubin, Baseline (Day -1), Negative | 18 Participants |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Number of Participants With Urinalysis Dipstick Results: Bilirubin and Nitrite | Nitrite, Baseline (Day -1), Negative | 18 Participants |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Number of Participants With Urinalysis Dipstick Results: Bilirubin and Nitrite | Bilirubin, Day 2, Negative | 18 Participants |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Number of Participants With Urinalysis Dipstick Results: Bilirubin and Nitrite | Nitrite, Day 5, Negative | 9 Participants |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Number of Participants With Urinalysis Dipstick Results: Bilirubin and Nitrite | Bilirubin, Day 5, Negative | 9 Participants |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Number of Participants With Urinalysis Dipstick Results: Bilirubin and Nitrite | Nitrite, Day 2, Negative | 18 Participants |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Number of Participants With Urinalysis Dipstick Results: Bilirubin and Nitrite | Bilirubin, Day 7, Negative | 9 Participants |
Secondary
Part 2: Number of Participants With Urinalysis Dipstick Results: Glucose
Urine samples were collected at indicated time points to analyze parameters including glucose by dipstick. Urinalysis included dipstick urine test which was used to screen for glucose. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameters of urine glucose can be read as negative in the urine sample. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period.
Time frame: Baseline (Day -1) and Days 2, 5 and 7
Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Number of Participants With Urinalysis Dipstick Results: Glucose | Baseline (Day -1), Negative | 17 Participants |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Number of Participants With Urinalysis Dipstick Results: Glucose | Day 2, Negative | 17 Participants |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Number of Participants With Urinalysis Dipstick Results: Glucose | Day 5, Negative | 8 Participants |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Number of Participants With Urinalysis Dipstick Results: Glucose | Day 7, Negative | 9 Participants |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Number of Participants With Urinalysis Dipstick Results: Glucose | Day 7, Negative | 9 Participants |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Number of Participants With Urinalysis Dipstick Results: Glucose | Baseline (Day -1), Negative | 18 Participants |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Number of Participants With Urinalysis Dipstick Results: Glucose | Day 5, Negative | 9 Participants |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Number of Participants With Urinalysis Dipstick Results: Glucose | Day 2, Negative | 18 Participants |
Secondary
Part 2: Number of Participants With Urinalysis Dipstick Results: Ketones
Urine samples were collected at indicated time points to analyze parameters including ketones by dipstick. Urinalysis included dipstick urine test which was used to screen for ketones. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameters of urine ketones can be read as negative, trace, 1+, 2+ indicating proportional concentrations in the urine sample. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period.
Time frame: Baseline (Day -1) and Days 2, 5 and 7
Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Number of Participants With Urinalysis Dipstick Results: Ketones | Baseline (Day -1), Trace | 0 Participants |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Number of Participants With Urinalysis Dipstick Results: Ketones | Day 5, Trace | 0 Participants |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Number of Participants With Urinalysis Dipstick Results: Ketones | Day 2, 1+ | 0 Participants |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Number of Participants With Urinalysis Dipstick Results: Ketones | Day 5, 2+ | 0 Participants |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Number of Participants With Urinalysis Dipstick Results: Ketones | Day 2, Negative | 17 Participants |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Number of Participants With Urinalysis Dipstick Results: Ketones | Day 7, Negative | 8 Participants |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Number of Participants With Urinalysis Dipstick Results: Ketones | Day 5, Negative | 8 Participants |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Number of Participants With Urinalysis Dipstick Results: Ketones | Day 7, Trace | 1 Participants |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Number of Participants With Urinalysis Dipstick Results: Ketones | Baseline (Day -1), Negative | 17 Participants |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Number of Participants With Urinalysis Dipstick Results: Ketones | Day 7, Trace | 0 Participants |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Number of Participants With Urinalysis Dipstick Results: Ketones | Baseline (Day -1), Negative | 17 Participants |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Number of Participants With Urinalysis Dipstick Results: Ketones | Baseline (Day -1), Trace | 1 Participants |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Number of Participants With Urinalysis Dipstick Results: Ketones | Day 2, Negative | 17 Participants |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Number of Participants With Urinalysis Dipstick Results: Ketones | Day 2, 1+ | 1 Participants |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Number of Participants With Urinalysis Dipstick Results: Ketones | Day 5, Negative | 7 Participants |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Number of Participants With Urinalysis Dipstick Results: Ketones | Day 5, Trace | 1 Participants |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Number of Participants With Urinalysis Dipstick Results: Ketones | Day 5, 2+ | 1 Participants |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Number of Participants With Urinalysis Dipstick Results: Ketones | Day 7, Negative | 9 Participants |
Secondary
Part 2: Number of Participants With Urinalysis Dipstick Results: Leukocyte Esterase
Urine samples were collected at indicated time points to analyze parameters including leukocyte esterase by dipstick. Urinalysis included dipstick urine test which was used to screen for leukocyte esterase. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameters of urine leukocyte esterase can be read as negative, trace indicating proportional concentrations in the urine sample. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period.
Time frame: Baseline (Day -1) and Days 2, 5 and 7
Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Number of Participants With Urinalysis Dipstick Results: Leukocyte Esterase | Day 7, Negative | 9 Participants |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Number of Participants With Urinalysis Dipstick Results: Leukocyte Esterase | Baseline (Day -1), Negative | 17 Participants |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Number of Participants With Urinalysis Dipstick Results: Leukocyte Esterase | Baseline (Day -1), Trace | 0 Participants |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Number of Participants With Urinalysis Dipstick Results: Leukocyte Esterase | Day 2, Negative | 15 Participants |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Number of Participants With Urinalysis Dipstick Results: Leukocyte Esterase | Day 2, Trace | 2 Participants |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Number of Participants With Urinalysis Dipstick Results: Leukocyte Esterase | Day 5, Negative | 8 Participants |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Number of Participants With Urinalysis Dipstick Results: Leukocyte Esterase | Day 2, Trace | 1 Participants |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Number of Participants With Urinalysis Dipstick Results: Leukocyte Esterase | Day 7, Negative | 9 Participants |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Number of Participants With Urinalysis Dipstick Results: Leukocyte Esterase | Day 2, Negative | 17 Participants |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Number of Participants With Urinalysis Dipstick Results: Leukocyte Esterase | Baseline (Day -1), Negative | 17 Participants |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Number of Participants With Urinalysis Dipstick Results: Leukocyte Esterase | Day 5, Negative | 9 Participants |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Number of Participants With Urinalysis Dipstick Results: Leukocyte Esterase | Baseline (Day -1), Trace | 1 Participants |
Secondary
Part 2: Number of Participants With Urinalysis Dipstick Results: Occult Blood
Urine samples were collected at indicated time points to analyze parameters including occult blood by dipstick. Urinalysis included dipstick urine test which was used to screen for occult blood. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameters of urine occult blood can be read as negative, trace, 1+, 2+, 3+ indicating proportional concentrations in the urine sample. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period.
Time frame: Baseline (Day -1) and Days 2, 5 and 7
Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Number of Participants With Urinalysis Dipstick Results: Occult Blood | Baseline (Day -1), 2+ | 1 Participants |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Number of Participants With Urinalysis Dipstick Results: Occult Blood | Day 5, Negative | 8 Participants |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Number of Participants With Urinalysis Dipstick Results: Occult Blood | Baseline (Day -1), 1+ | 0 Participants |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Number of Participants With Urinalysis Dipstick Results: Occult Blood | Day 5, Trace | 0 Participants |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Number of Participants With Urinalysis Dipstick Results: Occult Blood | Day 2, Negative | 17 Participants |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Number of Participants With Urinalysis Dipstick Results: Occult Blood | Day 7, Negative | 7 Participants |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Number of Participants With Urinalysis Dipstick Results: Occult Blood | Baseline (Day -1), Trace | 1 Participants |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Number of Participants With Urinalysis Dipstick Results: Occult Blood | Day 7, 1+ | 1 Participants |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Number of Participants With Urinalysis Dipstick Results: Occult Blood | Day 2, 1+ | 0 Participants |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Number of Participants With Urinalysis Dipstick Results: Occult Blood | Day 7, 2+ | 1 Participants |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Number of Participants With Urinalysis Dipstick Results: Occult Blood | Baseline (Day -1), Negative | 15 Participants |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Number of Participants With Urinalysis Dipstick Results: Occult Blood | Day 7, 2+ | 0 Participants |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Number of Participants With Urinalysis Dipstick Results: Occult Blood | Baseline (Day -1), Negative | 16 Participants |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Number of Participants With Urinalysis Dipstick Results: Occult Blood | Baseline (Day -1), Trace | 0 Participants |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Number of Participants With Urinalysis Dipstick Results: Occult Blood | Baseline (Day -1), 1+ | 1 Participants |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Number of Participants With Urinalysis Dipstick Results: Occult Blood | Baseline (Day -1), 2+ | 1 Participants |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Number of Participants With Urinalysis Dipstick Results: Occult Blood | Day 2, Negative | 17 Participants |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Number of Participants With Urinalysis Dipstick Results: Occult Blood | Day 2, 1+ | 1 Participants |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Number of Participants With Urinalysis Dipstick Results: Occult Blood | Day 5, Negative | 8 Participants |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Number of Participants With Urinalysis Dipstick Results: Occult Blood | Day 5, Trace | 1 Participants |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Number of Participants With Urinalysis Dipstick Results: Occult Blood | Day 7, Negative | 9 Participants |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Number of Participants With Urinalysis Dipstick Results: Occult Blood | Day 7, 1+ | 0 Participants |
Secondary
Part 2: Number of Participants With Urinalysis Dipstick Results: Protein
Urine samples were collected at indicated time points to analyze parameters including protein by dipstick. Urinalysis included dipstick urine test which was used to screen for protein. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameters of urine protein can be read as negative, and trace in the urine sample. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period.
Time frame: Baseline (Day -1) and Days 2, 5 and 7
Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Number of Participants With Urinalysis Dipstick Results: Protein | Day 2, Negative | 17 Participants |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Number of Participants With Urinalysis Dipstick Results: Protein | Day 7, Negative | 8 Participants |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Number of Participants With Urinalysis Dipstick Results: Protein | Day 5, Negative | 8 Participants |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Number of Participants With Urinalysis Dipstick Results: Protein | Day 7, Trace | 1 Participants |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Number of Participants With Urinalysis Dipstick Results: Protein | Baseline (Day -1), Negative | 17 Participants |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Number of Participants With Urinalysis Dipstick Results: Protein | Day 7, Trace | 0 Participants |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Number of Participants With Urinalysis Dipstick Results: Protein | Baseline (Day -1), Negative | 18 Participants |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Number of Participants With Urinalysis Dipstick Results: Protein | Day 2, Negative | 18 Participants |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Number of Participants With Urinalysis Dipstick Results: Protein | Day 5, Negative | 9 Participants |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Number of Participants With Urinalysis Dipstick Results: Protein | Day 7, Negative | 9 Participants |
Secondary
Part 2: Number of Participants With Worst Case Urine Parameter: Erythrocytes Results by Maximum Grade Increase Post-Baseline Relative to Baseline
Urine samples were collected to analyze the urine parameter: erythrocytes. Urinalysis parameters were graded according to Division of Acquired Immune Deficiency Syndrome (DAIDS) grading for severity of laboratory toxicities and clinical adverse events, version 2.1. The grades were grade 1 (mild), 2 (moderate), 3 (severe) and 4 (potentially life-threatening). Baseline was defined as the last assessment before the first dose of the study treatment. Only those urine parameters with maximum post-Baseline grade increase (Grade 1 to Grade 4) have been presented.
Time frame: Up to Day 9
Population: Safety Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Number of Participants With Worst Case Urine Parameter: Erythrocytes Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Increase to Grade 1 | 0 Participants |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Number of Participants With Worst Case Urine Parameter: Erythrocytes Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Increase to Grade 3 | 0 Participants |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Number of Participants With Worst Case Urine Parameter: Erythrocytes Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Increase to Grade 4 | 0 Participants |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Number of Participants With Worst Case Urine Parameter: Erythrocytes Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Increase to Grade 2 | 0 Participants |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Number of Participants With Worst Case Urine Parameter: Erythrocytes Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Increase to Grade 4 | 0 Participants |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Number of Participants With Worst Case Urine Parameter: Erythrocytes Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Increase to Grade 1 | 0 Participants |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Number of Participants With Worst Case Urine Parameter: Erythrocytes Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Increase to Grade 2 | 0 Participants |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Number of Participants With Worst Case Urine Parameter: Erythrocytes Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Increase to Grade 3 | 0 Participants |
Secondary
Part 2: Number of Participants With Worst Case Urine Parameter: Glucose Results by Maximum Grade Increase Post-Baseline Relative to Baseline
Urine samples were collected to analyze the urine parameter: glucose. Urinalysis parameters were graded according to Division of Acquired Immune Deficiency Syndrome (DAIDS) grading for severity of laboratory toxicities and clinical adverse events, version 2.1. The grades were grade 1 (mild), 2 (moderate), 3 (severe) and 4 (potentially life-threatening). Baseline was defined as the last assessment before the first dose of the study treatment. Only those urine parameters with maximum post-Baseline grade increase (Grade 1 to Grade 4) have been presented.
Time frame: Up to Day 9
Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Number of Participants With Worst Case Urine Parameter: Glucose Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Increase to Grade 3 | 0 Participants |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Number of Participants With Worst Case Urine Parameter: Glucose Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Increase to Grade 1 | 0 Participants |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Number of Participants With Worst Case Urine Parameter: Glucose Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Increase to Grade 4 | 0 Participants |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Number of Participants With Worst Case Urine Parameter: Glucose Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Increase to Grade 2 | 0 Participants |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Number of Participants With Worst Case Urine Parameter: Glucose Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Increase to Grade 4 | 0 Participants |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Number of Participants With Worst Case Urine Parameter: Glucose Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Increase to Grade 2 | 0 Participants |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Number of Participants With Worst Case Urine Parameter: Glucose Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Increase to Grade 3 | 0 Participants |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Number of Participants With Worst Case Urine Parameter: Glucose Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Increase to Grade 1 | 0 Participants |
Secondary
Part 2: Number of Participants With Worst Case Urine Parameter: Protein Results by Maximum Grade Increase Post-Baseline Relative to Baseline
Urine samples were collected to analyze the urine parameter: protein. Urinalysis parameters were graded according to Division of Acquired Immune Deficiency Syndrome (DAIDS) grading for severity of laboratory toxicities and clinical adverse events, version 2.1. The grades were grade 1 (mild), 2 (moderate), 3 (severe) and 4 (potentially life-threatening). Baseline was defined as the last assessment before the first dose of the study treatment. Only those urine parameters with maximum post-Baseline grade increase (Grade 1 to Grade 4) have been presented.
Time frame: Up to Day 9
Population: Safety Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Number of Participants With Worst Case Urine Parameter: Protein Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Increase to Grade 1 | 0 Participants |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Number of Participants With Worst Case Urine Parameter: Protein Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Increase to Grade 2 | 0 Participants |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Number of Participants With Worst Case Urine Parameter: Protein Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Increase to Grade 3 | 0 Participants |
| Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Part 2: Number of Participants With Worst Case Urine Parameter: Protein Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Increase to Grade 4 | 0 Participants |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Number of Participants With Worst Case Urine Parameter: Protein Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Increase to Grade 4 | 0 Participants |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Number of Participants With Worst Case Urine Parameter: Protein Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Increase to Grade 1 | 0 Participants |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Number of Participants With Worst Case Urine Parameter: Protein Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Increase to Grade 3 | 0 Participants |
| Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Part 2: Number of Participants With Worst Case Urine Parameter: Protein Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Increase to Grade 2 | 0 Participants |