HIV Infections
Conditions
Keywords
GSK3640254, dolutegravir, healthy subjects, two-way interaction, HIV
Brief summary
This is an open-label, single-sequence, two-way drug interaction study to investigate the PK, safety and tolerability of GSK3640254 and DTG when administered alone or in combination in healthy subjects. Treatment of human immunodeficiency virus (HIV) infection frequently involves combination therapy. Data from this study will contribute to dosing recommendations when GSK3640254 and DTG are given in combination. The study will consist of a Screening period and 3 sequential treatment periods. Subjects will be administered DTG 50 milligrams (mg) once daily (QD) in Period 1 followed by GSK3640254 200 mg QD in Period 2. There will be a washout period of 4 days between Periods 1 and 2. In Period 3, subjects will be co-administered DTG 50 mg QD and GSK3640254 200 mg QD. The total duration of the study will be approximately 55 days, including Screening.
Interventions
DRUGGSK3640254
GSK3640254 will be available as 100 mg capsules. Subjects will be administered GSK3640254 200 mg QD via the oral route.
DRUGDTG
DTG will be available as 50 mg tablets. Subjects will be administered DTG 50 mg QD via the oral route.
Sponsors
ViiV Healthcare
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Subject must be 18 to 55 years of age inclusive, at the time of signing the informed consent. * Subjects who are healthy as determined by the investigator or medically qualified designee based on a medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring (history and ECG). * Body weight \>=50 kilograms (kg) (110 pounds \[lbs\]) for men and \>=45.0 kg (99 lbs) for women and body mass index within the range 18.5 to 31.0 kilograms per square meter (kg/m\^2) (inclusive). * Male or female subjects can participate. A female subject is eligible to participate if she is not pregnant, not breastfeeding, and not a woman of childbearing potential (WOCBP). * Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and protocol.
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 gastrointestinal (GI) anatomy or motility (e.g., gastroesophageal reflux disease, gastric ulcers, gastritis), hepatic and/or renal function, that could interfere with the absorption, metabolism, and/or excretion of the study drugs or render the subject unable to take oral study intervention. * Any history of significant underlying psychiatric disorder, including but not limited to schizophrenia, bipolar disorder with or without psychotic symptoms, other psychotic disorders, or schizotypal (personality) disorder. * Any history of major depressive disorder with or without suicidal features, or anxiety disorders, that required medical intervention (pharmacologic or not) such as hospitalization or other inpatient treatment and/or chronic (\>6 months) outpatient treatment. Subjects with other conditions such as adjustment disorder or dysthymia that have required shorter term medical therapy (\<6 months) without inpatient treatment and are currently well-controlled clinically or resolved may be considered for entry after discussion and agreement with the ViiV Medical Monitor. * Any pre-existing physical or other psychiatric condition (including alcohol or drug abuse), which, in the opinion of the investigator (with or without psychiatric evaluation), could interfere with the subject's ability to comply with the dosing schedule and protocol evaluations or which might compromise the safety of the subject. * Medical history of cardiac arrhythmias or cardiac disease or a family or personal history of long QT syndrome. * Presence of Hepatitis B surface antigen (HBsAg) at Screening or within 3 months prior to starting study intervention. * Positive Hepatitis C antibody test result at Screening or within 3 months prior to starting study intervention and positive on reflex to Hepatitis C ribonucleic acid (RNA). * Positive HIV-1 and -2 antigen/antibody immunoassay at Screening. * ALT \>1.5 times upper limit of normal (ULN). A single repeat of ALT is allowed within a single screening period to determine eligibility. * Bilirubin \>1.5 times ULN (isolated bilirubin \>1.5 times ULN is acceptable if bilirubin is fractionated and direct bilirubin \<35 percent). * Any acute laboratory abnormality at Screening which, in the opinion of the investigator, should preclude participation in the study of an investigational compound. * Any Grade 2 to 4 laboratory abnormality at Screening, with the exception of creatine phosphokinase (CPK) and lipid abnormalities (e.g., total cholesterol, triglycerides), and ALT (described above), will exclude a subject from the study unless the investigator can provide a compelling explanation for the laboratory results and has the assent of the sponsor. A single repeat of any laboratory abnormality is allowed within a single screening period to determine eligibility. * A positive test result for drugs of abuse (including marijuana), alcohol, or cotinine (indicating active current smoking) at Screening or before the first dose of study intervention. * Unable to refrain from the use of prescription or non-prescription drugs including vitamins, herbal and dietary supplements (including St John's wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the first dose of study medication and for the duration of the study. * Treatment with any vaccine within 30 days prior to receiving study intervention. * Unwillingness to abstain from excessive consumption of any food or drink containing grapefruit and grapefruit juice, Seville oranges, blood oranges, or pomelos or their fruit juices within 7 days prior to the first dose of study intervention(s) until the end of the study. * Participation in another concurrent clinical study or prior clinical study (with the exception of imaging trials) prior to the first dosing day in the current study: 30 days, 5 half-lives, or twice the duration of the biological effect of the study intervention (whichever is longer). * Where participation in the study would result in donation of blood or blood products in excess of 500 milliliter (mL) within 56 days. * 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, sinoatrial pauses, bundle branch 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 subject. *
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Period 1: Area Under the Plasma Concentration-time Curve From Time 0 to the End of the Dosing (AUC[0 to Tau]) of Dolutegravir for Dolutegravir Arm | Day 5: Pre-dose, 1, 1.5, 2, 3, 3.5, 4, 4.5, 5, 6, 8, 12 and 24 hours post-dose | Blood samples were collected at the indicated time points for pharmacokinetic analysis of dolutegravir. The pharmacokinetic parameters were calculated by standard non-compartmental analysis. Pharmacokinetic Parameter Population consisted of all participants who underwent plasma pharmacokinetic sampling and had evaluable pharmacokinetic parameters estimated. |
| Period 3: AUC(0 to Tau) of Dolutegravir for Dolutegravir + GSK3640254 Arm | Day 7: Pre-dose, 1, 1.5, 2, 3, 3.5, 4, 4.5, 5, 6, 8, 12 and 24 hours post-dose | Blood samples were collected at the indicated time points for pharmacokinetic analysis of dolutegravir. The pharmacokinetic parameters were calculated by standard non-compartmental analysis. |
| Period 1: Maximum Observed Concentration (Cmax) of Dolutegravir for Dolutegravir Arm | Day 5: Pre-dose, 1, 1.5, 2, 3, 3.5, 4, 4.5, 5, 6, 8, 12 and 24 hours post-dose | Blood samples were collected at the indicated time points for pharmacokinetic analysis of dolutegravir. The pharmacokinetic parameters were calculated by standard non-compartmental analysis. |
| Period 3: Cmax of Dolutegravir for Dolutegravir + GSK3640254 Arm | Day 7: Pre-dose, 1, 1.5, 2, 3, 3.5, 4, 4.5, 5, 6, 8, 12 and 24 hours post-dose | Blood samples were collected at the indicated time points for pharmacokinetic analysis of dolutegravir. The pharmacokinetic parameters were calculated by standard non-compartmental analysis. |
| Period 1: Plasma Concentration at the End of the Dosing Interval (Ctau) of Dolutegravir for Dolutegravir Arm | Day 5: Pre-dose, 1, 1.5, 2, 3, 3.5, 4, 4.5, 5, 6, 8, 12 and 24 hours post-dose | Blood samples were collected at the indicated time points for pharmacokinetic analysis of dolutegravir. The pharmacokinetic parameters were calculated by standard non-compartmental analysis. |
| Period 3: Ctau of Dolutegravir for Dolutegravir + GSK3640254 Arm | Day 7: Pre-dose, 1, 1.5, 2, 3, 3.5, 4, 4.5, 5, 6, 8, 12 and 24 hours post-dose | Blood samples were collected at the indicated time points for pharmacokinetic analysis of dolutegravir. The pharmacokinetic parameters were calculated by standard non-compartmental analysis. |
| Period 2: AUC(0 to Tau) of GSK3640254 for GSK3640254 Arm | Day 7: Pre-dose, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12 and 24 hours post-dose | Blood samples were collected at the indicated time points for pharmacokinetic analysis of GSK3640254. The pharmacokinetic parameters were calculated by standard non-compartmental analysis. |
| Period 3: AUC(0 to Tau) of GSK3640254 for Dolutegravir + GSK3640254 Arm | Day 7: Pre-dose, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12 and 24 hours post-dose | Blood samples were collected at the indicated time points for pharmacokinetic analysis of GSK3640254. The pharmacokinetic parameters were calculated by standard non-compartmental analysis. |
| Period 2: Cmax of GSK3640254 for GSK3640254 Arm | Day 7: Pre-dose, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12 and 24 hours post-dose | Blood samples were collected at the indicated time points for pharmacokinetic analysis of GSK3640254. The pharmacokinetic parameters were calculated by standard non-compartmental analysis. |
| Period 3: Cmax of GSK3640254 for Dolutegravir + GSK3640254 Arm | Day 7: Pre-dose, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12 and 24 hours post-dose | Blood samples were collected at the indicated time points for pharmacokinetic analysis of GSK3640254. The pharmacokinetic parameters were calculated by standard non-compartmental analysis. |
| Period 2: Ctau of GSK3640254 for GSK3640254 Arm | Day 7: Pre-dose, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12 and 24 hours post-dose | Blood samples were collected at the indicated time points for pharmacokinetic analysis of GSK3640254. The pharmacokinetic parameters were calculated by standard non-compartmental analysis. |
| Period 3: Ctau of GSK3640254 for Dolutegravir + GSK3640254 Arm | Day 7: Pre-dose, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12 and 24 hours post-dose | Blood samples were collected at the indicated time points for pharmacokinetic analysis of GSK3640254. The pharmacokinetic parameters were calculated by standard non-compartmental analysis. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Period 2: Absolute Values for Hematology Parameter: Hematocrit | Day 7 | Blood samples were collected to analyze the hematology parameter: hematocrit. |
| Number of Participants With Non-serious Adverse Events (Non-SAEs) and Serious Adverse Events (SAEs) | Up to Day 27 | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; is a congenital anomaly/birth defect; and other important medical events which may require medical or surgical intervention. Safety Population consisted of all participants who received at least 1 dose of study medication. |
| Period 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count | Baseline (Day -1) and at Day 9 | Blood samples were collected to analyze the hematology parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelet count. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first treatment in Period 1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. |
| Period 2: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count | Baseline (Period 1 Day 9) and at Day 7 | Blood samples were collected to analyze the hematology parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelet count. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first treatment in Period 2. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. |
| Period 3: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count | Baseline (Period 2 Day 7) and at Days 4, 7 and 10 | Blood samples were collected to analyze the hematology parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelet count. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first treatment in Period 3. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. |
| Period 1: Change From Baseline in Hematology Parameter: Hemoglobin | Baseline (Day -1) and at Day 9 | 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 visits, before the first treatment in Period 1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. |
| Period 2: Change From Baseline in Hematology Parameter: Hemoglobin | Baseline (Period 1 Day 9) and at Day 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 visits, before the first treatment in Period 2. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. |
| Period 3: Change From Baseline in Hematology Parameter: Hemoglobin | Baseline (Period 2 Day 7) and at Days 4, 7 and 10 | 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 visits, before the first treatment in Period 3. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. |
| Period 1: Change From Baseline in Hematology Parameter: Hematocrit | Baseline (Day -1) and at Day 9 | 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 visits, before the first treatment in Period 1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. |
| Period 2: Change From Baseline in Hematology Parameter: Hematocrit | Baseline (Period 1 Day 9) and at Day 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 visits, before the first treatment in Period 2. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. |
| Period 3: Change From Baseline in Hematology Parameter: Hematocrit | Baseline (Period 2 Day 7) and at Days 4, 7 and 10 | 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 visits, before the first treatment in Period 3. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. |
| Period 1: Change From Baseline in Hematology Parameter: Erythrocytes | Baseline (Day -1) and at Day 9 | 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 visits, before the first treatment in Period 1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. |
| Period 2: Change From Baseline in Hematology Parameter: Erythrocytes | Baseline (Period 1 Day 9) and at Day 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 visits, before the first treatment in Period 2. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. |
| Period 3: Change From Baseline in Hematology Parameter: Erythrocytes | Baseline (Period 2 Day 7) and at Days 4, 7 and 10 | 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 visits, before the first treatment in Period 3. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. |
| Period 1: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume | Baseline (Day -1) and at Day 9 | 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 visits, before the first treatment in Period 1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. |
| Period 2: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume | Baseline (Period 1 Day 9) and at Day 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 visits, before the first treatment in Period 2. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. |
| Period 3: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume | Baseline (Period 2 Day 7) and at Days 4, 7 and 10 | 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 visits, before the first treatment in Period 3. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. |
| Period 1: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin | Baseline (Day -1) and at Day 9 | 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 visits, before the first treatment in Period 1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. |
| Period 2: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin | Baseline (Period 1 Day 9) and at Day 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 visits, before the first treatment in Period 2. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. |
| Period 3: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin | Baseline (Period 2 Day 7) and at Days 4, 7 and 10 | 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 visits, before the first treatment in Period 3. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. |
| Period 1: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Baseline (Day -1) and at Day 9 | Blood samples were collected to analyze the chemistry parameters: glucose, cholesterol, triglycerides, anion gap, calcium, carbon dioxide, chloride, phosphate, potassium, sodium and blood urea nitrogen. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first treatment in Period 1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. |
| Period 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Baseline (Period 1 Day 9) and at Day 7 | Blood samples were collected to analyze the chemistry parameters: glucose, cholesterol, triglycerides, anion gap, calcium, carbon dioxide, chloride, phosphate, potassium, sodium and blood urea nitrogen. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first treatment in Period 2. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. |
| Period 3: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Baseline (Period 2 Day 7) and at Days 4, 7 and 10 | Blood samples were collected to analyze the chemistry parameters: glucose, cholesterol, triglycerides, anion gap, calcium, carbon dioxide, chloride, phosphate, potassium, sodium and blood urea nitrogen. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first treatment in Period 3. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. |
| Period 1: Change From Baseline in Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase | Baseline (Day -1) and at Day 9 | Blood samples were collected to analyze the chemistry parameters: creatine kinase, lactate dehydrogenase, ALT, ALP, AST and gamma-glutamyl transferase. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first treatment in Period 1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. |
| Period 2: Change From Baseline in Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST, Gamma-glutamyl Transferase | Baseline (Period 1 Day 9) and at Day 7 | Blood samples were collected to analyze the chemistry parameters: creatine kinase, lactate dehydrogenase, ALT, ALP, AST and gamma-glutamyl transferase. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first treatment in Period 2. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. |
| Period 3: Change From Baseline in Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST, Gamma-glutamyl Transferase | Baseline (Period 2 Day 7) and at Days 4, 7 and 10 | Blood samples were collected to analyze the chemistry parameters: creatine kinase, lactate dehydrogenase, ALT, ALP, AST and gamma-glutamyl transferase. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first treatment in Period 3. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. |
| Period 3: Absolute Values for Hematology Parameter: Hematocrit | Days 4, 7 and 10 | Blood samples were collected to analyze the hematology parameter: hematocrit. |
| Period 1: Change From Baseline in Chemistry Parameters: Urate, Creatinine, Bilirubin, Direct Bilirubin | Baseline (Day -1) and at Day 9 | Blood samples were collected to analyze the chemistry parameters: urate, creatinine, bilirubin and direct bilirubin. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first treatment in Period 1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. |
| Period 2: Change From Baseline in Chemistry Parameters: Urate, Creatinine, Bilirubin, Direct Bilirubin | Baseline (Period 1 Day 9) and at Day 7 | Blood samples were collected to analyze the chemistry parameters: urate, creatinine, bilirubin and direct bilirubin. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first treatment in Period 2. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. |
| Period 3: Change From Baseline in Chemistry Parameters: Urate, Creatinine, Bilirubin, Direct Bilirubin | Baseline (Period 2 Day 7) and at Days 4, 7 and 10 | Blood samples were collected to analyze the chemistry parameters: urate, creatinine, bilirubin and direct bilirubin. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first treatment in Period 3. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. |
| Period 1: Change From Baseline in Chemistry Parameters: Albumin, Globulin, Protein | Baseline (Day -1) and at Day 9 | 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 visits, before the first treatment in Period 1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. |
| Period 2: Change From Baseline in Chemistry Parameters: Albumin, Globulin, Protein | Baseline (Period 1 Day 9) and at Day 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 visits, before the first treatment in Period 2. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. |
| Period 3: Change From Baseline in Chemistry Parameters: Albumin, Globulin, Protein | Baseline (Period 2 Day 7) and at Days 4, 7 and 10 | 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 visits, before the first treatment in Period 3. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. |
| Period 1: Change From Baseline in Chemistry Parameters: Amylase, Lipase | Baseline (Day -1) and at Day 9 | Blood samples were collected to analyze the chemistry parameters: amylase and lipase. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first treatment in Period 1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. |
| Period 2: Change From Baseline in Chemistry Parameters: Amylase, Lipase | Baseline (Period 1 Day 9) and at Day 7 | Blood samples were collected to analyze the chemistry parameters: amylase and lipase. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first treatment in Period 2. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. |
| Period 3: Change From Baseline in Chemistry Parameters: Amylase, Lipase | Baseline (Period 2 Day 7) and at Days 4, 7 and 10 | Blood samples were collected to analyze the chemistry parameters: amylase and lipase. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first treatment in Period 3. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. |
| Period 1: Change From Baseline in Urinalysis Parameter: Specific Gravity | Baseline (Day -1) and at Day 9 | 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 visits, before the first treatment in Period 1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. |
| Period 2: Change From Baseline in Urinalysis Parameter: Specific Gravity | Baseline (Period 1 Day 9) and at Day 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 visits, before the first treatment in Period 2. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. |
| Period 3: Change From Baseline in Urinalysis Parameter: Specific Gravity | Baseline (Period 2 Day 7) and at Days 4, 7 and 10 | 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 visits, before the first treatment in Period 3. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. |
| Period 1: Change From Baseline in Urinalysis Parameter: Urobilinogen | Baseline (Day -1) and at Day 9 | Urine samples were collected to analyze the urinalysis parameter: urobilinogen. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first treatment in Period 1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. |
| Period 2: Change From Baseline in Urinalysis Parameter: Urobilinogen | Baseline (Period 1 Day 9) and at Day 7 | Urine samples were collected to analyze the urinalysis parameter: urobilinogen. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first treatment in Period 2. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. |
| Period 3: Change From Baseline in Urinalysis Parameter: Urobilinogen | Baseline (Period 2 Day 7) and at Days 4, 7 and 10 | Urine samples were collected to analyze the urinalysis parameter: urobilinogen. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first treatment in Period 3. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. |
| Period 1: Absolute Values for Hematology Parameter: Erythrocytes | Day 9 | Blood samples were collected to analyze the hematology parameter: erythrocytes. |
| Period 1: Change From Baseline in Urinalysis Parameter: Potential of Hydrogen (pH) | Baseline (Day -1) and at Day 9 | 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. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0). Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first treatment in Period 1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. |
| Period 2: Change From Baseline in Urinalysis Parameter: pH | Baseline (Period 1 Day 9) and at Day 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. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0). Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first treatment in Period 2. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. |
| Period 3: Change From Baseline in Urinalysis Parameter: pH | Baseline (Period 2 Day 7) and at Days 4, 7 and 10 | 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. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0). Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first treatment in Period 3. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. |
| Period 1: Number of Participants With Urinalysis Dipstick Results | Day 9 | Urine samples were collected at indicated time points to analyze parameters including glucose, protein, occult blood, ketones, nitrite, bilirubin and leukocyte esterase levels by dipstick. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameters can be read as negative, Trace, 1+ (low concentrations present) and 2+ (moderate concentrations present) indicating proportional concentrations in the urine sample. |
| Period 2: Number of Participants With Urinalysis Dipstick Results | Day 7 | Urine samples were collected at indicated time points to analyze parameters including glucose, protein, occult blood, ketones, nitrite, bilirubin and leukocyte esterase levels by dipstick. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameters can be read as negative, Trace, 1+ (low concentrations present), and 2+ (moderate concentrations present) indicating proportional concentrations in the urine sample. |
| Period 3: Number of Participants With Urinalysis Dipstick Results | Days 4, 7 and 10 | Urine samples were collected at indicated time points to analyze parameters including glucose, protein, occult blood, ketones, nitrite, bilirubin and leukocyte esterase levels by dipstick. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameters can be read as negative, Trace, 1+ (low concentrations present), and 2+ (moderate concentrations present)indicating proportional concentrations in the urine sample. |
| Period 1: Change From Baseline in PR Interval, QRS Duration, QT Interval, Fridericia QT Correction Formula (QTcF), Bazett's QT Correction Formula (QTcB) | Baseline, Day 1: 2 hours, 4 hours; Day 5: Pre-dose, 2 hours and 4 hours | Twelve-lead electrocardiograms (ECG) were obtained to measure PR Interval, QRS Duration, QT Interval, QTcF Interval and QTcB Interval. Twelve-lead ECGs were performed with the participant in a supine or semi-supine position after a rest of at least 10 minutes. Baseline was defined as the average of the triplicate pre-dose assessments on Day 1 of Period 1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. |
| Period 2: Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB | Baseline; Day 1: 2 hours, 4 hours; Day 5: Pre-dose, 2 hours and 4 hours | Twelve-lead ECG were obtained to measure PR Interval, QRS Duration, QT Interval, QTcF Interval and QTcB Interval. Twelve-lead ECGs were performed with the participant in a supine or semi-supine position after a rest of at least 10 minutes. Baseline was defined as the average of the triplicate pre-dose assessments on Day 1 of Period 2. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. |
| Period 3: Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB | Baseline; Day 1: 2 hours, 4 hours; Days 4, 5 and 7: Pre-dose, 2 hours and 4 hours; Day 10 | Twelve-lead ECG were obtained to measure PR Interval, QRS Duration, QT Interval, QTcF Interval and QTcB Interval. Twelve-lead ECGs were performed with the participant in a supine or semi-supine position after a rest of at least 10 minutes. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, in Period 3. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. |
| Period 1: Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Baseline (Day 1, Pre-dose), Days 2, 3, 4 and 5 | SBP and DBP were measured in the semi-recumbent position with a completely automated device. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, in Period 1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. |
| Period 2: Change From Baseline in SBP and DBP | Baseline (Day 1, Pre-dose), Days 2, 3, 4, 5, 6 and 7 | SBP and DBP were measured in the semi-recumbent position with a completely automated device. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, in Period 2. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. |
| Period 3: Change From Baseline in SBP and DBP | Baseline (Day 1, Pre-dose), Days 2, 3, 4, 5, 6, 7, 8, 9, 10 and 11 | SBP and DBP were measured in the semi-recumbent position with a completely automated device. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, in Period 3. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. |
| Period 1: Change From Baseline in Pulse Rate | Baseline (Day 1, Pre-dose), Days 2, 3, 4 and 5 | Pulse rate was measured in the semi-recumbent position with a completely automated device. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, in Period 1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. |
| Period 2: Change From Baseline in Pulse Rate | Baseline (Day 1, Pre-dose), Days 2, 3, 4, 5, 6 and 7 | Pulse rate was measured in the semi-recumbent position with a completely automated device. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, in Period 2. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. |
| Period 3: Change From Baseline in Pulse Rate | Baseline (Day 1, Pre-dose), Days 2, 3, 4, 5, 6, 7, 8, 9, 10 and 11 | Pulse rate was measured in the semi-recumbent position with a completely automated device. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, in Period 3. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. |
| Period 1: Change From Baseline in Respiratory Rate | Baseline (Day 1, Pre-dose), Days 2, 3, 4 and 5 | Respiratory rate was measured in the semi-recumbent position 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, in Period 1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. |
| Period 2: Change From Baseline in Respiratory Rate | Baseline (Day 1, Pre-dose), Days 2, 3, 4, 5, 6 and 7 | Respiratory rate was measured in the semi-recumbent position 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, in Period 2. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. |
| Period 3: Change From Baseline in Respiratory Rate | Baseline (Day 1, Pre-dose), Days 2, 3, 4, 5, 6, 7, 8, 9, 10 and 11 | Respiratory rate was measured in the semi-recumbent position 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, in Period 3. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. |
| Period 1: Change From Baseline in Body Temperature | Baseline (Day 1, Pre-dose), Days 2, 3, 4 and 5 | Body temperature was measured in the semi-recumbent position 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, in Period 1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. |
| Period 2: Change From Baseline in Body Temperature | Baseline (Day 1, Pre-dose), Days 2, 3, 4, 5, 6 and 7 | Body temperature was measured in the semi-recumbent position 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, in Period 2. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. |
| Period 3: Change From Baseline in Body Temperature | Baseline (Day 1, Pre-dose), Days 2, 3, 4, 5, 6, 7, 8, 9, 10 and 11 | Body temperature was measured in the semi-recumbent position 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, in Period 3. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. |
| Period 1: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count | Day 9 | Blood samples were collected to analyze the hematology parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelet count. |
| Period 2: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count | Day 7 | Blood samples were collected to analyze the hematology parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelet count. |
| Period 3: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count | Days 4, 7 and 10 | Blood samples were collected to analyze the hematology parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelet count. |
| Period 1: Absolute Values for Hematology Parameter: Hemoglobin | Day 9 | Blood samples were collected to analyze the hematology parameter: hemoglobin. |
| Period 2: Absolute Values for Hematology Parameter: Hemoglobin | Day 7 | Blood samples were collected to analyze the hematology parameter: hemoglobin. |
| Period 3: Absolute Values for Hematology Parameter: Hemoglobin | Days 4, 7 and 10 | Blood samples were collected to analyze the hematology parameter: hemoglobin. |
| Period 1: Absolute Values for Hematology Parameter: Hematocrit | Day 9 | Blood samples were collected to analyze the hematology parameter: hematocrit. |
| Period 2: Absolute Values for Hematology Parameter: Erythrocytes | Day 7 | Blood samples were collected to analyze the hematology parameter: erythrocytes. |
| Period 3: Absolute Values for Hematology Parameter: Erythrocytes | Days 4, 7 and 10 | Blood samples were collected to analyze the hematology parameter: erythrocytes. |
| Period 1: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Volume | Day 9 | Blood samples were collected to analyze the hematology parameter: erythrocytes mean corpuscular volume. |
| Period 2: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Volume | Day 7 | Blood samples were collected to analyze the hematology parameter: erythrocytes mean corpuscular volume. |
| Period 3: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Volume | Days 4, 7 and 10 | Blood samples were collected to analyze the hematology parameter: erythrocytes mean corpuscular volume. |
| Period 1: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin | Day 9 | Blood samples were collected to analyze the hematology parameter: erythrocytes mean corpuscular hemoglobin. |
| Period 2: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin | Day 7 | Blood samples were collected to analyze the hematology parameter: erythrocytes mean corpuscular hemoglobin. |
| Period 3: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin | Days 4, 7 and 10 | Blood samples were collected to analyze the hematology parameter: erythrocytes mean corpuscular hemoglobin. |
| Period 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Day 9 | Blood samples were collected to analyze the chemistry parameters: glucose, cholesterol, triglycerides, anion gap, calcium, carbon dioxide, chloride, phosphate, potassium, sodium and blood urea nitrogen. |
| Period 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Day 7 | Blood samples were collected to analyze the chemistry parameters: glucose, cholesterol, triglycerides, anion gap, calcium, carbon dioxide, chloride, phosphate, potassium, sodium and blood urea nitrogen. |
| Period 3: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Days 4, 7 and 10 | Blood samples were collected to analyze the chemistry parameters: glucose, cholesterol, triglycerides, anion gap, calcium, carbon dioxide, chloride, phosphate, potassium, sodium and blood urea nitrogen. |
| Period 1: Absolute Values for Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST, Gamma-glutamyl Transferase | Day 9 | Blood samples were collected to analyze the chemistry parameters: creatine kinase, lactate dehydrogenase, ALT, ALP, AST and gamma-glutamyl transferase. |
| Period 2: Absolute Values for Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST, Gamma-glutamyl Transferase | Day 7 | Blood samples were collected to analyze the chemistry parameters: creatine kinase, lactate dehydrogenase, ALT, ALP, AST and gamma-glutamyl transferase. |
| Period 3: Absolute Values for Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST, Gamma-glutamyl Transferase | Days 4, 7 and 10 | Blood samples were collected to analyze the chemistry parameters: creatine kinase, lactate dehydrogenase, ALT, ALP, AST and gamma-glutamyl transferase. |
| Period 1: Absolute Values for Chemistry Parameters: Urate, Creatinine, Bilirubin, Direct Bilirubin | Day 9 | Blood samples were collected to analyze the chemistry parameters: urate, creatinine, bilirubin and direct bilirubin. |
| Period 2: Absolute Values for Chemistry Parameters: Urate, Creatinine, Bilirubin, Direct Bilirubin | Day 7 | Blood samples were collected to analyze the chemistry parameters: urate, creatinine, bilirubin and direct bilirubin. |
| Period 3: Absolute Values for Chemistry Parameters: Urate, Creatinine, Bilirubin, Direct Bilirubin | Days 4, 7 and 10 | Blood samples were collected to analyze the chemistry parameters: urate, creatinine, bilirubin and direct bilirubin. |
| Period 1: Absolute Values for Chemistry Parameters: Albumin, Globulin, Protein | Day 9 | Blood samples were collected to analyze the chemistry parameters: albumin, globulin and protein. |
| Period 2: Absolute Values for Chemistry Parameters: Albumin, Globulin, Protein | Day 7 | Blood samples were collected to analyze the chemistry parameters: albumin, globulin and protein. |
| Period 3: Absolute Values for Chemistry Parameters: Albumin, Globulin, Protein | Days 4, 7 and 10 | Blood samples were collected to analyze the chemistry parameters: albumin, globulin and protein. |
| Period 1: Absolute Values for Chemistry Parameters: Amylase, Lipase | Day 9 | Blood samples were collected to analyze the chemistry parameters: amylase and lipase. |
| Period 2: Absolute Values for Chemistry Parameters: Amylase, Lipase | Day 7 | Blood samples were collected to analyze the chemistry parameters: amylase and lipase. |
| Period 3: Absolute Values for Chemistry Parameters: Amylase, Lipase | Days 4, 7 and 10 | Blood samples were collected to analyze the chemistry parameters: amylase and lipase. |
| Period 1: Absolute Values for Urinalysis Parameter: Specific Gravity | Day 9 | 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. |
| Period 2: Absolute Values for Urinalysis Parameter: Specific Gravity | Day 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. |
| Period 3: Absolute Values for Urinalysis Parameter: Specific Gravity | Days 4, 7 and 10 | 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. |
| Period 1: Absolute Values for Urinalysis Parameter: Urobilinogen | Day 9 | Urine samples were collected to analyze the urinalysis parameter: urobilinogen. |
| Period 2: Absolute Values for Urinalysis Parameter: Urobilinogen | Day 7 | Urine samples were collected to analyze the urinalysis parameter: urobilinogen. |
| Period 3: Absolute Values for Urinalysis Parameter: Urobilinogen | Days 4, 7 and 10 | Urine samples were collected to analyze the urinalysis parameter: urobilinogen. |
| Period 1: Absolute Values for Urinalysis Parameter: pH | Day 9 | 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. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0). |
| Period 2: Absolute Values for Urinalysis Parameter: pH | Day 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. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0). |
| Period 3: Absolute Values for Urinalysis Parameter: pH | Days 4, 7 and 10 | 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. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0). |
| Period 1: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB | Day 1: 2 hours, 4 hours; Day 5: Pre-dose, 2 hours and 4 hours | Twelve-lead ECG were obtained to measure PR Interval, QRS Duration, QT Interval, QTcF Interval and QTcB Interval. Twelve-lead ECGs were performed with the participant in a supine or semi-supine position after a rest of at least 10 minutes. |
| Period 2: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB | Day 1: 2 hours, 4 hours; Day 5: Pre-dose, 2 hours and 4 hours | Twelve-lead ECG were obtained to measure PR Interval, QRS Duration, QT Interval, QTcF Interval and QTcB Interval. Twelve-lead ECGs were performed with the participant in a supine or semi-supine position after a rest of at least 10 minutes. |
| Period 3: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB | Day 1: 2 hours, 4 hours; Days 4, 5 and 7: Pre-dose, 2 hours and 4 hours; Day 10 | Twelve-lead ECG were obtained to measure PR Interval, QRS Duration, QT Interval, QTcF Interval and QTcB Interval. Twelve-lead ECGs were performed with the participant in a supine or semi-supine position after a rest of at least 10 minutes. |
| Period 1: Absolute Values for SBP and DBP | Days 2, 3, 4 and 5 | SBP and DBP were measured in the semi-recumbent position with a completely automated device. |
| Period 2: Absolute Values for SBP and DBP | Days 2, 3, 4, 5, 6 and 7 | SBP and DBP were measured in the semi-recumbent position with a completely automated device. |
| Period 3: Absolute Values for SBP and DBP | Days 2, 3, 4, 5, 6, 7, 8, 9, 10 and 11 | SBP and DBP were measured in the semi-recumbent position with a completely automated device. |
| Period 1: Absolute Values for Pulse Rate | Days 2, 3, 4 and 5 | Pulse rate was measured in the semi-recumbent position with a completely automated device. |
| Period 2: Absolute Values for Pulse Rate | Days 2, 3, 4, 5, 6 and 7 | Pulse rate was measured in the semi-recumbent position with a completely automated device. |
| Period 3: Absolute Values for Pulse Rate | Days 2, 3, 4, 5, 6, 7, 8, 9, 10 and 11 | Pulse rate was measured in the semi-recumbent position with a completely automated device. |
| Period 1: Absolute Values for Respiratory Rate | Days 2, 3, 4 and 5 | Respiratory rate was measured in the semi-recumbent position after at least 5 minutes of rest for the participant in a quiet setting without distractions. |
| Period 2: Absolute Values for Respiratory Rate | Days 2, 3, 4, 5, 6 and 7 | Respiratory rate was measured in the semi-recumbent position after at least 5 minutes of rest for the participant in a quiet setting without distractions. |
| Period 3: Absolute Values for Respiratory Rate | Days 2, 3, 4, 5, 6, 7, 8, 9, 10 and 11 | Respiratory rate was measured in the semi-recumbent position after at least 5 minutes of rest for the participant in a quiet setting without distractions. |
| Period 1: Absolute Values for Body Temperature | Days 2, 3, 4 and 5 | Body temperature was measured in the semi-recumbent position after at least 5 minutes of rest for the participant in a quiet setting without distractions. |
| Period 2: Absolute Values for Body Temperature | Days 2, 3, 4, 5, 6 and 7 | Body temperature was measured in the semi-recumbent position after at least 5 minutes of rest for the participant in a quiet setting without distractions. |
| Period 3: Absolute Values for Body Temperature | Days 2, 3, 4, 5, 6, 7, 8, 9, 10 and 11 | Body temperature was measured in the semi-recumbent position after at least 5 minutes of rest for the participant in a quiet setting without distractions. |
| Period 2: Time of Maximum Observed Concentration (Tmax) of GSK3640254 for GSK3640254 Arm | Day 7: Pre-dose, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12 and 24 hours post-dose | Blood samples were collected at the indicated time points for pharmacokinetic analysis of GSK3640254. The pharmacokinetic parameters were calculated by standard non-compartmental analysis. |
| Period 3: Tmax of GSK3640254 for Dolutegravir + GSK3640254 Arm | Day 7: Pre-dose, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12 and 24 hours post-dose | Blood samples were collected at the indicated time points for pharmacokinetic analysis of GSK3640254. The pharmacokinetic parameters were calculated by standard non-compartmental analysis. |
| Period 2: Apparent Terminal Phase Half-life (T1/2) of GSK3640254 for GSK3640254 Arm | Day 7: Pre-dose, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12 and 24 hours post-dose | Blood samples were collected at the indicated time points for pharmacokinetic analysis of GSK3640254. The pharmacokinetic parameters were calculated by standard non-compartmental analysis. Data could not be determined due to limited sampling points after final dosing (during elimination phase). An accurate determination of GSK3640254 half-life would require sampling up to 3 times half-life (3 \* approximately 24 hours). However sampling in Period 2 was performed up to only 24 hours post-dose. |
| Period 3: T1/2 of GSK3640254 for Dolutegravir + GSK3640254 Arm | Day 7: Pre-dose, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12 and 24 hours post-dose | Blood samples were collected at the indicated time points for pharmacokinetic analysis of GSK3640254. The pharmacokinetic parameters were calculated by standard non-compartmental analysis. |
| Period 1: Tmax of Dolutegravir for Dolutegravir Arm | Day 5: Pre-dose, 1, 1.5, 2, 3, 3.5, 4, 4.5, 5, 6, 8, 12 and 24 hours post-dose | Blood samples were collected at the indicated time points for pharmacokinetic analysis of dolutegravir. The pharmacokinetic parameters were calculated by standard non-compartmental analysis. |
| Period 3: Tmax of Dolutegravir for Dolutegravir + GSK3640254 Arm | Day 7: Pre-dose, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12 and 24 hours post-dose | Blood samples were collected at the indicated time points for pharmacokinetic analysis of dolutegravir. The pharmacokinetic parameters were calculated by standard non-compartmental analysis. |
| Period 1: T1/2 of Dolutegravir for Dolutegravir Arm | Day 5: Pre-dose, 1, 1.5, 2, 3, 3.5, 4, 4.5, 5, 6, 8, 12 and 24 hours post-dose | Blood samples were collected at the indicated time points for pharmacokinetic analysis of dolutegravir. The pharmacokinetic parameters were calculated by standard non-compartmental analysis. |
| Period 3: T1/2 of Dolutegravir for Dolutegravir + GSK3640254 Arm | Day 7: Pre-dose, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12 and 24 hours post-dose | Blood samples were collected at the indicated time points for pharmacokinetic analysis of dolutegravir. The pharmacokinetic parameters were calculated by standard non-compartmental analysis. |
Countries
United States
Participant flow
Recruitment details
This was an open-label, fixed-sequence, two-way drug interaction and 3-period study. Participants received treatment A- dolutegravir 50 milligram (mg) in Period 1; treatment B- GSK3640254 200 mg in Period 2 and treatment C- dolutegravir 50 mg and GSK3640254 200 mg in Period 3.
Pre-assignment details
A total of 30 participants were screened, of which 14 were screening failures. Hence, 16 participants were enrolled in this study. This study was conducted at a single center in the United States.
Participants by arm
| Arm | Count |
|---|---|
| Dolutegravir/GSK3640254/Dolutegravir+GSK3640254 Participants received treatment A- dolutegravir 50 mg, tablets, orally, once daily on Days 1 to 5 in Period 1; followed by washout period of 4 days between last dose of study treatment A in Period 1 and initiation of study treatment B in Period 2; followed by treatment B- GSK3640254 200 mg, capsules, orally, once daily on Days 1 to 7 in Period 2; further followed by treatment C- dolutegravir 50 mg, tablets, orally, once daily along with GSK3640254 200 mg, capsules, orally, once daily on Days 1 to 7 in Period 3. | 16 |
| Total | 16 |
Baseline characteristics
| Characteristic | Dolutegravir/GSK3640254/Dolutegravir+GSK3640254 |
|---|---|
| Age, Continuous | 36.7 Years STANDARD_DEVIATION 10.66 |
| Race/Ethnicity, Customized Asian - East Asian Heritage | 1 Participants |
| Race/Ethnicity, Customized Asian - South East Asian Heritage | 1 Participants |
| Race/Ethnicity, Customized Black or African American | 3 Participants |
| Race/Ethnicity, Customized White - White/Caucasian/European Heritage | 11 Participants |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 16 | 0 / 16 | 0 / 16 |
| other Total, other adverse events | 1 / 16 | 3 / 16 | 2 / 16 |
| serious Total, serious adverse events | 0 / 16 | 0 / 16 | 0 / 16 |
Outcome results
Primary
Period 1: Area Under the Plasma Concentration-time Curve From Time 0 to the End of the Dosing (AUC[0 to Tau]) of Dolutegravir for Dolutegravir Arm
Blood samples were collected at the indicated time points for pharmacokinetic analysis of dolutegravir. The pharmacokinetic parameters were calculated by standard non-compartmental analysis. Pharmacokinetic Parameter Population consisted of all participants who underwent plasma pharmacokinetic sampling and had evaluable pharmacokinetic parameters estimated.
Time frame: Day 5: Pre-dose, 1, 1.5, 2, 3, 3.5, 4, 4.5, 5, 6, 8, 12 and 24 hours post-dose
Population: Pharmacokinetic Parameter Population.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Dolutegravir 50 mg | Period 1: Area Under the Plasma Concentration-time Curve From Time 0 to the End of the Dosing (AUC[0 to Tau]) of Dolutegravir for Dolutegravir Arm | 64627.8 Hours* nanogram per milliliter | Geometric Coefficient of Variation 20.1 |
Primary
Period 1: Maximum Observed Concentration (Cmax) of Dolutegravir for Dolutegravir Arm
Blood samples were collected at the indicated time points for pharmacokinetic analysis of dolutegravir. The pharmacokinetic parameters were calculated by standard non-compartmental analysis.
Time frame: Day 5: Pre-dose, 1, 1.5, 2, 3, 3.5, 4, 4.5, 5, 6, 8, 12 and 24 hours post-dose
Population: Pharmacokinetic Parameter Population.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Dolutegravir 50 mg | Period 1: Maximum Observed Concentration (Cmax) of Dolutegravir for Dolutegravir Arm | 4962 Nanogram per milliliter | Geometric Coefficient of Variation 16.5 |
Primary
Period 1: Plasma Concentration at the End of the Dosing Interval (Ctau) of Dolutegravir for Dolutegravir Arm
Blood samples were collected at the indicated time points for pharmacokinetic analysis of dolutegravir. The pharmacokinetic parameters were calculated by standard non-compartmental analysis.
Time frame: Day 5: Pre-dose, 1, 1.5, 2, 3, 3.5, 4, 4.5, 5, 6, 8, 12 and 24 hours post-dose
Population: Pharmacokinetic Parameter Population.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Dolutegravir 50 mg | Period 1: Plasma Concentration at the End of the Dosing Interval (Ctau) of Dolutegravir for Dolutegravir Arm | 1373 Nanogram per milliliter | Geometric Coefficient of Variation 30.6 |
Primary
Period 2: AUC(0 to Tau) of GSK3640254 for GSK3640254 Arm
Blood samples were collected at the indicated time points for pharmacokinetic analysis of GSK3640254. The pharmacokinetic parameters were calculated by standard non-compartmental analysis.
Time frame: Day 7: Pre-dose, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12 and 24 hours post-dose
Population: Pharmacokinetic Parameter Population.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Dolutegravir 50 mg | Period 2: AUC(0 to Tau) of GSK3640254 for GSK3640254 Arm | 26.72 Hours* microgram per milliliter | Geometric Coefficient of Variation 32.3 |
Primary
Period 2: Cmax of GSK3640254 for GSK3640254 Arm
Blood samples were collected at the indicated time points for pharmacokinetic analysis of GSK3640254. The pharmacokinetic parameters were calculated by standard non-compartmental analysis.
Time frame: Day 7: Pre-dose, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12 and 24 hours post-dose
Population: Pharmacokinetic Parameter Population.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Dolutegravir 50 mg | Period 2: Cmax of GSK3640254 for GSK3640254 Arm | 1.676 Microgram per milliliter | Geometric Coefficient of Variation 26.4 |
Primary
Period 2: Ctau of GSK3640254 for GSK3640254 Arm
Blood samples were collected at the indicated time points for pharmacokinetic analysis of GSK3640254. The pharmacokinetic parameters were calculated by standard non-compartmental analysis.
Time frame: Day 7: Pre-dose, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12 and 24 hours post-dose
Population: Pharmacokinetic Parameter Population.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Dolutegravir 50 mg | Period 2: Ctau of GSK3640254 for GSK3640254 Arm | 0.8583 Microgram per milliliter | Geometric Coefficient of Variation 38.3 |
Primary
Period 3: AUC(0 to Tau) of Dolutegravir for Dolutegravir + GSK3640254 Arm
Blood samples were collected at the indicated time points for pharmacokinetic analysis of dolutegravir. The pharmacokinetic parameters were calculated by standard non-compartmental analysis.
Time frame: Day 7: Pre-dose, 1, 1.5, 2, 3, 3.5, 4, 4.5, 5, 6, 8, 12 and 24 hours post-dose
Population: Pharmacokinetic Parameter Population.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Dolutegravir 50 mg | Period 3: AUC(0 to Tau) of Dolutegravir for Dolutegravir + GSK3640254 Arm | 75860.5 Hours* nanogram per milliliter | Geometric Coefficient of Variation 22.7 |
Primary
Period 3: AUC(0 to Tau) of GSK3640254 for Dolutegravir + GSK3640254 Arm
Blood samples were collected at the indicated time points for pharmacokinetic analysis of GSK3640254. The pharmacokinetic parameters were calculated by standard non-compartmental analysis.
Time frame: Day 7: Pre-dose, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12 and 24 hours post-dose
Population: Pharmacokinetic Parameter Population.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Dolutegravir 50 mg | Period 3: AUC(0 to Tau) of GSK3640254 for Dolutegravir + GSK3640254 Arm | 27.84 Hours* microgram per milliliter | Geometric Coefficient of Variation 30.1 |
Primary
Period 3: Cmax of Dolutegravir for Dolutegravir + GSK3640254 Arm
Blood samples were collected at the indicated time points for pharmacokinetic analysis of dolutegravir. The pharmacokinetic parameters were calculated by standard non-compartmental analysis.
Time frame: Day 7: Pre-dose, 1, 1.5, 2, 3, 3.5, 4, 4.5, 5, 6, 8, 12 and 24 hours post-dose
Population: Pharmacokinetic Parameter Population.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Dolutegravir 50 mg | Period 3: Cmax of Dolutegravir for Dolutegravir + GSK3640254 Arm | 5408 Nanogram per milliliter | Geometric Coefficient of Variation 17.2 |
Primary
Period 3: Cmax of GSK3640254 for Dolutegravir + GSK3640254 Arm
Blood samples were collected at the indicated time points for pharmacokinetic analysis of GSK3640254. The pharmacokinetic parameters were calculated by standard non-compartmental analysis.
Time frame: Day 7: Pre-dose, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12 and 24 hours post-dose
Population: Pharmacokinetic Parameter Population.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Dolutegravir 50 mg | Period 3: Cmax of GSK3640254 for Dolutegravir + GSK3640254 Arm | 1.662 Microgram per milliliter | Geometric Coefficient of Variation 26.8 |
Primary
Period 3: Ctau of Dolutegravir for Dolutegravir + GSK3640254 Arm
Blood samples were collected at the indicated time points for pharmacokinetic analysis of dolutegravir. The pharmacokinetic parameters were calculated by standard non-compartmental analysis.
Time frame: Day 7: Pre-dose, 1, 1.5, 2, 3, 3.5, 4, 4.5, 5, 6, 8, 12 and 24 hours post-dose
Population: Pharmacokinetic Parameter Population.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Dolutegravir 50 mg | Period 3: Ctau of Dolutegravir for Dolutegravir + GSK3640254 Arm | 1696 Nanogram per milliliter | Geometric Coefficient of Variation 31.1 |
Primary
Period 3: Ctau of GSK3640254 for Dolutegravir + GSK3640254 Arm
Blood samples were collected at the indicated time points for pharmacokinetic analysis of GSK3640254. The pharmacokinetic parameters were calculated by standard non-compartmental analysis.
Time frame: Day 7: Pre-dose, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12 and 24 hours post-dose
Population: Pharmacokinetic Parameter Population.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Dolutegravir 50 mg | Period 3: Ctau of GSK3640254 for Dolutegravir + GSK3640254 Arm | 0.8549 Microgram per milliliter | Geometric Coefficient of Variation 34.1 |
Secondary
Number of Participants With Non-serious Adverse Events (Non-SAEs) and Serious Adverse Events (SAEs)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; is a congenital anomaly/birth defect; and other important medical events which may require medical or surgical intervention. Safety Population consisted of all participants who received at least 1 dose of study medication.
Time frame: Up to Day 27
Population: Safety Population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Dolutegravir 50 mg | Number of Participants With Non-serious Adverse Events (Non-SAEs) and Serious Adverse Events (SAEs) | Non-SAEs | 1 Participants |
| Dolutegravir 50 mg | Number of Participants With Non-serious Adverse Events (Non-SAEs) and Serious Adverse Events (SAEs) | SAEs | 0 Participants |
| GSK3640254 200 mg | Number of Participants With Non-serious Adverse Events (Non-SAEs) and Serious Adverse Events (SAEs) | SAEs | 0 Participants |
| GSK3640254 200 mg | Number of Participants With Non-serious Adverse Events (Non-SAEs) and Serious Adverse Events (SAEs) | Non-SAEs | 3 Participants |
| Dolutegravir 50 mg + GSK3640254 200 mg | Number of Participants With Non-serious Adverse Events (Non-SAEs) and Serious Adverse Events (SAEs) | Non-SAEs | 2 Participants |
| Dolutegravir 50 mg + GSK3640254 200 mg | Number of Participants With Non-serious Adverse Events (Non-SAEs) and Serious Adverse Events (SAEs) | SAEs | 0 Participants |
Secondary
Period 1: Absolute Values for Body Temperature
Body temperature was measured in the semi-recumbent position after at least 5 minutes of rest for the participant in a quiet setting without distractions.
Time frame: Days 2, 3, 4 and 5
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dolutegravir 50 mg | Period 1: Absolute Values for Body Temperature | Day 2 | 36.36 Degrees Celsius | Standard Deviation 0.303 |
| Dolutegravir 50 mg | Period 1: Absolute Values for Body Temperature | Day 3 | 36.26 Degrees Celsius | Standard Deviation 0.287 |
| Dolutegravir 50 mg | Period 1: Absolute Values for Body Temperature | Day 4 | 36.21 Degrees Celsius | Standard Deviation 0.361 |
| Dolutegravir 50 mg | Period 1: Absolute Values for Body Temperature | Day 5 | 36.43 Degrees Celsius | Standard Deviation 0.27 |
Secondary
Period 1: Absolute Values for Chemistry Parameters: Albumin, Globulin, Protein
Blood samples were collected to analyze the chemistry parameters: albumin, globulin and protein.
Time frame: Day 9
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dolutegravir 50 mg | Period 1: Absolute Values for Chemistry Parameters: Albumin, Globulin, Protein | Protein | 71.9 Grams per liter | Standard Deviation 4.63 |
| Dolutegravir 50 mg | Period 1: Absolute Values for Chemistry Parameters: Albumin, Globulin, Protein | Albumin | 44.1 Grams per liter | Standard Deviation 3.32 |
| Dolutegravir 50 mg | Period 1: Absolute Values for Chemistry Parameters: Albumin, Globulin, Protein | Globulin | 27.9 Grams per liter | Standard Deviation 3.59 |
Secondary
Period 1: Absolute Values for Chemistry Parameters: Amylase, Lipase
Blood samples were collected to analyze the chemistry parameters: amylase and lipase.
Time frame: Day 9
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dolutegravir 50 mg | Period 1: Absolute Values for Chemistry Parameters: Amylase, Lipase | Amylase | 59.6 Units per liter | Standard Deviation 21.96 |
| Dolutegravir 50 mg | Period 1: Absolute Values for Chemistry Parameters: Amylase, Lipase | Lipase | 22.4 Units per liter | Standard Deviation 8.57 |
Secondary
Period 1: Absolute Values for Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST, Gamma-glutamyl Transferase
Blood samples were collected to analyze the chemistry parameters: creatine kinase, lactate dehydrogenase, ALT, ALP, AST and gamma-glutamyl transferase.
Time frame: Day 9
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dolutegravir 50 mg | Period 1: Absolute Values for Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST, Gamma-glutamyl Transferase | Lactate dehydrogenase | 107.4 International units per liter | Standard Deviation 14.33 |
| Dolutegravir 50 mg | Period 1: Absolute Values for Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST, Gamma-glutamyl Transferase | ALT | 21.0 International units per liter | Standard Deviation 10.71 |
| Dolutegravir 50 mg | Period 1: Absolute Values for Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST, Gamma-glutamyl Transferase | ALP | 57.4 International units per liter | Standard Deviation 8.74 |
| Dolutegravir 50 mg | Period 1: Absolute Values for Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST, Gamma-glutamyl Transferase | AST | 16.6 International units per liter | Standard Deviation 3.86 |
| Dolutegravir 50 mg | Period 1: Absolute Values for Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST, Gamma-glutamyl Transferase | Gamma-glutamyl transferase | 21.1 International units per liter | Standard Deviation 9.24 |
| Dolutegravir 50 mg | Period 1: Absolute Values for Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST, Gamma-glutamyl Transferase | Creatine kinase | 101.3 International units per liter | Standard Deviation 57.1 |
Secondary
Period 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Blood samples were collected to analyze the chemistry parameters: glucose, cholesterol, triglycerides, anion gap, calcium, carbon dioxide, chloride, phosphate, potassium, sodium and blood urea nitrogen.
Time frame: Day 9
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dolutegravir 50 mg | Period 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Glucose | 5.165 Millimoles per liter | Standard Deviation 0.4788 |
| Dolutegravir 50 mg | Period 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Cholesterol | 4.456 Millimoles per liter | Standard Deviation 0.6591 |
| Dolutegravir 50 mg | Period 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Triglycerides | 1.107 Millimoles per liter | Standard Deviation 0.5362 |
| Dolutegravir 50 mg | Period 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Anion gap | 9.2 Millimoles per liter | Standard Deviation 1.28 |
| Dolutegravir 50 mg | Period 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Calcium | 2.393 Millimoles per liter | Standard Deviation 0.0781 |
| Dolutegravir 50 mg | Period 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Chloride | 103.8 Millimoles per liter | Standard Deviation 2.32 |
| Dolutegravir 50 mg | Period 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Phosphate | 1.244 Millimoles per liter | Standard Deviation 0.1658 |
| Dolutegravir 50 mg | Period 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Potassium | 4.31 Millimoles per liter | Standard Deviation 0.427 |
| Dolutegravir 50 mg | Period 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Sodium | 139.3 Millimoles per liter | Standard Deviation 2.52 |
| Dolutegravir 50 mg | Period 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Blood urea nitrogen | 5.406 Millimoles per liter | Standard Deviation 0.7575 |
| Dolutegravir 50 mg | Period 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Carbon dioxide | 30.5 Millimoles per liter | Standard Deviation 1.15 |
Secondary
Period 1: Absolute Values for Chemistry Parameters: Urate, Creatinine, Bilirubin, Direct Bilirubin
Blood samples were collected to analyze the chemistry parameters: urate, creatinine, bilirubin and direct bilirubin.
Time frame: Day 9
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dolutegravir 50 mg | Period 1: Absolute Values for Chemistry Parameters: Urate, Creatinine, Bilirubin, Direct Bilirubin | Urate | 321.9 Micromoles per liter | Standard Deviation 64.43 |
| Dolutegravir 50 mg | Period 1: Absolute Values for Chemistry Parameters: Urate, Creatinine, Bilirubin, Direct Bilirubin | Creatinine | 90.28 Micromoles per liter | Standard Deviation 11.281 |
| Dolutegravir 50 mg | Period 1: Absolute Values for Chemistry Parameters: Urate, Creatinine, Bilirubin, Direct Bilirubin | Bilirubin | 9.14 Micromoles per liter | Standard Deviation 2.423 |
| Dolutegravir 50 mg | Period 1: Absolute Values for Chemistry Parameters: Urate, Creatinine, Bilirubin, Direct Bilirubin | Direct bilirubin | 1.87 Micromoles per liter | Standard Deviation 0.551 |
Secondary
Period 1: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB
Twelve-lead ECG were obtained to measure PR Interval, QRS Duration, QT Interval, QTcF Interval and QTcB Interval. Twelve-lead ECGs were performed with the participant in a supine or semi-supine position after a rest of at least 10 minutes.
Time frame: Day 1: 2 hours, 4 hours; Day 5: Pre-dose, 2 hours and 4 hours
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dolutegravir 50 mg | Period 1: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB | PR Interval: Day 1, 2 hours | 159.1 Milliseconds | Standard Deviation 14.42 |
| Dolutegravir 50 mg | Period 1: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB | PR Interval: Day 1, 4 hours | 161.3 Milliseconds | Standard Deviation 16.51 |
| Dolutegravir 50 mg | Period 1: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB | PR Interval: Day 5, Pre-dose | 164.3 Milliseconds | Standard Deviation 14.87 |
| Dolutegravir 50 mg | Period 1: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB | PR Interval: Day 5, 2 hours | 160.9 Milliseconds | Standard Deviation 11.34 |
| Dolutegravir 50 mg | Period 1: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB | PR Interval: Day 5, 4 hours | 161.5 Milliseconds | Standard Deviation 12.66 |
| Dolutegravir 50 mg | Period 1: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB | QRS Duration: Day 1, 2 hours | 95.2 Milliseconds | Standard Deviation 9.59 |
| Dolutegravir 50 mg | Period 1: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB | QRS Duration: Day 1, 4 hours | 94.7 Milliseconds | Standard Deviation 10.9 |
| Dolutegravir 50 mg | Period 1: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB | QRS Duration: Day 5, Pre-dose | 92.6 Milliseconds | Standard Deviation 8.39 |
| Dolutegravir 50 mg | Period 1: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB | QRS Duration: Day 5, 2 hours | 94.2 Milliseconds | Standard Deviation 10.78 |
| Dolutegravir 50 mg | Period 1: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB | QRS Duration: Day 5, 4 hours | 94.0 Milliseconds | Standard Deviation 9.26 |
| Dolutegravir 50 mg | Period 1: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB | QT Interval: Day 1, 2 hours | 386.4 Milliseconds | Standard Deviation 16.06 |
| Dolutegravir 50 mg | Period 1: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB | QT Interval: Day 1, 4 hours | 401.8 Milliseconds | Standard Deviation 19.94 |
| Dolutegravir 50 mg | Period 1: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB | QT Interval: Day 5, Pre-dose | 385.1 Milliseconds | Standard Deviation 13.96 |
| Dolutegravir 50 mg | Period 1: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB | QT Interval: Day 5, 2 hours | 375.6 Milliseconds | Standard Deviation 11.46 |
| Dolutegravir 50 mg | Period 1: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB | QT Interval: Day 5, 4 hours | 393.1 Milliseconds | Standard Deviation 18.8 |
| Dolutegravir 50 mg | Period 1: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB | QTcF Interval: Day 1, 2 hours | 391.6 Milliseconds | Standard Deviation 11.37 |
| Dolutegravir 50 mg | Period 1: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB | QTcF Interval: Day 1, 4 hours | 395.0 Milliseconds | Standard Deviation 12.9 |
| Dolutegravir 50 mg | Period 1: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB | QTcF Interval: Day 5, Pre-dose | 389.5 Milliseconds | Standard Deviation 10.92 |
| Dolutegravir 50 mg | Period 1: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB | QTcF Interval: Day 5, 2 hours | 388.6 Milliseconds | Standard Deviation 14.47 |
| Dolutegravir 50 mg | Period 1: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB | QTcF Interval: Day 5, 4 hours | 392.7 Milliseconds | Standard Deviation 14.11 |
| Dolutegravir 50 mg | Period 1: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB | QTcB Interval: Day 1, 2 hours | 393.1 Milliseconds | Standard Deviation 15.31 |
| Dolutegravir 50 mg | Period 1: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB | QTcB Interval: Day 1, 4 hours | 390.2 Milliseconds | Standard Deviation 16.01 |
| Dolutegravir 50 mg | Period 1: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB | QTcB Interval: Day 5, Pre-dose | 390.9 Milliseconds | Standard Deviation 14.91 |
| Dolutegravir 50 mg | Period 1: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB | QTcB Interval: Day 5, 2 hours | 394.2 Milliseconds | Standard Deviation 21.59 |
| Dolutegravir 50 mg | Period 1: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB | QTcB Interval: Day 5, 4 hours | 391.7 Milliseconds | Standard Deviation 19.71 |
Secondary
Period 1: Absolute Values for Hematology Parameter: Erythrocytes
Blood samples were collected to analyze the hematology parameter: erythrocytes.
Time frame: Day 9
Population: Safety Population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dolutegravir 50 mg | Period 1: Absolute Values for Hematology Parameter: Erythrocytes | 5.143 Trillion cells per liter | Standard Deviation 0.358 |
Secondary
Period 1: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin
Blood samples were collected to analyze the hematology parameter: erythrocytes mean corpuscular hemoglobin.
Time frame: Day 9
Population: Safety Population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dolutegravir 50 mg | Period 1: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin | 28.58 Picograms | Standard Deviation 2.446 |
Secondary
Period 1: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Volume
Blood samples were collected to analyze the hematology parameter: erythrocytes mean corpuscular volume.
Time frame: Day 9
Population: Safety Population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dolutegravir 50 mg | Period 1: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Volume | 86.22 Femtoliter | Standard Deviation 5.67 |
Secondary
Period 1: Absolute Values for Hematology Parameter: Hematocrit
Blood samples were collected to analyze the hematology parameter: hematocrit.
Time frame: Day 9
Population: Safety Population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dolutegravir 50 mg | Period 1: Absolute Values for Hematology Parameter: Hematocrit | 0.4419 Proportion of red blood cells in blood | Standard Deviation 0.01697 |
Secondary
Period 1: Absolute Values for Hematology Parameter: Hemoglobin
Blood samples were collected to analyze the hematology parameter: hemoglobin.
Time frame: Day 9
Population: Safety Population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dolutegravir 50 mg | Period 1: Absolute Values for Hematology Parameter: Hemoglobin | 146.4 Grams per liter | Standard Deviation 8.02 |
Secondary
Period 1: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count
Blood samples were collected to analyze the hematology parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelet count.
Time frame: Day 9
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dolutegravir 50 mg | Period 1: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count | Basophils | 0.045 10^9 cells per liter | Standard Deviation 0.0115 |
| Dolutegravir 50 mg | Period 1: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count | Eosinophils | 0.232 10^9 cells per liter | Standard Deviation 0.144 |
| Dolutegravir 50 mg | Period 1: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count | Lymphocytes | 2.023 10^9 cells per liter | Standard Deviation 0.5931 |
| Dolutegravir 50 mg | Period 1: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count | Monocytes | 0.512 10^9 cells per liter | Standard Deviation 0.1133 |
| Dolutegravir 50 mg | Period 1: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count | Neutrophils | 3.038 10^9 cells per liter | Standard Deviation 0.7559 |
| Dolutegravir 50 mg | Period 1: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count | Platelet count | 270.2 10^9 cells per liter | Standard Deviation 47.62 |
Secondary
Period 1: Absolute Values for Pulse Rate
Pulse rate was measured in the semi-recumbent position with a completely automated device.
Time frame: Days 2, 3, 4 and 5
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dolutegravir 50 mg | Period 1: Absolute Values for Pulse Rate | Day 2 | 67.8 Beats per minute | Standard Deviation 8.47 |
| Dolutegravir 50 mg | Period 1: Absolute Values for Pulse Rate | Day 3 | 66.8 Beats per minute | Standard Deviation 6.68 |
| Dolutegravir 50 mg | Period 1: Absolute Values for Pulse Rate | Day 4 | 70.1 Beats per minute | Standard Deviation 10.57 |
| Dolutegravir 50 mg | Period 1: Absolute Values for Pulse Rate | Day 5 | 66.4 Beats per minute | Standard Deviation 8.21 |
Secondary
Period 1: Absolute Values for Respiratory Rate
Respiratory rate was measured in the semi-recumbent position after at least 5 minutes of rest for the participant in a quiet setting without distractions.
Time frame: Days 2, 3, 4 and 5
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dolutegravir 50 mg | Period 1: Absolute Values for Respiratory Rate | Day 2 | 13.5 Breaths per minute | Standard Deviation 1.37 |
| Dolutegravir 50 mg | Period 1: Absolute Values for Respiratory Rate | Day 3 | 14.6 Breaths per minute | Standard Deviation 2.16 |
| Dolutegravir 50 mg | Period 1: Absolute Values for Respiratory Rate | Day 4 | 12.9 Breaths per minute | Standard Deviation 1.78 |
| Dolutegravir 50 mg | Period 1: Absolute Values for Respiratory Rate | Day 5 | 13.6 Breaths per minute | Standard Deviation 2.22 |
Secondary
Period 1: Absolute Values for SBP and DBP
SBP and DBP were measured in the semi-recumbent position with a completely automated device.
Time frame: Days 2, 3, 4 and 5
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dolutegravir 50 mg | Period 1: Absolute Values for SBP and DBP | SBP: Day 2 | 118.8 Millimeters of mercury | Standard Deviation 8.57 |
| Dolutegravir 50 mg | Period 1: Absolute Values for SBP and DBP | SBP: Day 3 | 114.9 Millimeters of mercury | Standard Deviation 8.09 |
| Dolutegravir 50 mg | Period 1: Absolute Values for SBP and DBP | SBP: Day 4 | 119.0 Millimeters of mercury | Standard Deviation 9.81 |
| Dolutegravir 50 mg | Period 1: Absolute Values for SBP and DBP | SBP: Day 5 | 109.1 Millimeters of mercury | Standard Deviation 7.16 |
| Dolutegravir 50 mg | Period 1: Absolute Values for SBP and DBP | DBP: Day 2 | 76.1 Millimeters of mercury | Standard Deviation 6.53 |
| Dolutegravir 50 mg | Period 1: Absolute Values for SBP and DBP | DBP: Day 3 | 72.7 Millimeters of mercury | Standard Deviation 8.32 |
| Dolutegravir 50 mg | Period 1: Absolute Values for SBP and DBP | DBP: Day 4 | 74.1 Millimeters of mercury | Standard Deviation 8.58 |
| Dolutegravir 50 mg | Period 1: Absolute Values for SBP and DBP | DBP: Day 5 | 69.2 Millimeters of mercury | Standard Deviation 9.77 |
Secondary
Period 1: Absolute Values for Urinalysis Parameter: 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. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0).
Time frame: Day 9
Population: Safety Population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dolutegravir 50 mg | Period 1: Absolute Values for Urinalysis Parameter: pH | 5.88 pH | Standard Deviation 0.465 |
Secondary
Period 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.
Time frame: Day 9
Population: Safety Population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dolutegravir 50 mg | Period 1: Absolute Values for Urinalysis Parameter: Specific Gravity | 1.0181 Ratio | Standard Deviation 0.00662 |
Secondary
Period 1: Absolute Values for Urinalysis Parameter: Urobilinogen
Urine samples were collected to analyze the urinalysis parameter: urobilinogen.
Time frame: Day 9
Population: Safety Population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dolutegravir 50 mg | Period 1: Absolute Values for Urinalysis Parameter: Urobilinogen | 3.3860 Micromoles per liter | Standard Deviation 0 |
Secondary
Period 1: Change From Baseline in Body Temperature
Body temperature was measured in the semi-recumbent position 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, in Period 1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.
Time frame: Baseline (Day 1, Pre-dose), Days 2, 3, 4 and 5
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dolutegravir 50 mg | Period 1: Change From Baseline in Body Temperature | Day 2 | -0.04 Degrees Celsius | Standard Deviation 0.326 |
| Dolutegravir 50 mg | Period 1: Change From Baseline in Body Temperature | Day 3 | -0.14 Degrees Celsius | Standard Deviation 0.287 |
| Dolutegravir 50 mg | Period 1: Change From Baseline in Body Temperature | Day 4 | -0.19 Degrees Celsius | Standard Deviation 0.37 |
| Dolutegravir 50 mg | Period 1: Change From Baseline in Body Temperature | Day 5 | 0.03 Degrees Celsius | Standard Deviation 0.275 |
Secondary
Period 1: Change From Baseline in Chemistry Parameters: Albumin, Globulin, 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 visits, before the first treatment in Period 1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.
Time frame: Baseline (Day -1) and at Day 9
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dolutegravir 50 mg | Period 1: Change From Baseline in Chemistry Parameters: Albumin, Globulin, Protein | Protein | 1.2 Grams per liter | Standard Deviation 3.06 |
| Dolutegravir 50 mg | Period 1: Change From Baseline in Chemistry Parameters: Albumin, Globulin, Protein | Albumin | 0.4 Grams per liter | Standard Deviation 2.45 |
| Dolutegravir 50 mg | Period 1: Change From Baseline in Chemistry Parameters: Albumin, Globulin, Protein | Globulin | 0.8 Grams per liter | Standard Deviation 1.11 |
Secondary
Period 1: Change From Baseline in Chemistry Parameters: Amylase, Lipase
Blood samples were collected to analyze the chemistry parameters: amylase and lipase. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first treatment in Period 1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.
Time frame: Baseline (Day -1) and at Day 9
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dolutegravir 50 mg | Period 1: Change From Baseline in Chemistry Parameters: Amylase, Lipase | Amylase | 3.1 Units per liter | Standard Deviation 9.63 |
| Dolutegravir 50 mg | Period 1: Change From Baseline in Chemistry Parameters: Amylase, Lipase | Lipase | -3.4 Units per liter | Standard Deviation 8.97 |
Secondary
Period 1: Change From Baseline in Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase
Blood samples were collected to analyze the chemistry parameters: creatine kinase, lactate dehydrogenase, ALT, ALP, AST and gamma-glutamyl transferase. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first treatment in Period 1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.
Time frame: Baseline (Day -1) and at Day 9
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dolutegravir 50 mg | Period 1: Change From Baseline in Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase | Creatine kinase | -32.0 International units per liter | Standard Deviation 61.33 |
| Dolutegravir 50 mg | Period 1: Change From Baseline in Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase | ALT | -0.3 International units per liter | Standard Deviation 8.28 |
| Dolutegravir 50 mg | Period 1: Change From Baseline in Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase | AST | -0.7 International units per liter | Standard Deviation 3.36 |
| Dolutegravir 50 mg | Period 1: Change From Baseline in Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase | Gamma-glutamyl transferase | -2.1 International units per liter | Standard Deviation 3.13 |
| Dolutegravir 50 mg | Period 1: Change From Baseline in Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase | Lactate dehydrogenase | -21.9 International units per liter | Standard Deviation 14.16 |
| Dolutegravir 50 mg | Period 1: Change From Baseline in Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase | ALP | -0.1 International units per liter | Standard Deviation 7.67 |
Secondary
Period 1: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Blood samples were collected to analyze the chemistry parameters: glucose, cholesterol, triglycerides, anion gap, calcium, carbon dioxide, chloride, phosphate, potassium, sodium and blood urea nitrogen. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first treatment in Period 1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.
Time frame: Baseline (Day -1) and at Day 9
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dolutegravir 50 mg | Period 1: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Cholesterol | 0.088 Millimoles per liter | Standard Deviation 0.6858 |
| Dolutegravir 50 mg | Period 1: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Triglycerides | -0.084 Millimoles per liter | Standard Deviation 0.3983 |
| Dolutegravir 50 mg | Period 1: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Anion gap | -1.2 Millimoles per liter | Standard Deviation 1.33 |
| Dolutegravir 50 mg | Period 1: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Calcium | 0.025 Millimoles per liter | Standard Deviation 0.0599 |
| Dolutegravir 50 mg | Period 1: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Phosphate | 0.091 Millimoles per liter | Standard Deviation 0.1531 |
| Dolutegravir 50 mg | Period 1: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Potassium | 0.05 Millimoles per liter | Standard Deviation 0.356 |
| Dolutegravir 50 mg | Period 1: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Sodium | 0.3 Millimoles per liter | Standard Deviation 2.15 |
| Dolutegravir 50 mg | Period 1: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Glucose | 0.063 Millimoles per liter | Standard Deviation 0.4235 |
| Dolutegravir 50 mg | Period 1: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Carbon dioxide | -0.1 Millimoles per liter | Standard Deviation 2.03 |
| Dolutegravir 50 mg | Period 1: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Chloride | 1.6 Millimoles per liter | Standard Deviation 2.63 |
| Dolutegravir 50 mg | Period 1: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Blood urea nitrogen | 0.297 Millimoles per liter | Standard Deviation 0.9823 |
Secondary
Period 1: Change From Baseline in Chemistry Parameters: Urate, Creatinine, Bilirubin, Direct Bilirubin
Blood samples were collected to analyze the chemistry parameters: urate, creatinine, bilirubin and direct bilirubin. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first treatment in Period 1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.
Time frame: Baseline (Day -1) and at Day 9
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dolutegravir 50 mg | Period 1: Change From Baseline in Chemistry Parameters: Urate, Creatinine, Bilirubin, Direct Bilirubin | Urate | -32.3 Micromoles per liter | Standard Deviation 42.01 |
| Dolutegravir 50 mg | Period 1: Change From Baseline in Chemistry Parameters: Urate, Creatinine, Bilirubin, Direct Bilirubin | Bilirubin | 0.01 Micromoles per liter | Standard Deviation 4.516 |
| Dolutegravir 50 mg | Period 1: Change From Baseline in Chemistry Parameters: Urate, Creatinine, Bilirubin, Direct Bilirubin | Direct bilirubin | 0.03 Micromoles per liter | Standard Deviation 0.677 |
| Dolutegravir 50 mg | Period 1: Change From Baseline in Chemistry Parameters: Urate, Creatinine, Bilirubin, Direct Bilirubin | Creatinine | 5.41 Micromoles per liter | Standard Deviation 7.253 |
Secondary
Period 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 visits, before the first treatment in Period 1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.
Time frame: Baseline (Day -1) and at Day 9
Population: Safety Population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dolutegravir 50 mg | Period 1: Change From Baseline in Hematology Parameter: Erythrocytes | 0.170 Trillion cells per liter | Standard Deviation 0.208 |
Secondary
Period 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 visits, before the first treatment in Period 1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.
Time frame: Baseline (Day -1) and at Day 9
Population: Safety Population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dolutegravir 50 mg | Period 1: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin | -0.11 Picograms | Standard Deviation 0.279 |
Secondary
Period 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 visits, before the first treatment in Period 1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.
Time frame: Baseline (Day -1) and at Day 9
Population: Safety Population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dolutegravir 50 mg | Period 1: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume | 0.63 Femtoliter | Standard Deviation 0.774 |
Secondary
Period 1: Change From Baseline in Hematology Parameter: 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 visits, before the first treatment in Period 1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.
Time frame: Baseline (Day -1) and at Day 9
Population: Safety Population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dolutegravir 50 mg | Period 1: Change From Baseline in Hematology Parameter: Hematocrit | 0.0178 Proportion of red blood cells in blood | Standard Deviation 0.01988 |
Secondary
Period 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 visits, before the first treatment in Period 1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.
Time frame: Baseline (Day -1) and at Day 9
Population: Safety Population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dolutegravir 50 mg | Period 1: Change From Baseline in Hematology Parameter: Hemoglobin | 4.4 Grams per liter | Standard Deviation 5.97 |
Secondary
Period 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count
Blood samples were collected to analyze the hematology parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelet count. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first treatment in Period 1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.
Time frame: Baseline (Day -1) and at Day 9
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dolutegravir 50 mg | Period 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count | Basophils | -0.003 10^9 cells per liter | Standard Deviation 0.0124 |
| Dolutegravir 50 mg | Period 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count | Eosinophils | 0.046 10^9 cells per liter | Standard Deviation 0.1198 |
| Dolutegravir 50 mg | Period 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count | Lymphocytes | 0.013 10^9 cells per liter | Standard Deviation 0.3793 |
| Dolutegravir 50 mg | Period 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count | Monocytes | -0.020 10^9 cells per liter | Standard Deviation 0.0829 |
| Dolutegravir 50 mg | Period 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count | Neutrophils | -0.217 10^9 cells per liter | Standard Deviation 0.6421 |
| Dolutegravir 50 mg | Period 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count | Platelet count | -6.5 10^9 cells per liter | Standard Deviation 21.73 |
Secondary
Period 1: Change From Baseline in PR Interval, QRS Duration, QT Interval, Fridericia QT Correction Formula (QTcF), Bazett's QT Correction Formula (QTcB)
Twelve-lead electrocardiograms (ECG) were obtained to measure PR Interval, QRS Duration, QT Interval, QTcF Interval and QTcB Interval. Twelve-lead ECGs were performed with the participant in a supine or semi-supine position after a rest of at least 10 minutes. Baseline was defined as the average of the triplicate pre-dose assessments on Day 1 of Period 1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.
Time frame: Baseline, Day 1: 2 hours, 4 hours; Day 5: Pre-dose, 2 hours and 4 hours
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dolutegravir 50 mg | Period 1: Change From Baseline in PR Interval, QRS Duration, QT Interval, Fridericia QT Correction Formula (QTcF), Bazett's QT Correction Formula (QTcB) | PR Interval: Day 1, 2 hours | -0.5 Milliseconds | Standard Deviation 9.33 |
| Dolutegravir 50 mg | Period 1: Change From Baseline in PR Interval, QRS Duration, QT Interval, Fridericia QT Correction Formula (QTcF), Bazett's QT Correction Formula (QTcB) | PR Interval: Day 1, 4 hours | 1.7 Milliseconds | Standard Deviation 8.34 |
| Dolutegravir 50 mg | Period 1: Change From Baseline in PR Interval, QRS Duration, QT Interval, Fridericia QT Correction Formula (QTcF), Bazett's QT Correction Formula (QTcB) | PR Interval: Day 5, Pre-dose | 4.7 Milliseconds | Standard Deviation 6.32 |
| Dolutegravir 50 mg | Period 1: Change From Baseline in PR Interval, QRS Duration, QT Interval, Fridericia QT Correction Formula (QTcF), Bazett's QT Correction Formula (QTcB) | PR Interval: Day 5, 2 hours | 1.3 Milliseconds | Standard Deviation 8.52 |
| Dolutegravir 50 mg | Period 1: Change From Baseline in PR Interval, QRS Duration, QT Interval, Fridericia QT Correction Formula (QTcF), Bazett's QT Correction Formula (QTcB) | PR Interval: Day 5, 4 hours | 1.9 Milliseconds | Standard Deviation 12.94 |
| Dolutegravir 50 mg | Period 1: Change From Baseline in PR Interval, QRS Duration, QT Interval, Fridericia QT Correction Formula (QTcF), Bazett's QT Correction Formula (QTcB) | QRS Duration: Day 1, 2 hours | 1.8 Milliseconds | Standard Deviation 3.04 |
| Dolutegravir 50 mg | Period 1: Change From Baseline in PR Interval, QRS Duration, QT Interval, Fridericia QT Correction Formula (QTcF), Bazett's QT Correction Formula (QTcB) | QRS Duration: Day 5, 4 hours | 0.6 Milliseconds | Standard Deviation 2.78 |
| Dolutegravir 50 mg | Period 1: Change From Baseline in PR Interval, QRS Duration, QT Interval, Fridericia QT Correction Formula (QTcF), Bazett's QT Correction Formula (QTcB) | QT Interval: Day 1, 2 hours | -5.5 Milliseconds | Standard Deviation 8.21 |
| Dolutegravir 50 mg | Period 1: Change From Baseline in PR Interval, QRS Duration, QT Interval, Fridericia QT Correction Formula (QTcF), Bazett's QT Correction Formula (QTcB) | QT Interval: Day 5, Pre-dose | -6.8 Milliseconds | Standard Deviation 11.74 |
| Dolutegravir 50 mg | Period 1: Change From Baseline in PR Interval, QRS Duration, QT Interval, Fridericia QT Correction Formula (QTcF), Bazett's QT Correction Formula (QTcB) | QT Interval: Day 5, 2 hours | -16.3 Milliseconds | Standard Deviation 16.64 |
| Dolutegravir 50 mg | Period 1: Change From Baseline in PR Interval, QRS Duration, QT Interval, Fridericia QT Correction Formula (QTcF), Bazett's QT Correction Formula (QTcB) | QT Interval: Day 5, 4 hours | 1.2 Milliseconds | Standard Deviation 16.07 |
| Dolutegravir 50 mg | Period 1: Change From Baseline in PR Interval, QRS Duration, QT Interval, Fridericia QT Correction Formula (QTcF), Bazett's QT Correction Formula (QTcB) | QTcF Interval: Day 1, 2 hours | -5.0 Milliseconds | Standard Deviation 8.42 |
| Dolutegravir 50 mg | Period 1: Change From Baseline in PR Interval, QRS Duration, QT Interval, Fridericia QT Correction Formula (QTcF), Bazett's QT Correction Formula (QTcB) | QTcF Interval: Day 1, 4 hours | -1.6 Milliseconds | Standard Deviation 8.52 |
| Dolutegravir 50 mg | Period 1: Change From Baseline in PR Interval, QRS Duration, QT Interval, Fridericia QT Correction Formula (QTcF), Bazett's QT Correction Formula (QTcB) | QTcF Interval: Day 5, Pre-dose | -7.1 Milliseconds | Standard Deviation 8.53 |
| Dolutegravir 50 mg | Period 1: Change From Baseline in PR Interval, QRS Duration, QT Interval, Fridericia QT Correction Formula (QTcF), Bazett's QT Correction Formula (QTcB) | QTcF Interval: Day 5, 2 hours | -7.9 Milliseconds | Standard Deviation 9.92 |
| Dolutegravir 50 mg | Period 1: Change From Baseline in PR Interval, QRS Duration, QT Interval, Fridericia QT Correction Formula (QTcF), Bazett's QT Correction Formula (QTcB) | QTcF Interval: Day 5, 4 hours | -3.9 Milliseconds | Standard Deviation 7.56 |
| Dolutegravir 50 mg | Period 1: Change From Baseline in PR Interval, QRS Duration, QT Interval, Fridericia QT Correction Formula (QTcF), Bazett's QT Correction Formula (QTcB) | QTcB Interval: Day 1, 2 hours | -4.5 Milliseconds | Standard Deviation 10.26 |
| Dolutegravir 50 mg | Period 1: Change From Baseline in PR Interval, QRS Duration, QT Interval, Fridericia QT Correction Formula (QTcF), Bazett's QT Correction Formula (QTcB) | QTcB Interval: Day 1, 4 hours | -7.4 Milliseconds | Standard Deviation 9.16 |
| Dolutegravir 50 mg | Period 1: Change From Baseline in PR Interval, QRS Duration, QT Interval, Fridericia QT Correction Formula (QTcF), Bazett's QT Correction Formula (QTcB) | QTcB Interval: Day 5, Pre-dose | -6.7 Milliseconds | Standard Deviation 8.16 |
| Dolutegravir 50 mg | Period 1: Change From Baseline in PR Interval, QRS Duration, QT Interval, Fridericia QT Correction Formula (QTcF), Bazett's QT Correction Formula (QTcB) | QTcB Interval: Day 5, 2 hours | -3.4 Milliseconds | Standard Deviation 10.84 |
| Dolutegravir 50 mg | Period 1: Change From Baseline in PR Interval, QRS Duration, QT Interval, Fridericia QT Correction Formula (QTcF), Bazett's QT Correction Formula (QTcB) | QTcB Interval: Day 5, 4 hours | -5.9 Milliseconds | Standard Deviation 11.62 |
| Dolutegravir 50 mg | Period 1: Change From Baseline in PR Interval, QRS Duration, QT Interval, Fridericia QT Correction Formula (QTcF), Bazett's QT Correction Formula (QTcB) | QRS Duration: Day 1, 4 hours | 1.3 Milliseconds | Standard Deviation 3.32 |
| Dolutegravir 50 mg | Period 1: Change From Baseline in PR Interval, QRS Duration, QT Interval, Fridericia QT Correction Formula (QTcF), Bazett's QT Correction Formula (QTcB) | QRS Duration: Day 5, Pre-dose | -0.8 Milliseconds | Standard Deviation 3.21 |
| Dolutegravir 50 mg | Period 1: Change From Baseline in PR Interval, QRS Duration, QT Interval, Fridericia QT Correction Formula (QTcF), Bazett's QT Correction Formula (QTcB) | QRS Duration: Day 5, 2 hours | 0.8 Milliseconds | Standard Deviation 3.99 |
| Dolutegravir 50 mg | Period 1: Change From Baseline in PR Interval, QRS Duration, QT Interval, Fridericia QT Correction Formula (QTcF), Bazett's QT Correction Formula (QTcB) | QT Interval: Day 1, 4 hours | 9.9 Milliseconds | Standard Deviation 12.91 |
Secondary
Period 1: Change From Baseline in Pulse Rate
Pulse rate was measured in the semi-recumbent position with a completely automated device. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, in Period 1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.
Time frame: Baseline (Day 1, Pre-dose), Days 2, 3, 4 and 5
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dolutegravir 50 mg | Period 1: Change From Baseline in Pulse Rate | Day 2 | -0.3 Beats per minute | Standard Deviation 4.3 |
| Dolutegravir 50 mg | Period 1: Change From Baseline in Pulse Rate | Day 3 | -1.3 Beats per minute | Standard Deviation 4.63 |
| Dolutegravir 50 mg | Period 1: Change From Baseline in Pulse Rate | Day 5 | -1.6 Beats per minute | Standard Deviation 5.08 |
| Dolutegravir 50 mg | Period 1: Change From Baseline in Pulse Rate | Day 4 | 2.0 Beats per minute | Standard Deviation 8.46 |
Secondary
Period 1: Change From Baseline in Respiratory Rate
Respiratory rate was measured in the semi-recumbent position 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, in Period 1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.
Time frame: Baseline (Day 1, Pre-dose), Days 2, 3, 4 and 5
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dolutegravir 50 mg | Period 1: Change From Baseline in Respiratory Rate | Day 2 | -0.9 Breaths per minute | Standard Deviation 3.18 |
| Dolutegravir 50 mg | Period 1: Change From Baseline in Respiratory Rate | Day 3 | 0.3 Breaths per minute | Standard Deviation 2.05 |
| Dolutegravir 50 mg | Period 1: Change From Baseline in Respiratory Rate | Day 4 | -1.5 Breaths per minute | Standard Deviation 3.06 |
| Dolutegravir 50 mg | Period 1: Change From Baseline in Respiratory Rate | Day 5 | -0.8 Breaths per minute | Standard Deviation 2.29 |
Secondary
Period 1: Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SBP and DBP were measured in the semi-recumbent position with a completely automated device. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, in Period 1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.
Time frame: Baseline (Day 1, Pre-dose), Days 2, 3, 4 and 5
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dolutegravir 50 mg | Period 1: Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP: Day 2 | 3.5 Millimeters of mercury | Standard Deviation 9.97 |
| Dolutegravir 50 mg | Period 1: Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP: Day 3 | -0.4 Millimeters of mercury | Standard Deviation 8.88 |
| Dolutegravir 50 mg | Period 1: Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP: Day 4 | 3.7 Millimeters of mercury | Standard Deviation 11.97 |
| Dolutegravir 50 mg | Period 1: Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP: Day 5 | -6.2 Millimeters of mercury | Standard Deviation 8.88 |
| Dolutegravir 50 mg | Period 1: Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP: Day 4 | 2.3 Millimeters of mercury | Standard Deviation 8.5 |
| Dolutegravir 50 mg | Period 1: Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP: Day 5 | -2.6 Millimeters of mercury | Standard Deviation 10.7 |
| Dolutegravir 50 mg | Period 1: Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP: Day 2 | 4.3 Millimeters of mercury | Standard Deviation 6.7 |
| Dolutegravir 50 mg | Period 1: Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP: Day 3 | 0.9 Millimeters of mercury | Standard Deviation 9.89 |
Secondary
Period 1: Change From Baseline in Urinalysis Parameter: 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. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0). Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first treatment in Period 1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.
Time frame: Baseline (Day -1) and at Day 9
Population: Safety Population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dolutegravir 50 mg | Period 1: Change From Baseline in Urinalysis Parameter: Potential of Hydrogen (pH) | -0.22 pH | Standard Deviation 0.73 |
Secondary
Period 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 visits, before the first treatment in Period 1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.
Time frame: Baseline (Day -1) and at Day 9
Population: Safety Population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dolutegravir 50 mg | Period 1: Change From Baseline in Urinalysis Parameter: Specific Gravity | 0.0053 Ratio | Standard Deviation 0.00865 |
Secondary
Period 1: Change From Baseline in Urinalysis Parameter: Urobilinogen
Urine samples were collected to analyze the urinalysis parameter: urobilinogen. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first treatment in Period 1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.
Time frame: Baseline (Day -1) and at Day 9
Population: Safety Population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dolutegravir 50 mg | Period 1: Change From Baseline in Urinalysis Parameter: Urobilinogen | 0.0000 Micromoles per liter | Standard Deviation 0 |
Secondary
Period 1: Number of Participants With Urinalysis Dipstick Results
Urine samples were collected at indicated time points to analyze parameters including glucose, protein, occult blood, ketones, nitrite, bilirubin and leukocyte esterase levels by dipstick. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameters can be read as negative, Trace, 1+ (low concentrations present) and 2+ (moderate concentrations present) indicating proportional concentrations in the urine sample.
Time frame: Day 9
Population: Safety Population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Dolutegravir 50 mg | Period 1: Number of Participants With Urinalysis Dipstick Results | Bilirubin: Negative | 16 Participants |
| Dolutegravir 50 mg | Period 1: Number of Participants With Urinalysis Dipstick Results | Glucose: Negative | 16 Participants |
| Dolutegravir 50 mg | Period 1: Number of Participants With Urinalysis Dipstick Results | Ketones: Negative | 15 Participants |
| Dolutegravir 50 mg | Period 1: Number of Participants With Urinalysis Dipstick Results | Ketones: Trace | 1 Participants |
| Dolutegravir 50 mg | Period 1: Number of Participants With Urinalysis Dipstick Results | Leukocyte Esterase: Negative | 16 Participants |
| Dolutegravir 50 mg | Period 1: Number of Participants With Urinalysis Dipstick Results | Nitrite: Negative | 16 Participants |
| Dolutegravir 50 mg | Period 1: Number of Participants With Urinalysis Dipstick Results | Occult Blood: Negative | 15 Participants |
| Dolutegravir 50 mg | Period 1: Number of Participants With Urinalysis Dipstick Results | Occult Blood: 2+ | 1 Participants |
| Dolutegravir 50 mg | Period 1: Number of Participants With Urinalysis Dipstick Results | Protein: Negative | 16 Participants |
Secondary
Period 1: T1/2 of Dolutegravir for Dolutegravir Arm
Blood samples were collected at the indicated time points for pharmacokinetic analysis of dolutegravir. The pharmacokinetic parameters were calculated by standard non-compartmental analysis.
Time frame: Day 5: Pre-dose, 1, 1.5, 2, 3, 3.5, 4, 4.5, 5, 6, 8, 12 and 24 hours post-dose
Population: Pharmacokinetic Parameter Population.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Dolutegravir 50 mg | Period 1: T1/2 of Dolutegravir for Dolutegravir Arm | 14.492 Hours | Geometric Coefficient of Variation 11.8 |
Secondary
Period 1: Tmax of Dolutegravir for Dolutegravir Arm
Blood samples were collected at the indicated time points for pharmacokinetic analysis of dolutegravir. The pharmacokinetic parameters were calculated by standard non-compartmental analysis.
Time frame: Day 5: Pre-dose, 1, 1.5, 2, 3, 3.5, 4, 4.5, 5, 6, 8, 12 and 24 hours post-dose
Population: Pharmacokinetic Parameter Population.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Dolutegravir 50 mg | Period 1: Tmax of Dolutegravir for Dolutegravir Arm | 3.000 Hours |
Secondary
Period 2: Absolute Values for Body Temperature
Body temperature was measured in the semi-recumbent position after at least 5 minutes of rest for the participant in a quiet setting without distractions.
Time frame: Days 2, 3, 4, 5, 6 and 7
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dolutegravir 50 mg | Period 2: Absolute Values for Body Temperature | Day 2 | 36.26 Degrees Celsius | Standard Deviation 0.339 |
| Dolutegravir 50 mg | Period 2: Absolute Values for Body Temperature | Day 3 | 36.15 Degrees Celsius | Standard Deviation 0.361 |
| Dolutegravir 50 mg | Period 2: Absolute Values for Body Temperature | Day 4 | 36.21 Degrees Celsius | Standard Deviation 0.318 |
| Dolutegravir 50 mg | Period 2: Absolute Values for Body Temperature | Day 5 | 36.35 Degrees Celsius | Standard Deviation 0.306 |
| Dolutegravir 50 mg | Period 2: Absolute Values for Body Temperature | Day 6 | 36.28 Degrees Celsius | Standard Deviation 0.309 |
| Dolutegravir 50 mg | Period 2: Absolute Values for Body Temperature | Day 7 | 36.28 Degrees Celsius | Standard Deviation 0.394 |
Secondary
Period 2: Absolute Values for Chemistry Parameters: Albumin, Globulin, Protein
Blood samples were collected to analyze the chemistry parameters: albumin, globulin and protein.
Time frame: Day 7
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dolutegravir 50 mg | Period 2: Absolute Values for Chemistry Parameters: Albumin, Globulin, Protein | Albumin | 44.9 Grams per liter | Standard Deviation 3.13 |
| Dolutegravir 50 mg | Period 2: Absolute Values for Chemistry Parameters: Albumin, Globulin, Protein | Globulin | 26.8 Grams per liter | Standard Deviation 3.78 |
| Dolutegravir 50 mg | Period 2: Absolute Values for Chemistry Parameters: Albumin, Globulin, Protein | Protein | 71.8 Grams per liter | Standard Deviation 4.73 |
Secondary
Period 2: Absolute Values for Chemistry Parameters: Amylase, Lipase
Blood samples were collected to analyze the chemistry parameters: amylase and lipase.
Time frame: Day 7
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dolutegravir 50 mg | Period 2: Absolute Values for Chemistry Parameters: Amylase, Lipase | Amylase | 56.8 Units per liter | Standard Deviation 19.06 |
| Dolutegravir 50 mg | Period 2: Absolute Values for Chemistry Parameters: Amylase, Lipase | Lipase | 21.7 Units per liter | Standard Deviation 7.34 |
Secondary
Period 2: Absolute Values for Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST, Gamma-glutamyl Transferase
Blood samples were collected to analyze the chemistry parameters: creatine kinase, lactate dehydrogenase, ALT, ALP, AST and gamma-glutamyl transferase.
Time frame: Day 7
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dolutegravir 50 mg | Period 2: Absolute Values for Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST, Gamma-glutamyl Transferase | Creatine kinase | 123.9 International units per liter | Standard Deviation 112.28 |
| Dolutegravir 50 mg | Period 2: Absolute Values for Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST, Gamma-glutamyl Transferase | Lactate dehydrogenase | 116.5 International units per liter | Standard Deviation 15.1 |
| Dolutegravir 50 mg | Period 2: Absolute Values for Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST, Gamma-glutamyl Transferase | ALT | 20.4 International units per liter | Standard Deviation 9.88 |
| Dolutegravir 50 mg | Period 2: Absolute Values for Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST, Gamma-glutamyl Transferase | ALP | 59.3 International units per liter | Standard Deviation 9.19 |
| Dolutegravir 50 mg | Period 2: Absolute Values for Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST, Gamma-glutamyl Transferase | AST | 16.8 International units per liter | Standard Deviation 3.8 |
| Dolutegravir 50 mg | Period 2: Absolute Values for Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST, Gamma-glutamyl Transferase | Gamma-glutamyl transferase | 20.3 International units per liter | Standard Deviation 8.44 |
Secondary
Period 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Blood samples were collected to analyze the chemistry parameters: glucose, cholesterol, triglycerides, anion gap, calcium, carbon dioxide, chloride, phosphate, potassium, sodium and blood urea nitrogen.
Time frame: Day 7
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dolutegravir 50 mg | Period 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Glucose | 4.916 Millimoles per liter | Standard Deviation 0.4825 |
| Dolutegravir 50 mg | Period 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Cholesterol | 4.187 Millimoles per liter | Standard Deviation 0.6783 |
| Dolutegravir 50 mg | Period 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Triglycerides | 1.194 Millimoles per liter | Standard Deviation 0.7294 |
| Dolutegravir 50 mg | Period 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Anion gap | 11.4 Millimoles per liter | Standard Deviation 1.2 |
| Dolutegravir 50 mg | Period 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Calcium | 2.406 Millimoles per liter | Standard Deviation 0.0772 |
| Dolutegravir 50 mg | Period 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Carbon dioxide | 29.3 Millimoles per liter | Standard Deviation 1.57 |
| Dolutegravir 50 mg | Period 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Chloride | 103.1 Millimoles per liter | Standard Deviation 2.35 |
| Dolutegravir 50 mg | Period 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Phosphate | 1.281 Millimoles per liter | Standard Deviation 0.151 |
| Dolutegravir 50 mg | Period 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Potassium | 4.23 Millimoles per liter | Standard Deviation 0.249 |
| Dolutegravir 50 mg | Period 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Sodium | 139.6 Millimoles per liter | Standard Deviation 1.9 |
| Dolutegravir 50 mg | Period 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Blood urea nitrogen | 5.065 Millimoles per liter | Standard Deviation 0.6775 |
Secondary
Period 2: Absolute Values for Chemistry Parameters: Urate, Creatinine, Bilirubin, Direct Bilirubin
Blood samples were collected to analyze the chemistry parameters: urate, creatinine, bilirubin and direct bilirubin.
Time frame: Day 7
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dolutegravir 50 mg | Period 2: Absolute Values for Chemistry Parameters: Urate, Creatinine, Bilirubin, Direct Bilirubin | Urate | 314.8 Micromoles per liter | Standard Deviation 69.34 |
| Dolutegravir 50 mg | Period 2: Absolute Values for Chemistry Parameters: Urate, Creatinine, Bilirubin, Direct Bilirubin | Creatinine | 86.92 Micromoles per liter | Standard Deviation 11.567 |
| Dolutegravir 50 mg | Period 2: Absolute Values for Chemistry Parameters: Urate, Creatinine, Bilirubin, Direct Bilirubin | Bilirubin | 9.41 Micromoles per liter | Standard Deviation 3.014 |
| Dolutegravir 50 mg | Period 2: Absolute Values for Chemistry Parameters: Urate, Creatinine, Bilirubin, Direct Bilirubin | Direct bilirubin | 1.93 Micromoles per liter | Standard Deviation 0.704 |
Secondary
Period 2: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB
Twelve-lead ECG were obtained to measure PR Interval, QRS Duration, QT Interval, QTcF Interval and QTcB Interval. Twelve-lead ECGs were performed with the participant in a supine or semi-supine position after a rest of at least 10 minutes.
Time frame: Day 1: 2 hours, 4 hours; Day 5: Pre-dose, 2 hours and 4 hours
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dolutegravir 50 mg | Period 2: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB | PR Interval: Day 1, 2 hours | 165.1 Milliseconds | Standard Deviation 15.46 |
| Dolutegravir 50 mg | Period 2: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB | PR Interval: Day 1, 4 hours | 165.4 Milliseconds | Standard Deviation 14.32 |
| Dolutegravir 50 mg | Period 2: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB | PR Interval: Day 5, Pre-dose | 166.3 Milliseconds | Standard Deviation 16.89 |
| Dolutegravir 50 mg | Period 2: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB | PR Interval: Day 5, 2 hours | 165.0 Milliseconds | Standard Deviation 19.9 |
| Dolutegravir 50 mg | Period 2: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB | PR Interval: Day 5, 4 hours | 162.0 Milliseconds | Standard Deviation 13.64 |
| Dolutegravir 50 mg | Period 2: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB | QRS Duration: Day 1, 2 hours | 94.1 Milliseconds | Standard Deviation 9.66 |
| Dolutegravir 50 mg | Period 2: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB | QRS Duration: Day 1, 4 hours | 92.9 Milliseconds | Standard Deviation 9.2 |
| Dolutegravir 50 mg | Period 2: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB | QRS Duration: Day 5, Pre-dose | 94.3 Milliseconds | Standard Deviation 10.12 |
| Dolutegravir 50 mg | Period 2: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB | QRS Duration: Day 5, 2 hours | 93.9 Milliseconds | Standard Deviation 9 |
| Dolutegravir 50 mg | Period 2: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB | QRS Duration: Day 5, 4 hours | 94.7 Milliseconds | Standard Deviation 8.51 |
| Dolutegravir 50 mg | Period 2: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB | QT Interval: Day 1, 2 hours | 381.8 Milliseconds | Standard Deviation 14.37 |
| Dolutegravir 50 mg | Period 2: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB | QT Interval: Day 5, 2 hours | 382.6 Milliseconds | Standard Deviation 17.13 |
| Dolutegravir 50 mg | Period 2: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB | QT Interval: Day 5, 4 hours | 396.0 Milliseconds | Standard Deviation 21.45 |
| Dolutegravir 50 mg | Period 2: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB | QTcF Interval: Day 1, 2 hours | 390.0 Milliseconds | Standard Deviation 13.74 |
| Dolutegravir 50 mg | Period 2: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB | QTcF Interval: Day 1, 4 hours | 394.4 Milliseconds | Standard Deviation 12.38 |
| Dolutegravir 50 mg | Period 2: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB | QTcF Interval: Day 5, Pre-dose | 397.9 Milliseconds | Standard Deviation 14.64 |
| Dolutegravir 50 mg | Period 2: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB | QTcF Interval: Day 5, 2 hours | 395.0 Milliseconds | Standard Deviation 14.7 |
| Dolutegravir 50 mg | Period 2: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB | QTcF Interval: Day 5, 4 hours | 401.5 Milliseconds | Standard Deviation 12.66 |
| Dolutegravir 50 mg | Period 2: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB | QTcB Interval: Day 1, 2 hours | 393.3 Milliseconds | Standard Deviation 18.57 |
| Dolutegravir 50 mg | Period 2: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB | QTcB Interval: Day 1, 4 hours | 393.4 Milliseconds | Standard Deviation 18.53 |
| Dolutegravir 50 mg | Period 2: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB | QTcB Interval: Day 5, Pre-dose | 399.2 Milliseconds | Standard Deviation 16.61 |
| Dolutegravir 50 mg | Period 2: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB | QT Interval: Day 1, 4 hours | 394.4 Milliseconds | Standard Deviation 19.18 |
| Dolutegravir 50 mg | Period 2: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB | QT Interval: Day 5, Pre-dose | 392.6 Milliseconds | Standard Deviation 23.2 |
| Dolutegravir 50 mg | Period 2: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB | QTcB Interval: Day 5, 2 hours | 400.7 Milliseconds | Standard Deviation 20.02 |
| Dolutegravir 50 mg | Period 2: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB | QTcB Interval: Day 5, 4 hours | 403.2 Milliseconds | Standard Deviation 13.41 |
Secondary
Period 2: Absolute Values for Hematology Parameter: Erythrocytes
Blood samples were collected to analyze the hematology parameter: erythrocytes.
Time frame: Day 7
Population: Safety Population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dolutegravir 50 mg | Period 2: Absolute Values for Hematology Parameter: Erythrocytes | 5.179 Trillion cells per liter | Standard Deviation 0.3575 |
Secondary
Period 2: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin
Blood samples were collected to analyze the hematology parameter: erythrocytes mean corpuscular hemoglobin.
Time frame: Day 7
Population: Safety Population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dolutegravir 50 mg | Period 2: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin | 28.41 Picograms | Standard Deviation 2.385 |
Secondary
Period 2: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Volume
Blood samples were collected to analyze the hematology parameter: erythrocytes mean corpuscular volume.
Time frame: Day 7
Population: Safety Population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dolutegravir 50 mg | Period 2: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Volume | 85.36 Femtoliter | Standard Deviation 5.509 |
Secondary
Period 2: Absolute Values for Hematology Parameter: Hematocrit
Blood samples were collected to analyze the hematology parameter: hematocrit.
Time frame: Day 7
Population: Safety Population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dolutegravir 50 mg | Period 2: Absolute Values for Hematology Parameter: Hematocrit | 0.4406 Proportion of red blood cells in blood | Standard Deviation 0.01887 |
Secondary
Period 2: Absolute Values for Hematology Parameter: Hemoglobin
Blood samples were collected to analyze the hematology parameter: hemoglobin.
Time frame: Day 7
Population: Safety Population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dolutegravir 50 mg | Period 2: Absolute Values for Hematology Parameter: Hemoglobin | 146.5 Grams per liter | Standard Deviation 8.68 |
Secondary
Period 2: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count
Blood samples were collected to analyze the hematology parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelet count.
Time frame: Day 7
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dolutegravir 50 mg | Period 2: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count | Basophils | 0.039 10^9 cells per liter | Standard Deviation 0.0134 |
| Dolutegravir 50 mg | Period 2: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count | Eosinophils | 0.206 10^9 cells per liter | Standard Deviation 0.096 |
| Dolutegravir 50 mg | Period 2: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count | Lymphocytes | 1.869 10^9 cells per liter | Standard Deviation 0.4383 |
| Dolutegravir 50 mg | Period 2: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count | Monocytes | 0.488 10^9 cells per liter | Standard Deviation 0.1081 |
| Dolutegravir 50 mg | Period 2: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count | Neutrophils | 2.878 10^9 cells per liter | Standard Deviation 0.6859 |
| Dolutegravir 50 mg | Period 2: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count | Platelet count | 264.2 10^9 cells per liter | Standard Deviation 48.37 |
Secondary
Period 2: Absolute Values for Pulse Rate
Pulse rate was measured in the semi-recumbent position with a completely automated device.
Time frame: Days 2, 3, 4, 5, 6 and 7
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dolutegravir 50 mg | Period 2: Absolute Values for Pulse Rate | Day 2 | 68.3 Beats per minute | Standard Deviation 9.75 |
| Dolutegravir 50 mg | Period 2: Absolute Values for Pulse Rate | Day 3 | 69.7 Beats per minute | Standard Deviation 8.65 |
| Dolutegravir 50 mg | Period 2: Absolute Values for Pulse Rate | Day 4 | 69.1 Beats per minute | Standard Deviation 8.21 |
| Dolutegravir 50 mg | Period 2: Absolute Values for Pulse Rate | Day 5 | 68.5 Beats per minute | Standard Deviation 11.14 |
| Dolutegravir 50 mg | Period 2: Absolute Values for Pulse Rate | Day 6 | 68.1 Beats per minute | Standard Deviation 8.88 |
| Dolutegravir 50 mg | Period 2: Absolute Values for Pulse Rate | Day 7 | 67.0 Beats per minute | Standard Deviation 8.95 |
Secondary
Period 2: Absolute Values for Respiratory Rate
Respiratory rate was measured in the semi-recumbent position after at least 5 minutes of rest for the participant in a quiet setting without distractions.
Time frame: Days 2, 3, 4, 5, 6 and 7
Population: Safety Population. Only those participants with data available at the indicated time points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dolutegravir 50 mg | Period 2: Absolute Values for Respiratory Rate | Day 2, n=16 | 13.6 Breaths per minute | Standard Deviation 0.81 |
| Dolutegravir 50 mg | Period 2: Absolute Values for Respiratory Rate | Day 3, n=16 | 14.5 Breaths per minute | Standard Deviation 2 |
| Dolutegravir 50 mg | Period 2: Absolute Values for Respiratory Rate | Day 4, n=16 | 13.5 Breaths per minute | Standard Deviation 1.15 |
| Dolutegravir 50 mg | Period 2: Absolute Values for Respiratory Rate | Day 5, n=15 | 15.3 Breaths per minute | Standard Deviation 2.09 |
| Dolutegravir 50 mg | Period 2: Absolute Values for Respiratory Rate | Day 6, n=16 | 13.8 Breaths per minute | Standard Deviation 2.52 |
| Dolutegravir 50 mg | Period 2: Absolute Values for Respiratory Rate | Day 7, n=16 | 14.3 Breaths per minute | Standard Deviation 2.18 |
Secondary
Period 2: Absolute Values for SBP and DBP
SBP and DBP were measured in the semi-recumbent position with a completely automated device.
Time frame: Days 2, 3, 4, 5, 6 and 7
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dolutegravir 50 mg | Period 2: Absolute Values for SBP and DBP | SBP: Day 2 | 115.8 Millimeters of mercury | Standard Deviation 7.15 |
| Dolutegravir 50 mg | Period 2: Absolute Values for SBP and DBP | SBP: Day 5 | 113.6 Millimeters of mercury | Standard Deviation 7.35 |
| Dolutegravir 50 mg | Period 2: Absolute Values for SBP and DBP | SBP: Day 6 | 113.9 Millimeters of mercury | Standard Deviation 8.29 |
| Dolutegravir 50 mg | Period 2: Absolute Values for SBP and DBP | SBP: Day 7 | 114.6 Millimeters of mercury | Standard Deviation 5.73 |
| Dolutegravir 50 mg | Period 2: Absolute Values for SBP and DBP | DBP: Day 2 | 69.6 Millimeters of mercury | Standard Deviation 8.5 |
| Dolutegravir 50 mg | Period 2: Absolute Values for SBP and DBP | DBP: Day 3 | 71.1 Millimeters of mercury | Standard Deviation 7.65 |
| Dolutegravir 50 mg | Period 2: Absolute Values for SBP and DBP | DBP: Day 4 | 69.6 Millimeters of mercury | Standard Deviation 5.24 |
| Dolutegravir 50 mg | Period 2: Absolute Values for SBP and DBP | DBP: Day 5 | 68.8 Millimeters of mercury | Standard Deviation 6.49 |
| Dolutegravir 50 mg | Period 2: Absolute Values for SBP and DBP | DBP: Day 6 | 70.3 Millimeters of mercury | Standard Deviation 7.02 |
| Dolutegravir 50 mg | Period 2: Absolute Values for SBP and DBP | DBP: Day 7 | 70.4 Millimeters of mercury | Standard Deviation 6.65 |
| Dolutegravir 50 mg | Period 2: Absolute Values for SBP and DBP | SBP: Day 3 | 115.3 Millimeters of mercury | Standard Deviation 7.57 |
| Dolutegravir 50 mg | Period 2: Absolute Values for SBP and DBP | SBP: Day 4 | 117.1 Millimeters of mercury | Standard Deviation 8.74 |
Secondary
Period 2: Absolute Values for Urinalysis Parameter: 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. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0).
Time frame: Day 7
Population: Safety Population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dolutegravir 50 mg | Period 2: Absolute Values for Urinalysis Parameter: pH | 6.00 pH | Standard Deviation 0.548 |
Secondary
Period 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.
Time frame: Day 7
Population: Safety Population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dolutegravir 50 mg | Period 2: Absolute Values for Urinalysis Parameter: Specific Gravity | 1.0176 Ratio | Standard Deviation 0.00552 |
Secondary
Period 2: Absolute Values for Urinalysis Parameter: Urobilinogen
Urine samples were collected to analyze the urinalysis parameter: urobilinogen.
Time frame: Day 7
Population: Safety Population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dolutegravir 50 mg | Period 2: Absolute Values for Urinalysis Parameter: Urobilinogen | 3.3860 Micromoles per liter | Standard Deviation 0 |
Secondary
Period 2: Apparent Terminal Phase Half-life (T1/2) of GSK3640254 for GSK3640254 Arm
Blood samples were collected at the indicated time points for pharmacokinetic analysis of GSK3640254. The pharmacokinetic parameters were calculated by standard non-compartmental analysis. Data could not be determined due to limited sampling points after final dosing (during elimination phase). An accurate determination of GSK3640254 half-life would require sampling up to 3 times half-life (3 \* approximately 24 hours). However sampling in Period 2 was performed up to only 24 hours post-dose.
Time frame: Day 7: Pre-dose, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12 and 24 hours post-dose
Population: Pharmacokinetic Parameter Population.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Dolutegravir 50 mg | Period 2: Apparent Terminal Phase Half-life (T1/2) of GSK3640254 for GSK3640254 Arm | NA Hours |
Secondary
Period 2: Change From Baseline in Body Temperature
Body temperature was measured in the semi-recumbent position 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, in Period 2. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.
Time frame: Baseline (Day 1, Pre-dose), Days 2, 3, 4, 5, 6 and 7
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dolutegravir 50 mg | Period 2: Change From Baseline in Body Temperature | Day 2 | -0.14 Degrees Celsius | Standard Deviation 0.299 |
| Dolutegravir 50 mg | Period 2: Change From Baseline in Body Temperature | Day 3 | -0.25 Degrees Celsius | Standard Deviation 0.415 |
| Dolutegravir 50 mg | Period 2: Change From Baseline in Body Temperature | Day 4 | -0.19 Degrees Celsius | Standard Deviation 0.294 |
| Dolutegravir 50 mg | Period 2: Change From Baseline in Body Temperature | Day 5 | -0.05 Degrees Celsius | Standard Deviation 0.363 |
| Dolutegravir 50 mg | Period 2: Change From Baseline in Body Temperature | Day 6 | -0.13 Degrees Celsius | Standard Deviation 0.3 |
| Dolutegravir 50 mg | Period 2: Change From Baseline in Body Temperature | Day 7 | -0.13 Degrees Celsius | Standard Deviation 0.373 |
Secondary
Period 2: Change From Baseline in Chemistry Parameters: Albumin, Globulin, 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 visits, before the first treatment in Period 2. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.
Time frame: Baseline (Period 1 Day 9) and at Day 7
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dolutegravir 50 mg | Period 2: Change From Baseline in Chemistry Parameters: Albumin, Globulin, Protein | Albumin | 0.9 Grams per liter | Standard Deviation 1.45 |
| Dolutegravir 50 mg | Period 2: Change From Baseline in Chemistry Parameters: Albumin, Globulin, Protein | Globulin | -1.1 Grams per liter | Standard Deviation 0.77 |
| Dolutegravir 50 mg | Period 2: Change From Baseline in Chemistry Parameters: Albumin, Globulin, Protein | Protein | -0.2 Grams per liter | Standard Deviation 1.76 |
Secondary
Period 2: Change From Baseline in Chemistry Parameters: Amylase, Lipase
Blood samples were collected to analyze the chemistry parameters: amylase and lipase. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first treatment in Period 2. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.
Time frame: Baseline (Period 1 Day 9) and at Day 7
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dolutegravir 50 mg | Period 2: Change From Baseline in Chemistry Parameters: Amylase, Lipase | Amylase | -2.8 Units per liter | Standard Deviation 4.65 |
| Dolutegravir 50 mg | Period 2: Change From Baseline in Chemistry Parameters: Amylase, Lipase | Lipase | -0.7 Units per liter | Standard Deviation 3.79 |
Secondary
Period 2: Change From Baseline in Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST, Gamma-glutamyl Transferase
Blood samples were collected to analyze the chemistry parameters: creatine kinase, lactate dehydrogenase, ALT, ALP, AST and gamma-glutamyl transferase. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first treatment in Period 2. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.
Time frame: Baseline (Period 1 Day 9) and at Day 7
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dolutegravir 50 mg | Period 2: Change From Baseline in Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST, Gamma-glutamyl Transferase | Creatine kinase | 22.6 International units per liter | Standard Deviation 58.21 |
| Dolutegravir 50 mg | Period 2: Change From Baseline in Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST, Gamma-glutamyl Transferase | Lactate dehydrogenase | 9.1 International units per liter | Standard Deviation 5.76 |
| Dolutegravir 50 mg | Period 2: Change From Baseline in Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST, Gamma-glutamyl Transferase | ALT | -0.6 International units per liter | Standard Deviation 2.8 |
| Dolutegravir 50 mg | Period 2: Change From Baseline in Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST, Gamma-glutamyl Transferase | ALP | 1.9 International units per liter | Standard Deviation 2.7 |
| Dolutegravir 50 mg | Period 2: Change From Baseline in Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST, Gamma-glutamyl Transferase | AST | 0.2 International units per liter | Standard Deviation 1.87 |
| Dolutegravir 50 mg | Period 2: Change From Baseline in Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST, Gamma-glutamyl Transferase | Gamma-glutamyl transferase | -0.8 International units per liter | Standard Deviation 1.28 |
Secondary
Period 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Blood samples were collected to analyze the chemistry parameters: glucose, cholesterol, triglycerides, anion gap, calcium, carbon dioxide, chloride, phosphate, potassium, sodium and blood urea nitrogen. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first treatment in Period 2. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.
Time frame: Baseline (Period 1 Day 9) and at Day 7
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dolutegravir 50 mg | Period 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Glucose | -0.249 Millimoles per liter | Standard Deviation 0.1748 |
| Dolutegravir 50 mg | Period 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Cholesterol | -0.269 Millimoles per liter | Standard Deviation 0.2363 |
| Dolutegravir 50 mg | Period 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Anion gap | 2.2 Millimoles per liter | Standard Deviation 1.52 |
| Dolutegravir 50 mg | Period 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Chloride | -0.7 Millimoles per liter | Standard Deviation 1.78 |
| Dolutegravir 50 mg | Period 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Phosphate | 0.037 Millimoles per liter | Standard Deviation 0.0955 |
| Dolutegravir 50 mg | Period 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Triglycerides | 0.087 Millimoles per liter | Standard Deviation 0.2374 |
| Dolutegravir 50 mg | Period 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Calcium | 0.014 Millimoles per liter | Standard Deviation 0.0245 |
| Dolutegravir 50 mg | Period 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Carbon dioxide | -1.3 Millimoles per liter | Standard Deviation 1.53 |
| Dolutegravir 50 mg | Period 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Potassium | -0.03 Millimoles per liter | Standard Deviation 0.272 |
| Dolutegravir 50 mg | Period 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Sodium | 0.3 Millimoles per liter | Standard Deviation 1.74 |
| Dolutegravir 50 mg | Period 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Blood urea nitrogen | -0.341 Millimoles per liter | Standard Deviation 0.3937 |
Secondary
Period 2: Change From Baseline in Chemistry Parameters: Urate, Creatinine, Bilirubin, Direct Bilirubin
Blood samples were collected to analyze the chemistry parameters: urate, creatinine, bilirubin and direct bilirubin. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first treatment in Period 2. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.
Time frame: Baseline (Period 1 Day 9) and at Day 7
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dolutegravir 50 mg | Period 2: Change From Baseline in Chemistry Parameters: Urate, Creatinine, Bilirubin, Direct Bilirubin | Urate | -7.1 Micromoles per liter | Standard Deviation 14.52 |
| Dolutegravir 50 mg | Period 2: Change From Baseline in Chemistry Parameters: Urate, Creatinine, Bilirubin, Direct Bilirubin | Creatinine | -3.36 Micromoles per liter | Standard Deviation 4.219 |
| Dolutegravir 50 mg | Period 2: Change From Baseline in Chemistry Parameters: Urate, Creatinine, Bilirubin, Direct Bilirubin | Direct bilirubin | 0.06 Micromoles per liter | Standard Deviation 0.328 |
| Dolutegravir 50 mg | Period 2: Change From Baseline in Chemistry Parameters: Urate, Creatinine, Bilirubin, Direct Bilirubin | Bilirubin | 0.27 Micromoles per liter | Standard Deviation 1.299 |
Secondary
Period 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 visits, before the first treatment in Period 2. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.
Time frame: Baseline (Period 1 Day 9) and at Day 7
Population: Safety Population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dolutegravir 50 mg | Period 2: Change From Baseline in Hematology Parameter: Erythrocytes | 0.036 Trillion cells per liter | Standard Deviation 0.102 |
Secondary
Period 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 visits, before the first treatment in Period 2. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.
Time frame: Baseline (Period 1 Day 9) and at Day 7
Population: Safety Population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dolutegravir 50 mg | Period 2: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin | -0.17 Picograms | Standard Deviation 0.218 |
Secondary
Period 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 visits, before the first treatment in Period 2. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.
Time frame: Baseline (Period 1 Day 9) and at Day 7
Population: Safety Population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dolutegravir 50 mg | Period 2: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume | -0.86 Femtoliter | Standard Deviation 0.564 |
Secondary
Period 2: Change From Baseline in Hematology Parameter: 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 visits, before the first treatment in Period 2. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.
Time frame: Baseline (Period 1 Day 9) and at Day 7
Population: Safety Population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dolutegravir 50 mg | Period 2: Change From Baseline in Hematology Parameter: Hematocrit | -0.0013 Proportion of red blood cells in blood | Standard Deviation 0.00948 |
Secondary
Period 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 visits, before the first treatment in Period 2. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.
Time frame: Baseline (Period 1 Day 9) and at Day 7
Population: Safety Population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dolutegravir 50 mg | Period 2: Change From Baseline in Hematology Parameter: Hemoglobin | 0.1 Grams per liter | Standard Deviation 2.53 |
Secondary
Period 2: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count
Blood samples were collected to analyze the hematology parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelet count. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first treatment in Period 2. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.
Time frame: Baseline (Period 1 Day 9) and at Day 7
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dolutegravir 50 mg | Period 2: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count | Basophils | -0.006 10^9 cells per liter | Standard Deviation 0.0089 |
| Dolutegravir 50 mg | Period 2: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count | Eosinophils | -0.026 10^9 cells per liter | Standard Deviation 0.081 |
| Dolutegravir 50 mg | Period 2: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count | Lymphocytes | -0.154 10^9 cells per liter | Standard Deviation 0.2718 |
| Dolutegravir 50 mg | Period 2: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count | Monocytes | -0.024 10^9 cells per liter | Standard Deviation 0.0701 |
| Dolutegravir 50 mg | Period 2: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count | Neutrophils | -0.160 10^9 cells per liter | Standard Deviation 0.3762 |
| Dolutegravir 50 mg | Period 2: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count | Platelet count | -6.0 10^9 cells per liter | Standard Deviation 30.58 |
Secondary
Period 2: Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB
Twelve-lead ECG were obtained to measure PR Interval, QRS Duration, QT Interval, QTcF Interval and QTcB Interval. Twelve-lead ECGs were performed with the participant in a supine or semi-supine position after a rest of at least 10 minutes. Baseline was defined as the average of the triplicate pre-dose assessments on Day 1 of Period 2. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.
Time frame: Baseline; Day 1: 2 hours, 4 hours; Day 5: Pre-dose, 2 hours and 4 hours
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dolutegravir 50 mg | Period 2: Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB | PR Interval: Day 1, 2 hours | -3.3 Milliseconds | Standard Deviation 6.31 |
| Dolutegravir 50 mg | Period 2: Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB | PR Interval: Day 1, 4 hours | -3.0 Milliseconds | Standard Deviation 5.55 |
| Dolutegravir 50 mg | Period 2: Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB | PR Interval: Day 5, Pre-dose | -2.1 Milliseconds | Standard Deviation 6.15 |
| Dolutegravir 50 mg | Period 2: Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB | PR Interval: Day 5, 2 hours | -3.4 Milliseconds | Standard Deviation 7.81 |
| Dolutegravir 50 mg | Period 2: Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB | PR Interval: Day 5, 4 hours | -6.4 Milliseconds | Standard Deviation 6.77 |
| Dolutegravir 50 mg | Period 2: Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB | QRS Duration: Day 1, 4 hours | -1.1 Milliseconds | Standard Deviation 4.08 |
| Dolutegravir 50 mg | Period 2: Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB | QRS Duration: Day 5, Pre-dose | 0.3 Milliseconds | Standard Deviation 3.89 |
| Dolutegravir 50 mg | Period 2: Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB | QRS Duration: Day 5, 2 hours | -0.2 Milliseconds | Standard Deviation 3.85 |
| Dolutegravir 50 mg | Period 2: Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB | QT Interval: Day 1, 2 hours | -7.9 Milliseconds | Standard Deviation 11.47 |
| Dolutegravir 50 mg | Period 2: Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB | QT Interval: Day 1, 4 hours | 4.6 Milliseconds | Standard Deviation 13.48 |
| Dolutegravir 50 mg | Period 2: Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB | QT Interval: Day 5, Pre-dose | 2.8 Milliseconds | Standard Deviation 17.38 |
| Dolutegravir 50 mg | Period 2: Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB | QT Interval: Day 5, 2 hours | -7.1 Milliseconds | Standard Deviation 16.13 |
| Dolutegravir 50 mg | Period 2: Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB | QT Interval: Day 5, 4 hours | 6.3 Milliseconds | Standard Deviation 20.51 |
| Dolutegravir 50 mg | Period 2: Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB | QTcF Interval: Day 1, 2 hours | -1.3 Milliseconds | Standard Deviation 8.74 |
| Dolutegravir 50 mg | Period 2: Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB | QTcF Interval: Day 1, 4 hours | 3.1 Milliseconds | Standard Deviation 6.44 |
| Dolutegravir 50 mg | Period 2: Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB | QTcF Interval: Day 5, Pre-dose | 6.6 Milliseconds | Standard Deviation 6.79 |
| Dolutegravir 50 mg | Period 2: Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB | QTcF Interval: Day 5, 2 hours | 3.7 Milliseconds | Standard Deviation 9.36 |
| Dolutegravir 50 mg | Period 2: Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB | QTcF Interval: Day 5, 4 hours | 10.2 Milliseconds | Standard Deviation 10.44 |
| Dolutegravir 50 mg | Period 2: Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB | QTcB Interval: Day 1, 2 hours | 2.4 Milliseconds | Standard Deviation 13.45 |
| Dolutegravir 50 mg | Period 2: Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB | QTcB Interval: Day 1, 4 hours | 2.6 Milliseconds | Standard Deviation 12.62 |
| Dolutegravir 50 mg | Period 2: Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB | QTcB Interval: Day 5, Pre-dose | 8.4 Milliseconds | Standard Deviation 5.92 |
| Dolutegravir 50 mg | Period 2: Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB | QTcB Interval: Day 5, 2 hours | 9.9 Milliseconds | Standard Deviation 11.93 |
| Dolutegravir 50 mg | Period 2: Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB | QTcB Interval: Day 5, 4 hours | 12.4 Milliseconds | Standard Deviation 8.57 |
| Dolutegravir 50 mg | Period 2: Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB | QRS Duration: Day 1, 2 hours | 0.1 Milliseconds | Standard Deviation 2.54 |
| Dolutegravir 50 mg | Period 2: Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB | QRS Duration: Day 5, 4 hours | 0.6 Milliseconds | Standard Deviation 2.7 |
Secondary
Period 2: Change From Baseline in Pulse Rate
Pulse rate was measured in the semi-recumbent position with a completely automated device. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, in Period 2. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.
Time frame: Baseline (Day 1, Pre-dose), Days 2, 3, 4, 5, 6 and 7
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dolutegravir 50 mg | Period 2: Change From Baseline in Pulse Rate | Day 2 | 3.9 Beats per minute | Standard Deviation 8.54 |
| Dolutegravir 50 mg | Period 2: Change From Baseline in Pulse Rate | Day 3 | 5.4 Beats per minute | Standard Deviation 7.19 |
| Dolutegravir 50 mg | Period 2: Change From Baseline in Pulse Rate | Day 4 | 4.8 Beats per minute | Standard Deviation 7.5 |
| Dolutegravir 50 mg | Period 2: Change From Baseline in Pulse Rate | Day 5 | 4.2 Beats per minute | Standard Deviation 8.73 |
| Dolutegravir 50 mg | Period 2: Change From Baseline in Pulse Rate | Day 6 | 3.8 Beats per minute | Standard Deviation 6.51 |
| Dolutegravir 50 mg | Period 2: Change From Baseline in Pulse Rate | Day 7 | 2.7 Beats per minute | Standard Deviation 5.78 |
Secondary
Period 2: Change From Baseline in Respiratory Rate
Respiratory rate was measured in the semi-recumbent position 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, in Period 2. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.
Time frame: Baseline (Day 1, Pre-dose), Days 2, 3, 4, 5, 6 and 7
Population: Safety Population. Only those participants with data available at the indicated time points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dolutegravir 50 mg | Period 2: Change From Baseline in Respiratory Rate | Day 7, n=16 | 0.1 Breaths per minute | Standard Deviation 3.3 |
| Dolutegravir 50 mg | Period 2: Change From Baseline in Respiratory Rate | Day 2, n=16 | -0.5 Breaths per minute | Standard Deviation 2.58 |
| Dolutegravir 50 mg | Period 2: Change From Baseline in Respiratory Rate | Day 4, n=16 | -0.6 Breaths per minute | Standard Deviation 3.07 |
| Dolutegravir 50 mg | Period 2: Change From Baseline in Respiratory Rate | Day 5, n=15 | 1.3 Breaths per minute | Standard Deviation 2.47 |
| Dolutegravir 50 mg | Period 2: Change From Baseline in Respiratory Rate | Day 6, n=16 | -0.4 Breaths per minute | Standard Deviation 2.55 |
| Dolutegravir 50 mg | Period 2: Change From Baseline in Respiratory Rate | Day 3, n=16 | 0.4 Breaths per minute | Standard Deviation 3.03 |
Secondary
Period 2: Change From Baseline in SBP and DBP
SBP and DBP were measured in the semi-recumbent position with a completely automated device. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, in Period 2. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.
Time frame: Baseline (Day 1, Pre-dose), Days 2, 3, 4, 5, 6 and 7
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dolutegravir 50 mg | Period 2: Change From Baseline in SBP and DBP | SBP: Day 2 | 1.7 Millimeters of mercury | Standard Deviation 5.19 |
| Dolutegravir 50 mg | Period 2: Change From Baseline in SBP and DBP | SBP: Day 3 | 1.3 Millimeters of mercury | Standard Deviation 6.83 |
| Dolutegravir 50 mg | Period 2: Change From Baseline in SBP and DBP | SBP: Day 5 | -0.5 Millimeters of mercury | Standard Deviation 5.4 |
| Dolutegravir 50 mg | Period 2: Change From Baseline in SBP and DBP | SBP: Day 6 | -0.1 Millimeters of mercury | Standard Deviation 8.01 |
| Dolutegravir 50 mg | Period 2: Change From Baseline in SBP and DBP | SBP: Day 7 | 0.6 Millimeters of mercury | Standard Deviation 4.57 |
| Dolutegravir 50 mg | Period 2: Change From Baseline in SBP and DBP | DBP: Day 2 | -0.4 Millimeters of mercury | Standard Deviation 7.03 |
| Dolutegravir 50 mg | Period 2: Change From Baseline in SBP and DBP | DBP: Day 3 | 1.1 Millimeters of mercury | Standard Deviation 4.46 |
| Dolutegravir 50 mg | Period 2: Change From Baseline in SBP and DBP | DBP: Day 4 | -0.4 Millimeters of mercury | Standard Deviation 4.67 |
| Dolutegravir 50 mg | Period 2: Change From Baseline in SBP and DBP | DBP: Day 5 | -1.3 Millimeters of mercury | Standard Deviation 4.85 |
| Dolutegravir 50 mg | Period 2: Change From Baseline in SBP and DBP | DBP: Day 6 | 0.3 Millimeters of mercury | Standard Deviation 6.37 |
| Dolutegravir 50 mg | Period 2: Change From Baseline in SBP and DBP | DBP: Day 7 | 0.4 Millimeters of mercury | Standard Deviation 5.62 |
| Dolutegravir 50 mg | Period 2: Change From Baseline in SBP and DBP | SBP: Day 4 | 3.0 Millimeters of mercury | Standard Deviation 7.73 |
Secondary
Period 2: Change From Baseline in Urinalysis Parameter: 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. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0). Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first treatment in Period 2. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.
Time frame: Baseline (Period 1 Day 9) and at Day 7
Population: Safety Population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dolutegravir 50 mg | Period 2: Change From Baseline in Urinalysis Parameter: pH | 0.13 pH | Standard Deviation 0.428 |
Secondary
Period 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 visits, before the first treatment in Period 2. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.
Time frame: Baseline (Period 1 Day 9) and at Day 7
Population: Safety Population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dolutegravir 50 mg | Period 2: Change From Baseline in Urinalysis Parameter: Specific Gravity | -0.0004 Ratio | Standard Deviation 0.00645 |
Secondary
Period 2: Change From Baseline in Urinalysis Parameter: Urobilinogen
Urine samples were collected to analyze the urinalysis parameter: urobilinogen. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first treatment in Period 2. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.
Time frame: Baseline (Period 1 Day 9) and at Day 7
Population: Safety Population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dolutegravir 50 mg | Period 2: Change From Baseline in Urinalysis Parameter: Urobilinogen | 0.0000 Micromoles per liter | Standard Deviation 0 |
Secondary
Period 2: Number of Participants With Urinalysis Dipstick Results
Urine samples were collected at indicated time points to analyze parameters including glucose, protein, occult blood, ketones, nitrite, bilirubin and leukocyte esterase levels by dipstick. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameters can be read as negative, Trace, 1+ (low concentrations present), and 2+ (moderate concentrations present) indicating proportional concentrations in the urine sample.
Time frame: Day 7
Population: Safety Population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Dolutegravir 50 mg | Period 2: Number of Participants With Urinalysis Dipstick Results | Bilirubin: Negative | 16 Participants |
| Dolutegravir 50 mg | Period 2: Number of Participants With Urinalysis Dipstick Results | Glucose: Negative | 16 Participants |
| Dolutegravir 50 mg | Period 2: Number of Participants With Urinalysis Dipstick Results | Ketones: Negative | 15 Participants |
| Dolutegravir 50 mg | Period 2: Number of Participants With Urinalysis Dipstick Results | Ketones: 1+ | 1 Participants |
| Dolutegravir 50 mg | Period 2: Number of Participants With Urinalysis Dipstick Results | Leukocyte Esterase: 1+ | 1 Participants |
| Dolutegravir 50 mg | Period 2: Number of Participants With Urinalysis Dipstick Results | Nitrite: Negative | 16 Participants |
| Dolutegravir 50 mg | Period 2: Number of Participants With Urinalysis Dipstick Results | Occult Blood: Negative | 16 Participants |
| Dolutegravir 50 mg | Period 2: Number of Participants With Urinalysis Dipstick Results | Protein: Negative | 16 Participants |
| Dolutegravir 50 mg | Period 2: Number of Participants With Urinalysis Dipstick Results | Leukocyte Esterase: Negative | 15 Participants |
Secondary
Period 2: Time of Maximum Observed Concentration (Tmax) of GSK3640254 for GSK3640254 Arm
Blood samples were collected at the indicated time points for pharmacokinetic analysis of GSK3640254. The pharmacokinetic parameters were calculated by standard non-compartmental analysis.
Time frame: Day 7: Pre-dose, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12 and 24 hours post-dose
Population: Pharmacokinetic Parameter Population.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Dolutegravir 50 mg | Period 2: Time of Maximum Observed Concentration (Tmax) of GSK3640254 for GSK3640254 Arm | 5.000 Hours |
Secondary
Period 3: Absolute Values for Body Temperature
Body temperature was measured in the semi-recumbent position after at least 5 minutes of rest for the participant in a quiet setting without distractions.
Time frame: Days 2, 3, 4, 5, 6, 7, 8, 9, 10 and 11
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dolutegravir 50 mg | Period 3: Absolute Values for Body Temperature | Day 2 | 36.33 Degrees Celsius | Standard Deviation 0.284 |
| Dolutegravir 50 mg | Period 3: Absolute Values for Body Temperature | Day 9 | 36.30 Degrees Celsius | Standard Deviation 0.337 |
| Dolutegravir 50 mg | Period 3: Absolute Values for Body Temperature | Day 10 | 36.37 Degrees Celsius | Standard Deviation 0.294 |
| Dolutegravir 50 mg | Period 3: Absolute Values for Body Temperature | Day 3 | 36.22 Degrees Celsius | Standard Deviation 0.369 |
| Dolutegravir 50 mg | Period 3: Absolute Values for Body Temperature | Day 4 | 36.42 Degrees Celsius | Standard Deviation 0.412 |
| Dolutegravir 50 mg | Period 3: Absolute Values for Body Temperature | Day 5 | 36.40 Degrees Celsius | Standard Deviation 0.405 |
| Dolutegravir 50 mg | Period 3: Absolute Values for Body Temperature | Day 6 | 36.37 Degrees Celsius | Standard Deviation 0.366 |
| Dolutegravir 50 mg | Period 3: Absolute Values for Body Temperature | Day 7 | 36.46 Degrees Celsius | Standard Deviation 0.371 |
| Dolutegravir 50 mg | Period 3: Absolute Values for Body Temperature | Day 8 | 36.28 Degrees Celsius | Standard Deviation 0.451 |
| Dolutegravir 50 mg | Period 3: Absolute Values for Body Temperature | Day 11 | 36.53 Degrees Celsius | Standard Deviation 0.307 |
Secondary
Period 3: Absolute Values for Chemistry Parameters: Albumin, Globulin, Protein
Blood samples were collected to analyze the chemistry parameters: albumin, globulin and protein.
Time frame: Days 4, 7 and 10
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dolutegravir 50 mg | Period 3: Absolute Values for Chemistry Parameters: Albumin, Globulin, Protein | Day 4: Albumin | 45.9 Grams per liter | Standard Deviation 3.12 |
| Dolutegravir 50 mg | Period 3: Absolute Values for Chemistry Parameters: Albumin, Globulin, Protein | Day 7: Albumin | 45.1 Grams per liter | Standard Deviation 2.83 |
| Dolutegravir 50 mg | Period 3: Absolute Values for Chemistry Parameters: Albumin, Globulin, Protein | Day 10: Albumin | 45.3 Grams per liter | Standard Deviation 2.8 |
| Dolutegravir 50 mg | Period 3: Absolute Values for Chemistry Parameters: Albumin, Globulin, Protein | Day 4: Globulin | 25.9 Grams per liter | Standard Deviation 3.52 |
| Dolutegravir 50 mg | Period 3: Absolute Values for Chemistry Parameters: Albumin, Globulin, Protein | Day 7: Globulin | 27.8 Grams per liter | Standard Deviation 3.49 |
| Dolutegravir 50 mg | Period 3: Absolute Values for Chemistry Parameters: Albumin, Globulin, Protein | Day 10: Globulin | 27.3 Grams per liter | Standard Deviation 3.34 |
| Dolutegravir 50 mg | Period 3: Absolute Values for Chemistry Parameters: Albumin, Globulin, Protein | Day 4: Protein | 71.8 Grams per liter | Standard Deviation 3.89 |
| Dolutegravir 50 mg | Period 3: Absolute Values for Chemistry Parameters: Albumin, Globulin, Protein | Day 7: Protein | 72.9 Grams per liter | Standard Deviation 4.28 |
| Dolutegravir 50 mg | Period 3: Absolute Values for Chemistry Parameters: Albumin, Globulin, Protein | Day 10: Protein | 72.6 Grams per liter | Standard Deviation 4.11 |
Secondary
Period 3: Absolute Values for Chemistry Parameters: Amylase, Lipase
Blood samples were collected to analyze the chemistry parameters: amylase and lipase.
Time frame: Days 4, 7 and 10
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dolutegravir 50 mg | Period 3: Absolute Values for Chemistry Parameters: Amylase, Lipase | Day 7: Amylase | 56.9 Units per liter | Standard Deviation 21.03 |
| Dolutegravir 50 mg | Period 3: Absolute Values for Chemistry Parameters: Amylase, Lipase | Day 10: Amylase | 55.9 Units per liter | Standard Deviation 20.57 |
| Dolutegravir 50 mg | Period 3: Absolute Values for Chemistry Parameters: Amylase, Lipase | Day 4: Lipase | 26.4 Units per liter | Standard Deviation 11.1 |
| Dolutegravir 50 mg | Period 3: Absolute Values for Chemistry Parameters: Amylase, Lipase | Day 7: Lipase | 20.9 Units per liter | Standard Deviation 9.12 |
| Dolutegravir 50 mg | Period 3: Absolute Values for Chemistry Parameters: Amylase, Lipase | Day 10: Lipase | 21.8 Units per liter | Standard Deviation 9.25 |
| Dolutegravir 50 mg | Period 3: Absolute Values for Chemistry Parameters: Amylase, Lipase | Day 4: Amylase | 55.3 Units per liter | Standard Deviation 18.81 |
Secondary
Period 3: Absolute Values for Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST, Gamma-glutamyl Transferase
Blood samples were collected to analyze the chemistry parameters: creatine kinase, lactate dehydrogenase, ALT, ALP, AST and gamma-glutamyl transferase.
Time frame: Days 4, 7 and 10
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dolutegravir 50 mg | Period 3: Absolute Values for Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST, Gamma-glutamyl Transferase | Day 4: Creatine kinase | 110.3 International units per liter | Standard Deviation 67.02 |
| Dolutegravir 50 mg | Period 3: Absolute Values for Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST, Gamma-glutamyl Transferase | Day 7: Creatine kinase | 105.3 International units per liter | Standard Deviation 63.83 |
| Dolutegravir 50 mg | Period 3: Absolute Values for Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST, Gamma-glutamyl Transferase | Day 10: Creatine kinase | 100.3 International units per liter | Standard Deviation 50.51 |
| Dolutegravir 50 mg | Period 3: Absolute Values for Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST, Gamma-glutamyl Transferase | Day 4: Lactate dehydrogenase | 122.4 International units per liter | Standard Deviation 16.26 |
| Dolutegravir 50 mg | Period 3: Absolute Values for Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST, Gamma-glutamyl Transferase | Day 7: Lactate dehydrogenase | 115.6 International units per liter | Standard Deviation 15.47 |
| Dolutegravir 50 mg | Period 3: Absolute Values for Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST, Gamma-glutamyl Transferase | Day 10: Lactate dehydrogenase | 116.6 International units per liter | Standard Deviation 18.79 |
| Dolutegravir 50 mg | Period 3: Absolute Values for Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST, Gamma-glutamyl Transferase | Day 4: ALT | 21.4 International units per liter | Standard Deviation 11.98 |
| Dolutegravir 50 mg | Period 3: Absolute Values for Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST, Gamma-glutamyl Transferase | Day 7: ALT | 21.1 International units per liter | Standard Deviation 12 |
| Dolutegravir 50 mg | Period 3: Absolute Values for Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST, Gamma-glutamyl Transferase | Day 10: ALT | 22.3 International units per liter | Standard Deviation 12.93 |
| Dolutegravir 50 mg | Period 3: Absolute Values for Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST, Gamma-glutamyl Transferase | Day 4: ALP | 57.8 International units per liter | Standard Deviation 9.34 |
| Dolutegravir 50 mg | Period 3: Absolute Values for Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST, Gamma-glutamyl Transferase | Day 7: ALP | 58.8 International units per liter | Standard Deviation 9.63 |
| Dolutegravir 50 mg | Period 3: Absolute Values for Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST, Gamma-glutamyl Transferase | Day 10: ALP | 60.1 International units per liter | Standard Deviation 9.07 |
| Dolutegravir 50 mg | Period 3: Absolute Values for Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST, Gamma-glutamyl Transferase | Day 4: AST | 17.7 International units per liter | Standard Deviation 5.12 |
| Dolutegravir 50 mg | Period 3: Absolute Values for Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST, Gamma-glutamyl Transferase | Day 7: Gamma-glutamyl transferase | 20.1 International units per liter | Standard Deviation 8.35 |
| Dolutegravir 50 mg | Period 3: Absolute Values for Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST, Gamma-glutamyl Transferase | Day 10: Gamma-glutamyl transferase | 20.8 International units per liter | Standard Deviation 9.13 |
| Dolutegravir 50 mg | Period 3: Absolute Values for Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST, Gamma-glutamyl Transferase | Day 7: AST | 16.3 International units per liter | Standard Deviation 4.78 |
| Dolutegravir 50 mg | Period 3: Absolute Values for Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST, Gamma-glutamyl Transferase | Day 10: AST | 17.1 International units per liter | Standard Deviation 4.55 |
| Dolutegravir 50 mg | Period 3: Absolute Values for Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST, Gamma-glutamyl Transferase | Day 4: Gamma-glutamyl transferase | 19.5 International units per liter | Standard Deviation 8.38 |
Secondary
Period 3: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Blood samples were collected to analyze the chemistry parameters: glucose, cholesterol, triglycerides, anion gap, calcium, carbon dioxide, chloride, phosphate, potassium, sodium and blood urea nitrogen.
Time frame: Days 4, 7 and 10
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dolutegravir 50 mg | Period 3: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Day 4: Glucose | 4.978 Millimoles per liter | Standard Deviation 0.4655 |
| Dolutegravir 50 mg | Period 3: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Day 7: Glucose | 5.018 Millimoles per liter | Standard Deviation 0.3977 |
| Dolutegravir 50 mg | Period 3: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Day 10: Glucose | 4.849 Millimoles per liter | Standard Deviation 0.3858 |
| Dolutegravir 50 mg | Period 3: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Day 4: Cholesterol | 4.283 Millimoles per liter | Standard Deviation 0.8001 |
| Dolutegravir 50 mg | Period 3: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Day 7: Cholesterol | 4.179 Millimoles per liter | Standard Deviation 0.7438 |
| Dolutegravir 50 mg | Period 3: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Day 10: Cholesterol | 4.157 Millimoles per liter | Standard Deviation 0.8037 |
| Dolutegravir 50 mg | Period 3: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Day 7: Triglycerides | 1.100 Millimoles per liter | Standard Deviation 0.5887 |
| Dolutegravir 50 mg | Period 3: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Day 10: Triglycerides | 1.289 Millimoles per liter | Standard Deviation 0.6625 |
| Dolutegravir 50 mg | Period 3: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Day 4: Anion gap | 7.3 Millimoles per liter | Standard Deviation 1.01 |
| Dolutegravir 50 mg | Period 3: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Day 7: Anion gap | 11.4 Millimoles per liter | Standard Deviation 1.75 |
| Dolutegravir 50 mg | Period 3: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Day 4: Chloride | 103.8 Millimoles per liter | Standard Deviation 2.77 |
| Dolutegravir 50 mg | Period 3: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Day 7: Chloride | 102.8 Millimoles per liter | Standard Deviation 2.07 |
| Dolutegravir 50 mg | Period 3: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Day 10: Chloride | 101.9 Millimoles per liter | Standard Deviation 2.02 |
| Dolutegravir 50 mg | Period 3: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Day 4: Phosphate | 1.276 Millimoles per liter | Standard Deviation 0.1304 |
| Dolutegravir 50 mg | Period 3: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Day 7: Phosphate | 1.268 Millimoles per liter | Standard Deviation 0.1802 |
| Dolutegravir 50 mg | Period 3: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Day 10: Phosphate | 1.229 Millimoles per liter | Standard Deviation 0.1213 |
| Dolutegravir 50 mg | Period 3: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Day 4: Potassium | 4.19 Millimoles per liter | Standard Deviation 0.15 |
| Dolutegravir 50 mg | Period 3: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Day 7: Potassium | 4.19 Millimoles per liter | Standard Deviation 0.217 |
| Dolutegravir 50 mg | Period 3: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Day 10: Potassium | 4.29 Millimoles per liter | Standard Deviation 0.275 |
| Dolutegravir 50 mg | Period 3: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Day 4: Sodium | 137.6 Millimoles per liter | Standard Deviation 2.06 |
| Dolutegravir 50 mg | Period 3: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Day 7: Sodium | 139.5 Millimoles per liter | Standard Deviation 2.56 |
| Dolutegravir 50 mg | Period 3: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Day 10: Sodium | 140.1 Millimoles per liter | Standard Deviation 2.11 |
| Dolutegravir 50 mg | Period 3: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Day 4: Blood urea nitrogen | 5.119 Millimoles per liter | Standard Deviation 0.8548 |
| Dolutegravir 50 mg | Period 3: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Day 7: Blood urea nitrogen | 4.887 Millimoles per liter | Standard Deviation 0.6388 |
| Dolutegravir 50 mg | Period 3: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Day 10: Blood urea nitrogen | 5.039 Millimoles per liter | Standard Deviation 0.8264 |
| Dolutegravir 50 mg | Period 3: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Day 4: Triglycerides | 1.228 Millimoles per liter | Standard Deviation 0.6403 |
| Dolutegravir 50 mg | Period 3: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Day 10: Anion gap | 12.1 Millimoles per liter | Standard Deviation 1.31 |
| Dolutegravir 50 mg | Period 3: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Day 4: Calcium | 2.404 Millimoles per liter | Standard Deviation 0.0855 |
| Dolutegravir 50 mg | Period 3: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Day 7: Calcium | 2.433 Millimoles per liter | Standard Deviation 0.0827 |
| Dolutegravir 50 mg | Period 3: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Day 10: Calcium | 2.441 Millimoles per liter | Standard Deviation 0.0681 |
| Dolutegravir 50 mg | Period 3: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Day 4: Carbon dioxide | 30.2 Millimoles per liter | Standard Deviation 1.56 |
| Dolutegravir 50 mg | Period 3: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Day 7: Carbon dioxide | 29.4 Millimoles per liter | Standard Deviation 1.15 |
| Dolutegravir 50 mg | Period 3: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Day 10: Carbon dioxide | 30.3 Millimoles per liter | Standard Deviation 1.53 |
Secondary
Period 3: Absolute Values for Chemistry Parameters: Urate, Creatinine, Bilirubin, Direct Bilirubin
Blood samples were collected to analyze the chemistry parameters: urate, creatinine, bilirubin and direct bilirubin.
Time frame: Days 4, 7 and 10
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dolutegravir 50 mg | Period 3: Absolute Values for Chemistry Parameters: Urate, Creatinine, Bilirubin, Direct Bilirubin | Day 10: Creatinine | 88.91 Micromoles per liter | Standard Deviation 12.545 |
| Dolutegravir 50 mg | Period 3: Absolute Values for Chemistry Parameters: Urate, Creatinine, Bilirubin, Direct Bilirubin | Day 4: Urate | 314.8 Micromoles per liter | Standard Deviation 65.44 |
| Dolutegravir 50 mg | Period 3: Absolute Values for Chemistry Parameters: Urate, Creatinine, Bilirubin, Direct Bilirubin | Day 7: Urate | 299.3 Micromoles per liter | Standard Deviation 62.85 |
| Dolutegravir 50 mg | Period 3: Absolute Values for Chemistry Parameters: Urate, Creatinine, Bilirubin, Direct Bilirubin | Day 10: Urate | 313.4 Micromoles per liter | Standard Deviation 60.33 |
| Dolutegravir 50 mg | Period 3: Absolute Values for Chemistry Parameters: Urate, Creatinine, Bilirubin, Direct Bilirubin | Day 4: Creatinine | 94.82 Micromoles per liter | Standard Deviation 13.65 |
| Dolutegravir 50 mg | Period 3: Absolute Values for Chemistry Parameters: Urate, Creatinine, Bilirubin, Direct Bilirubin | Day 7: Creatinine | 96.81 Micromoles per liter | Standard Deviation 12.861 |
| Dolutegravir 50 mg | Period 3: Absolute Values for Chemistry Parameters: Urate, Creatinine, Bilirubin, Direct Bilirubin | Day 4: Bilirubin | 11.64 Micromoles per liter | Standard Deviation 4.856 |
| Dolutegravir 50 mg | Period 3: Absolute Values for Chemistry Parameters: Urate, Creatinine, Bilirubin, Direct Bilirubin | Day 7: Bilirubin | 9.19 Micromoles per liter | Standard Deviation 2.511 |
| Dolutegravir 50 mg | Period 3: Absolute Values for Chemistry Parameters: Urate, Creatinine, Bilirubin, Direct Bilirubin | Day 10: Bilirubin | 10.83 Micromoles per liter | Standard Deviation 3.796 |
| Dolutegravir 50 mg | Period 3: Absolute Values for Chemistry Parameters: Urate, Creatinine, Bilirubin, Direct Bilirubin | Day 4: Direct bilirubin | 2.26 Micromoles per liter | Standard Deviation 0.995 |
| Dolutegravir 50 mg | Period 3: Absolute Values for Chemistry Parameters: Urate, Creatinine, Bilirubin, Direct Bilirubin | Day 7: Direct bilirubin | 1.74 Micromoles per liter | Standard Deviation 0.617 |
| Dolutegravir 50 mg | Period 3: Absolute Values for Chemistry Parameters: Urate, Creatinine, Bilirubin, Direct Bilirubin | Day 10: Direct bilirubin | 2.15 Micromoles per liter | Standard Deviation 0.784 |
Secondary
Period 3: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB
Twelve-lead ECG were obtained to measure PR Interval, QRS Duration, QT Interval, QTcF Interval and QTcB Interval. Twelve-lead ECGs were performed with the participant in a supine or semi-supine position after a rest of at least 10 minutes.
Time frame: Day 1: 2 hours, 4 hours; Days 4, 5 and 7: Pre-dose, 2 hours and 4 hours; Day 10
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dolutegravir 50 mg | Period 3: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB | PR Interval: Day 1, 2 hours | 167.9 Milliseconds | Standard Deviation 13.86 |
| Dolutegravir 50 mg | Period 3: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB | PR Interval: Day 1, 4 hours | 164.1 Milliseconds | Standard Deviation 15.12 |
| Dolutegravir 50 mg | Period 3: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB | PR Interval: Day 4, Pre-dose | 165.6 Milliseconds | Standard Deviation 16.02 |
| Dolutegravir 50 mg | Period 3: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB | PR Interval: Day 4, 2 hours | 166.9 Milliseconds | Standard Deviation 15.67 |
| Dolutegravir 50 mg | Period 3: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB | PR Interval: Day 4, 4 hours | 163.1 Milliseconds | Standard Deviation 15.13 |
| Dolutegravir 50 mg | Period 3: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB | PR Interval: Day 5, Pre-dose | 164.6 Milliseconds | Standard Deviation 18.3 |
| Dolutegravir 50 mg | Period 3: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB | PR Interval: Day 5, 2 hours | 162.8 Milliseconds | Standard Deviation 12.71 |
| Dolutegravir 50 mg | Period 3: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB | PR Interval: Day 5, 4 hours | 163.3 Milliseconds | Standard Deviation 14.96 |
| Dolutegravir 50 mg | Period 3: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB | PR Interval: Day 7, Pre-dose | 169.6 Milliseconds | Standard Deviation 17.47 |
| Dolutegravir 50 mg | Period 3: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB | PR Interval: Day 7, 2 hours | 165.0 Milliseconds | Standard Deviation 15.69 |
| Dolutegravir 50 mg | Period 3: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB | PR Interval: Day 7, 4 hours | 165.6 Milliseconds | Standard Deviation 15 |
| Dolutegravir 50 mg | Period 3: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB | PR Interval: Day 10 | 168.3 Milliseconds | Standard Deviation 17.14 |
| Dolutegravir 50 mg | Period 3: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB | QRS Duration: Day 1, 2 hours | 95.9 Milliseconds | Standard Deviation 10.49 |
| Dolutegravir 50 mg | Period 3: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB | QRS Duration: Day 1, 4 hours | 92.8 Milliseconds | Standard Deviation 8.76 |
| Dolutegravir 50 mg | Period 3: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB | QRS Duration: Day 4, Pre-dose | 96.8 Milliseconds | Standard Deviation 9.41 |
| Dolutegravir 50 mg | Period 3: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB | QRS Duration: Day 4, 2 hours | 93.5 Milliseconds | Standard Deviation 8.21 |
| Dolutegravir 50 mg | Period 3: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB | QRS Duration: Day 4, 4 hours | 95.3 Milliseconds | Standard Deviation 8.79 |
| Dolutegravir 50 mg | Period 3: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB | QRS Duration: Day 5, Pre-dose | 96.6 Milliseconds | Standard Deviation 9.77 |
| Dolutegravir 50 mg | Period 3: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB | QRS Duration: Day 5, 2 hours | 96.1 Milliseconds | Standard Deviation 11.66 |
| Dolutegravir 50 mg | Period 3: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB | QRS Duration: Day 5, 4 hours | 94.3 Milliseconds | Standard Deviation 9.56 |
| Dolutegravir 50 mg | Period 3: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB | QRS Duration: Day 7, Pre-dose | 95.4 Milliseconds | Standard Deviation 9.44 |
| Dolutegravir 50 mg | Period 3: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB | QRS Duration: Day 7, 2 hours | 95.1 Milliseconds | Standard Deviation 9.52 |
| Dolutegravir 50 mg | Period 3: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB | QRS Duration: Day 7, 4 hours | 94.4 Milliseconds | Standard Deviation 9.3 |
| Dolutegravir 50 mg | Period 3: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB | QRS Duration: Day 10 | 96.5 Milliseconds | Standard Deviation 9.14 |
| Dolutegravir 50 mg | Period 3: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB | QT Interval: Day 1, 2 hours | 380.0 Milliseconds | Standard Deviation 12.9 |
| Dolutegravir 50 mg | Period 3: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB | QT Interval: Day 1, 4 hours | 392.3 Milliseconds | Standard Deviation 16.39 |
| Dolutegravir 50 mg | Period 3: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB | QT Interval: Day 4, Pre-dose | 389.2 Milliseconds | Standard Deviation 18.65 |
| Dolutegravir 50 mg | Period 3: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB | QT Interval: Day 4, 2 hours | 376.6 Milliseconds | Standard Deviation 18.49 |
| Dolutegravir 50 mg | Period 3: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB | QT Interval: Day 4, 4 hours | 395.3 Milliseconds | Standard Deviation 17.89 |
| Dolutegravir 50 mg | Period 3: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB | QT Interval: Day 5, Pre-dose | 386.4 Milliseconds | Standard Deviation 18.49 |
| Dolutegravir 50 mg | Period 3: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB | QT Interval: Day 5, 2 hours | 380.9 Milliseconds | Standard Deviation 13.91 |
| Dolutegravir 50 mg | Period 3: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB | QT Interval: Day 5, 4 hours | 391.8 Milliseconds | Standard Deviation 20.53 |
| Dolutegravir 50 mg | Period 3: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB | QT Interval: Day 7, Pre-dose | 391.0 Milliseconds | Standard Deviation 21.99 |
| Dolutegravir 50 mg | Period 3: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB | QT Interval: Day 7, 2 hours | 382.3 Milliseconds | Standard Deviation 13.85 |
| Dolutegravir 50 mg | Period 3: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB | QT Interval: Day 7, 4 hours | 395.8 Milliseconds | Standard Deviation 20.94 |
| Dolutegravir 50 mg | Period 3: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB | QT Interval: Day 10 | 392.9 Milliseconds | Standard Deviation 14.54 |
| Dolutegravir 50 mg | Period 3: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB | QTcF Interval: Day 1, 2 hours | 392.7 Milliseconds | Standard Deviation 11.45 |
| Dolutegravir 50 mg | Period 3: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB | QTcF Interval: Day 4, 2 hours | 390.6 Milliseconds | Standard Deviation 12.33 |
| Dolutegravir 50 mg | Period 3: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB | QTcF Interval: Day 4, 4 hours | 401.2 Milliseconds | Standard Deviation 13.55 |
| Dolutegravir 50 mg | Period 3: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB | QTcF Interval: Day 5, Pre-dose | 399.2 Milliseconds | Standard Deviation 14.92 |
| Dolutegravir 50 mg | Period 3: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB | QTcF Interval: Day 5, 2 hours | 394.3 Milliseconds | Standard Deviation 12.83 |
| Dolutegravir 50 mg | Period 3: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB | QTcF Interval: Day 5, 4 hours | 401.7 Milliseconds | Standard Deviation 11.91 |
| Dolutegravir 50 mg | Period 3: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB | QTcF Interval: Day 7, Pre-dose | 395.1 Milliseconds | Standard Deviation 12.91 |
| Dolutegravir 50 mg | Period 3: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB | QTcF Interval: Day 7, 2 hours | 393.7 Milliseconds | Standard Deviation 12.69 |
| Dolutegravir 50 mg | Period 3: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB | QTcF Interval: Day 7, 4 hours | 396.8 Milliseconds | Standard Deviation 13.47 |
| Dolutegravir 50 mg | Period 3: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB | QTcF Interval: Day 10 | 394.8 Milliseconds | Standard Deviation 13.08 |
| Dolutegravir 50 mg | Period 3: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB | QTcB Interval: Day 1, 2 hours | 398.4 Milliseconds | Standard Deviation 15.81 |
| Dolutegravir 50 mg | Period 3: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB | QTcB Interval: Day 1, 4 hours | 402.0 Milliseconds | Standard Deviation 15.46 |
| Dolutegravir 50 mg | Period 3: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB | QTcB Interval: Day 4, Pre-dose | 398.4 Milliseconds | Standard Deviation 17.82 |
| Dolutegravir 50 mg | Period 3: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB | QTcB Interval: Day 4, 2 hours | 394.0 Milliseconds | Standard Deviation 21.41 |
| Dolutegravir 50 mg | Period 3: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB | QTcB Interval: Day 4, 4 hours | 403.1 Milliseconds | Standard Deviation 17.67 |
| Dolutegravir 50 mg | Period 3: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB | QTcB Interval: Day 5, Pre-dose | 405.1 Milliseconds | Standard Deviation 23 |
| Dolutegravir 50 mg | Period 3: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB | QTcB Interval: Day 5, 2 hours | 400.1 Milliseconds | Standard Deviation 18.05 |
| Dolutegravir 50 mg | Period 3: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB | QTcB Interval: Day 5, 4 hours | 405.9 Milliseconds | Standard Deviation 16.27 |
| Dolutegravir 50 mg | Period 3: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB | QTcB Interval: Day 7, Pre-dose | 396.6 Milliseconds | Standard Deviation 17.5 |
| Dolutegravir 50 mg | Period 3: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB | QTcB Interval: Day 7, 2 hours | 398.9 Milliseconds | Standard Deviation 21.21 |
| Dolutegravir 50 mg | Period 3: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB | QTcB Interval: Day 7, 4 hours | 396.0 Milliseconds | Standard Deviation 18.1 |
| Dolutegravir 50 mg | Period 3: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB | QTcB Interval: Day 10 | 394.8 Milliseconds | Standard Deviation 18.39 |
| Dolutegravir 50 mg | Period 3: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB | QTcF Interval: Day 1, 4 hours | 399.7 Milliseconds | Standard Deviation 10.37 |
| Dolutegravir 50 mg | Period 3: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB | QTcF Interval: Day 4, Pre-dose | 395.8 Milliseconds | Standard Deviation 13.94 |
Secondary
Period 3: Absolute Values for Hematology Parameter: Erythrocytes
Blood samples were collected to analyze the hematology parameter: erythrocytes.
Time frame: Days 4, 7 and 10
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dolutegravir 50 mg | Period 3: Absolute Values for Hematology Parameter: Erythrocytes | Day 4 | 5.194 Trillion cells per liter | Standard Deviation 0.3476 |
| Dolutegravir 50 mg | Period 3: Absolute Values for Hematology Parameter: Erythrocytes | Day 7 | 5.099 Trillion cells per liter | Standard Deviation 0.3798 |
| Dolutegravir 50 mg | Period 3: Absolute Values for Hematology Parameter: Erythrocytes | Day 10 | 5.124 Trillion cells per liter | Standard Deviation 0.3678 |
Secondary
Period 3: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin
Blood samples were collected to analyze the hematology parameter: erythrocytes mean corpuscular hemoglobin.
Time frame: Days 4, 7 and 10
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dolutegravir 50 mg | Period 3: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin | Day 4 | 28.96 Picograms | Standard Deviation 2.514 |
| Dolutegravir 50 mg | Period 3: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin | Day 7 | 28.96 Picograms | Standard Deviation 2.404 |
| Dolutegravir 50 mg | Period 3: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin | Day 10 | 28.93 Picograms | Standard Deviation 2.53 |
Secondary
Period 3: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Volume
Blood samples were collected to analyze the hematology parameter: erythrocytes mean corpuscular volume.
Time frame: Days 4, 7 and 10
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dolutegravir 50 mg | Period 3: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Volume | Day 4 | 85.76 Femtoliter | Standard Deviation 5.323 |
| Dolutegravir 50 mg | Period 3: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Volume | Day 7 | 85.72 Femtoliter | Standard Deviation 5.117 |
| Dolutegravir 50 mg | Period 3: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Volume | Day 10 | 85.41 Femtoliter | Standard Deviation 5.03 |
Secondary
Period 3: Absolute Values for Hematology Parameter: Hematocrit
Blood samples were collected to analyze the hematology parameter: hematocrit.
Time frame: Days 4, 7 and 10
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dolutegravir 50 mg | Period 3: Absolute Values for Hematology Parameter: Hematocrit | Day 10 | 0.4364 Proportion of red blood cells in blood | Standard Deviation 0.02267 |
| Dolutegravir 50 mg | Period 3: Absolute Values for Hematology Parameter: Hematocrit | Day 4 | 0.4441 Proportion of red blood cells in blood | Standard Deviation 0.01956 |
| Dolutegravir 50 mg | Period 3: Absolute Values for Hematology Parameter: Hematocrit | Day 7 | 0.4357 Proportion of red blood cells in blood | Standard Deviation 0.01924 |
Secondary
Period 3: Absolute Values for Hematology Parameter: Hemoglobin
Blood samples were collected to analyze the hematology parameter: hemoglobin.
Time frame: Days 4, 7 and 10
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dolutegravir 50 mg | Period 3: Absolute Values for Hematology Parameter: Hemoglobin | Day 4 | 149.8 Grams per liter | Standard Deviation 8.74 |
| Dolutegravir 50 mg | Period 3: Absolute Values for Hematology Parameter: Hemoglobin | Day 7 | 147.1 Grams per liter | Standard Deviation 8.23 |
| Dolutegravir 50 mg | Period 3: Absolute Values for Hematology Parameter: Hemoglobin | Day 10 | 147.7 Grams per liter | Standard Deviation 9.17 |
Secondary
Period 3: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count
Blood samples were collected to analyze the hematology parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelet count.
Time frame: Days 4, 7 and 10
Population: Safety Population. Only those participants with data available at the indicated time points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dolutegravir 50 mg | Period 3: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count | Day 4: Basophils, n=16 | 0.043 10^9 cells per liter | Standard Deviation 0.0165 |
| Dolutegravir 50 mg | Period 3: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count | Day 7: Basophils, n=16 | 0.046 10^9 cells per liter | Standard Deviation 0.0196 |
| Dolutegravir 50 mg | Period 3: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count | Day 10: Basophils, n=16 | 0.042 10^9 cells per liter | Standard Deviation 0.0142 |
| Dolutegravir 50 mg | Period 3: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count | Day 4: Eosinophils, n=16 | 0.206 10^9 cells per liter | Standard Deviation 0.112 |
| Dolutegravir 50 mg | Period 3: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count | Day 7: Eosinophils, n=16 | 0.211 10^9 cells per liter | Standard Deviation 0.1512 |
| Dolutegravir 50 mg | Period 3: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count | Day 10: Eosinophils, n=16 | 0.171 10^9 cells per liter | Standard Deviation 0.0874 |
| Dolutegravir 50 mg | Period 3: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count | Day 7: Lymphocytes, n=16 | 1.837 10^9 cells per liter | Standard Deviation 0.3916 |
| Dolutegravir 50 mg | Period 3: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count | Day 10: Lymphocytes, n=16 | 1.753 10^9 cells per liter | Standard Deviation 0.345 |
| Dolutegravir 50 mg | Period 3: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count | Day 4: Monocytes, n=16 | 0.537 10^9 cells per liter | Standard Deviation 0.1821 |
| Dolutegravir 50 mg | Period 3: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count | Day 7: Monocytes, n=16 | 0.490 10^9 cells per liter | Standard Deviation 0.1157 |
| Dolutegravir 50 mg | Period 3: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count | Day 10: Monocytes, n=16 | 0.470 10^9 cells per liter | Standard Deviation 0.1128 |
| Dolutegravir 50 mg | Period 3: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count | Day 4: Neutrophils, n=16 | 3.321 10^9 cells per liter | Standard Deviation 1.4579 |
| Dolutegravir 50 mg | Period 3: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count | Day 7: Neutrophils, n=16 | 2.954 10^9 cells per liter | Standard Deviation 0.56 |
| Dolutegravir 50 mg | Period 3: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count | Day 10: Neutrophils, n=16 | 3.082 10^9 cells per liter | Standard Deviation 0.6649 |
| Dolutegravir 50 mg | Period 3: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count | Day 4: Platelet count, n=16 | 259.3 10^9 cells per liter | Standard Deviation 46.03 |
| Dolutegravir 50 mg | Period 3: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count | Day 7: Platelet count, n=15 | 255.3 10^9 cells per liter | Standard Deviation 46.2 |
| Dolutegravir 50 mg | Period 3: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count | Day 10: Platelet count, n=16 | 258.3 10^9 cells per liter | Standard Deviation 42.92 |
| Dolutegravir 50 mg | Period 3: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count | Day 4: Lymphocytes, n=16 | 1.739 10^9 cells per liter | Standard Deviation 0.3701 |
Secondary
Period 3: Absolute Values for Pulse Rate
Pulse rate was measured in the semi-recumbent position with a completely automated device.
Time frame: Days 2, 3, 4, 5, 6, 7, 8, 9, 10 and 11
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dolutegravir 50 mg | Period 3: Absolute Values for Pulse Rate | Day 2 | 68.4 Beats per minute | Standard Deviation 9.79 |
| Dolutegravir 50 mg | Period 3: Absolute Values for Pulse Rate | Day 3 | 68.9 Beats per minute | Standard Deviation 8.63 |
| Dolutegravir 50 mg | Period 3: Absolute Values for Pulse Rate | Day 4 | 66.9 Beats per minute | Standard Deviation 9.26 |
| Dolutegravir 50 mg | Period 3: Absolute Values for Pulse Rate | Day 5 | 69.8 Beats per minute | Standard Deviation 10.57 |
| Dolutegravir 50 mg | Period 3: Absolute Values for Pulse Rate | Day 6 | 67.9 Beats per minute | Standard Deviation 10.12 |
| Dolutegravir 50 mg | Period 3: Absolute Values for Pulse Rate | Day 7 | 64.6 Beats per minute | Standard Deviation 8.02 |
| Dolutegravir 50 mg | Period 3: Absolute Values for Pulse Rate | Day 11 | 68.4 Beats per minute | Standard Deviation 12.27 |
| Dolutegravir 50 mg | Period 3: Absolute Values for Pulse Rate | Day 8 | 69.0 Beats per minute | Standard Deviation 12.02 |
| Dolutegravir 50 mg | Period 3: Absolute Values for Pulse Rate | Day 9 | 65.9 Beats per minute | Standard Deviation 10.12 |
| Dolutegravir 50 mg | Period 3: Absolute Values for Pulse Rate | Day 10 | 63.8 Beats per minute | Standard Deviation 8.53 |
Secondary
Period 3: Absolute Values for Respiratory Rate
Respiratory rate was measured in the semi-recumbent position after at least 5 minutes of rest for the participant in a quiet setting without distractions.
Time frame: Days 2, 3, 4, 5, 6, 7, 8, 9, 10 and 11
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dolutegravir 50 mg | Period 3: Absolute Values for Respiratory Rate | Day 3 | 14.1 Breaths per minute | Standard Deviation 1.54 |
| Dolutegravir 50 mg | Period 3: Absolute Values for Respiratory Rate | Day 4 | 13.9 Breaths per minute | Standard Deviation 2.96 |
| Dolutegravir 50 mg | Period 3: Absolute Values for Respiratory Rate | Day 5 | 13.1 Breaths per minute | Standard Deviation 1.45 |
| Dolutegravir 50 mg | Period 3: Absolute Values for Respiratory Rate | Day 6 | 14.3 Breaths per minute | Standard Deviation 2.05 |
| Dolutegravir 50 mg | Period 3: Absolute Values for Respiratory Rate | Day 7 | 13.9 Breaths per minute | Standard Deviation 1.86 |
| Dolutegravir 50 mg | Period 3: Absolute Values for Respiratory Rate | Day 8 | 15.0 Breaths per minute | Standard Deviation 1.03 |
| Dolutegravir 50 mg | Period 3: Absolute Values for Respiratory Rate | Day 11 | 16.4 Breaths per minute | Standard Deviation 1.31 |
| Dolutegravir 50 mg | Period 3: Absolute Values for Respiratory Rate | Day 2 | 15.0 Breaths per minute | Standard Deviation 2.42 |
| Dolutegravir 50 mg | Period 3: Absolute Values for Respiratory Rate | Day 9 | 13.3 Breaths per minute | Standard Deviation 3 |
| Dolutegravir 50 mg | Period 3: Absolute Values for Respiratory Rate | Day 10 | 15.0 Breaths per minute | Standard Deviation 1.79 |
Secondary
Period 3: Absolute Values for SBP and DBP
SBP and DBP were measured in the semi-recumbent position with a completely automated device.
Time frame: Days 2, 3, 4, 5, 6, 7, 8, 9, 10 and 11
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dolutegravir 50 mg | Period 3: Absolute Values for SBP and DBP | SBP: Day 2 | 115.8 Millimeters of mercury | Standard Deviation 8.12 |
| Dolutegravir 50 mg | Period 3: Absolute Values for SBP and DBP | SBP: Day 3 | 112.5 Millimeters of mercury | Standard Deviation 5.81 |
| Dolutegravir 50 mg | Period 3: Absolute Values for SBP and DBP | SBP: Day 4 | 112.6 Millimeters of mercury | Standard Deviation 6.11 |
| Dolutegravir 50 mg | Period 3: Absolute Values for SBP and DBP | SBP: Day 5 | 119.4 Millimeters of mercury | Standard Deviation 19.7 |
| Dolutegravir 50 mg | Period 3: Absolute Values for SBP and DBP | SBP: Day 6 | 114.4 Millimeters of mercury | Standard Deviation 7.45 |
| Dolutegravir 50 mg | Period 3: Absolute Values for SBP and DBP | SBP: Day 7 | 113.8 Millimeters of mercury | Standard Deviation 8.13 |
| Dolutegravir 50 mg | Period 3: Absolute Values for SBP and DBP | SBP: Day 8 | 113.9 Millimeters of mercury | Standard Deviation 6.72 |
| Dolutegravir 50 mg | Period 3: Absolute Values for SBP and DBP | SBP: Day 9 | 113.6 Millimeters of mercury | Standard Deviation 7.67 |
| Dolutegravir 50 mg | Period 3: Absolute Values for SBP and DBP | SBP: Day 10 | 111.6 Millimeters of mercury | Standard Deviation 6.38 |
| Dolutegravir 50 mg | Period 3: Absolute Values for SBP and DBP | SBP: Day 11 | 112.4 Millimeters of mercury | Standard Deviation 7.69 |
| Dolutegravir 50 mg | Period 3: Absolute Values for SBP and DBP | DBP: Day 2 | 69.0 Millimeters of mercury | Standard Deviation 6.46 |
| Dolutegravir 50 mg | Period 3: Absolute Values for SBP and DBP | DBP: Day 3 | 67.7 Millimeters of mercury | Standard Deviation 6.52 |
| Dolutegravir 50 mg | Period 3: Absolute Values for SBP and DBP | DBP: Day 4 | 68.9 Millimeters of mercury | Standard Deviation 6.33 |
| Dolutegravir 50 mg | Period 3: Absolute Values for SBP and DBP | DBP: Day 5 | 74.4 Millimeters of mercury | Standard Deviation 21.9 |
| Dolutegravir 50 mg | Period 3: Absolute Values for SBP and DBP | DBP: Day 6 | 69.2 Millimeters of mercury | Standard Deviation 8.27 |
| Dolutegravir 50 mg | Period 3: Absolute Values for SBP and DBP | DBP: Day 7 | 70.6 Millimeters of mercury | Standard Deviation 5.78 |
| Dolutegravir 50 mg | Period 3: Absolute Values for SBP and DBP | DBP: Day 8 | 69.5 Millimeters of mercury | Standard Deviation 9.34 |
| Dolutegravir 50 mg | Period 3: Absolute Values for SBP and DBP | DBP: Day 9 | 69.8 Millimeters of mercury | Standard Deviation 5.98 |
| Dolutegravir 50 mg | Period 3: Absolute Values for SBP and DBP | DBP: Day 10 | 70.0 Millimeters of mercury | Standard Deviation 5.14 |
| Dolutegravir 50 mg | Period 3: Absolute Values for SBP and DBP | DBP: Day 11 | 67.7 Millimeters of mercury | Standard Deviation 4.32 |
Secondary
Period 3: Absolute Values for Urinalysis Parameter: 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. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0).
Time frame: Days 4, 7 and 10
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dolutegravir 50 mg | Period 3: Absolute Values for Urinalysis Parameter: pH | Day 4 | 6.03 pH | Standard Deviation 0.591 |
| Dolutegravir 50 mg | Period 3: Absolute Values for Urinalysis Parameter: pH | Day 7 | 5.88 pH | Standard Deviation 0.387 |
| Dolutegravir 50 mg | Period 3: Absolute Values for Urinalysis Parameter: pH | Day 10 | 6.16 pH | Standard Deviation 0.473 |
Secondary
Period 3: 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.
Time frame: Days 4, 7 and 10
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dolutegravir 50 mg | Period 3: Absolute Values for Urinalysis Parameter: Specific Gravity | Day 4 | 1.0179 Ratio | Standard Deviation 0.00712 |
| Dolutegravir 50 mg | Period 3: Absolute Values for Urinalysis Parameter: Specific Gravity | Day 7 | 1.0169 Ratio | Standard Deviation 0.0064 |
| Dolutegravir 50 mg | Period 3: Absolute Values for Urinalysis Parameter: Specific Gravity | Day 10 | 1.0160 Ratio | Standard Deviation 0.00747 |
Secondary
Period 3: Absolute Values for Urinalysis Parameter: Urobilinogen
Urine samples were collected to analyze the urinalysis parameter: urobilinogen.
Time frame: Days 4, 7 and 10
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dolutegravir 50 mg | Period 3: Absolute Values for Urinalysis Parameter: Urobilinogen | Day 4 | 3.3860 Micromoles per liter | Standard Deviation 0 |
| Dolutegravir 50 mg | Period 3: Absolute Values for Urinalysis Parameter: Urobilinogen | Day 7 | 3.3860 Micromoles per liter | Standard Deviation 0 |
| Dolutegravir 50 mg | Period 3: Absolute Values for Urinalysis Parameter: Urobilinogen | Day 10 | 3.3860 Micromoles per liter | Standard Deviation 0 |
Secondary
Period 3: Change From Baseline in Body Temperature
Body temperature was measured in the semi-recumbent position 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, in Period 3. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.
Time frame: Baseline (Day 1, Pre-dose), Days 2, 3, 4, 5, 6, 7, 8, 9, 10 and 11
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dolutegravir 50 mg | Period 3: Change From Baseline in Body Temperature | Day 2 | -0.08 Degrees Celsius | Standard Deviation 0.286 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in Body Temperature | Day 3 | -0.18 Degrees Celsius | Standard Deviation 0.423 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in Body Temperature | Day 6 | -0.03 Degrees Celsius | Standard Deviation 0.318 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in Body Temperature | Day 7 | 0.06 Degrees Celsius | Standard Deviation 0.287 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in Body Temperature | Day 8 | -0.13 Degrees Celsius | Standard Deviation 0.458 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in Body Temperature | Day 9 | -0.10 Degrees Celsius | Standard Deviation 0.329 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in Body Temperature | Day 10 | -0.03 Degrees Celsius | Standard Deviation 0.291 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in Body Temperature | Day 11 | 0.13 Degrees Celsius | Standard Deviation 0.302 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in Body Temperature | Day 4 | 0.02 Degrees Celsius | Standard Deviation 0.229 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in Body Temperature | Day 5 | 0.00 Degrees Celsius | Standard Deviation 0.175 |
Secondary
Period 3: Change From Baseline in Chemistry Parameters: Albumin, Globulin, 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 visits, before the first treatment in Period 3. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.
Time frame: Baseline (Period 2 Day 7) and at Days 4, 7 and 10
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dolutegravir 50 mg | Period 3: Change From Baseline in Chemistry Parameters: Albumin, Globulin, Protein | Day 4: Albumin | 0.9 Grams per liter | Standard Deviation 1 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in Chemistry Parameters: Albumin, Globulin, Protein | Day 7: Albumin | 0.2 Grams per liter | Standard Deviation 1.22 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in Chemistry Parameters: Albumin, Globulin, Protein | Day 10: Albumin | 0.4 Grams per liter | Standard Deviation 2.06 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in Chemistry Parameters: Albumin, Globulin, Protein | Day 10: Globulin | 0.5 Grams per liter | Standard Deviation 1.32 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in Chemistry Parameters: Albumin, Globulin, Protein | Day 4: Protein | 0.0 Grams per liter | Standard Deviation 1.75 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in Chemistry Parameters: Albumin, Globulin, Protein | Day 7: Protein | 1.2 Grams per liter | Standard Deviation 1.8 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in Chemistry Parameters: Albumin, Globulin, Protein | Day 10: Protein | 0.9 Grams per liter | Standard Deviation 2.9 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in Chemistry Parameters: Albumin, Globulin, Protein | Day 4: Globulin | -0.9 Grams per liter | Standard Deviation 1.29 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in Chemistry Parameters: Albumin, Globulin, Protein | Day 7: Globulin | 1.0 Grams per liter | Standard Deviation 1.1 |
Secondary
Period 3: Change From Baseline in Chemistry Parameters: Amylase, Lipase
Blood samples were collected to analyze the chemistry parameters: amylase and lipase. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first treatment in Period 3. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.
Time frame: Baseline (Period 2 Day 7) and at Days 4, 7 and 10
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dolutegravir 50 mg | Period 3: Change From Baseline in Chemistry Parameters: Amylase, Lipase | Day 10: Amylase | -0.9 Units per liter | Standard Deviation 6.08 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in Chemistry Parameters: Amylase, Lipase | Day 4: Lipase | 4.7 Units per liter | Standard Deviation 6.1 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in Chemistry Parameters: Amylase, Lipase | Day 7: Lipase | -0.8 Units per liter | Standard Deviation 4.76 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in Chemistry Parameters: Amylase, Lipase | Day 10: Lipase | 0.1 Units per liter | Standard Deviation 5.24 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in Chemistry Parameters: Amylase, Lipase | Day 4: Amylase | -1.6 Units per liter | Standard Deviation 3.18 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in Chemistry Parameters: Amylase, Lipase | Day 7: Amylase | 0.1 Units per liter | Standard Deviation 4.25 |
Secondary
Period 3: Change From Baseline in Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST, Gamma-glutamyl Transferase
Blood samples were collected to analyze the chemistry parameters: creatine kinase, lactate dehydrogenase, ALT, ALP, AST and gamma-glutamyl transferase. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first treatment in Period 3. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.
Time frame: Baseline (Period 2 Day 7) and at Days 4, 7 and 10
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dolutegravir 50 mg | Period 3: Change From Baseline in Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST, Gamma-glutamyl Transferase | Day 7: Creatine kinase | -37.1 International units per liter | Standard Deviation 158.35 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST, Gamma-glutamyl Transferase | Day 10: Creatine kinase | -42.1 International units per liter | Standard Deviation 162.94 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST, Gamma-glutamyl Transferase | Day 4: Lactate dehydrogenase | 5.9 International units per liter | Standard Deviation 7.38 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST, Gamma-glutamyl Transferase | Day 10: Lactate dehydrogenase | 0.1 International units per liter | Standard Deviation 10.32 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST, Gamma-glutamyl Transferase | Day 4: ALT | 1.1 International units per liter | Standard Deviation 4.36 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST, Gamma-glutamyl Transferase | Day 7: ALT | 0.7 International units per liter | Standard Deviation 4.69 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST, Gamma-glutamyl Transferase | Day 4: ALP | -1.6 International units per liter | Standard Deviation 2 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST, Gamma-glutamyl Transferase | Day 10: ALP | 0.8 International units per liter | Standard Deviation 4.06 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST, Gamma-glutamyl Transferase | Day 4: AST | 0.9 International units per liter | Standard Deviation 2.45 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST, Gamma-glutamyl Transferase | Day 7: AST | -0.5 International units per liter | Standard Deviation 2.68 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST, Gamma-glutamyl Transferase | Day 4: Gamma-glutamyl transferase | -0.8 International units per liter | Standard Deviation 0.75 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST, Gamma-glutamyl Transferase | Day 7: Gamma-glutamyl transferase | -0.3 International units per liter | Standard Deviation 1.06 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST, Gamma-glutamyl Transferase | Day 10: Gamma-glutamyl transferase | 0.5 International units per liter | Standard Deviation 1.51 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST, Gamma-glutamyl Transferase | Day 4: Creatine kinase | -32.1 International units per liter | Standard Deviation 131.3 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST, Gamma-glutamyl Transferase | Day 7: Lactate dehydrogenase | -0.9 International units per liter | Standard Deviation 7.02 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST, Gamma-glutamyl Transferase | Day 10: ALT | 1.9 International units per liter | Standard Deviation 4.11 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST, Gamma-glutamyl Transferase | Day 7: ALP | -0.6 International units per liter | Standard Deviation 2.39 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST, Gamma-glutamyl Transferase | Day 10: AST | 0.3 International units per liter | Standard Deviation 2.29 |
Secondary
Period 3: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Blood samples were collected to analyze the chemistry parameters: glucose, cholesterol, triglycerides, anion gap, calcium, carbon dioxide, chloride, phosphate, potassium, sodium and blood urea nitrogen. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first treatment in Period 3. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.
Time frame: Baseline (Period 2 Day 7) and at Days 4, 7 and 10
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dolutegravir 50 mg | Period 3: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Day 4: Glucose | 0.062 Millimoles per liter | Standard Deviation 0.1638 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Day 7: Glucose | 0.103 Millimoles per liter | Standard Deviation 0.1806 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Day 10: Glucose | -0.066 Millimoles per liter | Standard Deviation 0.2205 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Day 4: Cholesterol | 0.096 Millimoles per liter | Standard Deviation 0.24 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Day 7: Cholesterol | -0.008 Millimoles per liter | Standard Deviation 0.2693 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Day 10: Cholesterol | -0.030 Millimoles per liter | Standard Deviation 0.2366 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Day 4: Triglycerides | 0.034 Millimoles per liter | Standard Deviation 0.2316 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Day 7: Triglycerides | -0.094 Millimoles per liter | Standard Deviation 0.2578 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Day 10: Triglycerides | 0.095 Millimoles per liter | Standard Deviation 0.2178 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Day 7: Anion gap | 0.1 Millimoles per liter | Standard Deviation 1.69 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Day 10: Anion gap | 0.8 Millimoles per liter | Standard Deviation 1.65 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Day 4: Calcium | -0.003 Millimoles per liter | Standard Deviation 0.0416 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Day 10: Carbon dioxide | 1.0 Millimoles per liter | Standard Deviation 2.16 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Day 4: Chloride | 0.7 Millimoles per liter | Standard Deviation 1.92 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Day 7: Chloride | -0.3 Millimoles per liter | Standard Deviation 1.39 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Day 10: Chloride | -1.1 Millimoles per liter | Standard Deviation 1.86 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Day 4: Phosphate | -0.004 Millimoles per liter | Standard Deviation 0.0808 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Day 7: Phosphate | -0.013 Millimoles per liter | Standard Deviation 0.1151 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Day 10: Phosphate | -0.051 Millimoles per liter | Standard Deviation 0.1115 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Day 4: Potassium | -0.04 Millimoles per liter | Standard Deviation 0.239 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Day 7: Potassium | -0.03 Millimoles per liter | Standard Deviation 0.218 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Day 10: Potassium | 0.06 Millimoles per liter | Standard Deviation 0.189 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Day 4: Sodium | -2.0 Millimoles per liter | Standard Deviation 1.37 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Day 7: Sodium | -0.1 Millimoles per liter | Standard Deviation 1.65 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Day 10: Sodium | 0.5 Millimoles per liter | Standard Deviation 1.9 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Day 4: Blood urea nitrogen | 0.054 Millimoles per liter | Standard Deviation 0.5287 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Day 7: Blood urea nitrogen | -0.178 Millimoles per liter | Standard Deviation 0.3542 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Day 10: Blood urea nitrogen | -0.026 Millimoles per liter | Standard Deviation 0.5156 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Day 4: Anion gap | -4.1 Millimoles per liter | Standard Deviation 1.24 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Day 7: Calcium | 0.026 Millimoles per liter | Standard Deviation 0.0413 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Day 10: Calcium: | 0.035 Millimoles per liter | Standard Deviation 0.0561 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Day 4: Carbon dioxide | 0.9 Millimoles per liter | Standard Deviation 1.65 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Day 7: Carbon dioxide | 0.1 Millimoles per liter | Standard Deviation 1.59 |
Secondary
Period 3: Change From Baseline in Chemistry Parameters: Urate, Creatinine, Bilirubin, Direct Bilirubin
Blood samples were collected to analyze the chemistry parameters: urate, creatinine, bilirubin and direct bilirubin. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first treatment in Period 3. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.
Time frame: Baseline (Period 2 Day 7) and at Days 4, 7 and 10
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dolutegravir 50 mg | Period 3: Change From Baseline in Chemistry Parameters: Urate, Creatinine, Bilirubin, Direct Bilirubin | Day 4: Urate | 0.0 Micromoles per liter | Standard Deviation 16.23 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in Chemistry Parameters: Urate, Creatinine, Bilirubin, Direct Bilirubin | Day 7: Urate | -15.6 Micromoles per liter | Standard Deviation 26.39 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in Chemistry Parameters: Urate, Creatinine, Bilirubin, Direct Bilirubin | Day 10: Urate | -1.4 Micromoles per liter | Standard Deviation 24.69 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in Chemistry Parameters: Urate, Creatinine, Bilirubin, Direct Bilirubin | Day 7: Bilirubin | -0.21 Micromoles per liter | Standard Deviation 1.455 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in Chemistry Parameters: Urate, Creatinine, Bilirubin, Direct Bilirubin | Day 4: Direct bilirubin | 0.33 Micromoles per liter | Standard Deviation 0.425 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in Chemistry Parameters: Urate, Creatinine, Bilirubin, Direct Bilirubin | Day 7: Direct bilirubin | -0.19 Micromoles per liter | Standard Deviation 0.436 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in Chemistry Parameters: Urate, Creatinine, Bilirubin, Direct Bilirubin | Day 10: Direct bilirubin | 0.22 Micromoles per liter | Standard Deviation 0.248 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in Chemistry Parameters: Urate, Creatinine, Bilirubin, Direct Bilirubin | Day 4: Creatinine | 7.90 Micromoles per liter | Standard Deviation 4.239 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in Chemistry Parameters: Urate, Creatinine, Bilirubin, Direct Bilirubin | Day 7: Creatinine | 9.89 Micromoles per liter | Standard Deviation 4.014 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in Chemistry Parameters: Urate, Creatinine, Bilirubin, Direct Bilirubin | Day 10: Creatinine | 1.99 Micromoles per liter | Standard Deviation 4.739 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in Chemistry Parameters: Urate, Creatinine, Bilirubin, Direct Bilirubin | Day 4: Bilirubin | 2.24 Micromoles per liter | Standard Deviation 2.659 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in Chemistry Parameters: Urate, Creatinine, Bilirubin, Direct Bilirubin | Day 10: Bilirubin | 1.43 Micromoles per liter | Standard Deviation 2.011 |
Secondary
Period 3: 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 visits, before the first treatment in Period 3. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.
Time frame: Baseline (Period 2 Day 7) and at Days 4, 7 and 10
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dolutegravir 50 mg | Period 3: Change From Baseline in Hematology Parameter: Erythrocytes | Day 4 | 0.016 Trillion cells per liter | Standard Deviation 0.0943 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in Hematology Parameter: Erythrocytes | Day 7 | -0.079 Trillion cells per liter | Standard Deviation 0.1038 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in Hematology Parameter: Erythrocytes | Day 10 | -0.054 Trillion cells per liter | Standard Deviation 0.154 |
Secondary
Period 3: 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 visits, before the first treatment in Period 3. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.
Time frame: Baseline (Period 2 Day 7) and at Days 4, 7 and 10
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dolutegravir 50 mg | Period 3: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin | Day 4 | 0.55 Picograms | Standard Deviation 0.225 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin | Day 7 | 0.55 Picograms | Standard Deviation 0.329 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin | Day 10 | 0.52 Picograms | Standard Deviation 0.315 |
Secondary
Period 3: 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 visits, before the first treatment in Period 3. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.
Time frame: Baseline (Period 2 Day 7) and at Days 4, 7 and 10
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dolutegravir 50 mg | Period 3: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume | Day 7 | 0.36 Femtoliter | Standard Deviation 0.762 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume | Day 10 | 0.05 Femtoliter | Standard Deviation 0.954 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume | Day 4 | 0.40 Femtoliter | Standard Deviation 0.542 |
Secondary
Period 3: Change From Baseline in Hematology Parameter: 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 visits, before the first treatment in Period 3. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.
Time frame: Baseline (Period 2 Day 7) and at Days 4, 7 and 10
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dolutegravir 50 mg | Period 3: Change From Baseline in Hematology Parameter: Hematocrit | Day 4 | 0.0035 Proportion of red blood cells in blood | Standard Deviation 0.00794 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in Hematology Parameter: Hematocrit | Day 7 | -0.0049 Proportion of red blood cells in blood | Standard Deviation 0.01101 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in Hematology Parameter: Hematocrit | Day 10 | -0.0041 Proportion of red blood cells in blood | Standard Deviation 0.01402 |
Secondary
Period 3: 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 visits, before the first treatment in Period 3. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.
Time frame: Baseline (Period 2 Day 7) and at Days 4, 7 and 10
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dolutegravir 50 mg | Period 3: Change From Baseline in Hematology Parameter: Hemoglobin | Day 10 | 1.2 Grams per liter | Standard Deviation 3.69 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in Hematology Parameter: Hemoglobin | Day 4 | 3.3 Grams per liter | Standard Deviation 3 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in Hematology Parameter: Hemoglobin | Day 7 | 0.6 Grams per liter | Standard Deviation 3.5 |
Secondary
Period 3: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count
Blood samples were collected to analyze the hematology parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelet count. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first treatment in Period 3. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.
Time frame: Baseline (Period 2 Day 7) and at Days 4, 7 and 10
Population: Safety Population. Only those participants with data available at the indicated time points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dolutegravir 50 mg | Period 3: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count | Day 7: Basophils, n=16 | 0.007 10^9 cells per liter | Standard Deviation 0.0135 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count | Day 10: Basophils, n=16 | 0.003 10^9 cells per liter | Standard Deviation 0.0144 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count | Day 4: Eosinophils, n=16 | -0.001 10^9 cells per liter | Standard Deviation 0.0448 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count | Day 7: Eosinophils, n=16 | 0.004 10^9 cells per liter | Standard Deviation 0.0846 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count | Day 10: Lymphocytes, n=16 | -0.117 10^9 cells per liter | Standard Deviation 0.2628 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count | Day 4: Monocytes, n=16 | 0.049 10^9 cells per liter | Standard Deviation 0.1627 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count | Day 7: Monocytes, n=16 | 0.003 10^9 cells per liter | Standard Deviation 0.085 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count | Day 10: Monocytes, n=16 | -0.018 10^9 cells per liter | Standard Deviation 0.0693 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count | Day 4: Neutrophils, n=16 | 0.443 10^9 cells per liter | Standard Deviation 1.5098 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count | Day 7: Neutrophils, n=16 | 0.076 10^9 cells per liter | Standard Deviation 0.5969 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count | Day 4: Basophils, n=16 | 0.003 10^9 cells per liter | Standard Deviation 0.0101 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count | Day 10: Eosinophils, n=16 | -0.036 10^9 cells per liter | Standard Deviation 0.0468 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count | Day 4: Lymphocytes, n=16 | -0.130 10^9 cells per liter | Standard Deviation 0.2931 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count | Day 7: Lymphocytes, n=16 | -0.033 10^9 cells per liter | Standard Deviation 0.326 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count | Day 10: Neutrophils, n=16 | 0.204 10^9 cells per liter | Standard Deviation 0.5116 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count | Day 4: Platelet count, n=16 | -4.9 10^9 cells per liter | Standard Deviation 11.08 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count | Day 7: Platelet count, n=15 | -11.5 10^9 cells per liter | Standard Deviation 12.03 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count | Day 10: Platelet count, n=16 | -5.9 10^9 cells per liter | Standard Deviation 16.5 |
Secondary
Period 3: Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB
Twelve-lead ECG were obtained to measure PR Interval, QRS Duration, QT Interval, QTcF Interval and QTcB Interval. Twelve-lead ECGs were performed with the participant in a supine or semi-supine position after a rest of at least 10 minutes. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, in Period 3. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.
Time frame: Baseline; Day 1: 2 hours, 4 hours; Days 4, 5 and 7: Pre-dose, 2 hours and 4 hours; Day 10
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dolutegravir 50 mg | Period 3: Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB | PR Interval: Day 1, 2 hours | 1.9 Milliseconds | Standard Deviation 7.47 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB | PR Interval: Day 4, 2 hours | 0.9 Milliseconds | Standard Deviation 8.48 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB | PR Interval: Day 4, 4 hours | -2.9 Milliseconds | Standard Deviation 9.53 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB | PR Interval: Day 5, 2 hours | -3.2 Milliseconds | Standard Deviation 9.13 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB | PR Interval: Day 5, 4 hours | -2.7 Milliseconds | Standard Deviation 7.77 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB | PR Interval: Day 7, Pre-dose | 3.6 Milliseconds | Standard Deviation 7.61 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB | PR Interval: Day 7, 2 hours | -1.0 Milliseconds | Standard Deviation 9.47 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB | PR Interval: Day 7, 4 hours | -0.4 Milliseconds | Standard Deviation 7.61 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB | PR Interval: Day 10 | 2.3 Milliseconds | Standard Deviation 8.6 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB | QRS Duration: Day 1, 2 hours | 1.1 Milliseconds | Standard Deviation 5.47 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB | QRS Duration: Day 4, 4 hours | 0.5 Milliseconds | Standard Deviation 6.63 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB | QRS Duration: Day 5, Pre-dose | 1.8 Milliseconds | Standard Deviation 6.18 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB | QRS Duration: Day 5, 4 hours | -0.5 Milliseconds | Standard Deviation 3.31 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB | QRS Duration: Day 7, Pre-dose | 0.6 Milliseconds | Standard Deviation 3.58 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB | QRS Duration: Day 7, 2 hours | 0.3 Milliseconds | Standard Deviation 4.93 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB | QRS Duration: Day 7, 4 hours | -0.4 Milliseconds | Standard Deviation 3.72 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB | QT Interval: Day 1, 2 hours | -7.8 Milliseconds | Standard Deviation 8.68 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB | QT Interval: Day 1, 4 hours | 4.4 Milliseconds | Standard Deviation 13.15 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB | QT Interval: Day 4, Pre-dose | 1.4 Milliseconds | Standard Deviation 14.28 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB | QT Interval: Day 4, 2 hours | -11.2 Milliseconds | Standard Deviation 14.53 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB | QT Interval: Day 4, 4 hours | 7.4 Milliseconds | Standard Deviation 13.68 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB | QT Interval: Day 5, Pre-dose | -1.4 Milliseconds | Standard Deviation 13.57 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB | QT Interval: Day 5, 4 hours | 3.9 Milliseconds | Standard Deviation 14.59 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB | QT Interval: Day 7, Pre-dose | 3.2 Milliseconds | Standard Deviation 17.34 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB | QT Interval: Day 7, 2 hours | -5.6 Milliseconds | Standard Deviation 14.01 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB | QTcF Interval: Day 1, 2 hours | -0.4 Milliseconds | Standard Deviation 5.63 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB | QTcF Interval: Day 1, 4 hours | 6.6 Milliseconds | Standard Deviation 4.97 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB | QTcF Interval: Day 4, Pre-dose | 2.7 Milliseconds | Standard Deviation 8.21 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB | QTcF Interval: Day 4, 2 hours | -2.5 Milliseconds | Standard Deviation 8.41 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB | QTcF Interval: Day 4, 4 hours | 8.1 Milliseconds | Standard Deviation 9.1 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB | QTcF Interval: Day 5, Pre-dose | 6.1 Milliseconds | Standard Deviation 8.14 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB | QTcF Interval: Day 5, 2 hours | 1.1 Milliseconds | Standard Deviation 9.42 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB | QTcF Interval: Day 5, 4 hours | 8.6 Milliseconds | Standard Deviation 6.26 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB | QTcF Interval: Day 7, Pre-dose | 2.0 Milliseconds | Standard Deviation 9.21 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB | QTcF Interval: Day 7, 2 hours | 0.6 Milliseconds | Standard Deviation 7.46 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB | QTcB Interval: Day 1, 2 hours | 3.8 Milliseconds | Standard Deviation 9.5 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB | QTcB Interval: Day 1, 4 hours | 7.4 Milliseconds | Standard Deviation 10.78 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB | QTcB Interval: Day 4, 4 hours | 8.6 Milliseconds | Standard Deviation 12.83 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB | QTcB Interval: Day 5, Pre-dose | 10.6 Milliseconds | Standard Deviation 13.25 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB | QTcB Interval: Day 5, 2 hours | 5.5 Milliseconds | Standard Deviation 12.47 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB | QTcB Interval: Day 5, 4 hours | 11.3 Milliseconds | Standard Deviation 9.5 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB | QTcB Interval: Day 7, Pre-dose | 2.1 Milliseconds | Standard Deviation 14.09 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB | QTcB Interval: Day 7, 4 hours | 1.4 Milliseconds | Standard Deviation 10.35 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB | QTcB Interval: Day 10 | 0.2 Milliseconds | Standard Deviation 10.89 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB | PR Interval: Day 1, 4 hours | -1.9 Milliseconds | Standard Deviation 8.19 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB | PR Interval: Day 4, Pre-dose | -0.4 Milliseconds | Standard Deviation 6.97 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB | PR Interval: Day 5, Pre-dose | -1.4 Milliseconds | Standard Deviation 10.59 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB | QRS Duration: Day 1, 4 hours | -2.1 Milliseconds | Standard Deviation 3.8 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB | QRS Duration: Day 4, Pre-dose | 2.0 Milliseconds | Standard Deviation 5.61 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB | QRS Duration: Day 4, 2 hours | -1.3 Milliseconds | Standard Deviation 3.09 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB | QRS Duration: Day 5, 2 hours | 1.3 Milliseconds | Standard Deviation 5.11 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB | QRS Duration: Day 10 | 1.7 Milliseconds | Standard Deviation 5.45 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB | QT Interval: Day 5, 2 hours | -6.9 Milliseconds | Standard Deviation 10.65 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB | QT Interval: Day 7, 4 hours | 8.0 Milliseconds | Standard Deviation 15.38 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB | QT Interval: Day 10 | 5.1 Milliseconds | Standard Deviation 10.39 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB | QTcF Interval: Day 7, 4 hours | 3.6 Milliseconds | Standard Deviation 7.28 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB | QTcF Interval: Day 10 | 1.6 Milliseconds | Standard Deviation 7.36 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB | QTcB Interval: Day 4, Pre-dose | 3.8 Milliseconds | Standard Deviation 13.72 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB | QTcB Interval: Day 4, 2 hours | -0.6 Milliseconds | Standard Deviation 17.78 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB | QTcB Interval: Day 7, 2 hours | 4.4 Milliseconds | Standard Deviation 14.43 |
Secondary
Period 3: Change From Baseline in Pulse Rate
Pulse rate was measured in the semi-recumbent position with a completely automated device. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, in Period 3. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.
Time frame: Baseline (Day 1, Pre-dose), Days 2, 3, 4, 5, 6, 7, 8, 9, 10 and 11
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dolutegravir 50 mg | Period 3: Change From Baseline in Pulse Rate | Day 2 | 1.8 Beats per minute | Standard Deviation 5.65 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in Pulse Rate | Day 6 | 1.3 Beats per minute | Standard Deviation 6.97 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in Pulse Rate | Day 7 | -2.1 Beats per minute | Standard Deviation 5.94 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in Pulse Rate | Day 8 | 2.3 Beats per minute | Standard Deviation 9.34 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in Pulse Rate | Day 9 | -0.8 Beats per minute | Standard Deviation 7.9 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in Pulse Rate | Day 10 | -2.9 Beats per minute | Standard Deviation 5.34 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in Pulse Rate | Day 11 | 1.7 Beats per minute | Standard Deviation 10.56 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in Pulse Rate | Day 3 | 2.2 Beats per minute | Standard Deviation 6.88 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in Pulse Rate | Day 4 | 0.3 Beats per minute | Standard Deviation 7.63 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in Pulse Rate | Day 5 | 3.1 Beats per minute | Standard Deviation 7.79 |
Secondary
Period 3: Change From Baseline in Respiratory Rate
Respiratory rate was measured in the semi-recumbent position 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, in Period 3. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.
Time frame: Baseline (Day 1, Pre-dose), Days 2, 3, 4, 5, 6, 7, 8, 9, 10 and 11
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dolutegravir 50 mg | Period 3: Change From Baseline in Respiratory Rate | Day 2 | 1.4 Breaths per minute | Standard Deviation 3.07 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in Respiratory Rate | Day 3 | 0.5 Breaths per minute | Standard Deviation 3.39 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in Respiratory Rate | Day 4 | 0.3 Breaths per minute | Standard Deviation 3.34 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in Respiratory Rate | Day 5 | -0.5 Breaths per minute | Standard Deviation 2.97 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in Respiratory Rate | Day 7 | 0.3 Breaths per minute | Standard Deviation 3.09 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in Respiratory Rate | Day 8 | 1.4 Breaths per minute | Standard Deviation 2.8 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in Respiratory Rate | Day 9 | -0.4 Breaths per minute | Standard Deviation 3.36 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in Respiratory Rate | Day 10 | 1.4 Breaths per minute | Standard Deviation 2.8 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in Respiratory Rate | Day 11 | 2.8 Breaths per minute | Standard Deviation 2.41 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in Respiratory Rate | Day 6 | 0.6 Breaths per minute | Standard Deviation 3.24 |
Secondary
Period 3: Change From Baseline in SBP and DBP
SBP and DBP were measured in the semi-recumbent position with a completely automated device. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, in Period 3. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.
Time frame: Baseline (Day 1, Pre-dose), Days 2, 3, 4, 5, 6, 7, 8, 9, 10 and 11
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dolutegravir 50 mg | Period 3: Change From Baseline in SBP and DBP | DBP: Day 7 | 2.9 Millimeters of mercury | Standard Deviation 5.88 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in SBP and DBP | DBP: Day 8 | 1.8 Millimeters of mercury | Standard Deviation 9.89 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in SBP and DBP | DBP: Day 9 | 2.1 Millimeters of mercury | Standard Deviation 5.87 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in SBP and DBP | SBP: Day 2 | -0.1 Millimeters of mercury | Standard Deviation 7.66 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in SBP and DBP | SBP: Day 3 | -3.4 Millimeters of mercury | Standard Deviation 6.54 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in SBP and DBP | SBP: Day 4 | -3.3 Millimeters of mercury | Standard Deviation 6.63 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in SBP and DBP | SBP: Day 5 | 3.6 Millimeters of mercury | Standard Deviation 17.17 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in SBP and DBP | SBP: Day 6 | -1.4 Millimeters of mercury | Standard Deviation 7.08 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in SBP and DBP | SBP: Day 7 | -2.1 Millimeters of mercury | Standard Deviation 7.76 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in SBP and DBP | SBP: Day 8 | -2.0 Millimeters of mercury | Standard Deviation 9.36 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in SBP and DBP | SBP: Day 9 | -2.3 Millimeters of mercury | Standard Deviation 8 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in SBP and DBP | SBP: Day 10 | -4.3 Millimeters of mercury | Standard Deviation 8.35 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in SBP and DBP | SBP: Day 11 | -3.4 Millimeters of mercury | Standard Deviation 7.69 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in SBP and DBP | DBP: Day 2 | 1.3 Millimeters of mercury | Standard Deviation 3.32 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in SBP and DBP | DBP: Day 3 | -0.1 Millimeters of mercury | Standard Deviation 5.73 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in SBP and DBP | DBP: Day 4 | 1.2 Millimeters of mercury | Standard Deviation 4.51 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in SBP and DBP | DBP: Day 5 | 6.7 Millimeters of mercury | Standard Deviation 22.2 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in SBP and DBP | DBP: Day 6 | 1.4 Millimeters of mercury | Standard Deviation 6.99 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in SBP and DBP | DBP: Day 10 | 2.3 Millimeters of mercury | Standard Deviation 4.91 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in SBP and DBP | DBP: Day 11 | -0.1 Millimeters of mercury | Standard Deviation 5.43 |
Secondary
Period 3: Change From Baseline in Urinalysis Parameter: 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. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0). Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first treatment in Period 3. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.
Time frame: Baseline (Period 2 Day 7) and at Days 4, 7 and 10
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dolutegravir 50 mg | Period 3: Change From Baseline in Urinalysis Parameter: pH | Day 4 | 0.03 pH | Standard Deviation 0.531 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in Urinalysis Parameter: pH | Day 7 | -0.13 pH | Standard Deviation 0.5 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in Urinalysis Parameter: pH | Day 10 | 0.16 pH | Standard Deviation 0.569 |
Secondary
Period 3: 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 visits, before the first treatment in Period 3. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.
Time frame: Baseline (Period 2 Day 7) and at Days 4, 7 and 10
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dolutegravir 50 mg | Period 3: Change From Baseline in Urinalysis Parameter: Specific Gravity | Day 4 | 0.0003 Ratio | Standard Deviation 0.00652 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in Urinalysis Parameter: Specific Gravity | Day 7 | -0.0007 Ratio | Standard Deviation 0.00545 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in Urinalysis Parameter: Specific Gravity | Day 10 | -0.0016 Ratio | Standard Deviation 0.00901 |
Secondary
Period 3: Change From Baseline in Urinalysis Parameter: Urobilinogen
Urine samples were collected to analyze the urinalysis parameter: urobilinogen. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first treatment in Period 3. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.
Time frame: Baseline (Period 2 Day 7) and at Days 4, 7 and 10
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dolutegravir 50 mg | Period 3: Change From Baseline in Urinalysis Parameter: Urobilinogen | Day 4 | 0.0000 Micromoles per liter | Standard Deviation 0 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in Urinalysis Parameter: Urobilinogen | Day 7 | 0.0000 Micromoles per liter | Standard Deviation 0 |
| Dolutegravir 50 mg | Period 3: Change From Baseline in Urinalysis Parameter: Urobilinogen | Day 10 | 0.0000 Micromoles per liter | Standard Deviation 0 |
Secondary
Period 3: Number of Participants With Urinalysis Dipstick Results
Urine samples were collected at indicated time points to analyze parameters including glucose, protein, occult blood, ketones, nitrite, bilirubin and leukocyte esterase levels by dipstick. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameters can be read as negative, Trace, 1+ (low concentrations present), and 2+ (moderate concentrations present)indicating proportional concentrations in the urine sample.
Time frame: Days 4, 7 and 10
Population: Safety Population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Dolutegravir 50 mg | Period 3: Number of Participants With Urinalysis Dipstick Results | Bilirubin: Day 4, Negative | 16 Participants |
| Dolutegravir 50 mg | Period 3: Number of Participants With Urinalysis Dipstick Results | Bilirubin: Day 7, Negative | 16 Participants |
| Dolutegravir 50 mg | Period 3: Number of Participants With Urinalysis Dipstick Results | Bilirubin: Day 10, Negative | 16 Participants |
| Dolutegravir 50 mg | Period 3: Number of Participants With Urinalysis Dipstick Results | Glucose: Day 4, Negative | 16 Participants |
| Dolutegravir 50 mg | Period 3: Number of Participants With Urinalysis Dipstick Results | Glucose: Day 7, Negative | 16 Participants |
| Dolutegravir 50 mg | Period 3: Number of Participants With Urinalysis Dipstick Results | Glucose: Day 10, Negative | 16 Participants |
| Dolutegravir 50 mg | Period 3: Number of Participants With Urinalysis Dipstick Results | Ketones: Day 4, Negative | 16 Participants |
| Dolutegravir 50 mg | Period 3: Number of Participants With Urinalysis Dipstick Results | Ketones: Day 7, Negative | 16 Participants |
| Dolutegravir 50 mg | Period 3: Number of Participants With Urinalysis Dipstick Results | Leukocyte Esterase: Day 7, Negative | 16 Participants |
| Dolutegravir 50 mg | Period 3: Number of Participants With Urinalysis Dipstick Results | Leukocyte Esterase: Day 10, Negative | 16 Participants |
| Dolutegravir 50 mg | Period 3: Number of Participants With Urinalysis Dipstick Results | Nitrite: Day 4, Negative | 16 Participants |
| Dolutegravir 50 mg | Period 3: Number of Participants With Urinalysis Dipstick Results | Nitrite: Day 7, Negative | 16 Participants |
| Dolutegravir 50 mg | Period 3: Number of Participants With Urinalysis Dipstick Results | Nitrite: Day 10, Negative | 16 Participants |
| Dolutegravir 50 mg | Period 3: Number of Participants With Urinalysis Dipstick Results | Occult Blood: Day 4, Negative | 16 Participants |
| Dolutegravir 50 mg | Period 3: Number of Participants With Urinalysis Dipstick Results | Occult Blood: Day 7, Negative | 16 Participants |
| Dolutegravir 50 mg | Period 3: Number of Participants With Urinalysis Dipstick Results | Occult Blood: Day 10, Negative | 16 Participants |
| Dolutegravir 50 mg | Period 3: Number of Participants With Urinalysis Dipstick Results | Protein: Day 4, Negative | 16 Participants |
| Dolutegravir 50 mg | Period 3: Number of Participants With Urinalysis Dipstick Results | Protein: Day 10, Negative | 16 Participants |
| Dolutegravir 50 mg | Period 3: Number of Participants With Urinalysis Dipstick Results | Ketones: Day 10, Negative | 16 Participants |
| Dolutegravir 50 mg | Period 3: Number of Participants With Urinalysis Dipstick Results | Leukocyte Esterase: Day 4, Negative | 16 Participants |
| Dolutegravir 50 mg | Period 3: Number of Participants With Urinalysis Dipstick Results | Protein: Day 7, Negative | 16 Participants |
Secondary
Period 3: T1/2 of Dolutegravir for Dolutegravir + GSK3640254 Arm
Blood samples were collected at the indicated time points for pharmacokinetic analysis of dolutegravir. The pharmacokinetic parameters were calculated by standard non-compartmental analysis.
Time frame: Day 7: Pre-dose, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12 and 24 hours post-dose
Population: Pharmacokinetic Parameter Population.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Dolutegravir 50 mg | Period 3: T1/2 of Dolutegravir for Dolutegravir + GSK3640254 Arm | 14.690 Hours | Geometric Coefficient of Variation 12.1 |
Secondary
Period 3: T1/2 of GSK3640254 for Dolutegravir + GSK3640254 Arm
Blood samples were collected at the indicated time points for pharmacokinetic analysis of GSK3640254. The pharmacokinetic parameters were calculated by standard non-compartmental analysis.
Time frame: Day 7: Pre-dose, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12 and 24 hours post-dose
Population: Pharmacokinetic Parameter Population.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Dolutegravir 50 mg | Period 3: T1/2 of GSK3640254 for Dolutegravir + GSK3640254 Arm | 23.417 Hours | Geometric Coefficient of Variation 15 |
Secondary
Period 3: Tmax of Dolutegravir for Dolutegravir + GSK3640254 Arm
Blood samples were collected at the indicated time points for pharmacokinetic analysis of dolutegravir. The pharmacokinetic parameters were calculated by standard non-compartmental analysis.
Time frame: Day 7: Pre-dose, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12 and 24 hours post-dose
Population: Pharmacokinetic Parameter Population.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Dolutegravir 50 mg | Period 3: Tmax of Dolutegravir for Dolutegravir + GSK3640254 Arm | 3.000 Hours |
Secondary
Period 3: Tmax of GSK3640254 for Dolutegravir + GSK3640254 Arm
Blood samples were collected at the indicated time points for pharmacokinetic analysis of GSK3640254. The pharmacokinetic parameters were calculated by standard non-compartmental analysis.
Time frame: Day 7: Pre-dose, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12 and 24 hours post-dose
Population: Pharmacokinetic Parameter Population.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Dolutegravir 50 mg | Period 3: Tmax of GSK3640254 for Dolutegravir + GSK3640254 Arm | 5.000 Hours |