HIV Infections
Conditions
Keywords
Darunavir, Ritonavir, Etravirine, GSK3640254, Pharmacokinetics
Brief summary
This is an open-label, single-sequence, multiple-dose, 3 cohort study to investigate the effects of DRV/RTV and/or ETR on the pharmacokinetics (PK) of GSK3640254 and the effects of GSK3640254 on the PK of DRV/RTV and/or ETR. This study will aid in understanding these interactions and resulting changes in exposure (if any) when given in combination with GSK3640254.
Interventions
DRUGGSK3640254
GSK3640254 will be available as oral tablets.
DRUGDarunavir/Ritonavir (DRV/RTV)
DRV/RTV will be available as oral tablets.
DRUGEtravirine (ETR)
ETR will be available as oral tablets.
Sponsors
ViiV Healthcare
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Masking description
This is an open-label study.
Intervention model description
This is an open-label, single-sequence, multiple-dose and 3-cohort study.
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Participant must be 18 to 50 years of age inclusive, at the time of signing the informed consent. * Participants who are overtly healthy as determined by investigator or medically qualified designee based on a medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring (history and screening ECG). * Body weight more than or equal to (\>=)50.0 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 participants: 1. Male participants should not engage in intercourse while confined in the study site. There is no need for an extended period of double barrier use or prolonged abstinence after study discharge. 2. Female participants: (i) A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies: Is not a woman of childbearing potential (WOCBP) OR Is a WOCBP and using a non-hormonal contraceptive method that is highly effective, with a failure rate of less than (\<)1 percent (%) for 28 days before intervention, during the intervention period, and for at least 28 days after the last dose of study intervention. The investigator should evaluate the effectiveness of the contraceptive method in relationship to the first dose of study intervention. (ii) A WOCBP must have a negative highly sensitive serum or urine pregnancy test at screening and check-in (Day -1). * Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the Informed consent form (ICF) and in this protocol.
Exclusion criteria
* Participants with 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 (for example \[e.g.\], gastroesophageal reflux disease, gastric ulcers, gastritis) or hepatic and/or renal function that could interfere with the absorption, metabolism, and/or excretion of the study intervention or render the participant unable to take oral study intervention. * Prior cholecystectomy surgery (prior appendectomy is acceptable). * Clinically significant illness, including viral syndromes within 3 weeks of dosing. * A participant with known or suspected active Coronavirus Disease-2019 (COVID-19) infection or contact with an individual with known COVID-19, within 14 days of study enrollment (World Health Organization \[WHO\] definitions). * 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 (more than \[\>\]6 months) outpatient treatment. Participants 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 Healthcare/GlaxoSmithKline (VH/GSK) 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 participant's ability to comply with the dosing schedule and protocol evaluations or which might compromise the safety of the participant. * Medical history of cardiac arrhythmias, prior myocardial infarction in the past 3 months, or cardiac disease or a family or personal history of long QT syndrome. * Presence of hepatitis B surface antigen at screening or within 3 months prior to starting study intervention. * Positive hepatitis C antibody test result at screening or within 3 months prior to starting study intervention. * Positive Human immunodeficiency virus (HIV)-1 and -2 antigen/antibody immunoassay at screening. * Alanine aminotransferase (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%). A single repeat of any laboratory abnormality is allowed within a single screening period to determine eligibility. * Any acute laboratory abnormality at screening which, in the opinion of the investigator, should preclude participation in the study of an investigational compound. * Any Grade 2 to 4 laboratory abnormality at screening, with the exception of creatine phosphokinase (CPK), lipid abnormalities (e.g., total cholesterol, triglycerides), and ALT (described above), will exclude a participant from the study unless the investigator can provide a compelling explanation for the laboratory result(s) and has the assent of the sponsor. A single repeat of any laboratory abnormality is allowed within a single screening period to determine eligibility. * Urine drug screen positive (showing presence of): amphetamines, barbiturates, cannabinoids, cocaine, or phencyclidine, or non-prescribed opiates, oxycodone, benzodiazepines, methadone, Methylenedioxymethamphetamine (MDMA), methamphetamines, or tricyclic antidepressants at screening or before the first dose of study intervention. * Unable to refrain from the use of prescription or nonprescription drugs including vitamins, herbal and dietary supplements (including Saint \[St\] John's wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the first dose of study intervention and for the duration of the study. * 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). * Prior exposure to GSK3640254 or prior intolerance to DRV/RTV or ETR in this or another clinical study. * Prior intolerance to any other study medications: DRV/RTV or ETR. * Where participation in the study would result in donation of blood or blood products in excess of 500 milliliters (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). * Systolic blood pressure \<100 millimeters of mercury (mm Hg). Up to 2 repeats are allowed for confirmation. * Any significant arrhythmia or ECG finding (e.g., prior myocardial infarction in the past 3 months, symptomatic bradycardia, non-sustained or sustained atrial arrhythmias, non-sustained or sustained ventricular tachycardia, any degree of atrioventricular block, or conduction abnormality) which, in the opinion of the investigator or VH/GSK medical monitor, will interfere with the safety for the individual participant. *
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cohort 1: Area Under the Plasma Concentration-time Curve From Time Zero to the End of the Dosing Interval at Steady State (AUC[0-tau]) of GSK3640254 | Pre-dose and 0.5 Hours, 1 Hour, 1.5 Hours, 2 Hours, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 16 Hours, 24 Hours post-dose in Treatment Periods 1 and 3 | Blood samples were collected at indicated time points. Pharmacokinetic analysis was conducted using standard non-compartmental methods. |
| Cohort 1: Maximum Observed Concentration (Cmax) of GSK3640254 | Pre-dose and 0.5 Hours, 1 Hour, 1.5 Hours, 2 Hours, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 16 Hours, 24 Hours post-dose in Treatment Periods 1 and 3 | Blood samples were collected at indicated time points. Pharmacokinetic analysis was conducted using standard non-compartmental methods. |
| Cohort 1: AUC(0-tau) of DRV | Pre-dose and 0.5 Hours, 1 Hour, 1.5 Hours, 2 Hours, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours post-dose in Treatment Periods 2 and 3 | Blood samples were collected at indicated time points. Pharmacokinetic analysis was conducted using standard non-compartmental methods. |
| Cohort 1: Cmax of DRV | Pre-dose and 0.5 Hours, 1 Hour, 1.5 Hours, 2 Hours, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours post-dose in Treatment Periods 2 and 3 | Blood samples were collected at indicated time points. Pharmacokinetic analysis was conducted using standard non-compartmental methods. |
| Cohort 1: AUC(0-tau) of RTV | Pre-dose and 0.5 Hours, 1 Hour, 1.5 Hours, 2 Hours, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours post-dose in Treatment Periods 2 and 3 | Blood samples were collected at indicated time points. Pharmacokinetic analysis was conducted using standard non-compartmental methods. |
| Cohort 1: Cmax of RTV | Pre-dose and 0.5 Hours, 1 Hour, 1.5 Hours, 2 Hours, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours post-dose in Treatment Periods 2 and 3 | Blood samples were collected at indicated time points. Pharmacokinetic analysis was conducted using standard non-compartmental methods. |
| Cohort 2: AUC(0-tau) of GSK3640254 | Pre-dose and 0.5 Hours, 1 Hour, 1.5 Hours, 2 Hours, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 16 Hours, 24 Hours post-dose in Treatment Periods 1 and 3 | Blood samples were collected at indicated time points. Pharmacokinetic analysis was conducted using standard non-compartmental methods. |
| Cohort 2: Cmax of GSK3640254 | Pre-dose and 0.5 Hours, 1 Hour, 1.5 Hours, 2 Hours, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 16 Hours, 24 Hours post-dose in Treatment Periods 1 and 3 | Blood samples were collected at indicated time points. Pharmacokinetic analysis was conducted using standard non-compartmental methods. |
| Cohort 2: AUC(0-tau) of ETR | Pre-dose and 0.5 Hours, 1 Hour, 1.5 Hours, 2 Hours, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours post-dose in Treatment Periods 2 and 3 | Blood samples were collected at indicated time points. Pharmacokinetic analysis was conducted using standard non-compartmental methods. |
| Cohort 2: Cmax of ETR | Pre-dose and 0.5 Hours, 1 Hour, 1.5 Hours, 2 Hours, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours post-dose in Treatment Periods 2 and 3 | Blood samples were collected at indicated time points. Pharmacokinetic analysis was conducted using standard non-compartmental methods. |
| Cohort 3: AUC(0-tau) of GSK3640254 | Pre-dose and 0.5 Hours, 1 Hour, 1.5 Hours, 2 Hours, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 16 Hours, 24 Hours post-dose in Treatment Periods 1 and 2 | Blood samples were collected at indicated time points. Pharmacokinetic analysis was conducted using standard non-compartmental methods. |
| Cohort 3: Cmax of GSK3640254 | Pre-dose and 0.5 Hours, 1 Hour, 1.5 Hours, 2 Hours, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 16 Hours, 24 Hours post-dose in Treatment Periods 1 and 2 | Blood samples were collected at indicated time points. Pharmacokinetic analysis was conducted using standard non-compartmental methods. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cohort 3: Number of Participants With SAEs and Non-SAEs | Up to Day 26 | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is defined as any untoward medical occurrence that, at any dose that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or other situations as per medical or scientific judgment. Adverse events which were not Serious were considered as Non-Serious adverse events. |
| Cohort 1: Number of Participants With AEs Leading to Discontinuations and Deaths | Up to Day 35 | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. Number of participants with AEs leading to discontinuations and deaths were reported. |
| Cohort 2: Number of Participants With AEs Leading to Discontinuations and Deaths | Up to Day 36 | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. Number of participants with AEs leading to discontinuations and deaths were reported. |
| Cohort 3: Number of Participants With AEs Leading to Discontinuations and Deaths | Up to Day 26 | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. Number of participants with AEs leading to discontinuations and deaths were reported. |
| Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Hematology Parameters | Baseline (Pre-dose, Day-1) and up to Day 35 | Blood samples were collected for analysis of hematology parameters. Laboratory abnormalities were graded according to Division of Acquired Immunodeficiency Syndrome (DAIDS) grading table Version 2.1. For Hemoglobin Low, Grade 3: 7.0 to \<9.0 Grams per deciliter (g/dL) (males) and 6.5 to \<8.5 g/dL (females),Grade 4: \<7.0 g/dL (males) and \<6.5 g/dL (females); Leukocytes Low, Grade 3: 1000 to 1499 cells per cubic millimeter (cells/mm\^3),Grade 4: \<1000 cells/mm\^3; Lymphocytes Low, Grade 3: 350 to \<500 cells per liter (cells/L),Grade 4: \<350 cells/L; Neutrophils Low, Grade 3: 400 to 599 cells/mm\^3, Grade 4: \<400 cells/mm\^3; Platelets Low, Grade 3: 25,000 to \<50,000 cells/mm\^3, Grade 4: \<25,000 cells/mm\^3. Baseline was defined as latest pre-dose assessment with a non-missing value, including those from unscheduled visits. An increase is defined as an increase in DAIDS grade relative to Baseline grade. |
| Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Hematology Parameters | Baseline (Pre-dose, Day-1) and up to Day 36 | Blood samples were collected for analysis of hematology parameters. Laboratory abnormalities were graded according to DAIDS grading table Version 2.1. For Hemoglobin Low, Grade 3: 7.0 to \<9.0 g/dL (males) and 6.5 to \<8.5 g/dL (females),Grade 4: \<7.0 g/dL (males) and \<6.5 g/dL (females); Leukocytes Low, Grade 3: 1000 to 1499 cells/mm\^3,Grade 4: \<1000 cells/mm\^3; Lymphocytes Low, Grade 3: 350 to \<500 cells/L,Grade 4: \<350 cells/L; Neutrophils Low, Grade 3: 400 to 599 cells/mm\^3, Grade 4: \<400 cells/mm\^3; Platelets Low, Grade 3: 25,000 to \<50,000 cells/mm\^3, Grade 4: \<25,000 cells/mm\^3. Baseline was defined as latest pre-dose assessment with a non-missing value, including those from unscheduled visits. An increase is defined as an increase in DAIDS grade relative to Baseline grade. |
| Cohort 3: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Hematology Parameters | Baseline (Pre-dose, Day-1) and up to Day 26 | Blood samples were collected for analysis of hematology parameters. Laboratory abnormalities were graded according to DAIDS grading table Version 2.1. For Hemoglobin Low, Grade 3: 7.0 to \<9.0 g/dL (males) and 6.5 to \<8.5 g/dL (females),Grade 4: \<7.0 g/dL (males) and \<6.5 g/dL (females); Leukocytes Low, Grade 3: 1000 to 1499 cells/mm\^3,Grade 4: \<1000 cells/mm\^3; Lymphocytes Low, Grade 3: 350 to \<500 cells/L,Grade 4: \<350 cells/L; Neutrophils Low, Grade 3: 400 to 599 cells/mm\^3, Grade 4: \<400 cells/mm\^3; Platelets Low, Grade 3: 25,000 to \<50,000 cells/mm\^3, Grade 4: \<25,000 cells/mm\^3. Baseline was defined as latest pre-dose assessment with a non-missing value, including those from unscheduled visits. An increase is defined as an increase in DAIDS grade relative to Baseline grade. |
| Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Bilirubin and Direct Bilirubin | Baseline (Pre-dose, Day-1) and up to Day 35 | Blood samples were collected for analysis of clinical chemistry parameters. Laboratory abnormalities were graded according to DAIDS grading table Version 2.1. For Alanine Aminotransferase High; Grade 3: 5.0 to \<10.0 times (×) Upper Limit Normal (ULN), Grade 4: \>=10.0 × ULN; Albumin Low, Grade 3: \<2.0 grams per deciliter (g/dL), Grade 4: Not Applicable; Alkaline Phosphatase High, Grade 3: 5.0 to \<10.0 × ULN, Grade 4: \>=10.0 × ULN; Amylase High, Grade 3: 3.0 to \<5.0 × ULN, Grade 4: \>=5.0 × ULN; Aspartate Aminotransferase High, Grade 3: 5.0 to \<10.0 × ULN, Grade 4: \>=10.0 × ULN; Bilirubin High, Grade 3: 2.6 to\<5.0 × ULN, Grade 4: \>=5.0 × ULN and Direct Bilirubin High, Grade 3: \>ULN with other signs and symptoms of hepatotoxicity, Grade 4: \>ULN with life-threatening consequences. Baseline was defined as latest pre-dose assessment with a non-missing value, including those from unscheduled visits. An increase is defined as an increase in DAIDS grade relative to Baseline grade. |
| Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Calcium, Creatine Kinase, Creatinine, Phosphate, Potassium and Sodium | Baseline (Pre-dose, Day-1) and up to Day 35 | Blood samples were collected for analysis of clinical chemistry parameters. Laboratory abnormalities were graded according to DAIDS grading table Version 2.1. For Calcium High, Grade 3: 12.5 to \<13.5 milligrams/deciliter (mg/dL), Grade 4: \>=13.5 mg/dL; Calcium Low, Grade 3: 6.1 to \<7.0 mg/dL, Grade 4: \<6.1 mg/dL; Creatine Kinase High, Grade 3: 10 to \<20 × ULN, Grade 4: \>=20 × ULN; Creatinine High, Grade 3: \>1.8 to \<3.5 ULN, Grade 4: \>=3.5 × ULN; Phosphate Low, Grade 3: 1.0 to \<1.4 mg/dL, Grade 4: \<1.0 mg/dL; Potassium High, Grade 3: 6.5 to \<7.0 Milliequivalents per liter (mEq/L),Grade 4: \>=7.0 mEq/L; Potassium Low, Grade 3: 2.0 to \<2.5 mEq/L, Grade 4: \<2.00 mEq/L; Sodium High, Grade 3: 154 to \<160 mEq/L, Grade 4:\>=160 mEq/L; Sodium Low, Grade 3: 121 to \<125 mEq/L, Grade 4:\<=120 mEq/L. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. An increase is defined as an increase in DAIDS grade relative to Baseline grade. |
| Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Glucose, Triglycerides, Lipase, Urate and Cholesterol | Baseline (Pre-dose, Day-1) and up to Day 35 | Blood samples were collected for analysis of clinical chemistry parameters. Laboratory abnormalities were graded according to DAIDS grading table Version 2.1. For Glucose High, Grade 3: \>250 to 500 mg/dL, Grade 4: \>=500 mg/dL, Glucose Low, Grade 3: 30 to\<40 mg/dL, Grade 4:\<30 mg/dL; Triglycerides High, Grade 3: \>500 to \<1.000 mg/dL, Grade 4:\>1000 mg/dL; Lipase High, Grade 3: 3.0 to \<5.0×ULN, Grade 4:\>=5.0×ULN; Urate High, Grade 3: 12.0 to \<15.0 mEq/L, Grade 4:\>=15.0 mEq/L; Cholesterol High, Grade 3: \>=300 mg/dL, Grade 4: Not Applicable. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. An increase is defined as an increase in DAIDS grade relative to Baseline grade. |
| Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Bilirubin and Direct Bilirubin | Baseline (Pre-dose, Day-1) and up to Day 36 | Blood samples were collected for analysis of clinical chemistry parameters. Laboratory abnormalities were graded according to DAIDS grading table Version 2.1. For Alanine Aminotransferase High; Grade 3: 5.0 to \<10.0 × ULN, Grade 4: \>=10.0 × ULN; Albumin Low, Grade 3: \<2.0 g/dL, Grade 4: Not Applicable; Alkaline Phosphatase High, Grade 3: 5.0 to \<10.0 × ULN, Grade 4: \>=10.0 × ULN; Amylase High, Grade 3: 3.0 to \<5.0 × ULN, Grade 4: \>=5.0 × ULN; Aspartate Aminotransferase High, Grade 3: 5.0 to \<10.0 × ULN, Grade 4: \>=10.0 × ULN; Bilirubin High, Grade 3: 2.6 to\<5.0 × ULN, Grade 4: \>=5.0 × ULN and Direct Bilirubin High, Grade 3: \>ULN with other signs and symptoms of hepatotoxicity, Grade 4: \>ULN with life-threatening consequences. Baseline was defined as latest pre-dose assessment with a non-missing value, including those from unscheduled visits. An increase is defined as an increase in DAIDS grade relative to Baseline grade. |
| Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Calcium, Creatine Kinase, Creatinine, Phosphate, Potassium and Sodium | Baseline (Pre-dose, Day-1) and up to Day 36 | Blood samples were collected for analysis of clinical chemistry parameters. Laboratory abnormalities were graded according to DAIDS grading table Version 2.1. For Calcium High, Grade 3: 12.5 to \<13.5 mg/dL, Grade 4: \>=13.5 mg/dL; Calcium Low, Grade 3: 6.1 to \<7.0 mg/dL, Grade 4: \<6.1 mg/dL; Creatine Kinase High, Grade 3: 10 to \<20 × ULN, Grade 4: \>=20 × ULN; Creatinine High, Grade 3: \>1.8 to \<3.5 ULN, Grade 4: \>=3.5 × ULN; Phosphate Low, Grade 3: 1.0 to \<1.4 mg/dL, Grade 4: \<1.0 mg/dL; Potassium High, Grade 3: 6.5 to \<7.0 mEq/L,Grade 4: \>=7.0 mEq/L; Potassium Low, Grade 3: 2.0 to \<2.5 mEq/L, Grade 4: \<2.00 mEq/L; Sodium High, Grade 3: 154 to \<160 mEq/L, Grade 4:\>=160 mEq/L; Sodium Low, Grade 3: 121 to \<125 mEq/L, Grade 4:\<=120 mEq/L. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. An increase is defined as an increase in DAIDS grade relative to Baseline grade. |
| Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Glucose, Triglycerides, Lipase, Urate and Cholesterol | Baseline (Pre-dose, Day-1) and up to Day 36 | Blood samples were collected for analysis of clinical chemistry parameters. Laboratory abnormalities were graded according to DAIDS grading table Version 2.1. For Glucose High, Grade 3: \>250 to 500 mg/dL, Grade 4: \>=500 mg/dL, Glucose Low, Grade 3: 30 to\<40 mg/dL, Grade 4:\<30 mg/dL; Triglycerides High, Grade 3: \>500 to \<1.000 mg/dL, Grade 4:\>1000 mg/dL; Lipase High, Grade 3: 3.0 to \<5.0×ULN, Grade 4:\>=5.0×ULN; Urate High, Grade 3: 12.0 to \<15.0 mEq/L, Grade 4:\>=15.0 mEq/L; Cholesterol High, Grade 3: \>=300 mg/dL, Grade 4: Not Applicable. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. An increase is defined as an increase in DAIDS grade relative to Baseline grade. |
| Cohort 3: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Bilirubin and Direct Bilirubin | Baseline (Pre-dose, Day-1) and up to Day 26 | Blood samples were collected for analysis of clinical chemistry parameters. Laboratory abnormalities were graded according to DAIDS grading table Version 2.1. For Alanine Aminotransferase High; Grade 3: 5.0 to \<10.0 × ULN, Grade 4: \>=10.0 × ULN; Albumin Low, Grade 3: \<2.0 g/dL, Grade 4: Not Applicable; Alkaline Phosphatase High, Grade 3: 5.0 to \<10.0 × ULN, Grade 4: \>=10.0 × ULN; Amylase High, Grade 3: 3.0 to \<5.0 × ULN, Grade 4: \>=5.0 × ULN; Aspartate Aminotransferase High, Grade 3: 5.0 to \<10.0 × ULN, Grade 4: \>=10.0 × ULN; Bilirubin High, Grade 3: 2.6 to\<5.0 × ULN, Grade 4: \>=5.0 × ULN and Direct Bilirubin High, Grade 3: \>ULN with other signs and symptoms of hepatotoxicity, Grade 4: \>ULN with life-threatening consequences. Baseline was defined as latest pre-dose assessment with a non-missing value, including those from unscheduled visits. An increase is defined as an increase in DAIDS grade relative to Baseline grade. |
| Cohort 3: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Calcium, Creatine Kinase, Creatinine, Phosphate, Potassium and Sodium | Baseline (Pre-dose, Day-1) and up to Day 26 | Blood samples were collected for analysis of clinical chemistry parameters. Laboratory abnormalities were graded according to DAIDS grading table Version 2.1. For Calcium High, Grade 3: 12.5 to \<13.5 mg/dL, Grade 4: \>=13.5 mg/dL; Calcium Low, Grade 3: 6.1 to \<7.0 mg/dL, Grade 4: \<6.1 mg/dL; Creatine Kinase High, Grade 3: 10 to \<20 × ULN, Grade 4: \>=20 × ULN; Creatinine High, Grade 3: \>1.8 to \<3.5 ULN, Grade 4: \>=3.5 × ULN; Phosphate Low, Grade 3: 1.0 to \<1.4 mg/dL, Grade 4: \<1.0 mg/dL; Potassium High, Grade 3: 6.5 to \<7.0 mEq/L,Grade 4: \>=7.0 mEq/L; Potassium Low, Grade 3: 2.0 to \<2.5 mEq/L, Grade 4: \<2.00 mEq/L; Sodium High, Grade 3: 154 to \<160 mEq/L, Grade 4:\>=160 mEq/L; Sodium Low, Grade 3: 121 to \<125 mEq/L, Grade 4:\<=120 mEq/L. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. An increase is defined as an increase in DAIDS grade relative to Baseline grade. |
| Cohort 3: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Glucose, Triglycerides, Lipase, Urate and Cholesterol | Baseline (Pre-dose, Day-1) and up to Day 26 | Blood samples were collected for analysis of clinical chemistry parameters. Laboratory abnormalities were graded according to DAIDS grading table Version 2.1. For Glucose High, Grade 3: \>250 to 500 mg/dL, Grade 4: \>=500 mg/dL, Glucose Low, Grade 3: 30 to\<40 mg/dL, Grade 4:\<30 mg/dL; Triglycerides High, Grade 3: \>500 to \<1.000 mg/dL, Grade 4:\>1000 mg/dL; Lipase High, Grade 3: 3.0 to \<5.0×ULN, Grade 4:\>=5.0×ULN; Urate High, Grade 3: 12.0 to \<15.0 mEq/L, Grade 4:\>=15.0 mEq/L; Cholesterol High, Grade 3: \>=300 mg/dL, Grade 4: Not Applicable. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. An increase is defined as an increase in DAIDS grade relative to Baseline grade. |
| Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Urinalysis Parameters | Baseline (Pre-dose, Day-1) and up to Day 35 | Urine samples were collected for urinalysis parameters. Laboratory abnormalities were graded according to DAIDS grading table Version 2.1. For Erythrocytes High, Grade 3: Gross, with or without clots OR with Red Blood Cells (RBC) casts OR intervention indicated, Grade 4: Life-threatening consequences; Glucose High, Grade 3: \>2+ (proportionate concentration by dipstick test) or \>500 mg, Grade 4: \>500 mg; Protein High, Grade 3: 3+ (proportionate concentration by dipstick test) or higher, Grade 4: Not Applicable. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. An increase is defined as an increase in DAIDS grade relative to Baseline grade. |
| Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Urinalysis Parameters | Baseline (Pre-dose, Day-1) and up to Day 36 | Urine samples were collected for urinalysis parameters. Laboratory abnormalities were graded according to DAIDS grading table Version 2.1. For Erythrocytes High, Grade 3: Gross, with or without clots OR with RBC casts OR intervention indicated, Grade 4: Life-threatening consequences; Glucose High, Grade 3: \>2+ (proportionate concentration by dipstick test) or \>500 mg, Grade 4: \>500 mg; Protein High, Grade 3: 3+ (proportionate concentration by dipstick test) or higher, Grade 4: Not Applicable. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. An increase is defined as an increase in DAIDS grade relative to Baseline grade. |
| Cohort 1: Plasma Concentration at the End of the Dosing Interval (Ctau) of DRV | Pre-dose and 0.5 Hours, 1 Hour, 1.5 Hours, 2 Hours, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours post-dose in Treatment Periods 2 and 3 | Blood samples were collected at indicated time points. Pharmacokinetic analysis was conducted using standard non-compartmental methods. |
| Cohort 1: Number of Participants With Vital Sign Values of Potential Clinical Importance (PCI) Criteria | Up to Day 35 | Vital signs including systolic blood pressure (SBP), diastolic blood pressure (DBP) and pulse rate were measured in a supine position after atleast 5 minutes of rest. The PCI ranges for vitals were as follows; for SBP \<85 or \>140 millimeters of mercury (mmHg), for DBP \<45 or \>90 mmHg, for pulse rate \<40 or \>100 beats per minute. The number of participants with vital signs of PCI were presented. |
| Cohort 2: Number of Participants With Vital Sign Values of PCI Criteria | Up to Day 36 | Vital signs including SBP, DBP and pulse rate were measured in a supine position after atleast 5 minutes of rest. The PCI ranges for vitals were as follows; for SBP \<85 or \>140 mmHg, for DBP \<45 or \>90 mmHg, for pulse rate \<40 or \>100 beats per minute. The number of participants with vital signs of PCI were presented. |
| Cohort 3: Number of Participants With Vital Sign Values of PCI Criteria | Up to Day 26 | Vital signs including SBP, DBP and pulse rate were measured in a supine position after atleast 5 minutes of rest. The PCI ranges for vitals were as follows; for SBP \<85 or \>140 mmHg, for DBP \<45 or \>90 mmHg, for pulse rate \<40 or \>100 beats per minute. The number of participants with vital signs of PCI were presented. |
| Cohort 1: Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG) Findings | Day 1 (2,4,6 Hours), Day 7 and Day 11 in Treatment Period 1; Day 12 (2,4,6 Hours), Day 21 in Treatment Period 2; Day 22 (2,4,6 Hours), Day 26 and Day 35 in Treatment Period 3 | A 12-lead ECG was recorded with the participant in a supine position using an automated ECG machine. Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. Data for number of participants with clinically significant abnormal ECG findings were reported. Data has been presented for the participants with respect to the actual treatment received in respective treatment periods. |
| Cohort 2: Number of Participants With Clinically Significant Abnormal ECG Findings | Day 1 (2,4,6 Hours), Day 7 and Day 11 in Treatment Period 1; Day 12 (2,4,6 Hours), Day 21 in Treatment Period 2; Day 22 (2,4,6 Hours), Day 26 and Day 36 in Treatment Period 3 | A 12-lead ECG was recorded with the participant in a supine position using an automated ECG machine. Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. Data for number of participants with clinically significant abnormal ECG findings were reported. Data has been presented for the participants with respect to the actual treatment received in respective treatment periods. |
| Cohort 3: Number of Participants With Clinically Significant Abnormal ECG Findings | Day 1 (2,4,6 Hours) in Treatment Period 1; Day 8 (2,4,6 Hours), Day 9 (2,4,6 Hours), Day 26 in Treatment Period 2 | A 12-lead ECG was recorded with the participant in a supine position using an automated ECG machine. Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. Data for number of participants with clinically significant abnormal ECG findings were reported. Data has been presented for the participants with respect to the actual treatment received in respective treatment periods. |
| Cohort 3: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Urinalysis Parameters | Baseline (Pre-dose, Day-1) and up to Day 26 | Urine samples were collected for urinalysis parameters. Laboratory abnormalities were graded according to DAIDS grading table Version 2.1. For Erythrocytes High, Grade 3: Gross, with or without clots OR with RBC casts OR intervention indicated, Grade 4: Life-threatening consequences; Glucose High, Grade 3: \>2+ (proportionate concentration by dipstick test) or \>500 mg, Grade 4: \>500 mg; Protein High, Grade 3: 3+ (proportionate concentration by dipstick test) or higher, Grade 4: Not Applicable. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. An increase is defined as an increase in DAIDS grade relative to Baseline grade. |
| Cohort 1: Time of Maximum Observed Concentration (Tmax) of DRV | Pre-dose and 0.5 Hours, 1 Hour, 1.5 Hours, 2 Hours, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours post-dose in Treatment Periods 2 and 3 | Blood samples were collected at indicated time points. Pharmacokinetic analysis was conducted using standard non-compartmental methods. |
| Cohort 1: Ctau of RTV | Pre-dose and 0.5 Hours, 1 Hour, 1.5 Hours, 2 Hours, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours post-dose in Treatment Periods 2 and 3 | Blood samples were collected at indicated time points. Pharmacokinetic analysis was conducted using standard non-compartmental methods. |
| Cohort 1: Tmax of RTV | Pre-dose and 0.5 Hours, 1 Hour, 1.5 Hours, 2 Hours, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours post-dose in Treatment Periods 2 and 3 | Blood samples were collected at indicated time points. Pharmacokinetic analysis was conducted using standard non-compartmental methods. |
| Cohort 1: Ctau of GSK3640254 | Pre-dose and 0.5 Hours, 1 Hour, 1.5 Hours, 2 Hours, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 16 Hours, 24 Hours post-dose in Treatment Periods 1 and 3 | Blood samples were collected at indicated time points. Pharmacokinetic analysis was conducted using standard non-compartmental methods. |
| Cohort 1: Tmax of GSK3640254 | Pre-dose and 0.5 Hours, 1 Hour, 1.5 Hours, 2 Hours, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 16 Hours, 24 Hours post-dose in Treatment Periods 1 and 3 | Blood samples were collected at indicated time points. Pharmacokinetic analysis was conducted using standard non-compartmental methods. |
| Cohort 2: Ctau of ETR | Pre-dose and 0.5 Hours, 1 Hour, 1.5 Hours, 2 Hours, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours post-dose in Treatment Periods 2 and 3 | Blood samples were collected at indicated time points. Pharmacokinetic analysis was conducted using standard non-compartmental methods. |
| Cohort 2: Tmax of ETR | Pre-dose and 0.5 Hours, 1 Hour, 1.5 Hours, 2 Hours, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours post-dose in Treatment Periods 2 and 3 | Blood samples were collected at indicated time points. Pharmacokinetic analysis was conducted using standard non-compartmental methods. |
| Cohort 2: Ctau of GSK3640254 | Pre-dose and 0.5 Hours, 1 Hour, 1.5 Hours, 2 Hours, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 16 Hours, 24 Hours post-dose in Treatment Periods 1 and 3 | Blood samples were collected at indicated time points. Pharmacokinetic analysis was conducted using standard non-compartmental methods. |
| Cohort 2: Tmax of GSK3640254 | Pre-dose and 0.5 Hours, 1 Hour, 1.5 Hours, 2 Hours, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 16 Hours, 24 Hours post-dose in Treatment Periods 1 and 3 | Blood samples were collected at indicated time points. Pharmacokinetic analysis was conducted using standard non-compartmental methods. |
| Cohort 1: Number of Participants With Serious Adverse Events (SAEs) and Non-serious Adverse Events (Non-SAEs) | Up to Day 35 | An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is defined as any untoward medical occurrence that, at any dose that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or other situations as per medical or scientific judgment. Adverse events which were not Serious were considered as Non-Serious adverse events. |
| Cohort 2: Number of Participants With SAEs and Non-SAEs | Up to Day 36 | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is defined as any untoward medical occurrence that, at any dose that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or other situations as per medical or scientific judgment. Adverse events which were not Serious were considered as Non-Serious adverse events. |
Countries
United States
Participant flow
Recruitment details
This study was conducted at a single center in the United States.
Pre-assignment details
A total of 54 participants (19 in Cohort 1, 19 in Cohort 2 and 16 in Cohort 3) were enrolled in the study (Safety Population: It comprised of all participants who received at least 1 dose of study medication).
Participants by arm
| Arm | Count |
|---|---|
| Cohort 1: GSK3640254 Then DRV/RTV Then GSK3640254 + DRV/RTV Participants received GSK3640254 200 milligram (mg) tablets once daily on Days 1 to 7 in treatment period 1 followed by Darunavir/Ritonavir (DRV/RTV) 600/100 mg tablets twice daily on Days 12 to 21 in treatment period 2. There was a washout period on Days 8 to 11 between treatment periods 1 and 2. Participants also received GSK3640254 200 mg tablets once daily along with DRV/RTV 600/100 mg tablets twice daily on Days 22 to 31 in treatment period 3. | 19 |
| Cohort 2: GSK3640254 Then ETR Then GSK3640254 + ETR Participants received GSK3640254 200 mg tablets once daily on Days 1 to 7 in treatment period 1 followed by Etravirine (ETR) 200 mg tablets twice daily on Days 12 to 21 in treatment period 2. There was a washout period on Days 8 to 11 between treatment periods 1 and 2. Participants also received GSK3640254 200 mg tablets once daily along with ETR 200 mg tablets twice daily on Days 22 to 31 in treatment period 3. | 19 |
| Cohort 3: GSK3640254 Then GSK3640254 + DRV/RTV + ETR Participants received GSK3640254 200 mg tablets once daily on Days 1 to 7 in treatment period 1. Participants received GSK3640254 200 mg tablets once daily along with DRV/RTV 600/100 mg tablets twice daily and ETR 200 mg tablets twice daily on Days 8 to 21 in treatment period 2. | 16 |
| Total | 54 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Cohort1:Treatment Period2(Days 12 to 21) | Physician Decision | 2 | 0 | 0 |
| Cohort1:Treatment Period3(Days 22 to 31) | Adverse Event | 1 | 0 | 0 |
| Cohort1:Treatment Period3(Days 22 to 31) | Physician Decision | 1 | 0 | 0 |
| Cohort2:Treatment Period2(Days 12 to 21) | Physician Decision | 0 | 2 | 0 |
| Cohort2:Treatment Period3(Days 22 to 31) | Adverse Event | 0 | 1 | 0 |
| Cohort2:Treatment Period3(Days 22 to 31) | Physician Decision | 0 | 2 | 0 |
| Cohort 3:Treatment Period2(Days 8 to 21) | Adverse Event | 0 | 0 | 1 |
| Cohort 3:Treatment Period2(Days 8 to 21) | Physician Decision | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | Cohort 1: GSK3640254 Then DRV/RTV Then GSK3640254 + DRV/RTV | Cohort 2: GSK3640254 Then ETR Then GSK3640254 + ETR | Cohort 3: GSK3640254 Then GSK3640254 + DRV/RTV + ETR | Total |
|---|---|---|---|---|
| Age, Continuous | 34.3 Years STANDARD_DEVIATION 5.98 | 31.2 Years STANDARD_DEVIATION 6.18 | 32.0 Years STANDARD_DEVIATION 9.21 | 32.5 Years STANDARD_DEVIATION 7.14 |
| Race/Ethnicity, Customized AME INDIAN OR ALASKA NATIVE &BLA OR AFR AMR &WHITE | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized ASIAN-CENTRAL/SOUTH ASIAN HERITAGE (H) | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized ASIAN-JAPANESE H/EAST ASIAN H/SOUTH EAST ASIAN H | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized BLACK (BLA) OR AFRICAN AMERICAN (AFR AME) | 10 Participants | 8 Participants | 6 Participants | 24 Participants |
| Race/Ethnicity, Customized WHITE-ARABIC NORTH AFR WHITE H | 1 Participants | 2 Participants | 1 Participants | 4 Participants |
| Race/Ethnicity, Customized WHITE-CAUCASIAN EUROPEAN WHITE H | 7 Participants | 7 Participants | 9 Participants | 23 Participants |
| Sex: Female, Male Female | 5 Participants | 4 Participants | 2 Participants | 11 Participants |
| Sex: Female, Male Male | 14 Participants | 15 Participants | 14 Participants | 43 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk |
|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 19 | 0 / 16 | 0 / 15 | 0 / 19 | 0 / 16 | 0 / 16 | 0 / 16 | 0 / 15 |
| other Total, other adverse events | 6 / 19 | 4 / 16 | 5 / 15 | 3 / 19 | 4 / 16 | 7 / 16 | 1 / 16 | 8 / 15 |
| serious Total, serious adverse events | 0 / 19 | 0 / 16 | 0 / 15 | 0 / 19 | 0 / 16 | 0 / 16 | 0 / 16 | 0 / 15 |
Outcome results
Primary
Cohort 1: Area Under the Plasma Concentration-time Curve From Time Zero to the End of the Dosing Interval at Steady State (AUC[0-tau]) of GSK3640254
Blood samples were collected at indicated time points. Pharmacokinetic analysis was conducted using standard non-compartmental methods.
Time frame: Pre-dose and 0.5 Hours, 1 Hour, 1.5 Hours, 2 Hours, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 16 Hours, 24 Hours post-dose in Treatment Periods 1 and 3
Population: Pharmacokinetic Parameter Population comprised of all participants who underwent plasma pharmacokinetic sampling and had at least 1 evaluable Pharmacokinetic parameter estimated. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1: GSK3640254 200 mg | Cohort 1: Area Under the Plasma Concentration-time Curve From Time Zero to the End of the Dosing Interval at Steady State (AUC[0-tau]) of GSK3640254 | 27.03 Hours*micrograms per milliliter | Geometric Coefficient of Variation 33.7 |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 1: Area Under the Plasma Concentration-time Curve From Time Zero to the End of the Dosing Interval at Steady State (AUC[0-tau]) of GSK3640254 | 30.70 Hours*micrograms per milliliter | Geometric Coefficient of Variation 33.6 |
90% CI: [0.999, 1.293]
Primary
Cohort 1: AUC(0-tau) of DRV
Blood samples were collected at indicated time points. Pharmacokinetic analysis was conducted using standard non-compartmental methods.
Time frame: Pre-dose and 0.5 Hours, 1 Hour, 1.5 Hours, 2 Hours, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours post-dose in Treatment Periods 2 and 3
Population: Pharmacokinetic Parameter Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1: GSK3640254 200 mg | Cohort 1: AUC(0-tau) of DRV | 57.47 Hours*micrograms per milliliter | Geometric Coefficient of Variation 25.7 |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 1: AUC(0-tau) of DRV | 53.37 Hours*micrograms per milliliter | Geometric Coefficient of Variation 22.1 |
90% CI: [0.9313, 1.051]
Primary
Cohort 1: AUC(0-tau) of RTV
Blood samples were collected at indicated time points. Pharmacokinetic analysis was conducted using standard non-compartmental methods.
Time frame: Pre-dose and 0.5 Hours, 1 Hour, 1.5 Hours, 2 Hours, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours post-dose in Treatment Periods 2 and 3
Population: Pharmacokinetic Parameter Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1: GSK3640254 200 mg | Cohort 1: AUC(0-tau) of RTV | 7.303 Hours* micrograms per milliliter | Geometric Coefficient of Variation 48.7 |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 1: AUC(0-tau) of RTV | 7.790 Hours* micrograms per milliliter | Geometric Coefficient of Variation 45.9 |
90% CI: [1.025, 1.185]
Primary
Cohort 1: Cmax of DRV
Blood samples were collected at indicated time points. Pharmacokinetic analysis was conducted using standard non-compartmental methods.
Time frame: Pre-dose and 0.5 Hours, 1 Hour, 1.5 Hours, 2 Hours, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours post-dose in Treatment Periods 2 and 3
Population: Pharmacokinetic Parameter Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1: GSK3640254 200 mg | Cohort 1: Cmax of DRV | 7.037 Micrograms per milliliter | Geometric Coefficient of Variation 24.4 |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 1: Cmax of DRV | 7.268 Micrograms per milliliter | Geometric Coefficient of Variation 21.7 |
90% CI: [0.9816, 1.122]
Primary
Cohort 1: Cmax of RTV
Blood samples were collected at indicated time points. Pharmacokinetic analysis was conducted using standard non-compartmental methods.
Time frame: Pre-dose and 0.5 Hours, 1 Hour, 1.5 Hours, 2 Hours, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours post-dose in Treatment Periods 2 and 3
Population: Pharmacokinetic Parameter Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1: GSK3640254 200 mg | Cohort 1: Cmax of RTV | 1.178 Micrograms per milliliter | Geometric Coefficient of Variation 43.1 |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 1: Cmax of RTV | 1.306 Micrograms per milliliter | Geometric Coefficient of Variation 36.6 |
90% CI: [0.9947, 1.26]
Primary
Cohort 1: Maximum Observed Concentration (Cmax) of GSK3640254
Blood samples were collected at indicated time points. Pharmacokinetic analysis was conducted using standard non-compartmental methods.
Time frame: Pre-dose and 0.5 Hours, 1 Hour, 1.5 Hours, 2 Hours, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 16 Hours, 24 Hours post-dose in Treatment Periods 1 and 3
Population: Pharmacokinetic Parameter Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1: GSK3640254 200 mg | Cohort 1: Maximum Observed Concentration (Cmax) of GSK3640254 | 1.752 Micrograms per milliliter | Geometric Coefficient of Variation 39.1 |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 1: Maximum Observed Concentration (Cmax) of GSK3640254 | 1.863 Micrograms per milliliter | Geometric Coefficient of Variation 41 |
90% CI: [0.9185, 1.242]
Primary
Cohort 2: AUC(0-tau) of ETR
Blood samples were collected at indicated time points. Pharmacokinetic analysis was conducted using standard non-compartmental methods.
Time frame: Pre-dose and 0.5 Hours, 1 Hour, 1.5 Hours, 2 Hours, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours post-dose in Treatment Periods 2 and 3
Population: Pharmacokinetic Parameter Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1: GSK3640254 200 mg | Cohort 2: AUC(0-tau) of ETR | 8.340 Hours*micrograms per milliliter | Geometric Coefficient of Variation 36 |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 2: AUC(0-tau) of ETR | 9.791 Hours*micrograms per milliliter | Geometric Coefficient of Variation 32.8 |
90% CI: [1.082, 1.21]
Primary
Cohort 2: AUC(0-tau) of GSK3640254
Blood samples were collected at indicated time points. Pharmacokinetic analysis was conducted using standard non-compartmental methods.
Time frame: Pre-dose and 0.5 Hours, 1 Hour, 1.5 Hours, 2 Hours, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 16 Hours, 24 Hours post-dose in Treatment Periods 1 and 3
Population: Pharmacokinetic Parameter Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1: GSK3640254 200 mg | Cohort 2: AUC(0-tau) of GSK3640254 | 27.86 Hours*micrograms per milliliter | Geometric Coefficient of Variation 27.8 |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 2: AUC(0-tau) of GSK3640254 | 14.73 Hours*micrograms per milliliter | Geometric Coefficient of Variation 26.5 |
90% CI: [0.4801, 0.5848]
Primary
Cohort 2: Cmax of ETR
Blood samples were collected at indicated time points. Pharmacokinetic analysis was conducted using standard non-compartmental methods.
Time frame: Pre-dose and 0.5 Hours, 1 Hour, 1.5 Hours, 2 Hours, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours post-dose in Treatment Periods 2 and 3
Population: Pharmacokinetic Parameter Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1: GSK3640254 200 mg | Cohort 2: Cmax of ETR | 0.9749 Micrograms per milliliter | Geometric Coefficient of Variation 35.1 |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 2: Cmax of ETR | 1.102 Micrograms per milliliter | Geometric Coefficient of Variation 33 |
90% CI: [1.026, 1.187]
Primary
Cohort 2: Cmax of GSK3640254
Blood samples were collected at indicated time points. Pharmacokinetic analysis was conducted using standard non-compartmental methods.
Time frame: Pre-dose and 0.5 Hours, 1 Hour, 1.5 Hours, 2 Hours, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 16 Hours, 24 Hours post-dose in Treatment Periods 1 and 3
Population: Pharmacokinetic Parameter Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1: GSK3640254 200 mg | Cohort 2: Cmax of GSK3640254 | 1.889 Micrograms per milliliter | Geometric Coefficient of Variation 38.2 |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 2: Cmax of GSK3640254 | 1.136 Micrograms per milliliter | Geometric Coefficient of Variation 28.5 |
90% CI: [0.5271, 0.6833]
Primary
Cohort 3: AUC(0-tau) of GSK3640254
Blood samples were collected at indicated time points. Pharmacokinetic analysis was conducted using standard non-compartmental methods.
Time frame: Pre-dose and 0.5 Hours, 1 Hour, 1.5 Hours, 2 Hours, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 16 Hours, 24 Hours post-dose in Treatment Periods 1 and 2
Population: Pharmacokinetic Parameter Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1: GSK3640254 200 mg | Cohort 3: AUC(0-tau) of GSK3640254 | 24.99 Hours*micrograms per milliliter | Geometric Coefficient of Variation 34.7 |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 3: AUC(0-tau) of GSK3640254 | 22.78 Hours*micrograms per milliliter | Geometric Coefficient of Variation 34.3 |
90% CI: [0.8147, 1.093]
Primary
Cohort 3: Cmax of GSK3640254
Blood samples were collected at indicated time points. Pharmacokinetic analysis was conducted using standard non-compartmental methods.
Time frame: Pre-dose and 0.5 Hours, 1 Hour, 1.5 Hours, 2 Hours, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 16 Hours, 24 Hours post-dose in Treatment Periods 1 and 2
Population: Pharmacokinetic Parameter Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1: GSK3640254 200 mg | Cohort 3: Cmax of GSK3640254 | 1.578 Micrograms per milliliter | Geometric Coefficient of Variation 34.8 |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 3: Cmax of GSK3640254 | 1.383 Micrograms per milliliter | Geometric Coefficient of Variation 32.5 |
90% CI: [0.7467, 1.068]
Secondary
Cohort 1: Ctau of GSK3640254
Blood samples were collected at indicated time points. Pharmacokinetic analysis was conducted using standard non-compartmental methods.
Time frame: Pre-dose and 0.5 Hours, 1 Hour, 1.5 Hours, 2 Hours, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 16 Hours, 24 Hours post-dose in Treatment Periods 1 and 3
Population: Pharmacokinetic Parameter Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1: GSK3640254 200 mg | Cohort 1: Ctau of GSK3640254 | 0.8152 Micrograms per milliliter | Geometric Coefficient of Variation 34.5 |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 1: Ctau of GSK3640254 | 0.9530 Micrograms per milliliter | Geometric Coefficient of Variation 35.2 |
Secondary
Cohort 1: Ctau of RTV
Blood samples were collected at indicated time points. Pharmacokinetic analysis was conducted using standard non-compartmental methods.
Time frame: Pre-dose and 0.5 Hours, 1 Hour, 1.5 Hours, 2 Hours, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours post-dose in Treatment Periods 2 and 3
Population: Pharmacokinetic Parameter Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1: GSK3640254 200 mg | Cohort 1: Ctau of RTV | 0.3194 Micrograms per milliliter | Geometric Coefficient of Variation 77.4 |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 1: Ctau of RTV | 0.3314 Micrograms per milliliter | Geometric Coefficient of Variation 91.1 |
Secondary
Cohort 1: Number of Participants With AEs Leading to Discontinuations and Deaths
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. Number of participants with AEs leading to discontinuations and deaths were reported.
Time frame: Up to Day 35
Population: Safety Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1: GSK3640254 200 mg | Cohort 1: Number of Participants With AEs Leading to Discontinuations and Deaths | AEs leading to discontinuations | 0 Participants |
| Cohort 1: GSK3640254 200 mg | Cohort 1: Number of Participants With AEs Leading to Discontinuations and Deaths | AES leading to deaths | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 1: Number of Participants With AEs Leading to Discontinuations and Deaths | AEs leading to discontinuations | 1 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 1: Number of Participants With AEs Leading to Discontinuations and Deaths | AES leading to deaths | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 1: Number of Participants With AEs Leading to Discontinuations and Deaths | AEs leading to discontinuations | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 1: Number of Participants With AEs Leading to Discontinuations and Deaths | AES leading to deaths | 0 Participants |
Secondary
Cohort 1: Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG) Findings
A 12-lead ECG was recorded with the participant in a supine position using an automated ECG machine. Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. Data for number of participants with clinically significant abnormal ECG findings were reported. Data has been presented for the participants with respect to the actual treatment received in respective treatment periods.
Time frame: Day 1 (2,4,6 Hours), Day 7 and Day 11 in Treatment Period 1; Day 12 (2,4,6 Hours), Day 21 in Treatment Period 2; Day 22 (2,4,6 Hours), Day 26 and Day 35 in Treatment Period 3
Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1: GSK3640254 200 mg | Cohort 1: Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG) Findings | 2 Hours, Day 1 | 0 Participants |
| Cohort 1: GSK3640254 200 mg | Cohort 1: Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG) Findings | 4 Hours, Day 1 | 0 Participants |
| Cohort 1: GSK3640254 200 mg | Cohort 1: Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG) Findings | 6 Hours; Day 1 | 0 Participants |
| Cohort 1: GSK3640254 200 mg | Cohort 1: Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG) Findings | Day 7 | 0 Participants |
| Cohort 1: GSK3640254 200 mg | Cohort 1: Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG) Findings | Day 11 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 1: Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG) Findings | 2 Hours, Day 12 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 1: Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG) Findings | 4 Hours, Day 12 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 1: Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG) Findings | 6 Hours; Day 12 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 1: Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG) Findings | Day 21 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 1: Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG) Findings | 2 Hours; Day 22 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 1: Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG) Findings | 4 Hours; Day 22 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 1: Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG) Findings | 6 Hours; Day 22 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 1: Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG) Findings | Day 26 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 1: Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG) Findings | Day 35 | 0 Participants |
Secondary
Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Bilirubin and Direct Bilirubin
Blood samples were collected for analysis of clinical chemistry parameters. Laboratory abnormalities were graded according to DAIDS grading table Version 2.1. For Alanine Aminotransferase High; Grade 3: 5.0 to \<10.0 times (×) Upper Limit Normal (ULN), Grade 4: \>=10.0 × ULN; Albumin Low, Grade 3: \<2.0 grams per deciliter (g/dL), Grade 4: Not Applicable; Alkaline Phosphatase High, Grade 3: 5.0 to \<10.0 × ULN, Grade 4: \>=10.0 × ULN; Amylase High, Grade 3: 3.0 to \<5.0 × ULN, Grade 4: \>=5.0 × ULN; Aspartate Aminotransferase High, Grade 3: 5.0 to \<10.0 × ULN, Grade 4: \>=10.0 × ULN; Bilirubin High, Grade 3: 2.6 to\<5.0 × ULN, Grade 4: \>=5.0 × ULN and Direct Bilirubin High, Grade 3: \>ULN with other signs and symptoms of hepatotoxicity, Grade 4: \>ULN with life-threatening consequences. Baseline was defined as latest pre-dose assessment with a non-missing value, including those from unscheduled visits. An increase is defined as an increase in DAIDS grade relative to Baseline grade.
Time frame: Baseline (Pre-dose, Day-1) and up to Day 35
Population: Safety Population. Only those participants with increase to grade 3 and increase to grade 4 were presented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1: GSK3640254 200 mg | Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Bilirubin and Direct Bilirubin | Direct Bilirubin, High, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg | Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Bilirubin and Direct Bilirubin | Aspartate Aminotransferase, High, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg | Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Bilirubin and Direct Bilirubin | Alkaline Phosphatase, High, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg | Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Bilirubin and Direct Bilirubin | Alanine Aminotransferase, High, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg | Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Bilirubin and Direct Bilirubin | Aspartate Aminotransferase, High, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg | Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Bilirubin and Direct Bilirubin | Alanine Aminotransferase, High, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg | Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Bilirubin and Direct Bilirubin | Amylase, High, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg | Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Bilirubin and Direct Bilirubin | Direct Bilirubin, High, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg | Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Bilirubin and Direct Bilirubin | Albumin, Low, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg | Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Bilirubin and Direct Bilirubin | Amylase, High, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg | Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Bilirubin and Direct Bilirubin | Bilirubin, High, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg | Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Bilirubin and Direct Bilirubin | Albumin, Low, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg | Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Bilirubin and Direct Bilirubin | Bilirubin, High, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg | Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Bilirubin and Direct Bilirubin | Alkaline Phosphatase, High, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Bilirubin and Direct Bilirubin | Bilirubin, High, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Bilirubin and Direct Bilirubin | Alanine Aminotransferase, High, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Bilirubin and Direct Bilirubin | Alanine Aminotransferase, High, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Bilirubin and Direct Bilirubin | Albumin, Low, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Bilirubin and Direct Bilirubin | Alkaline Phosphatase, High, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Bilirubin and Direct Bilirubin | Alkaline Phosphatase, High, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Bilirubin and Direct Bilirubin | Amylase, High, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Bilirubin and Direct Bilirubin | Amylase, High, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Bilirubin and Direct Bilirubin | Aspartate Aminotransferase, High, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Bilirubin and Direct Bilirubin | Aspartate Aminotransferase, High, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Bilirubin and Direct Bilirubin | Albumin, Low, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Bilirubin and Direct Bilirubin | Bilirubin, High, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Bilirubin and Direct Bilirubin | Direct Bilirubin, High, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Bilirubin and Direct Bilirubin | Direct Bilirubin, High, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Bilirubin and Direct Bilirubin | Direct Bilirubin, High, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Bilirubin and Direct Bilirubin | Aspartate Aminotransferase, High, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Bilirubin and Direct Bilirubin | Albumin, Low, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Bilirubin and Direct Bilirubin | Direct Bilirubin, High, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Bilirubin and Direct Bilirubin | Bilirubin, High, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Bilirubin and Direct Bilirubin | Albumin, Low, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Bilirubin and Direct Bilirubin | Alanine Aminotransferase, High, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Bilirubin and Direct Bilirubin | Amylase, High, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Bilirubin and Direct Bilirubin | Bilirubin, High, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Bilirubin and Direct Bilirubin | Amylase, High, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Bilirubin and Direct Bilirubin | Alkaline Phosphatase, High, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Bilirubin and Direct Bilirubin | Alanine Aminotransferase, High, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Bilirubin and Direct Bilirubin | Aspartate Aminotransferase, High, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Bilirubin and Direct Bilirubin | Alkaline Phosphatase, High, Increase to Grade 3 | 0 Participants |
Secondary
Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Calcium, Creatine Kinase, Creatinine, Phosphate, Potassium and Sodium
Blood samples were collected for analysis of clinical chemistry parameters. Laboratory abnormalities were graded according to DAIDS grading table Version 2.1. For Calcium High, Grade 3: 12.5 to \<13.5 milligrams/deciliter (mg/dL), Grade 4: \>=13.5 mg/dL; Calcium Low, Grade 3: 6.1 to \<7.0 mg/dL, Grade 4: \<6.1 mg/dL; Creatine Kinase High, Grade 3: 10 to \<20 × ULN, Grade 4: \>=20 × ULN; Creatinine High, Grade 3: \>1.8 to \<3.5 ULN, Grade 4: \>=3.5 × ULN; Phosphate Low, Grade 3: 1.0 to \<1.4 mg/dL, Grade 4: \<1.0 mg/dL; Potassium High, Grade 3: 6.5 to \<7.0 Milliequivalents per liter (mEq/L),Grade 4: \>=7.0 mEq/L; Potassium Low, Grade 3: 2.0 to \<2.5 mEq/L, Grade 4: \<2.00 mEq/L; Sodium High, Grade 3: 154 to \<160 mEq/L, Grade 4:\>=160 mEq/L; Sodium Low, Grade 3: 121 to \<125 mEq/L, Grade 4:\<=120 mEq/L. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. An increase is defined as an increase in DAIDS grade relative to Baseline grade.
Time frame: Baseline (Pre-dose, Day-1) and up to Day 35
Population: Safety Population. Only those participants with increase to grade 3 and increase to grade 4 were presented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1: GSK3640254 200 mg | Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Calcium, Creatine Kinase, Creatinine, Phosphate, Potassium and Sodium | Calcium, Low, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg | Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Calcium, Creatine Kinase, Creatinine, Phosphate, Potassium and Sodium | Potassium, Low, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg | Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Calcium, Creatine Kinase, Creatinine, Phosphate, Potassium and Sodium | Creatinine, High, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg | Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Calcium, Creatine Kinase, Creatinine, Phosphate, Potassium and Sodium | Sodium, Low, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg | Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Calcium, Creatine Kinase, Creatinine, Phosphate, Potassium and Sodium | Potassium, Low, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg | Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Calcium, Creatine Kinase, Creatinine, Phosphate, Potassium and Sodium | Creatinine, High, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg | Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Calcium, Creatine Kinase, Creatinine, Phosphate, Potassium and Sodium | Calcium, High, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg | Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Calcium, Creatine Kinase, Creatinine, Phosphate, Potassium and Sodium | Phosphate, Low, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg | Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Calcium, Creatine Kinase, Creatinine, Phosphate, Potassium and Sodium | Phosphate, Low, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg | Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Calcium, Creatine Kinase, Creatinine, Phosphate, Potassium and Sodium | Sodium, High, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg | Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Calcium, Creatine Kinase, Creatinine, Phosphate, Potassium and Sodium | Sodium, Low, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg | Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Calcium, Creatine Kinase, Creatinine, Phosphate, Potassium and Sodium | Calcium, High, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg | Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Calcium, Creatine Kinase, Creatinine, Phosphate, Potassium and Sodium | Sodium, High, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg | Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Calcium, Creatine Kinase, Creatinine, Phosphate, Potassium and Sodium | Potassium, High, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg | Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Calcium, Creatine Kinase, Creatinine, Phosphate, Potassium and Sodium | Creatine Kinase, High, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg | Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Calcium, Creatine Kinase, Creatinine, Phosphate, Potassium and Sodium | Calcium, Low, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg | Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Calcium, Creatine Kinase, Creatinine, Phosphate, Potassium and Sodium | Potassium, High, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg | Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Calcium, Creatine Kinase, Creatinine, Phosphate, Potassium and Sodium | Creatine Kinase, High, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Calcium, Creatine Kinase, Creatinine, Phosphate, Potassium and Sodium | Potassium, High, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Calcium, Creatine Kinase, Creatinine, Phosphate, Potassium and Sodium | Calcium, Low, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Calcium, Creatine Kinase, Creatinine, Phosphate, Potassium and Sodium | Calcium, Low, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Calcium, Creatine Kinase, Creatinine, Phosphate, Potassium and Sodium | Calcium, High, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Calcium, Creatine Kinase, Creatinine, Phosphate, Potassium and Sodium | Calcium, High, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Calcium, Creatine Kinase, Creatinine, Phosphate, Potassium and Sodium | Creatine Kinase, High, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Calcium, Creatine Kinase, Creatinine, Phosphate, Potassium and Sodium | Creatine Kinase, High, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Calcium, Creatine Kinase, Creatinine, Phosphate, Potassium and Sodium | Creatinine, High, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Calcium, Creatine Kinase, Creatinine, Phosphate, Potassium and Sodium | Creatinine, High, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Calcium, Creatine Kinase, Creatinine, Phosphate, Potassium and Sodium | Phosphate, Low, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Calcium, Creatine Kinase, Creatinine, Phosphate, Potassium and Sodium | Phosphate, Low, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Calcium, Creatine Kinase, Creatinine, Phosphate, Potassium and Sodium | Potassium, Low, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Calcium, Creatine Kinase, Creatinine, Phosphate, Potassium and Sodium | Potassium, Low, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Calcium, Creatine Kinase, Creatinine, Phosphate, Potassium and Sodium | Potassium, High, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Calcium, Creatine Kinase, Creatinine, Phosphate, Potassium and Sodium | Sodium, Low, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Calcium, Creatine Kinase, Creatinine, Phosphate, Potassium and Sodium | Sodium, Low, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Calcium, Creatine Kinase, Creatinine, Phosphate, Potassium and Sodium | Sodium, High, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Calcium, Creatine Kinase, Creatinine, Phosphate, Potassium and Sodium | Sodium, High, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Calcium, Creatine Kinase, Creatinine, Phosphate, Potassium and Sodium | Sodium, Low, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Calcium, Creatine Kinase, Creatinine, Phosphate, Potassium and Sodium | Potassium, Low, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Calcium, Creatine Kinase, Creatinine, Phosphate, Potassium and Sodium | Creatine Kinase, High, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Calcium, Creatine Kinase, Creatinine, Phosphate, Potassium and Sodium | Calcium, Low, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Calcium, Creatine Kinase, Creatinine, Phosphate, Potassium and Sodium | Potassium, High, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Calcium, Creatine Kinase, Creatinine, Phosphate, Potassium and Sodium | Calcium, High, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Calcium, Creatine Kinase, Creatinine, Phosphate, Potassium and Sodium | Potassium, High, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Calcium, Creatine Kinase, Creatinine, Phosphate, Potassium and Sodium | Calcium, High, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Calcium, Creatine Kinase, Creatinine, Phosphate, Potassium and Sodium | Sodium, High, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Calcium, Creatine Kinase, Creatinine, Phosphate, Potassium and Sodium | Sodium, Low, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Calcium, Creatine Kinase, Creatinine, Phosphate, Potassium and Sodium | Phosphate, Low, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Calcium, Creatine Kinase, Creatinine, Phosphate, Potassium and Sodium | Creatinine, High, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Calcium, Creatine Kinase, Creatinine, Phosphate, Potassium and Sodium | Calcium, Low, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Calcium, Creatine Kinase, Creatinine, Phosphate, Potassium and Sodium | Phosphate, Low, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Calcium, Creatine Kinase, Creatinine, Phosphate, Potassium and Sodium | Creatinine, High, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Calcium, Creatine Kinase, Creatinine, Phosphate, Potassium and Sodium | Sodium, High, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Calcium, Creatine Kinase, Creatinine, Phosphate, Potassium and Sodium | Potassium, Low, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Calcium, Creatine Kinase, Creatinine, Phosphate, Potassium and Sodium | Creatine Kinase, High, Increase to Grade 4 | 0 Participants |
Secondary
Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Glucose, Triglycerides, Lipase, Urate and Cholesterol
Blood samples were collected for analysis of clinical chemistry parameters. Laboratory abnormalities were graded according to DAIDS grading table Version 2.1. For Glucose High, Grade 3: \>250 to 500 mg/dL, Grade 4: \>=500 mg/dL, Glucose Low, Grade 3: 30 to\<40 mg/dL, Grade 4:\<30 mg/dL; Triglycerides High, Grade 3: \>500 to \<1.000 mg/dL, Grade 4:\>1000 mg/dL; Lipase High, Grade 3: 3.0 to \<5.0×ULN, Grade 4:\>=5.0×ULN; Urate High, Grade 3: 12.0 to \<15.0 mEq/L, Grade 4:\>=15.0 mEq/L; Cholesterol High, Grade 3: \>=300 mg/dL, Grade 4: Not Applicable. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. An increase is defined as an increase in DAIDS grade relative to Baseline grade.
Time frame: Baseline (Pre-dose, Day-1) and up to Day 35
Population: Safety Population. Only those participants with increase to grade 3 and increase to grade 4 were presented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1: GSK3640254 200 mg | Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Glucose, Triglycerides, Lipase, Urate and Cholesterol | Lipase, High, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg | Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Glucose, Triglycerides, Lipase, Urate and Cholesterol | Urate, High, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg | Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Glucose, Triglycerides, Lipase, Urate and Cholesterol | Cholesterol, High, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg | Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Glucose, Triglycerides, Lipase, Urate and Cholesterol | Urate, High, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg | Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Glucose, Triglycerides, Lipase, Urate and Cholesterol | Glucose, High, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg | Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Glucose, Triglycerides, Lipase, Urate and Cholesterol | Cholesterol, High, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg | Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Glucose, Triglycerides, Lipase, Urate and Cholesterol | Glucose, Low, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg | Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Glucose, Triglycerides, Lipase, Urate and Cholesterol | Glucose, High, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg | Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Glucose, Triglycerides, Lipase, Urate and Cholesterol | Triglycerides, High, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg | Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Glucose, Triglycerides, Lipase, Urate and Cholesterol | Triglycerides, High, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg | Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Glucose, Triglycerides, Lipase, Urate and Cholesterol | Glucose, Low, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg | Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Glucose, Triglycerides, Lipase, Urate and Cholesterol | Lipase, High, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Glucose, Triglycerides, Lipase, Urate and Cholesterol | Triglycerides, High, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Glucose, Triglycerides, Lipase, Urate and Cholesterol | Lipase, High, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Glucose, Triglycerides, Lipase, Urate and Cholesterol | Glucose, High, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Glucose, Triglycerides, Lipase, Urate and Cholesterol | Urate, High, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Glucose, Triglycerides, Lipase, Urate and Cholesterol | Glucose, Low, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Glucose, Triglycerides, Lipase, Urate and Cholesterol | Lipase, High, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Glucose, Triglycerides, Lipase, Urate and Cholesterol | Urate, High, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Glucose, Triglycerides, Lipase, Urate and Cholesterol | Triglycerides, High, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Glucose, Triglycerides, Lipase, Urate and Cholesterol | Cholesterol, High, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Glucose, Triglycerides, Lipase, Urate and Cholesterol | Glucose, High, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Glucose, Triglycerides, Lipase, Urate and Cholesterol | Cholesterol, High, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Glucose, Triglycerides, Lipase, Urate and Cholesterol | Glucose, Low, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Glucose, Triglycerides, Lipase, Urate and Cholesterol | Cholesterol, High, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Glucose, Triglycerides, Lipase, Urate and Cholesterol | Glucose, Low, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Glucose, Triglycerides, Lipase, Urate and Cholesterol | Glucose, Low, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Glucose, Triglycerides, Lipase, Urate and Cholesterol | Glucose, High, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Glucose, Triglycerides, Lipase, Urate and Cholesterol | Glucose, High, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Glucose, Triglycerides, Lipase, Urate and Cholesterol | Triglycerides, High, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Glucose, Triglycerides, Lipase, Urate and Cholesterol | Triglycerides, High, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Glucose, Triglycerides, Lipase, Urate and Cholesterol | Lipase, High, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Glucose, Triglycerides, Lipase, Urate and Cholesterol | Urate, High, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Glucose, Triglycerides, Lipase, Urate and Cholesterol | Urate, High, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Glucose, Triglycerides, Lipase, Urate and Cholesterol | Cholesterol, High, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Glucose, Triglycerides, Lipase, Urate and Cholesterol | Lipase, High, Increase to Grade 4 | 0 Participants |
Secondary
Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Hematology Parameters
Blood samples were collected for analysis of hematology parameters. Laboratory abnormalities were graded according to Division of Acquired Immunodeficiency Syndrome (DAIDS) grading table Version 2.1. For Hemoglobin Low, Grade 3: 7.0 to \<9.0 Grams per deciliter (g/dL) (males) and 6.5 to \<8.5 g/dL (females),Grade 4: \<7.0 g/dL (males) and \<6.5 g/dL (females); Leukocytes Low, Grade 3: 1000 to 1499 cells per cubic millimeter (cells/mm\^3),Grade 4: \<1000 cells/mm\^3; Lymphocytes Low, Grade 3: 350 to \<500 cells per liter (cells/L),Grade 4: \<350 cells/L; Neutrophils Low, Grade 3: 400 to 599 cells/mm\^3, Grade 4: \<400 cells/mm\^3; Platelets Low, Grade 3: 25,000 to \<50,000 cells/mm\^3, Grade 4: \<25,000 cells/mm\^3. Baseline was defined as latest pre-dose assessment with a non-missing value, including those from unscheduled visits. An increase is defined as an increase in DAIDS grade relative to Baseline grade.
Time frame: Baseline (Pre-dose, Day-1) and up to Day 35
Population: Safety Population. Only those participants with increase to grade 3 and increase to grade 4 were presented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1: GSK3640254 200 mg | Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Hematology Parameters | Lymphocytes, Low, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg | Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Hematology Parameters | Neutrophils, Low, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg | Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Hematology Parameters | Neutrophils, Low, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg | Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Hematology Parameters | Platelets, Low, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg | Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Hematology Parameters | Hemoglobin, Low, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg | Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Hematology Parameters | Platelets, Low, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg | Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Hematology Parameters | Leukocytes, Low, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg | Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Hematology Parameters | Leukocytes, Low, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg | Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Hematology Parameters | Lymphocytes, Low, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg | Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Hematology Parameters | Hemoglobin, Low, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Hematology Parameters | Lymphocytes, Low, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Hematology Parameters | Leukocytes, Low, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Hematology Parameters | Neutrophils, Low, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Hematology Parameters | Hemoglobin, Low, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Hematology Parameters | Hemoglobin, Low, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Hematology Parameters | Neutrophils, Low, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Hematology Parameters | Lymphocytes, Low, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Hematology Parameters | Platelets, Low, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Hematology Parameters | Leukocytes, Low, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Hematology Parameters | Platelets, Low, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Hematology Parameters | Leukocytes, Low, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Hematology Parameters | Neutrophils, Low, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Hematology Parameters | Platelets, Low, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Hematology Parameters | Hemoglobin, Low, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Hematology Parameters | Hemoglobin, Low, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Hematology Parameters | Leukocytes, Low, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Hematology Parameters | Lymphocytes, Low, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Hematology Parameters | Lymphocytes, Low, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Hematology Parameters | Neutrophils, Low, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Hematology Parameters | Platelets, Low, Increase to Grade 3 | 0 Participants |
Secondary
Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Urinalysis Parameters
Urine samples were collected for urinalysis parameters. Laboratory abnormalities were graded according to DAIDS grading table Version 2.1. For Erythrocytes High, Grade 3: Gross, with or without clots OR with Red Blood Cells (RBC) casts OR intervention indicated, Grade 4: Life-threatening consequences; Glucose High, Grade 3: \>2+ (proportionate concentration by dipstick test) or \>500 mg, Grade 4: \>500 mg; Protein High, Grade 3: 3+ (proportionate concentration by dipstick test) or higher, Grade 4: Not Applicable. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. An increase is defined as an increase in DAIDS grade relative to Baseline grade.
Time frame: Baseline (Pre-dose, Day-1) and up to Day 35
Population: Safety Population. Only those participants with increase to grade 3 and increase to grade 4 were presented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1: GSK3640254 200 mg | Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Urinalysis Parameters | Erythrocytes, High, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg | Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Urinalysis Parameters | Erythrocytes, High, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg | Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Urinalysis Parameters | Glucose, High, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg | Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Urinalysis Parameters | Glucose, High, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg | Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Urinalysis Parameters | Protein, High, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg | Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Urinalysis Parameters | Protein, High, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Urinalysis Parameters | Protein, High, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Urinalysis Parameters | Erythrocytes, High, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Urinalysis Parameters | Glucose, High, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Urinalysis Parameters | Protein, High, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Urinalysis Parameters | Erythrocytes, High, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Urinalysis Parameters | Glucose, High, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Urinalysis Parameters | Erythrocytes, High, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Urinalysis Parameters | Glucose, High, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Urinalysis Parameters | Protein, High, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Urinalysis Parameters | Glucose, High, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Urinalysis Parameters | Erythrocytes, High, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Urinalysis Parameters | Protein, High, Increase to Grade 3 | 0 Participants |
Secondary
Cohort 1: Number of Participants With Serious Adverse Events (SAEs) and Non-serious Adverse Events (Non-SAEs)
An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is defined as any untoward medical occurrence that, at any dose that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or other situations as per medical or scientific judgment. Adverse events which were not Serious were considered as Non-Serious adverse events.
Time frame: Up to Day 35
Population: Safety Population comprised of all participants who received at least 1 dose of study medication.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1: GSK3640254 200 mg | Cohort 1: Number of Participants With Serious Adverse Events (SAEs) and Non-serious Adverse Events (Non-SAEs) | non-SAE | 6 Participants |
| Cohort 1: GSK3640254 200 mg | Cohort 1: Number of Participants With Serious Adverse Events (SAEs) and Non-serious Adverse Events (Non-SAEs) | SAE | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 1: Number of Participants With Serious Adverse Events (SAEs) and Non-serious Adverse Events (Non-SAEs) | SAE | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 1: Number of Participants With Serious Adverse Events (SAEs) and Non-serious Adverse Events (Non-SAEs) | non-SAE | 4 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 1: Number of Participants With Serious Adverse Events (SAEs) and Non-serious Adverse Events (Non-SAEs) | SAE | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 1: Number of Participants With Serious Adverse Events (SAEs) and Non-serious Adverse Events (Non-SAEs) | non-SAE | 5 Participants |
Secondary
Cohort 1: Number of Participants With Vital Sign Values of Potential Clinical Importance (PCI) Criteria
Vital signs including systolic blood pressure (SBP), diastolic blood pressure (DBP) and pulse rate were measured in a supine position after atleast 5 minutes of rest. The PCI ranges for vitals were as follows; for SBP \<85 or \>140 millimeters of mercury (mmHg), for DBP \<45 or \>90 mmHg, for pulse rate \<40 or \>100 beats per minute. The number of participants with vital signs of PCI were presented.
Time frame: Up to Day 35
Population: Safety Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1: GSK3640254 200 mg | Cohort 1: Number of Participants With Vital Sign Values of Potential Clinical Importance (PCI) Criteria | DBP | 0 Participants |
| Cohort 1: GSK3640254 200 mg | Cohort 1: Number of Participants With Vital Sign Values of Potential Clinical Importance (PCI) Criteria | SBP | 0 Participants |
| Cohort 1: GSK3640254 200 mg | Cohort 1: Number of Participants With Vital Sign Values of Potential Clinical Importance (PCI) Criteria | Pulse rate | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 1: Number of Participants With Vital Sign Values of Potential Clinical Importance (PCI) Criteria | DBP | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 1: Number of Participants With Vital Sign Values of Potential Clinical Importance (PCI) Criteria | SBP | 2 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 1: Number of Participants With Vital Sign Values of Potential Clinical Importance (PCI) Criteria | Pulse rate | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 1: Number of Participants With Vital Sign Values of Potential Clinical Importance (PCI) Criteria | SBP | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 1: Number of Participants With Vital Sign Values of Potential Clinical Importance (PCI) Criteria | Pulse rate | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 1: Number of Participants With Vital Sign Values of Potential Clinical Importance (PCI) Criteria | DBP | 0 Participants |
Secondary
Cohort 1: Plasma Concentration at the End of the Dosing Interval (Ctau) of DRV
Blood samples were collected at indicated time points. Pharmacokinetic analysis was conducted using standard non-compartmental methods.
Time frame: Pre-dose and 0.5 Hours, 1 Hour, 1.5 Hours, 2 Hours, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours post-dose in Treatment Periods 2 and 3
Population: Pharmacokinetic Parameter Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1: GSK3640254 200 mg | Cohort 1: Plasma Concentration at the End of the Dosing Interval (Ctau) of DRV | 2.957 Micrograms per milliliter | Geometric Coefficient of Variation 37 |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 1: Plasma Concentration at the End of the Dosing Interval (Ctau) of DRV | 2.637 Micrograms per milliliter | Geometric Coefficient of Variation 36.5 |
Secondary
Cohort 1: Time of Maximum Observed Concentration (Tmax) of DRV
Blood samples were collected at indicated time points. Pharmacokinetic analysis was conducted using standard non-compartmental methods.
Time frame: Pre-dose and 0.5 Hours, 1 Hour, 1.5 Hours, 2 Hours, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours post-dose in Treatment Periods 2 and 3
Population: Pharmacokinetic Parameter Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Cohort 1: GSK3640254 200 mg | Cohort 1: Time of Maximum Observed Concentration (Tmax) of DRV | 3.000 Hours |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 1: Time of Maximum Observed Concentration (Tmax) of DRV | 3.000 Hours |
Secondary
Cohort 1: Tmax of GSK3640254
Blood samples were collected at indicated time points. Pharmacokinetic analysis was conducted using standard non-compartmental methods.
Time frame: Pre-dose and 0.5 Hours, 1 Hour, 1.5 Hours, 2 Hours, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 16 Hours, 24 Hours post-dose in Treatment Periods 1 and 3
Population: Pharmacokinetic Parameter Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Cohort 1: GSK3640254 200 mg | Cohort 1: Tmax of GSK3640254 | 4.000 Hours |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 1: Tmax of GSK3640254 | 4.000 Hours |
Secondary
Cohort 1: Tmax of RTV
Blood samples were collected at indicated time points. Pharmacokinetic analysis was conducted using standard non-compartmental methods.
Time frame: Pre-dose and 0.5 Hours, 1 Hour, 1.5 Hours, 2 Hours, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours post-dose in Treatment Periods 2 and 3
Population: Pharmacokinetic Parameter Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Cohort 1: GSK3640254 200 mg | Cohort 1: Tmax of RTV | 4.000 Hours |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 1: Tmax of RTV | 4.000 Hours |
Secondary
Cohort 2: Ctau of ETR
Blood samples were collected at indicated time points. Pharmacokinetic analysis was conducted using standard non-compartmental methods.
Time frame: Pre-dose and 0.5 Hours, 1 Hour, 1.5 Hours, 2 Hours, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours post-dose in Treatment Periods 2 and 3
Population: Pharmacokinetic Parameter Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1: GSK3640254 200 mg | Cohort 2: Ctau of ETR | 0.4705 Micrograms per milliliter | Geometric Coefficient of Variation 37.8 |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 2: Ctau of ETR | 0.5837 Micrograms per milliliter | Geometric Coefficient of Variation 33.1 |
Secondary
Cohort 2: Ctau of GSK3640254
Blood samples were collected at indicated time points. Pharmacokinetic analysis was conducted using standard non-compartmental methods.
Time frame: Pre-dose and 0.5 Hours, 1 Hour, 1.5 Hours, 2 Hours, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 16 Hours, 24 Hours post-dose in Treatment Periods 1 and 3
Population: Pharmacokinetic Parameter Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1: GSK3640254 200 mg | Cohort 2: Ctau of GSK3640254 | 0.7706 Micrograms per milliliter | Geometric Coefficient of Variation 36.3 |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 2: Ctau of GSK3640254 | 0.3901 Micrograms per milliliter | Geometric Coefficient of Variation 50.2 |
Secondary
Cohort 2: Number of Participants With AEs Leading to Discontinuations and Deaths
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. Number of participants with AEs leading to discontinuations and deaths were reported.
Time frame: Up to Day 36
Population: Safety Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1: GSK3640254 200 mg | Cohort 2: Number of Participants With AEs Leading to Discontinuations and Deaths | AES leading to deaths | 0 Participants |
| Cohort 1: GSK3640254 200 mg | Cohort 2: Number of Participants With AEs Leading to Discontinuations and Deaths | AEs leading to discontinuations | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 2: Number of Participants With AEs Leading to Discontinuations and Deaths | AES leading to deaths | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 2: Number of Participants With AEs Leading to Discontinuations and Deaths | AEs leading to discontinuations | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 2: Number of Participants With AEs Leading to Discontinuations and Deaths | AEs leading to discontinuations | 1 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 2: Number of Participants With AEs Leading to Discontinuations and Deaths | AES leading to deaths | 0 Participants |
Secondary
Cohort 2: Number of Participants With Clinically Significant Abnormal ECG Findings
A 12-lead ECG was recorded with the participant in a supine position using an automated ECG machine. Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. Data for number of participants with clinically significant abnormal ECG findings were reported. Data has been presented for the participants with respect to the actual treatment received in respective treatment periods.
Time frame: Day 1 (2,4,6 Hours), Day 7 and Day 11 in Treatment Period 1; Day 12 (2,4,6 Hours), Day 21 in Treatment Period 2; Day 22 (2,4,6 Hours), Day 26 and Day 36 in Treatment Period 3
Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1: GSK3640254 200 mg | Cohort 2: Number of Participants With Clinically Significant Abnormal ECG Findings | 2 Hours, Day 1 | 0 Participants |
| Cohort 1: GSK3640254 200 mg | Cohort 2: Number of Participants With Clinically Significant Abnormal ECG Findings | 4 Hours, Day 1 | 0 Participants |
| Cohort 1: GSK3640254 200 mg | Cohort 2: Number of Participants With Clinically Significant Abnormal ECG Findings | 6 Hours; Day 1 | 0 Participants |
| Cohort 1: GSK3640254 200 mg | Cohort 2: Number of Participants With Clinically Significant Abnormal ECG Findings | Day 7 | 0 Participants |
| Cohort 1: GSK3640254 200 mg | Cohort 2: Number of Participants With Clinically Significant Abnormal ECG Findings | Day 11 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 2: Number of Participants With Clinically Significant Abnormal ECG Findings | 2 Hours, Day 12 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 2: Number of Participants With Clinically Significant Abnormal ECG Findings | 4 Hours, Day 12 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 2: Number of Participants With Clinically Significant Abnormal ECG Findings | 6 Hours; Day 12 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 2: Number of Participants With Clinically Significant Abnormal ECG Findings | Day 21 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 2: Number of Participants With Clinically Significant Abnormal ECG Findings | 2 Hours; Day 22 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 2: Number of Participants With Clinically Significant Abnormal ECG Findings | 4 Hours; Day 22 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 2: Number of Participants With Clinically Significant Abnormal ECG Findings | 6 Hours; Day 22 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 2: Number of Participants With Clinically Significant Abnormal ECG Findings | Day 26 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 2: Number of Participants With Clinically Significant Abnormal ECG Findings | Day 36 | 0 Participants |
Secondary
Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Bilirubin and Direct Bilirubin
Blood samples were collected for analysis of clinical chemistry parameters. Laboratory abnormalities were graded according to DAIDS grading table Version 2.1. For Alanine Aminotransferase High; Grade 3: 5.0 to \<10.0 × ULN, Grade 4: \>=10.0 × ULN; Albumin Low, Grade 3: \<2.0 g/dL, Grade 4: Not Applicable; Alkaline Phosphatase High, Grade 3: 5.0 to \<10.0 × ULN, Grade 4: \>=10.0 × ULN; Amylase High, Grade 3: 3.0 to \<5.0 × ULN, Grade 4: \>=5.0 × ULN; Aspartate Aminotransferase High, Grade 3: 5.0 to \<10.0 × ULN, Grade 4: \>=10.0 × ULN; Bilirubin High, Grade 3: 2.6 to\<5.0 × ULN, Grade 4: \>=5.0 × ULN and Direct Bilirubin High, Grade 3: \>ULN with other signs and symptoms of hepatotoxicity, Grade 4: \>ULN with life-threatening consequences. Baseline was defined as latest pre-dose assessment with a non-missing value, including those from unscheduled visits. An increase is defined as an increase in DAIDS grade relative to Baseline grade.
Time frame: Baseline (Pre-dose, Day-1) and up to Day 36
Population: Safety Population. Only those participants with increase to grade 3 and increase to grade 4 were presented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1: GSK3640254 200 mg | Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Bilirubin and Direct Bilirubin | Bilirubin, High, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg | Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Bilirubin and Direct Bilirubin | Albumin, Low, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg | Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Bilirubin and Direct Bilirubin | Alanine Aminotransferase, High, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg | Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Bilirubin and Direct Bilirubin | Aspartate Aminotransferase, High, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg | Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Bilirubin and Direct Bilirubin | Alkaline Phosphatase, High, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg | Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Bilirubin and Direct Bilirubin | Direct Bilirubin, High, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg | Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Bilirubin and Direct Bilirubin | Amylase, High, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg | Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Bilirubin and Direct Bilirubin | Alkaline Phosphatase, High, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg | Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Bilirubin and Direct Bilirubin | Direct Bilirubin, High, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg | Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Bilirubin and Direct Bilirubin | Alanine Aminotransferase, High, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg | Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Bilirubin and Direct Bilirubin | Aspartate Aminotransferase, High, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg | Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Bilirubin and Direct Bilirubin | Bilirubin, High, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg | Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Bilirubin and Direct Bilirubin | Albumin, Low, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg | Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Bilirubin and Direct Bilirubin | Amylase, High, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Bilirubin and Direct Bilirubin | Bilirubin, High, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Bilirubin and Direct Bilirubin | Amylase, High, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Bilirubin and Direct Bilirubin | Aspartate Aminotransferase, High, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Bilirubin and Direct Bilirubin | Alanine Aminotransferase, High, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Bilirubin and Direct Bilirubin | Alanine Aminotransferase, High, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Bilirubin and Direct Bilirubin | Albumin, Low, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Bilirubin and Direct Bilirubin | Albumin, Low, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Bilirubin and Direct Bilirubin | Alkaline Phosphatase, High, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Bilirubin and Direct Bilirubin | Alkaline Phosphatase, High, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Bilirubin and Direct Bilirubin | Aspartate Aminotransferase, High, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Bilirubin and Direct Bilirubin | Amylase, High, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Bilirubin and Direct Bilirubin | Bilirubin, High, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Bilirubin and Direct Bilirubin | Direct Bilirubin, High, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Bilirubin and Direct Bilirubin | Direct Bilirubin, High, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Bilirubin and Direct Bilirubin | Direct Bilirubin, High, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Bilirubin and Direct Bilirubin | Aspartate Aminotransferase, High, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Bilirubin and Direct Bilirubin | Albumin, Low, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Bilirubin and Direct Bilirubin | Direct Bilirubin, High, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Bilirubin and Direct Bilirubin | Bilirubin, High, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Bilirubin and Direct Bilirubin | Alanine Aminotransferase, High, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Bilirubin and Direct Bilirubin | Amylase, High, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Bilirubin and Direct Bilirubin | Bilirubin, High, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Bilirubin and Direct Bilirubin | Alanine Aminotransferase, High, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Bilirubin and Direct Bilirubin | Alkaline Phosphatase, High, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Bilirubin and Direct Bilirubin | Alkaline Phosphatase, High, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Bilirubin and Direct Bilirubin | Aspartate Aminotransferase, High, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Bilirubin and Direct Bilirubin | Amylase, High, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Bilirubin and Direct Bilirubin | Albumin, Low, Increase to Grade 4 | 0 Participants |
Secondary
Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Calcium, Creatine Kinase, Creatinine, Phosphate, Potassium and Sodium
Blood samples were collected for analysis of clinical chemistry parameters. Laboratory abnormalities were graded according to DAIDS grading table Version 2.1. For Calcium High, Grade 3: 12.5 to \<13.5 mg/dL, Grade 4: \>=13.5 mg/dL; Calcium Low, Grade 3: 6.1 to \<7.0 mg/dL, Grade 4: \<6.1 mg/dL; Creatine Kinase High, Grade 3: 10 to \<20 × ULN, Grade 4: \>=20 × ULN; Creatinine High, Grade 3: \>1.8 to \<3.5 ULN, Grade 4: \>=3.5 × ULN; Phosphate Low, Grade 3: 1.0 to \<1.4 mg/dL, Grade 4: \<1.0 mg/dL; Potassium High, Grade 3: 6.5 to \<7.0 mEq/L,Grade 4: \>=7.0 mEq/L; Potassium Low, Grade 3: 2.0 to \<2.5 mEq/L, Grade 4: \<2.00 mEq/L; Sodium High, Grade 3: 154 to \<160 mEq/L, Grade 4:\>=160 mEq/L; Sodium Low, Grade 3: 121 to \<125 mEq/L, Grade 4:\<=120 mEq/L. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. An increase is defined as an increase in DAIDS grade relative to Baseline grade.
Time frame: Baseline (Pre-dose, Day-1) and up to Day 36
Population: Safety Population. Only those participants with increase to grade 3 and increase to grade 4 presented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1: GSK3640254 200 mg | Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Calcium, Creatine Kinase, Creatinine, Phosphate, Potassium and Sodium | Creatine Kinase, High, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg | Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Calcium, Creatine Kinase, Creatinine, Phosphate, Potassium and Sodium | Calcium, Low, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg | Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Calcium, Creatine Kinase, Creatinine, Phosphate, Potassium and Sodium | Calcium, High, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg | Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Calcium, Creatine Kinase, Creatinine, Phosphate, Potassium and Sodium | Calcium, High, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg | Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Calcium, Creatine Kinase, Creatinine, Phosphate, Potassium and Sodium | Calcium, Low, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg | Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Calcium, Creatine Kinase, Creatinine, Phosphate, Potassium and Sodium | Creatine Kinase, High, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg | Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Calcium, Creatine Kinase, Creatinine, Phosphate, Potassium and Sodium | Creatinine, High, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg | Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Calcium, Creatine Kinase, Creatinine, Phosphate, Potassium and Sodium | Creatinine, High, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg | Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Calcium, Creatine Kinase, Creatinine, Phosphate, Potassium and Sodium | Phosphate, Low, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg | Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Calcium, Creatine Kinase, Creatinine, Phosphate, Potassium and Sodium | Phosphate, Low, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg | Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Calcium, Creatine Kinase, Creatinine, Phosphate, Potassium and Sodium | Potassium, Low, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg | Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Calcium, Creatine Kinase, Creatinine, Phosphate, Potassium and Sodium | Potassium, Low, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg | Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Calcium, Creatine Kinase, Creatinine, Phosphate, Potassium and Sodium | Potassium, High, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg | Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Calcium, Creatine Kinase, Creatinine, Phosphate, Potassium and Sodium | Potassium, High, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg | Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Calcium, Creatine Kinase, Creatinine, Phosphate, Potassium and Sodium | Sodium, Low, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg | Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Calcium, Creatine Kinase, Creatinine, Phosphate, Potassium and Sodium | Sodium, Low, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg | Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Calcium, Creatine Kinase, Creatinine, Phosphate, Potassium and Sodium | Sodium, High, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg | Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Calcium, Creatine Kinase, Creatinine, Phosphate, Potassium and Sodium | Sodium, High, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Calcium, Creatine Kinase, Creatinine, Phosphate, Potassium and Sodium | Sodium, High, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Calcium, Creatine Kinase, Creatinine, Phosphate, Potassium and Sodium | Potassium, High, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Calcium, Creatine Kinase, Creatinine, Phosphate, Potassium and Sodium | Calcium, Low, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Calcium, Creatine Kinase, Creatinine, Phosphate, Potassium and Sodium | Phosphate, Low, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Calcium, Creatine Kinase, Creatinine, Phosphate, Potassium and Sodium | Calcium, Low, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Calcium, Creatine Kinase, Creatinine, Phosphate, Potassium and Sodium | Sodium, Low, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Calcium, Creatine Kinase, Creatinine, Phosphate, Potassium and Sodium | Sodium, Low, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Calcium, Creatine Kinase, Creatinine, Phosphate, Potassium and Sodium | Calcium, High, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Calcium, Creatine Kinase, Creatinine, Phosphate, Potassium and Sodium | Potassium, Low, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Calcium, Creatine Kinase, Creatinine, Phosphate, Potassium and Sodium | Sodium, High, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Calcium, Creatine Kinase, Creatinine, Phosphate, Potassium and Sodium | Calcium, High, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Calcium, Creatine Kinase, Creatinine, Phosphate, Potassium and Sodium | Phosphate, Low, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Calcium, Creatine Kinase, Creatinine, Phosphate, Potassium and Sodium | Potassium, High, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Calcium, Creatine Kinase, Creatinine, Phosphate, Potassium and Sodium | Creatine Kinase, High, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Calcium, Creatine Kinase, Creatinine, Phosphate, Potassium and Sodium | Creatinine, High, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Calcium, Creatine Kinase, Creatinine, Phosphate, Potassium and Sodium | Potassium, Low, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Calcium, Creatine Kinase, Creatinine, Phosphate, Potassium and Sodium | Creatine Kinase, High, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Calcium, Creatine Kinase, Creatinine, Phosphate, Potassium and Sodium | Creatinine, High, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Calcium, Creatine Kinase, Creatinine, Phosphate, Potassium and Sodium | Creatine Kinase, High, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Calcium, Creatine Kinase, Creatinine, Phosphate, Potassium and Sodium | Creatinine, High, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Calcium, Creatine Kinase, Creatinine, Phosphate, Potassium and Sodium | Creatinine, High, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Calcium, Creatine Kinase, Creatinine, Phosphate, Potassium and Sodium | Sodium, Low, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Calcium, Creatine Kinase, Creatinine, Phosphate, Potassium and Sodium | Phosphate, Low, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Calcium, Creatine Kinase, Creatinine, Phosphate, Potassium and Sodium | Sodium, High, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Calcium, Creatine Kinase, Creatinine, Phosphate, Potassium and Sodium | Phosphate, Low, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Calcium, Creatine Kinase, Creatinine, Phosphate, Potassium and Sodium | Potassium, Low, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Calcium, Creatine Kinase, Creatinine, Phosphate, Potassium and Sodium | Sodium, Low, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Calcium, Creatine Kinase, Creatinine, Phosphate, Potassium and Sodium | Potassium, Low, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Calcium, Creatine Kinase, Creatinine, Phosphate, Potassium and Sodium | Calcium, Low, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Calcium, Creatine Kinase, Creatinine, Phosphate, Potassium and Sodium | Calcium, Low, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Calcium, Creatine Kinase, Creatinine, Phosphate, Potassium and Sodium | Potassium, High, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Calcium, Creatine Kinase, Creatinine, Phosphate, Potassium and Sodium | Calcium, High, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Calcium, Creatine Kinase, Creatinine, Phosphate, Potassium and Sodium | Calcium, High, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Calcium, Creatine Kinase, Creatinine, Phosphate, Potassium and Sodium | Creatine Kinase, High, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Calcium, Creatine Kinase, Creatinine, Phosphate, Potassium and Sodium | Potassium, High, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Calcium, Creatine Kinase, Creatinine, Phosphate, Potassium and Sodium | Sodium, High, Increase to Grade 3 | 0 Participants |
Secondary
Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Glucose, Triglycerides, Lipase, Urate and Cholesterol
Blood samples were collected for analysis of clinical chemistry parameters. Laboratory abnormalities were graded according to DAIDS grading table Version 2.1. For Glucose High, Grade 3: \>250 to 500 mg/dL, Grade 4: \>=500 mg/dL, Glucose Low, Grade 3: 30 to\<40 mg/dL, Grade 4:\<30 mg/dL; Triglycerides High, Grade 3: \>500 to \<1.000 mg/dL, Grade 4:\>1000 mg/dL; Lipase High, Grade 3: 3.0 to \<5.0×ULN, Grade 4:\>=5.0×ULN; Urate High, Grade 3: 12.0 to \<15.0 mEq/L, Grade 4:\>=15.0 mEq/L; Cholesterol High, Grade 3: \>=300 mg/dL, Grade 4: Not Applicable. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. An increase is defined as an increase in DAIDS grade relative to Baseline grade.
Time frame: Baseline (Pre-dose, Day-1) and up to Day 36
Population: Safety Population. Only those participants with increase to grade 3 and increase to grade 4 were presented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1: GSK3640254 200 mg | Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Glucose, Triglycerides, Lipase, Urate and Cholesterol | Glucose, Low, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg | Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Glucose, Triglycerides, Lipase, Urate and Cholesterol | Glucose, Low, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg | Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Glucose, Triglycerides, Lipase, Urate and Cholesterol | Glucose, High, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg | Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Glucose, Triglycerides, Lipase, Urate and Cholesterol | Glucose, High, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg | Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Glucose, Triglycerides, Lipase, Urate and Cholesterol | Triglycerides, High, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg | Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Glucose, Triglycerides, Lipase, Urate and Cholesterol | Triglycerides, High, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg | Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Glucose, Triglycerides, Lipase, Urate and Cholesterol | Lipase, High, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg | Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Glucose, Triglycerides, Lipase, Urate and Cholesterol | Lipase, High, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg | Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Glucose, Triglycerides, Lipase, Urate and Cholesterol | Urate, High, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg | Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Glucose, Triglycerides, Lipase, Urate and Cholesterol | Urate, High, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg | Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Glucose, Triglycerides, Lipase, Urate and Cholesterol | Cholesterol, High, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg | Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Glucose, Triglycerides, Lipase, Urate and Cholesterol | Cholesterol, High, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Glucose, Triglycerides, Lipase, Urate and Cholesterol | Cholesterol, High, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Glucose, Triglycerides, Lipase, Urate and Cholesterol | Glucose, Low, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Glucose, Triglycerides, Lipase, Urate and Cholesterol | Lipase, High, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Glucose, Triglycerides, Lipase, Urate and Cholesterol | Urate, High, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Glucose, Triglycerides, Lipase, Urate and Cholesterol | Glucose, Low, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Glucose, Triglycerides, Lipase, Urate and Cholesterol | Triglycerides, High, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Glucose, Triglycerides, Lipase, Urate and Cholesterol | Cholesterol, High, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Glucose, Triglycerides, Lipase, Urate and Cholesterol | Glucose, High, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Glucose, Triglycerides, Lipase, Urate and Cholesterol | Lipase, High, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Glucose, Triglycerides, Lipase, Urate and Cholesterol | Triglycerides, High, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Glucose, Triglycerides, Lipase, Urate and Cholesterol | Glucose, High, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Glucose, Triglycerides, Lipase, Urate and Cholesterol | Urate, High, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Glucose, Triglycerides, Lipase, Urate and Cholesterol | Glucose, High, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Glucose, Triglycerides, Lipase, Urate and Cholesterol | Triglycerides, High, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Glucose, Triglycerides, Lipase, Urate and Cholesterol | Urate, High, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Glucose, Triglycerides, Lipase, Urate and Cholesterol | Triglycerides, High, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Glucose, Triglycerides, Lipase, Urate and Cholesterol | Lipase, High, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Glucose, Triglycerides, Lipase, Urate and Cholesterol | Lipase, High, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Glucose, Triglycerides, Lipase, Urate and Cholesterol | Cholesterol, High, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Glucose, Triglycerides, Lipase, Urate and Cholesterol | Glucose, Low, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Glucose, Triglycerides, Lipase, Urate and Cholesterol | Glucose, Low, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Glucose, Triglycerides, Lipase, Urate and Cholesterol | Urate, High, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Glucose, Triglycerides, Lipase, Urate and Cholesterol | Glucose, High, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Glucose, Triglycerides, Lipase, Urate and Cholesterol | Cholesterol, High, Increase to Grade 4 | 0 Participants |
Secondary
Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Hematology Parameters
Blood samples were collected for analysis of hematology parameters. Laboratory abnormalities were graded according to DAIDS grading table Version 2.1. For Hemoglobin Low, Grade 3: 7.0 to \<9.0 g/dL (males) and 6.5 to \<8.5 g/dL (females),Grade 4: \<7.0 g/dL (males) and \<6.5 g/dL (females); Leukocytes Low, Grade 3: 1000 to 1499 cells/mm\^3,Grade 4: \<1000 cells/mm\^3; Lymphocytes Low, Grade 3: 350 to \<500 cells/L,Grade 4: \<350 cells/L; Neutrophils Low, Grade 3: 400 to 599 cells/mm\^3, Grade 4: \<400 cells/mm\^3; Platelets Low, Grade 3: 25,000 to \<50,000 cells/mm\^3, Grade 4: \<25,000 cells/mm\^3. Baseline was defined as latest pre-dose assessment with a non-missing value, including those from unscheduled visits. An increase is defined as an increase in DAIDS grade relative to Baseline grade.
Time frame: Baseline (Pre-dose, Day-1) and up to Day 36
Population: Safety Population. Only those participants with increase to grade 3 and increase to grade 4 were presented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1: GSK3640254 200 mg | Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Hematology Parameters | Leukocytes, Low, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg | Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Hematology Parameters | Hemoglobin, Low, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg | Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Hematology Parameters | Neutrophils, Low, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg | Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Hematology Parameters | Lymphocytes, Low, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg | Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Hematology Parameters | Neutrophils, Low, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg | Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Hematology Parameters | Lymphocytes, Low, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg | Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Hematology Parameters | Platelets, Low, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg | Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Hematology Parameters | Leukocytes, Low, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg | Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Hematology Parameters | Platelets, Low, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg | Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Hematology Parameters | Hemoglobin, Low, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Hematology Parameters | Platelets, Low, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Hematology Parameters | Hemoglobin, Low, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Hematology Parameters | Platelets, Low, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Hematology Parameters | Hemoglobin, Low, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Hematology Parameters | Leukocytes, Low, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Hematology Parameters | Leukocytes, Low, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Hematology Parameters | Lymphocytes, Low, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Hematology Parameters | Lymphocytes, Low, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Hematology Parameters | Neutrophils, Low, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Hematology Parameters | Neutrophils, Low, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Hematology Parameters | Lymphocytes, Low, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Hematology Parameters | Leukocytes, Low, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Hematology Parameters | Platelets, Low, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Hematology Parameters | Neutrophils, Low, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Hematology Parameters | Hemoglobin, Low, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Hematology Parameters | Hemoglobin, Low, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Hematology Parameters | Leukocytes, Low, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Hematology Parameters | Neutrophils, Low, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Hematology Parameters | Lymphocytes, Low, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Hematology Parameters | Platelets, Low, Increase to Grade 3 | 0 Participants |
Secondary
Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Urinalysis Parameters
Urine samples were collected for urinalysis parameters. Laboratory abnormalities were graded according to DAIDS grading table Version 2.1. For Erythrocytes High, Grade 3: Gross, with or without clots OR with RBC casts OR intervention indicated, Grade 4: Life-threatening consequences; Glucose High, Grade 3: \>2+ (proportionate concentration by dipstick test) or \>500 mg, Grade 4: \>500 mg; Protein High, Grade 3: 3+ (proportionate concentration by dipstick test) or higher, Grade 4: Not Applicable. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. An increase is defined as an increase in DAIDS grade relative to Baseline grade.
Time frame: Baseline (Pre-dose, Day-1) and up to Day 36
Population: Safety Population. Only those participants with increase to grade 3 and increase to grade 4 were presented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1: GSK3640254 200 mg | Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Urinalysis Parameters | Erythrocytes, High, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg | Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Urinalysis Parameters | Erythrocytes, High, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg | Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Urinalysis Parameters | Glucose, High, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg | Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Urinalysis Parameters | Glucose, High, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg | Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Urinalysis Parameters | Protein, High, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg | Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Urinalysis Parameters | Protein, High, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Urinalysis Parameters | Protein, High, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Urinalysis Parameters | Erythrocytes, High, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Urinalysis Parameters | Glucose, High, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Urinalysis Parameters | Protein, High, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Urinalysis Parameters | Erythrocytes, High, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Urinalysis Parameters | Glucose, High, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Urinalysis Parameters | Erythrocytes, High, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Urinalysis Parameters | Glucose, High, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Urinalysis Parameters | Protein, High, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Urinalysis Parameters | Glucose, High, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Urinalysis Parameters | Erythrocytes, High, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Urinalysis Parameters | Protein, High, Increase to Grade 3 | 0 Participants |
Secondary
Cohort 2: Number of Participants With SAEs and Non-SAEs
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is defined as any untoward medical occurrence that, at any dose that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or other situations as per medical or scientific judgment. Adverse events which were not Serious were considered as Non-Serious adverse events.
Time frame: Up to Day 36
Population: Safety Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1: GSK3640254 200 mg | Cohort 2: Number of Participants With SAEs and Non-SAEs | SAE | 0 Participants |
| Cohort 1: GSK3640254 200 mg | Cohort 2: Number of Participants With SAEs and Non-SAEs | non-SAE | 3 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 2: Number of Participants With SAEs and Non-SAEs | SAE | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 2: Number of Participants With SAEs and Non-SAEs | non-SAE | 4 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 2: Number of Participants With SAEs and Non-SAEs | SAE | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 2: Number of Participants With SAEs and Non-SAEs | non-SAE | 7 Participants |
Secondary
Cohort 2: Number of Participants With Vital Sign Values of PCI Criteria
Vital signs including SBP, DBP and pulse rate were measured in a supine position after atleast 5 minutes of rest. The PCI ranges for vitals were as follows; for SBP \<85 or \>140 mmHg, for DBP \<45 or \>90 mmHg, for pulse rate \<40 or \>100 beats per minute. The number of participants with vital signs of PCI were presented.
Time frame: Up to Day 36
Population: Safety Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1: GSK3640254 200 mg | Cohort 2: Number of Participants With Vital Sign Values of PCI Criteria | DBP | 0 Participants |
| Cohort 1: GSK3640254 200 mg | Cohort 2: Number of Participants With Vital Sign Values of PCI Criteria | SBP | 0 Participants |
| Cohort 1: GSK3640254 200 mg | Cohort 2: Number of Participants With Vital Sign Values of PCI Criteria | Pulse rate | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 2: Number of Participants With Vital Sign Values of PCI Criteria | DBP | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 2: Number of Participants With Vital Sign Values of PCI Criteria | SBP | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 2: Number of Participants With Vital Sign Values of PCI Criteria | Pulse rate | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 2: Number of Participants With Vital Sign Values of PCI Criteria | SBP | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 2: Number of Participants With Vital Sign Values of PCI Criteria | Pulse rate | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 2: Number of Participants With Vital Sign Values of PCI Criteria | DBP | 1 Participants |
Secondary
Cohort 2: Tmax of ETR
Blood samples were collected at indicated time points. Pharmacokinetic analysis was conducted using standard non-compartmental methods.
Time frame: Pre-dose and 0.5 Hours, 1 Hour, 1.5 Hours, 2 Hours, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours post-dose in Treatment Periods 2 and 3
Population: Pharmacokinetic Parameter Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Cohort 1: GSK3640254 200 mg | Cohort 2: Tmax of ETR | 3.500 Hours |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 2: Tmax of ETR | 4.000 Hours |
Secondary
Cohort 2: Tmax of GSK3640254
Blood samples were collected at indicated time points. Pharmacokinetic analysis was conducted using standard non-compartmental methods.
Time frame: Pre-dose and 0.5 Hours, 1 Hour, 1.5 Hours, 2 Hours, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 16 Hours, 24 Hours post-dose in Treatment Periods 1 and 3
Population: Pharmacokinetic Parameter Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Cohort 1: GSK3640254 200 mg | Cohort 2: Tmax of GSK3640254 | 4.000 Hours |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 2: Tmax of GSK3640254 | 3.000 Hours |
Secondary
Cohort 3: Number of Participants With AEs Leading to Discontinuations and Deaths
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. Number of participants with AEs leading to discontinuations and deaths were reported.
Time frame: Up to Day 26
Population: Safety Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1: GSK3640254 200 mg | Cohort 3: Number of Participants With AEs Leading to Discontinuations and Deaths | AEs leading to discontinuations | 0 Participants |
| Cohort 1: GSK3640254 200 mg | Cohort 3: Number of Participants With AEs Leading to Discontinuations and Deaths | AES leading to deaths | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 3: Number of Participants With AEs Leading to Discontinuations and Deaths | AEs leading to discontinuations | 1 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 3: Number of Participants With AEs Leading to Discontinuations and Deaths | AES leading to deaths | 0 Participants |
Secondary
Cohort 3: Number of Participants With Clinically Significant Abnormal ECG Findings
A 12-lead ECG was recorded with the participant in a supine position using an automated ECG machine. Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. Data for number of participants with clinically significant abnormal ECG findings were reported. Data has been presented for the participants with respect to the actual treatment received in respective treatment periods.
Time frame: Day 1 (2,4,6 Hours) in Treatment Period 1; Day 8 (2,4,6 Hours), Day 9 (2,4,6 Hours), Day 26 in Treatment Period 2
Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1: GSK3640254 200 mg | Cohort 3: Number of Participants With Clinically Significant Abnormal ECG Findings | 2 Hours, Day 1 | 0 Participants |
| Cohort 1: GSK3640254 200 mg | Cohort 3: Number of Participants With Clinically Significant Abnormal ECG Findings | 4 Hours, Day 1 | 0 Participants |
| Cohort 1: GSK3640254 200 mg | Cohort 3: Number of Participants With Clinically Significant Abnormal ECG Findings | 6 Hours, Day 1 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 3: Number of Participants With Clinically Significant Abnormal ECG Findings | 2 Hours, Day 8 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 3: Number of Participants With Clinically Significant Abnormal ECG Findings | 4 Hours, Day 8 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 3: Number of Participants With Clinically Significant Abnormal ECG Findings | 6 Hours, Day 8 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 3: Number of Participants With Clinically Significant Abnormal ECG Findings | 2 Hours; Day 9 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 3: Number of Participants With Clinically Significant Abnormal ECG Findings | 4 Hours; Day 9 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 3: Number of Participants With Clinically Significant Abnormal ECG Findings | 6 Hours; Day 9 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 3: Number of Participants With Clinically Significant Abnormal ECG Findings | Day 26 | 0 Participants |
Secondary
Cohort 3: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Bilirubin and Direct Bilirubin
Blood samples were collected for analysis of clinical chemistry parameters. Laboratory abnormalities were graded according to DAIDS grading table Version 2.1. For Alanine Aminotransferase High; Grade 3: 5.0 to \<10.0 × ULN, Grade 4: \>=10.0 × ULN; Albumin Low, Grade 3: \<2.0 g/dL, Grade 4: Not Applicable; Alkaline Phosphatase High, Grade 3: 5.0 to \<10.0 × ULN, Grade 4: \>=10.0 × ULN; Amylase High, Grade 3: 3.0 to \<5.0 × ULN, Grade 4: \>=5.0 × ULN; Aspartate Aminotransferase High, Grade 3: 5.0 to \<10.0 × ULN, Grade 4: \>=10.0 × ULN; Bilirubin High, Grade 3: 2.6 to\<5.0 × ULN, Grade 4: \>=5.0 × ULN and Direct Bilirubin High, Grade 3: \>ULN with other signs and symptoms of hepatotoxicity, Grade 4: \>ULN with life-threatening consequences. Baseline was defined as latest pre-dose assessment with a non-missing value, including those from unscheduled visits. An increase is defined as an increase in DAIDS grade relative to Baseline grade.
Time frame: Baseline (Pre-dose, Day-1) and up to Day 26
Population: Safety Population. Only those participants with increase to grade 3 and increase to grade 4 were presented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1: GSK3640254 200 mg | Cohort 3: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Bilirubin and Direct Bilirubin | Alanine Aminotransferase, High, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg | Cohort 3: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Bilirubin and Direct Bilirubin | Alanine Aminotransferase, High, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg | Cohort 3: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Bilirubin and Direct Bilirubin | Albumin, Low, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg | Cohort 3: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Bilirubin and Direct Bilirubin | Albumin, Low, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg | Cohort 3: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Bilirubin and Direct Bilirubin | Alkaline Phosphatase, High, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg | Cohort 3: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Bilirubin and Direct Bilirubin | Alkaline Phosphatase, High, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg | Cohort 3: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Bilirubin and Direct Bilirubin | Amylase, High, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg | Cohort 3: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Bilirubin and Direct Bilirubin | Amylase, High, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg | Cohort 3: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Bilirubin and Direct Bilirubin | Aspartate Aminotransferase, High, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg | Cohort 3: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Bilirubin and Direct Bilirubin | Aspartate Aminotransferase, High, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg | Cohort 3: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Bilirubin and Direct Bilirubin | Bilirubin, High, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg | Cohort 3: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Bilirubin and Direct Bilirubin | Bilirubin, High, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg | Cohort 3: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Bilirubin and Direct Bilirubin | Direct Bilirubin, High, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg | Cohort 3: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Bilirubin and Direct Bilirubin | Direct Bilirubin, High, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 3: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Bilirubin and Direct Bilirubin | Bilirubin, High, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 3: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Bilirubin and Direct Bilirubin | Alanine Aminotransferase, High, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 3: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Bilirubin and Direct Bilirubin | Amylase, High, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 3: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Bilirubin and Direct Bilirubin | Alanine Aminotransferase, High, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 3: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Bilirubin and Direct Bilirubin | Direct Bilirubin, High, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 3: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Bilirubin and Direct Bilirubin | Albumin, Low, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 3: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Bilirubin and Direct Bilirubin | Aspartate Aminotransferase, High, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 3: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Bilirubin and Direct Bilirubin | Albumin, Low, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 3: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Bilirubin and Direct Bilirubin | Bilirubin, High, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 3: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Bilirubin and Direct Bilirubin | Alkaline Phosphatase, High, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 3: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Bilirubin and Direct Bilirubin | Aspartate Aminotransferase, High, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 3: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Bilirubin and Direct Bilirubin | Alkaline Phosphatase, High, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 3: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Bilirubin and Direct Bilirubin | Direct Bilirubin, High, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 3: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Bilirubin and Direct Bilirubin | Amylase, High, Increase to Grade 3 | 0 Participants |
Secondary
Cohort 3: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Calcium, Creatine Kinase, Creatinine, Phosphate, Potassium and Sodium
Blood samples were collected for analysis of clinical chemistry parameters. Laboratory abnormalities were graded according to DAIDS grading table Version 2.1. For Calcium High, Grade 3: 12.5 to \<13.5 mg/dL, Grade 4: \>=13.5 mg/dL; Calcium Low, Grade 3: 6.1 to \<7.0 mg/dL, Grade 4: \<6.1 mg/dL; Creatine Kinase High, Grade 3: 10 to \<20 × ULN, Grade 4: \>=20 × ULN; Creatinine High, Grade 3: \>1.8 to \<3.5 ULN, Grade 4: \>=3.5 × ULN; Phosphate Low, Grade 3: 1.0 to \<1.4 mg/dL, Grade 4: \<1.0 mg/dL; Potassium High, Grade 3: 6.5 to \<7.0 mEq/L,Grade 4: \>=7.0 mEq/L; Potassium Low, Grade 3: 2.0 to \<2.5 mEq/L, Grade 4: \<2.00 mEq/L; Sodium High, Grade 3: 154 to \<160 mEq/L, Grade 4:\>=160 mEq/L; Sodium Low, Grade 3: 121 to \<125 mEq/L, Grade 4:\<=120 mEq/L. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. An increase is defined as an increase in DAIDS grade relative to Baseline grade.
Time frame: Baseline (Pre-dose, Day-1) and up to Day 26
Population: Safety Population. Only those participants with increase to grade 3 and increase to grade 4 were presented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1: GSK3640254 200 mg | Cohort 3: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Calcium, Creatine Kinase, Creatinine, Phosphate, Potassium and Sodium | Creatine Kinase, High, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg | Cohort 3: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Calcium, Creatine Kinase, Creatinine, Phosphate, Potassium and Sodium | Potassium, Low, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg | Cohort 3: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Calcium, Creatine Kinase, Creatinine, Phosphate, Potassium and Sodium | Calcium, High, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg | Cohort 3: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Calcium, Creatine Kinase, Creatinine, Phosphate, Potassium and Sodium | Potassium, Low, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg | Cohort 3: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Calcium, Creatine Kinase, Creatinine, Phosphate, Potassium and Sodium | Creatinine, High, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg | Cohort 3: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Calcium, Creatine Kinase, Creatinine, Phosphate, Potassium and Sodium | Potassium, High, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg | Cohort 3: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Calcium, Creatine Kinase, Creatinine, Phosphate, Potassium and Sodium | Calcium, High, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg | Cohort 3: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Calcium, Creatine Kinase, Creatinine, Phosphate, Potassium and Sodium | Potassium, High, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg | Cohort 3: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Calcium, Creatine Kinase, Creatinine, Phosphate, Potassium and Sodium | Creatinine, High, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg | Cohort 3: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Calcium, Creatine Kinase, Creatinine, Phosphate, Potassium and Sodium | Sodium, Low, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg | Cohort 3: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Calcium, Creatine Kinase, Creatinine, Phosphate, Potassium and Sodium | Creatine Kinase, High, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg | Cohort 3: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Calcium, Creatine Kinase, Creatinine, Phosphate, Potassium and Sodium | Sodium, Low, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg | Cohort 3: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Calcium, Creatine Kinase, Creatinine, Phosphate, Potassium and Sodium | Phosphate, Low, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg | Cohort 3: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Calcium, Creatine Kinase, Creatinine, Phosphate, Potassium and Sodium | Sodium, High, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg | Cohort 3: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Calcium, Creatine Kinase, Creatinine, Phosphate, Potassium and Sodium | Calcium, Low, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg | Cohort 3: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Calcium, Creatine Kinase, Creatinine, Phosphate, Potassium and Sodium | Sodium, High, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg | Cohort 3: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Calcium, Creatine Kinase, Creatinine, Phosphate, Potassium and Sodium | Phosphate, Low, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg | Cohort 3: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Calcium, Creatine Kinase, Creatinine, Phosphate, Potassium and Sodium | Calcium, Low, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 3: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Calcium, Creatine Kinase, Creatinine, Phosphate, Potassium and Sodium | Phosphate, Low, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 3: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Calcium, Creatine Kinase, Creatinine, Phosphate, Potassium and Sodium | Calcium, Low, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 3: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Calcium, Creatine Kinase, Creatinine, Phosphate, Potassium and Sodium | Calcium, High, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 3: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Calcium, Creatine Kinase, Creatinine, Phosphate, Potassium and Sodium | Calcium, High, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 3: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Calcium, Creatine Kinase, Creatinine, Phosphate, Potassium and Sodium | Creatine Kinase, High, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 3: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Calcium, Creatine Kinase, Creatinine, Phosphate, Potassium and Sodium | Creatine Kinase, High, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 3: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Calcium, Creatine Kinase, Creatinine, Phosphate, Potassium and Sodium | Creatinine, High, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 3: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Calcium, Creatine Kinase, Creatinine, Phosphate, Potassium and Sodium | Creatinine, High, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 3: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Calcium, Creatine Kinase, Creatinine, Phosphate, Potassium and Sodium | Phosphate, Low, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 3: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Calcium, Creatine Kinase, Creatinine, Phosphate, Potassium and Sodium | Calcium, Low, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 3: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Calcium, Creatine Kinase, Creatinine, Phosphate, Potassium and Sodium | Potassium, Low, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 3: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Calcium, Creatine Kinase, Creatinine, Phosphate, Potassium and Sodium | Potassium, Low, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 3: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Calcium, Creatine Kinase, Creatinine, Phosphate, Potassium and Sodium | Potassium, High, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 3: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Calcium, Creatine Kinase, Creatinine, Phosphate, Potassium and Sodium | Potassium, High, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 3: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Calcium, Creatine Kinase, Creatinine, Phosphate, Potassium and Sodium | Sodium, Low, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 3: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Calcium, Creatine Kinase, Creatinine, Phosphate, Potassium and Sodium | Sodium, Low, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 3: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Calcium, Creatine Kinase, Creatinine, Phosphate, Potassium and Sodium | Sodium, High, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 3: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Calcium, Creatine Kinase, Creatinine, Phosphate, Potassium and Sodium | Sodium, High, Increase to Grade 4 | 0 Participants |
Secondary
Cohort 3: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Glucose, Triglycerides, Lipase, Urate and Cholesterol
Blood samples were collected for analysis of clinical chemistry parameters. Laboratory abnormalities were graded according to DAIDS grading table Version 2.1. For Glucose High, Grade 3: \>250 to 500 mg/dL, Grade 4: \>=500 mg/dL, Glucose Low, Grade 3: 30 to\<40 mg/dL, Grade 4:\<30 mg/dL; Triglycerides High, Grade 3: \>500 to \<1.000 mg/dL, Grade 4:\>1000 mg/dL; Lipase High, Grade 3: 3.0 to \<5.0×ULN, Grade 4:\>=5.0×ULN; Urate High, Grade 3: 12.0 to \<15.0 mEq/L, Grade 4:\>=15.0 mEq/L; Cholesterol High, Grade 3: \>=300 mg/dL, Grade 4: Not Applicable. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. An increase is defined as an increase in DAIDS grade relative to Baseline grade.
Time frame: Baseline (Pre-dose, Day-1) and up to Day 26
Population: Safety Population. Only those participants with increase to grade 3 and increase to grade 4 were presented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1: GSK3640254 200 mg | Cohort 3: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Glucose, Triglycerides, Lipase, Urate and Cholesterol | Glucose, Low, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg | Cohort 3: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Glucose, Triglycerides, Lipase, Urate and Cholesterol | Glucose, Low, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg | Cohort 3: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Glucose, Triglycerides, Lipase, Urate and Cholesterol | Glucose, High, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg | Cohort 3: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Glucose, Triglycerides, Lipase, Urate and Cholesterol | Glucose, High, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg | Cohort 3: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Glucose, Triglycerides, Lipase, Urate and Cholesterol | Triglycerides, High, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg | Cohort 3: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Glucose, Triglycerides, Lipase, Urate and Cholesterol | Triglycerides, High, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg | Cohort 3: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Glucose, Triglycerides, Lipase, Urate and Cholesterol | Lipase, High, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg | Cohort 3: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Glucose, Triglycerides, Lipase, Urate and Cholesterol | Lipase, High, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg | Cohort 3: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Glucose, Triglycerides, Lipase, Urate and Cholesterol | Urate, High, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg | Cohort 3: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Glucose, Triglycerides, Lipase, Urate and Cholesterol | Urate, High, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg | Cohort 3: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Glucose, Triglycerides, Lipase, Urate and Cholesterol | Cholesterol, High, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg | Cohort 3: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Glucose, Triglycerides, Lipase, Urate and Cholesterol | Cholesterol, High, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 3: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Glucose, Triglycerides, Lipase, Urate and Cholesterol | Cholesterol, High, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 3: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Glucose, Triglycerides, Lipase, Urate and Cholesterol | Glucose, Low, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 3: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Glucose, Triglycerides, Lipase, Urate and Cholesterol | Lipase, High, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 3: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Glucose, Triglycerides, Lipase, Urate and Cholesterol | Glucose, Low, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 3: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Glucose, Triglycerides, Lipase, Urate and Cholesterol | Urate, High, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 3: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Glucose, Triglycerides, Lipase, Urate and Cholesterol | Glucose, High, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 3: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Glucose, Triglycerides, Lipase, Urate and Cholesterol | Lipase, High, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 3: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Glucose, Triglycerides, Lipase, Urate and Cholesterol | Glucose, High, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 3: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Glucose, Triglycerides, Lipase, Urate and Cholesterol | Cholesterol, High, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 3: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Glucose, Triglycerides, Lipase, Urate and Cholesterol | Triglycerides, High, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 3: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Glucose, Triglycerides, Lipase, Urate and Cholesterol | Urate, High, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 3: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Glucose, Triglycerides, Lipase, Urate and Cholesterol | Triglycerides, High, Increase to Grade 4 | 0 Participants |
Secondary
Cohort 3: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Hematology Parameters
Blood samples were collected for analysis of hematology parameters. Laboratory abnormalities were graded according to DAIDS grading table Version 2.1. For Hemoglobin Low, Grade 3: 7.0 to \<9.0 g/dL (males) and 6.5 to \<8.5 g/dL (females),Grade 4: \<7.0 g/dL (males) and \<6.5 g/dL (females); Leukocytes Low, Grade 3: 1000 to 1499 cells/mm\^3,Grade 4: \<1000 cells/mm\^3; Lymphocytes Low, Grade 3: 350 to \<500 cells/L,Grade 4: \<350 cells/L; Neutrophils Low, Grade 3: 400 to 599 cells/mm\^3, Grade 4: \<400 cells/mm\^3; Platelets Low, Grade 3: 25,000 to \<50,000 cells/mm\^3, Grade 4: \<25,000 cells/mm\^3. Baseline was defined as latest pre-dose assessment with a non-missing value, including those from unscheduled visits. An increase is defined as an increase in DAIDS grade relative to Baseline grade.
Time frame: Baseline (Pre-dose, Day-1) and up to Day 26
Population: Safety Population. Only those participants with increase to grade 3 and increase to grade 4 were presented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1: GSK3640254 200 mg | Cohort 3: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Hematology Parameters | Lymphocytes, Low, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg | Cohort 3: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Hematology Parameters | Hemoglobin, Low, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg | Cohort 3: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Hematology Parameters | Hemoglobin, Low, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg | Cohort 3: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Hematology Parameters | Leukocytes, Low, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg | Cohort 3: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Hematology Parameters | Leukocytes, Low, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg | Cohort 3: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Hematology Parameters | Lymphocytes, Low, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg | Cohort 3: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Hematology Parameters | Neutrophils, Low, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg | Cohort 3: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Hematology Parameters | Neutrophils, Low, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg | Cohort 3: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Hematology Parameters | Platelets, Low, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg | Cohort 3: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Hematology Parameters | Platelets, Low, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 3: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Hematology Parameters | Neutrophils, Low, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 3: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Hematology Parameters | Lymphocytes, Low, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 3: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Hematology Parameters | Hemoglobin, Low, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 3: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Hematology Parameters | Platelets, Low, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 3: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Hematology Parameters | Hemoglobin, Low, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 3: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Hematology Parameters | Neutrophils, Low, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 3: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Hematology Parameters | Leukocytes, Low, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 3: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Hematology Parameters | Platelets, Low, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 3: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Hematology Parameters | Leukocytes, Low, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 3: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Hematology Parameters | Lymphocytes, Low, Increase to Grade 3 | 0 Participants |
Secondary
Cohort 3: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Urinalysis Parameters
Urine samples were collected for urinalysis parameters. Laboratory abnormalities were graded according to DAIDS grading table Version 2.1. For Erythrocytes High, Grade 3: Gross, with or without clots OR with RBC casts OR intervention indicated, Grade 4: Life-threatening consequences; Glucose High, Grade 3: \>2+ (proportionate concentration by dipstick test) or \>500 mg, Grade 4: \>500 mg; Protein High, Grade 3: 3+ (proportionate concentration by dipstick test) or higher, Grade 4: Not Applicable. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. An increase is defined as an increase in DAIDS grade relative to Baseline grade.
Time frame: Baseline (Pre-dose, Day-1) and up to Day 26
Population: Safety Population. Only those participants with increase to grade 3 and increase to grade 4 were presented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1: GSK3640254 200 mg | Cohort 3: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Urinalysis Parameters | Erythrocytes, High, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg | Cohort 3: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Urinalysis Parameters | Erythrocytes, High, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg | Cohort 3: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Urinalysis Parameters | Glucose, High, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg | Cohort 3: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Urinalysis Parameters | Glucose, High, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg | Cohort 3: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Urinalysis Parameters | Protein, High, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg | Cohort 3: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Urinalysis Parameters | Protein, High, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 3: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Urinalysis Parameters | Protein, High, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 3: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Urinalysis Parameters | Erythrocytes, High, Increase to Grade 3 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 3: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Urinalysis Parameters | Glucose, High, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 3: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Urinalysis Parameters | Erythrocytes, High, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 3: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Urinalysis Parameters | Protein, High, Increase to Grade 4 | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 3: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Urinalysis Parameters | Glucose, High, Increase to Grade 3 | 0 Participants |
Secondary
Cohort 3: Number of Participants With SAEs and Non-SAEs
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is defined as any untoward medical occurrence that, at any dose that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or other situations as per medical or scientific judgment. Adverse events which were not Serious were considered as Non-Serious adverse events.
Time frame: Up to Day 26
Population: Safety Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1: GSK3640254 200 mg | Cohort 3: Number of Participants With SAEs and Non-SAEs | SAE | 0 Participants |
| Cohort 1: GSK3640254 200 mg | Cohort 3: Number of Participants With SAEs and Non-SAEs | non-SAE | 1 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 3: Number of Participants With SAEs and Non-SAEs | non-SAE | 8 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 3: Number of Participants With SAEs and Non-SAEs | SAE | 0 Participants |
Secondary
Cohort 3: Number of Participants With Vital Sign Values of PCI Criteria
Vital signs including SBP, DBP and pulse rate were measured in a supine position after atleast 5 minutes of rest. The PCI ranges for vitals were as follows; for SBP \<85 or \>140 mmHg, for DBP \<45 or \>90 mmHg, for pulse rate \<40 or \>100 beats per minute. The number of participants with vital signs of PCI were presented.
Time frame: Up to Day 26
Population: Safety Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1: GSK3640254 200 mg | Cohort 3: Number of Participants With Vital Sign Values of PCI Criteria | SBP | 1 Participants |
| Cohort 1: GSK3640254 200 mg | Cohort 3: Number of Participants With Vital Sign Values of PCI Criteria | DBP | 0 Participants |
| Cohort 1: GSK3640254 200 mg | Cohort 3: Number of Participants With Vital Sign Values of PCI Criteria | Pulse rate | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 3: Number of Participants With Vital Sign Values of PCI Criteria | SBP | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 3: Number of Participants With Vital Sign Values of PCI Criteria | DBP | 0 Participants |
| Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg | Cohort 3: Number of Participants With Vital Sign Values of PCI Criteria | Pulse rate | 0 Participants |