HIV Infections, Infection, Human Immunodeficiency Virus
Conditions
Keywords
GSK2838232, safety, food effect, capsule, healthy, PK, tablet
Brief summary
This study will be conducted in two Parts to confirm the acceptability/selection of a tablet formulation for future clinical development of GSK2838232. Part 1 of the study will assess single ritonavir (RTV)-boosted doses of a new tablet formulation given with food (containing approximately 30% fat) against the reference capsule formulation also given with food and then will assess the impact of fasted conditions on the tablet performance. In Part 2, non-boosted GSK2838232 will be given as once-daily tablet doses for 11 days in a separate group of subjects, assuming the tablet performance is considered acceptable from Part 1. Approximately 16 healthy subjects will be enrolled to provide at least 12 evaluable subjects through the three study periods in Part 1. 10 healthy subjects will be enrolled to provide at least 8 evaluable subjects through the single study period in Part 2. The maximum duration of study participation will be approximately 9 to 10 weeks for Part 1; and 8 to 9 weeks for Part 2.
Interventions
DRUGGSK2838232 100 mg tablet
It is a white to slightly colored tablet. It will be supplied as prefilled tablets in bulk for dispensing to subjects at the site according to the treatment code.
DRUGGSK2838232 50 mg capsule
It is a pink unmarked capsule. It will be supplied as prefilled capsules in bulk for dispensing to subjects at the site according to the treatment code.
DRUGRitonavir 100 mg tablets
It is a white film-coated ovaloid tablets.
DRUGPlacebo for GSK2838232 tablets
It is a white to slightly colored tablet. The placebo tablets supplied will not be identical to GSK2838232 tablets. It will be administered by site staff via an opaque card or paper tube.
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Part 1 of the study will be open label and thus not be blinded. Part 2 of the study will be single blinded because of the unavailability of matching placebo tablets. The Principal Investigator and the subject will be completely blinded to specific treatment assignment.
Intervention model description
The randomization number will determine the allocation of treatment sequences (ABC or BAC) for Part 1, and of treatment (GSK2838232 without RTV or placebo) for Part 2. Allocation to treatment for Part 1A or Part 1B (with Part 2 being fixed) will be according to a predetermined random order.
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Between 18 and 55 years of age inclusive, at the time of signing the informed consent. * Healthy as determined by the Investigator or medically qualified designee based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring. * A subject with a clinical abnormality or laboratory parameter(s) which is/are not specifically listed in the inclusion or
Exclusion criteria
, and outside the reference range for the population being studied, may be included only if the Investigator in consultation with the medical monitor, if required, agree and document that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures. * A creatinine clearance (CLcr) \> 80 milliliter per minute (mL/min) as determined by Cockcroft-Gault equation: CLcr = (140 minus age) multiplied by weight divided by (72 multiplied by serum creatinine) (times 0.85 if female) where age is in years, weight in kilogram (kg), and serum creatinine is in units of milligram per deciliter (mg/dL). * Body weight \>=50.0 kg (110 pounds \[lbs.\]) for men and \>=45.0 kg (99 lbs) for women and body mass index (BMI) within the range 18.5 to 31.0 kg/meter (m)\^2 (inclusive). * Males or females. * A female subject is eligible to participate if she is not pregnant (as confirmed by a negative serum human chorionic gonadotrophin \[hCG\] test), not lactating, and of non-reproductive potential which is defined as: Reproductive potential: There is no definitive drug-drug interaction (DDI) information with GSK2838232 and an interaction with oral contraceptives is possible, so other (barrier, inter-uterine device etc.) methods of contraception will be required. Females of reproductive potential may only be enrolled if they are using two forms of complementary contraception, which must include at least one barrier method. They will be counseled on safer sex practices. Fertile females, who have an established, long-term lifestyle of sexual abstinence, or only same sex partners, require no other means of birth control. Non-reproductive potential: * Pre-menopausal females with one of the following: Documented tubal ligation; documented hysteroscopic tubal occlusion procedure with follow-up confirmation of bilateral tubal occlusion; hysterectomy; documented Bilateral Oophorectomy. * Postmenopausal defined as 12 months of spontaneous amenorrhea in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) and estradiol levels consistent with menopause. Females on hormone replacement therapy (HRT) must discontinue HRT to allow confirmation of post-menopausal status prior to study enrolment. * Male subjects with female partners of child bearing potential must comply with the following contraception requirements from the time of first dose of study medication until one week after the last dose of study medication. * Vasectomy with documentation of azoospermia. * Male condom plus partner use of one of the contraceptive options below: Contraceptive subdermal implant with a \<1 percent rate of failure per year; intrauterine device or intrauterine system with a \<1 percent rate of failure per year; oral contraceptive, either combined or progestogen alone or injectable progestogen; contraceptive vaginal ring; percutaneous contraceptive patches. * Capable of giving signed informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Part 2: Time of Last Quantifiable Concentration (Tlast) Following Administration of Non-boosted Once-daily Doses of GSK2838232 Tablet in Fed State on Day 11 | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96 and 120 hours post-dose on Day 11 in Part 2 | Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK2838232 given as a non-boosted once-daily dosing tablet in fed state. Pharmacokinetic parameters were determined using standard non-compartmental methods. |
| Part 1: AUC (0-infinity) Following Administration of GSK2838232 Tablet in Fasted and Fed State | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 120 hours post-dose in treatment periods 1, 2 and 3 of Part 1 | Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK2838232 given as tablet formulation in fed and fasted state. Pharmacokinetic parameters were determined using standard non-compartmental methods. |
| Part 1: Cmax Following Administration of GSK2838232 Tablet in Fasted and Fed State | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 120 hours post-dose in treatment periods 1, 2 and 3 of Part 1 | Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK2838232 given as tablet formulation in fed and fasted state. Pharmacokinetic parameters were determined using standard non-compartmental methods. |
| Part 1: Time of Occurrence of Cmax (Tmax) Following Administration of GSK2838232 Tablet in Fasted and Fed State | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 120 hours post-dose in treatment periods 1, 2 and 3 of Part 1 | Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK2838232 given as tablet formulation in fed and fasted state. Pharmacokinetic parameters were determined using standard non-compartmental methods. |
| Part 2: Number of Participants With Serious Adverse Events (SAEs) and Non-SAEs | Up to 25 days | An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/ birth defect, is associated with liver injury or impaired liver function or any other situations as per medical or scientific judgment. Safety Population comprised of all participants who received at least 1 dose of the study treatment (including placebo) with at least 1 post-Baseline safety assessment. Number of participants with SAEs and common non-SAEs (\>=5%) are presented. |
| Part 2: Number of Participants With Worst Case Hematology Results to Potential Clinical Importance (PCI) Criteria | Up to 25 days | Blood samples were collected from participants for analysis of following hematology parameters; hematocrit, hemoglobin, leukocytes, lymphocytes, neutrophils and platelets. PCI ranges were \< 0.075 or \>0.54 proportion of red blood cells in blood for hematocrit, \<25 or \>180 grams per liter (g/L) for hemoglobin, \< 3 or \>20 cells per liter (cells/L) for leukocytes, 0.8 x10\^9 cells/L for lymphocytes, 1.5 x10\^9 cells/L for neutrophils, and \<100 or \>550 cells/L for platelets. Participants were counted in the worst case category that their value changes to (low, within range or no change, or high), unless there is no change in their category. Participants whose laboratory value category was unchanged (example given \[e.g.\], High to High), or whose value became within range, were recorded in the To within Range or No Change category. |
| Part 2: Number of Participants With Worst Case Clinical Chemistry Results to PCI Criteria | Up to 25 days | Blood samples were collected from participants for analysis of following clinical chemistry parameters; glucose, alanine aminotransferase (ALT), albumin, alkaline phosphatase, aspartate aminotransferase (AST), bilirubin, calcium, potassium and sodium. PCI ranges were \<30 g/L for albumin, \<2 or \>2.75 millimoles per liter (mmol/L) for calcium, \<3 or \>9 mmol/L for glucose, \>=2 times Upper limit of Normal (ULN) units per liter (U/L) for ALT, \>=2 times ULN U/L for alkaline phosphatase, \>=2 times ULN U/L for AST, \>=1.5 times ULN micromoles per liter (µmol/L) for bilirubin, \<3 or \>5.5 mmol/L for potassium, and \<130 or \>150 mmol/L for sodium. Participants were counted in the worst case category that their value changes to (low, within range or no change,or high), unless there is no change in their category. Participants whose laboratory value category was unchanged (e.g., High to High), or whose value became within range, were recorded in the To within Range or No Change category. |
| Part 2: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | Up to 25 days | Urine samples were collected from participants for analysis of following urinalysis parameters; specific gravity, potential of hydrogen (pH), presence of glucose, protein, occult blood, ketones in urine analyzed by dipstick method. The dipstick test gives results in a semi-quantitative manner. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The reference range is 1.002-1.030. Urine pH is an acid-base measurement. Normal urine has a slightly acid pH (5.0 - 6.0). Participants were counted in the worst case category that their value changes to (low, normal or high), unless there is no change in their category. Participants whose laboratory value category was unchanged (e.g., High to High), or whose value became normal, were recorded in the To Normal or No Change category. |
| Part 2: Blood Pressure at Indicated Time Points | Day -1; Pre-dose, 1, 4 hours on Day 1; 24 hours (Day 2); 48 hours (Day 3); 72 hours (Day 4), Days 5, 6, 7, 8, 9, 10; Pre-dose, 1, 4 , 24, 48, 72 hours on Day 11; Follow-up (Day 25) | Systolic blood pressure (SBP) and diastolic blood pressure (DBP) were measured in supine position after 10 minutes rest for the participants at indicated time points. |
| Part 2: Change From Baseline in Blood Pressure | Baseline (Day -1) and 1, 4 hours on Day 1; 24 hours (Day 2); 48 hours (Day 3); 72 hours (Day 4), Days 5, 6, 7, 8, 9, 10; Pre-dose, 1, 4 , 24, 48, 72 hours on Day 11; Follow-up (Day 25) | SBP and DBP were measured in supine position after 10 minutes rest for participants at indicated time points. Baseline was defined as the latest pre-dose assessment, including those from unscheduled visits. Change from Baseline was defined as any visit value minus Baseline value. |
| Part 2: Pulse Rate at Indicated Time Points | Day -1; Pre-dose, 1, 4 hours on Day 1; 24 hours (Day 2); 48 hours (Day 3); 72 hours (Day 4), Days 5, 6, 7, 8, 9, 10; Pre-dose, 1, 4 , 24, 48, 72 hours on Day 11; Follow-up (Day 25) | Pulse rate of participants was measured in supine position after 10 minutes rest at indicated time points. |
| Part 2: Change From Baseline in Pulse Rate | Baseline (Day -1) and 1, 4 hours on Day 1; 24 hours (Day 2); 48 hours (Day 3); 72 hours (Day 4), Days 5, 6, 7, 8, 9, 10; Pre-dose, 1, 4 , 24, 48, 72 hours on Day 11; Follow-up (Day 25) | Pulse rate was measured in supine position after 10 minutes rest at indicated time points. Baseline was defined as the latest pre-dose assessment, including those from unscheduled visits. Change from Baseline was defined as any visit value minus Baseline value. |
| Part 2: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | Day -1; 1, 4, 12 hours on Day 1; Days 2, 3, 5, 8; 1, 4, 12, 24 Hours on Day 11; Follow-up (Day 25) | Single and triplicate 12-lead ECG's were obtained at least 5 minutes apart in the supine position after 10 minutes of rest at indicated time points using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT and QT duration corrected for heart rate by Fridericia's formula (QTcF) intervals. Clinically significant (CS) and not clinically significant (NCS) abnormal ECG findings have been presented. CS 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. |
| Part 2: Change From Baseline in Mean Heart Rate Values as ECG Parameter | Baseline (Day -1) and 1, 4, 12 hours on Day 1; Days 2, 3 5, 8; Pre-dose, 1, 4, 12, 24 hours Day 11; Follow-up (Day 25) | Single and triplicate 12-lead ECG's were obtained at least 5 minutes apart in the supine position after 10 minutes of rest at indicated time points using an ECG machine that automatically calculates the heart rate. Baseline was defined as the latest pre-dose assessment, including those from unscheduled visits. Change from Baseline was defined as any visit value minus Baseline value. |
| Part 2: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | Baseline (Day -1) and 1, 4, 12 hours on Day 1; Days 2, 3 5, 8; Pre-dose, 1, 4, 12, 24 hours Day 11; Follow-up (Day 25) | Single and triplicate 12-lead ECG's were obtained at least 5 minutes apart in the supine position after 10 minutes of rest at indicated time points using an ECG machine that automatically calculates measures PR, QRS, QT and QTcF intervals. Baseline was defined as the latest pre-dose assessment, including those from unscheduled visits. Change from Baseline was defined as any visit value minus Baseline value. |
| Part 2: Area Under the Plasma Drug Concentration Time Curve From Pre-dose to the End of the Dosing Interval at Steady State (AUC[0-tau]) Following Administration of Non-boosted Once-daily Doses of GSK2838232 Tablet in Fed State | Pre-dose, 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12 and 24 hours post-dose on Day 1; Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96 and 120 hours post-dose on Day 11 in Part 2 | Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK2838232 given as a non-boosted once-daily dosing tablet in fed state. Pharmacokinetic parameters were determined using standard non-compartmental methods. |
| Part 2: Cmax Following Administration of Non-boosted Once-daily Doses of GSK2838232 Tablet in Fed State | Pre-dose, 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12 and 24 hours post-dose on Day 1; Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96 and 120 hours post-dose on Day 11 in Part 2 | Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK2838232 given as a non-boosted once-daily dosing tablet in fed state. Pharmacokinetic parameters were determined using standard non-compartmental methods. |
| Part 2: Observed Concentration at the End of the Dosing Interval (Ctau) Following Administration of Non-boosted Once-daily Doses of GSK2838232 Tablet in Fed State | Pre-dose, 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12 and 24 hours post-dose on Day 1; Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96 and 120 hours post-dose on Day 11 in Part 2 | Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK2838232 given as a non-boosted once-daily dosing tablet in fed state. Pharmacokinetic parameters were determined using standard non-compartmental methods. |
| Part 2: Tmax Following Administration of Non-boosted Once-daily Doses of GSK2838232 Tablet in Fed State | Pre-dose, 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12 and 24 hours post-dose on Day 1; Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96 and 120 hours post-dose on Day 11 in Part 2 | Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK2838232 given as a non-boosted once-daily dosing tablet in fed state. Pharmacokinetic parameters were determined using standard non-compartmental methods. |
| Part 2: Lag-time (Tlag) Following Administration of Non-boosted Once-daily Doses of GSK2838232 Tablet in Fed State on Day 1 | Pre-dose, 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12 and 24 hours post-dose on Day 1 in Part 2 | Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK2838232 given as a non-boosted once-daily dosing tablet in fed state. Tlag is a time delay between drug administration and first observed concentration. Pharmacokinetic parameters were determined using standard non-compartmental methods. |
| Part 2: AUC(0-infinity) Following Administration of Non-boosted Once-daily Doses of GSK2838232 Tablet in Fed State on Day 11 | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96 and 120 hours post-dose on Day 11 in Part 2 | Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK2838232 given as a non-boosted once-daily dosing tablet in fed state. Pharmacokinetic parameters were determined using standard non-compartmental methods. |
| Part 2: Apparent Terminal Phase Half-life (T1/2) Following Administration of Non-boosted Once-daily Doses of GSK2838232 Tablet in Fed State on Day 11 | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96 and 120 hours post-dose on Day 11 in Part 2 | Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK2838232 given as a non-boosted once-daily dosing tablet in fed state. Pharmacokinetic parameters were determined using standard non-compartmental methods. |
| Part 1: Area Under the Concentration-time Curve From Time Zero (Pre-dose) Extrapolated to Infinite Time (AUC [0-infinity]) Following Administration of GSK2838232 Tablet and Capsule Formulation in Fed State | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 120 hours post-dose in treatment periods 1 and 2 of Part 1 | Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK2838232 given as tablet and capsule formulation in fed state. Pharmacokinetic parameters were determined using standard non-compartmental methods. Pharmacokinetic Population comprised of all participants in the Safety Population who had at least 1 non-missing pharmacokinetic assessment (Non-quantifiable \[NQ\] values were considered as non-missing values). |
| Part 1: Maximum Observed Concentration (Cmax) Following Administration of GSK2838232 Tablet and Capsule Formulation in Fed State | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 120 hours post-dose in treatment periods 1 and 2 of Part 1 | Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK2838232 given as tablet and capsule formulation in fed state. Pharmacokinetic parameters were determined using standard non-compartmental methods. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Part 1: Number of Participants With Worst Case Hematology Results to PCI Criteria | Up to 60 days | Blood samples were collected from participants for analysis of following hematology parameters; hematocrit, hemoglobin, leukocytes, lymphocytes, neutrophils and platelets. PCI ranges were \>0.54 as proportion of red blood cells in blood for hematocrit, \>180 g/L for hemoglobin, \< 3 or \>20 cells/L for leukocytes, 0.8 x10\^9 cells/L for lymphocytes, 1.5 x10\^9 cells/L for neutrophils, and \<100 or \>550 cells/L for platelets. Participants were counted in the worst case category that their value changes to (low, within range or no change, or high), unless there is no change in their category. Participants whose laboratory value category was unchanged (e.g., High to High), or whose value became within range, were recorded in the To within Range or No Change category. |
| Part 1: Number of Participants With Worst Case Clinical Chemistry Results to PCI Criteria | Up to 60 days | Blood samples were collected from participants for analysis of following clinical chemistry parameters; glucose, ALT, albumin, alkaline phosphatase, AST, bilirubin, calcium, potassium and sodium. PCI ranges were \<30 g/L for albumin, \<2 or 2.75 mmol/L for calcium, \<3 or \>9 mmol/L for glucose, \>=2 times ULN U/L for ALT, \>=2 times ULN U/L for alkaline phosphatase, \>=2 times ULN U/L for AST, \>=1.5 times ULN µmol/L for bilirubin, \<3 or \>5.5 mmol/L for potassium, and \<130 or \>150 mmol/L for sodium. Participants were counted in the worst case category that their value changes to (low, within range or no change,or high), unless there is no change in their category. Participants whose laboratory value category was unchanged (e.g., High to High), or whose value became within range, were recorded in the To within Range or No Change category. |
| Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | Up to 60 days | Urine samples were collected from participants for analysis of following urinalysis parameters; specific gravity, pH, presence of glucose, protein, occult blood, ketones in urine analyzed by dipstick method. The dipstick test gives results in a semi-quantitative manner. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The reference range is 1.002-1.030. Urine pH is an acid-base measurement. Normal urine has a slightly acid pH (5.0 - 6.0). Participants were counted in the worst case category that their value changes to (low, normal or high), unless there is no change in their category. Participants whose laboratory value category was unchanged (e.g., High to High), or whose value became normal, were recorded in the To Normal or No Change category. |
| Part 1: Blood Pressure at Indicated Time Points | Day -2; Day -1; Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 Hours on Day 1 | SBP and DBP of participants were measured in supine position after 10 minutes rest at indicated time points. |
| Part 1: Change From Baseline in Blood Pressure | Baseline (Day -1) and 1, 2, 4, 6, 8, 12, 24, 48, 72 Hours on Day 1 | SBP and DBP were measured in supine position after 10 minutes rest for the participant at indicated time points. Baseline was defined as the latest pre-dose assessment, including those from unscheduled visits. Change from Baseline was defined as any visit value minus Baseline value. |
| Part 1: Pulse Rate at Indicated Time Points | Day -2; Day -1; Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 Hours on Day 1 | Pulse rate was measured in supine position after 10 minutes rest for the participant at indicated time points. |
| Part 1: Change From Baseline in Pulse Rate | Baseline (Day -1) and 1, 2, 4, 6, 8, 12, 24, 48, 72 Hours on Day 1 | Pulse rate was measured in supine position after 10 minutes rest for the participant at indicated time points. Baseline was defined as the latest pre-dose assessment, including those from unscheduled visits. Change from Baseline was defined as any visit value minus Baseline value. |
| Part 1: Number of Participants With Abnormal ECG Findings | Day -2, Day -1; 1, 2, 4, 6, 8, , 12, 24, 48, 72 hours on Day 1 | Single and triplicate 12-lead ECG's were obtained at least 5 minutes apart in the supine position after 10 minutes of rest at indicated time points using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT and QTcF intervals. CS and NCS abnormal ECG findings have been presented. CS 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. |
| Part 1: Change From Baseline in Mean Heart Rate Values as ECG Parameter | Baseline (Day -1) and 1, 2, 4, 6, 8, 12, 24, 48, 72 hours on Day 1 | Single and triplicate 12-lead ECG's were obtained at least 5 minutes apart in the supine position after 10 minutes of rest at indicated time points using an ECG machine that automatically calculates the heart rate. Baseline was defined as the latest pre-dose assessment, including those from unscheduled visits. Change from Baseline was defined as any visit value minus Baseline value. |
| Part 1: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | Baseline (Day -1) and 1, 2, 4, 6, 8, 12, 24, 48, 72 hours on Day 1 | Single and triplicate 12-lead ECG's were obtained at least 5 minutes apart in the supine position after 10 minutes of rest at indicated time points using an ECG machine that automatically calculates measures PR, QRS, QT and QTcF intervals. Baseline was defined as the latest pre-dose assessment, including those from unscheduled visits. Change from Baseline was defined as any visit value minus Baseline value. |
| Part 1: Tlag Following Administration of GSK2838232 Tablet and Capsule Formulation in Fed State and Tablet Formulation in Fasted State | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 120 hours post-dose in treatment periods 1, 2 and 3 of Part 1 | Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK2838232 given as capsule and tablet formulation in fed state as well as tablet formulation in fasted state. Tlag is a time delay between drug administration and first observed concentration. Pharmacokinetic parameters were determined using standard non-compartmental methods. |
| Part 1: Tmax Following Administration of GSK2838232 Tablet and Capsule Formulation in Fed State and Tablet Formulation in Fasted State | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 120 hours post-dose in treatment periods 1, 2 and 3 of Part 1 | Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK2838232 given as capsule and tablet formulation in fed state as well as tablet formulation in fasted state. Pharmacokinetic parameters were determined using standard non-compartmental methods. |
| Part 1: T1/2 Following Administration of GSK2838232 Tablet and Capsule Formulation in Fed State and Tablet Formulation in Fasted State | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 120 hours post-dose in treatment periods 1, 2 and 3 of Part 1 | Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK2838232 given as capsule and tablet formulation in fed state as well as tablet formulation in fasted state. Pharmacokinetic parameters were determined using standard non-compartmental methods. |
| Part 1: Tlast Following Administration of GSK2838232 Tablet and Capsule Formulation in Fed State and Tablet Formulation in Fasted State | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 120 hours post-dose in treatment periods 1, 2 and 3 of Part 1 | Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK2838232 given as capsule and tablet formulation in fed state as well as tablet formulation in fasted state. Pharmacokinetic parameters were determined using standard non-compartmental methods. |
| Part 1: Plasma Drug Concentration at 24 Hours (C24) Following Administration of GSK2838232 Tablet and Capsule Formulation in Fed State and Tablet Formulation in Fasted State | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 120 hours post-dose in treatment periods 1, 2 and 3 of Part 1 | Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK2838232 given as capsule and tablet formulation in fed state as well as tablet formulation in fasted state. Pharmacokinetic parameters were determined using standard non-compartmental methods. |
| Part 1: AUC(0-t) Following Administration of GSK2838232 Tablet and Capsule Formulation in Fed State and Tablet Formulation in Fasted State | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 120 hours post-dose in treatment periods 1, 2 and 3 of Part 1 | Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK2838232 given as capsule and tablet formulation in fed state as well as tablet formulation in fasted state. Pharmacokinetic parameters were determined using standard non-compartmental methods. |
| Part 2: Slope of Pre-dose Concentration of GSK2838232 Administered as Non-boosted Once-daily Doses of a Tablet Formulation to Assess Achievement of Steady State | Pre-dose on Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 10 and Day 11 in Part 2 | Blood sample were collected at indicated time points to assess pre-dose concentration of GSK2838232 when administered as non-boosted once-daily doses of a tablet formulation for 11 days in Part 2. Slope and 90 percent confidence interval have been presented. |
| Part 2: Accumulation Ratio Calculated From AUC(0-tau) Following Administration of GSK2838232 as Non-boosted Once-daily Doses of a Tablet Formulation | Pre-dose, 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12 and 24 hours post-dose on Day 1; Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96 and 120 hours post-dose on Day 11 in Part 2 | Blood sample were collected at indicated time points to calculate accumulation ratio from AUC(0-tau) following administration of GSK2838232 as non-boosted once-daily doses of a tablet formulation. Accumulation ratio of GSK2838232 was evaluated by Day 11, AUC (0-tau) divided by Day 1, AUC (0-tau). |
| Part 2: Accumulation Ratio Calculated From Cmax Following Administration of GSK2838232 as Non-boosted Once-daily Doses of a Tablet Formulation | Pre-dose, 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12 and 24 hours post-dose on Day 1; Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96 and 120 hours post-dose on Day 11 in Part 2 | Blood sample were collected at indicated time points to calculate accumulation ratio from Cmax following administration of GSK2838232 as non-boosted once-daily doses of a tablet formulation. Accumulation ratio of GSK2838232 was evaluated by Day 11, Cmax divided by Day 1, Cmax. |
| Part 2: Accumulation Ratio Calculated From Ctau Following Administration of GSK2838232 as Non-boosted Once-daily Doses of a Tablet Formulation | Pre-dose, 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12 and 24 hours post-dose on Day 1; Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96 and 120 hours post-dose on Day 11 in Part 2 | Blood sample were collected at indicated time points to calculate accumulation ratio from Ctau following administration of GSK2838232 as non-boosted once-daily doses of a tablet formulation. Accumulation ratio of GSK2838232 was evaluated by Day 11, Ctau divided by Day 1, Ctau. |
| Part 1: Number of Participants With SAEs and Non-SAEs | Up to 60 days | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/ birth defect, is associated with liver injury or impaired liver function or any other situations as per medical or scientific judgment. Number of participants with SAEs and common non-SAEs (\>=5%) are presented. |
Countries
United States
Participant flow
Recruitment details
This two-part study assessed the relative bioavailability and food effect of a novel tablet formulation of boosted-GSK2838232 compared to capsule along with safety and pharmacokinetics of repeated once-daily doses of non-boosted GSK2838232. This study was conducted at a single center in the United States.
Pre-assignment details
Participants received GSK2838232 200 milligrams (mg)/ritonavir as capsule or tablet formulation in Part 1 and GSK2838232 500 mg or placebo in Part 2. A total number of 16 participants were enrolled in Part 1 of the study and 10 participants were enrolled in Part 2. In total, 26 participants were enrolled in the study.
Participants by arm
| Arm | Count |
|---|---|
| Part 1: All Participants Receiving GSK2838232/Ritonavir Eligible participants were assigned to treatment sequence AB or BA where A=single dose of GSK2838232 200 mg (as 4 x 50 mg) capsule under fed condition and B=single dose of GSK2838232 200 mg (as 4 x 50 mg) tablet formulations administered under fed condition in treatment periods 1 and 2 along with ritonavir 100 mg to be taken with water in fed condition. Participants received a single dose of GSK2838232 200 mg (as 2 x 10 mg) tablet administered under fasted conditions in treatment period 3 along with ritonavir 100 mg to be taken with water in fasted condition. Treatment periods 1 and 2 were separated by a wash-out period of 10 days. Treatment periods 2 and 3 were separated by a wash-out period of 15 days. | 16 |
| Part 2: Placebo Eligible participants received single daily doses of placebo tablet orally along with water in fed condition for 11 days. | 3 |
| Part 2: GSK2838232 500 mg Tablet Fed Eligible participants received non-ritonavir boosted GSK2838232 500 mg, given as single daily doses in fed condition for 11 days. | 7 |
| Total | 26 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Part 1:Washout Period 1 (Up to 10 Days) | Adverse Event | 1 | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | Part 1: All Participants Receiving GSK2838232/Ritonavir | Part 2: Placebo | Part 2: GSK2838232 500 mg Tablet Fed | Total |
|---|---|---|---|---|
| Age, Continuous | 36.3 Years STANDARD_DEVIATION 9.54 | 41.0 Years STANDARD_DEVIATION 9.64 | 34.6 Years STANDARD_DEVIATION 7.81 | 36.38 Years STANDARD_DEVIATION 9.3 |
| Race/Ethnicity, Customized AMERICAN INDIAN OR ALASKA NATIVE | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized BLACK OR AFRICAN AMERICAN | 8 Participants | 2 Participants | 6 Participants | 16 Participants |
| Race/Ethnicity, Customized MULTIPLE-ASIAN & BLACK OR AFRICAN AMERICAN | 2 Participants | 0 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized WHITE - WHITE/CAUCASIAN/EUROPEAN HERITAGE | 6 Participants | 1 Participants | 0 Participants | 7 Participants |
| Sex: Female, Male Female | 9 Participants | 0 Participants | 1 Participants | 10 Participants |
| Sex: Female, Male Male | 7 Participants | 3 Participants | 6 Participants | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 15 | 0 / 14 | 0 / 3 | 0 / 7 |
| other Total, other adverse events | 3 / 15 | 2 / 15 | 1 / 14 | 1 / 3 | 0 / 7 |
| serious Total, serious adverse events | 0 / 15 | 0 / 15 | 0 / 14 | 0 / 3 | 0 / 7 |
Outcome results
Primary
Part 1: Area Under the Concentration-time Curve From Time Zero (Pre-dose) Extrapolated to Infinite Time (AUC [0-infinity]) Following Administration of GSK2838232 Tablet and Capsule Formulation in Fed State
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK2838232 given as tablet and capsule formulation in fed state. Pharmacokinetic parameters were determined using standard non-compartmental methods. Pharmacokinetic Population comprised of all participants in the Safety Population who had at least 1 non-missing pharmacokinetic assessment (Non-quantifiable \[NQ\] values were considered as non-missing values).
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 120 hours post-dose in treatment periods 1 and 2 of Part 1
Population: Pharmacokinetic Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Area Under the Concentration-time Curve From Time Zero (Pre-dose) Extrapolated to Infinite Time (AUC [0-infinity]) Following Administration of GSK2838232 Tablet and Capsule Formulation in Fed State | 4672.28 Hours*nanogram per milliliter | Geometric Coefficient of Variation 40.68 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Area Under the Concentration-time Curve From Time Zero (Pre-dose) Extrapolated to Infinite Time (AUC [0-infinity]) Following Administration of GSK2838232 Tablet and Capsule Formulation in Fed State | 4437.98 Hours*nanogram per milliliter | Geometric Coefficient of Variation 30.83 |
Primary
Part 1: AUC (0-infinity) Following Administration of GSK2838232 Tablet in Fasted and Fed State
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK2838232 given as tablet formulation in fed and fasted state. Pharmacokinetic parameters were determined using standard non-compartmental methods.
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 120 hours post-dose in treatment periods 1, 2 and 3 of Part 1
Population: Pharmacokinetic Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: AUC (0-infinity) Following Administration of GSK2838232 Tablet in Fasted and Fed State | 4437.98 Hours*nanogram per milliliter | Geometric Coefficient of Variation 30.83 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: AUC (0-infinity) Following Administration of GSK2838232 Tablet in Fasted and Fed State | 1816.27 Hours*nanogram per milliliter | Geometric Coefficient of Variation 36.42 |
Primary
Part 1: Cmax Following Administration of GSK2838232 Tablet in Fasted and Fed State
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK2838232 given as tablet formulation in fed and fasted state. Pharmacokinetic parameters were determined using standard non-compartmental methods.
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 120 hours post-dose in treatment periods 1, 2 and 3 of Part 1
Population: Pharmacokinetic Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Cmax Following Administration of GSK2838232 Tablet in Fasted and Fed State | 118.118 Nanograms per milliliter | Geometric Coefficient of Variation 27.59 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Cmax Following Administration of GSK2838232 Tablet in Fasted and Fed State | 50.437 Nanograms per milliliter | Geometric Coefficient of Variation 35.61 |
Primary
Part 1: Maximum Observed Concentration (Cmax) Following Administration of GSK2838232 Tablet and Capsule Formulation in Fed State
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK2838232 given as tablet and capsule formulation in fed state. Pharmacokinetic parameters were determined using standard non-compartmental methods.
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 120 hours post-dose in treatment periods 1 and 2 of Part 1
Population: Pharmacokinetic Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Maximum Observed Concentration (Cmax) Following Administration of GSK2838232 Tablet and Capsule Formulation in Fed State | 109.054 Nanograms per milliliter | Geometric Coefficient of Variation 48.01 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Maximum Observed Concentration (Cmax) Following Administration of GSK2838232 Tablet and Capsule Formulation in Fed State | 118.118 Nanograms per milliliter | Geometric Coefficient of Variation 27.59 |
Primary
Part 1: Time of Occurrence of Cmax (Tmax) Following Administration of GSK2838232 Tablet in Fasted and Fed State
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK2838232 given as tablet formulation in fed and fasted state. Pharmacokinetic parameters were determined using standard non-compartmental methods.
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 120 hours post-dose in treatment periods 1, 2 and 3 of Part 1
Population: Pharmacokinetic Population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Time of Occurrence of Cmax (Tmax) Following Administration of GSK2838232 Tablet in Fasted and Fed State | 5.983 Hours |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Time of Occurrence of Cmax (Tmax) Following Administration of GSK2838232 Tablet in Fasted and Fed State | 3.508 Hours |
Primary
Part 2: Apparent Terminal Phase Half-life (T1/2) Following Administration of Non-boosted Once-daily Doses of GSK2838232 Tablet in Fed State on Day 11
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK2838232 given as a non-boosted once-daily dosing tablet in fed state. Pharmacokinetic parameters were determined using standard non-compartmental methods.
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96 and 120 hours post-dose on Day 11 in Part 2
Population: Pharmacokinetic Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Apparent Terminal Phase Half-life (T1/2) Following Administration of Non-boosted Once-daily Doses of GSK2838232 Tablet in Fed State on Day 11 | 23.217 Hours | Geometric Coefficient of Variation 37.85 |
Primary
Part 2: Area Under the Plasma Drug Concentration Time Curve From Pre-dose to the End of the Dosing Interval at Steady State (AUC[0-tau]) Following Administration of Non-boosted Once-daily Doses of GSK2838232 Tablet in Fed State
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK2838232 given as a non-boosted once-daily dosing tablet in fed state. Pharmacokinetic parameters were determined using standard non-compartmental methods.
Time frame: Pre-dose, 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12 and 24 hours post-dose on Day 1; Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96 and 120 hours post-dose on Day 11 in Part 2
Population: Pharmacokinetic Population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Area Under the Plasma Drug Concentration Time Curve From Pre-dose to the End of the Dosing Interval at Steady State (AUC[0-tau]) Following Administration of Non-boosted Once-daily Doses of GSK2838232 Tablet in Fed State | Day 11 | 1184.55 Hours*nanograms per milliliter | Geometric Coefficient of Variation 35.34 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Area Under the Plasma Drug Concentration Time Curve From Pre-dose to the End of the Dosing Interval at Steady State (AUC[0-tau]) Following Administration of Non-boosted Once-daily Doses of GSK2838232 Tablet in Fed State | Day 1 | 895.42 Hours*nanograms per milliliter | Geometric Coefficient of Variation 39.08 |
Primary
Part 2: AUC(0-infinity) Following Administration of Non-boosted Once-daily Doses of GSK2838232 Tablet in Fed State on Day 11
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK2838232 given as a non-boosted once-daily dosing tablet in fed state. Pharmacokinetic parameters were determined using standard non-compartmental methods.
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96 and 120 hours post-dose on Day 11 in Part 2
Population: Pharmacokinetic Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: AUC(0-infinity) Following Administration of Non-boosted Once-daily Doses of GSK2838232 Tablet in Fed State on Day 11 | 1816.34 Hours*nanograms per milliliter | Geometric Coefficient of Variation 37.32 |
Primary
Part 2: Blood Pressure at Indicated Time Points
Systolic blood pressure (SBP) and diastolic blood pressure (DBP) were measured in supine position after 10 minutes rest for the participants at indicated time points.
Time frame: Day -1; Pre-dose, 1, 4 hours on Day 1; 24 hours (Day 2); 48 hours (Day 3); 72 hours (Day 4), Days 5, 6, 7, 8, 9, 10; Pre-dose, 1, 4 , 24, 48, 72 hours on Day 11; Follow-up (Day 25)
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Blood Pressure at Indicated Time Points | SBP; DAY 4, 72 Hours | 108.333 Millimeter of mercury | Standard Deviation 7.6376 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Blood Pressure at Indicated Time Points | DBP; DAY 1, PREDOSE | 65.443 Millimeter of mercury | Standard Deviation 2.6925 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Blood Pressure at Indicated Time Points | DBP; DAY 1, 1 Hour | 54.667 Millimeter of mercury | Standard Deviation 3.7859 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Blood Pressure at Indicated Time Points | DBP; DAY 1, 4 Hours | 62.000 Millimeter of mercury | Standard Deviation 1 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Blood Pressure at Indicated Time Points | DBP; DAY 6 | 62.667 Millimeter of mercury | Standard Deviation 4.5092 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Blood Pressure at Indicated Time Points | DBP; DAY 7 | 64.333 Millimeter of mercury | Standard Deviation 3.0551 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Blood Pressure at Indicated Time Points | DBP; DAY 8 | 66.000 Millimeter of mercury | Standard Deviation 2.6458 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Blood Pressure at Indicated Time Points | DBP; DAY 9 | 69.000 Millimeter of mercury | Standard Deviation 4 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Blood Pressure at Indicated Time Points | DBP; Follow-Up (DAY 25) | 71.000 Millimeter of mercury | Standard Deviation 1 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Blood Pressure at Indicated Time Points | SBP; DAY 3, 48 Hours | 111.333 Millimeter of mercury | Standard Deviation 2.3094 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Blood Pressure at Indicated Time Points | DBP; DAY -1 | 73.667 Millimeter of mercury | Standard Deviation 7.5056 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Blood Pressure at Indicated Time Points | SBP; DAY 5 | 105.667 Millimeter of mercury | Standard Deviation 2.3094 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Blood Pressure at Indicated Time Points | SBP; DAY 6 | 106.667 Millimeter of mercury | Standard Deviation 4.7258 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Blood Pressure at Indicated Time Points | SBP; DAY 7 | 103.333 Millimeter of mercury | Standard Deviation 1.1547 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Blood Pressure at Indicated Time Points | SBP; DAY 8 | 105.667 Millimeter of mercury | Standard Deviation 4.1633 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Blood Pressure at Indicated Time Points | SBP; DAY 9 | 107.333 Millimeter of mercury | Standard Deviation 7.2342 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Blood Pressure at Indicated Time Points | SBP; DAY 11, 1 Hour | 113.000 Millimeter of mercury | Standard Deviation 3.4641 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Blood Pressure at Indicated Time Points | SBP; DAY 11, 24 Hours | 107.333 Millimeter of mercury | Standard Deviation 13.2035 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Blood Pressure at Indicated Time Points | SBP; DAY 11, 48 Hours | 109.667 Millimeter of mercury | Standard Deviation 8.0829 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Blood Pressure at Indicated Time Points | SBP; DAY 11, 72 Hours | 110.333 Millimeter of mercury | Standard Deviation 2.3094 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Blood Pressure at Indicated Time Points | SBP; DAY 10 | 110.000 Millimeter of mercury | Standard Deviation 4 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Blood Pressure at Indicated Time Points | SBP; DAY 11, PREDOSE | 107.113 Millimeter of mercury | Standard Deviation 3.8626 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Blood Pressure at Indicated Time Points | SBP; DAY 11, 4 Hours | 108.667 Millimeter of mercury | Standard Deviation 6.0277 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Blood Pressure at Indicated Time Points | SBP; Follow-Up (DAY 25) | 115.667 Millimeter of mercury | Standard Deviation 5.8595 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Blood Pressure at Indicated Time Points | DBP; DAY 2, 24 Hours | 73.667 Millimeter of mercury | Standard Deviation 4.0415 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Blood Pressure at Indicated Time Points | DBP; DAY 3, 48 Hours | 66.000 Millimeter of mercury | Standard Deviation 1.7321 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Blood Pressure at Indicated Time Points | DBP; DAY 4, 72 Hours | 69.000 Millimeter of mercury | Standard Deviation 2.6458 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Blood Pressure at Indicated Time Points | DBP; DAY 5 | 62.333 Millimeter of mercury | Standard Deviation 4.9329 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Blood Pressure at Indicated Time Points | DBP; DAY 10 | 65.000 Millimeter of mercury | Standard Deviation 7.2111 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Blood Pressure at Indicated Time Points | DBP; DAY 11, PREDOSE | 65.333 Millimeter of mercury | Standard Deviation 5.1316 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Blood Pressure at Indicated Time Points | DBP; DAY 11, 1 Hour | 62.667 Millimeter of mercury | Standard Deviation 7.3711 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Blood Pressure at Indicated Time Points | DBP; DAY 11, 4 Hours | 63.333 Millimeter of mercury | Standard Deviation 4.5092 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Blood Pressure at Indicated Time Points | DBP; DAY 11, 24 Hours | 67.667 Millimeter of mercury | Standard Deviation 4.5092 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Blood Pressure at Indicated Time Points | DBP; DAY 11, 48 Hours | 66.000 Millimeter of mercury | Standard Deviation 5.5678 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Blood Pressure at Indicated Time Points | DBP; DAY 11, 72 Hours | 66.333 Millimeter of mercury | Standard Deviation 3.7859 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Blood Pressure at Indicated Time Points | SBP; DAY -1 | 121.000 Millimeter of mercury | Standard Deviation 4.5826 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Blood Pressure at Indicated Time Points | SBP; DAY 1, PREDOSE | 107.553 Millimeter of mercury | Standard Deviation 4.14 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Blood Pressure at Indicated Time Points | SBP; DAY 1, 1 Hour | 99.333 Millimeter of mercury | Standard Deviation 2.0817 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Blood Pressure at Indicated Time Points | SBP; DAY 1, 4 Hours | 105.000 Millimeter of mercury | Standard Deviation 8.1854 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Blood Pressure at Indicated Time Points | SBP; DAY 2, 24 Hours | 110.667 Millimeter of mercury | Standard Deviation 7.7675 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Blood Pressure at Indicated Time Points | DBP; DAY 11, PREDOSE | 67.000 Millimeter of mercury | Standard Deviation 8.0179 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Blood Pressure at Indicated Time Points | DBP; DAY -1 | 73.143 Millimeter of mercury | Standard Deviation 4.7759 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Blood Pressure at Indicated Time Points | SBP; DAY 10 | 106.714 Millimeter of mercury | Standard Deviation 8.8828 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Blood Pressure at Indicated Time Points | SBP; DAY 1, 1 Hour | 113.000 Millimeter of mercury | Standard Deviation 8.7178 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Blood Pressure at Indicated Time Points | DBP; DAY 1, 1 Hour | 64.714 Millimeter of mercury | Standard Deviation 5.8228 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Blood Pressure at Indicated Time Points | SBP; DAY 11, 1 Hour | 111.571 Millimeter of mercury | Standard Deviation 15.7041 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Blood Pressure at Indicated Time Points | DBP; DAY 11, 1 Hour | 66.571 Millimeter of mercury | Standard Deviation 7.6563 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Blood Pressure at Indicated Time Points | DBP; DAY 6 | 66.143 Millimeter of mercury | Standard Deviation 6.669 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Blood Pressure at Indicated Time Points | SBP; DAY -1 | 123.000 Millimeter of mercury | Standard Deviation 7.3258 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Blood Pressure at Indicated Time Points | DBP; DAY 7 | 67.286 Millimeter of mercury | Standard Deviation 4.8892 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Blood Pressure at Indicated Time Points | SBP; Follow-Up (DAY 25) | 123.714 Millimeter of mercury | Standard Deviation 10.6413 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Blood Pressure at Indicated Time Points | DBP; DAY 8 | 69.286 Millimeter of mercury | Standard Deviation 6.3957 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Blood Pressure at Indicated Time Points | DBP; DAY 1, PREDOSE | 72.333 Millimeter of mercury | Standard Deviation 8.1636 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Blood Pressure at Indicated Time Points | DBP; DAY 9 | 66.714 Millimeter of mercury | Standard Deviation 5.0568 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Blood Pressure at Indicated Time Points | SBP; DAY 5 | 109.000 Millimeter of mercury | Standard Deviation 3.0551 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Blood Pressure at Indicated Time Points | DBP; DAY 11, 72 Hours | 65.000 Millimeter of mercury | Standard Deviation 5.8878 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Blood Pressure at Indicated Time Points | DBP; DAY 1, 4 Hours | 63.714 Millimeter of mercury | Standard Deviation 6.7507 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Blood Pressure at Indicated Time Points | DBP; Follow-Up (DAY 25) | 76.143 Millimeter of mercury | Standard Deviation 10.5424 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Blood Pressure at Indicated Time Points | DBP; DAY 11, 4 Hours | 65.571 Millimeter of mercury | Standard Deviation 8.5021 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Blood Pressure at Indicated Time Points | SBP; DAY 3, 48 Hours | 111.714 Millimeter of mercury | Standard Deviation 8.7695 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Blood Pressure at Indicated Time Points | DBP; DAY 2, 24 Hours | 73.714 Millimeter of mercury | Standard Deviation 6.0474 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Blood Pressure at Indicated Time Points | SBP; DAY 4, 72 Hours | 109.000 Millimeter of mercury | Standard Deviation 8.226 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Blood Pressure at Indicated Time Points | SBP; DAY 2, 24 Hours | 113.286 Millimeter of mercury | Standard Deviation 5.0568 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Blood Pressure at Indicated Time Points | DBP; DAY 3, 48 Hours | 68.000 Millimeter of mercury | Standard Deviation 7.3485 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Blood Pressure at Indicated Time Points | SBP; DAY 6 | 107.857 Millimeter of mercury | Standard Deviation 9.0079 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Blood Pressure at Indicated Time Points | DBP; DAY 11, 24 Hours | 64.714 Millimeter of mercury | Standard Deviation 7.0643 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Blood Pressure at Indicated Time Points | SBP; DAY 7 | 112.143 Millimeter of mercury | Standard Deviation 8.6106 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Blood Pressure at Indicated Time Points | DBP; DAY 4, 72 Hours | 65.143 Millimeter of mercury | Standard Deviation 8.3552 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Blood Pressure at Indicated Time Points | SBP; DAY 8 | 109.571 Millimeter of mercury | Standard Deviation 6.2412 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Blood Pressure at Indicated Time Points | SBP; DAY 1, PREDOSE | 121.190 Millimeter of mercury | Standard Deviation 10.8374 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Blood Pressure at Indicated Time Points | SBP; DAY 11, PREDOSE | 110.333 Millimeter of mercury | Standard Deviation 9.7088 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Blood Pressure at Indicated Time Points | DBP; DAY 5 | 65.000 Millimeter of mercury | Standard Deviation 7.3258 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Blood Pressure at Indicated Time Points | SBP; DAY 11, 4 Hours | 109.857 Millimeter of mercury | Standard Deviation 8.7069 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Blood Pressure at Indicated Time Points | DBP; DAY 11, 48 Hours | 68.000 Millimeter of mercury | Standard Deviation 8.9815 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Blood Pressure at Indicated Time Points | SBP; DAY 11, 24 Hours | 105.143 Millimeter of mercury | Standard Deviation 7.7337 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Blood Pressure at Indicated Time Points | DBP; DAY 10 | 66.571 Millimeter of mercury | Standard Deviation 8.0593 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Blood Pressure at Indicated Time Points | SBP; DAY 11, 48 Hours | 109.286 Millimeter of mercury | Standard Deviation 8.8828 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Blood Pressure at Indicated Time Points | SBP; DAY 1, 4 Hours | 106.286 Millimeter of mercury | Standard Deviation 9.6214 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Blood Pressure at Indicated Time Points | SBP; DAY 11, 72 Hours | 110.286 Millimeter of mercury | Standard Deviation 7.6966 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Blood Pressure at Indicated Time Points | SBP; DAY 9 | 110.143 Millimeter of mercury | Standard Deviation 8.7069 |
Primary
Part 2: Change From Baseline in Blood Pressure
SBP and DBP were measured in supine position after 10 minutes rest for participants at indicated time points. Baseline was defined as the latest pre-dose assessment, including those from unscheduled visits. Change from Baseline was defined as any visit value minus Baseline value.
Time frame: Baseline (Day -1) and 1, 4 hours on Day 1; 24 hours (Day 2); 48 hours (Day 3); 72 hours (Day 4), Days 5, 6, 7, 8, 9, 10; Pre-dose, 1, 4 , 24, 48, 72 hours on Day 11; Follow-up (Day 25)
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Change From Baseline in Blood Pressure | DBP; DAY 6 | -2.777 Millimeter of mercury | Standard Deviation 3.7175 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Change From Baseline in Blood Pressure | SBP; DAY 11, PREDOSE | -0.440 Millimeter of mercury | Standard Deviation 4.4381 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Change From Baseline in Blood Pressure | DBP; DAY 7 | -1.110 Millimeter of mercury | Standard Deviation 4.4381 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Change From Baseline in Blood Pressure | DBP; DAY 9 | 3.557 Millimeter of mercury | Standard Deviation 5.5901 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Change From Baseline in Blood Pressure | DBP; DAY 8 | 0.557 Millimeter of mercury | Standard Deviation 0.5095 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Change From Baseline in Blood Pressure | SBP; DAY 11, 1 Hour | 5.447 Millimeter of mercury | Standard Deviation 6.6678 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Change From Baseline in Blood Pressure | DBP; DAY 10 | -0.443 Millimeter of mercury | Standard Deviation 5.3488 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Change From Baseline in Blood Pressure | SBP; DAY 1, 1 Hour | -8.220 Millimeter of mercury | Standard Deviation 3.006 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Change From Baseline in Blood Pressure | DBP; DAY 11, PREDOSE | -0.110 Millimeter of mercury | Standard Deviation 3.4708 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Change From Baseline in Blood Pressure | SBP; DAY 11, 24 Hours | -0.220 Millimeter of mercury | Standard Deviation 13.2912 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Change From Baseline in Blood Pressure | DBP; DAY 11, 1 Hour | -2.777 Millimeter of mercury | Standard Deviation 5.3385 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Change From Baseline in Blood Pressure | DBP; DAY 5 | -3.110 Millimeter of mercury | Standard Deviation 2.8366 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Change From Baseline in Blood Pressure | DBP; DAY 11, 4 Hours | -2.110 Millimeter of mercury | Standard Deviation 3.3729 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Change From Baseline in Blood Pressure | SBP; DAY 11, 48 Hours | 2.113 Millimeter of mercury | Standard Deviation 12.0648 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Change From Baseline in Blood Pressure | DBP; DAY 11, 24 Hours | 2.223 Millimeter of mercury | Standard Deviation 5.9279 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Change From Baseline in Blood Pressure | DBP; DAY 11, 72 Hours | 0.890 Millimeter of mercury | Standard Deviation 4.6224 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Change From Baseline in Blood Pressure | SBP; Follow-Up (DAY 25) | 8.113 Millimeter of mercury | Standard Deviation 4.6808 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Change From Baseline in Blood Pressure | SBP; DAY 1, 4 Hours | -2.553 Millimeter of mercury | Standard Deviation 5.6718 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Change From Baseline in Blood Pressure | SBP; DAY 2, 24 Hours | 3.113 Millimeter of mercury | Standard Deviation 5.8232 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Change From Baseline in Blood Pressure | DBP; DAY 1, 1 Hour | -10.777 Millimeter of mercury | Standard Deviation 4.669 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Change From Baseline in Blood Pressure | SBP; DAY 3, 48 Hours | 3.780 Millimeter of mercury | Standard Deviation 1.8347 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Change From Baseline in Blood Pressure | SBP; DAY 6 | -0.887 Millimeter of mercury | Standard Deviation 7.0661 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Change From Baseline in Blood Pressure | SBP; DAY 4, 72 Hours | 0.780 Millimeter of mercury | Standard Deviation 5.4181 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Change From Baseline in Blood Pressure | DBP; DAY 1, 4 Hours | -3.443 Millimeter of mercury | Standard Deviation 3.6851 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Change From Baseline in Blood Pressure | SBP; DAY 5 | -1.887 Millimeter of mercury | Standard Deviation 3.6851 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Change From Baseline in Blood Pressure | DBP; DAY 11, 48 Hours | 0.557 Millimeter of mercury | Standard Deviation 6.7022 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Change From Baseline in Blood Pressure | SBP; DAY 7 | -4.220 Millimeter of mercury | Standard Deviation 3.7452 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Change From Baseline in Blood Pressure | DBP; DAY 2, 24 Hours | 8.223 Millimeter of mercury | Standard Deviation 2.5455 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Change From Baseline in Blood Pressure | SBP; DAY 8 | -1.887 Millimeter of mercury | Standard Deviation 5.1225 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Change From Baseline in Blood Pressure | DBP; DAY 4, 72 Hours | 3.557 Millimeter of mercury | Standard Deviation 2.218 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Change From Baseline in Blood Pressure | SBP; DAY 9 | -0.220 Millimeter of mercury | Standard Deviation 6.1657 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Change From Baseline in Blood Pressure | SBP; DAY 10 | 2.447 Millimeter of mercury | Standard Deviation 7.8192 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Change From Baseline in Blood Pressure | SBP; DAY 11, 4 Hours | 1.113 Millimeter of mercury | Standard Deviation 2.6962 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Change From Baseline in Blood Pressure | DBP; Follow-Up (DAY 25) | 5.557 Millimeter of mercury | Standard Deviation 3.2015 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Change From Baseline in Blood Pressure | SBP; DAY 11, 72 Hours | 2.780 Millimeter of mercury | Standard Deviation 1.8347 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Change From Baseline in Blood Pressure | DBP; DAY 3, 48 Hours | 0.557 Millimeter of mercury | Standard Deviation 4.3485 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Change From Baseline in Blood Pressure | SBP; DAY 11, 72 Hours | -10.904 Millimeter of mercury | Standard Deviation 13.159 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Change From Baseline in Blood Pressure | DBP; DAY 3, 48 Hours | -4.333 Millimeter of mercury | Standard Deviation 8.5244 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Change From Baseline in Blood Pressure | DBP; DAY 8 | -3.047 Millimeter of mercury | Standard Deviation 9.4939 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Change From Baseline in Blood Pressure | DBP; DAY 11, 24 Hours | -7.619 Millimeter of mercury | Standard Deviation 10.1445 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Change From Baseline in Blood Pressure | DBP; DAY 11, 48 Hours | -4.333 Millimeter of mercury | Standard Deviation 9.7243 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Change From Baseline in Blood Pressure | DBP; Follow-Up (DAY 25) | 3.810 Millimeter of mercury | Standard Deviation 10.1939 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Change From Baseline in Blood Pressure | SBP; DAY 1, 1 Hour | -8.190 Millimeter of mercury | Standard Deviation 10.8776 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Change From Baseline in Blood Pressure | SBP; DAY 6 | -13.333 Millimeter of mercury | Standard Deviation 15.5386 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Change From Baseline in Blood Pressure | SBP; DAY 9 | -11.047 Millimeter of mercury | Standard Deviation 14.9222 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Change From Baseline in Blood Pressure | SBP; DAY 10 | -14.476 Millimeter of mercury | Standard Deviation 13.8688 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Change From Baseline in Blood Pressure | SBP; DAY 11, PREDOSE | -10.857 Millimeter of mercury | Standard Deviation 13.9763 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Change From Baseline in Blood Pressure | SBP; DAY 11, 4 Hours | -11.333 Millimeter of mercury | Standard Deviation 14.3479 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Change From Baseline in Blood Pressure | SBP; DAY 11, 24 Hours | -16.047 Millimeter of mercury | Standard Deviation 15.2791 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Change From Baseline in Blood Pressure | SBP; Follow-Up (DAY 25) | 2.524 Millimeter of mercury | Standard Deviation 10.1553 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Change From Baseline in Blood Pressure | DBP; DAY 1, 1 Hour | -7.619 Millimeter of mercury | Standard Deviation 4.9086 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Change From Baseline in Blood Pressure | DBP; DAY 1, 4 Hours | -8.619 Millimeter of mercury | Standard Deviation 9.3099 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Change From Baseline in Blood Pressure | DBP; DAY 2, 24 Hours | 1.381 Millimeter of mercury | Standard Deviation 5.6866 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Change From Baseline in Blood Pressure | DBP; DAY 4, 72 Hours | -7.190 Millimeter of mercury | Standard Deviation 8.9524 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Change From Baseline in Blood Pressure | DBP; DAY 5 | -7.333 Millimeter of mercury | Standard Deviation 10.9039 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Change From Baseline in Blood Pressure | DBP; DAY 6 | -6.190 Millimeter of mercury | Standard Deviation 7.8255 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Change From Baseline in Blood Pressure | DBP; DAY 7 | -5.047 Millimeter of mercury | Standard Deviation 8.9388 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Change From Baseline in Blood Pressure | DBP; DAY 9 | -5.619 Millimeter of mercury | Standard Deviation 8.577 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Change From Baseline in Blood Pressure | DBP; DAY 10 | -5.761 Millimeter of mercury | Standard Deviation 10.0756 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Change From Baseline in Blood Pressure | DBP; DAY 11, PREDOSE | -5.333 Millimeter of mercury | Standard Deviation 11.3081 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Change From Baseline in Blood Pressure | DBP; DAY 11, 1 Hour | -5.761 Millimeter of mercury | Standard Deviation 12.2366 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Change From Baseline in Blood Pressure | DBP; DAY 11, 4 Hours | -6.761 Millimeter of mercury | Standard Deviation 10.3364 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Change From Baseline in Blood Pressure | DBP; DAY 11, 72 Hours | -7.333 Millimeter of mercury | Standard Deviation 9.2678 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Change From Baseline in Blood Pressure | SBP; DAY 1, 4 Hours | -14.904 Millimeter of mercury | Standard Deviation 8.226 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Change From Baseline in Blood Pressure | SBP; DAY 2, 24 Hours | -7.904 Millimeter of mercury | Standard Deviation 8.7636 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Change From Baseline in Blood Pressure | SBP; DAY 3, 48 Hours | -9.476 Millimeter of mercury | Standard Deviation 6.2626 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Change From Baseline in Blood Pressure | SBP; DAY 4, 72 Hours | -12.190 Millimeter of mercury | Standard Deviation 7.1567 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Change From Baseline in Blood Pressure | SBP; DAY 5 | -12.190 Millimeter of mercury | Standard Deviation 11.9632 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Change From Baseline in Blood Pressure | SBP; DAY 7 | -9.047 Millimeter of mercury | Standard Deviation 13.8084 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Change From Baseline in Blood Pressure | SBP; DAY 8 | -11.619 Millimeter of mercury | Standard Deviation 11.8726 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Change From Baseline in Blood Pressure | SBP; DAY 11, 1 Hour | -9.619 Millimeter of mercury | Standard Deviation 19.6856 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Change From Baseline in Blood Pressure | SBP; DAY 11, 48 Hours | -11.904 Millimeter of mercury | Standard Deviation 11.8344 |
Primary
Part 2: Change From Baseline in Mean Heart Rate Values as ECG Parameter
Single and triplicate 12-lead ECG's were obtained at least 5 minutes apart in the supine position after 10 minutes of rest at indicated time points using an ECG machine that automatically calculates the heart rate. Baseline was defined as the latest pre-dose assessment, including those from unscheduled visits. Change from Baseline was defined as any visit value minus Baseline value.
Time frame: Baseline (Day -1) and 1, 4, 12 hours on Day 1; Days 2, 3 5, 8; Pre-dose, 1, 4, 12, 24 hours Day 11; Follow-up (Day 25)
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Change From Baseline in Mean Heart Rate Values as ECG Parameter | DAY 3 | -5.333 Beats per minute | Standard Deviation 5.4902 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Change From Baseline in Mean Heart Rate Values as ECG Parameter | DAY 1, 4 Hours | 2.000 Beats per minute | Standard Deviation 5.9287 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Change From Baseline in Mean Heart Rate Values as ECG Parameter | DAY 11, 24 Hours | 2.667 Beats per minute | Standard Deviation 4.8106 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Change From Baseline in Mean Heart Rate Values as ECG Parameter | DAY 5 | -3.667 Beats per minute | Standard Deviation 2.6062 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Change From Baseline in Mean Heart Rate Values as ECG Parameter | Follow-up (DAY 25) | 2.333 Beats per minute | Standard Deviation 12.4705 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Change From Baseline in Mean Heart Rate Values as ECG Parameter | DAY 2 | -8.000 Beats per minute | Standard Deviation 0.8826 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Change From Baseline in Mean Heart Rate Values as ECG Parameter | DAY 1, 1 Hour | 4.000 Beats per minute | Standard Deviation 10.1734 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Change From Baseline in Mean Heart Rate Values as ECG Parameter | DAY 8 | -2.000 Beats per minute | Standard Deviation 1.8571 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Change From Baseline in Mean Heart Rate Values as ECG Parameter | DAY 11, PREDOSE | -4.333 Beats per minute | Standard Deviation 1.767 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Change From Baseline in Mean Heart Rate Values as ECG Parameter | DAY 1, 12 Hours | -6.000 Beats per minute | Standard Deviation 6.8912 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Change From Baseline in Mean Heart Rate Values as ECG Parameter | DAY 11, 1 Hour | 10.333 Beats per minute | Standard Deviation 7.7564 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Change From Baseline in Mean Heart Rate Values as ECG Parameter | DAY 11, 4 Hours | 1.000 Beats per minute | Standard Deviation 4.0986 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Change From Baseline in Mean Heart Rate Values as ECG Parameter | DAY 11, 12 Hours | -0.667 Beats per minute | Standard Deviation 3.8461 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Change From Baseline in Mean Heart Rate Values as ECG Parameter | DAY 11, 4 Hours | 4.811 Beats per minute | Standard Deviation 8.2683 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Change From Baseline in Mean Heart Rate Values as ECG Parameter | DAY 1, 12 Hours | 0.526 Beats per minute | Standard Deviation 5.1336 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Change From Baseline in Mean Heart Rate Values as ECG Parameter | DAY 2 | -5.331 Beats per minute | Standard Deviation 4.8861 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Change From Baseline in Mean Heart Rate Values as ECG Parameter | DAY 3 | -1.046 Beats per minute | Standard Deviation 4.9332 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Change From Baseline in Mean Heart Rate Values as ECG Parameter | DAY 5 | 2.669 Beats per minute | Standard Deviation 11.9804 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Change From Baseline in Mean Heart Rate Values as ECG Parameter | DAY 8 | 0.954 Beats per minute | Standard Deviation 5.8978 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Change From Baseline in Mean Heart Rate Values as ECG Parameter | DAY 1, 1 Hour | 10.240 Beats per minute | Standard Deviation 5.093 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Change From Baseline in Mean Heart Rate Values as ECG Parameter | DAY 11, 12 Hours | -0.189 Beats per minute | Standard Deviation 5.649 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Change From Baseline in Mean Heart Rate Values as ECG Parameter | DAY 11, 24 Hours | 0.954 Beats per minute | Standard Deviation 4.8878 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Change From Baseline in Mean Heart Rate Values as ECG Parameter | Follow-up (DAY 25) | 0.669 Beats per minute | Standard Deviation 8.2733 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Change From Baseline in Mean Heart Rate Values as ECG Parameter | DAY 1, 4 Hours | 1.954 Beats per minute | Standard Deviation 3.9733 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Change From Baseline in Mean Heart Rate Values as ECG Parameter | DAY 11, PREDOSE | -0.903 Beats per minute | Standard Deviation 6.9388 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Change From Baseline in Mean Heart Rate Values as ECG Parameter | DAY 11, 1 Hour | 6.383 Beats per minute | Standard Deviation 5.9634 |
Primary
Part 2: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters
Single and triplicate 12-lead ECG's were obtained at least 5 minutes apart in the supine position after 10 minutes of rest at indicated time points using an ECG machine that automatically calculates measures PR, QRS, QT and QTcF intervals. Baseline was defined as the latest pre-dose assessment, including those from unscheduled visits. Change from Baseline was defined as any visit value minus Baseline value.
Time frame: Baseline (Day -1) and 1, 4, 12 hours on Day 1; Days 2, 3 5, 8; Pre-dose, 1, 4, 12, 24 hours Day 11; Follow-up (Day 25)
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | QTcF interval; DAY 11, 24 Hours | -5.667 Milliseconds | Standard Deviation 2.9652 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | QRS interval; DAY 3 | 2.663 Milliseconds | Standard Deviation 3.0551 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | QT interval; DAY 3 | 5.777 Milliseconds | Standard Deviation 18.7403 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | QRS interval; DAY 5 | 3.997 Milliseconds | Standard Deviation 4.1633 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | QT interval; DAY 11, PREDOSE | 5.553 Milliseconds | Standard Deviation 6.1963 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | QRS interval; DAY 8 | -0.003 Milliseconds | Standard Deviation 1.1547 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | PR interval; DAY 1, 4 Hours | -6.443 Milliseconds | Standard Deviation 3.7945 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | QRS interval; DAY 11, PREDOSE | 1.107 Milliseconds | Standard Deviation 4.3393 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | QRS interval; DAY 1, 4 Hours | 1.997 Milliseconds | Standard Deviation 4.6188 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | QRS interval; DAY 11, 1 Hour | -0.003 Milliseconds | Standard Deviation 2.3094 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | PR interval; DAY 1, 12 Hours | -0.443 Milliseconds | Standard Deviation 11.9348 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | QRS interval; DAY 11, 4 Hours | -1.337 Milliseconds | Standard Deviation 1.1547 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | QT interval; DAY 11, 1 Hour | -18.223 Milliseconds | Standard Deviation 12.2979 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | PR interval; DAY 1, 1 Hour | -7.110 Milliseconds | Standard Deviation 2.036 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | QRS interval; DAY 11, 24 Hours | -1.337 Milliseconds | Standard Deviation 1.1547 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | QRS interval; Follow-up (DAY 25) | 1.997 Milliseconds | Standard Deviation 11.0151 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | PR interval; DAY 2 | 4.890 Milliseconds | Standard Deviation 3.6695 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | QT interval; DAY 1, 1 Hour | -8.223 Milliseconds | Standard Deviation 18.0177 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | PR interval; DAY 3 | 1.557 Milliseconds | Standard Deviation 4.2847 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | QT interval; DAY 1, 4 Hours | -3.557 Milliseconds | Standard Deviation 9.7159 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | QT interval; DAY 11, 4 Hours | -8.223 Milliseconds | Standard Deviation 10.0299 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | QT interval; DAY 2 | 5.777 Milliseconds | Standard Deviation 4.0741 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | PR interval; DAY 8 | 6.223 Milliseconds | Standard Deviation 10.8609 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | QT interval; DAY 5 | -0.890 Milliseconds | Standard Deviation 8.9502 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | PR interval; DAY 11, 24 Hours | 2.890 Milliseconds | Standard Deviation 10.8418 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | QT interval; DAY 8 | 1.110 Milliseconds | Standard Deviation 2.3378 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | PR interval; DAY 11, PREDOSE | 5.113 Milliseconds | Standard Deviation 10.1172 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | QT interval; DAY 11, 12 Hours | 5.777 Milliseconds | Standard Deviation 10.5451 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | QT interval; DAY 11, 24 Hours | -10.890 Milliseconds | Standard Deviation 12.601 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | PR interval; DAY 11, 1 Hour | -5.777 Milliseconds | Standard Deviation 7.3456 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | QT interval; Follow-up (DAY 25) | 0.443 Milliseconds | Standard Deviation 26.9777 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | QTcF interval; DAY 2 | -10.667 Milliseconds | Standard Deviation 4.6671 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | QTcF interval; DAY 1, 1 Hour | -0.667 Milliseconds | Standard Deviation 6.3366 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | PR interval; DAY 11, 4 Hours | -3.110 Milliseconds | Standard Deviation 10.8418 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | QTcF interval; DAY 1, 4 Hours | 1.000 Milliseconds | Standard Deviation 2.1838 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | QT interval; DAY 1, 12 Hours | 18.443 Milliseconds | Standard Deviation 18.0654 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | QTcF interval; DAY 1, 12 Hours | 7.000 Milliseconds | Standard Deviation 8.2158 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | PR interval; Follow-up (DAY 25) | -10.443 Milliseconds | Standard Deviation 5.0039 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | QTcF interval; DAY 3 | -5.000 Milliseconds | Standard Deviation 7.6908 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | QTcF interval; DAY 5 | -7.667 Milliseconds | Standard Deviation 4.18 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | PR interval; DAY 5 | 6.223 Milliseconds | Standard Deviation 9.1999 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | QTcF interval; DAY 8 | -2.000 Milliseconds | Standard Deviation 2.0246 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | QRS interval; DAY 1, 1 Hour | 3.330 Milliseconds | Standard Deviation 5.2915 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | QTcF interval; DAY 11, PREDOSE | -2.887 Milliseconds | Standard Deviation 2.915 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | QTcF interval; DAY 11, 1 Hour | 1.000 Milliseconds | Standard Deviation 4.8434 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | QRS interval; DAY 1, 12 Hours | 6.663 Milliseconds | Standard Deviation 4.6188 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | QTcF interval; DAY 11, 4 Hours | -5.667 Milliseconds | Standard Deviation 6.1719 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | PR interval; DAY 11, 12 Hours | 4.223 Milliseconds | Standard Deviation 12.6221 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | QTcF interval; DAY 11, 12 Hours | 5.333 Milliseconds | Standard Deviation 3.8474 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | QRS interval; DAY 11, 12 Hours | 3.330 Milliseconds | Standard Deviation 3.4641 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | QTcF interval; Follow-up (DAY 25) | 4.000 Milliseconds | Standard Deviation 5.8145 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | QRS interval; DAY 2 | 1.330 Milliseconds | Standard Deviation 2 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | QRS interval; DAY 11, 12 Hours | -0.856 Milliseconds | Standard Deviation 4.4676 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | PR interval; DAY 3 | 4.573 Milliseconds | Standard Deviation 6.1252 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | PR interval; DAY 11, 12 Hours | 1.716 Milliseconds | Standard Deviation 9.4661 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | PR interval; DAY 11, 24 Hours | 3.144 Milliseconds | Standard Deviation 6.0321 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | QRS interval; DAY 1, 1 Hour | -1.713 Milliseconds | Standard Deviation 3.3072 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | QRS interval; DAY 1, 4 Hours | -1.713 Milliseconds | Standard Deviation 1.4322 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | QRS interval; DAY 11, 24 Hours | -0.570 Milliseconds | Standard Deviation 3.7401 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | QT interval; DAY 1, 12 Hours | -7.237 Milliseconds | Standard Deviation 15.5856 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | QT interval; DAY 2 | 0.763 Milliseconds | Standard Deviation 9.3458 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | QT interval; DAY 11, PREDOSE | -4.283 Milliseconds | Standard Deviation 13.756 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | QT interval; DAY 11, 1 Hour | -28.380 Milliseconds | Standard Deviation 19.3087 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | QT interval; DAY 11, 4 Hours | -20.380 Milliseconds | Standard Deviation 17.774 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | QTcF interval; DAY 2 | -10.143 Milliseconds | Standard Deviation 6.7366 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | QTcF interval; DAY 3 | -10.714 Milliseconds | Standard Deviation 9.6264 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | QTcF interval; DAY 11, PREDOSE | -6.476 Milliseconds | Standard Deviation 5.7033 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | QTcF interval; DAY 11, 24 Hours | -10.429 Milliseconds | Standard Deviation 7.7286 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | PR interval; DAY 1, 1 Hour | -3.999 Milliseconds | Standard Deviation 10.611 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | PR interval; DAY 1, 4 Hours | -12.284 Milliseconds | Standard Deviation 13.98 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | PR interval; DAY 1, 12 Hours | 3.430 Milliseconds | Standard Deviation 5.7511 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | PR interval; DAY 2 | 3.716 Milliseconds | Standard Deviation 5.1471 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | PR interval; DAY 5 | 2.287 Milliseconds | Standard Deviation 9.5818 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | PR interval; DAY 8 | 7.430 Milliseconds | Standard Deviation 11.6897 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | PR interval; DAY 11, PREDOSE | 7.620 Milliseconds | Standard Deviation 5.5483 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | PR interval; DAY 11, 1 Hour | 2.287 Milliseconds | Standard Deviation 5.2749 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | PR interval; DAY 11, 4 Hours | -0.570 Milliseconds | Standard Deviation 9.9657 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | PR interval; Follow-up (DAY 25) | 2.001 Milliseconds | Standard Deviation 13.1373 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | QRS interval; DAY 1, 12 Hours | 1.716 Milliseconds | Standard Deviation 3.6295 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | QRS interval; DAY 2 | 0.287 Milliseconds | Standard Deviation 2.2711 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | QRS interval; DAY 3 | -4.570 Milliseconds | Standard Deviation 5.8288 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | QRS interval; DAY 5 | -1.999 Milliseconds | Standard Deviation 2.8532 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | QRS interval; DAY 8 | -3.141 Milliseconds | Standard Deviation 4.1578 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | QRS interval; DAY 11, PREDOSE | -0.570 Milliseconds | Standard Deviation 1.9401 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | QRS interval; DAY 11, 1 Hour | -0.856 Milliseconds | Standard Deviation 5.1594 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | QRS interval; DAY 11, 4 Hours | -2.570 Milliseconds | Standard Deviation 3.089 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | QRS interval; Follow-up (DAY 25) | 1.716 Milliseconds | Standard Deviation 1.5811 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | QT interval; DAY 1, 1 Hour | -26.094 Milliseconds | Standard Deviation 12.8322 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | QT interval; DAY 1, 4 Hours | -11.523 Milliseconds | Standard Deviation 11.6047 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | QT interval; DAY 3 | -8.951 Milliseconds | Standard Deviation 11.9189 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | QT interval; DAY 5 | -10.666 Milliseconds | Standard Deviation 19.1883 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | QT interval; DAY 8 | -8.951 Milliseconds | Standard Deviation 14.2945 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | QT interval; DAY 11, 12 Hours | -13.237 Milliseconds | Standard Deviation 13.1751 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | QT interval; DAY 11, 24 Hours | -13.523 Milliseconds | Standard Deviation 11.7381 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | QT interval; Follow-up (DAY 25) | -3.237 Milliseconds | Standard Deviation 20.6284 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | QTcF interval; DAY 1, 1 Hour | -5.857 Milliseconds | Standard Deviation 10.3146 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | QTcF interval; DAY 1, 4 Hours | -7.429 Milliseconds | Standard Deviation 7.1165 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | QTcF interval; DAY 1, 12 Hours | -6.286 Milliseconds | Standard Deviation 10.9182 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | QTcF interval; DAY 5 | -6.286 Milliseconds | Standard Deviation 7.6605 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | QTcF interval; DAY 8 | -6.714 Milliseconds | Standard Deviation 6.5305 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | QTcF interval; DAY 11, 1 Hour | -15.286 Milliseconds | Standard Deviation 11.1814 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | QTcF interval; DAY 11, 4 Hours | -11.000 Milliseconds | Standard Deviation 4.8767 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | QTcF interval; DAY 11, 12 Hours | -12.571 Milliseconds | Standard Deviation 7.6845 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | QTcF interval; Follow-up (DAY 25) | -2.571 Milliseconds | Standard Deviation 12.9581 |
Primary
Part 2: Change From Baseline in Pulse Rate
Pulse rate was measured in supine position after 10 minutes rest at indicated time points. Baseline was defined as the latest pre-dose assessment, including those from unscheduled visits. Change from Baseline was defined as any visit value minus Baseline value.
Time frame: Baseline (Day -1) and 1, 4 hours on Day 1; 24 hours (Day 2); 48 hours (Day 3); 72 hours (Day 4), Days 5, 6, 7, 8, 9, 10; Pre-dose, 1, 4 , 24, 48, 72 hours on Day 11; Follow-up (Day 25)
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Change From Baseline in Pulse Rate | DAY 4, 72 Hours | -4.997 Beats per minute | Standard Deviation 5.1316 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Change From Baseline in Pulse Rate | DAY 8 | 0.670 Beats per minute | Standard Deviation 0 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Change From Baseline in Pulse Rate | DAY 11, 72 Hours | -0.663 Beats per minute | Standard Deviation 4.0415 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Change From Baseline in Pulse Rate | DAY 9 | -2.663 Beats per minute | Standard Deviation 4.9329 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Change From Baseline in Pulse Rate | DAY 2, 24 Hours | -5.997 Beats per minute | Standard Deviation 2.5166 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Change From Baseline in Pulse Rate | DAY 10 | 0.003 Beats per minute | Standard Deviation 7.5056 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Change From Baseline in Pulse Rate | DAY 1, 1 Hour | 4.337 Beats per minute | Standard Deviation 11.2398 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Change From Baseline in Pulse Rate | DAY 11, PREDOSE | -1.777 Beats per minute | Standard Deviation 4.14 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Change From Baseline in Pulse Rate | DAY 6 | -1.330 Beats per minute | Standard Deviation 4.3589 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Change From Baseline in Pulse Rate | DAY 11, 1 Hour | 9.003 Beats per minute | Standard Deviation 8.3865 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Change From Baseline in Pulse Rate | DAY 1, 4 Hours | 1.003 Beats per minute | Standard Deviation 6.6583 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Change From Baseline in Pulse Rate | DAY 11, 4 Hours | 4.337 Beats per minute | Standard Deviation 8.5049 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Change From Baseline in Pulse Rate | DAY 5 | -2.997 Beats per minute | Standard Deviation 5.6862 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Change From Baseline in Pulse Rate | DAY 11, 24 Hours | 4.003 Beats per minute | Standard Deviation 6.5064 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Change From Baseline in Pulse Rate | DAY 11, 48 Hours | -1.997 Beats per minute | Standard Deviation 9.4516 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Change From Baseline in Pulse Rate | DAY 7 | -4.330 Beats per minute | Standard Deviation 1 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Change From Baseline in Pulse Rate | Follow-Up (DAY 25) | 7.003 Beats per minute | Standard Deviation 11.9304 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Change From Baseline in Pulse Rate | DAY 3, 48 Hours | -5.663 Beats per minute | Standard Deviation 4.9329 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Change From Baseline in Pulse Rate | Follow-Up (DAY 25) | 0.143 Beats per minute | Standard Deviation 10.7995 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Change From Baseline in Pulse Rate | DAY 3, 48 Hours | -4.286 Beats per minute | Standard Deviation 5.9568 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Change From Baseline in Pulse Rate | DAY 4, 72 Hours | -5.429 Beats per minute | Standard Deviation 7.0937 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Change From Baseline in Pulse Rate | DAY 5 | 2.714 Beats per minute | Standard Deviation 11.2383 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Change From Baseline in Pulse Rate | DAY 6 | -4.571 Beats per minute | Standard Deviation 9.8771 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Change From Baseline in Pulse Rate | DAY 11, 48 Hours | -2.000 Beats per minute | Standard Deviation 9.6686 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Change From Baseline in Pulse Rate | DAY 1, 1 Hour | 8.571 Beats per minute | Standard Deviation 5.4337 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Change From Baseline in Pulse Rate | DAY 1, 4 Hours | 2.286 Beats per minute | Standard Deviation 9.4965 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Change From Baseline in Pulse Rate | DAY 2, 24 Hours | -5.429 Beats per minute | Standard Deviation 4.4808 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Change From Baseline in Pulse Rate | DAY 7 | -0.286 Beats per minute | Standard Deviation 12.4265 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Change From Baseline in Pulse Rate | DAY 8 | -1.714 Beats per minute | Standard Deviation 8.2357 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Change From Baseline in Pulse Rate | DAY 9 | -3.000 Beats per minute | Standard Deviation 9.7265 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Change From Baseline in Pulse Rate | DAY 10 | -3.571 Beats per minute | Standard Deviation 10.5886 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Change From Baseline in Pulse Rate | DAY 11, PREDOSE | -2.904 Beats per minute | Standard Deviation 10.5699 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Change From Baseline in Pulse Rate | DAY 11, 1 Hour | 6.429 Beats per minute | Standard Deviation 10.376 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Change From Baseline in Pulse Rate | DAY 11, 4 Hours | 5.143 Beats per minute | Standard Deviation 10.9028 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Change From Baseline in Pulse Rate | DAY 11, 24 Hours | 0.857 Beats per minute | Standard Deviation 10.2185 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Change From Baseline in Pulse Rate | DAY 11, 72 Hours | -2.857 Beats per minute | Standard Deviation 8.7974 |
Primary
Part 2: Cmax Following Administration of Non-boosted Once-daily Doses of GSK2838232 Tablet in Fed State
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK2838232 given as a non-boosted once-daily dosing tablet in fed state. Pharmacokinetic parameters were determined using standard non-compartmental methods.
Time frame: Pre-dose, 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12 and 24 hours post-dose on Day 1; Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96 and 120 hours post-dose on Day 11 in Part 2
Population: Pharmacokinetic Population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Cmax Following Administration of Non-boosted Once-daily Doses of GSK2838232 Tablet in Fed State | Day 1 | 79.575 Nanograms per milliliter | Geometric Coefficient of Variation 45.69 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Cmax Following Administration of Non-boosted Once-daily Doses of GSK2838232 Tablet in Fed State | Day 11 | 94.239 Nanograms per milliliter | Geometric Coefficient of Variation 34.24 |
Primary
Part 2: Lag-time (Tlag) Following Administration of Non-boosted Once-daily Doses of GSK2838232 Tablet in Fed State on Day 1
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK2838232 given as a non-boosted once-daily dosing tablet in fed state. Tlag is a time delay between drug administration and first observed concentration. Pharmacokinetic parameters were determined using standard non-compartmental methods.
Time frame: Pre-dose, 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12 and 24 hours post-dose on Day 1 in Part 2
Population: Pharmacokinetic Population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Lag-time (Tlag) Following Administration of Non-boosted Once-daily Doses of GSK2838232 Tablet in Fed State on Day 1 | 0.500 Hours |
Primary
Part 2: Number of Participants With Abnormal Electrocardiogram (ECG) Findings
Single and triplicate 12-lead ECG's were obtained at least 5 minutes apart in the supine position after 10 minutes of rest at indicated time points using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT and QT duration corrected for heart rate by Fridericia's formula (QTcF) intervals. Clinically significant (CS) and not clinically significant (NCS) abnormal ECG findings have been presented. CS 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.
Time frame: Day -1; 1, 4, 12 hours on Day 1; Days 2, 3, 5, 8; 1, 4, 12, 24 Hours on Day 11; Follow-up (Day 25)
Population: Safety Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | CS: DAY 8 | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | NCS: DAY 1, 4 Hours | 2 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | CS: DAY 1, 4 Hours | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | NCS: DAY 1, 12 Hours | 3 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | CS: DAY 1, 12 Hours | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | NCS: DAY 2 | 2 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | CS: DAY 3 | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | NCS: DAY 8 | 2 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | CS: DAY 11, 1 Hour | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | NCS: DAY 11, 4 Hours | 2 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | CS: DAY 11, 12 Hours | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | NCS: DAY 11, 24 Hours | 2 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | CS: DAY 11, 24 Hours | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | NCS: DAY -1 | 2 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | CS: DAY -1 | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | NCS: DAY 1, 1 Hour | 2 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | CS: DAY 1, 1 Hour | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | CS: DAY 2 | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | NCS: DAY 3 | 3 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | NCS: DAY 5 | 3 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | CS: DAY 5 | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | NCS: DAY 11, 1 Hour | 2 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | CS: DAY 11, 4 Hours | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | NCS: DAY 11, 12 Hours | 2 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | NCS: Follow-up (DAY 25) | 1 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | CS: Follow-up (DAY 25) | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | NCS: DAY 11, 12 Hours | 4 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | NCS: DAY 1, 1 Hour | 4 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | NCS: DAY 1, 4 Hours | 6 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | NCS: DAY 11, 1 Hour | 3 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | CS: DAY 1, 1 Hour | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | NCS: DAY 1, 12 Hours | 6 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | CS: DAY 1, 4 Hours | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | CS: DAY 1, 12 Hours | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | NCS: DAY 2 | 5 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | NCS: DAY 11, 4 Hours | 5 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | CS: DAY 3 | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | NCS: DAY 5 | 6 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | CS: DAY 5 | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | CS: DAY 2 | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | CS: DAY 11, 12 Hours | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | CS: DAY 11, 1 Hour | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | NCS: DAY 3 | 5 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | CS: DAY 11, 4 Hours | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | NCS: Follow-up (DAY 25) | 6 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | NCS: DAY 11, 24 Hours | 5 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | NCS: DAY 8 | 7 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | CS: DAY 11, 24 Hours | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | CS: Follow-up (DAY 25) | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | CS: DAY -1 | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | NCS: DAY -1 | 6 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | CS: DAY 8 | 0 Participants |
Primary
Part 2: Number of Participants With Serious Adverse Events (SAEs) and Non-SAEs
An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/ birth defect, is associated with liver injury or impaired liver function or any other situations as per medical or scientific judgment. Safety Population comprised of all participants who received at least 1 dose of the study treatment (including placebo) with at least 1 post-Baseline safety assessment. Number of participants with SAEs and common non-SAEs (\>=5%) are presented.
Time frame: Up to 25 days
Population: Safety Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Number of Participants With Serious Adverse Events (SAEs) and Non-SAEs | Any SAE | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Number of Participants With Serious Adverse Events (SAEs) and Non-SAEs | Any non-SAE | 1 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Number of Participants With Serious Adverse Events (SAEs) and Non-SAEs | Any non-SAE | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Number of Participants With Serious Adverse Events (SAEs) and Non-SAEs | Any SAE | 0 Participants |
Primary
Part 2: Number of Participants With Worst Case Clinical Chemistry Results to PCI Criteria
Blood samples were collected from participants for analysis of following clinical chemistry parameters; glucose, alanine aminotransferase (ALT), albumin, alkaline phosphatase, aspartate aminotransferase (AST), bilirubin, calcium, potassium and sodium. PCI ranges were \<30 g/L for albumin, \<2 or \>2.75 millimoles per liter (mmol/L) for calcium, \<3 or \>9 mmol/L for glucose, \>=2 times Upper limit of Normal (ULN) units per liter (U/L) for ALT, \>=2 times ULN U/L for alkaline phosphatase, \>=2 times ULN U/L for AST, \>=1.5 times ULN micromoles per liter (µmol/L) for bilirubin, \<3 or \>5.5 mmol/L for potassium, and \<130 or \>150 mmol/L for sodium. Participants were counted in the worst case category that their value changes to (low, within range or no change,or high), unless there is no change in their category. Participants whose laboratory value category was unchanged (e.g., High to High), or whose value became within range, were recorded in the To within Range or No Change category.
Time frame: Up to 25 days
Population: Safety Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Number of Participants With Worst Case Clinical Chemistry Results to PCI Criteria | Glucose; To within Range or No Change | 3 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Number of Participants With Worst Case Clinical Chemistry Results to PCI Criteria | Alkaline phosphatase; To within Range or No Change | 3 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Number of Participants With Worst Case Clinical Chemistry Results to PCI Criteria | Calcium; To Low | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Number of Participants With Worst Case Clinical Chemistry Results to PCI Criteria | Alkaline phosphatase; To High | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Number of Participants With Worst Case Clinical Chemistry Results to PCI Criteria | Glucose; To High | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Number of Participants With Worst Case Clinical Chemistry Results to PCI Criteria | AST; To Low | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Number of Participants With Worst Case Clinical Chemistry Results to PCI Criteria | Potassium; To Low | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Number of Participants With Worst Case Clinical Chemistry Results to PCI Criteria | AST; To within Range or No Change | 3 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Number of Participants With Worst Case Clinical Chemistry Results to PCI Criteria | ALT; To Low | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Number of Participants With Worst Case Clinical Chemistry Results to PCI Criteria | AST; To High | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Number of Participants With Worst Case Clinical Chemistry Results to PCI Criteria | Albumin; To within Range or No Change | 3 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Number of Participants With Worst Case Clinical Chemistry Results to PCI Criteria | Bilirubin; To within Range or No Change | 3 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Number of Participants With Worst Case Clinical Chemistry Results to PCI Criteria | ALT; To within Range or No Change | 3 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Number of Participants With Worst Case Clinical Chemistry Results to PCI Criteria | Sodium; To Low | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Number of Participants With Worst Case Clinical Chemistry Results to PCI Criteria | ALT; To High | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Number of Participants With Worst Case Clinical Chemistry Results to PCI Criteria | Calcium; To within Range or No Change | 3 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Number of Participants With Worst Case Clinical Chemistry Results to PCI Criteria | Sodium; To within Range or No Change | 3 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Number of Participants With Worst Case Clinical Chemistry Results to PCI Criteria | Calcium; To High | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Number of Participants With Worst Case Clinical Chemistry Results to PCI Criteria | Albumin; To Low | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Number of Participants With Worst Case Clinical Chemistry Results to PCI Criteria | Potassium; To within Range or No Change | 3 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Number of Participants With Worst Case Clinical Chemistry Results to PCI Criteria | Glucose; To Low | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Number of Participants With Worst Case Clinical Chemistry Results to PCI Criteria | Potassium; To High | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Number of Participants With Worst Case Clinical Chemistry Results to PCI Criteria | Albumin; To High | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Number of Participants With Worst Case Clinical Chemistry Results to PCI Criteria | Bilirubin; To High | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Number of Participants With Worst Case Clinical Chemistry Results to PCI Criteria | Alkaline phosphatase; To Low | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Number of Participants With Worst Case Clinical Chemistry Results to PCI Criteria | Sodium; To High | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Number of Participants With Worst Case Clinical Chemistry Results to PCI Criteria | Bilirubin; To Low | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Number of Participants With Worst Case Clinical Chemistry Results to PCI Criteria | Sodium; To High | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Number of Participants With Worst Case Clinical Chemistry Results to PCI Criteria | AST; To High | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Number of Participants With Worst Case Clinical Chemistry Results to PCI Criteria | Potassium; To Low | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Number of Participants With Worst Case Clinical Chemistry Results to PCI Criteria | Glucose; To Low | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Number of Participants With Worst Case Clinical Chemistry Results to PCI Criteria | Glucose; To within Range or No Change | 7 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Number of Participants With Worst Case Clinical Chemistry Results to PCI Criteria | Glucose; To High | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Number of Participants With Worst Case Clinical Chemistry Results to PCI Criteria | ALT; To Low | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Number of Participants With Worst Case Clinical Chemistry Results to PCI Criteria | ALT; To within Range or No Change | 7 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Number of Participants With Worst Case Clinical Chemistry Results to PCI Criteria | ALT; To High | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Number of Participants With Worst Case Clinical Chemistry Results to PCI Criteria | Albumin; To within Range or No Change | 7 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Number of Participants With Worst Case Clinical Chemistry Results to PCI Criteria | Albumin; To High | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Number of Participants With Worst Case Clinical Chemistry Results to PCI Criteria | Alkaline phosphatase; To Low | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Number of Participants With Worst Case Clinical Chemistry Results to PCI Criteria | Alkaline phosphatase; To within Range or No Change | 7 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Number of Participants With Worst Case Clinical Chemistry Results to PCI Criteria | Alkaline phosphatase; To High | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Number of Participants With Worst Case Clinical Chemistry Results to PCI Criteria | AST; To Low | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Number of Participants With Worst Case Clinical Chemistry Results to PCI Criteria | AST; To within Range or No Change | 7 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Number of Participants With Worst Case Clinical Chemistry Results to PCI Criteria | Bilirubin; To Low | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Number of Participants With Worst Case Clinical Chemistry Results to PCI Criteria | Bilirubin; To within Range or No Change | 7 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Number of Participants With Worst Case Clinical Chemistry Results to PCI Criteria | Bilirubin; To High | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Number of Participants With Worst Case Clinical Chemistry Results to PCI Criteria | Calcium; To Low | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Number of Participants With Worst Case Clinical Chemistry Results to PCI Criteria | Calcium; To within Range or No Change | 7 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Number of Participants With Worst Case Clinical Chemistry Results to PCI Criteria | Calcium; To High | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Number of Participants With Worst Case Clinical Chemistry Results to PCI Criteria | Potassium; To within Range or No Change | 7 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Number of Participants With Worst Case Clinical Chemistry Results to PCI Criteria | Potassium; To High | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Number of Participants With Worst Case Clinical Chemistry Results to PCI Criteria | Sodium; To Low | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Number of Participants With Worst Case Clinical Chemistry Results to PCI Criteria | Sodium; To within Range or No Change | 7 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Number of Participants With Worst Case Clinical Chemistry Results to PCI Criteria | Albumin; To Low | 0 Participants |
Primary
Part 2: Number of Participants With Worst Case Hematology Results to Potential Clinical Importance (PCI) Criteria
Blood samples were collected from participants for analysis of following hematology parameters; hematocrit, hemoglobin, leukocytes, lymphocytes, neutrophils and platelets. PCI ranges were \< 0.075 or \>0.54 proportion of red blood cells in blood for hematocrit, \<25 or \>180 grams per liter (g/L) for hemoglobin, \< 3 or \>20 cells per liter (cells/L) for leukocytes, 0.8 x10\^9 cells/L for lymphocytes, 1.5 x10\^9 cells/L for neutrophils, and \<100 or \>550 cells/L for platelets. Participants were counted in the worst case category that their value changes to (low, within range or no change, or high), unless there is no change in their category. Participants whose laboratory value category was unchanged (example given \[e.g.\], High to High), or whose value became within range, were recorded in the To within Range or No Change category.
Time frame: Up to 25 days
Population: Safety Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Number of Participants With Worst Case Hematology Results to Potential Clinical Importance (PCI) Criteria | Leukocytes; To within Range or No Change | 3 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Number of Participants With Worst Case Hematology Results to Potential Clinical Importance (PCI) Criteria | Hemoglobin; To within Range or No Change | 3 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Number of Participants With Worst Case Hematology Results to Potential Clinical Importance (PCI) Criteria | Leukocytes; To High | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Number of Participants With Worst Case Hematology Results to Potential Clinical Importance (PCI) Criteria | Hematocrit; To within Range or No Change | 3 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Number of Participants With Worst Case Hematology Results to Potential Clinical Importance (PCI) Criteria | Lymphocytes; To Low | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Number of Participants With Worst Case Hematology Results to Potential Clinical Importance (PCI) Criteria | Neutrophils; To within Range or No Change | 2 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Number of Participants With Worst Case Hematology Results to Potential Clinical Importance (PCI) Criteria | Lymphocytes; To within Range or No Change | 3 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Number of Participants With Worst Case Hematology Results to Potential Clinical Importance (PCI) Criteria | Hemoglobin; To Low | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Number of Participants With Worst Case Hematology Results to Potential Clinical Importance (PCI) Criteria | Lymphocytes; To High | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Number of Participants With Worst Case Hematology Results to Potential Clinical Importance (PCI) Criteria | Hematocrit; To High | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Number of Participants With Worst Case Hematology Results to Potential Clinical Importance (PCI) Criteria | Neutrophils; To Low | 1 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Number of Participants With Worst Case Hematology Results to Potential Clinical Importance (PCI) Criteria | Hemoglobin; To High | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Number of Participants With Worst Case Hematology Results to Potential Clinical Importance (PCI) Criteria | Neutrophils; To High | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Number of Participants With Worst Case Hematology Results to Potential Clinical Importance (PCI) Criteria | Platelets; To Low | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Number of Participants With Worst Case Hematology Results to Potential Clinical Importance (PCI) Criteria | Platelets; To within Range or No Change | 3 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Number of Participants With Worst Case Hematology Results to Potential Clinical Importance (PCI) Criteria | Leukocytes; To Low | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Number of Participants With Worst Case Hematology Results to Potential Clinical Importance (PCI) Criteria | Platelets; To High | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Number of Participants With Worst Case Hematology Results to Potential Clinical Importance (PCI) Criteria | Hematocrit; To Low | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Number of Participants With Worst Case Hematology Results to Potential Clinical Importance (PCI) Criteria | Platelets; To High | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Number of Participants With Worst Case Hematology Results to Potential Clinical Importance (PCI) Criteria | Hemoglobin; To within Range or No Change | 7 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Number of Participants With Worst Case Hematology Results to Potential Clinical Importance (PCI) Criteria | Neutrophils; To Low | 1 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Number of Participants With Worst Case Hematology Results to Potential Clinical Importance (PCI) Criteria | Neutrophils; To High | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Number of Participants With Worst Case Hematology Results to Potential Clinical Importance (PCI) Criteria | Hematocrit; To Low | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Number of Participants With Worst Case Hematology Results to Potential Clinical Importance (PCI) Criteria | Hematocrit; To High | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Number of Participants With Worst Case Hematology Results to Potential Clinical Importance (PCI) Criteria | Hemoglobin; To Low | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Number of Participants With Worst Case Hematology Results to Potential Clinical Importance (PCI) Criteria | Hemoglobin; To High | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Number of Participants With Worst Case Hematology Results to Potential Clinical Importance (PCI) Criteria | Leukocytes; To Low | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Number of Participants With Worst Case Hematology Results to Potential Clinical Importance (PCI) Criteria | Leukocytes; To within Range or No Change | 7 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Number of Participants With Worst Case Hematology Results to Potential Clinical Importance (PCI) Criteria | Leukocytes; To High | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Number of Participants With Worst Case Hematology Results to Potential Clinical Importance (PCI) Criteria | Lymphocytes; To Low | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Number of Participants With Worst Case Hematology Results to Potential Clinical Importance (PCI) Criteria | Lymphocytes; To within Range or No Change | 7 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Number of Participants With Worst Case Hematology Results to Potential Clinical Importance (PCI) Criteria | Lymphocytes; To High | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Number of Participants With Worst Case Hematology Results to Potential Clinical Importance (PCI) Criteria | Neutrophils; To within Range or No Change | 6 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Number of Participants With Worst Case Hematology Results to Potential Clinical Importance (PCI) Criteria | Platelets; To Low | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Number of Participants With Worst Case Hematology Results to Potential Clinical Importance (PCI) Criteria | Platelets; To within Range or No Change | 7 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Number of Participants With Worst Case Hematology Results to Potential Clinical Importance (PCI) Criteria | Hematocrit; To within Range or No Change | 7 Participants |
Primary
Part 2: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria
Urine samples were collected from participants for analysis of following urinalysis parameters; specific gravity, potential of hydrogen (pH), presence of glucose, protein, occult blood, ketones in urine analyzed by dipstick method. The dipstick test gives results in a semi-quantitative manner. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The reference range is 1.002-1.030. Urine pH is an acid-base measurement. Normal urine has a slightly acid pH (5.0 - 6.0). Participants were counted in the worst case category that their value changes to (low, normal or high), unless there is no change in their category. Participants whose laboratory value category was unchanged (e.g., High to High), or whose value became normal, were recorded in the To Normal or No Change category.
Time frame: Up to 25 days
Population: Safety Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | Protein; To Normal or No Change | 3 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | Glucose; To Abnormal | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | Ketones; To Low | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | Protein; To High | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | Urine pH; To Low | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | Urine pH; To High | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | Urine pH; To Abnormal | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | Glucose; To Low | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | Glucose; To Normal or No Change | 3 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | Ketones; To Normal or No Change | 3 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | Ketones; To High | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | Ketones; To Abnormal | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | Occult blood; To Low | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | Occult blood; To Normal or No Change | 2 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | Occult blood; To High | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | Occult blood; To Abnormal | 1 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | Protein; To Low | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | Glucose; To High | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | Protein; To Abnormal | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | Specific gravity; To Low | 1 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | Specific gravity; To Normal or No Change | 2 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | Specific gravity; To High | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | Specific gravity; To Abnormal | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | Urine pH; To Normal or No Change | 3 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | Ketones; To High | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | Glucose; To High | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | Specific gravity; To High | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | Glucose; To Abnormal | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | Ketones; To Abnormal | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | Occult blood; To Normal or No Change | 6 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | Occult blood; To Abnormal | 1 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | Protein; To Normal or No Change | 7 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | Protein; To High | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | Specific gravity; To Abnormal | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | Occult blood; To Low | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | Urine pH; To Low | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | Specific gravity; To Normal or No Change | 7 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | Urine pH; To High | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | Protein; To Abnormal | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | Urine pH; To Abnormal | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | Occult blood; To High | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | Glucose; To Low | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | Urine pH; To Normal or No Change | 7 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | Glucose; To Normal or No Change | 7 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | Ketones; To Low | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | Specific gravity; To Low | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | Ketones; To Normal or No Change | 7 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | Protein; To Low | 0 Participants |
Primary
Part 2: Observed Concentration at the End of the Dosing Interval (Ctau) Following Administration of Non-boosted Once-daily Doses of GSK2838232 Tablet in Fed State
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK2838232 given as a non-boosted once-daily dosing tablet in fed state. Pharmacokinetic parameters were determined using standard non-compartmental methods.
Time frame: Pre-dose, 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12 and 24 hours post-dose on Day 1; Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96 and 120 hours post-dose on Day 11 in Part 2
Population: Pharmacokinetic Population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Observed Concentration at the End of the Dosing Interval (Ctau) Following Administration of Non-boosted Once-daily Doses of GSK2838232 Tablet in Fed State | Day 1 | 21.620 Nanograms per milliliter | Geometric Coefficient of Variation 42.51 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Observed Concentration at the End of the Dosing Interval (Ctau) Following Administration of Non-boosted Once-daily Doses of GSK2838232 Tablet in Fed State | Day 11 | 27.668 Nanograms per milliliter | Geometric Coefficient of Variation 41.16 |
Primary
Part 2: Pulse Rate at Indicated Time Points
Pulse rate of participants was measured in supine position after 10 minutes rest at indicated time points.
Time frame: Day -1; Pre-dose, 1, 4 hours on Day 1; 24 hours (Day 2); 48 hours (Day 3); 72 hours (Day 4), Days 5, 6, 7, 8, 9, 10; Pre-dose, 1, 4 , 24, 48, 72 hours on Day 11; Follow-up (Day 25)
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Pulse Rate at Indicated Time Points | DAY 1, 4 Hours | 64.667 Beats per minute | Standard Deviation 3.0551 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Pulse Rate at Indicated Time Points | DAY 11, 24 Hours | 67.667 Beats per minute | Standard Deviation 6.4291 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Pulse Rate at Indicated Time Points | DAY 8 | 64.333 Beats per minute | Standard Deviation 4.0415 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Pulse Rate at Indicated Time Points | DAY -1 | 63.667 Beats per minute | Standard Deviation 12.4231 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Pulse Rate at Indicated Time Points | DAY 1, 1 Hour | 68.000 Beats per minute | Standard Deviation 8.544 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Pulse Rate at Indicated Time Points | DAY 4, 72 Hours | 58.667 Beats per minute | Standard Deviation 1.1547 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Pulse Rate at Indicated Time Points | DAY 10 | 63.667 Beats per minute | Standard Deviation 3.5119 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Pulse Rate at Indicated Time Points | DAY 5 | 60.667 Beats per minute | Standard Deviation 2.5166 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Pulse Rate at Indicated Time Points | DAY 2, 24 Hours | 57.667 Beats per minute | Standard Deviation 2.8868 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Pulse Rate at Indicated Time Points | DAY 6 | 62.333 Beats per minute | Standard Deviation 2.3094 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Pulse Rate at Indicated Time Points | DAY 11, PREDOSE | 61.887 Beats per minute | Standard Deviation 1.3891 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Pulse Rate at Indicated Time Points | DAY 7 | 59.333 Beats per minute | Standard Deviation 3.7859 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Pulse Rate at Indicated Time Points | DAY 9 | 61.000 Beats per minute | Standard Deviation 2.6458 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Pulse Rate at Indicated Time Points | DAY 1, PREDOSE | 63.663 Beats per minute | Standard Deviation 4.0415 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Pulse Rate at Indicated Time Points | DAY 11, 48 Hours | 61.667 Beats per minute | Standard Deviation 6.5064 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Pulse Rate at Indicated Time Points | DAY 11, 1 Hour | 72.667 Beats per minute | Standard Deviation 4.7258 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Pulse Rate at Indicated Time Points | DAY 11, 72 Hours | 63.000 Beats per minute | Standard Deviation 2.6458 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Pulse Rate at Indicated Time Points | DAY 3, 48 Hours | 58.000 Beats per minute | Standard Deviation 2.6458 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Pulse Rate at Indicated Time Points | Follow-Up (DAY 25) | 70.667 Beats per minute | Standard Deviation 8.0829 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Pulse Rate at Indicated Time Points | DAY 11, 4 Hours | 68.000 Beats per minute | Standard Deviation 5.2915 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Pulse Rate at Indicated Time Points | Follow-Up (DAY 25) | 63.857 Beats per minute | Standard Deviation 9.4062 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Pulse Rate at Indicated Time Points | DAY 1, PREDOSE | 63.714 Beats per minute | Standard Deviation 11.3991 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Pulse Rate at Indicated Time Points | DAY 1, 1 Hour | 72.286 Beats per minute | Standard Deviation 7.5214 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Pulse Rate at Indicated Time Points | DAY 1, 4 Hours | 66.000 Beats per minute | Standard Deviation 10.116 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Pulse Rate at Indicated Time Points | DAY 2, 24 Hours | 58.286 Beats per minute | Standard Deviation 8.7123 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Pulse Rate at Indicated Time Points | DAY 7 | 63.429 Beats per minute | Standard Deviation 11.4143 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Pulse Rate at Indicated Time Points | DAY 8 | 62.000 Beats per minute | Standard Deviation 8.6795 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Pulse Rate at Indicated Time Points | DAY 10 | 60.143 Beats per minute | Standard Deviation 8.4346 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Pulse Rate at Indicated Time Points | DAY 11, PREDOSE | 60.810 Beats per minute | Standard Deviation 9.3355 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Pulse Rate at Indicated Time Points | DAY 11, 1 Hour | 70.143 Beats per minute | Standard Deviation 7.0102 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Pulse Rate at Indicated Time Points | DAY 11, 4 Hours | 68.857 Beats per minute | Standard Deviation 8.4148 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Pulse Rate at Indicated Time Points | DAY 11, 24 Hours | 64.571 Beats per minute | Standard Deviation 7.3679 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Pulse Rate at Indicated Time Points | DAY 3, 48 Hours | 59.429 Beats per minute | Standard Deviation 7.9762 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Pulse Rate at Indicated Time Points | DAY 4, 72 Hours | 58.286 Beats per minute | Standard Deviation 7.7613 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Pulse Rate at Indicated Time Points | DAY 5 | 66.429 Beats per minute | Standard Deviation 10.39 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Pulse Rate at Indicated Time Points | DAY 6 | 59.143 Beats per minute | Standard Deviation 6.2564 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Pulse Rate at Indicated Time Points | DAY 9 | 60.714 Beats per minute | Standard Deviation 6.9693 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Pulse Rate at Indicated Time Points | DAY 11, 48 Hours | 61.714 Beats per minute | Standard Deviation 4.6085 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Pulse Rate at Indicated Time Points | DAY 11, 72 Hours | 60.857 Beats per minute | Standard Deviation 3.934 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 2: Pulse Rate at Indicated Time Points | DAY -1 | 64.143 Beats per minute | Standard Deviation 11.7817 |
Primary
Part 2: Time of Last Quantifiable Concentration (Tlast) Following Administration of Non-boosted Once-daily Doses of GSK2838232 Tablet in Fed State on Day 11
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK2838232 given as a non-boosted once-daily dosing tablet in fed state. Pharmacokinetic parameters were determined using standard non-compartmental methods.
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96 and 120 hours post-dose on Day 11 in Part 2
Population: Pharmacokinetic Population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Time of Last Quantifiable Concentration (Tlast) Following Administration of Non-boosted Once-daily Doses of GSK2838232 Tablet in Fed State on Day 11 | 118.800 Hours |
Primary
Part 2: Tmax Following Administration of Non-boosted Once-daily Doses of GSK2838232 Tablet in Fed State
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK2838232 given as a non-boosted once-daily dosing tablet in fed state. Pharmacokinetic parameters were determined using standard non-compartmental methods.
Time frame: Pre-dose, 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12 and 24 hours post-dose on Day 1; Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96 and 120 hours post-dose on Day 11 in Part 2
Population: Pharmacokinetic Population
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Tmax Following Administration of Non-boosted Once-daily Doses of GSK2838232 Tablet in Fed State | Day 1 | 4.000 Hours |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Tmax Following Administration of Non-boosted Once-daily Doses of GSK2838232 Tablet in Fed State | Day 11 | 3.500 Hours |
Secondary
Part 1: AUC(0-t) Following Administration of GSK2838232 Tablet and Capsule Formulation in Fed State and Tablet Formulation in Fasted State
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK2838232 given as capsule and tablet formulation in fed state as well as tablet formulation in fasted state. Pharmacokinetic parameters were determined using standard non-compartmental methods.
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 120 hours post-dose in treatment periods 1, 2 and 3 of Part 1
Population: Pharmacokinetic Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: AUC(0-t) Following Administration of GSK2838232 Tablet and Capsule Formulation in Fed State and Tablet Formulation in Fasted State | 4595.35 Hours* nanograms per milliliter | Geometric Coefficient of Variation 40.28 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: AUC(0-t) Following Administration of GSK2838232 Tablet and Capsule Formulation in Fed State and Tablet Formulation in Fasted State | 4371.47 Hours* nanograms per milliliter | Geometric Coefficient of Variation 30.03 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: AUC(0-t) Following Administration of GSK2838232 Tablet and Capsule Formulation in Fed State and Tablet Formulation in Fasted State | 1776.21 Hours* nanograms per milliliter | Geometric Coefficient of Variation 36.6 |
Secondary
Part 1: Blood Pressure at Indicated Time Points
SBP and DBP of participants were measured in supine position after 10 minutes rest at indicated time points.
Time frame: Day -2; Day -1; Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 Hours on Day 1
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Blood Pressure at Indicated Time Points | SBP; DAY 1, 24 Hours | 106.200 Millimeter of mercury | Standard Deviation 9.9441 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Blood Pressure at Indicated Time Points | SBP; DAY 1, PREDOSE | 108.156 Millimeter of mercury | Standard Deviation 9.24 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Blood Pressure at Indicated Time Points | DBP; DAY 1, 8 Hours | 68.333 Millimeter of mercury | Standard Deviation 6.694 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Blood Pressure at Indicated Time Points | SBP; DAY 1, 8 Hours | 112.067 Millimeter of mercury | Standard Deviation 8.9639 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Blood Pressure at Indicated Time Points | SBP; DAY 1, 48 Hours | 106.867 Millimeter of mercury | Standard Deviation 10.162 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Blood Pressure at Indicated Time Points | DBP; DAY 1, 12 Hours | 68.867 Millimeter of mercury | Standard Deviation 5.5532 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Blood Pressure at Indicated Time Points | DBP; DAY 1, PREDOSE | 65.956 Millimeter of mercury | Standard Deviation 4.9419 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Blood Pressure at Indicated Time Points | SBP; DAY -1 | 110.067 Millimeter of mercury | Standard Deviation 10.2153 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Blood Pressure at Indicated Time Points | DBP; DAY 1, 24 Hours | 68.400 Millimeter of mercury | Standard Deviation 6.4343 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Blood Pressure at Indicated Time Points | DBP; DAY -2 | 68.667 Millimeter of mercury | Standard Deviation 6.2981 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Blood Pressure at Indicated Time Points | SBP; DAY -2 | 108.667 Millimeter of mercury | Standard Deviation 9.9115 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Blood Pressure at Indicated Time Points | DBP; DAY 1, 48 Hours | 66.600 Millimeter of mercury | Standard Deviation 7.4431 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Blood Pressure at Indicated Time Points | SBP; DAY 1, 6 Hours | 108.333 Millimeter of mercury | Standard Deviation 8.9894 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Blood Pressure at Indicated Time Points | DBP; DAY 1, 72 Hours | 66.600 Millimeter of mercury | Standard Deviation 8.025 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Blood Pressure at Indicated Time Points | DBP; DAY 1, 1 Hour | 63.200 Millimeter of mercury | Standard Deviation 6.1551 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Blood Pressure at Indicated Time Points | SBP; DAY 1, 72 Hours | 104.067 Millimeter of mercury | Standard Deviation 11.7075 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Blood Pressure at Indicated Time Points | SBP; DAY 1, 4 Hours | 107.733 Millimeter of mercury | Standard Deviation 9.1844 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Blood Pressure at Indicated Time Points | DBP; DAY 1, 2 Hours | 62.133 Millimeter of mercury | Standard Deviation 5.6552 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Blood Pressure at Indicated Time Points | SBP; DAY 1, 12 Hours | 110.133 Millimeter of mercury | Standard Deviation 10.2181 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Blood Pressure at Indicated Time Points | SBP; DAY 1, 2 Hours | 104.867 Millimeter of mercury | Standard Deviation 10.6091 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Blood Pressure at Indicated Time Points | DBP; DAY 1, 4 Hours | 63.733 Millimeter of mercury | Standard Deviation 6.649 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Blood Pressure at Indicated Time Points | DBP; DAY -1 | 67.467 Millimeter of mercury | Standard Deviation 6.232 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Blood Pressure at Indicated Time Points | SBP; DAY 1, 1 Hour | 106.000 Millimeter of mercury | Standard Deviation 10.0428 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Blood Pressure at Indicated Time Points | DBP; DAY 1, 6 Hours | 64.400 Millimeter of mercury | Standard Deviation 6.1968 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Blood Pressure at Indicated Time Points | SBP; DAY -1 | 104.000 Millimeter of mercury | Standard Deviation 9.798 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Blood Pressure at Indicated Time Points | SBP; DAY 1, 48 Hours | 107.067 Millimeter of mercury | Standard Deviation 6.386 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Blood Pressure at Indicated Time Points | SBP; DAY 1, 72 Hours | 105.933 Millimeter of mercury | Standard Deviation 10.8197 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Blood Pressure at Indicated Time Points | DBP; DAY -2 | 69.533 Millimeter of mercury | Standard Deviation 7.6426 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Blood Pressure at Indicated Time Points | DBP; DAY -1 | 68.467 Millimeter of mercury | Standard Deviation 8.7657 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Blood Pressure at Indicated Time Points | DBP; DAY 1, PREDOSE | 66.245 Millimeter of mercury | Standard Deviation 7.1653 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Blood Pressure at Indicated Time Points | DBP; DAY 1, 1 Hour | 64.133 Millimeter of mercury | Standard Deviation 6.1163 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Blood Pressure at Indicated Time Points | DBP; DAY 1, 2 Hours | 62.533 Millimeter of mercury | Standard Deviation 4.6425 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Blood Pressure at Indicated Time Points | DBP; DAY 1, 4 Hours | 64.400 Millimeter of mercury | Standard Deviation 5.3825 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Blood Pressure at Indicated Time Points | DBP; DAY 1, 6 Hours | 64.067 Millimeter of mercury | Standard Deviation 7.4878 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Blood Pressure at Indicated Time Points | DBP; DAY 1, 8 Hours | 66.933 Millimeter of mercury | Standard Deviation 5.0351 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Blood Pressure at Indicated Time Points | DBP; DAY 1, 12 Hours | 67.800 Millimeter of mercury | Standard Deviation 7.2723 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Blood Pressure at Indicated Time Points | DBP; DAY 1, 24 Hours | 66.533 Millimeter of mercury | Standard Deviation 6.2663 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Blood Pressure at Indicated Time Points | DBP; DAY 1, 48 Hours | 67.333 Millimeter of mercury | Standard Deviation 5.5377 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Blood Pressure at Indicated Time Points | DBP; DAY 1, 72 Hours | 67.067 Millimeter of mercury | Standard Deviation 5.2026 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Blood Pressure at Indicated Time Points | SBP; DAY -2 | 109.733 Millimeter of mercury | Standard Deviation 9.0116 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Blood Pressure at Indicated Time Points | SBP; DAY 1, PREDOSE | 108.289 Millimeter of mercury | Standard Deviation 11.1021 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Blood Pressure at Indicated Time Points | SBP; DAY 1, 1 Hour | 108.400 Millimeter of mercury | Standard Deviation 8.382 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Blood Pressure at Indicated Time Points | SBP; DAY 1, 2 Hours | 105.067 Millimeter of mercury | Standard Deviation 9.6323 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Blood Pressure at Indicated Time Points | SBP; DAY 1, 4 Hours | 106.000 Millimeter of mercury | Standard Deviation 8.8237 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Blood Pressure at Indicated Time Points | SBP; DAY 1, 6 Hours | 106.933 Millimeter of mercury | Standard Deviation 7.1661 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Blood Pressure at Indicated Time Points | SBP; DAY 1, 8 Hours | 110.600 Millimeter of mercury | Standard Deviation 12.3508 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Blood Pressure at Indicated Time Points | SBP; DAY 1, 12 Hours | 113.000 Millimeter of mercury | Standard Deviation 11.9762 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Blood Pressure at Indicated Time Points | SBP; DAY 1, 24 Hours | 107.467 Millimeter of mercury | Standard Deviation 10.8619 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: Blood Pressure at Indicated Time Points | SBP; DAY 1, 8 Hours | 106.000 Millimeter of mercury | Standard Deviation 12.3973 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: Blood Pressure at Indicated Time Points | SBP; DAY 1, PREDOSE | 106.858 Millimeter of mercury | Standard Deviation 9.59 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: Blood Pressure at Indicated Time Points | DBP; DAY 1, 4 Hours | 67.429 Millimeter of mercury | Standard Deviation 5.5152 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: Blood Pressure at Indicated Time Points | DBP; DAY -2 | 65.000 Millimeter of mercury | Standard Deviation 6.1893 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: Blood Pressure at Indicated Time Points | SBP; DAY 1, 1 Hour | 106.500 Millimeter of mercury | Standard Deviation 9.3377 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: Blood Pressure at Indicated Time Points | DBP; DAY 1, 2 Hours | 66.071 Millimeter of mercury | Standard Deviation 7.141 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: Blood Pressure at Indicated Time Points | SBP; DAY 1, 24 Hours | 105.500 Millimeter of mercury | Standard Deviation 11.1061 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: Blood Pressure at Indicated Time Points | SBP; DAY 1, 2 Hours | 106.214 Millimeter of mercury | Standard Deviation 11.8593 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: Blood Pressure at Indicated Time Points | DBP; DAY 1, 1 Hour | 67.357 Millimeter of mercury | Standard Deviation 5.4998 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: Blood Pressure at Indicated Time Points | SBP; DAY 1, 12 Hours | 107.786 Millimeter of mercury | Standard Deviation 12.1919 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: Blood Pressure at Indicated Time Points | SBP; DAY 1, 4 Hours | 106.714 Millimeter of mercury | Standard Deviation 10.8019 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: Blood Pressure at Indicated Time Points | DBP; DAY 1, PREDOSE | 66.929 Millimeter of mercury | Standard Deviation 7.4379 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: Blood Pressure at Indicated Time Points | SBP; DAY 1, 48 Hours | 102.000 Millimeter of mercury | Standard Deviation 12.2725 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: Blood Pressure at Indicated Time Points | SBP; DAY 1, 6 Hours | 108.214 Millimeter of mercury | Standard Deviation 11.8008 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: Blood Pressure at Indicated Time Points | DBP; DAY 1, 48 Hours | 64.643 Millimeter of mercury | Standard Deviation 6.1595 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: Blood Pressure at Indicated Time Points | DBP; DAY -1 | 65.643 Millimeter of mercury | Standard Deviation 7.7619 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: Blood Pressure at Indicated Time Points | DBP; DAY 1, 72 Hours | 64.429 Millimeter of mercury | Standard Deviation 7.1545 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: Blood Pressure at Indicated Time Points | DBP; DAY 1, 24 Hours | 66.929 Millimeter of mercury | Standard Deviation 7.087 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: Blood Pressure at Indicated Time Points | SBP; DAY 1, 72 Hours | 107.429 Millimeter of mercury | Standard Deviation 13.529 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: Blood Pressure at Indicated Time Points | SBP; DAY -2 | 105.786 Millimeter of mercury | Standard Deviation 9.8775 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: Blood Pressure at Indicated Time Points | DBP; DAY 1, 12 Hours | 66.214 Millimeter of mercury | Standard Deviation 5.1766 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: Blood Pressure at Indicated Time Points | DBP; DAY 1, 8 Hours | 68.000 Millimeter of mercury | Standard Deviation 6.1269 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: Blood Pressure at Indicated Time Points | SBP; DAY -1 | 108.429 Millimeter of mercury | Standard Deviation 11.1128 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: Blood Pressure at Indicated Time Points | DBP; DAY 1, 6 Hours | 66.071 Millimeter of mercury | Standard Deviation 5.5117 |
Secondary
Part 1: Change From Baseline in Blood Pressure
SBP and DBP were measured in supine position after 10 minutes rest for the participant at indicated time points. Baseline was defined as the latest pre-dose assessment, including those from unscheduled visits. Change from Baseline was defined as any visit value minus Baseline value.
Time frame: Baseline (Day -1) and 1, 2, 4, 6, 8, 12, 24, 48, 72 Hours on Day 1
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Change From Baseline in Blood Pressure | DBP; DAY 1, 6 Hours | -1.556 Millimeter of mercury | Standard Deviation 4.0795 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Change From Baseline in Blood Pressure | DBP; DAY 1, 1 Hour | -2.756 Millimeter of mercury | Standard Deviation 4.5583 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Change From Baseline in Blood Pressure | DBP; DAY 1, 2 Hours | -3.823 Millimeter of mercury | Standard Deviation 4.8274 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Change From Baseline in Blood Pressure | DBP; DAY 1, 4 Hours | -2.223 Millimeter of mercury | Standard Deviation 5.1037 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Change From Baseline in Blood Pressure | SBP; DAY 1, 6 Hours | 0.177 Millimeter of mercury | Standard Deviation 6.2989 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Change From Baseline in Blood Pressure | DBP; DAY 1, 8 Hours | 2.377 Millimeter of mercury | Standard Deviation 3.8999 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Change From Baseline in Blood Pressure | DBP; DAY 1, 12 Hours | 2.911 Millimeter of mercury | Standard Deviation 6.7287 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Change From Baseline in Blood Pressure | DBP; DAY 1, 24 Hours | 2.444 Millimeter of mercury | Standard Deviation 4.7072 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Change From Baseline in Blood Pressure | DBP; DAY 1, 48 Hours | 0.644 Millimeter of mercury | Standard Deviation 7.935 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Change From Baseline in Blood Pressure | DBP; DAY 1, 72 Hours | 0.644 Millimeter of mercury | Standard Deviation 6.4814 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Change From Baseline in Blood Pressure | SBP; DAY 1, 1 Hour | -2.156 Millimeter of mercury | Standard Deviation 5.2225 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Change From Baseline in Blood Pressure | SBP; DAY 1, 2 Hours | -3.289 Millimeter of mercury | Standard Deviation 8.9001 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Change From Baseline in Blood Pressure | SBP; DAY 1, 4 Hours | -0.423 Millimeter of mercury | Standard Deviation 7.3588 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Change From Baseline in Blood Pressure | SBP; DAY 1, 8 Hours | 3.911 Millimeter of mercury | Standard Deviation 7.8095 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Change From Baseline in Blood Pressure | SBP; DAY 1, 12 Hours | 1.977 Millimeter of mercury | Standard Deviation 6.7186 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Change From Baseline in Blood Pressure | SBP; DAY 1, 24 Hours | -1.956 Millimeter of mercury | Standard Deviation 7.9095 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Change From Baseline in Blood Pressure | SBP; DAY 1, 48 Hours | -1.289 Millimeter of mercury | Standard Deviation 4.9058 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Change From Baseline in Blood Pressure | SBP; DAY 1, 72 Hours | -4.089 Millimeter of mercury | Standard Deviation 7.4727 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Change From Baseline in Blood Pressure | DBP; DAY 1, 24 Hours | 0.288 Millimeter of mercury | Standard Deviation 6.5408 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Change From Baseline in Blood Pressure | SBP; DAY 1, 6 Hours | -1.355 Millimeter of mercury | Standard Deviation 8.9097 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Change From Baseline in Blood Pressure | DBP; DAY 1, 72 Hours | 0.821 Millimeter of mercury | Standard Deviation 6.3773 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Change From Baseline in Blood Pressure | SBP; DAY 1, 4 Hours | -2.289 Millimeter of mercury | Standard Deviation 10.0523 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Change From Baseline in Blood Pressure | DBP; DAY 1, 1 Hour | -2.112 Millimeter of mercury | Standard Deviation 5.8242 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Change From Baseline in Blood Pressure | DBP; DAY 1, 12 Hours | 1.555 Millimeter of mercury | Standard Deviation 7.1028 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Change From Baseline in Blood Pressure | SBP; DAY 1, 12 Hours | 4.711 Millimeter of mercury | Standard Deviation 7.4998 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Change From Baseline in Blood Pressure | DBP; DAY 1, 2 Hours | -3.712 Millimeter of mercury | Standard Deviation 7.5868 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Change From Baseline in Blood Pressure | SBP; DAY 1, 1 Hour | 0.111 Millimeter of mercury | Standard Deviation 8.8653 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Change From Baseline in Blood Pressure | DBP; DAY 1, 48 Hours | 1.088 Millimeter of mercury | Standard Deviation 8.1406 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Change From Baseline in Blood Pressure | DBP; DAY 1, 4 Hours | -1.845 Millimeter of mercury | Standard Deviation 6.6186 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Change From Baseline in Blood Pressure | SBP; DAY 1, 24 Hours | -0.822 Millimeter of mercury | Standard Deviation 9.281 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Change From Baseline in Blood Pressure | SBP; DAY 1, 72 Hours | -2.355 Millimeter of mercury | Standard Deviation 9.9198 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Change From Baseline in Blood Pressure | DBP; DAY 1, 6 Hours | -2.179 Millimeter of mercury | Standard Deviation 5.8416 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Change From Baseline in Blood Pressure | SBP; DAY 1, 2 Hours | -3.222 Millimeter of mercury | Standard Deviation 11.268 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Change From Baseline in Blood Pressure | SBP; DAY 1, 8 Hours | 2.311 Millimeter of mercury | Standard Deviation 11.0679 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Change From Baseline in Blood Pressure | DBP; DAY 1, 8 Hours | 0.688 Millimeter of mercury | Standard Deviation 7.8368 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Change From Baseline in Blood Pressure | SBP; DAY 1, 48 Hours | -1.222 Millimeter of mercury | Standard Deviation 10.7458 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: Change From Baseline in Blood Pressure | DBP; DAY 1, 8 Hours | 1.071 Millimeter of mercury | Standard Deviation 4.3963 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: Change From Baseline in Blood Pressure | DBP; DAY 1, 12 Hours | -0.714 Millimeter of mercury | Standard Deviation 6.2782 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: Change From Baseline in Blood Pressure | DBP; DAY 1, 24 Hours | 0.000 Millimeter of mercury | Standard Deviation 6.3519 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: Change From Baseline in Blood Pressure | DBP; DAY 1, 48 Hours | -2.286 Millimeter of mercury | Standard Deviation 4.2171 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: Change From Baseline in Blood Pressure | SBP; DAY 1, 12 Hours | 0.928 Millimeter of mercury | Standard Deviation 9.8279 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: Change From Baseline in Blood Pressure | DBP; DAY 1, 72 Hours | -2.500 Millimeter of mercury | Standard Deviation 7.5579 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: Change From Baseline in Blood Pressure | SBP; DAY 1, 72 Hours | 0.571 Millimeter of mercury | Standard Deviation 11.2671 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: Change From Baseline in Blood Pressure | SBP; DAY 1, 1 Hour | -0.358 Millimeter of mercury | Standard Deviation 7.2826 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: Change From Baseline in Blood Pressure | SBP; DAY 1, 2 Hours | -0.644 Millimeter of mercury | Standard Deviation 6.9132 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: Change From Baseline in Blood Pressure | SBP; DAY 1, 24 Hours | -1.358 Millimeter of mercury | Standard Deviation 4.6289 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: Change From Baseline in Blood Pressure | SBP; DAY 1, 48 Hours | -4.858 Millimeter of mercury | Standard Deviation 9.5294 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: Change From Baseline in Blood Pressure | DBP; DAY 1, 1 Hour | 0.429 Millimeter of mercury | Standard Deviation 6.295 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: Change From Baseline in Blood Pressure | SBP; DAY 1, 4 Hours | -0.144 Millimeter of mercury | Standard Deviation 8.8536 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: Change From Baseline in Blood Pressure | DBP; DAY 1, 2 Hours | -0.857 Millimeter of mercury | Standard Deviation 6.0936 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: Change From Baseline in Blood Pressure | SBP; DAY 1, 6 Hours | 1.356 Millimeter of mercury | Standard Deviation 9.9739 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: Change From Baseline in Blood Pressure | DBP; DAY 1, 4 Hours | 0.500 Millimeter of mercury | Standard Deviation 4.4191 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: Change From Baseline in Blood Pressure | DBP; DAY 1, 6 Hours | -0.857 Millimeter of mercury | Standard Deviation 6.7412 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: Change From Baseline in Blood Pressure | SBP; DAY 1, 8 Hours | -0.858 Millimeter of mercury | Standard Deviation 10.0987 |
Secondary
Part 1: Change From Baseline in Mean Heart Rate Values as ECG Parameter
Single and triplicate 12-lead ECG's were obtained at least 5 minutes apart in the supine position after 10 minutes of rest at indicated time points using an ECG machine that automatically calculates the heart rate. Baseline was defined as the latest pre-dose assessment, including those from unscheduled visits. Change from Baseline was defined as any visit value minus Baseline value.
Time frame: Baseline (Day -1) and 1, 2, 4, 6, 8, 12, 24, 48, 72 hours on Day 1
Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Change From Baseline in Mean Heart Rate Values as ECG Parameter | DAY 1, 1 Hour; n=15,15,14 | 11.623 Beats per minute | Standard Deviation 3.5038 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Change From Baseline in Mean Heart Rate Values as ECG Parameter | DAY 1, 48 Hours; n=15,15,14 | 1.023 Beats per minute | Standard Deviation 7.7608 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Change From Baseline in Mean Heart Rate Values as ECG Parameter | DAY 1, 6 Hours; n=14,14,14 | 6.072 Beats per minute | Standard Deviation 3.0746 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Change From Baseline in Mean Heart Rate Values as ECG Parameter | DAY 1, 24 Hours; n=15,15,14 | -2.377 Beats per minute | Standard Deviation 6.3879 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Change From Baseline in Mean Heart Rate Values as ECG Parameter | DAY 1, 4 Hours; n=15,14,14 | 4.156 Beats per minute | Standard Deviation 3.2562 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Change From Baseline in Mean Heart Rate Values as ECG Parameter | DAY 1, 8 Hours; n=15,15,14 | 2.223 Beats per minute | Standard Deviation 4.5377 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Change From Baseline in Mean Heart Rate Values as ECG Parameter | DAY 1, 72 Hours; n=15,15,14 | -0.911 Beats per minute | Standard Deviation 6.1612 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Change From Baseline in Mean Heart Rate Values as ECG Parameter | DAY 1, 2 Hours; n=15,15,13 | 10.623 Beats per minute | Standard Deviation 4.8877 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Change From Baseline in Mean Heart Rate Values as ECG Parameter | DAY 1, 12 Hours; n=15,15,14 | 4.089 Beats per minute | Standard Deviation 5.0734 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Change From Baseline in Mean Heart Rate Values as ECG Parameter | DAY 1, 4 Hours; n=15,14,14 | 2.500 Beats per minute | Standard Deviation 7.3292 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Change From Baseline in Mean Heart Rate Values as ECG Parameter | DAY 1, 2 Hours; n=15,15,13 | 8.489 Beats per minute | Standard Deviation 6.5565 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Change From Baseline in Mean Heart Rate Values as ECG Parameter | DAY 1, 24 Hours; n=15,15,14 | -4.711 Beats per minute | Standard Deviation 7.0854 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Change From Baseline in Mean Heart Rate Values as ECG Parameter | DAY 1, 48 Hours; n=15,15,14 | -2.378 Beats per minute | Standard Deviation 6.3181 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Change From Baseline in Mean Heart Rate Values as ECG Parameter | DAY 1, 12 Hours; n=15,15,14 | -0.178 Beats per minute | Standard Deviation 6.3675 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Change From Baseline in Mean Heart Rate Values as ECG Parameter | DAY 1, 1 Hour; n=15,15,14 | 7.955 Beats per minute | Standard Deviation 7.104 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Change From Baseline in Mean Heart Rate Values as ECG Parameter | DAY 1, 6 Hours; n=14,14,14 | 1.643 Beats per minute | Standard Deviation 7.5799 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Change From Baseline in Mean Heart Rate Values as ECG Parameter | DAY 1, 72 Hours; n=15,15,14 | -3.045 Beats per minute | Standard Deviation 6.1332 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Change From Baseline in Mean Heart Rate Values as ECG Parameter | DAY 1, 8 Hours; n=15,15,14 | 1.489 Beats per minute | Standard Deviation 7.0631 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: Change From Baseline in Mean Heart Rate Values as ECG Parameter | DAY 1, 72 Hours; n=15,15,14 | 2.286 Beats per minute | Standard Deviation 4.8518 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: Change From Baseline in Mean Heart Rate Values as ECG Parameter | DAY 1, 1 Hour; n=15,15,14 | -0.642 Beats per minute | Standard Deviation 3.6609 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: Change From Baseline in Mean Heart Rate Values as ECG Parameter | DAY 1, 2 Hours; n=15,15,13 | -1.230 Beats per minute | Standard Deviation 4.3393 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: Change From Baseline in Mean Heart Rate Values as ECG Parameter | DAY 1, 4 Hours; n=15,14,14 | 2.144 Beats per minute | Standard Deviation 4.9148 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: Change From Baseline in Mean Heart Rate Values as ECG Parameter | DAY 1, 6 Hours; n=14,14,14 | 5.786 Beats per minute | Standard Deviation 2.6441 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: Change From Baseline in Mean Heart Rate Values as ECG Parameter | DAY 1, 8 Hours; n=15,15,14 | 2.929 Beats per minute | Standard Deviation 4.3034 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: Change From Baseline in Mean Heart Rate Values as ECG Parameter | DAY 1, 12 Hours; n=15,15,14 | 6.072 Beats per minute | Standard Deviation 5.5851 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: Change From Baseline in Mean Heart Rate Values as ECG Parameter | DAY 1, 24 Hours; n=15,15,14 | 2.786 Beats per minute | Standard Deviation 4.2971 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: Change From Baseline in Mean Heart Rate Values as ECG Parameter | DAY 1, 48 Hours; n=15,15,14 | 2.358 Beats per minute | Standard Deviation 6.3093 |
Secondary
Part 1: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters
Single and triplicate 12-lead ECG's were obtained at least 5 minutes apart in the supine position after 10 minutes of rest at indicated time points using an ECG machine that automatically calculates measures PR, QRS, QT and QTcF intervals. Baseline was defined as the latest pre-dose assessment, including those from unscheduled visits. Change from Baseline was defined as any visit value minus Baseline value.
Time frame: Baseline (Day -1) and 1, 2, 4, 6, 8, 12, 24, 48, 72 hours on Day 1
Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | PR interval; DAY 1, 72 Hours; n=15,15,14 | 0.266 Milliseconds | Standard Deviation 6.727 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | QT interval; DAY 1, 8 Hours; n=15,15,14 | -9.511 Milliseconds | Standard Deviation 12.7754 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | QRS interval; DAY 1, 1 Hour; n=15,15,14 | 0.177 Milliseconds | Standard Deviation 4.0981 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | QTcF interval; DAY 1, 2 Hours; n=15,15,13 | -10.133 Milliseconds | Standard Deviation 10.8407 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | QRS interval; DAY 1, 2 Hours; n=15,15,13 | -1.289 Milliseconds | Standard Deviation 2.7414 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | QRS interval; DAY 1, 6 Hours; n=14,14,14 | 1.190 Milliseconds | Standard Deviation 4.4691 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | QRS interval; DAY 1, 8 Hours; n=15,15,14 | -1.023 Milliseconds | Standard Deviation 5.4315 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | QT interval; DAY 1, 12 Hours; n=15,15,14 | -16.044 Milliseconds | Standard Deviation 19.727 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | QRS interval; DAY 1, 12 Hours; n=15,15,14 | 0.577 Milliseconds | Standard Deviation 5.0503 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | QTcF interval; DAY 1, 6 Hours; n=14,14,14 | -3.714 Milliseconds | Standard Deviation 9.3976 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | QRS interval; DAY 1, 24 Hours; n=15,15,14 | -0.489 Milliseconds | Standard Deviation 3.9399 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | QRS interval; DAY 1, 48 Hours; n=15,15,14 | -0.489 Milliseconds | Standard Deviation 4.0107 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | QRS interval; DAY 1, 72 Hours; n=15,15,14 | 0.311 Milliseconds | Standard Deviation 3.4718 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | QTcF interval; DAY 1, 8 Hours; n=15,15,14 | -4.333 Milliseconds | Standard Deviation 11.3261 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | QT interval; DAY 1, 1 Hour; n=15,15,14 | -27.511 Milliseconds | Standard Deviation 9.5694 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | QT interval; DAY 1, 2 Hours; n=15,15,13 | -30.844 Milliseconds | Standard Deviation 12.7773 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | QT interval; DAY 1, 4 Hours; n=15,14,14 | -17.377 Milliseconds | Standard Deviation 12.8317 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | QT interval; DAY 1, 6 Hours; n=14,14,14 | -15.524 Milliseconds | Standard Deviation 10.6107 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | QTcF interval; DAY 1, 12 Hours; n=15,15,14 | -7.199 Milliseconds | Standard Deviation 11.5629 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | QT interval; DAY 1, 24 Hours; n=15,15,14 | -2.044 Milliseconds | Standard Deviation 14.0881 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | QTcF interval; DAY 1, 24 Hours; n=15,15,14 | -6.933 Milliseconds | Standard Deviation 10.715 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | QTcF interval; DAY 1, 48 Hours; n=15,15,14 | -0.999 Milliseconds | Standard Deviation 12.4826 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | QTcF interval; DAY 1, 4 Hours; n=15,14,14 | -8.466 Milliseconds | Standard Deviation 10.1552 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | QTcF interval; DAY 1, 72 Hours; n=15,15,14 | -2.466 Milliseconds | Standard Deviation 9.5081 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | QT interval; DAY 1, 48 Hours; n=15,15,14 | -3.644 Milliseconds | Standard Deviation 17.8393 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | PR interval; DAY 1, 1 Hour; n= 15,15,14 | -4.667 Milliseconds | Standard Deviation 8.7068 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | PR interval; DAY 1, 2 Hours; n=15,15,13 | -6.001 Milliseconds | Standard Deviation 7.733 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | PR interval; DAY 1, 4 Hours; n=15,14,14 | -7.067 Milliseconds | Standard Deviation 10.2033 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | QT interval; DAY 1, 72 Hours; n=15,15,14 | -0.977 Milliseconds | Standard Deviation 15.5657 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | PR interval; DAY 1, 6 Hours; n=14,14,14 | -5.286 Milliseconds | Standard Deviation 8.1501 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | PR interval; DAY 1, 8 Hours; n=15,15,14 | -2.267 Milliseconds | Standard Deviation 9.6666 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | QRS interval; DAY 1, 4 Hours; n=15,14,14 | -0.223 Milliseconds | Standard Deviation 4.7522 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | PR interval; DAY 1, 12 Hours; n=15,15,14 | 3.599 Milliseconds | Standard Deviation 7.2967 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | PR interval; DAY 1, 24 Hours; n=15,15,14 | 0.133 Milliseconds | Standard Deviation 6.254 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | QTcF interval; DAY 1, 1 Hour; n=15,15,14 | -4.666 Milliseconds | Standard Deviation 10.4724 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | PR interval; DAY 1, 48 Hours; n=15,15,14 | 0.533 Milliseconds | Standard Deviation 9.8492 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | PR interval; DAY 1, 72 Hours; n=15,15,14 | -0.800 Milliseconds | Standard Deviation 8.3925 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | QTcF interval; DAY 1, 12 Hours; n=15,15,14 | -9.735 Milliseconds | Standard Deviation 15.8796 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | PR interval; DAY 1, 4 Hours; n=15,14,14 | -5.905 Milliseconds | Standard Deviation 8.8947 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | QRS interval; DAY 1, 1 Hour; n=15,15,14 | -1.067 Milliseconds | Standard Deviation 2.1485 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | PR interval; DAY 1, 12 Hours; n=15,15,14 | 3.600 Milliseconds | Standard Deviation 10.7074 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | QTcF interval; DAY 1, 24 Hours; n=15,15,14 | -9.601 Milliseconds | Standard Deviation 9.4605 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | QRS interval; DAY 1, 2 Hours; n=15,15,13 | -3.601 Milliseconds | Standard Deviation 5.5916 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | QRS interval; DAY 1, 4 Hours; n=15,14,14 | -3.144 Milliseconds | Standard Deviation 5.5231 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | QTcF interval; DAY 1, 2 Hours; n=15,15,13 | -11.068 Milliseconds | Standard Deviation 8.0958 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | QT interval; DAY 1, 24 Hours; n=15,15,14 | 0.801 Milliseconds | Standard Deviation 12.2568 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | QRS interval; DAY 1, 6 Hours; n=14,14,14 | -1.096 Milliseconds | Standard Deviation 3.4838 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | QT interval; DAY 1, 6 Hours; n=14,14,14 | -10.619 Milliseconds | Standard Deviation 14.9602 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | PR interval; DAY 1, 48 Hours; n=15,15,14 | 0.267 Milliseconds | Standard Deviation 9.71 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | QRS interval; DAY 1, 8 Hours; n=15,15,14 | -1.201 Milliseconds | Standard Deviation 3.2956 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | QTcF interval; DAY 1, 48 Hours; n=15,15,14 | -5.601 Milliseconds | Standard Deviation 5.4868 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | PR interval; DAY 1, 6 Hours; n=14,14,14 | -4.048 Milliseconds | Standard Deviation 7.9887 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | QRS interval; DAY 1, 12 Hours; n=15,15,14 | 0.266 Milliseconds | Standard Deviation 3.0628 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | QT interval; DAY 1, 72 Hours; n=15,15,14 | 0.134 Milliseconds | Standard Deviation 13.0685 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | QTcF interval; DAY 1, 72 Hours; n=15,15,14 | -6.401 Milliseconds | Standard Deviation 10.0613 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | QRS interval; DAY 1, 24 Hours; n=15,15,14 | -0.001 Milliseconds | Standard Deviation 3.2548 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | QTcF interval; DAY 1, 6 Hours; n=14,14,14 | -7.573 Milliseconds | Standard Deviation 12.1949 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | PR interval; DAY 1, 24 Hours; n=15,15,14 | 0.667 Milliseconds | Standard Deviation 11.6569 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | QRS interval; DAY 1, 48 Hours; n=15,15,14 | -3.601 Milliseconds | Standard Deviation 5.2408 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | QT interval; DAY 1, 12 Hours; n=15,15,14 | -9.466 Milliseconds | Standard Deviation 15.0727 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | PR interval; DAY 1, 8 Hours; n=15,15,14 | 0.267 Milliseconds | Standard Deviation 9.2972 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | QRS interval; DAY 1, 72 Hours; n=15,15,14 | -1.067 Milliseconds | Standard Deviation 4.7049 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | PR interval; DAY 1, 1 Hour; n= 15,15,14 | -3.067 Milliseconds | Standard Deviation 8.0354 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | QT interval; DAY 1, 48 Hours; n=15,15,14 | -0.666 Milliseconds | Standard Deviation 14.5496 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | QT interval; DAY 1, 1 Hour; n=15,15,14 | -23.333 Milliseconds | Standard Deviation 8.8511 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | QTcF interval; DAY 1, 1 Hour; n=15,15,14 | -8.868 Milliseconds | Standard Deviation 7.0866 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | QT interval; DAY 1, 2 Hours; n=15,15,13 | -26.266 Milliseconds | Standard Deviation 8.5061 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | QTcF interval; DAY 1, 8 Hours; n=15,15,14 | -3.268 Milliseconds | Standard Deviation 14.6848 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | PR interval; DAY 1, 2 Hours; n=15,15,13 | -8.000 Milliseconds | Standard Deviation 11.0362 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | QT interval; DAY 1, 4 Hours; n=15,14,14 | -15.523 Milliseconds | Standard Deviation 12.6937 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | QT interval; DAY 1, 8 Hours; n=15,15,14 | -6.266 Milliseconds | Standard Deviation 16.7718 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | QTcF interval; DAY 1, 4 Hours; n=15,14,14 | -11.335 Milliseconds | Standard Deviation 10.1802 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | PR interval; DAY 1, 24 Hours; n=15,15,14 | -4.000 Milliseconds | Standard Deviation 5.2761 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | QRS interval; DAY 1, 2 Hours; n=15,15,13 | -1.949 Milliseconds | Standard Deviation 3.6451 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | QT interval; DAY 1, 1 Hour; n=15,15,14 | -0.334 Milliseconds | Standard Deviation 6.8828 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | QT interval; DAY 1, 6 Hours; n=14,14,14 | -23.334 Milliseconds | Standard Deviation 16.4029 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | QT interval; DAY 1, 8 Hours; n=15,15,14 | -12.762 Milliseconds | Standard Deviation 13.296 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | QT interval; DAY 1, 12 Hours; n=15,15,14 | -24.334 Milliseconds | Standard Deviation 22.8434 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | QT interval; DAY 1, 24 Hours; n=15,15,14 | -11.476 Milliseconds | Standard Deviation 12.3125 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | QT interval; DAY 1, 48 Hours; n=15,15,14 | -7.476 Milliseconds | Standard Deviation 12.3459 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | QT interval; DAY 1, 72 Hours; n=15,15,14 | -12.762 Milliseconds | Standard Deviation 15.3517 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | QTcF interval; DAY 1, 1 Hour; n=15,15,14 | -2.285 Milliseconds | Standard Deviation 11.8494 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | QTcF interval; DAY 1, 2 Hours; n=15,15,13 | -2.076 Milliseconds | Standard Deviation 12.2719 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | QTcF interval; DAY 1, 4 Hours; n=15,14,14 | 1.858 Milliseconds | Standard Deviation 10.9901 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | QTcF interval; DAY 1, 6 Hours; n=14,14,14 | -10.499 Milliseconds | Standard Deviation 12.0696 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | QTcF interval; DAY 1, 8 Hours; n=15,15,14 | -6.356 Milliseconds | Standard Deviation 11.4959 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | QTcF interval; DAY 1, 12 Hours; n=15,15,14 | -11.214 Milliseconds | Standard Deviation 12.2055 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | QTcF interval; DAY 1, 24 Hours; n=15,15,14 | -5.856 Milliseconds | Standard Deviation 9.6316 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | QTcF interval; DAY 1, 48 Hours; n=15,15,14 | -3.785 Milliseconds | Standard Deviation 9.7479 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | QTcF interval; DAY 1, 72 Hours; n=15,15,14 | -7.785 Milliseconds | Standard Deviation 12.1949 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | PR interval; DAY 1, 1 Hour; n= 15,15,14 | -3.000 Milliseconds | Standard Deviation 4.1236 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | PR interval; DAY 1, 2 Hours; n=15,15,13 | -1.846 Milliseconds | Standard Deviation 6.4305 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | PR interval; DAY 1, 4 Hours; n=15,14,14 | -2.571 Milliseconds | Standard Deviation 5.262 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | PR interval; DAY 1, 6 Hours; n=14,14,14 | -7.286 Milliseconds | Standard Deviation 6.333 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | PR interval; DAY 1, 8 Hours; n=15,15,14 | -7.571 Milliseconds | Standard Deviation 5.4017 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | PR interval; DAY 1, 12 Hours; n=15,15,14 | -5.143 Milliseconds | Standard Deviation 5.5061 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | PR interval; DAY 1, 48 Hours; n=15,15,14 | -2.857 Milliseconds | Standard Deviation 4.9369 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | PR interval; DAY 1, 72 Hours; n=15,15,14 | 0.286 Milliseconds | Standard Deviation 9.5887 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | QRS interval; DAY 1, 1 Hour; n=15,15,14 | -1.191 Milliseconds | Standard Deviation 2.1266 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | QRS interval; DAY 1, 4 Hours; n=15,14,14 | -1.334 Milliseconds | Standard Deviation 3.5564 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | QRS interval; DAY 1, 6 Hours; n=14,14,14 | -0.048 Milliseconds | Standard Deviation 2.9515 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | QRS interval; DAY 1, 8 Hours; n=15,15,14 | -1.476 Milliseconds | Standard Deviation 3.0398 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | QRS interval; DAY 1, 12 Hours; n=15,15,14 | -0.905 Milliseconds | Standard Deviation 2.3614 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | QRS interval; DAY 1, 24 Hours; n=15,15,14 | -1.762 Milliseconds | Standard Deviation 2.7249 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | QRS interval; DAY 1, 48 Hours; n=15,15,14 | -2.905 Milliseconds | Standard Deviation 2.8351 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | QRS interval; DAY 1, 72 Hours; n=15,15,14 | -1.905 Milliseconds | Standard Deviation 2.6381 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | QT interval; DAY 1, 2 Hours; n=15,15,13 | 1.435 Milliseconds | Standard Deviation 9.3833 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters | QT interval; DAY 1, 4 Hours; n=15,14,14 | -2.191 Milliseconds | Standard Deviation 12.9124 |
Secondary
Part 1: Change From Baseline in Pulse Rate
Pulse rate was measured in supine position after 10 minutes rest for the participant at indicated time points. Baseline was defined as the latest pre-dose assessment, including those from unscheduled visits. Change from Baseline was defined as any visit value minus Baseline value.
Time frame: Baseline (Day -1) and 1, 2, 4, 6, 8, 12, 24, 48, 72 Hours on Day 1
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Change From Baseline in Pulse Rate | DAY 1, 24 Hours | -1.623 Beats per minute | Standard Deviation 8.9894 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Change From Baseline in Pulse Rate | DAY 1, 6 Hours | 3.844 Beats per minute | Standard Deviation 8.0953 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Change From Baseline in Pulse Rate | DAY 1, 2 Hours | 7.644 Beats per minute | Standard Deviation 10.5927 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Change From Baseline in Pulse Rate | DAY 1, 12 Hours | -0.156 Beats per minute | Standard Deviation 8.6466 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Change From Baseline in Pulse Rate | DAY 1, 8 Hours | 1.511 Beats per minute | Standard Deviation 9.0965 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Change From Baseline in Pulse Rate | DAY 1, 1 Hour | 9.644 Beats per minute | Standard Deviation 9.2897 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Change From Baseline in Pulse Rate | DAY 1, 48 Hours | -0.689 Beats per minute | Standard Deviation 8.0818 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Change From Baseline in Pulse Rate | DAY 1, 4 Hours | 3.111 Beats per minute | Standard Deviation 7.1157 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Change From Baseline in Pulse Rate | DAY 1, 72 Hours | -2.756 Beats per minute | Standard Deviation 9.7834 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Change From Baseline in Pulse Rate | DAY 1, 72 Hours | -1.844 Beats per minute | Standard Deviation 7.4755 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Change From Baseline in Pulse Rate | DAY 1, 1 Hour | 8.023 Beats per minute | Standard Deviation 9.3536 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Change From Baseline in Pulse Rate | DAY 1, 2 Hours | 8.623 Beats per minute | Standard Deviation 8.8718 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Change From Baseline in Pulse Rate | DAY 1, 4 Hours | 5.156 Beats per minute | Standard Deviation 10.5863 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Change From Baseline in Pulse Rate | DAY 1, 6 Hours | 3.823 Beats per minute | Standard Deviation 11.4959 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Change From Baseline in Pulse Rate | DAY 1, 8 Hours | 2.623 Beats per minute | Standard Deviation 9.1496 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Change From Baseline in Pulse Rate | DAY 1, 12 Hours | 1.556 Beats per minute | Standard Deviation 7.3741 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Change From Baseline in Pulse Rate | DAY 1, 24 Hours | -3.044 Beats per minute | Standard Deviation 8.7852 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Change From Baseline in Pulse Rate | DAY 1, 48 Hours | -0.777 Beats per minute | Standard Deviation 7.8056 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: Change From Baseline in Pulse Rate | DAY 1, 12 Hours | 7.286 Beats per minute | Standard Deviation 8.0517 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: Change From Baseline in Pulse Rate | DAY 1, 4 Hours | 1.357 Beats per minute | Standard Deviation 4.6853 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: Change From Baseline in Pulse Rate | DAY 1, 1 Hour | -1.286 Beats per minute | Standard Deviation 4.439 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: Change From Baseline in Pulse Rate | DAY 1, 24 Hours | 4.214 Beats per minute | Standard Deviation 6.315 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: Change From Baseline in Pulse Rate | DAY 1, 2 Hours | 0.357 Beats per minute | Standard Deviation 5.2912 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: Change From Baseline in Pulse Rate | DAY 1, 72 Hours | 2.429 Beats per minute | Standard Deviation 6.621 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: Change From Baseline in Pulse Rate | DAY 1, 8 Hours | 3.714 Beats per minute | Standard Deviation 5.1408 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: Change From Baseline in Pulse Rate | DAY 1, 6 Hours | 6.643 Beats per minute | Standard Deviation 2.458 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: Change From Baseline in Pulse Rate | DAY 1, 48 Hours | 3.429 Beats per minute | Standard Deviation 7.7752 |
Secondary
Part 1: Number of Participants With Abnormal ECG Findings
Single and triplicate 12-lead ECG's were obtained at least 5 minutes apart in the supine position after 10 minutes of rest at indicated time points using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT and QTcF intervals. CS and NCS abnormal ECG findings have been presented. CS 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.
Time frame: Day -2, Day -1; 1, 2, 4, 6, 8, , 12, 24, 48, 72 hours on Day 1
Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Number of Participants With Abnormal ECG Findings | CS: DAY 1, 72 Hours; n=15, 15, 14 | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Number of Participants With Abnormal ECG Findings | CS: DAY 1, 12 Hours; n=15, 14, 14 | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Number of Participants With Abnormal ECG Findings | NCS: DAY 1, 4 Hours; n=15, 13, 14 | 5 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Number of Participants With Abnormal ECG Findings | CS: DAY 1, 48 Hours; n=15, 15, 14 | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Number of Participants With Abnormal ECG Findings | NCS: DAY 1, 12 Hours; n=15, 14, 14 | 7 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Number of Participants With Abnormal ECG Findings | CS: DAY 1, 4 Hours; n=15, 13, 14 | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Number of Participants With Abnormal ECG Findings | CS: DAY -1; n=15, 14, 14 | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Number of Participants With Abnormal ECG Findings | CS: DAY 1, 8 Hours; n=15, 15, 14 | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Number of Participants With Abnormal ECG Findings | NCS: DAY 1, 6 Hours; n=14, 14, 14 | 3 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Number of Participants With Abnormal ECG Findings | CS: DAY -2; n=15, 15, 14 | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Number of Participants With Abnormal ECG Findings | NCS: DAY 1, 8 Hours; n=15, 15, 14 | 7 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Number of Participants With Abnormal ECG Findings | CS: DAY 1, 6 Hours; n=14, 14, 14 | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Number of Participants With Abnormal ECG Findings | NCS: DAY 1, 48 Hours; n=15, 15, 14 | 8 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Number of Participants With Abnormal ECG Findings | NCS: DAY 1, 1 Hour; n=15, 15, 14 | 6 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Number of Participants With Abnormal ECG Findings | NCS: DAY -2; n=15, 15, 14 | 10 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Number of Participants With Abnormal ECG Findings | CS: DAY 1, 24 Hours; n=14, 15, 14 | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Number of Participants With Abnormal ECG Findings | CS: DAY 1, 1 Hour; n=15, 15, 14 | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Number of Participants With Abnormal ECG Findings | NCS: DAY 1, 72 Hours; n=15, 15, 14 | 10 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Number of Participants With Abnormal ECG Findings | CS: DAY 1, 2 Hours; n=15, 15, 13 | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Number of Participants With Abnormal ECG Findings | NCS: DAY 1, 2 Hours; n=15, 15, 13 | 5 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Number of Participants With Abnormal ECG Findings | NCS: DAY -1; n=15, 14, 14 | 7 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Number of Participants With Abnormal ECG Findings | NCS: DAY 1, 24 Hours; n=14, 15, 14 | 11 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Number of Participants With Abnormal ECG Findings | NCS: DAY 1, 24 Hours; n=14, 15, 14 | 10 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Number of Participants With Abnormal ECG Findings | NCS: DAY -2; n=15, 15, 14 | 9 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Number of Participants With Abnormal ECG Findings | CS: DAY -2; n=15, 15, 14 | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Number of Participants With Abnormal ECG Findings | NCS: DAY -1; n=15, 14, 14 | 9 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Number of Participants With Abnormal ECG Findings | CS: DAY -1; n=15, 14, 14 | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Number of Participants With Abnormal ECG Findings | NCS: DAY 1, 1 Hour; n=15, 15, 14 | 5 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Number of Participants With Abnormal ECG Findings | CS: DAY 1, 1 Hour; n=15, 15, 14 | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Number of Participants With Abnormal ECG Findings | NCS: DAY 1, 2 Hours; n=15, 15, 13 | 5 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Number of Participants With Abnormal ECG Findings | CS: DAY 1, 2 Hours; n=15, 15, 13 | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Number of Participants With Abnormal ECG Findings | NCS: DAY 1, 4 Hours; n=15, 13, 14 | 3 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Number of Participants With Abnormal ECG Findings | CS: DAY 1, 4 Hours; n=15, 13, 14 | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Number of Participants With Abnormal ECG Findings | NCS: DAY 1, 6 Hours; n=14, 14, 14 | 3 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Number of Participants With Abnormal ECG Findings | CS: DAY 1, 6 Hours; n=14, 14, 14 | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Number of Participants With Abnormal ECG Findings | NCS: DAY 1, 8 Hours; n=15, 15, 14 | 5 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Number of Participants With Abnormal ECG Findings | CS: DAY 1, 8 Hours; n=15, 15, 14 | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Number of Participants With Abnormal ECG Findings | NCS: DAY 1, 12 Hours; n=15, 14, 14 | 4 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Number of Participants With Abnormal ECG Findings | CS: DAY 1, 12 Hours; n=15, 14, 14 | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Number of Participants With Abnormal ECG Findings | CS: DAY 1, 24 Hours; n=14, 15, 14 | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Number of Participants With Abnormal ECG Findings | NCS: DAY 1, 48 Hours; n=15, 15, 14 | 9 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Number of Participants With Abnormal ECG Findings | CS: DAY 1, 48 Hours; n=15, 15, 14 | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Number of Participants With Abnormal ECG Findings | NCS: DAY 1, 72 Hours; n=15, 15, 14 | 8 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Number of Participants With Abnormal ECG Findings | CS: DAY 1, 72 Hours; n=15, 15, 14 | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: Number of Participants With Abnormal ECG Findings | NCS: DAY 1, 12 Hours; n=15, 14, 14 | 9 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: Number of Participants With Abnormal ECG Findings | CS: DAY 1, 2 Hours; n=15, 15, 13 | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: Number of Participants With Abnormal ECG Findings | CS: DAY -2; n=15, 15, 14 | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: Number of Participants With Abnormal ECG Findings | CS: DAY 1, 12 Hours; n=15, 14, 14 | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: Number of Participants With Abnormal ECG Findings | NCS: DAY 1, 2 Hours; n=15, 15, 13 | 10 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: Number of Participants With Abnormal ECG Findings | CS: DAY 1, 1 Hour; n=15, 15, 14 | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: Number of Participants With Abnormal ECG Findings | NCS: DAY 1, 24 Hours; n=14, 15, 14 | 10 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: Number of Participants With Abnormal ECG Findings | NCS: DAY 1, 1 Hour; n=15, 15, 14 | 11 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: Number of Participants With Abnormal ECG Findings | CS: DAY 1, 72 Hours; n=15, 15, 14 | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: Number of Participants With Abnormal ECG Findings | CS: DAY 1, 24 Hours; n=14, 15, 14 | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: Number of Participants With Abnormal ECG Findings | CS: DAY -1; n=15, 14, 14 | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: Number of Participants With Abnormal ECG Findings | NCS: DAY 1, 72 Hours; n=15, 15, 14 | 11 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: Number of Participants With Abnormal ECG Findings | NCS: DAY 1, 48 Hours; n=15, 15, 14 | 11 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: Number of Participants With Abnormal ECG Findings | CS: DAY 1, 6 Hours; n=14, 14, 14 | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: Number of Participants With Abnormal ECG Findings | NCS: DAY 1, 6 Hours; n=14, 14, 14 | 5 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: Number of Participants With Abnormal ECG Findings | NCS: DAY -1; n=15, 14, 14 | 12 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: Number of Participants With Abnormal ECG Findings | NCS: DAY 1, 8 Hours; n=15, 15, 14 | 8 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: Number of Participants With Abnormal ECG Findings | CS: DAY 1, 4 Hours; n=15, 13, 14 | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: Number of Participants With Abnormal ECG Findings | NCS: DAY -2; n=15, 15, 14 | 9 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: Number of Participants With Abnormal ECG Findings | CS: DAY 1, 8 Hours; n=15, 15, 14 | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: Number of Participants With Abnormal ECG Findings | NCS: DAY 1, 4 Hours; n=15, 13, 14 | 13 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: Number of Participants With Abnormal ECG Findings | CS: DAY 1, 48 Hours; n=15, 15, 14 | 0 Participants |
Secondary
Part 1: 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 treatment, whether or not considered related to the study treatment. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/ birth defect, is associated with liver injury or impaired liver function or any other situations as per medical or scientific judgment. Number of participants with SAEs and common non-SAEs (\>=5%) are presented.
Time frame: Up to 60 days
Population: Safety Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Number of Participants With SAEs and Non-SAEs | Any SAE | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Number of Participants With SAEs and Non-SAEs | Any non-SAE | 3 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Number of Participants With SAEs and Non-SAEs | Any SAE | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Number of Participants With SAEs and Non-SAEs | Any non-SAE | 2 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: Number of Participants With SAEs and Non-SAEs | Any SAE | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: Number of Participants With SAEs and Non-SAEs | Any non-SAE | 1 Participants |
Secondary
Part 1: Number of Participants With Worst Case Clinical Chemistry Results to PCI Criteria
Blood samples were collected from participants for analysis of following clinical chemistry parameters; glucose, ALT, albumin, alkaline phosphatase, AST, bilirubin, calcium, potassium and sodium. PCI ranges were \<30 g/L for albumin, \<2 or 2.75 mmol/L for calcium, \<3 or \>9 mmol/L for glucose, \>=2 times ULN U/L for ALT, \>=2 times ULN U/L for alkaline phosphatase, \>=2 times ULN U/L for AST, \>=1.5 times ULN µmol/L for bilirubin, \<3 or \>5.5 mmol/L for potassium, and \<130 or \>150 mmol/L for sodium. Participants were counted in the worst case category that their value changes to (low, within range or no change,or high), unless there is no change in their category. Participants whose laboratory value category was unchanged (e.g., High to High), or whose value became within range, were recorded in the To within Range or No Change category.
Time frame: Up to 60 days
Population: Safety Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Number of Participants With Worst Case Clinical Chemistry Results to PCI Criteria | Albumin; To Low | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Number of Participants With Worst Case Clinical Chemistry Results to PCI Criteria | Bilirubin; To High | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Number of Participants With Worst Case Clinical Chemistry Results to PCI Criteria | Potassium; To within Range or No Change | 15 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Number of Participants With Worst Case Clinical Chemistry Results to PCI Criteria | Calcium; To Low | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Number of Participants With Worst Case Clinical Chemistry Results to PCI Criteria | ALT; To High | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Number of Participants With Worst Case Clinical Chemistry Results to PCI Criteria | Glucose; To Low | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Number of Participants With Worst Case Clinical Chemistry Results to PCI Criteria | Sodium; To within Range or No Change | 15 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Number of Participants With Worst Case Clinical Chemistry Results to PCI Criteria | Potassium; To Low | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Number of Participants With Worst Case Clinical Chemistry Results to PCI Criteria | Glucose; To within Range or No Change | 15 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Number of Participants With Worst Case Clinical Chemistry Results to PCI Criteria | Glucose; To High | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Number of Participants With Worst Case Clinical Chemistry Results to PCI Criteria | Potassium; To High | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Number of Participants With Worst Case Clinical Chemistry Results to PCI Criteria | ALT; To Low | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Number of Participants With Worst Case Clinical Chemistry Results to PCI Criteria | Bilirubin; To within Range or No Change | 15 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Number of Participants With Worst Case Clinical Chemistry Results to PCI Criteria | Sodium; To High | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Number of Participants With Worst Case Clinical Chemistry Results to PCI Criteria | Calcium; To High | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Number of Participants With Worst Case Clinical Chemistry Results to PCI Criteria | AST; To High | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Number of Participants With Worst Case Clinical Chemistry Results to PCI Criteria | Calcium; To within Range or No Change | 15 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Number of Participants With Worst Case Clinical Chemistry Results to PCI Criteria | AST; To within Range or No Change | 15 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Number of Participants With Worst Case Clinical Chemistry Results to PCI Criteria | AST; To Low | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Number of Participants With Worst Case Clinical Chemistry Results to PCI Criteria | ALT; To within Range or No Change | 15 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Number of Participants With Worst Case Clinical Chemistry Results to PCI Criteria | Sodium; To Low | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Number of Participants With Worst Case Clinical Chemistry Results to PCI Criteria | Alkaline phosphatase; To High | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Number of Participants With Worst Case Clinical Chemistry Results to PCI Criteria | Alkaline phosphatase; To within Range or No Change | 15 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Number of Participants With Worst Case Clinical Chemistry Results to PCI Criteria | Albumin; To High | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Number of Participants With Worst Case Clinical Chemistry Results to PCI Criteria | Alkaline phosphatase; To Low | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Number of Participants With Worst Case Clinical Chemistry Results to PCI Criteria | Albumin; To within Range or No Change | 15 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Number of Participants With Worst Case Clinical Chemistry Results to PCI Criteria | Bilirubin; To Low | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Number of Participants With Worst Case Clinical Chemistry Results to PCI Criteria | ALT; To Low | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Number of Participants With Worst Case Clinical Chemistry Results to PCI Criteria | Potassium; To Low | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Number of Participants With Worst Case Clinical Chemistry Results to PCI Criteria | Potassium; To High | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Number of Participants With Worst Case Clinical Chemistry Results to PCI Criteria | Sodium; To Low | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Number of Participants With Worst Case Clinical Chemistry Results to PCI Criteria | Sodium; To within Range or No Change | 15 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Number of Participants With Worst Case Clinical Chemistry Results to PCI Criteria | Sodium; To High | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Number of Participants With Worst Case Clinical Chemistry Results to PCI Criteria | Glucose; To within Range or No Change | 15 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Number of Participants With Worst Case Clinical Chemistry Results to PCI Criteria | ALT; To within Range or No Change | 15 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Number of Participants With Worst Case Clinical Chemistry Results to PCI Criteria | Calcium; To within Range or No Change | 15 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Number of Participants With Worst Case Clinical Chemistry Results to PCI Criteria | Potassium; To within Range or No Change | 15 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Number of Participants With Worst Case Clinical Chemistry Results to PCI Criteria | Glucose; To Low | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Number of Participants With Worst Case Clinical Chemistry Results to PCI Criteria | Glucose; To High | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Number of Participants With Worst Case Clinical Chemistry Results to PCI Criteria | ALT; To High | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Number of Participants With Worst Case Clinical Chemistry Results to PCI Criteria | Albumin; To Low | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Number of Participants With Worst Case Clinical Chemistry Results to PCI Criteria | Albumin; To within Range or No Change | 15 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Number of Participants With Worst Case Clinical Chemistry Results to PCI Criteria | Albumin; To High | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Number of Participants With Worst Case Clinical Chemistry Results to PCI Criteria | Alkaline phosphatase; To Low | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Number of Participants With Worst Case Clinical Chemistry Results to PCI Criteria | Alkaline phosphatase; To within Range or No Change | 15 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Number of Participants With Worst Case Clinical Chemistry Results to PCI Criteria | Alkaline phosphatase; To High | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Number of Participants With Worst Case Clinical Chemistry Results to PCI Criteria | AST; To Low | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Number of Participants With Worst Case Clinical Chemistry Results to PCI Criteria | AST; To within Range or No Change | 15 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Number of Participants With Worst Case Clinical Chemistry Results to PCI Criteria | AST; To High | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Number of Participants With Worst Case Clinical Chemistry Results to PCI Criteria | Bilirubin; To Low | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Number of Participants With Worst Case Clinical Chemistry Results to PCI Criteria | Bilirubin; To within Range or No Change | 15 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Number of Participants With Worst Case Clinical Chemistry Results to PCI Criteria | Bilirubin; To High | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Number of Participants With Worst Case Clinical Chemistry Results to PCI Criteria | Calcium; To Low | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Number of Participants With Worst Case Clinical Chemistry Results to PCI Criteria | Calcium; To High | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: Number of Participants With Worst Case Clinical Chemistry Results to PCI Criteria | Potassium; To Low | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: Number of Participants With Worst Case Clinical Chemistry Results to PCI Criteria | Alkaline phosphatase; To within Range or No Change | 14 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: Number of Participants With Worst Case Clinical Chemistry Results to PCI Criteria | ALT; To within Range or No Change | 14 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: Number of Participants With Worst Case Clinical Chemistry Results to PCI Criteria | Bilirubin; To High | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: Number of Participants With Worst Case Clinical Chemistry Results to PCI Criteria | ALT; To Low | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: Number of Participants With Worst Case Clinical Chemistry Results to PCI Criteria | Sodium; To Low | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: Number of Participants With Worst Case Clinical Chemistry Results to PCI Criteria | AST; To Low | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: Number of Participants With Worst Case Clinical Chemistry Results to PCI Criteria | Glucose; To within Range or No Change | 14 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: Number of Participants With Worst Case Clinical Chemistry Results to PCI Criteria | Calcium; To High | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: Number of Participants With Worst Case Clinical Chemistry Results to PCI Criteria | AST; To within Range or No Change | 14 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: Number of Participants With Worst Case Clinical Chemistry Results to PCI Criteria | Sodium; To High | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: Number of Participants With Worst Case Clinical Chemistry Results to PCI Criteria | Calcium; To Low | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: Number of Participants With Worst Case Clinical Chemistry Results to PCI Criteria | Glucose; To High | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: Number of Participants With Worst Case Clinical Chemistry Results to PCI Criteria | Glucose; To Low | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: Number of Participants With Worst Case Clinical Chemistry Results to PCI Criteria | Potassium; To within Range or No Change | 14 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: Number of Participants With Worst Case Clinical Chemistry Results to PCI Criteria | AST; To High | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: Number of Participants With Worst Case Clinical Chemistry Results to PCI Criteria | ALT; To High | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: Number of Participants With Worst Case Clinical Chemistry Results to PCI Criteria | Bilirubin; To Low | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: Number of Participants With Worst Case Clinical Chemistry Results to PCI Criteria | Potassium; To High | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: Number of Participants With Worst Case Clinical Chemistry Results to PCI Criteria | Alkaline phosphatase; To High | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: Number of Participants With Worst Case Clinical Chemistry Results to PCI Criteria | Sodium; To within Range or No Change | 14 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: Number of Participants With Worst Case Clinical Chemistry Results to PCI Criteria | Albumin; To within Range or No Change | 14 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: Number of Participants With Worst Case Clinical Chemistry Results to PCI Criteria | Calcium; To within Range or No Change | 14 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: Number of Participants With Worst Case Clinical Chemistry Results to PCI Criteria | Albumin; To High | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: Number of Participants With Worst Case Clinical Chemistry Results to PCI Criteria | Bilirubin; To within Range or No Change | 14 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: Number of Participants With Worst Case Clinical Chemistry Results to PCI Criteria | Alkaline phosphatase; To Low | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: Number of Participants With Worst Case Clinical Chemistry Results to PCI Criteria | Albumin; To Low | 0 Participants |
Secondary
Part 1: Number of Participants With Worst Case Hematology Results to PCI Criteria
Blood samples were collected from participants for analysis of following hematology parameters; hematocrit, hemoglobin, leukocytes, lymphocytes, neutrophils and platelets. PCI ranges were \>0.54 as proportion of red blood cells in blood for hematocrit, \>180 g/L for hemoglobin, \< 3 or \>20 cells/L for leukocytes, 0.8 x10\^9 cells/L for lymphocytes, 1.5 x10\^9 cells/L for neutrophils, and \<100 or \>550 cells/L for platelets. Participants were counted in the worst case category that their value changes to (low, within range or no change, or high), unless there is no change in their category. Participants whose laboratory value category was unchanged (e.g., High to High), or whose value became within range, were recorded in the To within Range or No Change category.
Time frame: Up to 60 days
Population: Safety Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Number of Participants With Worst Case Hematology Results to PCI Criteria | Neutrophils; To Low | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Number of Participants With Worst Case Hematology Results to PCI Criteria | Hemoglobin; To within Range or No Change | 15 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Number of Participants With Worst Case Hematology Results to PCI Criteria | Platelets; To Low | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Number of Participants With Worst Case Hematology Results to PCI Criteria | Hemoglobin; To High | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Number of Participants With Worst Case Hematology Results to PCI Criteria | Leukocytes; To Low | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Number of Participants With Worst Case Hematology Results to PCI Criteria | Hemoglobin; To Low | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Number of Participants With Worst Case Hematology Results to PCI Criteria | Platelets; To within Range or No Change | 15 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Number of Participants With Worst Case Hematology Results to PCI Criteria | Leukocytes; To within Range or No Change | 15 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Number of Participants With Worst Case Hematology Results to PCI Criteria | Hematocrit; To within Range or No Change | 15 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Number of Participants With Worst Case Hematology Results to PCI Criteria | Neutrophils; To within Range or No Change | 15 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Number of Participants With Worst Case Hematology Results to PCI Criteria | Leukocytes; To High | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Number of Participants With Worst Case Hematology Results to PCI Criteria | Hematocrit; To High | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Number of Participants With Worst Case Hematology Results to PCI Criteria | Platelets; To High | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Number of Participants With Worst Case Hematology Results to PCI Criteria | Lymphocytes; To Low | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Number of Participants With Worst Case Hematology Results to PCI Criteria | Neutrophils; To High | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Number of Participants With Worst Case Hematology Results to PCI Criteria | Hematocrit; To Low | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Number of Participants With Worst Case Hematology Results to PCI Criteria | Lymphocytes; To within Range or No Change | 15 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Number of Participants With Worst Case Hematology Results to PCI Criteria | Lymphocytes; To High | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Number of Participants With Worst Case Hematology Results to PCI Criteria | Hemoglobin; To High | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Number of Participants With Worst Case Hematology Results to PCI Criteria | Lymphocytes; To High | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Number of Participants With Worst Case Hematology Results to PCI Criteria | Neutrophils; To Low | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Number of Participants With Worst Case Hematology Results to PCI Criteria | Hematocrit; To Low | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Number of Participants With Worst Case Hematology Results to PCI Criteria | Neutrophils; To High | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Number of Participants With Worst Case Hematology Results to PCI Criteria | Hematocrit; To within Range or No Change | 15 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Number of Participants With Worst Case Hematology Results to PCI Criteria | Platelets; To within Range or No Change | 15 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Number of Participants With Worst Case Hematology Results to PCI Criteria | Platelets; To High | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Number of Participants With Worst Case Hematology Results to PCI Criteria | Hemoglobin; To Low | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Number of Participants With Worst Case Hematology Results to PCI Criteria | Hematocrit; To High | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Number of Participants With Worst Case Hematology Results to PCI Criteria | Hemoglobin; To within Range or No Change | 15 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Number of Participants With Worst Case Hematology Results to PCI Criteria | Leukocytes; To Low | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Number of Participants With Worst Case Hematology Results to PCI Criteria | Lymphocytes; To within Range or No Change | 15 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Number of Participants With Worst Case Hematology Results to PCI Criteria | Leukocytes; To within Range or No Change | 15 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Number of Participants With Worst Case Hematology Results to PCI Criteria | Leukocytes; To High | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Number of Participants With Worst Case Hematology Results to PCI Criteria | Neutrophils; To within Range or No Change | 15 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Number of Participants With Worst Case Hematology Results to PCI Criteria | Lymphocytes; To Low | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Number of Participants With Worst Case Hematology Results to PCI Criteria | Platelets; To Low | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: Number of Participants With Worst Case Hematology Results to PCI Criteria | Platelets; To High | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: Number of Participants With Worst Case Hematology Results to PCI Criteria | Hematocrit; To High | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: Number of Participants With Worst Case Hematology Results to PCI Criteria | Hemoglobin; To within Range or No Change | 14 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: Number of Participants With Worst Case Hematology Results to PCI Criteria | Hematocrit; To within Range or No Change | 14 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: Number of Participants With Worst Case Hematology Results to PCI Criteria | Hemoglobin; To Low | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: Number of Participants With Worst Case Hematology Results to PCI Criteria | Hemoglobin; To High | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: Number of Participants With Worst Case Hematology Results to PCI Criteria | Leukocytes; To Low | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: Number of Participants With Worst Case Hematology Results to PCI Criteria | Leukocytes; To within Range or No Change | 14 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: Number of Participants With Worst Case Hematology Results to PCI Criteria | Leukocytes; To High | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: Number of Participants With Worst Case Hematology Results to PCI Criteria | Lymphocytes; To Low | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: Number of Participants With Worst Case Hematology Results to PCI Criteria | Lymphocytes; To within Range or No Change | 14 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: Number of Participants With Worst Case Hematology Results to PCI Criteria | Lymphocytes; To High | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: Number of Participants With Worst Case Hematology Results to PCI Criteria | Neutrophils; To Low | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: Number of Participants With Worst Case Hematology Results to PCI Criteria | Neutrophils; To within Range or No Change | 14 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: Number of Participants With Worst Case Hematology Results to PCI Criteria | Neutrophils; To High | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: Number of Participants With Worst Case Hematology Results to PCI Criteria | Platelets; To Low | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: Number of Participants With Worst Case Hematology Results to PCI Criteria | Platelets; To within Range or No Change | 14 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: Number of Participants With Worst Case Hematology Results to PCI Criteria | Hematocrit; To Low | 0 Participants |
Secondary
Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria
Urine samples were collected from participants for analysis of following urinalysis parameters; specific gravity, pH, presence of glucose, protein, occult blood, ketones in urine analyzed by dipstick method. The dipstick test gives results in a semi-quantitative manner. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The reference range is 1.002-1.030. Urine pH is an acid-base measurement. Normal urine has a slightly acid pH (5.0 - 6.0). Participants were counted in the worst case category that their value changes to (low, normal or high), unless there is no change in their category. Participants whose laboratory value category was unchanged (e.g., High to High), or whose value became normal, were recorded in the To Normal or No Change category.
Time frame: Up to 60 days
Population: Safety Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | Glucose; To Abnormal | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | Specific gravity; To High | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | Protein; To Low | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | Occult blood; To Low | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | Glucose; To Low | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | Occult blood To Abnormal | 1 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | Occult blood ; To Normal or No Change | 14 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | Specific gravity; To Low | 1 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | Occult blood; To High | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | Specific gravity; To Normal or No Change | 14 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | Urine pH; To Abnormal | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | Urine pH; To High | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | Ketones; To Low | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | Urine pH; To Normal or No Change | 15 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | Protein To Abnormal | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | Ketones; To Normal or No Change | 14 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | Glucose; To High | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | Protein; To High | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | Ketones; To High | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | Glucose; To Normal or No Change | 15 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | Protein; To Normal or No Change | 15 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | Specific gravity To Abnormal | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | Ketones To Abnormal | 1 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | Urine pH; To Low | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | Urine pH; To Normal or No Change | 15 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | Glucose; To Low | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | Glucose; To Normal or No Change | 15 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | Glucose; To High | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | Glucose; To Abnormal | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | Ketones; To Low | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | Ketones; To Normal or No Change | 15 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | Ketones; To High | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | Ketones To Abnormal | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | Protein; To Normal or No Change | 15 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | Occult blood; To Low | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | Specific gravity; To Low | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | Urine pH; To High | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | Urine pH; To Abnormal | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | Occult blood ; To Normal or No Change | 13 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | Occult blood; To High | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | Occult blood To Abnormal | 2 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | Specific gravity; To Normal or No Change | 15 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | Specific gravity; To High | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | Protein; To Low | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | Protein; To High | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | Protein To Abnormal | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | Specific gravity To Abnormal | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | Urine pH; To Low | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | Occult blood To Abnormal | 4 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | Protein; To High | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | Glucose; To Normal or No Change | 14 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | Specific gravity; To Normal or No Change | 12 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | Protein; To Normal or No Change | 14 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | Specific gravity To Abnormal | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | Specific gravity; To High | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | Ketones To Abnormal | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | Glucose; To High | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | Protein; To Low | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | Ketones; To High | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | Ketones; To Normal or No Change | 14 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | Glucose; To Low | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | Urine pH; To High | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | Urine pH; To Normal or No Change | 14 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | Ketones; To Low | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | Urine pH; To Abnormal | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | Urine pH; To Low | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | Occult blood ; To Normal or No Change | 10 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | Specific gravity; To Low | 2 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | Protein To Abnormal | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | Occult blood; To High | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | Occult blood; To Low | 0 Participants |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | Glucose; To Abnormal | 0 Participants |
Secondary
Part 1: Plasma Drug Concentration at 24 Hours (C24) Following Administration of GSK2838232 Tablet and Capsule Formulation in Fed State and Tablet Formulation in Fasted State
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK2838232 given as capsule and tablet formulation in fed state as well as tablet formulation in fasted state. Pharmacokinetic parameters were determined using standard non-compartmental methods.
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 120 hours post-dose in treatment periods 1, 2 and 3 of Part 1
Population: Pharmacokinetic Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Plasma Drug Concentration at 24 Hours (C24) Following Administration of GSK2838232 Tablet and Capsule Formulation in Fed State and Tablet Formulation in Fasted State | 84.536 Nanograms per milliliter | Geometric Coefficient of Variation 41.93 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Plasma Drug Concentration at 24 Hours (C24) Following Administration of GSK2838232 Tablet and Capsule Formulation in Fed State and Tablet Formulation in Fasted State | 75.643 Nanograms per milliliter | Geometric Coefficient of Variation 32.57 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: Plasma Drug Concentration at 24 Hours (C24) Following Administration of GSK2838232 Tablet and Capsule Formulation in Fed State and Tablet Formulation in Fasted State | 26.852 Nanograms per milliliter | Geometric Coefficient of Variation 35.39 |
Secondary
Part 1: Pulse Rate at Indicated Time Points
Pulse rate was measured in supine position after 10 minutes rest for the participant at indicated time points.
Time frame: Day -2; Day -1; Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 Hours on Day 1
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Pulse Rate at Indicated Time Points | DAY -1 | 62.333 Beats per minute | Standard Deviation 10.6212 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Pulse Rate at Indicated Time Points | DAY 1, 2 Hours | 72.667 Beats per minute | Standard Deviation 11.8301 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Pulse Rate at Indicated Time Points | DAY 1, 48 Hours | 64.333 Beats per minute | Standard Deviation 6.7259 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Pulse Rate at Indicated Time Points | DAY 1, 24 Hours | 63.400 Beats per minute | Standard Deviation 7.1992 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Pulse Rate at Indicated Time Points | DAY 1, 4 Hours | 68.133 Beats per minute | Standard Deviation 7.8728 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Pulse Rate at Indicated Time Points | DAY 1, 1 Hour | 74.667 Beats per minute | Standard Deviation 8.5996 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Pulse Rate at Indicated Time Points | DAY 1, 72 Hours | 62.267 Beats per minute | Standard Deviation 6.9639 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Pulse Rate at Indicated Time Points | DAY 1, 6 Hours | 68.867 Beats per minute | Standard Deviation 9.9417 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Pulse Rate at Indicated Time Points | DAY 1, 12 Hours | 64.867 Beats per minute | Standard Deviation 9.0069 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Pulse Rate at Indicated Time Points | DAY 1, PREDOSE | 65.023 Beats per minute | Standard Deviation 10.7156 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Pulse Rate at Indicated Time Points | DAY 1, 8 Hours | 66.533 Beats per minute | Standard Deviation 10.5144 |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Pulse Rate at Indicated Time Points | DAY -2 | 64.067 Beats per minute | Standard Deviation 14.6066 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Pulse Rate at Indicated Time Points | DAY 1, 8 Hours | 66.933 Beats per minute | Standard Deviation 7.2552 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Pulse Rate at Indicated Time Points | DAY 1, 12 Hours | 65.867 Beats per minute | Standard Deviation 6.4128 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Pulse Rate at Indicated Time Points | DAY 1, 24 Hours | 61.267 Beats per minute | Standard Deviation 7.6295 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Pulse Rate at Indicated Time Points | DAY 1, 48 Hours | 63.533 Beats per minute | Standard Deviation 6.4572 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Pulse Rate at Indicated Time Points | DAY 1, 72 Hours | 62.467 Beats per minute | Standard Deviation 8.0166 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Pulse Rate at Indicated Time Points | DAY 1, 1 Hour | 72.333 Beats per minute | Standard Deviation 9.2711 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Pulse Rate at Indicated Time Points | DAY 1, 2 Hours | 72.933 Beats per minute | Standard Deviation 9.5877 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Pulse Rate at Indicated Time Points | DAY -1 | 63.067 Beats per minute | Standard Deviation 7.6108 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Pulse Rate at Indicated Time Points | DAY 1, 4 Hours | 69.467 Beats per minute | Standard Deviation 11.0574 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Pulse Rate at Indicated Time Points | DAY -2 | 62.333 Beats per minute | Standard Deviation 10.8737 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Pulse Rate at Indicated Time Points | DAY 1, 6 Hours | 68.133 Beats per minute | Standard Deviation 11.0961 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Pulse Rate at Indicated Time Points | DAY 1, PREDOSE | 64.311 Beats per minute | Standard Deviation 7.9777 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: Pulse Rate at Indicated Time Points | DAY 1, 72 Hours | 62.286 Beats per minute | Standard Deviation 11.09 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: Pulse Rate at Indicated Time Points | DAY -2 | 60.214 Beats per minute | Standard Deviation 9.4558 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: Pulse Rate at Indicated Time Points | DAY -1 | 59.071 Beats per minute | Standard Deviation 10.6516 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: Pulse Rate at Indicated Time Points | DAY 1, PREDOSE | 59.857 Beats per minute | Standard Deviation 8.3402 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: Pulse Rate at Indicated Time Points | DAY 1, 1 Hour | 58.571 Beats per minute | Standard Deviation 9.3949 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: Pulse Rate at Indicated Time Points | DAY 1, 2 Hours | 60.214 Beats per minute | Standard Deviation 10.401 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: Pulse Rate at Indicated Time Points | DAY 1, 4 Hours | 61.214 Beats per minute | Standard Deviation 9.5287 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: Pulse Rate at Indicated Time Points | DAY 1, 6 Hours | 66.500 Beats per minute | Standard Deviation 9.436 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: Pulse Rate at Indicated Time Points | DAY 1, 8 Hours | 63.571 Beats per minute | Standard Deviation 10.6027 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: Pulse Rate at Indicated Time Points | DAY 1, 24 Hours | 64.071 Beats per minute | Standard Deviation 11.519 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: Pulse Rate at Indicated Time Points | DAY 1, 48 Hours | 63.286 Beats per minute | Standard Deviation 10.5278 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: Pulse Rate at Indicated Time Points | DAY 1, 12 Hours | 67.143 Beats per minute | Standard Deviation 11.4546 |
Secondary
Part 1: T1/2 Following Administration of GSK2838232 Tablet and Capsule Formulation in Fed State and Tablet Formulation in Fasted State
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK2838232 given as capsule and tablet formulation in fed state as well as tablet formulation in fasted state. Pharmacokinetic parameters were determined using standard non-compartmental methods.
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 120 hours post-dose in treatment periods 1, 2 and 3 of Part 1
Population: Pharmacokinetic Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: T1/2 Following Administration of GSK2838232 Tablet and Capsule Formulation in Fed State and Tablet Formulation in Fasted State | 15.606 Hours | Geometric Coefficient of Variation 14.84 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: T1/2 Following Administration of GSK2838232 Tablet and Capsule Formulation in Fed State and Tablet Formulation in Fasted State | 15.692 Hours | Geometric Coefficient of Variation 17.28 |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: T1/2 Following Administration of GSK2838232 Tablet and Capsule Formulation in Fed State and Tablet Formulation in Fasted State | 17.061 Hours | Geometric Coefficient of Variation 19.01 |
Secondary
Part 1: Tlag Following Administration of GSK2838232 Tablet and Capsule Formulation in Fed State and Tablet Formulation in Fasted State
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK2838232 given as capsule and tablet formulation in fed state as well as tablet formulation in fasted state. Tlag is a time delay between drug administration and first observed concentration. Pharmacokinetic parameters were determined using standard non-compartmental methods.
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 120 hours post-dose in treatment periods 1, 2 and 3 of Part 1
Population: Pharmacokinetic Population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Tlag Following Administration of GSK2838232 Tablet and Capsule Formulation in Fed State and Tablet Formulation in Fasted State | 1.000 Hours |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Tlag Following Administration of GSK2838232 Tablet and Capsule Formulation in Fed State and Tablet Formulation in Fasted State | 1.000 Hours |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: Tlag Following Administration of GSK2838232 Tablet and Capsule Formulation in Fed State and Tablet Formulation in Fasted State | 0.500 Hours |
Secondary
Part 1: Tlast Following Administration of GSK2838232 Tablet and Capsule Formulation in Fed State and Tablet Formulation in Fasted State
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK2838232 given as capsule and tablet formulation in fed state as well as tablet formulation in fasted state. Pharmacokinetic parameters were determined using standard non-compartmental methods.
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 120 hours post-dose in treatment periods 1, 2 and 3 of Part 1
Population: Pharmacokinetic Population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Tlast Following Administration of GSK2838232 Tablet and Capsule Formulation in Fed State and Tablet Formulation in Fasted State | 119.983 Hours |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Tlast Following Administration of GSK2838232 Tablet and Capsule Formulation in Fed State and Tablet Formulation in Fasted State | 119.983 Hours |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: Tlast Following Administration of GSK2838232 Tablet and Capsule Formulation in Fed State and Tablet Formulation in Fasted State | 120.017 Hours |
Secondary
Part 1: Tmax Following Administration of GSK2838232 Tablet and Capsule Formulation in Fed State and Tablet Formulation in Fasted State
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK2838232 given as capsule and tablet formulation in fed state as well as tablet formulation in fasted state. Pharmacokinetic parameters were determined using standard non-compartmental methods.
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 120 hours post-dose in treatment periods 1, 2 and 3 of Part 1
Population: Pharmacokinetic Population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 1: Tmax Following Administration of GSK2838232 Tablet and Capsule Formulation in Fed State and Tablet Formulation in Fasted State | 11.967 Hours |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Part 1: Tmax Following Administration of GSK2838232 Tablet and Capsule Formulation in Fed State and Tablet Formulation in Fasted State | 5.983 Hours |
| Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Part 1: Tmax Following Administration of GSK2838232 Tablet and Capsule Formulation in Fed State and Tablet Formulation in Fasted State | 3.508 Hours |
Secondary
Part 2: Accumulation Ratio Calculated From AUC(0-tau) Following Administration of GSK2838232 as Non-boosted Once-daily Doses of a Tablet Formulation
Blood sample were collected at indicated time points to calculate accumulation ratio from AUC(0-tau) following administration of GSK2838232 as non-boosted once-daily doses of a tablet formulation. Accumulation ratio of GSK2838232 was evaluated by Day 11, AUC (0-tau) divided by Day 1, AUC (0-tau).
Time frame: Pre-dose, 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12 and 24 hours post-dose on Day 1; Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96 and 120 hours post-dose on Day 11 in Part 2
Population: Pharmacokinetic Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Accumulation Ratio Calculated From AUC(0-tau) Following Administration of GSK2838232 as Non-boosted Once-daily Doses of a Tablet Formulation | 1.3340 Ratio of AUC | Standard Deviation 0.18272 |
Secondary
Part 2: Accumulation Ratio Calculated From Cmax Following Administration of GSK2838232 as Non-boosted Once-daily Doses of a Tablet Formulation
Blood sample were collected at indicated time points to calculate accumulation ratio from Cmax following administration of GSK2838232 as non-boosted once-daily doses of a tablet formulation. Accumulation ratio of GSK2838232 was evaluated by Day 11, Cmax divided by Day 1, Cmax.
Time frame: Pre-dose, 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12 and 24 hours post-dose on Day 1; Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96 and 120 hours post-dose on Day 11 in Part 2
Population: Pharmacokinetic Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Accumulation Ratio Calculated From Cmax Following Administration of GSK2838232 as Non-boosted Once-daily Doses of a Tablet Formulation | 1.2118 Ratio of Cmax | Standard Deviation 0.28582 |
Secondary
Part 2: Accumulation Ratio Calculated From Ctau Following Administration of GSK2838232 as Non-boosted Once-daily Doses of a Tablet Formulation
Blood sample were collected at indicated time points to calculate accumulation ratio from Ctau following administration of GSK2838232 as non-boosted once-daily doses of a tablet formulation. Accumulation ratio of GSK2838232 was evaluated by Day 11, Ctau divided by Day 1, Ctau.
Time frame: Pre-dose, 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12 and 24 hours post-dose on Day 1; Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96 and 120 hours post-dose on Day 11 in Part 2
Population: Pharmacokinetic Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Accumulation Ratio Calculated From Ctau Following Administration of GSK2838232 as Non-boosted Once-daily Doses of a Tablet Formulation | 1.3205 Ratio of Ctau | Standard Deviation 0.32907 |
Secondary
Part 2: Slope of Pre-dose Concentration of GSK2838232 Administered as Non-boosted Once-daily Doses of a Tablet Formulation to Assess Achievement of Steady State
Blood sample were collected at indicated time points to assess pre-dose concentration of GSK2838232 when administered as non-boosted once-daily doses of a tablet formulation for 11 days in Part 2. Slope and 90 percent confidence interval have been presented.
Time frame: Pre-dose on Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 10 and Day 11 in Part 2
Population: Pharmacokinetic Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Slope of Pre-dose Concentration of GSK2838232 Administered as Non-boosted Once-daily Doses of a Tablet Formulation to Assess Achievement of Steady State | Pre-dose, Days 3-11 | -0.00910 Nanograms per milliliter per study day |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Slope of Pre-dose Concentration of GSK2838232 Administered as Non-boosted Once-daily Doses of a Tablet Formulation to Assess Achievement of Steady State | Pre-dose, Days 4-11 | -0.0150 Nanograms per milliliter per study day |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Slope of Pre-dose Concentration of GSK2838232 Administered as Non-boosted Once-daily Doses of a Tablet Formulation to Assess Achievement of Steady State | Pre-dose, Days 5-11 | -0.0379 Nanograms per milliliter per study day |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Slope of Pre-dose Concentration of GSK2838232 Administered as Non-boosted Once-daily Doses of a Tablet Formulation to Assess Achievement of Steady State | Pre-dose, Days 6-11 | -0.0490 Nanograms per milliliter per study day |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Slope of Pre-dose Concentration of GSK2838232 Administered as Non-boosted Once-daily Doses of a Tablet Formulation to Assess Achievement of Steady State | Pre-dose, Days 7-11 | -0.0679 Nanograms per milliliter per study day |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Slope of Pre-dose Concentration of GSK2838232 Administered as Non-boosted Once-daily Doses of a Tablet Formulation to Assess Achievement of Steady State | Pre-dose, Days 8-11 | -0.0672 Nanograms per milliliter per study day |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Slope of Pre-dose Concentration of GSK2838232 Administered as Non-boosted Once-daily Doses of a Tablet Formulation to Assess Achievement of Steady State | Pre-dose, Days 9-11 | -0.107 Nanograms per milliliter per study day |
| Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Part 2: Slope of Pre-dose Concentration of GSK2838232 Administered as Non-boosted Once-daily Doses of a Tablet Formulation to Assess Achievement of Steady State | Pre-dose, Days 10-11 | -0.263 Nanograms per milliliter per study day |