| 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). | Pharmacokinetic Population | Posted | | Geometric Mean | Geometric Coefficient of Variation | Hours*nanogram per milliliter | | 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 | | | | ID | Title | Description |
|---|
| OG000 | Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Participants received a single dose of GSK2838232 200 mg (as 4 x 50 mg) capsule formulation along with ritonavir 100 mg tablet administered under fed conditions in treatment periods 1 and 2. | | OG001 | Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Participants received a single dose of GSK2838232 200 mg (as 2 x 10 mg) tablet formulation along with ritonavir 100 mg tablet administered under fed conditions in treatment periods 1 and 2. |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG0004672.28± 40.68
- OG0014437.98± 30.83
|
|
| |
| 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. | Pharmacokinetic Population | Posted | | Geometric Mean | Geometric Coefficient of Variation | Nanograms per milliliter | | 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 | | | | ID | Title | Description |
|---|
| OG000 | Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Participants received a single dose of GSK2838232 200 mg (as 4 x 50 mg) capsule formulation along with ritonavir 100 mg tablet administered under fed conditions in treatment periods 1 and 2. | | OG001 | Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Participants received a single dose of GSK2838232 200 mg (as 2 x 10 mg) tablet formulation along with ritonavir 100 mg tablet administered under fed conditions in treatment periods 1 and 2. |
| |
| 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. | Pharmacokinetic Population | Posted | | Geometric Mean | Geometric Coefficient of Variation | Hours*nanogram per milliliter | | 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 | | | | ID | Title | Description |
|---|
| OG000 | Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Participants received a single dose of GSK2838232 200 mg (as 2 x 10 mg) tablet formulation administered under fed conditions in treatment periods 1 and 2 along with ritonavir 100 mg tablet to be taken with water in fed condition. | | OG001 | Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Participants received a single dose of GSK2838232 200 mg (as 2 x 100 mg) tablet formulation under fasted conditions in treatment period 3 along with ritonavir 100 mg tablet to be taken with water in fasted condition. |
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| 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. | Pharmacokinetic Population | Posted | | Geometric Mean | Geometric Coefficient of Variation | Nanograms per milliliter | | 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 | | | | ID | Title | Description |
|---|
| OG000 | Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Participants received a single dose of GSK2838232 200 mg (as 2 x 10 mg) tablet formulation administered under fed conditions in treatment periods 1 and 2 along with ritonavir 100 mg tablet to be taken with water in fed condition. | | OG001 | Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Participants received a single dose of GSK2838232 200 mg (as 2 x 100 mg) tablet formulation under fasted conditions in treatment period 3 along with ritonavir 100 mg tablet to be taken with water in fasted condition. |
| |
| 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. | Pharmacokinetic Population | Posted | | Median | Full Range | Hours | | 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 | | | | ID | Title | Description |
|---|
| OG000 | Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Participants received a single dose of GSK2838232 200 mg (as 2 x 10 mg) tablet formulation administered under fed conditions in treatment periods 1 and 2 along with ritonavir 100 mg tablet to be taken with water in fed condition. | | OG001 | Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Participants received a single dose of GSK2838232 200 mg (as 2 x 100 mg) tablet formulation under fasted conditions in treatment period 3 along with ritonavir 100 mg tablet to be taken with water in fasted condition. |
| |
| 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. | | Posted | | Count of Participants | | Participants | | Up to 25 days | | | | ID | Title | Description |
|---|
| OG000 | Part 2: Placebo | Eligible participants received single daily doses of placebo tablet orally along with water in fed condition for 11 days. | | OG001 | 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. |
| |
| 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. | | Posted | | Count of Participants | | Participants | | Up to 25 days | | | | ID | Title | Description |
|---|
| OG000 | Part 2: Placebo | Eligible participants received single daily doses of placebo tablet orally along with water in fed condition for 11 days. | | OG001 | 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. |
| |
| 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. | | Posted | | Count of Participants | | Participants | | Up to 25 days | | | | ID | Title | Description |
|---|
| OG000 | Part 2: Placebo | Eligible participants received single daily doses of placebo tablet orally along with water in fed condition for 11 days. | | OG001 | 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. |
|
| 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. | | Posted | | Count of Participants | | Participants | | Up to 25 days | | | | ID | Title | Description |
|---|
| OG000 | Part 2: Placebo | Eligible participants received single daily doses of placebo tablet orally along with water in fed condition for 11 days. | | OG001 | 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. |
|
| 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. | | Posted | | Mean | Standard Deviation | Millimeter of mercury | | 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) | | | | ID | Title | Description |
|---|
| OG000 | Part 2: Placebo | Eligible participants received single daily doses of placebo tablet orally along with water in fed condition for 11 days. | | OG001 | 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. |
| |
| 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. | | Posted | | Mean | Standard Deviation | Millimeter of mercury | | 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) | | | | ID | Title | Description |
|---|
| OG000 | Part 2: Placebo | Eligible participants received single daily doses of placebo tablet orally along with water in fed condition for 11 days. | | OG001 | 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. |
| |
| 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. | | Posted | | Mean | Standard Deviation | Beats per minute | | 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) | | | | ID | Title | Description |
|---|
| OG000 | Part 2: Placebo | Eligible participants received single daily doses of placebo tablet orally along with water in fed condition for 11 days. | | OG001 | 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. |
| |
| 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. | | Posted | | Mean | Standard Deviation | Beats per minute | | 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) | | | | ID | Title | Description |
|---|
| OG000 | Part 2: Placebo | Eligible participants received single daily doses of placebo tablet orally along with water in fed condition for 11 days. | | OG001 | 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. |
| |
| 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. | | Posted | | Count of Participants | | Participants | | 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) | | | | ID | Title | Description |
|---|
| OG000 | Part 2: Placebo | Eligible participants received single daily doses of placebo tablet orally along with water in fed condition for 11 days. | | OG001 | 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. |
| |
| 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. | | Posted | | Mean | Standard Deviation | Beats per minute | | 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) | | | | ID | Title | Description |
|---|
| OG000 | Part 2: Placebo | Eligible participants received single daily doses of placebo tablet orally along with water in fed condition for 11 days. | | OG001 | 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. |
| |
| 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. | | Posted | | Mean | Standard Deviation | Milliseconds | | 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) | | | | ID | Title | Description |
|---|
| OG000 | Part 2: Placebo | Eligible participants received single daily doses of placebo tablet orally along with water in fed condition for 11 days. | | OG001 | 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. |
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| 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. | Pharmacokinetic Population | Posted | | Geometric Mean | Geometric Coefficient of Variation | Hours*nanograms per milliliter | | 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 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| 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. | Pharmacokinetic Population | Posted | | Geometric Mean | Geometric Coefficient of Variation | Nanograms per milliliter | | 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 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| 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. | Pharmacokinetic Population | Posted | | Geometric Mean | Geometric Coefficient of Variation | Nanograms per milliliter | | 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 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| 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. | Pharmacokinetic Population | Posted | | Median | Full Range | Hours | | 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 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| 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. | Pharmacokinetic Population | Posted | | Median | Full Range | Hours | | 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 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| 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. | Pharmacokinetic Population | Posted | | Geometric Mean | Geometric Coefficient of Variation | Hours*nanograms per milliliter | | 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 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| 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. | Pharmacokinetic Population | Posted | | Geometric Mean | Geometric Coefficient of Variation | Hours | | 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 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| 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. | Pharmacokinetic Population | Posted | | Median | Full Range | Hours | | 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 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| 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. | | Posted | | Count of Participants | | Participants | | Up to 60 days | | | | ID | Title | Description |
|---|
| OG000 | Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Participants received a single dose of GSK2838232 200 mg (as 4 x 50 mg) capsule formulation along with ritonavir 100 mg tablet administered under fed conditions in treatment periods 1 and 2. | | OG001 | Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Participants received a single dose of GSK2838232 200 mg (as 2 x 10 mg) tablet formulation along with ritonavir 100 mg tablet administered under fed conditions in treatment periods 1 and 2. | | OG002 | Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted |
|
| 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. | | Posted | | Count of Participants | | Participants | | Up to 60 days | | | | ID | Title | Description |
|---|
| OG000 | Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Participants received a single dose of GSK2838232 200 mg (as 4 x 50 mg) capsule formulation along with ritonavir 100 mg tablet administered under fed conditions in treatment periods 1 and 2. | | OG001 | Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Participants received a single dose of GSK2838232 200 mg (as 2 x 10 mg) tablet formulation along with ritonavir 100 mg tablet administered under fed conditions in treatment periods 1 and 2. |
|
| 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. | | Posted | | Count of Participants | | Participants | | Up to 60 days | | | | ID | Title | Description |
|---|
| OG000 | Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Participants received a single dose of GSK2838232 200 mg (as 4 x 50 mg) capsule formulation along with ritonavir 100 mg tablet administered under fed conditions in treatment periods 1 and 2. | | OG001 | Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Participants received a single dose of GSK2838232 200 mg (as 2 x 10 mg) tablet formulation along with ritonavir 100 mg tablet administered under fed conditions in treatment periods 1 and 2. |
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| 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. | | Posted | | Count of Participants | | Participants | | Up to 60 days | | | | ID | Title | Description |
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| OG000 | Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Participants received a single dose of GSK2838232 200 mg (as 4 x 50 mg) capsule formulation along with ritonavir 100 mg tablet administered under fed conditions in treatment periods 1 and 2. | | OG001 | Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Participants received a single dose of GSK2838232 200 mg (as 2 x 10 mg) tablet formulation along with ritonavir 100 mg tablet administered under fed conditions in treatment periods 1 and 2. |
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| 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. | | Posted | | Mean | Standard Deviation | Millimeter of mercury | | Day -2; Day -1; Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 Hours on Day 1 | | | | ID | Title | Description |
|---|
| OG000 | Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Participants received a single dose of GSK2838232 200 mg (as 4 x 50 mg) capsule formulation along with ritonavir 100 mg tablet administered under fed conditions in treatment periods 1 and 2. | | OG001 | Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Participants received a single dose of GSK2838232 200 mg (as 2 x 10 mg) tablet formulation along with ritonavir 100 mg tablet administered under fed conditions in treatment periods 1 and 2. | | OG002 | Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Participants received a single dose of GSK2838232 200 mg (as 2 x 100 mg) tablet formulation under fasted conditions in treatment period 3 along with ritonavir 100 mg tablet to be taken with water in fasted condition. |
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| 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. | | Posted | | Mean | Standard Deviation | Millimeter of mercury | | Baseline (Day -1) and 1, 2, 4, 6, 8, 12, 24, 48, 72 Hours on Day 1 | | | | ID | Title | Description |
|---|
| OG000 | Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Participants received a single dose of GSK2838232 200 mg (as 4 x 50 mg) capsule formulation along with ritonavir 100 mg tablet administered under fed conditions in treatment periods 1 and 2. | | OG001 | Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Participants received a single dose of GSK2838232 200 mg (as 2 x 10 mg) tablet formulation along with ritonavir 100 mg tablet administered under fed conditions in treatment periods 1 and 2. | | OG002 | Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | Participants received a single dose of GSK2838232 200 mg (as 2 x 100 mg) tablet formulation under fasted conditions in treatment period 3 along with ritonavir 100 mg tablet to be taken with water in fasted condition. |
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| 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. | | Posted | | Mean | Standard Deviation | Beats per minute | | Day -2; Day -1; Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 Hours on Day 1 | | | | ID | Title | Description |
|---|
| OG000 | Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Participants received a single dose of GSK2838232 200 mg (as 4 x 50 mg) capsule formulation along with ritonavir 100 mg tablet administered under fed conditions in treatment periods 1 and 2. | | OG001 | Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Participants received a single dose of GSK2838232 200 mg (as 2 x 10 mg) tablet formulation along with ritonavir 100 mg tablet administered under fed conditions in treatment periods 1 and 2. | | OG002 | Part 1: GSK 200 mg/Ritonavir Tablet Fasted | Participants received a single dose of GSK2838232 200 mg (as 2 x 100 mg) tablet formulation under fasted conditions in treatment period 3 along with ritonavir 100 mg tablet to be taken with water in fasted condition. |
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| 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. | | Posted | | Mean | Standard Deviation | Beats per minute | | Baseline (Day -1) and 1, 2, 4, 6, 8, 12, 24, 48, 72 Hours on Day 1 | | | | ID | Title | Description |
|---|
| OG000 | Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Participants received a single dose of GSK2838232 200 mg (as 4 x 50 mg) capsule formulation along with ritonavir 100 mg tablet administered under fed conditions in treatment periods 1 and 2. | | OG001 | Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Participants received a single dose of GSK2838232 200 mg (as 2 x 10 mg) tablet formulation along with ritonavir 100 mg tablet administered under fed conditions in treatment periods 1 and 2. | | OG002 | Part 1: GSK 200 mg/Ritonavir Tablet Fasted | Participants received a single dose of GSK2838232 200 mg (as 2 x 100 mg) tablet formulation under fasted conditions in treatment period 3 along with ritonavir 100 mg tablet to be taken with water in fasted condition. |
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| 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. | Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). | Posted | | Count of Participants | | Participants | | Day -2, Day -1; 1, 2, 4, 6, 8, , 12, 24, 48, 72 hours on Day 1 | | | | ID | Title | Description |
|---|
| OG000 | Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Participants received a single dose of GSK2838232 200 mg (as 4 x 50 mg) capsule formulation along with ritonavir 100 mg tablet administered under fed conditions in treatment periods 1 and 2. | | OG001 | Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Participants received a single dose of GSK2838232 200 mg (as 2 x 10 mg) tablet formulation along with ritonavir 100 mg tablet administered under fed conditions in treatment periods 1 and 2. | | OG002 |
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| 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. | Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). | Posted | | Mean | Standard Deviation | Beats per minute | | Baseline (Day -1) and 1, 2, 4, 6, 8, 12, 24, 48, 72 hours on Day 1 | | | | ID | Title | Description |
|---|
| OG000 | Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Participants received a single dose of GSK2838232 200 mg (as 4 x 50 mg) capsule formulation along with ritonavir 100 mg tablet administered under fed conditions in treatment periods 1 and 2. | | OG001 | Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Participants received a single dose of GSK2838232 200 mg (as 2 x 10 mg) tablet formulation along with ritonavir 100 mg tablet administered under fed conditions in treatment periods 1 and 2. | | OG002 | Part 1: GSK 200 mg/Ritonavir Tablet Fasted |
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| 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. | Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). | Posted | | Mean | Standard Deviation | Milliseconds | | Baseline (Day -1) and 1, 2, 4, 6, 8, 12, 24, 48, 72 hours on Day 1 | | | | ID | Title | Description |
|---|
| OG000 | Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Participants received a single dose of GSK2838232 200 mg (as 4 x 50 mg) capsule formulation along with ritonavir 100 mg tablet administered under fed conditions in treatment periods 1 and 2. | | OG001 | Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Participants received a single dose of GSK2838232 200 mg (as 2 x 10 mg) tablet formulation along with ritonavir 100 mg tablet administered under fed conditions in treatment periods 1 and 2. | | OG002 | Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted |
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| 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. | Pharmacokinetic Population | Posted | | Median | Full Range | Hours | | 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 | | | | ID | Title | Description |
|---|
| OG000 | Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Participants received a single dose of GSK2838232 200 mg (as 4 x 50 mg) capsule formulation along with ritonavir 100 mg tablet administered under fed conditions in treatment periods 1 and 2. | | OG001 | Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Participants received a single dose of GSK2838232 200 mg (as 2 x 10 mg) tablet formulation along with ritonavir 100 mg tablet administered under fed conditions in treatment periods 1 and 2. | | OG002 | Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted |
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| 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. | Pharmacokinetic Population | Posted | | Median | Full Range | Hours | | 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 | | | | ID | Title | Description |
|---|
| OG000 | Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Participants received a single dose of GSK2838232 200 mg (as 4 x 50 mg) capsule formulation along with ritonavir 100 mg tablet administered under fed conditions in treatment periods 1 and 2. | | OG001 | Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Participants received a single dose of GSK2838232 200 mg (as 2 x 10 mg) tablet formulation along with ritonavir 100 mg tablet administered under fed conditions in treatment periods 1 and 2. | | OG002 | Part 1: GSK 200 mg/Ritonavir Tablet Fasted | Participants received a single dose of GSK2838232 200 mg (as 2 x 100 mg) tablet formulation under fasted conditions in treatment period 3 along with ritonavir 100 mg tablet to be taken with water in fasted condition. |
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| 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. | Pharmacokinetic Population | Posted | | Geometric Mean | Geometric Coefficient of Variation | Hours | | 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 | | | | ID | Title | Description |
|---|
| OG000 | Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Participants received a single dose of GSK2838232 200 mg (as 4 x 50 mg) capsule formulation along with ritonavir 100 mg tablet administered under fed conditions in treatment periods 1 and 2. | | OG001 | Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Participants received a single dose of GSK2838232 200 mg (as 2 x 10 mg) tablet formulation along with ritonavir 100 mg tablet administered under fed conditions in treatment periods 1 and 2. | | OG002 | Part 1: GSK 200 mg/Ritonavir Tablet Fasted | |
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| 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. | Pharmacokinetic Population | Posted | | Median | Full Range | Hours | | 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 | | | | ID | Title | Description |
|---|
| OG000 | Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Participants received a single dose of GSK2838232 200 mg (as 4 x 50 mg) capsule formulation along with ritonavir 100 mg tablet administered under fed conditions in treatment periods 1 and 2. | | OG001 | Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Participants received a single dose of GSK2838232 200 mg (as 2 x 10 mg) tablet formulation along with ritonavir 100 mg tablet administered under fed conditions in treatment periods 1 and 2. | | OG002 | Part 1: GSK 200 mg/Ritonavir Tablet Fasted | Participants received a single dose of GSK2838232 200 mg (as 2 x 100 mg) tablet formulation under fasted conditions in treatment period 3 along with ritonavir 100 mg tablet to be taken with water in fasted condition. |
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| 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. | Pharmacokinetic Population | Posted | | Geometric Mean | Geometric Coefficient of Variation | Nanograms per milliliter | | 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 | | | | ID | Title | Description |
|---|
| OG000 | Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Participants received a single dose of GSK2838232 200 mg (as 4 x 50 mg) capsule formulation along with ritonavir 100 mg tablet administered under fed conditions in treatment periods 1 and 2. | | OG001 | Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Participants received a single dose of GSK2838232 200 mg (as 2 x 10 mg) tablet formulation along with ritonavir 100 mg tablet administered under fed conditions in treatment periods 1 and 2. | | OG002 | Part 1: GSK 200 mg/Ritonavir Tablet Fasted |
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| 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. | Pharmacokinetic Population | Posted | | Geometric Mean | Geometric Coefficient of Variation | Hours* nanograms per milliliter | | 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 | | | | ID | Title | Description |
|---|
| OG000 | Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed | Participants received a single dose of GSK2838232 200 mg (as 4 x 50 mg) capsule formulation along with ritonavir 100 mg tablet administered under fed conditions in treatment periods 1 and 2. | | OG001 | Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed | Participants received a single dose of GSK2838232 200 mg (as 2 x 10 mg) tablet formulation along with ritonavir 100 mg tablet administered under fed conditions in treatment periods 1 and 2. | | OG002 | Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted | |
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| 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. | Pharmacokinetic Population | Posted | | Number | 90% Confidence Interval | Nanograms per milliliter per study day | | 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 | | | | ID | Title | Description |
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| OG000 | 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. |
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| 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). | Pharmacokinetic Population | Posted | | Mean | Standard Deviation | Ratio of AUC | | 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 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
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| 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. | Pharmacokinetic Population | Posted | | Mean | Standard Deviation | Ratio of Cmax | | 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 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
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| 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. | Pharmacokinetic Population | Posted | | Mean | Standard Deviation | Ratio of Ctau | | 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 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
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