| Primary | Number of Participant Achieving Rapid Virological Response (RVR) at Day 28, Nominal Analysis | RVR was defined as the proportion of participants below the assay lower limit of detection (LOD) <18 International units per milliliter (IU/mL) for Hepatitis C virus (HCV) ribonucleic acid (RNA) after 4 weeks of treatment (Day 28). Participants achieving RVR at Day 28 were considered treatment responders. Participants with missing HCV RNA values at Day 28 or discontinued before Day 28 were considered as treatment failure . Proportion of participants with HCV genotype 1 achieving RVR was the primary comparison of interest to show superiority of GSK2336805 over placebo in genotype 1 participants. | Intent-to-Treat Exposed population comprised of all participants who meet study criteria and were randomly assigned to treatment in the study with documented evidence of had received at least 1 dose of randomized treatment and at least 1 post-baseline HCV RNA measurement. | Posted | | Count of Participants | | Participants | | Day 28 | | | | ID | Title | Description |
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| OG000 | GSK2336805 60 mg + PEG + RIBA | Eligible participants received GSK2336805 60 mg orally once daily on Day 1 (Part A) of the study. Part 2 of the study then proceeded without interruption with the co-administration of GSK2336805 60 mg once daily with PEG 180 mcg per week as SC and RIBA 1000 mg (if <75 kg) or 1200 mg (if <75 kg) orally in 2 divided doses with food (morning and evening) (2 or three 200 mg tablets in the morning and three 200 mg tablets in the evening) through 4 weeks of treatment from Day 2 through Day 28 of the study. | | OG001 | Placebo + PEG + RIBA | Eligible participants received matching placebo orally once daily on Day 1 (Part A) of the study. Part 2 of the study then proceeded without interruption with the co-administration of matching placebo once daily with PEG 180 mcg per week as SC and RIBA 1000 mg (if <75 kg) or 1200 mg (if <75 kg) orally in 2 divided doses with food (morning and evening) (2 or three 200 mg tablets in the morning and three 200 mg tablets in the evening) through 4 weeks of treatment from Day 2 through Day 28 of the study. |
| | | Title | Denominators | Categories |
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| HCV RNA >= Low Limit of Quantification (LLOQ) | | | | Undetectable HCV RNA | | |
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| Primary | Number of Participant Achieving RVR at Day 28, (Primary and Supportive Analyses) | RVR was defined as the proportion of participants LOD <18 IU/mL for HCV RNA after 4 weeks of treatment (Day 28). Participants achieving RVR at Day 28 were considered treatment responders. Participants with missing HCV RNA values at Day 28 or discontinued before Day 28 were considered as treatment failure. Proportion of participants with HCV genotype 1 achieving RVR was the primary comparison of interest to show superiority of GSK2336805 over placebo in genotype 1 participants. The primary and supportive analysis differs from the nominal analysis as supportive analysis is assessed at Day 28 ± 2 (2 days visit window) whereas, the nominal analysis was assessed at Day 28. | Intent-to-Treat Exposed population. | Posted | | Count of Participants | | Participants | | Day 28 | | | | ID | Title | Description |
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| OG000 | GSK2336805 60 mg + PEG + RIBA | Eligible participants received GSK2336805 60 mg orally once daily on Day 1 (Part A) of the study. Part 2 of the study then proceeded without interruption with the co-administration of GSK2336805 60 mg once daily with PEG 180 mcg per week as SC and RIBA 1000 mg (if <75 kg) or 1200 mg (if <75 kg) orally in 2 divided doses with food (morning and evening) (2 or three 200 mg tablets in the morning and three 200 mg tablets in the evening) through 4 weeks of treatment from Day 2 through Day 28 of the study. | | OG001 | Placebo + PEG + RIBA | Eligible participants received matching placebo orally once daily on Day 1 (Part A) of the study. Part 2 of the study then proceeded without interruption with the co-administration of matching placebo once daily with PEG 180 mcg per week as SC and RIBA 1000 mg (if <75 kg) or 1200 mg (if <75 kg) orally in 2 divided doses with food (morning and evening) (2 or three 200 mg tablets in the morning and three 200 mg tablets in the evening) through 4 weeks of treatment from Day 2 through Day 28 of the study. |
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| Primary | Probability of Participants With HCV Genotype 1 Achieving RVR At Day 28, Nominal Analysis | The primary comparison of interest was performed using a Bayesian probability model. Probability of achieving undetectable HCV RNA distribution analyzed by nominal analysis was reported. | Intent-to-Treat Exposed population. | Posted | | Mean | Standard Deviation | Posterior probability | | Day 28 | | | | ID | Title | Description |
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| OG000 | GSK2336805 60 mg + PEG + RIBA | Eligible participants received GSK2336805 60 mg orally once daily on Day 1 (Part A) of the study. Part 2 of the study then proceeded without interruption with the co-administration of GSK2336805 60 mg once daily with PEG 180 mcg per week as SC and RIBA 1000 mg (if <75 kg) or 1200 mg (if <75 kg) orally in 2 divided doses with food (morning and evening) (2 or three 200 mg tablets in the morning and three 200 mg tablets in the evening) through 4 weeks of treatment from Day 2 through Day 28 of the study. | | OG001 | Placebo + PEG + RIBA | Eligible participants received matching placebo orally once daily on Day 1 (Part A) of the study. Part 2 of the study then proceeded without interruption with the co-administration of matching placebo once daily with PEG 180 mcg per week as SC and RIBA 1000 mg (if <75 kg) or 1200 mg (if <75 kg) orally in 2 divided doses with food (morning and evening) (2 or three 200 mg tablets in the morning and three 200 mg tablets in the evening) through 4 weeks of treatment from Day 2 through Day 28 of the study. |
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| Primary | Probability of Participants With HCV Genotype 1 Achieving RVR at Day 28, Primary and Supportive Analyses | The primary comparison of interest was performed using a Bayesian probability model. Probability of achieving undetectable HCV RNA distribution analyzed was reported. | Intent-to-Treat Exposed population. | Posted | | Mean | Standard Deviation | Posterior probability | | Day 28 | | | | ID | Title | Description |
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| OG000 | GSK2336805 60 mg + PEG + RIBA | Eligible participants received GSK2336805 60 mg orally once daily on Day 1 (Part A) of the study. Part 2 of the study then proceeded without interruption with the co-administration of GSK2336805 60 mg once daily with PEG 180 mcg per week as SC and RIBA 1000 mg (if <75 kg) or 1200 mg (if <75 kg) orally in 2 divided doses with food (morning and evening) (2 or three 200 mg tablets in the morning and three 200 mg tablets in the evening) through 4 weeks of treatment from Day 2 through Day 28 of the study. | | OG001 | Placebo + PEG + RIBA | Eligible participants received matching placebo orally once daily on Day 1 (Part A) of the study. Part 2 of the study then proceeded without interruption with the co-administration of matching placebo once daily with PEG 180 mcg per week as SC and RIBA 1000 mg (if <75 kg) or 1200 mg (if <75 kg) orally in 2 divided doses with food (morning and evening) (2 or three 200 mg tablets in the morning and three 200 mg tablets in the evening) through 4 weeks of treatment from Day 2 through Day 28 of the study. |
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| Primary | Number of Participants With HCV Genotype 1 With Virologic Response | Serum for determination of HCV genotype was collected at the screening visit. Genotype was determined by the VERSANT HCV genotype 2.0 Assay (LiPA). Number of participants with HCV genotype 1 were reported. | Intent-to-Treat Exposed population. | Posted | | Count of Participants | | Participants | | Day 7, 14 and 21 | | | | ID | Title | Description |
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| OG000 | GSK2336805 60 mg + PEG + RIBA | Eligible participants received GSK2336805 60 mg orally once daily on Day 1 (Part A) of the study. Part 2 of the study then proceeded without interruption with the co-administration of GSK2336805 60 mg once daily with PEG 180 mcg per week as SC and RIBA 1000 mg (if <75 kg) or 1200 mg (if <75 kg) orally in 2 divided doses with food (morning and evening) (2 or three 200 mg tablets in the morning and three 200 mg tablets in the evening) through 4 weeks of treatment from Day 2 through Day 28 of the study. | | OG001 | Placebo + PEG + RIBA | Eligible participants received matching placebo orally once daily on Day 1 (Part A) of the study. Part 2 of the study then proceeded without interruption with the co-administration of matching placebo once daily with PEG 180 mcg per week as SC and RIBA 1000 mg (if <75 kg) or 1200 mg (if <75 kg) orally in 2 divided doses with food (morning and evening) (2 or three 200 mg tablets in the morning and three 200 mg tablets in the evening) through 4 weeks of treatment from Day 2 through Day 28 of the study. |
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| Primary | Change From Baseline in HCV Viral Load During 24 Hour (h) Following a Single Dose of GSK2336805 on the Log 10 Scale | Blood samples for determination of HCV RNA levels were collected at immediately prior to and 1, 2, 4, 6, and 8 and 24 h after the first dose in Part 1 (Day 1). Measurement of HCV viral load was analyzed by the central laboratory using the COBAS AmpliPrep/COBAS TaqMan HCV test. Baseline was defined as the last non-missing assessment on or before the first dose of study drug. Change from Baseline was computed as value at post Baseline specified time point minus Baseline value. Virus RNA levels reported as <43 are undetectable levels. If the result for HCV RNA (IU/ML) was <43, then change from Baseline was calculated using 42, and the change from Baseline on the log scale was calculated using log (42). | Intent-to-Treat Exposed population. | Posted | | Mean | Standard Deviation | Log IU/mL | | Day 1 (Baseline [Pre-dose], 1, 2, 4, 6, and 8 and 24 h) | | | | ID | Title | Description |
|---|
| OG000 | GSK2336805 60 mg (Part A) | Eligible participants received GSK2336805 60 mg once daily on Day 1 (Part A) of the study. | | OG001 | Placebo (Part A) | Eligible participants received matching placebo once daily on Day 1 (Part A) of the study |
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| Primary | Number of Participants With Any Adverse Events (AEs) and Any Serious Adverse Event (SAE) During Treatment Period | AE was defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE include AEs those result in death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal functions, or a congenital anomaly/birth defect. Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered serious when, based upon appropriate medical judgment, they may jeopardize the participant and may require medical or surgical intervention to prevent one of the outcomes listed in this definition. | Safety population was consisted of all participants who received at least 1 dose of study medication (GSK2336805 or matching placebo). | Posted | | Count of Participants | | Participants | | Up to Day 28 | | | | ID | Title | Description |
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| OG000 | GSK2336805 60 mg + PEG + RIBA | Eligible participants received GSK2336805 60 mg orally once daily on Day 1 (Part A) of the study. Part 2 of the study then proceeded without interruption with the co-administration of GSK2336805 60 mg once daily with PEG 180 mcg per week as SC and RIBA 1000 mg (if <75 kg) or 1200 mg (if <75 kg) orally in 2 divided doses with food (morning and evening) (2 or three 200 mg tablets in the morning and three 200 mg tablets in the evening) through 4 weeks of treatment from Day 2 through Day 28 of the study. |
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| Primary | Change From Baseline in QTcF Interval at Day 2 and 28 | Single 12-lead electrocardiogram (ECG) was obtained. The standard ECG criteria of potential clinical importance were 1) absolute QTc Interval, > 450 milliseconds (msec), 2) absolute PR Interval, <110 msec, 3) absolute QRS Interval, < 75 msec and 4) increase from baseline in QTc > 60 msec. QTc Interval was calculated using Frederica correction formula: QTcF = QT / (RR)^1/3. Change from Baseline was calculated by subtracting the Baseline assessment value from post Baseline visit value. Baseline was defined as the last non-missing assessment on or before the first dose of study drug. The change from Baseline in QTc Interval at Day 2 and 28 were reported. | | Posted | | Mean | Standard Deviation | msec | | Baseline (Day 1, Pre-dose ), Day 2 and Day 28 | | | | ID | Title | Description |
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| OG000 | GSK2336805 60 mg + PEG + RIBA | Eligible participants received GSK2336805 60 mg orally once daily on Day 1 (Part A) of the study. Part 2 of the study then proceeded without interruption with the co-administration of GSK2336805 60 mg once daily with PEG 180 mcg per week as SC and RIBA 1000 mg (if <75 kg) or 1200 mg (if <75 kg) orally in 2 divided doses with food (morning and evening) (2 or three 200 mg tablets in the morning and three 200 mg tablets in the evening) through 4 weeks of treatment from Day 2 through Day 28 of the study. | | OG001 | Placebo + PEG + RIBA | Eligible participants received matching placebo orally once daily on Day 1 (Part A) of the study. Part 2 of the study then proceeded without interruption with the co-administration of matching placebo once daily with PEG 180 mcg per week as SC and RIBA 1000 mg (if <75 kg) or 1200 mg (if <75 kg) orally in 2 divided doses with food (morning and evening) (2 or three 200 mg tablets in the morning and three 200 mg tablets in the evening) through 4 weeks of treatment from Day 2 through Day 28 of the study. |
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| Secondary | Number of Participants With Shift From Baseline to Worst Post Baseline Toxicity Grade Hematology Parameters for Day 1 to Day 28 | Laboratory abnormalities were graded according to the modified division of AIDS ( DAIDS）version 1.0. Shift from Baseline to worst post baseline toxicity grade (where applicable) were presented for Day 1 to Day 28. The toxicity Grades were, Grade 1: mild (no or minimal interference with usual social & functional activities); Grade 2: moderate (greater than minimal interference with usual social and functional activities); Grade 3: severe (inability to perform usual social and functional activities); Grade 4: potentially life threatening (inability to perform basic self-care functions or Medical or operative intervention indicated to prevent permanent impairment, persistent disability, or death). Hematology parameters were red blood cell, hemoglobin, hematocrit, platelet white blood cell count with differential leukocyte count, mean corpuscular volume, prothrombin time and international normalized ratio. | | Posted | | Count of Participants | | Participants | | Baseline (Day 1) to Day 28 | | | | ID | Title | Description |
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| OG000 | GSK2336805 60 mg + PEG + RIBA | Eligible participants received GSK2336805 60 mg orally once daily on Day 1 (Part A) of the study. Part 2 of the study then proceeded without interruption with the co-administration of GSK2336805 60 mg once daily with PEG 180 mcg per week as SC and RIBA 1000 mg (if <75 kg) or 1200 mg (if <75 kg) orally in 2 divided doses with food (morning and evening) (2 or three 200 mg tablets in the morning and three 200 mg tablets in the evening) through 4 weeks of treatment from Day 2 through Day 28 of the study. |
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| Secondary | Number of Participants With Shift From Baseline to Worst Post Baseline Toxicity Grade for Serum Chemistry Parameters for Day 1 to Day 28 | Abnormalities were graded according to the modified DAIDS version 1.0. Shift from Baseline to worst post Baseline toxicity grade were presented for Day 1 to Day 28. The toxicity Grades were, Grade 1: mild (no or minimal interference with usual social & functional activities); Grade 2: moderate (greater than minimal interference with usual social and functional activities); Grade 3: severe (inability to perform usual social and functional activities); Grade 4: potentially life threatening (inability to perform basic self-care functions or Medical or operative intervention indicated to prevent permanent impairment, persistent disability, or death). Clinical chemistry parameters were alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, blood urea nitrogen, creatine phosphokinase, total CO2, chloride, creatinine, glucose, sodium, phosphate, potassium, total albumin, total bilirubin, and direct bilirubin. Only participants with change in toxicity grades are reported. | | Posted | | Count of Participants | | Participants | | Baseline (Day 1) and 28 | | | | ID | Title | Description |
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| OG000 | GSK2336805 60 mg + PEG + RIBA | Eligible participants received GSK2336805 60 mg orally once daily on Day 1 (Part A) of the study. Part 2 of the study then proceeded without interruption with the co-administration of GSK2336805 60 mg once daily with PEG 180 mcg per week as SC and RIBA 1000 mg (if <75 kg) or 1200 mg (if <75 kg) orally in 2 divided doses with food (morning and evening) (2 or three 200 mg tablets in the morning and three 200 mg tablets in the evening) through 4 weeks of treatment from Day 2 through Day 28 of the study. |
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| Secondary | Number of Participants With Shifts in Urinalysis Parameters From Normal at Baseline to Abnormal | The urinalysis parameters analyzed were Leukocyte esterase, bilirubin, occult blood, glucose, ketones, nitrite, pH, specific gravity and dipstick assessments. Only those parameters for which at least one value of potential clinical importance was reported are summarized. The number of participants with potential clinical important urinalysis findings at specified visit were reported. Visits where no abnormal values were observed not reported. | Safety population. Only those participants available at the specified time points were analyzed. | Posted | | Count of Participants | | Participants | | Day 14, 28, Follow-up (Day 42) | | | | ID | Title | Description |
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| OG000 | GSK2336805 60 mg + PEG + RIBA | Eligible participants received GSK2336805 60 mg orally once daily on Day 1 (Part A) of the study. Part 2 of the study then proceeded without interruption with the co-administration of GSK2336805 60 mg once daily with PEG 180 mcg per week as SC and RIBA 1000 mg (if <75 kg) or 1200 mg (if <75 kg) orally in 2 divided doses with food (morning and evening) (2 or three 200 mg tablets in the morning and three 200 mg tablets in the evening) through 4 weeks of treatment from Day 2 through Day 28 of the study. | | OG001 | Placebo + PEG + RIBA | Eligible participants received matching placebo orally once daily on Day 1 (Part A) of the study. Part 2 of the study then proceeded without interruption with the co-administration of matching placebo once daily with PEG 180 mcg per week as SC and RIBA 1000 mg (if <75 kg) or 1200 mg (if <75 kg) orally in 2 divided doses with food (morning and evening) (2 or three 200 mg tablets in the morning and three 200 mg tablets in the evening) through 4 weeks of treatment from Day 2 through Day 28 of the study. |
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| Secondary | Number of Participants With Vital Signs of Potential Clinical Concern | The potential clinical importance ranges (low and high) of the vital sign parameters were for systolic blood pressure (<85 and >160 millimeter of mercury [mmHg]), diastolic blood pressure (<45 and >100 mmHg) and heart rate (<40 and >110 beats per minute). Only those parameters for which at least one value of potential clinical importance was reported are summarized. The number of participants with potential clinical important vital parameter findings at any visit were reported. | | Posted | | Count of Participants | | Participants | | Up to 42 days | | | | ID | Title | Description |
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| OG000 | GSK2336805 60 mg + PEG + RIBA | Eligible participants received GSK2336805 60 mg orally once daily on Day 1 (Part A) of the study. Part 2 of the study then proceeded without interruption with the co-administration of GSK2336805 60 mg once daily with PEG 180 mcg per week as SC and RIBA 1000 mg (if <75 kg) or 1200 mg (if <75 kg) orally in 2 divided doses with food (morning and evening) (2 or three 200 mg tablets in the morning and three 200 mg tablets in the evening) through 4 weeks of treatment from Day 2 through Day 28 of the study. | | OG001 | Placebo + PEG + RIBA | Eligible participants received matching placebo orally once daily on Day 1 (Part A) of the study. Part 2 of the study then proceeded without interruption with the co-administration of matching placebo once daily with PEG 180 mcg per week as SC and RIBA 1000 mg (if <75 kg) or 1200 mg (if <75 kg) orally in 2 divided doses with food (morning and evening) (2 or three 200 mg tablets in the morning and three 200 mg tablets in the evening) through 4 weeks of treatment from Day 2 through Day 28 of the study. |
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| Secondary | Mean Serum HCV RNA Levels at Baseline (Day 1), Day 2 and Day 28 | Blood samples for determination of HCV RNA levels were collected from screening, immediately prior to and 1, 2, 4, 6, and 8 h after the first dose in Part 1 (Day 1), during Part 2 on Days 2 (24 h after the Day 1 dose), 7, 14, 21, and 28, and at the post-treatment follow-up visit on Day 42. All viral load samples, with the exception of the one taken during the screening visit, were taken in duplicate. The actual time and date of each sample collection will be recorded. Measurement of HCV viral load was analyzed by the central laboratory using the COBAS AmpliPrep/COBAS TaqMan HCV test. | Intent-to-Treat Exposed population. Only those participants available at the specified time points were analyzed. | Posted | | Mean | Standard Deviation | Log IU/mL | | Baseline (Day 1, pre-dose), Day 2 (24 h, Post-dose) and Day 28 | | | | ID | Title | Description |
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| OG000 | GSK2336805 60 mg + PEG + RIBA | Eligible participants received GSK2336805 60 mg orally once daily on Day 1 (Part A) of the study. Part 2 of the study then proceeded without interruption with the co-administration of GSK2336805 60 mg once daily with PEG 180 mcg per week as SC and RIBA 1000 mg (if <75 kg) or 1200 mg (if <75 kg) orally in 2 divided doses with food (morning and evening) (2 or three 200 mg tablets in the morning and three 200 mg tablets in the evening) through 4 weeks of treatment from Day 2 through Day 28 of the study. | | OG001 | Placebo + PEG + RIBA | |
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| Secondary | Mean Change From Baseline in Serum HCV RNA Levels at Day 2 and Day 28 | Blood samples for determination of HCV RNA levels were collected from screening, immediately prior to and 1, 2, 4, 6, and 8 h after the first dose in Part 1 (Day 1), during Part 2 on Days 2 (24 h after the Day 1 dose), 7, 14, 21, and 28, and at the post-treatment follow-up visit on Day 42. All viral load samples, with the exception of the one taken during the screening visit, were taken in duplicate. The actual time and date of each sample collection will be recorded. Measurement of HCV viral load was analyzed by the central laboratory using the COBAS AmpliPrep/COBAS TaqMan HCV test. | Intent-to-Treat Exposed population. Only those participants available at the specified time points were analyzed. | Posted | | Mean | Standard Deviation | Log IU/mL | | Baseline (Day 1, Pre -dose ) and Day 2 (24 h, post-dose), Day 28 | | | | ID | Title | Description |
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| OG000 | GSK2336805 60 mg + PEG + RIBA | Eligible participants received GSK2336805 60 mg orally once daily on Day 1 (Part A) of the study. Part 2 of the study then proceeded without interruption with the co-administration of GSK2336805 60 mg once daily with PEG 180 mcg per week as SC and RIBA 1000 mg (if <75 kg) or 1200 mg (if <75 kg) orally in 2 divided doses with food (morning and evening) (2 or three 200 mg tablets in the morning and three 200 mg tablets in the evening) through 4 weeks of treatment from Day 2 through Day 28 of the study. | | OG001 | Placebo + PEG + RIBA | |
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| Secondary | Change From Baseline in Serum Alanine Aminotransferase Levels | Blood samples were collected at Baseline (Day 1, Pre-dose), Day 7, 14, 21, 28 and 42 for determination of serum alanine aminotransferase levels. Baseline was defined as the last non-missing assessment on or before the first dose of study drug. Change from Baseline was computed as value at post Baseline specified time point minus Baseline value. | Safety population. Only those participants available at the specified time points were analyzed. | Posted | | Mean | Standard Deviation | Units per litre (U/L) | | Baseline (Day 1, Pre-dose), Day 7, 14, 21, 28 and 42 | | | | ID | Title | Description |
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| OG000 | GSK2336805 60 mg + PEG + RIBA | Eligible participants received GSK2336805 60 mg orally once daily on Day 1 (Part A) of the study. Part 2 of the study then proceeded without interruption with the co-administration of GSK2336805 60 mg once daily with PEG 180 mcg per week as SC and RIBA 1000 mg (if <75 kg) or 1200 mg (if <75 kg) orally in 2 divided doses with food (morning and evening) (2 or three 200 mg tablets in the morning and three 200 mg tablets in the evening) through 4 weeks of treatment from Day 2 through Day 28 of the study. | | OG001 | Placebo + PEG + RIBA | Eligible participants received matching placebo orally once daily on Day 1 (Part A) of the study. Part 2 of the study then proceeded without interruption with the co-administration of matching placebo once daily with PEG 180 mcg per week as SC and RIBA 1000 mg (if <75 kg) or 1200 mg (if <75 kg) orally in 2 divided doses with food (morning and evening) (2 or three 200 mg tablets in the morning and three 200 mg tablets in the evening) through 4 weeks of treatment from Day 2 through Day 28 of the study. |
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| Secondary | Median Serum Alanine Aminotransferase at Baseline, Day 7, 14, 21, 28 and 42 | Blood samples were collected at Baseline (Day 1, Pre-dose), Day 7, 14, 21, 28 and 42 for determination of serum alanine aminotransferase levels. | Safety Population. Only those participants available at the specified time points were analyzed. | Posted | | Median | Full Range | U/L | | Baseline (Day 1, Pre-dose), Day 7, 14, 21, 28 and 42 | | | | ID | Title | Description |
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| OG000 | GSK2336805 60 mg + PEG + RIBA | Eligible participants received GSK2336805 60 mg orally once daily on Day 1 (Part A) of the study. Part 2 of the study then proceeded without interruption with the co-administration of GSK2336805 60 mg once daily with PEG 180 mcg per week as SC and RIBA 1000 mg (if <75 kg) or 1200 mg (if <75 kg) orally in 2 divided doses with food (morning and evening) (2 or three 200 mg tablets in the morning and three 200 mg tablets in the evening) through 4 weeks of treatment from Day 2 through Day 28 of the study. | | OG001 | Placebo + PEG + RIBA | Eligible participants received matching placebo orally once daily on Day 1 (Part A) of the study. Part 2 of the study then proceeded without interruption with the co-administration of matching placebo once daily with PEG 180 mcg per week as SC and RIBA 1000 mg (if <75 kg) or 1200 mg (if <75 kg) orally in 2 divided doses with food (morning and evening) (2 or three 200 mg tablets in the morning and three 200 mg tablets in the evening) through 4 weeks of treatment from Day 2 through Day 28 of the study. |
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| Secondary | Mean Area Under the Concentration-time Curve (AUC[0-24]), AUC From Time 0 Extrapolated to Infinity (AUC[0-inf]) of GSK2336805, at Day 1 | AUC values were determined using the linear-up, log-down trapezoidal rule. The individual plasma concentration and actual time data was used to derive the PK parameters of GSK2336805 on Day 1 by noncompartmental PK analyses. For the calculation of PK parameters all plasma concentrations that were below quantification limit (BLQ) before the first measurable concentration were set to zero. The BLQ values that occur at the end of the profile after the last quantifiable concentration were set to missing. Actual sampling times, rather than scheduled sampling times, were used in all computations of PK parameters. | Intensive Pharmacokinetic (PK) Population comprised of all participants who received GSK2336805, undergo intensive PK sampling during part 1 (Day 1) of the study, and provide evaluable GSK2336805 PK parameters. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Nanogram (ng)*h/mL | | 0.0 (pre-dose) and 1, 2, 4, 6, 8, and 24 h post-dose (morning of Day 2) | | | | ID | Title | Description |
|---|
| OG000 | GSK2336805 60 mg (Part A) | Eligible participants received GSK2336805 60 mg once daily on Day 1 (Part A) of the study |
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| Secondary | Median Time of Maximal Plasma Concentration (Tmax) of GSK2336805 and Lag Time Before First Observation of Quantifiable Concentration (Tlag) at Day 1 | The individual plasma concentration and actual time data was used to derive the PK parameters of GSK2336805 on Day 1 by noncompartmental PK analyses. For the calculation of PK parameters all plasma concentrations that were BLQ before the first measurable concentration were set to zero. The BLQ values that occur at the end of the profile after the last quantifiable concentration were set to missing. Actual sampling times, rather than scheduled sampling times, were used in all computations of PK parameters | | Posted | | Median | Full Range | h | | 0.0 (pre-dose) and 1, 2, 4, 6, 8, and 24 h post-dose (morning of Day 2) | | | | ID | Title | Description |
|---|
| OG000 | GSK2336805 60 mg (Part A) | Eligible participants received GSK2336805 60 mg once daily on Day 1 (Part A) of the study |
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| Secondary | Mean Maximum Plasma Concentration of GSK2336805 (Cmax) and Concentration at 24 h (C24) at Day 1 | The individual plasma concentration and actual time data was used to derive the PK parameters of GSK2336805 on Day 1 by non-compartmental PK analyses. For the calculation of PK parameters all plasma concentrations that were BLQ before the first measurable concentration were set to zero. The BLQ values that occur at the end of the profile after the last quantifiable concentration were set to missing. Actual sampling times, rather than scheduled sampling times, were used in all computations of PK parameters. | | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng/mL | | 0.0 (pre-dose) and 1, 2, 4, 6, 8, and 24 h post-dose (morning of Day 1) | | | | ID | Title | Description |
|---|
| OG000 | GSK2336805 60 mg (Part A) | Eligible participants received GSK2336805 60 mg once daily on Day 1 (Part A) of the study |
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| Secondary | Mean Apparent Clearance (CL/F) of GSK2336805 | The individual plasma concentration and actual time data was used to derive the PK parameters of GSK2336805 on Day 1 by noncompartmental PK analyses. For the calculation of PK parameters all plasma concentrations that were BLQ before the first measurable concentration were set to zero. The BLQ values that occur at the end of the profile after the last quantifiable concentration were set to missing. Actual sampling times, rather than scheduled sampling times, were used in all computations of PK parameters | | Posted | | Geometric Mean | Geometric Coefficient of Variation | L/h | | 0.0 (pre-dose) and 1, 2, 4, 6, 8, and 24 h post-dose (morning of Day 1) | | | | ID | Title | Description |
|---|
| OG000 | GSK2336805 60 mg | Eligible participants received GSK2336805 60 mg once daily on Day 1 (Part A) of the study |
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| Secondary | Mean Pre-dose Concentration and Concentration at 2 to 4 h Post-dose of GSK2336805 at Days 7, 14, 21, and 28 | The individual plasma concentration and actual time data was used to derive the PK parameters of GSK2336805 on Day 1 by noncompartmental PK analyses. For the calculation of PK parameters all plasma concentrations that were BLQ before the first measurable concentration were set to zero. The BLQ values that occur at the end of the profile after the last quantifiable concentration were set to missing. Actual sampling times, rather than scheduled sampling times, were used in all computations of PK parameters. | Sparse PK population included all participant who received GSK2336805, underwent sparse PK sampling during part 2 of the study, and provide at least one evaluable GSK2336805 PK concentration. Only those participants available at the specified time points were analyzed. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng/ml | | 0 (pre-dose), 0 to 2 h, > 2 h up to 4 h, > 4 h up to 6 h, or > 6 h up to 10 h on Days 7, 14, 21 and 28 | | | | ID | Title | Description |
|---|
| OG000 | GSK2336805 60 mg (Part A) | Eligible participants received GSK2336805 60 mg once daily on Day 1 (Part A) of the study |
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