Please select the outcome measures that correspond to the clinical trial below.
Title: Double-Blind, Randomized, Placebo-Controlled Study to Assess Safety, Efficacy, and Pharmacokinetics (PK) of GSK2336805 in Combination With Peginterferon and Ribavirin in Treatment-naive Chronic Hepatitis C Subjects With Hepatitis C Virus Genotypes 1 or 4
Brief Summary: GSK2336805 is a hepatitis C virus (HCV) NS5A inhibitor being developed for the treatment of chronic hepatitis C (CHC). This study will assess the safety, antiviral activity, and pharmacokinetics of GSK2336805 alone and in combination with peginterferon alfa 2a and ribavirin in subjects with chronic hepatitis C (CHC).


Options:
A: Number of Participant Achieving Rapid Virological Response (RVR) at Day 28, Nominal Analysis (Day 28); Number of Participant Achieving RVR at Day 28, (Primary and Supportive Analyses) (Day 28); Probability of Participants With HCV Genotype 1 Achieving RVR At Day 28, Nominal Analysis (Day 28); Probability of Participants With HCV Genotype 1 Achieving RVR at Day 28, Primary and Supportive Analyses (Day 28); Number of Participants With HCV Genotype 1 With Virologic Response (Day 7, 14 and 21); Change From Baseline in HCV Viral Load During 24 Hour (h) Following a Single Dose of GSK2336805 on the Log 10 Scale (Day 1 (Baseline [Pre-dose], 1, 2, 4, 6, and 8 and 24 h)); Number of Participants With Any Adverse Events (AEs) and Any Serious Adverse Event (SAE) During Treatment Period (Up to Day 28); Change From Baseline in QTcF Interval at Day 2 and 28 (Baseline (Day 1, Pre-dose ), Day 2 and Day 28)
B: GSK2336805 safety parameters : adverse events (Part 1 change from baseline for 14 days; Part 2 change from baseline for 24 days; Part 3 change from baseline for 16 days); GSK2336805 safety parameters: telemetry (Part 1 change from baseline for 14 days; Part 2 change from baseline for 24 days; Part 3 change from baseline for 16 days); GSK2336805 safety parameters: absolute values and changes over time of hematology, clinical chemistry, urinalysis (Part 1 change from baseline for 14 days; Part 2 change from baseline for 24 days; Part 3 change from baseline for 16 days); GSK2336805 safety parameters: vital signs (blood pressure, heart rate) (Part 1 change from baseline for 14 days; Part 2 change from baseline for 24 days; Part 3 change from baseline for 16 days); GSK2336805 safety parameters: electrocardiogram (ECG) parameters (Part 1 change from baseline for 14 days; Part 2 change from baseline for 24 days; Part 3 change from baseline for 16 days); GSK2336805 PK parameters following single dose administration: area under the plasma concentration curve from time zero (pre-dose) extrapolated to infinite time (AUC(0-infinity) (Part 1 up to 48 hours; Part 2 for 7 and 14 days; Part 3 for 48 hours); GSK2336805 PK parameters following single dose administration: area under the plasma concentration curve over the dosing interval AUC(0-tau)) (Part 1 up to 48 hours; Part 2 for 7 and 14 days; Part 3 for 48 hours); GSK2336805 PK parameters following single dose administration: maximum observed concentration (Cmax) (Part 1 up to 48 hours; Part 2 for 7 and 14 days; Part 3 for 48 hours); GSK2336805 PK parameters following single dose administration: time to maximum observed concentration (tmax) (Part 1 up to 48 hours; Part 2 for 7 and 14 days; Part 3 for 48 hours); GSK2336805 PK parameters following single dose administration: observed concentration at 24h post-dose (C24) (Part 1 up to 48 hours; Part 2 for 7 and 14 days; Part 3 for 48 hours); GSK2336805 PK parameters following single dose administration: terminal half-life (t1/2) (Part 1 up to 48 hours; Part 2 for 7 and 14 days; Part 3 for 48 hours); GSK2336805 PK parameters following single dose administration: lag time (tlag) (Part 1 up to 48 hours; Part 2 for 7 and 14 days; Part 3 for 48 hours); GSK2336805 PK parameters following single dose administration: apparent clearance (CL/F) (Part 1 up to 48 hours; Part 2 for 7 and 14 days; Part 3 for 48 hours); GSK2336805 PK parameters following repeat dose administration:AUC(0-tau) (Day 7 and Day 14); GSK2336805 PK parameters following repeat dose administration: Pre-dose (trough) concentration at the end of the dosing interval Ctau (Day 7 and Day 14); GSK2336805 PK parameters following repeat dose administration: Cmax (Day 7 and Day 14); GSK2336805 PK parameters following repeat dose administration: tmax (Day 7 and Day 14); GSK2336805 PK parameters following repeat dose administration: t1/2, (Day 7 and day 14); GSK2336805 PK parameters following repeat dose administration: CL/F (Day 7 and Day 14); GSK2336805 PK parameters following single dose in HCV infected subjects: AUC(0-infinity) or AUC(0 - tau) (for 48 hours); GSK2336805 PK parameters following single dose in HCV infected subjects: Cmax (for 48 hours); GSK2336805 PK parameters following single dose in HCV infected subjects: C24 (for 48 hours); GSK2336805 PK parameters following single dose in HCV infected subjects: tmax (for 48 hours); GSK2336805 PK parameters following single dose in HCV infected subjects: tlag (for 48 hours); GSK2336805 PK parameters following single dose in HCV infected subjects: CL/F (for 48 hours); HCV Ribonucleic acid (RNA) viral load reduction from baseline during the 24hr and post-dosing following a single dose of GSK2336805 in HCV subjects (at baseline, 24 hours, and for 16 days); HCV RNA change from baseline to nadir (maximum change) in HCV subjects (baseline, and for 16 days); Time course of HCV viral load at baseline, after dosing with GSK2336805, and for greater than or equal to 2 weeks after GSK2336805 dosing (Part 3) (baseline and up to 16 days)
C: Safety Outcome Measures (Safety and tolerability assessments will be performed for a period of 7 days after administration of a single dose)
D: Percentage of Participants With Sustained Virologic Response 12 Weeks After the Planned End of Treatment (SVR12) (12 Weeks After the Planned End of Treatment (EOT: Week 48))

Answer: A