Please select the outcome measures that correspond to the clinical trial below.
Title: A Multiple Dose Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of MK-8742 in Hepatitis C Infected Males
Brief Summary: The purpose of this study is to assess the safety, pharmacokinetics (PK) and pharmacodynamics of elbasvir (MK-8742) in Hepatitis C Virus (HCV)-infected participants. There will be 3 parts to this study; Part I will enroll only genotype (GT) 1 HCV-infected participants, Part II will enroll GT3 HCV-infected participants, and Part III will enroll only GT1a HCV-infected participants. All parts may run concurrently, or Parts II and III may be staggered.

Hypothesis (Part I): At a once-daily dose that is sufficiently safe and well tolerated in HCV-infected participants, elbasvir administered for 5 consecutive days has superior antiviral activity in GT1 HCV-infected participants compared to placebo, as measured by change from baseline in plasma HCV ribonucleic acid (RNA; log 10 copies/mL) at Day 5, 24-hour postdose timepoint. (a true mean viral RNA reduction of at least 3 log10 is anticipated).

Hypothesis (Part II): At a dose that is sufficiently safe in GT3 HCV-infected participants, the mean maximum reduction in HCV viral load is greater following multiple dose oral administration of elbasvir as compared to placebo.

Hypothesis (Part III): At a once-daily dose that is sufficiently safe and well tolerated in HCV-infected participants, elbasvir administered for 5 consecutive days has superior antiviral activity in GT1a HCV-infected participants compared to placebo, as measured by change from baseline in plasma HCV RNA (log 10 copies/mL) at Day 5, 24-hour postdose timepoint. (a true mean viral RNA reduction of at least 3 log10 is anticipated).


Options:
A: Mean Reduction From Baseline in Log10 Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Day 5 - HCV GT1 (Baseline (Predose on Day 1) and 24-hour post-dose on Day 5); Mean Reduction From Baseline in Log10 Plasma HCV RNA at Day 5 - HCV GT3 (Baseline (Predose on Day 1) and 24-hour post-dose on Day 5); Mean Reduction From Baseline in Log10 Plasma HCV RNA at Day 5 - HCV GT1a (Baseline (Predose on Day 1) and 24-hour post-dose on Day 5); Mean Maximum Reduction in Log10 HCV Viral Load - HCV GT1 (Up to 5 days); Mean Maximum Reduction in Log10 HCV Viral Load - HCV GT3 (Up to 5 days); Mean Maximum Reduction in Log10 HCV Viral Load - HCV GT1a (Up to 5 days); Number of Participants Experiencing an Adverse Event (AE) - Day 1 to Day 5 (Up to 5 days); Number of Participants Who Had Study Drug Discontinued Due to an Adverse Event (Up to 5 days)
B: Percentage of Participants Who Experienced Adverse Events During the Sofosbuvir Treatment Period (Baseline to Week 12 plus 30 days)
C: Sustained virological response (SVR) (24 weeks post treatment end (ie weeks 48 or 72))
D: Percentage of Participants With Sustained Virologic Response 12 Weeks After Completing Study Therapy (SVR12) (Week 24 (Immediate Treatment + Intensive PK) or Week 40 (Deferred Treatment)); Number of Participants Experiencing an Adverse Event (AE) During the Initial Treatment and 14-day Follow-up Periods (Up to Week 14); Number of Participants Discontinuing Study Drug Due to AEs During the Initial Treatment Period (Up to Week 12)

Answer: A