Please select the arm or intervention descriptions that belong 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: Arm Label: GT1 HCV 10-mg Elbasvir (Panel A); Type: EXPERIMENTAL; Interventions: Drug: Elbasvir, Drug: Placebo | Arm Label: GTI HCV 50-g Elbasvir (Panel B); Type: EXPERIMENTAL; Interventions: Drug: Elbasvir, Drug: Placebo | Arm Label: GT1 HCV 5-mg Elbavir (Panel C); Type: EXPERIMENTAL; Interventions: Drug: Elbasvir, Drug: Placebo | Arm Label: GT1 HCV 200-mg Elbasvir (Panel D); Type: EXPERIMENTAL; Interventions: Drug: Elbasvir, Drug: Placebo | Arm Label: GT3 HCV 10-mg Elbasvir (Panel E); Type: EXPERIMENTAL; Interventions: Drug: Elbasvir, Drug: Placebo | Arm Label: GT3 HCV 50-mg Elbasvir (Panel F); Type: EXPERIMENTAL; Interventions: Drug: Elbasvir, Drug: Placebo | Arm Label: GT3 HCV 100-mg Elbasvir (Panel G); Type: EXPERIMENTAL; Interventions: Drug: Elbasvir, Drug: Placebo | Arm Label: GT3 HCV 200-mg Elbasvir (Panel H); Type: EXPERIMENTAL; Interventions: Drug: Elbasvir, Drug: Placebo | Arm Label: GT1a HCV 10-mg Elbasvir (Panel I); Type: EXPERIMENTAL; Interventions: Drug: Elbasvir, Drug: Placebo | Arm Label: GT1a HCV 50-mg Elbasvir (Panel J); Type: EXPERIMENTAL; Interventions: Drug: Elbasvir, Drug: Placebo | Intervention Type: DRUG; Name: Elbasvir; Assigned to Arm(s): GT1 HCV 10-mg Elbasvir (Panel A), GT1 HCV 200-mg Elbasvir (Panel D), GT1 HCV 5-mg Elbavir (Panel C), GT1a HCV 10-mg Elbasvir (Panel I), GT1a HCV 50-mg Elbasvir (Panel J), GT3 HCV 10-mg Elbasvir (Panel E), GT3 HCV 100-mg Elbasvir (Panel G), GT3 HCV 200-mg Elbasvir (Panel H), GT3 HCV 50-mg Elbasvir (Panel F), GTI HCV 50-g Elbasvir (Panel B) | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): GT1 HCV 10-mg Elbasvir (Panel A), GT1 HCV 200-mg Elbasvir (Panel D), GT1 HCV 5-mg Elbavir (Panel C), GT1a HCV 10-mg Elbasvir (Panel I), GT1a HCV 50-mg Elbasvir (Panel J), GT3 HCV 10-mg Elbasvir (Panel E), GT3 HCV 100-mg Elbasvir (Panel G), GT3 HCV 200-mg Elbasvir (Panel H), GT3 HCV 50-mg Elbasvir (Panel F), GTI HCV 50-g Elbasvir (Panel B)
B: Arm Label: Daclatasvir, plus Peginterferon alpha-2a, ribavirin (A); Type: EXPERIMENTAL; Interventions: Drug: Daclatasvir, Drug: Peginterferon alpha-2a, Drug: ribavirin | Arm Label: Daclatasvir, Peginterferon alpha-2a, ribavirin (B); Type: EXPERIMENTAL; Interventions: Drug: Daclatasvir, Drug: Peginterferon alpha-2a, Drug: ribavirin | Arm Label: Daclatasvir, Peginterferon alpha-2a, ribavirin (C); Type: EXPERIMENTAL; Interventions: Drug: Daclatasvir, Drug: Peginterferon alpha-2a, Drug: ribavirin | Arm Label: Placebo, Peginterferon alpha-2a, ribavirin (D); Type: ACTIVE_COMPARATOR; Interventions: Drug: Placebo, Drug: Peginterferon alpha-2a, Drug: ribavirin | Intervention Type: DRUG; Name: Daclatasvir; Assigned to Arm(s): Daclatasvir, plus Peginterferon alpha-2a, ribavirin (A) | Intervention Type: DRUG; Name: Daclatasvir; Assigned to Arm(s): Daclatasvir, Peginterferon alpha-2a, ribavirin (B) | Intervention Type: DRUG; Name: Daclatasvir; Assigned to Arm(s): Daclatasvir, Peginterferon alpha-2a, ribavirin (C) | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo, Peginterferon alpha-2a, ribavirin (D) | Intervention Type: DRUG; Name: Peginterferon alpha-2a; Assigned to Arm(s): Daclatasvir, Peginterferon alpha-2a, ribavirin (B), Daclatasvir, Peginterferon alpha-2a, ribavirin (C), Daclatasvir, plus Peginterferon alpha-2a, ribavirin (A), Placebo, Peginterferon alpha-2a, ribavirin (D) | Intervention Type: DRUG; Name: ribavirin; Assigned to Arm(s): Daclatasvir, Peginterferon alpha-2a, ribavirin (B), Daclatasvir, Peginterferon alpha-2a, ribavirin (C), Daclatasvir, plus Peginterferon alpha-2a, ribavirin (A), Placebo, Peginterferon alpha-2a, ribavirin (D)
C: Arm Label: Arm 1. PEG +RBV for 48 Wks (Part I); Type: ACTIVE_COMPARATOR; Interventions: Drug: peginterferon-alfa 2b (PegIntron), Drug: ribavirin | Arm Label: Arm 2. PEG + RBV + BOC for 28 Wks (Part I); Type: EXPERIMENTAL; Interventions: Drug: boceprevir (SCH 503034), Drug: peginterferon-alfa 2b (PegIntron), Drug: ribavirin | Arm Label: Arm 3. PEG + RBV + BOC (from Wk 4) for 24 Wks (Part I); Type: EXPERIMENTAL; Interventions: Drug: boceprevir (SCH 503034), Drug: peginterferon-alfa 2b (PegIntron), Drug: ribavirin | Arm Label: Arm 4. PEG +RBV + BOC for 48 Wks (Part I); Type: EXPERIMENTAL; Interventions: Drug: boceprevir (SCH 503034), Drug: peginterferon-alfa 2b (PegIntron), Drug: ribavirin | Arm Label: Arm 5. PEG + RBV + BOC (from Wk 4) for 44 Wks (Part I); Type: EXPERIMENTAL; Interventions: Drug: boceprevir (SCH 503034), Drug: peginterferon-alfa 2b (PegIntron), Drug: ribavirin | Arm Label: Arm 6. PEG + RBV + BOC for 48 Wks (Part II); Type: EXPERIMENTAL; Interventions: Drug: boceprevir (SCH 503034), Drug: peginterferon-alfa 2b (PegIntron), Drug: ribavirin | Arm Label: Arm 7. PEG +Low-dose RBV + BOC for 48 Wks (Part II); Type: EXPERIMENTAL; Interventions: Drug: boceprevir (SCH 503034), Drug: peginterferon-alfa 2b (PegIntron), Drug: ribavirin (low-dose) | Arm Label: Arm 8. PEG + RBV + BOC (from Wk 24) for 48 Wks (Part I); Type: EXPERIMENTAL; Interventions: Drug: boceprevir (SCH 503034), Drug: peginterferon-alfa 2b (PegIntron), Drug: ribavirin | Intervention Type: DRUG; Name: boceprevir (SCH 503034); Assigned to Arm(s): Arm 2. PEG + RBV + BOC for 28 Wks (Part I), Arm 3. PEG + RBV + BOC (from Wk 4) for 24 Wks (Part I), Arm 4. PEG +RBV + BOC for 48 Wks (Part I), Arm 5. PEG + RBV + BOC (from Wk 4) for 44 Wks (Part I), Arm 6. PEG + RBV + BOC for 48 Wks (Part II), Arm 7. PEG +Low-dose RBV + BOC for 48 Wks (Part II), Arm 8. PEG + RBV + BOC (from Wk 24) for 48 Wks (Part I) | Intervention Type: DRUG; Name: peginterferon-alfa 2b (PegIntron); Assigned to Arm(s): Arm 1. PEG +RBV for 48 Wks (Part I), Arm 2. PEG + RBV + BOC for 28 Wks (Part I), Arm 3. PEG + RBV + BOC (from Wk 4) for 24 Wks (Part I), Arm 4. PEG +RBV + BOC for 48 Wks (Part I), Arm 5. PEG + RBV + BOC (from Wk 4) for 44 Wks (Part I), Arm 6. PEG + RBV + BOC for 48 Wks (Part II), Arm 7. PEG +Low-dose RBV + BOC for 48 Wks (Part II), Arm 8. PEG + RBV + BOC (from Wk 24) for 48 Wks (Part I) | Intervention Type: DRUG; Name: ribavirin; Assigned to Arm(s): Arm 1. PEG +RBV for 48 Wks (Part I), Arm 2. PEG + RBV + BOC for 28 Wks (Part I), Arm 3. PEG + RBV + BOC (from Wk 4) for 24 Wks (Part I), Arm 4. PEG +RBV + BOC for 48 Wks (Part I), Arm 5. PEG + RBV + BOC (from Wk 4) for 44 Wks (Part I), Arm 6. PEG + RBV + BOC for 48 Wks (Part II), Arm 8. PEG + RBV + BOC (from Wk 24) for 48 Wks (Part I) | Intervention Type: DRUG; Name: ribavirin (low-dose); Assigned to Arm(s): Arm 7. PEG +Low-dose RBV + BOC for 48 Wks (Part II)
D: Arm Label: LDV/SOF (treatment naive); Type: EXPERIMENTAL; Interventions: Drug: LDV/SOF | Arm Label: LDV/SOF+RBV (treatment naive); Type: EXPERIMENTAL; Interventions: Drug: LDV/SOF, Drug: RBV | Arm Label: LDV/SOF (treatment experienced); Type: EXPERIMENTAL; Interventions: Drug: LDV/SOF | Arm Label: LDV/SOF+RBV (treatment experienced); Type: EXPERIMENTAL; Interventions: Drug: LDV/SOF, Drug: RBV | Intervention Type: DRUG; Name: LDV/SOF; Assigned to Arm(s): LDV/SOF (treatment experienced), LDV/SOF (treatment naive), LDV/SOF+RBV (treatment experienced), LDV/SOF+RBV (treatment naive) | Intervention Type: DRUG; Name: RBV; Assigned to Arm(s): LDV/SOF+RBV (treatment experienced), LDV/SOF+RBV (treatment naive)

Answer: A