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: Sofosbuvir 200 mg (Genotype 1); Type: EXPERIMENTAL; Interventions: Drug: Sofosbuvir, Drug: Placebo to match sofosbuvir, Drug: PEG, Drug: RBV | Arm Label: Sofosbuvir 400 mg (Genotype 1); Type: EXPERIMENTAL; Interventions: Drug: PEG, Drug: RBV | Arm Label: Placebo (Genotype 1); Type: ACTIVE_COMPARATOR; Interventions: Drug: Placebo to match sofosbuvir, Drug: PEG, Drug: RBV | Arm Label: Sofosbuvir 400 mg (Genotype 2/3); Type: EXPERIMENTAL; Interventions: Drug: Sofosbuvir, Drug: PEG, Drug: RBV | Intervention Type: DRUG; Name: Sofosbuvir; Assigned to Arm(s): Sofosbuvir 200 mg (Genotype 1), Sofosbuvir 400 mg (Genotype 2/3) | Intervention Type: DRUG; Name: Placebo to match sofosbuvir; Assigned to Arm(s): Placebo (Genotype 1), Sofosbuvir 200 mg (Genotype 1) | Intervention Type: DRUG; Name: PEG; Assigned to Arm(s): Placebo (Genotype 1), Sofosbuvir 200 mg (Genotype 1), Sofosbuvir 400 mg (Genotype 1), Sofosbuvir 400 mg (Genotype 2/3) | Intervention Type: DRUG; Name: RBV; Assigned to Arm(s): Placebo (Genotype 1), Sofosbuvir 200 mg (Genotype 1), Sofosbuvir 400 mg (Genotype 1), Sofosbuvir 400 mg (Genotype 2/3)
C: Arm Label: Group 1; Type: EXPERIMENTAL; Interventions: Drug: Copegus, Drug: Pegasys, Drug: RO4588161 | Arm Label: Group 2; Type: EXPERIMENTAL; Interventions: Drug: Copegus, Drug: Pegasys, Drug: RO4588161 | Arm Label: Group 3; Type: EXPERIMENTAL; Interventions: Drug: Copegus, Drug: Pegasys, Drug: RO4588161 | Arm Label: Group 4; Type: EXPERIMENTAL; Interventions: Drug: Copegus, Drug: Pegasys, Drug: RO4588161 | Arm Label: Group 5; Type: EXPERIMENTAL; Interventions: Drug: Copegus, Drug: Pegasys, Drug: RO4588161 | Arm Label: Group 6; Type: EXPERIMENTAL; Interventions: Drug: Copegus, Drug: Pegasys, Drug: RO4588161 | Arm Label: Group 7; Type: ACTIVE_COMPARATOR; Interventions: Drug: Copegus, Drug: Pegasys | Intervention Type: DRUG; Name: Copegus; Assigned to Arm(s): Group 1, Group 2, Group 3, Group 4, Group 5, Group 6, Group 7 | Intervention Type: DRUG; Name: Pegasys; Assigned to Arm(s): Group 1, Group 2, Group 3, Group 7 | Intervention Type: DRUG; Name: Pegasys; Assigned to Arm(s): Group 4, Group 5, Group 6 | Intervention Type: DRUG; Name: RO4588161; Assigned to Arm(s): Group 1, Group 5 | Intervention Type: DRUG; Name: RO4588161; Assigned to Arm(s): Group 2, Group 3, Group 6 | Intervention Type: DRUG; Name: RO4588161; Assigned to Arm(s): Group 4
D: Arm Label: Immediate Treatment; Type: EXPERIMENTAL; Interventions: Drug: Grazoprevir, Drug: Elbasvir | Arm Label: Deferred Treatment; Type: EXPERIMENTAL; Interventions: Drug: Grazoprevir, Drug: Elbasvir, Drug: Placebo to Grazoprevir, Drug: Placebo to Elbasvir | Arm Label: Intensive PK; Type: EXPERIMENTAL; Interventions: Drug: Grazoprevir, Drug: Elbasvir | Intervention Type: DRUG; Name: Grazoprevir; Assigned to Arm(s): Deferred Treatment, Immediate Treatment, Intensive PK | Intervention Type: DRUG; Name: Elbasvir; Assigned to Arm(s): Deferred Treatment, Immediate Treatment, Intensive PK | Intervention Type: DRUG; Name: Placebo to Grazoprevir; Assigned to Arm(s): Deferred Treatment | Intervention Type: DRUG; Name: Placebo to Elbasvir; Assigned to Arm(s): Deferred Treatment

Answer: A