Conditions: Hepatitis C
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 91
Healthy volunteers: no

Brief summary:
This multiple dose study will assess the safety, tolerability, pharmacokinetics and pharmacodynamics of grazoprevir (MK-5172) in Genotype (GT) 1 and GT3 Hepatitis C virus (HCV)- infected participants. The primary hypothesis is that administration of grazoprevir for 7 days is sufficiently safe and well tolerated in HCV-infected males.

Detailed description:

Arms:
arm 1: GT1 HCV-infected Participants: 400 mg Grazoprevir or Placebo arm 2: GT1 HCV-infected Participants: 600 mg Grazoprevir or Placebo arm 3: GT1 HCV-infected Participants: 800 mg Grazoprevir or Placebo arm 4: GT3 HCV-infected Participants: 400 mg Grazoprevir or Placebo arm 5: GT3 HCV-infected Participants: 600 mg Grazoprevir or Placebo arm 6: GT3 HCV-infected Participants: 800 mg Grazoprevir or Placebo arm 7: GT1 HCV-infected Participants: 200 mg Grazoprevir or Placebo arm 8: GT1 HCV-infected Participants: 100 mg Grazoprevir or Placebo arm 9: GT1 HCV-infected Participants: 50 mg Grazoprevir or Placebo arm 10: GT3 HCV-infected Participants: 200 mg Grazoprevir or Placebo arm 11: GT3 HCV-infected Participants: 100 mg Grazoprevir or Placebo arm 12: GT3 HCV-infected Participants: 50 mg Grazoprevir or Placebo arm 13: GT1 HCV-infected Participants: 30 mg Grazoprevir or Placebo arm 14: GT1 HCV-infected Participants: 10 mg Grazoprevir or Placebo

Interventions: intervention 1: Grazoprevir intervention 2: Placebo
Intervention descriptions: intervention 1: 10, 30, 50, 100, 200, 400, 600 or 800 mg Grazoprevir tablets, orally, once a day for 7 days intervention 2: Placebo tablet, orally, once a day for 7 days

Protocol document: