At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 91 enrolled
Drug / intervention
Grazoprevir +1 moredrug
Likely dose
Grazoprevir 800 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Grazoprevir (MK-5172) in Hepatitis C Infected Male Patients
In Brief
A Phase 1 clinical trial evaluating Grazoprevir and Placebo for Hepatitis C. Completed, enrolled 91 participants.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis C
Countries--
Collaborators--
Timeline
Phase 1CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedOct 2009
Enrollment StartFeb 2010
Primary CompletionNov 2012
TodayJul 2026
First PostedOct 21, 2009
Enrollment StartFeb 23, 2010
Primary CompletionNov 8, 2012
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 16.7 years ago
Interventions
Grazoprevirdrug
10, 30, 50, 100, 200, 400, 600 or 800 mg Grazoprevir tablets, orally, once a day for 7 days
Placebodrug
Placebo tablet, orally, once a day for 7 days