At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 50 enrolled
Drug / intervention
Grazoprevirdrug
Likely dose
Grazoprevir 200 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.
An Open-label, 3-Part, Multiple Dose Study to Investigate the Influence of Hepatic Insufficiency on the Pharmacokinetics of Grazoprevir (MK-5172)
In Brief
A Phase 1 clinical trial evaluating Grazoprevir for Hepatitis C. Completed, enrolled 50 participants.
Detailed Summary
This study will compare the pharmacokinetics (PK) of grazoprevir (MK-5172) when administered to participants with mild, moderate or severe hepatic insufficiency (assessed by the criteria of the Child-Pugh's scale) with the PK of grazoprevir when administered to healthy participants.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis C
Countries--
Collaborators--
Timeline
Phase 1CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJul 2011
Enrollment StartJul 2011
Primary CompletionSep 2014
Study CompletionSep 2014
TodayJul 2026
First PostedJul 11, 2011
Enrollment StartJul 28, 2011
Primary CompletionSep 5, 2014
Study CompletionSep 12, 2014
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 15.0 years ago
Interventions
Grazoprevirdrug
Part 1: oral morning dose of 200 mg daily for 10 days Part 2: oral morning dose of 100 mg daily for 10 days Part 3: oral morning dose of 50 mg daily for 10 days