At a glance

ClinicalIndex Comparison Record

Phase 1Completed· 60 enrolled

Drug / intervention

Vaniprevir 300 mg +1 moredrug

Likely dose

Vaniprevir 300 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.

Search/NCT01010906

NCT01010906Phase 1Completed

Compare CT.gov

An Open-label, 3-Part, Single-Dose Study to Investigate the Influence of Hepatic Insufficiency on the Pharmacokinetics of MK-7009

Merck Sharp & Dohme LLC·interventional·Posted Nov 10, 2009·Updated Oct 9, 2018

In Brief

A Phase 1 clinical trial evaluating Vaniprevir 300 mg and Vaniprevir 200 mg for Hepatitis C. Completed, enrolled 60 participants.

Detailed Summary

This was a 3-part study comparing the pharmacokinetics after administration of vaniprevir (MK-7009) for participants with mild, moderate or severe hepatic insufficiency with healthy matched control participants. The primary hypothesis is that the area under the curve (AUC) (0 to infinity) of vaniprevir for participants with mild, moderate, or severe hepatic insufficiency is similar to that observed in healthy matched controlled participants.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsHepatitis C

Countries--

Collaborators--

Timeline

Phase 1CompletedFinished

20102011201220132014201520162017201820192020202120222023202420252026

Enrollment StartJul 2009

First PostedNov 2009

Primary CompletionJun 2010

Study CompletionJun 2010

TodayJul 2026

First PostedNov 10, 2009

Enrollment StartJul 1, 2009

Primary CompletionJun 11, 2010

Study CompletionJun 21, 2010

TodayJul 2, 2026

Enrollment to primary: 11 monthsPosted 16.6 years ago

Interventions

Vaniprevir 300 mgdrug

single dose administration of 300 mg oral tablet

Vaniprevir 200 mgdrug

single dose administration of 200 mg oral tablet