drugset / Trial / NCT01010906

A Study Investigating the Influence of Hepatic Insufficiency on the Pharmacokinetics of Vaniprevir (MK-7009-005)

NCT01010906

Phase 1 Completed 60 enrolled Merck Sharp & Dohme LLC
Non-randomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2009-07-01
Primary completion
2010-06-11
Completion
2010-06-21

Drugs

EvaluationDrugModalityDoseRoute
Subject Vaniprevir Small molecule 200 mg Oral
Subject Vaniprevir Small molecule 300 mg Oral