Hepatic Pharmacokinetic Profile for Vaniprevir (MK-7009) and Hepatitis C Virus RNA Levels After Vaniprevir Administration (Study MK-7009-029-02)
This study has been terminated.
(This study was stopped for business and program changes. There is a plan to replace this study with a similar study design, but different study number.)
Information provided by (Responsible Party):
First received: August 6, 2009
Last updated: October 25, 2013
Last verified: October 2013
This study will evaluate the hepatic (liver) and plasma pharmacokinetics of Vaniprevir (MK-7009) by evaluation of RNA of the hepatitis C virus (HCV) in genotype 1, HCV-infected participants.
|Study Design:||Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Multiple Dose Study to Evaluate Pharmacokinetics and Hepatitis C Virus RNA Following Administration of MK-7009 in Hepatitis C Infected Patients|
Resource links provided by NLM:
U.S. FDA Resources
Further study details as provided by Merck:
Primary Outcome Measures:
- Steady-state hepatic pharmacokinetics of Vaniprevir (AUC) [ Time Frame: 0 to 24 hours postdose ] [ Designated as safety issue: No ]Area under the liver concentration versus time curve
- Steady-state hepatic pharmacokinetics of Vaniprevir (concentration of drug in the liver) [ Time Frame: 6 hour, 12 hour, 24 hour postdose ] [ Designated as safety issue: No ]Concentration of drug in the liver at 6, 12, and 24 hours postdose.
- Steady-state hepatic pharmacokinetics of Vaniprevir(apparent terminal half-life) [ Time Frame: 0 to 24 hours postdose ] [ Designated as safety issue: No ]Half-life of drug in plasma
|Study Start Date:||September 2010|
|Study Completion Date:||March 2011|
|Primary Completion Date:||March 2011 (Final data collection date for primary outcome measure)|
Vaniprevir (MK-7009) treatment
Drug: MK-7009 (Vaniprevir)
Period 1: Vaniprevir 600 mg twice daily on Days 1-3 and a single dose of Vaniprevir 600 mg on Day 4. Period 2: Vaniprevir 300 mg twice daily on Days 1-3 and a single dose of Vaniprevir 300 mg on Day 4. There will be at least a 30-day washout interval between periods 1 and 2.
Contacts and Locations
No Contacts or Locations Provided