NCT01547312

Evaluation of Hepatic Pharmacokinetics for Grazoprevir (MK-5172) in Participants With Chronic Hepatitis C (MK-5172-022)

A Randomized Clinical Trial Using Fine Needle Aspiration For Evaluation of Hepatic Pharmacokinetics of MK-5172 in Participants With Chronic Hepatitis C

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This study is divided into 2 segments, and proposes to qualify fine needle aspiration (FNA) as a platform to evaluate the hepatic pharmacokinetics of low and high oral doses of Grazoprevir (MK-5172) in non-cirrhotic participants chronically infected with hepatitis C virus (HCV). The first segment, is a procedural pilot conducted prior to the main study, that is aimed at ensuring optimal execution of the FNA procedure. During the procedural pilot, core needle biopsy (CNB) will be performed on participants as part of their standard of care, but no study drugs will be administered, nor will any procedures other than FNA be conducted. The second segment, the main study, is designed to evaluate the feasibility of measuring Grazoprevir by FNA. During the main study, drugs will be administered, and other additional procedures will be conducted.

Conditions

• Chronic Hepatitis C

Interventions

Type	Name	Description
DRUG	Peg-Interferon	Polyethyleneglycolated Interferon alfa-2b at 1.5 ug/kg/week, administered subcutaneously, once a week, over the entire course of the study.
PROCEDURE	Liver Samples from FNA	Tissue samples are collected at 3 separate visits, with each collection consisting of 3-4 fine needle aspiration (FNA) passes through the liver, guided by ultrasound.
PROCEDURE	Liver Samples from CNB	Tissue samples are collected at 1 of six possible visits by core needle biopsy (CNB) of the liver.
PROCEDURE	Blood Samples	Blood is collected from multiple blood draws, with the total volume for each participant not expected to exceed 500 ml.
DRUG	Ribavirin	Ribavirin, 600-1400 mg administered orally, twice daily, over the entire course of the study.
DRUG	800 mg Grazoprevir	800 mg Grazoprevir administered orally, once per day, for 7 consecutive days.
DRUG	100 mg Grazoprevir	100 mg Grazoprevir administered orally, once per day, for 7 consecutive days.
PROCEDURE	Liver samples from CNB and FNA	Tissue samples from the liver are collected by CNB as part of standard of care, and also by FNA during a single visit.

Timeline

• Start date: 2012-05-01
• Primary completion: 2012-11-01
• Completion: 2012-11-01
• First posted: 2012-03-07
• Last updated: 2015-10-14