Evaluation of Hepatic Pharmacokinetics for Grazoprevir (MK-5172) in Participants With Chronic Hepatitis C (MK-5172-022)
Status:
Withdrawn
Trial end date:
2012-11-01
Target enrollment:
Participant gender:
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.