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

NCT01547312 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2015-10-14

No results posted yet for this study

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

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.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-05-31
Primary Completion
2012-11-30
Completion
2012-11-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01547312 on ClinicalTrials.gov