A Randomized Clinical Trial Using Fine Needle Aspiration For Evaluation of Hepatic Pharmacokinetics of MK-5172 in Participants With Chronic Hepatitis C
Overview
- Phase
- Phase 1
- Intervention
- Peg-Interferon
- Conditions
- Chronic Hepatitis C
- Sponsor
- Merck Sharp & Dohme LLC
- Primary Endpoint
- Number of participants from whom detectable concentrations of hepatic Grazoprevir are obtained by FNA.
- Status
- Withdrawn
- Last Updated
- 10 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Has chronic compensated HCV infection.
- •No contraindications to CNB or FNA procedures.
- •Pilot study only: All comers with chronic HCV already scheduled to undergo CNB for fibrosis staging.
- •Pilot study only: Requires a diagnostic liver biopsy to monitor progression of liver disease.
- •Pilot study only: Does not have cirrhosis.
- •Main study only: Males or non-pregnant and postmenopausal females willing to use medically acceptable contraception during, and for 6 months or longer after study.
- •Main study only: Body mass index of 18.5 - 32.0 kg/m\^
- •Main study only: Can avoid aspirin, anticoagulants, and non steroidal inflammatory agents.
- •Main study only: Has undergone prior treatment or is treatment naive for chronic HCV infection.
- •Exclusion Criteria for Main study only:
Exclusion Criteria
- Not provided
Arms & Interventions
Main Pt. 2: 800 mg Grazoprevir + Peg-IFN/RBV
800 mg Grazoprevir combined with Peg-Interferon/Ribavirin treatment.
Intervention: Peg-Interferon
Main Pt. 2: 800 mg Grazoprevir + Peg-IFN/RBV
800 mg Grazoprevir combined with Peg-Interferon/Ribavirin treatment.
Intervention: Liver Samples from FNA
Main Pt. 2: 800 mg Grazoprevir + Peg-IFN/RBV
800 mg Grazoprevir combined with Peg-Interferon/Ribavirin treatment.
Intervention: Liver Samples from CNB
Main Pt. 2: 800 mg Grazoprevir + Peg-IFN/RBV
800 mg Grazoprevir combined with Peg-Interferon/Ribavirin treatment.
Intervention: Blood Samples
Main Pt. 2: 800 mg Grazoprevir + Peg-IFN/RBV
800 mg Grazoprevir combined with Peg-Interferon/Ribavirin treatment.
Intervention: Ribavirin
Main Pt. 2: 800 mg Grazoprevir + Peg-IFN/RBV
800 mg Grazoprevir combined with Peg-Interferon/Ribavirin treatment.
Intervention: 800 mg Grazoprevir
Main Pt. 2: 100 mg Grazoprevir + Peg-IFN/RBV
100 mg Grazoprevir combined with Peg-Interferon/Ribavirin treatment.
Intervention: Peg-Interferon
Main Pt. 2: 100 mg Grazoprevir + Peg-IFN/RBV
100 mg Grazoprevir combined with Peg-Interferon/Ribavirin treatment.
Intervention: Liver Samples from FNA
Main Pt. 2: 100 mg Grazoprevir + Peg-IFN/RBV
100 mg Grazoprevir combined with Peg-Interferon/Ribavirin treatment.
Intervention: Liver Samples from CNB
Main Pt. 2: 100 mg Grazoprevir + Peg-IFN/RBV
100 mg Grazoprevir combined with Peg-Interferon/Ribavirin treatment.
Intervention: Blood Samples
Main Pt. 2: 100 mg Grazoprevir + Peg-IFN/RBV
100 mg Grazoprevir combined with Peg-Interferon/Ribavirin treatment.
Intervention: Ribavirin
Main Pt. 2: 100 mg Grazoprevir + Peg-IFN/RBV
100 mg Grazoprevir combined with Peg-Interferon/Ribavirin treatment.
Intervention: 100 mg Grazoprevir
Main Pt.1: 800 mg Grazoprevir
800 mg Grazoprevir.
Intervention: Liver Samples from FNA
Main Pt.1: 800 mg Grazoprevir
800 mg Grazoprevir.
Intervention: Liver Samples from CNB
Main Pt.1: 800 mg Grazoprevir
800 mg Grazoprevir.
Intervention: Blood Samples
Main Pt.1: 800 mg Grazoprevir
800 mg Grazoprevir.
Intervention: 800 mg Grazoprevir
Procedural Pilot
Optimization of FNA procedure.
Intervention: Liver samples from CNB and FNA
Outcomes
Primary Outcomes
Number of participants from whom detectable concentrations of hepatic Grazoprevir are obtained by FNA.
Time Frame: Days 7-12.