Clinical trial NCT01547312: Evaluation of Hepatic Pharmacokinetics for Grazoprevir (MK-5172) in Participants With Chronic Hepatitis C (MK-5172-022)
Official title: A Randomized Clinical Trial Using Fine Needle Aspiration For Evaluation of Hepatic Pharmacokinetics of MK-5172 in Participants With Chronic Hepatitis C
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Chronic Hepatitis C
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2012-03-07
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


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\^2.
* 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:

* History of any of the following: stroke, chronic seizures, major neurological disorders, gastric bypass surgery or bowel resection.
* No viral response to prior interferon based therapy.
* Prior treatment for HCV with an NS3/4A protease inhibitor.
* History of either clinically significant, uncontrolled endocrine, gastrointestinal, cardiovascular, hematological, immunological, renal, respiratory, or genitourinary abnormalities/diseases.
* History of neoplastic or myeloproliferative disease.
* Has any of the following : cirrhosis, decompensated liver disease, or other advanced liver disease, hepatocellular carcinoma, infection with human immunodeficiency virus (HIV), or hepatitis B.
* Evidence of high grade bridging fibrosis from prior liver biopsy or chronic hepatitis not caused by HCV.
* History of illicit drug use or alcohol abuse.
* Had surgery, donated at least one unit of blood, or participated in any other investigational study within 4 weeks prior to screening visit.
* History of multiple and/or severe allergies.

Primary outcomes:
measure: Number of participants from whom detectable concentrations of hepatic Grazoprevir are obtained by FNA.
timeFrame: Days 7-12.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: