evaluating fine needle aspiration to measure hepatic vaniprevir (mk-7009) concentrations in participants with chronic hepatitis c (mk-7009-048)

Conditions: Chronic Hepatitis C

Summary: this study will evaluate the technical feasibility of using fine needle aspiration (fna) of liver tissue to obtain vaniprevir (mk-7009) liver pharmacokinetic (pk) data, working towards identifying a minimally invasive, reproducible platform to measure liver pk. the study will be done in 2 parts. in part 1, participants will be randomized to one of five fna/core needle biopsy (cnb) time-point collection sequences. in part 2, participants will be randomized to one of two possible doses of vaniprevir and will be assigned to one of five fna/cnb time-point collection sequences; participants in part 2 will also receive background therapy with pegylated interferon alpha-2b (peg-ifn alpha-2b) and ribavirin (rbv). the primary hypothesis is that there is a greater than 80% posterior probability that vaniprevir concentrations are successfully obtained at least 60% of the time from fna liver samples collected at 2 of 3 specified timepoints.


Eligibility criteria:
inclusion criteria: * body mass index (bmi) ≥18.5 kg/m\^2 and ≤32.0 kg/m\^2 * under evaluation for treatment of chronic hepatitis c virus (hcv) * chronic compensated, genotype 1 hcv infection * treatment-naïve or previously treated and tolerated at least 12 weeks of continuous licensed interferon (including pegylated interferon) and ribavirin combination therapy with at least a partial response, or previously treated with investigational products and/or vaccines, other than hcv nonstructural proteins (ns) ns3/4a protease inhibitors, either alone or in combination with other licensed therapies * able to avoid use of anticoagulants, nonsteroidal anti-inflammatory agents and aspirin for at least seven (7) days preceding the initial liver biopsy and continuing throughout the entire study * female participants of childbearing potential or male participants with female sexual partners of childbearing potential must agree to use two acceptable methods of birth control from 2 weeks prior to the first dose through at least 6 months after last dose of study drug, or longer if dictated by local regulation exclusion criteria: * pregnant, lactating, or intending to become pregnant or donate eggs, or intending to donate sperm * history of stroke, chronic seizures, or major neurological disorder * did not achieve a viral response to prior treatment with licensed interferon-based therapy * previously treated with an ns3/4a protease inhibitor (investigational or licensed) * evidence or history of chronic hepatitis not caused by hcv infection including but not limited to non-hcv viral hepatitis, nonalcoholic steatohepatitis (nash), drug-induced hepatitis or autoimmune hepatitis * clinical or laboratory evidence of cirrhosis or other advanced liver disease * decompensated liver disease as indicated by a history of ascites, hepatic encephalopathy, or bleeding esophageal varices * diagnosed with or suspected of having hepatocellular carcinoma * co-infection with human immunodeficiency virus (hiv) * positive hepatitis b surface antigen or other evidence of active hepatitis b infection * history of gastric bypass surgery or bowel resection * history of clinically significant uncontrolled endocrine, gastrointestinal, cardiovascular, hematological, immunological, renal, respiratory, or genitourinary abnormalities or diseases * history of clinically significant neoplastic disease * consumption of excessive amounts of alcohol, defined as greater than 3 glasses of alcoholic beverages (1 glass is approximately equivalent to: beer \[284 ml\], wine \[125 ml\], or distilled spirits \[25 ml\]) per day * regular user, including use of any illicit drugs, or has a history of drug (including alcohol) abuse within the last 3 months * surgery or donation of 1 unit of blood (approximately 500 ml) or participation in another investigational study within a period of 4 weeks prior to the prestudy (screening) visit * history of multiple and/or severe allergies, or has had an anaphylactic reaction or intolerability to prescription or nonprescription drugs or food