Evaluating Fine Needle Aspiration to Measure Hepatic Vaniprevir (MK-7009) Concentrations in Participants With Chronic Hepatitis C (MK-7009-048)
Evaluating Fine Needle Aspiration to Measure Hepatic Vaniprevir (MK-7009) Concentrations in Participants With Chronic Hepatitis C (MK-7009-048)
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.
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