Phase 1
Completed N=31
Evaluating Fine Needle Aspiration to Measure Hepatic Vaniprevir (MK-7009) Concentrations in Participants With Chronic Hepatitis C (MK-7009-048)
Chronic Hepatitis C
Source: ClinicalTrials.gov NCT01678131 ↗
Enrolled (actual)
31
Serious AEs
0.0%
Results posted
Sep 2014
Primary outcomePrimary: Number of Participants From Whom Detectable Concentrations of Hepatic Vaniprevir Are Obtained by FNA — 10; 9; 10 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants From Whom Detectable Concentrations of Hepatic Vaniprevir Are Obtained by FNA |
10; 9; 10 | — |
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
Data sourced from ClinicalTrials.gov (NCT01678131). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.