A Study to Evaluate Fine Needle Aspiration as a Method for MK-7009 Liver Pharmacokinetic Measurement in Participants With Chronic Hepatitis C (MK-7009-048)

This study is currently recruiting participants.

Verified November 2012 by Merck

Sponsor:

Information provided by (Responsible Party):

Merck

ClinicalTrials.gov Identifier:

NCT01678131

First received: August 30, 2012

Last updated: November 15, 2012

Last verified: November 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	August 30, 2012
Last Updated Date	November 15, 2012
Start Date ^ICMJE	October 2012
Estimated Primary Completion Date	June 2013 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: August 30, 2012)	Number of participants from whom detectable concentrations of hepatic MK-7009 are obtained by fine needle aspiration (FNA) [ Time Frame: Days 7 through 10, at a randomized sequence of 3 out of 5 possible collection time points (3, 12, 24, 48, or 72 hours post dose) ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01678131 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	A Study to Evaluate Fine Needle Aspiration as a Method for MK-7009 Liver Pharmacokinetic Measurement in Participants With Chronic Hepatitis C (MK-7009-048)
Official Title ^ICMJE	A Randomized Clinical Trial Using Fine Needle Aspiration For Evaluation of Hepatic Pharmacokinetics of MK-7009 in Chronic Hepatitis C Patients
Brief Summary	This study will evaluate the technical feasibility of using fine needle aspiration (FNA) of liver tissue to obtain 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 MK-7009 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).
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 1
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Diagnostic
Condition ^ICMJE	Chronic Hepatitis C
Intervention ^ICMJE	Drug: MK-7009 MK-7009 capsules, orally, twice per day (BID) on Days 1 through 6 and a single dose, orally, on Day 7. Biological: Peg-IFN alfa-2b Administered per product label Other Name: PegIntron™ Biological: Ribavirin Administered per product label Other Name: Rebetol™ Procedure: Liver samples from FNA and CNB
Study Arm (s)	Experimental: Treatment A: MK-7009 alone Participants in this study group will receive MK-7009 alone and will have liver biopsy done by FNA and CNB. Interventions: Drug: MK-7009 Procedure: Liver samples from FNA and CNB Experimental: Treatment B: MK-7009 High Dose + Peg-IFN alpha-2b + RBV Participants in this study group will receive MK-7009, Peg-IFN alpha-2b, and RBV and will have liver biopsy done by FNA and CNB. Interventions: Drug: MK-7009 Biological: Peg-IFN alfa-2b Biological: Ribavirin Procedure: Liver samples from FNA and CNB Experimental: Treatment C: MK-7009 MK-7009 Low Dose + Peg-IFN alpha-2b + RBV Participants in this study group will receive MK-7009, Peg-IFN alpha-2b, and RBV and will have liver biopsy done by FNA and CNB. Interventions: Drug: MK-7009 Biological: Peg-IFN alfa-2b Biological: Ribavirin Procedure: Liver samples from FNA and CNB
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Recruiting
Estimated Enrollment ^ICMJE	30
Estimated Completion Date	June 2013
Estimated Primary Completion Date	June 2013 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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 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
Gender	Both
Ages	18 Years to 65 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Not Provided
Location Countries ^ICMJE	Moldova, Republic of

Administrative Information
NCT Number ^ICMJE	NCT01678131
Other Study ID Numbers ^ICMJE	7009-048, 2012-003284-21
Has Data Monitoring Committee	No
Responsible Party	Merck
Study Sponsor ^ICMJE	Merck
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Merck
Verification Date	November 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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