Status:
COMPLETED
Safety and Pharmacokinetics of MK-7680 in Participants With Hepatitis C (MK-7680-003)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Hepatitis C
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
This is a two-part dose-finding trial of MK-7680 in participants with Hepatitis C Virus (HCV) infection of genotype (GT)1 (Part I) and GT3 (Part 2). The primary hypothesis is that daily administration...
Detailed Description
Parts 1 and 2 will each consist of 4 panels. In the first panel, a 200 mg dose of MK-7680 will be administered. In each of the following 3 panels, higher or lower doses of MK-7680 will be administered...
Eligibility Criteria
Inclusion
- Is in good health except for HCV infection
- Is male or is a female of non-childbearing potential
- Clinical diagnosis of HCV GT1 or GT3 with no evidence of mixed-GT or non-typeable infection
Exclusion
- Has a history of clinically significant and not stably controlled endocrine, gastrointestinal, cardiovascular, hematological, hepatic (excepting HCV infection), immunological, renal, respiratory, genitourinary, or major neurological abnormality or disease
- Has a history of cancer
- Has a history of significant multiple and/or severe allergies
- Is positive for hepatitis B or human immunodeficiency virus
- Has had major surgery, donated or lost 1 unit (500 mL) of blood within 4 weeks prior to screening
- Consumes more than 2 alcoholic beverages per day or is currently a regular user of any illicit drug(s) or has a history of alcohol/drug abuse within 12 months prior to screening
- Has chronic hepatitis not caused by HCV (e.g., nonalcoholic steatohepatitis \[NASH\])
- Has clinical or laboratory evidence of advanced or decompensated liver disease, or evidence of bridging or higher grade fibrosis
Key Trial Info
Start Date :
December 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2015
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT02269059
Start Date
December 1 2014
End Date
April 1 2015
Last Update
July 27 2015
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