Overview

Safety and Pharmacokinetics of MK-7680 in Participants With Hepatitis C (MK-7680-003)

Status:
Completed
Trial end date:
2015-04-01
Target enrollment:
0
Participant gender:
All
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 of a safe and well tolerated dose of MK-7680 will produce a decrease in HCV viral load.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Merck Sharp & Dohme Corp.
Criteria
Inclusion Criteria:

- 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 Criteria:

- 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