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