Evaluation of MK-1075 in Participants With Hepatitis C Virus (HCV) Infection (MK-1075-002)

• Status: Completed
• Trial end date: 2015-08-10
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the safety and pharmacokinetics of MK-1075, and to determine the ability of MK-1075 to reduce HCV viral load, following administration of a single dose in HCV-infected participants.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.

Criteria

Inclusion Criteria:

• Male or female of non-child bearing potential

• In good health other than HCV genotype (GT) 1 infection

Exclusion Criteria:

• Is mentally incapacitated or legally institutionalized

• 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 (including stroke and chronic seizures) abnormalities or diseases

• Has a history of cancer

• Is positive for hepatitis B surface antigen (HBsAg) or human immunodeficiency virus (HIV)

• Has participated in another investigational trial within 4 weeks (or 5 half-lives) prior to Screening

• Consumes >2 alcoholic beverages a day or uses illegal drugs

• Has evidence or history of chronic hepatitis not caused by HCV including but not limited to non-HCV viral hepatitis, non-alcoholic steatohepatitis (NASH), drug-induced hepatitis, or autoimmune hepatitis

• Has clinical or laboratory evidence of advanced or decompensated liver disease, evidence of bridging fibrosis or higher grade fibrosis (Metavir score ≥3) from prior liver biopsy