A Multiple-Dose Study to Evaluate MK-1075 in Hepatitis C Virus (HCV) Infected Participants (MK-1075-004)

• Status: Completed
• Trial end date: 2015-12-23
• Target enrollment: 0
• Participant gender: All

Summary

This study will evaluate safety, pharmacokinetics (PK), and the ability of MK-1075 to suppress viral load (VL) in HCV-infected participants during 7 days of once daily dose administration. The primary hypothesis is at a once-daily dose that is sufficiently safe and well tolerated in HCV-infected participants, the mean maximum HCV RNA (log10 IU/mL) reduction is at least 3 log10 IU/mL as compared to baseline following multiple dose oral administration of MK-1075 in HCV genotype 1 (GT1) and genotype 3 (GT3) infected participants.

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

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.

Criteria

Inclusion Criteria:

• Female of non-childbearing potential

• Have a body mass index (BMI) >=18 to =< 37 kg/m^2

• Excepting HCV infection, be in good health

• Have a clinical diagnosis of chronic HCV infection, exclusively GT1 or exclusively GT3

• Agree to follow smoking restrictions

Exclusion Criteria:

• Has a history of clinically significant, not stably controlled endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological abnormalities or diseases.

• Have been treated with amiodarone within the prior year, or is currently on beta-blockers or verapamil

• Has a history of cancer (malignancy)

• Has a history of significant multiple and/or severe allergies (e.g., food, drug, latex allergy), or has had an anaphylactic reaction or significant intolerability to prescription or non-prescription drugs or food

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

• Has had major surgery, donated or lost approximately 500 mL blood within 4 weeks prior to screening visit

• Has participated in another drug trial within 4 weeks prior to screening visit

• Is taking a non-permitted medication to treat a co-morbid condition

• Consumes greater than 2 glasses of alcoholic beverages

• Is a regular user of cannabis, any illicit drugs or has a history of drug (including alcohol) abuse within approximately 12 months

• 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 been treated with other HCV inhibitors, such as sofosbuvir or VX-135

• Has evidence of advanced or decompensated liver disease, bridging fibrosis or higher grade fibrosis from a prior liver biopsy