Overview

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