Safety and Pharmacokinetics of MK-7680 in Participants With Hepatitis C (MK-7680-003)
- Registration Number
- NCT02269059
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief 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.
- Detailed Description
Parts 1 and 2 will each consist of 4 panels. In the first panel, a 200 mg dose of MK-7680 will be administered. In each of the following 3 panels, higher or lower doses of MK-7680 will be administered. Each panel will only begin once the safety and tolerability data from the preceding panel have been evaluated.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 13
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description GT1 Participants MK-7680 Participants take MK-7680 capsules by mouth once daily (QD) for 7 days. The starting dose will be 200 mg and the dose will be adjusted in successive panels of participants based on analysis of results of the previous panel. GT3 Participants MK-7680 Participants take MK-7680 capsules by mouth QD for 7 days. The starting dose will be 200 mg and the dose will be adjusted in successive panels of participants based on analysis of results of the previous panel.
- Primary Outcome Measures
Name Time Method Number of participants experiencing an adverse event (AE) Up to 21 days Number of participants discontinuing from study therapy due to AEs Up to 7 days Change from baseline in HCV viral load Day 1: predose, 2, 4, 8, 12, and 24 hours postdose; Days 3, 4, 5, and 6: predose; and Day 7: predose, 4, 12, 24, and 48 hours postdose
- Secondary Outcome Measures
Name Time Method