Hepatitis C
Conditions
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.
Interventions
DRUGMK-7680
MK-7680 10 mg and 100 mg capsules
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
| 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 |
Outcome results
None listed