Safety and Pharmacokinetics of MK-7680 in Participants With Hepatitis C (MK-7680-003)

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Multiple Dose Study to Evaluate Safety, Pharmacokinetics, and Pharmacodynamics of MK-7680 in Patients With Hepatitis C Infection

Conditions
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Hepatitis C

Intervention / Treatment
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* Drug: MK-7680


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GT1 Participants<br>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. | Drug: MK-7680<br>* MK-7680 10 mg and 100 mg capsules<br>|
| Experimental: GT3 Participants<br>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. | Drug: MK-7680<br>* MK-7680 10 mg and 100 mg capsules<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 |