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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 1

Conditions: Hepatitis C

Treatments: Drug: MK-7680

Study type: Interventional

Funder types: Industry

Identifiers

NCT02269059

2014-003674-16 (EudraCT Number)

7680-003

Details and patient eligibility

About

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.

Full 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.

Enrollment: 13 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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13 participants in 2 patient groups

GT1 Participants

Experimental group

Description:

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.

Treatment:

Drug: MK-7680

GT3 Participants

Experimental group

Description:

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.

Treatment:

Drug: MK-7680