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

NCT ID: NCT02269059

Last Updated: 2015-07-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-12-31
• Study Completion Date: 2015-04-30

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.

Conditions

Hepatitis C

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

GT1 Participants

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.

Group Type: EXPERIMENTAL

MK-7680

Intervention Type: DRUG

MK-7680 10 mg and 100 mg capsules

GT3 Participants

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.

Group Type: EXPERIMENTAL

MK-7680

Intervention Type: DRUG

MK-7680 10 mg and 100 mg capsules

Interventions

MK-7680

MK-7680 10 mg and 100 mg capsules

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Other Identifiers

2014-003674-16

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

7680-003

Identifier Type: -

Identifier Source: org_study_id