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Safety and Pharmacokinetics of MK-7680 in Participants With Hepatitis C (MK-7680-003) | Clinical Trials | Clareo Health

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

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

NCT02269059•Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 65 years

Sex

ALL

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

Key Dates

Start Date

December 1, 2014

Primary Completion Date

February 1, 2015

Completion Date

April 1, 2015

Last Updated

July 27, 2015

Enrollment

ACTUAL participants

Conditions

Hepatitis C

Interventions

MK-7680

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 27, 2015Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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