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Safety, Pharmacokinetics, and Pharmacodynamics of MK-6325 in Hepatitis C Virus (HCV) Infections (MK-6325-003)

Phase 1
Completed
Conditions
Hepatitis C
Interventions
Registration Number
NCT01329913
Lead Sponsor
Merck Sharp & Dohme LLC
Brief Summary

This is a 2 part study of the safety, pharmacokinetics and pharmacodynamics of MK-6325 in HCV-infected participants. Part I of the study will be for Genotype (GT) 1 HCV-infected participants who will be randomized to receive either MK-6325 or placebo. If the drug is shown to be safe and efficacious in Part I, Part II will enroll GT 3 HCV-infected participants who will be randomized to receive either MK-6325 or placebo.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
36
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
GT3-HCV 200 mgPlacebo to MK-6325-
GTI-HCV 800 mgPlacebo to MK-6325-
GT1-HCV 200 mgPlacebo to MK-6325-
GT1-HCV 400 mgMK-6325-
GT1-HCV 400 mgPlacebo to MK-6325-
GT3-HCV 800 mgPlacebo to MK-6325-
GT3-HCV 400 mgPlacebo to MK-6325-
GT1-HCV 200 mgMK-6325-
GTI-HCV 800 mgMK-6325-
GT3-HCV 800 mgMK-6325-
GT3-HCV 200 mgMK-6325-
GT3-HCV 400 mgMK-6325-
Primary Outcome Measures
NameTimeMethod
Number of participants experiencing clinical and laboratory adverse events (AEs) (Parts I and II)Up to 15 days after last dose of study drug
Secondary Outcome Measures
NameTimeMethod
Viral load reduction in GT3 HCV-infected participants (Part II)7 Days
Viral load reduction in GT1 HCV-infected participants (Part I)7 Days

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