Safety, Pharmacokinetics, and Pharmacodynamics of MK-6325 in Hepatitis C Virus (HCV) Infections (MK-6325-003)
- 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
Group Intervention Description GT3-HCV 200 mg Placebo to MK-6325 - GTI-HCV 800 mg Placebo to MK-6325 - GT1-HCV 200 mg Placebo to MK-6325 - GT1-HCV 400 mg MK-6325 - GT1-HCV 400 mg Placebo to MK-6325 - GT3-HCV 800 mg Placebo to MK-6325 - GT3-HCV 400 mg Placebo to MK-6325 - GT1-HCV 200 mg MK-6325 - GTI-HCV 800 mg MK-6325 - GT3-HCV 800 mg MK-6325 - GT3-HCV 200 mg MK-6325 - GT3-HCV 400 mg MK-6325 -
- Primary Outcome Measures
Name Time Method 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
Name Time Method Viral load reduction in GT3 HCV-infected participants (Part II) 7 Days Viral load reduction in GT1 HCV-infected participants (Part I) 7 Days