NCT01554189

A Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of MK-8325 in Hepatitis C-Infected Males (MK-8325-002)

A Multiple Dose Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of MK-8325 in Hepatitis C Infected Males

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: Male
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This study is being done to assess the safety, pharmacokinetics (PK) and pharmacodynamics (PD) of MK-8325 in male hepatitis C virus (HCV)-infected participants. There will be 3 parts to this study. Part I will enroll only genotype 1 (GT1) HCV patients, Part II will enroll only genotype 3 (GT3) HCV-infected participants, and Part III will enroll only GT1a HCV-infected participants. All parts may run concurrently, or may be staggered as needed by the clinical sites.

Conditions

• Hepatitis C, Chronic

Interventions

Type	Name	Description
DRUG	MK-8325	MK-8325 capsules, orally, once per day for 5 days, at a dose determined by panel assignment (10-200 mg)
DRUG	Placebo	Placebo to match MK-8325 capsules, orally, once per day for 5 days

Timeline

• Start date: 2012-04-01
• Primary completion: 2013-04-01
• Completion: 2013-04-01
• First posted: 2012-03-14
• Last updated: 2015-07-21