A Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of MK-8325 in Hepatitis C-Infected Males (MK-8325-002)
- Registration Number
- NCT01554189
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Male
- Target Recruitment
- 37
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Panel D (GT1 200 mg) MK-8325 - Panel C (GT1 100 mg) MK-8325 - Panel J (GT1a 50 mg) MK-8325 - Panel H (GT3 200 mg) MK-8325 - Placebo Panel Placebo - Panel F (GT3 50 mg) MK-8325 - Panel E (GT3 10 mg) MK-8325 - Panel G (GT3 100 mg) MK-8325 - Panel B (GT1 50 mg) MK-8325 - Panel A (GT1 10 mg) MK-8325 - Panel I (GT1a 10 mg) MK-8325 -
- Primary Outcome Measures
Name Time Method Mean maximum reduction from baseline through Day 5 in HCV ribonucleic acid (RNA) in GT3 participants Day 1 predose and 2, 4, 8, 12, 24 and 36 hours post-dose, Days 3 and 4 predose, Day 5 predose and 2, 4, 8, 12, and 24 hours post-dose. Change from baseline to Day 5 in plasma HCV ribonucleic acid (RNA) in GT1 participants Day 1 predose and 2, 4, 8, 12, 24 and 36 hours post-dose, Days 3 and 4 predose, Day 5 predose and 2, 4, 8, 12, and 24 hours post-dose. Number of participants experiencing at least one adverse event Day 1 up to 56 days Number of participants discontinuing study drug due to an adverse event Days 1-5
- Secondary Outcome Measures
Name Time Method Area under the concentration curve from Hour 0 to Hour 24 (AUC0-24hr) for MK-8325 Day 1 predose and 0.25 0.5, 1, 2, 4, 5, 6, 7, 8, 12, 16 and 24 hours post-dose and Day 5 predose and 0.25, 0.5, 1, 2, 4, 5, 6, 7, 8, 12, 16 and 24 hours post-dose Maximum plasma concentration (Cmax) of MK-8325 Day 1 predose and 0.25 0.5, 1, 2, 4, 5, 6, 7, 8, 12, 16 and 24 hours post-dose and Day 5 predose and 0.25, 0.5, 1, 2, 4, 5, 6, 7, 8, 12, 16, 24, 36,48, 72, 96, 120, 144, 168, 192, 216, and 240 hours post-dose Trough plasma concentration (C24hr) of MK-8325 Day 1 predose and 0.25 0.5, 1, 2, 4, 5, 6, 7, 8, 12, 16 and 24 hours post-dose and Day 5 predose and 0.25, 0.5, 1, 2, 4, 5, 6, 7, 8, 12, 16, 24, 36,48, 72, 96, 120, 144, 168, 192, 216, and 240 hours post-dose