A Multiple Dose Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of MK-8325 in Hepatitis C Infected Males
Overview
- Phase
- Phase 1
- Intervention
- Placebo
- Conditions
- Hepatitis C, Chronic
- Sponsor
- Merck Sharp & Dohme LLC
- Enrollment
- 37
- Primary Endpoint
- Mean maximum reduction from baseline through Day 5 in HCV ribonucleic acid (RNA) in GT3 participants
- Status
- Terminated
- Last Updated
- 10 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Placebo Panel
Intervention: Placebo
Panel B (GT1 50 mg)
Intervention: MK-8325
Panel A (GT1 10 mg)
Intervention: MK-8325
Panel C (GT1 100 mg)
Intervention: MK-8325
Panel D (GT1 200 mg)
Intervention: MK-8325
Panel E (GT3 10 mg)
Intervention: MK-8325
Panel F (GT3 50 mg)
Intervention: MK-8325
Panel G (GT3 100 mg)
Intervention: MK-8325
Panel H (GT3 200 mg)
Intervention: MK-8325
Panel I (GT1a 10 mg)
Intervention: MK-8325
Panel J (GT1a 50 mg)
Intervention: MK-8325
Outcomes
Primary Outcomes
Mean maximum reduction from baseline through Day 5 in HCV ribonucleic acid (RNA) in GT3 participants
Time Frame: 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
Time Frame: 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
Time Frame: Day 1 up to 56 days
Number of participants discontinuing study drug due to an adverse event
Time Frame: Days 1-5
Secondary Outcomes
- 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)