A Multiple Dose Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of MK-8325 in Hepatitis C Infected Males
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 37
- 主要终点
- Mean maximum reduction from baseline through Day 5 in HCV ribonucleic acid (RNA) in GT3 participants
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Placebo Panel
干预措施: Placebo (Drug)
Panel B (GT1 50 mg)
干预措施: MK-8325 (Drug)
Panel A (GT1 10 mg)
干预措施: MK-8325 (Drug)
Panel C (GT1 100 mg)
干预措施: MK-8325 (Drug)
Panel D (GT1 200 mg)
干预措施: MK-8325 (Drug)
Panel E (GT3 10 mg)
干预措施: MK-8325 (Drug)
Panel F (GT3 50 mg)
干预措施: MK-8325 (Drug)
Panel G (GT3 100 mg)
干预措施: MK-8325 (Drug)
Panel H (GT3 200 mg)
干预措施: MK-8325 (Drug)
Panel I (GT1a 10 mg)
干预措施: MK-8325 (Drug)
Panel J (GT1a 50 mg)
干预措施: MK-8325 (Drug)
结局指标
主要结局
Mean maximum reduction from baseline through Day 5 in HCV ribonucleic acid (RNA) in GT3 participants
时间窗: 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
时间窗: 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
时间窗: Day 1 up to 56 days
Number of participants discontinuing study drug due to an adverse event
时间窗: Days 1-5
次要结局
- 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)