A Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Grazoprevir (MK-5172) in Hepatitis C Infected Male Patients
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 91
- 主要终点
- Number of Participants With Clinical and Laboratory Adverse Events (AEs)
研究概览
简要总结
This multiple dose study will assess the safety, tolerability, pharmacokinetics and pharmacodynamics of grazoprevir (MK-5172) in Genotype (GT) 1 and GT3 Hepatitis C virus (HCV)- infected participants. The primary hypothesis is that administration of grazoprevir for 7 days is sufficiently safe and well tolerated in HCV-infected males.
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
- •Baseline health is stable.
- •Has a clinical diagnosis of chronic HCV infection.
排除标准
- •Has a history of stroke or chronic seizures.
- •Has a history of cancer.
- •Has a history of human immunodeficiency virus (HIV) infection.
- •Has had major surgery, donated blood or participated in another investigational study within the past 3 months.
研究组 & 干预措施
100 mg Grazoprevir - GT1
GT1 HCV-infected Participants: 100 mg Grazoprevir or Placebo
干预措施: Placebo (Drug)
400 mg Grazoprevir - GT1
GT1 HCV-infected Participants: 400 mg Grazoprevir or Placebo
干预措施: Grazoprevir (Drug)
400 mg Grazoprevir - GT1
GT1 HCV-infected Participants: 400 mg Grazoprevir or Placebo
干预措施: Placebo (Drug)
600 mg Grazoprevir - GT1
GT1 HCV-infected Participants: 600 mg Grazoprevir or Placebo
干预措施: Grazoprevir (Drug)
600 mg Grazoprevir - GT1
GT1 HCV-infected Participants: 600 mg Grazoprevir or Placebo
干预措施: Placebo (Drug)
800 mg Grazoprevir - GT1
GT1 HCV-infected Participants: 800 mg Grazoprevir or Placebo
干预措施: Grazoprevir (Drug)
800 mg Grazoprevir - GT1
GT1 HCV-infected Participants: 800 mg Grazoprevir or Placebo
干预措施: Placebo (Drug)
400 mg Grazoprevir - GT3
GT3 HCV-infected Participants: 400 mg Grazoprevir or Placebo
干预措施: Grazoprevir (Drug)
400 mg Grazoprevir - GT3
GT3 HCV-infected Participants: 400 mg Grazoprevir or Placebo
干预措施: Placebo (Drug)
600 mg Grazoprevir - GT3
GT3 HCV-infected Participants: 600 mg Grazoprevir or Placebo
干预措施: Grazoprevir (Drug)
600 mg Grazoprevir - GT3
GT3 HCV-infected Participants: 600 mg Grazoprevir or Placebo
干预措施: Placebo (Drug)
800 mg Grazoprevir - GT3
GT3 HCV-infected Participants: 800 mg Grazoprevir or Placebo
干预措施: Grazoprevir (Drug)
800 mg Grazoprevir - GT3
GT3 HCV-infected Participants: 800 mg Grazoprevir or Placebo
干预措施: Placebo (Drug)
200 mg Grazoprevir - GT1
GT1 HCV-infected Participants: 200 mg Grazoprevir or Placebo
干预措施: Grazoprevir (Drug)
200 mg Grazoprevir - GT1
GT1 HCV-infected Participants: 200 mg Grazoprevir or Placebo
干预措施: Placebo (Drug)
100 mg Grazoprevir - GT1
GT1 HCV-infected Participants: 100 mg Grazoprevir or Placebo
干预措施: Grazoprevir (Drug)
50 mg Grazoprevir - GT1
GT1 HCV-infected Participants: 50 mg Grazoprevir or Placebo
干预措施: Grazoprevir (Drug)
50 mg Grazoprevir - GT1
GT1 HCV-infected Participants: 50 mg Grazoprevir or Placebo
干预措施: Placebo (Drug)
200 mg Grazoprevir - GT3
GT3 HCV-infected Participants: 200 mg Grazoprevir or Placebo
干预措施: Grazoprevir (Drug)
200 mg Grazoprevir - GT3
GT3 HCV-infected Participants: 200 mg Grazoprevir or Placebo
干预措施: Placebo (Drug)
100 mg Grazoprevir - GT3
GT3 HCV-infected Participants: 100 mg Grazoprevir or Placebo
干预措施: Grazoprevir (Drug)
100 mg Grazoprevir - GT3
GT3 HCV-infected Participants: 100 mg Grazoprevir or Placebo
干预措施: Placebo (Drug)
50 mg Grazoprevir - GT3
GT3 HCV-infected Participants: 50 mg Grazoprevir or Placebo
干预措施: Grazoprevir (Drug)
50 mg Grazoprevir - GT3
GT3 HCV-infected Participants: 50 mg Grazoprevir or Placebo
干预措施: Placebo (Drug)
30 mg Grazoprevir - GT1
GT1 HCV-infected Participants: 30 mg Grazoprevir or Placebo
干预措施: Grazoprevir (Drug)
30 mg Grazoprevir - GT1
GT1 HCV-infected Participants: 30 mg Grazoprevir or Placebo
干预措施: Placebo (Drug)
10 mg Grazoprevir - GT1
GT1 HCV-infected Participants: 10 mg Grazoprevir or Placebo
干预措施: Grazoprevir (Drug)
10 mg Grazoprevir - GT1
GT1 HCV-infected Participants: 10 mg Grazoprevir or Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants With Clinical and Laboratory Adverse Events (AEs)
时间窗: All AEs: 15 Days after last dose; Serious AEs (SAEs) up to 2 months after last dose (Up to 67 days)
An AE is any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR's product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR's product, is also an AE.
次要结局
- Maximum log10 HCV RNA Reduction From Baseline Following Administration of Grazoprevir in Participants With GT1 HCV or Pooled GT1 and GT3 HCV Participants Treated With Placebo(Baseline and up to approximately 2 months)
- 24 Hour Plasma Concentration (C[24hr]) of Grazoprevir on Day 7(Day 7 at 24 hours post-dose)
- Area Under the Curve for 0 to 24 Hours Post-dose (AUC[0-24hr]) of Grazoprevir on Day 7(Day 7 at the following time points: pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, and 24 hours post-dose)
- Maximum log10 HCV RNA Reduction From Baseline Following Administration of Grazoprevir in Participants With GT3 HCV or Pooled GT1 and GT3 HCV Participants Treated With Placebo(Baseline and up to approximately 2 months)