A Phase Ib Randomized, Placebo-Controlled Clinical Trial to Study the Safety and Efficacy of MK7009 in Hepatitis C Infected Patients
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 40
- 主要终点
- Safety and Tolerability of MK7009
研究概览
简要总结
The purpose of this study is to investigate the effectiveness, safety, and tolerability of MK7009 in patients infected with Hepatitis C
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is a man or a woman aged 18 to 55 years of age.
- •Subject has chronic Hepatitis C
- •Subject is willing to not use alcohol for 2 weeks prior to therapy and through the study follow-up period
排除标准
- •Patient has evidence of advanced liver disease.
- •Patient has human immunodeficiency virus (HIV)
- •Patient has Hepatitis B
研究组 & 干预措施
8
Placebo
干预措施: Comparator: Placebo (Drug)
1
25 mg b.i.d. MK7009
干预措施: Comparator: MK7009 (Drug)
2
75 mg b.i.d. MK7009
干预措施: Comparator: MK7009 (Drug)
3
250 mg b.i.d. MK7009
干预措施: Comparator: MK7009 (Drug)
4
500 mg b.i.d. MK7009
干预措施: Comparator: MK7009 (Drug)
5
700 mg b.i.d. MK7009
干预措施: Comparator: MK7009 (Drug)
6
125 mg q.d. MK7009
干预措施: Comparator: MK7009 (Drug)
7
600 mg q.d. MK7009
干预措施: Comparator: MK7009 (Drug)
结局指标
主要结局
Safety and Tolerability of MK7009
时间窗: 14 days after completion of study therapy
Number of participants who reported adverse experiences while on study medication as well as for 14 days after completion of study medication
Antiviral Activity of MK7009
时间窗: Baseline and Day 8
Change from Baseline in Log10 IU/mL hepatitis C virus (HCV) ribonucleic acid (RNA) on Day 8
次要结局
未报告次要终点