Phase I,Randomized,Double-blind,Placebo-controlled,Multiple Dose Study Evaluating Safety,Tolerability,Pharmacokinetics and Antiviral Activity of JTK-853 in HCV Genotype 1 Infected Subjects,Followed by a Genotypic Resistance Monitoring Study
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- Number of subjects with adverse events
研究概览
简要总结
The purpose of this study was to determine the safety, tolerability, pharmacokinetics and anti-viral activity of JTK-853 in hepatitis C virus genotype 1 infected subjects based on reduction in viral load (HCV RNA level) from baseline to end of treatment, followed by genotypic resistance monitoring for up to one year after study drug treatment.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females infected with chronic hepatitis C virus (HCV) infection and genotype 1a or 1b
- •Subjects with a viral load (HCV RNA level) of ≥50,000 IU/mL
- •Subjects with a body mass index (BMI) of 18.0-36.0 kg/m2 (inclusive)
排除标准
- •Subjects should not have previously received a direct acting anti-HCV agent
- •Subjects should not previously have received pegylated interferon/ribavirin for a duration of more than two weeks
研究组 & 干预措施
Dose 1 JTK-853
干预措施: JTK-853 (Drug)
Dose 2 JTK-853
干预措施: Dose 2 JTK-853 (Drug)
Dose 3 JTK-853
干预措施: Dose 3 JTK-853 (Drug)
Dose 4 JTK-853
干预措施: Dose 4 JTK-853 (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Number of subjects with adverse events
时间窗: 1 week
Maximum concentration (Cmax) of JTK-853 and metabolite M2
时间窗: 1 week
Time to reach maximum concentration (tmax) for JTK-853 and metabolite M2
时间窗: 1 week
Area under the concentration-time curve during the dosing interval (AUCtau) for JTK-853 and Metabolite M2
时间窗: 1 week
Trough concentration during multiple dosing prior to next dose (Ctrough) for JTK-853 and metabolite M2
时间窗: 1 week
Viral load change from baseline to end of treatment
时间窗: 48 weeks
Genotypic resistance assessment and viral load change from baseline over time
时间窗: 48 weeks
次要结局
未报告次要终点