NCT02719431已完成1 期
Drug-Drug Interaction Study to Assess the Effects of Multiple-Dose Administration of K-877 on the Pharmacodynamics and the Pharmacokinetics of Multiple-Dose Administration of Warfarin in Healthy Adult Volunteers
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 20
- 主要终点
- International normalized ratio (INR)
研究概览
简要总结
The purpose of this study is to assess the effects of K-877 on the pharmacodynamics and the pharmacokinetics of warfarin in healthy adults volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject provides written informed consent before any study specific evaluation is performed.
- •Subject is a healthy adult male or female volunteer between the ages of 18 and 45 years, inclusive.
- •Subject has a body mass index of 18 to 30 kg/m², inclusive.
排除标准
- •Subject has clinically relevant abnormalities in the screening or check in assessments.
- •Subject has clinically significant out-of-range PT, INR, activated partial thromboplastin time, fibrinogen, protein C, or protein S.
- •Subject has abnormal prolongation of skin bleeding time at Screening.
研究组 & 干预措施
Warfarin/Warfarin + K-877
Other
干预措施: Warfarin (Drug)
Warfarin/Warfarin + K-877
Other
干预措施: K-877 (Drug)
结局指标
主要结局
International normalized ratio (INR)
时间窗: 22 Days
次要结局
未报告次要终点
研究者
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