NCT02922465已完成1 期
Drug-Drug Interaction Study to Assess the Effects of Multi Dose Clopidogrel on the Pharmacokinetics of Single-Dose K-877 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
- Plasma exposure of K-877 by measuring Cmax when administered alone or with Clopidogrel
研究概览
简要总结
The primary objective of this study is to assess the effects of clopidogrel on the PK of K-877 in healthy adult subjects.
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 at screening;
- •Subject has a BMI of 18 to 30 kg/m², inclusive;
- •Subject has hematology, serum chemistry, and urinalysis test results within the reference ranges, or results that do not show clinically significant abnormalities, as judged by the Investigator at screening and check-in;
排除标准
- •Subject is a woman who is pregnant or breastfeeding;
- •Subject has clinically significant abnormalities in the screening or check-in assessments;
- •Subject has current or history of clinically significant coagulation, bleeding, or platelet disorders;
- •Subject or a family member of the subject has a history of coagulation or bleeding disorders or reasonable suspicion of vascular malformations, including aneurysms;
研究组 & 干预措施
K-877 & Clopidogrel
Experimental
K-877 & Clopidogrel orally
干预措施: K-877 (Drug)
K-877 & Clopidogrel
Experimental
K-877 & Clopidogrel orally
干预措施: Clopidogrel (Drug)
结局指标
主要结局
Plasma exposure of K-877 by measuring Cmax when administered alone or with Clopidogrel
时间窗: Up to 72 hours after dosing
Plasma exposure of K-877 by measuring AUC when administered alone or with Clopidogrel
时间窗: Up to 72 hours after dosing
次要结局
- Evaluation of 20 participants with treatment emergent adverse events as assessed by the principle investigator(Through study completion up to 17 days.)
研究者
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