NCT02276001已完成1 期
Drug-Drug Interaction Study 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
- 试验地点
- 1
- 主要终点
- Maximum concentration (Cmax)
研究概览
简要总结
The primary objective of this study is to assess the effects of cyclosporine on the pharmacokinetics of K-877 in healthy adult subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 is a healthy adult male or female volunteer between the ages of 18 and 45 years, inclusive, at Screening.
- •Subject has a body mass index of 18 to 30 kg/m2, inclusive, at Screening.
- •Subject has hematology, serum chemistry, and urinalysis test results within the reference ranges or is showing no clinically relevant deviations, as judged by the investigator at Screening.
排除标准
- •Subject has clinically relevant abnormalities in the screening or check in assessments.
- •Subject has a blood pressure (as measured at Screening during the collection of vital signs) after resting supine for at least 5 minutes that is higher than 140 mm Hg systolic or 90 mm Hg diastolic, or lower than 90 mm Hg systolic or 60 mm Hg diastolic (for males) and 50 mm Hg diastolic (for females).
- •Subject has a supine pulse rate (as measured at Screening during collection of vital signs) after resting for 5 minutes that is outside the range of 40 to 90 beats per minute.
研究组 & 干预措施
K-877 with Cyclosporine
Experimental
K-877 with Cyclosporine
干预措施: Cyclosporine (Drug)
K-877
Experimental
K-877
干预措施: K-877 (Drug)
K-877 with Cyclosporine
Experimental
K-877 with Cyclosporine
干预措施: K-877 (Drug)
结局指标
主要结局
Maximum concentration (Cmax)
时间窗: 72 hours
次要结局
- Area under concentration curve (AUC)(72 hours)
研究者
研究点 (1)
Loading locations...
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