NCT04237597已完成1 期
Pharmacokinetic Drug-Drug Interaction Study Between K-877 and CSG452 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
- Area under the plasma concentration versus time curve (AUC)
研究概览
简要总结
A study to compare the pharmacokinetic(s) of K-877 and CSG452 when each drug is administered alone and when both are administered together.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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, at Screening.
- •Subject meets all other inclusion criteria outlined in the clinical study protocol
排除标准
- •Subject has clinically relevant abnormalities at Screening or at Check-in assessments.
- •Subject is pregnant or breastfeeding or intends to become pregnant within 30 days after the last dose of study drug.
- •Subject does not meet any other exclusion criteria outlined in the clinical study protocol.
研究组 & 干预措施
K-877 & CSG452
Experimental
K-877 Single dose on Day 1 and Day 15 CSG452 Repeat dose on Day 2 Through Day 15
干预措施: K-877 (Drug)
K-877 & CSG452
Experimental
K-877 Single dose on Day 1 and Day 15 CSG452 Repeat dose on Day 2 Through Day 15
干预措施: CSG452 (Drug)
结局指标
主要结局
Area under the plasma concentration versus time curve (AUC)
时间窗: 0 to 24 hours
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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