NCT02708004已完成1 期
A Single-center, Double-blind, Randomized, Placebo-controlled, Two-way Crossover Study to Assess Body Fluid Homeostasis After Administration of ACT-132577 in Healthy Subjects
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
- 24
- 试验地点
- 1
- 主要终点
- Body weight
研究概览
简要总结
This clinical study will be conducted to evaluate the effect of ACT-132577 on fluid homeostasis in healthy subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Signed informed consent
- •Healthy on the basis of medical history, physical examination, cardiovascular assessments and hematology, clinical chemistry, and urinalysis tests
- •Body mass index between 20.0 and 25.0 kg/m2 (inclusive) at screening
排除标准
- •Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol
研究组 & 干预措施
ACT-132577
Experimental
3 different dose levels
干预措施: Aprocitentan (Drug)
Placebo
Placebo Comparator
Matching active drug
干预措施: Placebo (Other)
结局指标
主要结局
Body weight
时间窗: from Day 1 to Day 9
Change from baseline
次要结局
未报告次要终点
研究者
研究点 (1)
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