NCT03799978已完成1 期
A Single-center, Open-label, Randomized, Two Way Crossover Study to Investigate the Food Effect on the Pharmacokinetics of ACT-541468 in Healthy Male 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
- 20
- 试验地点
- 1
- 主要终点
- Pharmacokinetic endpoint: AUC0-24
研究概览
简要总结
This is a single-center, open-label, randomized, two way crossover study to investigate the food effect on the pharmacokinetics of ACT-541468 in healthy male 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
- None
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 prior to any study-mandated procedure
- •Healthy male subjects aged between 18 and 45 years (inclusive) at Screening
- •Body mass index (BMI) of 18.0 to 28.0 kg/m2 (inclusive) at Screening
- •No clinically relevant findings on the physical examination at Screening
排除标准
- •History of major medical or surgical disorders, which, in the opinion of the investigator, are likely to interfere with the absorption, distribution, metabolism, or excretion of the study treatments (appendectomy and herniotomy allowed, cholecystectomy not allowed)
- •Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol
- •Modified Swiss Narcolepsy Scale total score < 0 at screening or history of narcolepsy or cataplexy
研究组 & 干预措施
Treatment A: ACT-541468 50 mg under fasted conditions
Experimental
Single oral dose administered on Day 1 under fasted conditions.
干预措施: ACT-541468 (Drug)
Treatment B: ACT-541468 50 mg under fed conditions
Experimental
Single oral dose administered on Day 1 administered after food intake.
干预措施: ACT-541468 (Drug)
结局指标
主要结局
Pharmacokinetic endpoint: AUC0-24
时间窗: Multiple timepoints; duration: up to 48 hours in each treatment period
Area under the plasma concentration-time curve (AUC) from time zero to 24 h
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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