A Single-center, Double-blind, Placebo-controlled, Randomized Study to Investigate the Tolerability, Safety, Pharmacokinetics, and Pharmacodynamics of Single- and Multiple-dose ACT-541468 in Healthy Japanese and Caucasian Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Maximum plasma concentration (Cmax) of ACT-541468
研究概览
简要总结
So far, ACT-541468 has been studied mainly in Caucasian subjects. The present study will bridge results obtained in Caucasian subjects to those in Japanese subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Signed informed consent form;
- •Healthy male and female subjects aged between 20 and 50 years (inclusive) at screening;
- •Negative serum pregnancy tests at screening and negative urine pregnancy test at Day 1 for women of childbearing potential and agreement to use a reliable method of contraception for at least 90 days after last study drug intake;
- •Body mass index (BMI) of 18.0 to 26.0 kg/m2 (inclusive) at screening;
- •Healthy on the basis of physical examination, cardiovascular assessments and laboratory tests;
- •Caucasian or Japanese ethnicity.
- •Japanese subjects only:
- •must be of native Japanese descent (all parents/grandparents of Japanese descent);
- •must not have been away from Japan for more than 10 years (at screening visit);
- •lifestyle should not have changed significantly since relocation from Japan.
排除标准
- •Any contraindication to the study treatments;
- •History or clinical evidence of any disease or medical / surgical condition or treatment, which may put the subject at risk of participation in the study or may interfere with the absorption, distribution, metabolism or excretion of the study treatments;
- •History of narcolepsy or cataplexy or modified Swiss narcolepsy scale total score < 0;
- •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-541468 (25 mg)
8 Japanese and 8 Caucasian subjects will receive 25 mg (1 capsule) of ACT-541468 once daily for 5 days
干预措施: ACT-541468 (Drug)
ACT-541468 (50 mg)
8 Japanese and 8 Caucasian subjects will receive 50 mg (2 capsules) of ACT-541468 once daily for 5 days
干预措施: ACT-541468 (Drug)
Placebo
2 Japanese / 2 Caucasian subjects will receive 1 placebo capsule to match subjects in the ACT-541468 (25 mg) group and 2 other Japanese / 2 Caucasian subjects will receive 2 placebo capsules to match subjects in the ACT-541468 (50 mg) group
干预措施: placebo (Drug)
结局指标
主要结局
Maximum plasma concentration (Cmax) of ACT-541468
时间窗: From Day1 pre-dose to 48 hours after the last dose on Day 5
The geometric mean Cmax values will be calculated based on pharmacokinetic (PK) blood sampling
Area under the plasma concentration-time curves during a dosing interval [AUC(0-24)] of ACT-541468
时间窗: From Day1 pre-dose to 48 hours after the last dose on Day 5
The geometric mean AUC(0-24) values will be calculated based on PK blood sampling
次要结局
- Terminal half-life [t(1/2)] of ACT-541468(From Day1 pre-dose to 48 hours after the last dose on Day 5)
- Incidence of treatment-emergent adverse events(Up to Day 7 (end of study))
- Time to reach Cmax (tmax) of ACT-541468(From Day1 pre-dose to 48 hours after the last dose on Day 5)
- Incidence of adverse events leading to premature discontinuation of study treatment(Up to Day 5)
- Incidence of any clinical relevant findings in ECG variables(Up to Day 7 (end of study))
- Area under the plasma concentration-time curves from time 0 to 8 h [AUC(0-8)](From Day1 pre-dose to 48 hours after the last dose on Day 5)