A Double-blind, Randomized, Placebo-controlled, Double-dummy, Four-way Crossover Study to Investigate the Drug-drug Interactions Between ACT-541468 and Ethanol in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Change from baseline for saccadic peak velocity (degrees/sec) to assess sedation
研究概览
简要总结
A study to investigate the drug-drug interactions between ACT-541468 and ethanol 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
- All
- 接受健康志愿者
- 是
入选标准
- •Signed informed consent prior to any study-mandated procedure.
- •Healthy male and female subjects aged between 18 and 45 years (inclusive) at screening.
- •Women of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test on Day 1 pre-dose of each treatment period. They must consistently and correctly use a reliable method of contraception, be sexually inactive, or have a vasectomized partner.
- •Women of non-childbearing potential (i.e., postmenopausal).
- •Body mass index of 18.0 to 32.0 kg/m2 (inclusive) at screening.
- •Healthy on the basis of medical history, physical examination, cardiovascular assessments and serology and laboratory tests.
- •Previous experience with alcohol consumption and, therefore, familiar with the effects of alcohol.
排除标准
- •Pregnant or lactating women.
- •Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol.
- •Excessive caffeine consumption, defined as ≥ 800 mg per day at screening.
- •Nicotine intake within 3 months prior to screening and inability to refrain from nicotine intake from screening until End-of-Study (EOS).
- •Previous treatment with any prescribed medications (including vaccines) or over-the-counter (OTC) medications (including herbal medicines such as St John's Wort, homeopathic preparations, vitamins, and minerals) within 2 weeks prior to first study treatment administration.
- •History or clinical evidence of alcoholism or drug abuse.
- •History of regular alcohol consumption within 6 months of the study defined as an average weekly intake of more than 21 units or an average daily intake of more than 3 units (males), or defined as an average weekly intake of more than 14 units or an average daily intake of more than 2 units (females).
- •Individuals of Asian descent or other individuals reporting ethanol intolerance.
- •Modified Swiss Narcolepsy Scale total score < 0 at screening or history of narcolepsy or cataplexy.
研究组 & 干预措施
Treatment A (ethanol + ACT-541468)
5 h i.v. ethanol clamp at a level of 0.6 g/L in combination with a single oral dose of ACT-541468 (50 mg)
干预措施: ACT-541468 (Drug)
Treatment A (ethanol + ACT-541468)
5 h i.v. ethanol clamp at a level of 0.6 g/L in combination with a single oral dose of ACT-541468 (50 mg)
干预措施: Ethanol 10% (Other)
Treatment B (ethanol placebo + ACT-541468)
5 h i.v. placebo clamp in combination with a single oral dose of ACT-541468 (50 mg)
干预措施: ACT-541468 (Drug)
Treatment B (ethanol placebo + ACT-541468)
5 h i.v. placebo clamp in combination with a single oral dose of ACT-541468 (50 mg)
干预措施: Ethanol placebo (Other)
Treatment C (ethanol + ACT-541468 placebo)
5 h i.v. ethanol clamp at a level of 0.6 g/L in combination with a single oral dose of matching ACT-541468 placebo
干预措施: ACT-541468 placebo (Other)
Treatment C (ethanol + ACT-541468 placebo)
5 h i.v. ethanol clamp at a level of 0.6 g/L in combination with a single oral dose of matching ACT-541468 placebo
干预措施: Ethanol 10% (Other)
Treatment D (ethanol placebo + ACT-541468 placebo)
5 h i.v. placebo clamp in combination with a single oral dose of matching ACT-541468 placebo
干预措施: ACT-541468 placebo (Other)
Treatment D (ethanol placebo + ACT-541468 placebo)
5 h i.v. placebo clamp in combination with a single oral dose of matching ACT-541468 placebo
干预措施: Ethanol placebo (Other)
结局指标
主要结局
Change from baseline for saccadic peak velocity (degrees/sec) to assess sedation
时间窗: Several timepoints on Day 1; for up to 24 hours post-dose
次要结局
未报告次要终点