A Single-center, Single-blind, Randomized, Placebo-controlled, Sequential Design Phase 1 Study With the Inclusion of Two Double-blind Nested Crossover Parts to Investigate the Drug-drug Interactions Between ACT-541468 and Citalopram in Healthy Male and Female Subjects
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
- Change from baseline for Saccadic Peak Velocity (degrees/sec) to assess sedation
研究概览
简要总结
A clinical study to examine the drug-drug interactions between ACT-541468 and citalopram in healthy male and female 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
- Double (Participant, Investigator)
盲法说明
Double-blind to the administration of ACT-541468 (participant). Single- and double-blind to the administration of ACT-541468 (Investigator, single-/double blind is dependent on treatment arm team). Single-blind study with the inclusion of two double-blind nested crossover parts, i.e., subjects will remain blinded to all administrations of ACT-541468.
入排标准
- 年龄范围
- 24 Years 至 55 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 24 and 55 years (inclusive) at Screening.
- •Body mass index of 18.5 to 29.9 kg/m2 (inclusive) at Screening.
- •Women of childbearing potential must have a negative serum pregnancy test at Screening and a negative urine pregnancy test on Day -
- •They must consistently and correctly use a highly effective method of contraception, be sexually inactive, or have a vasectomized partner.
- •Women of non-childbearing potential (i.e., postmenopausal, with previous bilateral salpingectomy, bilateral salpingo oophorectomy or hysterectomy, or with premature ovarian failure, XY genotype, Turner syndrome, uterine agenesis).
- •Healthy on the basis of physical examination, cardiovascular assessments, and clinical laboratory tests.
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.
- •Modified Swiss Narcolepsy Scale total score < 0 at Screening or history of narcolepsy or cataplexy.
- •Any contraindication to citalopram or any other selective serotonin reuptake inhibitor.
- •History of cardiovascular disease (e.g., congenital long QT syndrome, arrhythmia).
- •Relevant history of a suicide attempt or suicidal behavior.
- •Personal or family history of psychiatric disorder(s).
- •Individuals of Asian descent.
- •History or clinical evidence of alcoholism or drug abuse within the 3-year period prior to Screening.
- •Excessive caffeine consumption, defined as ≥ 800 mg per day at screening.
- •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 or 5 terminal half-lives (t½; whichever is longer) prior to first study treatment administration.
- •Ongoing, recurrent, or chronic hypokalemia or hypomagnesemia.
研究组 & 干预措施
Treatment A and B
On Day 1 and Day 2, subjects will EITHER receive:
- a single dose of 50 mg ACT-541468 (Treatment A) on Day 1 and a single dose of ACT- 541468 placebo (Treatment B) on Day 2 OR
- a single dose of ACT-541468 placebo (Treatment B) on Day 1 and a single dose of 50 mg ACT-541468 (Treatment A) on Day 2.
干预措施: ACT541468 (Drug)
Treatment A and B
On Day 1 and Day 2, subjects will EITHER receive:
- a single dose of 50 mg ACT-541468 (Treatment A) on Day 1 and a single dose of ACT- 541468 placebo (Treatment B) on Day 2 OR
- a single dose of ACT-541468 placebo (Treatment B) on Day 1 and a single dose of 50 mg ACT-541468 (Treatment A) on Day 2.
干预措施: ACT541468 placebo (Drug)
Treatment C, D, E, and F
From Day 3 to Day 10, subjects will on each day receive:
• a single dose of 20 mg citalopram and EITHER a single dose of ACT-541468 placebo OR a single dose of 50 mg ACT-541468.
干预措施: ACT541468 (Drug)
Treatment C, D, E, and F
From Day 3 to Day 10, subjects will on each day receive:
• a single dose of 20 mg citalopram and EITHER a single dose of ACT-541468 placebo OR a single dose of 50 mg ACT-541468.
干预措施: ACT541468 placebo (Drug)
Treatment C, D, E, and F
From Day 3 to Day 10, subjects will on each day receive:
• a single dose of 20 mg citalopram and EITHER a single dose of ACT-541468 placebo OR a single dose of 50 mg ACT-541468.
干预措施: Citalopram (Drug)
结局指标
主要结局
Change from baseline for Saccadic Peak Velocity (degrees/sec) to assess sedation
时间窗: From pre-dose to 8 hours after dosing on Day 1, Day 2, Day 3, Day 9, and Day 10
次要结局
未报告次要终点