NCT05702177已完成1 期
Single-center, Randomized, Double-blind, Single-dose, 3-way Crossover Study to Compare the Effects of Daridorexant and Placebo on Postural Stability, the Auditory Awakening Threshold, and Cognitive Function in the Middle-of-the-night Following Evening Administration to Healthy Adult and Elderly 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
- 36
- 试验地点
- 1
- 主要终点
- Treatment difference in postural stability (daridorexant and placebo)
研究概览
简要总结
A Study of the Effect of Daridorexant on Nighttime Body Posture, the Noise Level Required to Wake up, and the Ability to Remember Words Previously Presented
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Signed informed consent in a language understandable to the subject prior to any study-mandated procedure.
- •Male and female subjects aged 18 years or older at Screening (18 subjects must be 65 years or older).
- •Woman of childbearing potential (WoCBP) who has a negative serum pregnancy test at Screening and a negative urine pregnancy test on Day 1 pre-dose. She must agree to use consistently and correctly (from Screening, during the entire study, and for at least 5-7 days after last study treatment administration) an acceptable method of contraception with a failure rate of less than 1% per year, be sexually inactive, or have a vasectomized partner. If a hormonal contraceptive is used, it must be initiated 1 month before first treatment administration.
- •Woman of non-childbearing potential, i.e., postmenopausal (defined as 12 consecutive months with no menses without an alternative medical cause, confirmed by a follicle-stimulating hormone [FSH] test), with previous bilateral salpingectomy, bilateral-oophorectomy or hysterectomy, or with premature ovarian failure (confirmed by a specialist), XY genotype, Turner syndrome, or uterine agenesis.
- •Body mass index (BMI) of 18.0 to 35.0 kg/m2 (inclusive) at Screening.
- •Ability to communicate well with the investigator, in a language understandable to the subject, and to understand and comply with the study requirements.
排除标准
- •Known hypersensitivity to daridorexant, or treatments of the same class, or any of its excipients.
- •Any known factor or disease (e.g., unstable medical condition, significant medical disorder, or acute illness) that might interfere with subject's safety, study conduct, or interpretation of the results, such as
- •History of narcolepsy.
- •Shift work within 2 weeks prior to Screening, or planned shift work during the study.
- •Travel across 3 or more time zones within 1 week prior to Screening, or planned travel across 3 or more time zones during the study.
- •Previous (i.e., within 2 weeks prior to first study treatment administration) and ongoing treatment with any prescribed central nervous system (CNS)-active medications, and/or diuretics that would affect nighttime rest, and/or moderate to strong cytochromes P450(CYP)3A4 inhibitors or inducers.
研究组 & 干预措施
Daridorexant 25 mg
Experimental
Subjects will receive a daridorexant 25 mg tablet for oral administration.
干预措施: Daridorexant 25 mg (Drug)
Daridorexant 50 mg
Experimental
Subjects will receive a daridorexant 50 mg tablet for oral administration.
干预措施: Daridorexant 50 mg (Drug)
Placebo
Placebo Comparator
Subjects will receive a daridorexant-matching placebo tablet for oral administration.
干预措施: Placebo (Drug)
结局指标
主要结局
Treatment difference in postural stability (daridorexant and placebo)
时间窗: Approximately 4 hours post-dose on Day 2 of the treatment period (daridorexant and placebo). Total duration: 12 hours.
Postural stability in the MOTN (at 4 h post-dose) evaluated by body sway. Body sway will be assessed approximately 5 min after awakening, with the subject standing comfortably, with eyes closed, using a body sway meter (string attached to the waist). Body movements over 2 min are integrated and expressed as mm sway.
次要结局
- Treatment difference in the visual verbal learning test (daridorexant and placebo)(Approximately 4 hours post-dose on Day 2 of the treatment period (daridorexant and placebo). Total duration: 12 hours.)
- Treatment difference in auditory awakening threshold (daridorexant and placebo)(Approximately 4 hours post-dose on Day 2 of the treatment period (daridorexant and placebo). Total duration: 12 hours.)
- Treatment difference in the timed up and go test (daridorexant and placebo)(Approximately 4 hours post-dose on Day 2 of the treatment period (daridorexant and placebo). Total duration: 12 hours.)
研究者
研究点 (1)
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