NL-OMON51304已完成不适用
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 - Study investigating the effects of daridorexant in healthy subjects
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Signed informed consent in a language understandable to the subject prior to
- •any study-mandated procedure.
- •2. Male and female subjects aged >= 18 years at Screening (18 subjects must be >=
- •3. 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 < 1% per year, be
- •sexually inactive, or have a vasectomized partner. If a hormonal contraceptive
- •is used, it must be initiated at least 1 month before first treatment
- •administration.
- •4. 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 salpingo-oophorectomy or hysterectomy, or
- •with premature ovarian failure (confirmed by a specialist), XY genotype, Turner
- •syndrome, or uterine agenesis.
- •5. Body mass index (BMI) of 18.0 to 35.0 kg/m2 (inclusive) at Screening.
- •6. Ability to communicate well with the investigator, in a language
- •understandable to the subject, and to understand and comply with the study
- •requirements.
- •7. Usual bedtime between 21:30 and 00:30 and usual sleep duration of at least 6
排除标准
- •1. Known hypersensitivity to daridorexant, or treatments of the same class, or
- •any of its excipients.
- •2. History of narcolepsy.
- •6. 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
- •non-compliance with medical regimen; history of hearing impairment, psychiatric
- •disease; or neurological disorder that may impact sleep, motor performance, or
- •cognition, including Parkinson disease, predementia, dementia, other
- •neurodegenerative disorder, and stroke.
- •16. Shift work within 2 weeks prior to Screening, or planned shift work during
- •17. Travel across >= 3 time zones within 1 week prior to Screening, or planned
- •travel across >= 3 time zones during the study.
- •18. 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 cytochrome P450 (CYP)3A4 inhibitors or inducers.
- •19. Mini Mental State Examination (MMSE) score < 25 in subjects >= 65 years at
研究者
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