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
- Conditions
- InsomniaSleeplessness10040998
- Registration Number
- NL-OMON51304
- Lead Sponsor
- Idorsia Pharmaceuticals Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 36
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 >=
65 years).
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
h.
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
the study.
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
Screening.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Pharmacodynamic endpoints </p><br>
- Secondary Outcome Measures
Name Time Method <p>Safety and tolerability endpoints </p><br>