Clinical trial NCT05702177: 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
Official title: 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Idorsia Pharmaceuticals Ltd.
Sponsor class: INDUSTRY
First posted: 2023-01-27
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: 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


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Treatment difference in postural stability (daridorexant and placebo)
timeFrame: Approximately 4 hours post-dose on Day 2 of the treatment period (daridorexant and placebo). Total duration: 12 hours.
Secondary outcomes:
measure: Treatment difference in auditory awakening threshold (daridorexant and placebo)
timeFrame: Approximately 4 hours post-dose on Day 2 of the treatment period (daridorexant and placebo). Total duration: 12 hours.
measure: Treatment difference in the timed up and go test (daridorexant and placebo)
timeFrame: Approximately 4 hours post-dose on Day 2 of the treatment period (daridorexant and placebo). Total duration: 12 hours.
measure: Treatment difference in the visual verbal learning test (daridorexant and placebo)
timeFrame: Approximately 4 hours post-dose on Day 2 of the treatment period (daridorexant and placebo). Total duration: 12 hours.
Other outcomes:
Locations:
city: Leiden
country: Netherlands
facility: Centre for Human Drug Research
Study officials:
affiliation: Idorsia Pharmaceuticals Ltd.
name: Clinical Trials
role: STUDY_DIRECTOR
References: