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

NCT05702177 | Completed Phase 1 FDA Drug

• 3 other identifiers: ID-078-1182022-002922-28NL83038.056.22
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Treatment difference in postural stability (daridorexant and placebo)

  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.

  Approximately 4 hours post-dose on Day 2 of the treatment period (daridorexant and placebo). Total duration: 12 hours.

Secondary Outcomes (3)

• 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.

• 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.

Study Arms (3)

Daridorexant 25 mg

EXPERIMENTAL

Subjects will receive a daridorexant 25 mg tablet for oral administration.

Drug: Daridorexant 25 mg

Daridorexant 50 mg

EXPERIMENTAL

Subjects will receive a daridorexant 50 mg tablet for oral administration.

Drug: Daridorexant 50 mg

Placebo

PLACEBO COMPARATOR

Subjects will receive a daridorexant-matching placebo tablet for oral administration.

Drug: Placebo

Interventions

Daridorexant 25 mg DRUG

A single-dose of daridorexant 25 mg will be administered in the evening 30 minutes prior to bedtime.

Also known as: Quviviq

Daridorexant 25 mg

Daridorexant 50 mg DRUG

A single-dose of daridorexant 50 mg will be administered in the evening 30 minutes prior to bedtime.

Also known as: Quviviq

Daridorexant 50 mg

Placebo DRUG

A single-dose of placebo matching daridorexant will be administered in the evening 30 minutes prior to bedtime.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Idorsia Pharmaceuticals Ltd.: lead

Study Sites (1)

Centre for Human Drug Research

Leiden, 2333CL, Netherlands

Location

Related Publications (1)

• Magliocca M, Koopmans I, Vaillant C, Lemoine V, Zuiker R, Dingemanse J, Muehlan C. Nighttime safety of daridorexant: Evaluation of responsiveness to an external noise stimulus, postural stability, walking, and cognitive function. J Psychopharmacol. 2025 Mar;39(3):223-232. doi: 10.1177/02698811241293997. Epub 2024 Dec 6.

  PMID: 39641404 DERIVED

MeSH Terms

Interventions

daridorexant

Study Officials

• Clinical Trials

  Idorsia Pharmaceuticals Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2023
• First Posted: January 27, 2023
• Study Start: January 5, 2023
• Primary Completion: April 25, 2023
• Study Completion: April 25, 2023
• Last Updated: May 12, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)