A Phase 1 interventional study of Daridorexant 25 mg and Daridorexant 50 mg in Healthy, sponsored by Idorsia Pharmaceuticals Ltd.. Completed at 1 site in Netherlands. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-05-12.
Sponsored by Idorsia Pharmaceuticals Ltd. · Phase 1, Interventional, and Other
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
Idorsia Pharmaceuticals Ltd. is the lead sponsor of 103 studies on the registry; 5 are open to participants now.
Of its 28 completed or terminated interventional studies of FDA-regulated products, 9 (32%) have results posted.
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Exclusion Criteria:
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
Subjects will receive a daridorexant 25 mg tablet for oral administration.
Drug: Daridorexant 25 mg
Subjects will receive a daridorexant 50 mg tablet for oral administration.
Drug: Daridorexant 50 mg
Subjects will receive a daridorexant-matching placebo tablet for oral administration.
Drug: Placebo
A single-dose of daridorexant 25 mg will be administered in the evening 30 minutes prior to bedtime.
Also known as: Quviviq
A single-dose of daridorexant 50 mg will be administered in the evening 30 minutes prior to bedtime.
Also known as: Quviviq
A single-dose of placebo matching daridorexant will be administered in the evening 30 minutes prior to bedtime.
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.
Time frame: 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)
The auditory awakening threshold will be assessed at 4 h post dose by applying a 1000 Hz tone, starting at a noise level of 35 dB, increasing in steps of 5 dB until either the subject is awake, or the maximum noise level (100 dB) is reached. The tone will be delivered via a calibrated loudspeaker for 3 s with a 15 s interval between the different noise levels. The subjects must confirm awakening by verbally saying "I'm awake" or similar response, e.g., waving a hand. If a subject does not respond after receiving the initial 100 dB tone, additional 100 dB stimuli will be applied in 15 s intervals for up to 2 min. The outcome measure is the noise level (dB) at which subjects indicate that they are awake. If a subject remains asleep, he/she will be physically awakened by a technician. If a subject will not awaken to any of the tones presented, the maximum 100 dB tone will be recorded as the auditory awakening threshold.
Time frame: 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)
Time frame: 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)
Time frame: Approximately 4 hours post-dose on Day 2 of the treatment period (daridorexant and placebo). Total duration: 12 hours.
Plan to share: No
This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Daridorexant
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