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

Sponsor
Idorsia Pharmaceuticals Ltd.
Study ID
NCT05702177
Phase
PHASE1
Status
Completed

Conditions

  • Healthy

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Daridorexant 25 mg — DRUG
    A single-dose of daridorexant 25 mg will be administered in the evening 30 minutes prior to bedtime.
  • Daridorexant 50 mg — DRUG
    A single-dose of daridorexant 50 mg will be administered in the evening 30 minutes prior to bedtime.
  • Placebo — DRUG
    A single-dose of placebo matching daridorexant will be administered in the evening 30 minutes prior to bedtime.

Study Details

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

Key Dates

Start date
Jan 5, 2023
Status verified
May 2023
Primary completion
Apr 25, 2023
Completion
Apr 25, 2023

Study Design

Enrollment
36 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER

Arms

  • Experimental: Daridorexant 25 mg
    Subjects will receive a daridorexant 25 mg tablet for oral administration.
  • Experimental: Daridorexant 50 mg
    Subjects will receive a daridorexant 50 mg tablet for oral administration.
  • Placebo Comparator: Placebo
    Subjects will receive a daridorexant-matching placebo tablet for oral administration.

Primary Outcome Measure

Treatment difference in postural stability (daridorexant and placebo) [ Time Frame: Approximately 4 hours post-dose on Day 2 of the treatment period (daridorexant and placebo). Total duration: 12 hours. ]

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