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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Idorsia Pharmaceuticals Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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

Interventions

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

Timeline

• Start date: 2023-01-05
• Primary completion: 2023-04-25
• Completion: 2023-04-25
• First posted: 2023-01-27
• Last updated: 2023-05-12

Locations

1 site across 1 country: Netherlands

Regulatory

• FDA-regulated drug study