NCT03796026

A Study to Assess the Effect of Seltorexant Compared to Placebo on Respiration During Sleep in Adult Participants With Obstructive Sleep Apnea

A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose, 2-period, Crossover, Sleep Laboratory Study to Assess the Effect of Seltorexant Compared to Placebo on Respiration During Sleep in Adult Patients With Obstructive Sleep Apnea

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Janssen Research & Development, LLC · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the effect of multiple doses of seltorexant compared with placebo on respiration during sleep in adult participants with mild to moderate obstructive sleep apnea.

Conditions

• Sleep Apnea, Obstructive

Interventions

Type	Name	Description
DRUG	Seltorexant 40 mg	Seltorexant 40 mg capsules (over-encapsulated tablets) will be administered orally.
DRUG	Placebo	Matching placebo to seltorexant 40 mg capsules (over-encapsulated tablets) will be administered orally.

Timeline

• Start date: 2019-01-04
• Primary completion: 2019-06-07
• Completion: 2019-06-14
• First posted: 2019-01-08
• Last updated: 2025-04-27

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study