At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Double-Blind, Placebo-Controlled, Crossover Study to Evaluate the Respiratory Safety of Lemborexant in Adult and Elderly Healthy Subjects and Adult and Elderly Subjects With Mild Obstructive Sleep Apnea
In Brief
A Phase 1 clinical trial evaluating Placebo, Lemborexant 10 mg, and 1 other intervention for Obstructive Sleep Apnea and Healthy Subjects. Completed, enrolled 146 participants across 11 sites.
Detailed Summary
This study will be conducted to determine whether lemborexant as compared to placebo decreases the peripheral oxygen saturation during total sleep time in healthy adult and elderly participants after a single dose of treatment and to determine whether it increases the apnea-hypopnea index after single and multiple doses of treatment in adult and elderly participants with mild obstructive sleep apnea (OSA).
Study Details
Timeline
Interventions
HV: Lemborexant-matched oral placebo will be administered at bedtime in the clinic (within 5 minutes of lights off).
HV: 10 mg oral lemborexant will be administered at bedtime in the clinic (within 5 minutes of lights off).
HV: 25 mg oral lemborexant will be administered at bedtime in the clinic (within 5 minutes of lights off).
OSA: Lemborexant-matched oral placebo will be administered at bedtime in the clinic (within 5 minutes of lights off) in the evening of Days 1 and 8. On Days 2 to 7, participants will take study drug at home, immediately (within 5 minutes) of the time they intend to try to sleep.
OSA: 10 mg oral lemborexant will be administered at bedtime in the clinic (within 5 minutes of lights off) in the evening of Days 1 and 8. On Days 2 to 7, participants will take study drug at home, immediately (within 5 minutes) of the time they intend to try to sleep.