drugset / Trial / NCT03471871

Study to Evaluate the Respiratory Safety of Lemborexant in Adult and Elderly Healthy Subjects and Adult and Elderly Subjects With Mild Obstructive Sleep Apnea

NCT03471871

Phase 1 Completed 146 enrolled Eisai Inc. Purdue Pharma LP · collab
RandomizedCrossoverDouble-blindOther

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).

Timeline

Start
2018-02-21
Primary completion
2018-08-03
Completion
2018-08-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Lemborexant Small molecule 10 mg Oral
Subject Lemborexant Small molecule 25 mg Oral