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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 146 (actual)
• Sponsor: Eisai Inc. · Industry
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Accepted

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).

Detailed description

Healthy Volunteer (HV) Cohort: The HV Cohort comprises a randomized, double-blind, placebo-controlled, 3-period crossover study. Eligible healthy adult and elderly participants will be randomized to treatment sequence A, B, or C, each consisting of 3 Treatment Periods, each of one night's duration, in which participants will receive a single dose of lemborexant 10 milligrams (mg), or lemborexant 25 mg, or placebo. Treatment Periods will be separated by a washout interval of at least 14 days. A sufficient number of participants will be randomized to ensure that 8 evaluable adult participants (\<65 years) and 4 evaluable elderly participants (≥65 years) complete the study. OSA Cohort: The OSA Cohort comprises a multiple-dose, randomized, double-blind, placebo-controlled, 2-period crossover study. Adult and elderly participants with mild OSA will be randomized to treatment sequence D or E, each consisting of 2 Treatment Periods, each of 8 nights' duration, in which participants will receive lemborexant 10 mg or placebo. The Treatment Periods will be separated by a washout interval of at least 14 days. A sufficient number of participants will be randomized to ensure that 20 evaluable adult participants (\<65 years) and 10 evaluable elderly participants (≥65 years) complete the study.

Conditions

• Obstructive Sleep Apnea
• Healthy Subjects

Interventions

Type	Name	Description
DRUG	Placebo	HV: Lemborexant-matched oral placebo will be administered at bedtime in the clinic (within 5 minutes of lights off).
DRUG	Lemborexant 10 mg	HV: 10 mg oral lemborexant will be administered at bedtime in the clinic (within 5 minutes of lights off).
DRUG	Lemborexant 25 mg	HV: 25 mg oral lemborexant will be administered at bedtime in the clinic (within 5 minutes of lights off).
DRUG	Placebo	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.
DRUG	Lemborexant 10 mg	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.

Timeline

• Start date: 2018-02-21
• Primary completion: 2018-08-03
• Completion: 2018-08-03
• First posted: 2018-03-21
• Last updated: 2020-02-17
• Results posted: 2020-01-18

Locations

11 sites across 1 country: United States

Regulatory

• FDA-regulated drug study