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

PHASE1CompletedINTERVENTIONAL
Enrollment

146

Participants

Timeline

Start Date

February 21, 2018

Primary Completion Date

August 3, 2018

Study Completion Date

August 3, 2018

Conditions
Obstructive Sleep ApneaHealthy Subjects
Interventions
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.

Trial Locations (11)

10019

Clinilabs Drug Development, New York

20815

The Center for Sleep & Wake Disorders, Chevy Chase

21046

Advarra, Columbia

30342

Neurotrials Research, Inc, Atlanta

33024

Research Centers of America, Hollywood

33511

PAB Clinical Research, Brandon

45212

CTI Clinical Research Center, Cincinnati

45227

Community Research, Cincinnati

85006

Pulmonary Associates, PA, Phoenix

85306

PACT, Glendale

92103

Pacific Research Network. LLC, San Diego

All Listed Sponsors
collaborator

Purdue Pharma LP

INDUSTRY

lead

Eisai Inc.

INDUSTRY

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 | Biotech Hunter | Biotech Hunter