A Study to Evaluate the Respiratory Safety of Lemborexant in Adult and Elderly Participants With Moderate to Severe Obstructive Sleep Apnea, and in Adult and Elderly Participants With Moderate to Severe Chronic Obstructive Pulmonary Disease

Completed · Phase 1 · Has a placebo group

Conditions studied: Sleep Apnea, Obstructive, Pulmonary Disease, Chronic Obstructive, Respiration Disorders

In brief

The primary purpose of the study is to determine whether lemborexant increases the apnea hypopnea index (AHI) on Day 8 of treatment in adult and elderly participants (adults greater than or equal to \[\>=\] 45 to less than \[\<\] 65 years; elderly \>=65 to 90 years) with moderate to severe obstructive sleep apnea (OSA) compared with placebo, and using pulse oximetry determine whether lemborexant decreases the peripheral oxygen saturation (SpO2) during total sleep time (TST) on Day 8 of treatment in adult and elderly participants (adults \>=45 to \<65 years; elderly \>=65 to 90 years) with moderate to severe chronic obstructive pulmonary disease (COPD) compared with placebo.

Key facts

Study ID

NCT04647383

Run by

Eisai Inc.

People needed

63

Starts

2021-01-06

Expected to finish

2022-02-10

Last updated by the study team

2023-10-10

Who can join

Age: 45 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female, age >=45 and <=90 at the time of informed consent
• Voluntary agreement and ability to provide written informed consent
• Body mass index (BMI) <40 Kilogram per meter square (kg/m\^2)
• Reports habitually sleeping for at least 5.5 hours per night
• Reports habitual bedtime between 21:00 and midnight
• Agrees to stay in bed for 7 hours per night for the duration of the study
• At Screening Visit 2: Has completed the sleep diary for at least 5 consecutive nights
• At Screening Visit 2: Confirmation of mean habitual bedtime (MHB) between 21:00 and midnight (sleep diary)
• Additional Inclusion Criteria (OSA Cohort)
• Moderate to severe OSA diagnosed according to the criteria of the ICSD, confirmed by PSG (home sleep testing by portable monitor is acceptable) within the previous 5 years or a repeated PSG during screening
• On screening PSG: moderate OSA (defined as 15 <=AHI <30) or severe OSA (defined as AHI >=30 per hour)
• SpO2 >=94% assessed as part of vital signs at Screening Visit 1
• Additional Inclusion Criteria (COPD Cohort)
• Screening spirometry performed as per the Global Initiative for Obstructive Lung Disease (GOLD) recommendations
• On screening spirometry, based on post-bronchodilator Forced Expiratory Volume in 1 second (FEV1):
• FEV1/Forced Vital Capacity (FVC) <0.70 and one of the following:
• 50% <=FEV1 <80% predicted (GOLD 2 Classification for moderate COPD) or
• 30% <=FEV1 <50% predicted (GOLD 3 Classification for severe COPD)
• Moderate to severe COPD according to medical history and screening spirometry as per the GOLD criteria (GOLD 2019)
• On screening PSG
• AHI <15
• SpO2 during wakefulness >90% (both supine and sitting)
• SpO2 during sleep >=80% for at least 75% of the recording period with no more than five continuous minutes <80% and with no SpO2 readings <70%

You may not qualify if…

• Females of childbearing potential
• A current diagnosis of restless legs syndrome, periodic limb movement disorder, circadian rhythm sleep disorder, or narcolepsy
• Reports symptoms potentially related to narcolepsy, that in the clinical opinion of the investigator indicate the need for referral for a diagnostic evaluation for the presence of narcolepsy
• A history of symptoms of rapid eye movement (REM) Behavior Disorder, sleep-related violent behavior, sleep-driving, or sleep-eating, or symptoms of another parasomnia that in the investigator's opinion make the participant unsuitable for the study
• Periodic Limb Movement with Arousal Index (PLMAI) as measured on the screening
• PSG:
• Age 18 to <65 years: PLMAI >=10
• Age >65 years: PLMAI >15
• A prolonged QT interval by Fredericia (QTcF) (QTcF >450 milliseconds [ms]) as demonstrated by a repeated electrocardiogram (ECG) at Screening
• Any suicidal ideation with intent with or without a plan at Screening or within 6 months of Screening (that is, answering "Yes" to questions 4 or 5 on the Suicidal Ideation section of the Columbia-Suicide Severity Rating Scale [C-SSRS])
• Any lifetime suicidal behavior (per the Suicidal Behavior section of the C-SSRS) within 10 years of Screening
• Evidence of clinically significant disease (example, cardiac, respiratory, gastrointestinal, renal disease) that in the opinion of the investigator(s) could affect the participant's safety or interfere with the study assessments
• Hypersensitivity to the study drug or any of the excipients
• Used any prohibited prescription or over-the-counter medications within 1 week or 5 half-lives, whichever is longer, before the screening PSG
• Any history of or concomitant medical condition that in the opinion of the investigator(s) would compromise the participant's ability to safely complete the study
• Scheduled for surgery during the study that requires general anesthesia or administration of prohibited medications
• Psychotic disorder(s) or unstable recurrent affective disorder(s) evident by use of antipsychotics or prior suicide attempt(s) within approximately the last 2 years
• History of drug or alcohol dependency or abuse within approximately the last 2 years
• Use of illegal recreational drugs (includes marijuana, regardless of whether prescribed for medicinal use)
• Currently enrolled in another clinical study or used any investigational drug or device within 28 days or 5*the half-life, whichever is longer preceding informed consent
• Previously participated in other clinical trial of lemborexant
• Exposure within the last 14 days to an individual with confirmed or probable corona virus disease 2019 (COVID-19) or symptoms within the last 14 days that are on the most recent Centers for Disease Control and Prevention (CDC) list of COVID symptoms or any other reason to consider the participant at potential risk for an acute COVID-19 infection
• Additional Exclusion Criteria (OSA Cohort)
• SpO2 <80% for >=5% of TST during the screening PSG
• Use of a continuous positive airway pressure (CPAP) device or dental appliance within 2 weeks of the screening PSG, and does not agree to abstain from the use of a CPAP device or dental appliance from the

Where it is running

• Pulmonary Associates — Glendale, Arizona, United States
• Pacific Research Network — San Diego, California, United States
• Teradan Clinical Trials — Brandon, Florida, United States
• St. Francis Medical Institute — Clearwater, Florida, United States
• Research Centers of America — Hollywood, Florida, United States
• Clinical Trials of Florida, LLC — Miami, Florida, United States
• Clinical Site Partners Orlando, LLC — Winter Park, Florida, United States
• NeuroTrials Research Inc. — Atlanta, Georgia, United States
• GNP Research — Valdosta, Georgia, United States
• CTI Clinical Trial & Consulting Services — Cincinnati, Ohio, United States
• Intrepid Research, LLC — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

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