Obstructive Sleep ApneaPhase 1NCT03471871
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 Phase 1 study testing Lemborexant 10 mg and Lemborexant 25 mg in people with Obstructive Sleep Apnea and Healthy Subjects, run by Eisai Inc. at 11 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Obstructive Sleep Apnea, Healthy Subjects
- What is being tested?
- Lemborexant 10 mg and Lemborexant 25 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 146 participants
- Where
- 11 sitesUnited States
- Study dates
- 21 Feb 2018to 3 Aug 2018
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants must meet all of the following criteria to be included in this study:
- Male or female, age ≥18 years and ≤90 years at the time of informed consent
- Voluntary agreement and ability to provide written informed consent
- Reports habitually sleeping for at least 5.5 hours per night
- Agrees to stay in bed for 7 hours per night for the duration of treatment
- Reports habitual bedtime between 21:00 and 01:00
Show all 14Show fewer
- Peripheral capillary oxygen saturation (SpO2) ≥94% assessed as part of vital signs at Screening Visit 1
- Additional Inclusion Criteria (Healthy Volunteer [HV] Cohort):
- Body mass index (BMI) less than or equal to 32 kilograms per meters squared (kg/m^2)
- On screening polysomnography (PSG) (Screening Visit 2): apnea-hypopnea index (AHI) <5
- Additional Inclusion Criteria (Obstructive Sleep Apnea [OSA] Cohort):
- BMI ≤40 kg/m^2
- OSA, diagnosed according to the criteria of the International Classification of Sleep Disorders, version 3
- On Screening PSG: AHI ≥5 to <15 (mild severity)
Who cannot join
- 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 a parasomnia or parasomnia observed on the Screening PSG that in the investigator's opinion makes 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
Show all 32Show fewer
- History of or suspected drug or alcohol use disorder within approximately 2 previous years
- A positive urine drug test or breath alcohol test at Screening or Baseline, or unwilling to refrain from use of recreational drugs during the study
- Known to be human immunodeficiency virus positive
- Active viral hepatitis (B or C) as demonstrated by positive viral serology at Screening
- A prolonged QT/corrected QT (QTc) interval (QT interval corrected for heart rate using Fridericia's formula [QTcF] >450 milliseconds [ms]) as demonstrated by a repeated electrocardiogram (ECG) at Screening (repeated if initial ECG indicates a QTcF interval >450 ms)
- Comorbid nocturia resulting in the need to get out of bed to use the bathroom more than 3 times during the night
- Any history of medical or psychiatric condition that in the opinion of the investigator could affect the participant's safety or interfere with the study assessments
- Any suicidal ideation with intent to act with or without a plan, current or within 6 months before the Columbia - Suicide Severity Rating Scale (C-SSRS) administration during the Screening (e.g., answering "Yes" to questions 4 or 5 on the Suicidal Ideation section of the C-SSRS
- Any suicidal behavior (per the Suicidal Behavior section of the C-SSRS) within 10 years of Screening
- Scheduled for surgery during the study that requires general anesthesia or administration of prohibited medications
- Used any prohibited prescription or over-the-counter medications within 1 week or 5 half-lives, whichever is longer, before the Screening PSG
- Hypersensitivity to lemborexant or excipients
- Currently enrolled in another interventional clinical trial or used any investigational drug or device within 30 days or 5 times the half-life, whichever is longer preceding informed consent
- Previously participated in other clinical trial of lemborexant
- Is unable to avoid working a night shift within 2 weeks before the Screening PSG, or between the Screening PSG and End-of-Study
- Has travelled across 3 or more time zones in the week prior to Screening, or plans to travel across more than 3 time zones during the study
- Clinically significant findings based on vital signs, physical examination, ECG, or clinical laboratory tests
- Additional Exclusion Criteria (HV Cohort):
- Any valid event of SpO2 <90% during the Screening PSG
- Current evidence of a clinically significant, active respiratory disorder. This includes bronchiectasis, emphysema, asthma, chronic obstructive pulmonary disease, or any other pulmonary disorder identified by review of medical history, physical examination, and which in the opinion of the investigator, could compromise the participant's safety or interfere with study assessments
- Presence of significant illness (including insomnia) that requires treatment or may influence the study assessments (e.g., psychiatric disorders, disorders of the gastrointestinal tract, liver, kidney, respiratory system, endocrine system, hematological system, neurological system, cardiovascular system, or a congenital abnormality), malignancy within the past 5 years (other than adequately treated basal cell carcinoma or in situ carcinoma of the cervix), or chronic pain that in the opinion of the investigator could interfere with the study assessments. Participants for whom a sedating drug would be contraindicated for safety reasons because of the participant's occupation or activities are also excluded
- Additional Exclusion Criteria (OSA Cohort):
- SpO2 less than 80% for ≥ 5% of total sleep time during the Screening PSG
- Uses or plans to use of continuous positive airway pressure device or dental appliance within 2 weeks of the Screening PSG (Screening Visit 2) or during the study
- Current evidence of a clinically significant, active respiratory disorder other than OSA. This includes bronchiectasis, emphysema, asthma, chronic obstructive pulmonary disease or any other pulmonary disorder identified by review of medical history, physical examination, and which in the opinion of the investigator, could compromise the participant's safety or interfere with study assessments
- Current evidence of other clinically significant disease (e.g., psychiatric disorders, disorders of the gastrointestinal tract, liver, kidney, respiratory system, endocrine system, hematological system, neurological system, cardiovascular system, or a congenital abnormality), malignancy within the past 5 years (other than adequately treated basal cell carcinoma or in situ carcinoma of the cervix), or chronic pain that in the opinion of the investigator could affect the participant's safety or interfere with the study assessments. Participants for whom a sedating drug would be contraindicated for safety reasons because of the participant's occupation or activities are also excluded. Participants with insomnia disorder, who complain of difficulties with sleep onset and/or sleep maintenance, are eligible provided that they meet this criterion. Note that medications to treat insomnia are prohibited.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Neurotrials Research, Inc
Atlanta, Georgia, 30342
PAB Clinical Research
Brandon, Florida, 33511
The Center for Sleep & Wake Disorders
Chevy Chase, Maryland, 20815
CTI Clinical Research Center
Cincinnati, Ohio, 45212
Community Research
Cincinnati, Ohio, 45227
Advarra
Columbia, Maryland, 21046
PACT
Glendale, Arizona, 85306
Research Centers of America
Hollywood, Florida, 33024
Clinilabs Drug Development
New York, New York, 10019
Pulmonary Associates, PA
Phoenix, Arizona, 85006
Pacific Research Network. LLC
San Diego, California, 92103
About this study
Official title: 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
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).
Read the 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
- Being tested
- Placebo, Lemborexant 10 mg, Lemborexant 25 mg
- Keywords
- Elderly Healthy Subjects, Adult Healthy Subjects, Lemborexant, Respiratory Safety, Peripheral Oxygen Saturation, Total Sleep Time
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
HV: Lemborexant-matched oral placebo will be administered at bedtime in the clinic (within 5 minutes of lights off).
Lemborexant 10 mgDrug
HV: 10 mg oral lemborexant will be administered at bedtime in the clinic (within 5 minutes of lights off).
Lemborexant 25 mgDrug
HV: 25 mg oral lemborexant will be administered at bedtime in the clinic (within 5 minutes of lights off).
PlaceboDrug
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.
Lemborexant 10 mgDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| HV Cohort,Sequence A:Placebo,Lemborexant 10mg,Lemborexant 25mg | Experimental | Eligible healthy adult and elderly participants will receive lemborexant-matched placebo (3 matched tablets) on the night of Day 1 of Treatment Period 1, followed by lemborexant 10 mg (1 lemborexant 10 mg tablet and 2 matching placebo tablets) on the night of Day 1 of Treatment Period 2, and then lemborexant 25 mg (2 lemborexant 10 mg tablets and 1 lemborexant 5 mg tablet) on the night of Day 1 of Treatment Period 3. A washout period of 14 days was maintained between each Treatment Period. Receives: Drug: Placebo; Drug: Lemborexant 10 mg; Drug: Lemborexant 25 mg |
| HV Cohort,Sequence B:Lemborexant 10mg,Lemborexant 25mg,Placebo | Experimental | Eligible healthy adult and elderly participants will receive lemborexant 10 mg (1 lemborexant 10 mg tablet and 2 matching placebo tablets) on the night of Day 1 of Treatment Period 1, followed by lemborexant 25 mg (2 lemborexant 10 mg tablets and 1 lemborexant 5 mg tablet) on the night of Day 1 of Treatment Period 2, and then lemborexant-matched placebo (3 matched tablets) on the night of Day 1 of Treatment Period 3. A washout period of 14 days was maintained between each Treatment Period. Receives: Drug: Placebo; Drug: Lemborexant 10 mg; Drug: Lemborexant 25 mg |
| HV Cohort,Sequence C:Lemborexant 25mg,Placebo,Lemborexant 10mg | Experimental | Eligible healthy adult and elderly participants will receive lemborexant 25 mg (2 lemborexant 10 mg tablet and 1 lemborexant 5 mg tablet) on the night of Day 1 of Treatment Period 1, followed by lemborexant-matched placebo (3 matched tablets) on the night of Day 1 of Treatment Period 2, and then lemborexant 10 mg (1 lemborexant 10 mg tablet and 2 matching placebo tablets) on the night of Day 1 of Treatment Period 3. A washout period of 14 days was maintained between each Treatment Period. Receives: Drug: Placebo; Drug: Lemborexant 10 mg; Drug: Lemborexant 25 mg |
| OSA Cohort, Sequence D: Placebo, Lemborexant 10mg | Experimental | Eligible adult and elderly participants with mild OSA will receive one lemborexant-matched placebo tablet on the night of Day 1 through Day 8 of Treatment Period 1, followed by one lemborexant 10 mg tablet on the night of Day 1 through Day 8 of Treatment Period 2. A washout period of 14 days was maintained between each Treatment Period. Receives: Drug: Placebo; Drug: Lemborexant 10 mg |
| OSA Cohort, Sequence E: Lemborexant 10mg, Placebo | Experimental | Eligible adult and elderly participants with mild OSA will receive one lemborexant 10 mg tablet on the night of Day 1 through Day 8 of Treatment Period 1, followed by one lemborexant-matched placebo tablet on the night of Day 1 through Day 8 of Treatment Period 2. A washout period of 14 days was maintained between each Treatment Period. Receives: Drug: Placebo; Drug: Lemborexant 10 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
HV Cohort: Peripheral Oxygen Saturation (SpO2) During Total Sleep Time (TST) on Day 1 of Treatment
SpO2 is an estimate of the amount of oxygen in the blood. It is the percentage of hemoglobin containing oxygen compared to the total amount of hemoglobin in the blood (that is, oxygenated hemoglobin versus oxygenated and non-oxygenated hemoglobin). SpO2 was monitored by noninvasive method known as transmissive pulse oximetry. TST was defined as the total time asleep in minutes using polysomnography (PSG).
Measured: Day 1
OSA Cohort: Apnea-Hypopnea Index (AHI) on Day 8 of Treatment
The AHI is the number of apneas and hypopneas per hour of sleep. AHI less than 5 is considered normal. An AHI from 5 to 14 denotes mild sleep apnea, 15 to 30 is moderate, while a greater than 30 AHI is considered severe.
Measured: Day 8
Secondary outcomes (7)
HV Cohort: AHI on Day 1 of Treatment
The AHI is the number of apneas and hypopneas per hour of sleep. AHI less than 5 is considered normal. An AHI from 5 to 14 denotes mild sleep apnea, 15 to 30 is moderate, while a greater than 30 AHI is considered severe.
Measured: Day 1
OSA Cohort: AHI on Day 1 of Treatment
The AHI is the number of apneas and hypopneas per hour of sleep. AHI less than 5 is considered normal. An AHI from 5 to 14 denotes mild sleep apnea, 15 to 30 is moderate, while a greater than 30 AHI is considered severe.
Measured: Day 1
HV Cohort: Percentage of TST During Which SpO2 Was Less Than (<) 90 Percent (%), 85 % and 80 % on Day 1 of Treatment
TST was defined as the total time asleep in minutes using PSG. SpO2 is an estimate of the amount of oxygen in the blood. It is the percentage of hemoglobin containing oxygen compared to the total amount of hemoglobin in the blood (that is, oxygenated hemoglobin versus oxygenated and non-oxygenated hemoglobin). SpO2 was monitored by noninvasive method known as transmissive pulse oximetry.
Measured: Day 1
HV Cohort: Percentage of Participants With at Least One Incident of SpO2 <90% for at Least 30 Seconds During TST on Day 1 of Treatment
SpO2 is an estimate of the amount of oxygen in the blood. It is the percentage of hemoglobin containing oxygen compared to the total amount of hemoglobin in the blood (that is, oxygenated hemoglobin versus oxygenated and non-oxygenated hemoglobin). SpO2 was monitored by noninvasive method known as transmissive pulse oximetry. TST was defined as the total time asleep in minutes using PSG.
Measured: Day 1
OSA Cohort: SpO2 During TST on Day 1 and Day 8 of Treatment
SpO2 is an estimate of the amount of oxygen in the blood. It is the percentage of hemoglobin containing oxygen compared to the total amount of hemoglobin in the blood (that is, oxygenated hemoglobin versus oxygenated and non-oxygenated hemoglobin). SpO2 was monitored by noninvasive method known as transmissive pulse oximetry. TST was defined as the total time asleep in minutes using PSG.
Measured: Day 1 and Day 8
OSA Cohort: Percentage of TST During Which the SpO2 is <90%, 85% and 80 % on Day 1 and Day 8 of Treatment
TST was defined as the total time asleep in minutes using PSG. SpO2 is an estimate of the amount of oxygen in the blood. It is the percentage of hemoglobin containing oxygen compared to the total amount of hemoglobin in the blood (that is, oxygenated hemoglobin versus oxygenated and non-oxygenated hemoglobin). SpO2 was monitored by noninvasive method known as transmissive pulse oximetry.
Measured: Day 1 and Day 8
OSA Cohort: Percentage of Participants With at Least One Incident of SpO2 <90% for at Least 30 Seconds During TST on Day 1 and Day 8 of Treatment
SpO2 is an estimate of the amount of oxygen in the blood. It is the percentage of hemoglobin containing oxygen compared to the total amount of hemoglobin in the blood (that is, oxygenated hemoglobin versus oxygenated and non-oxygenated hemoglobin). SpO2 was monitored by noninvasive method known as transmissive pulse oximetry. TST was defined as the total time asleep in minutes using PSG.
Measured: Day 1 and Day 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2018
- Study start21 Feb 2018
- Primary completion3 Aug 2018
- Study completion3 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- More trials run by Eisai Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eisai Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Purdue Pharma LP
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03471871
- Sponsor's protocol ID
- E2006-A001-102
- Status last verified
- Jul 2018
- First submitted
- 14 Mar 2018
- Last updated
- 17 Feb 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Khullar A, Boulos MI, Mak MSB, Moline M, Cheng JY, Hall N. Effect of lemborexant on sleep parameters and architecture in adult and elderly participants with mild-to-severe obstructive sleep apnea. Sleep Med. 2025 Oct;134:106757. doi: 10.1016/j.sleep.2025.106757. Epub 2025 Aug 18.
PubMed 40848323
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03471871
- Acronym / sponsor ID
- E2006-A001-102
- Conditions
- Obstructive Sleep Apnea, Healthy Subjects
- Keywords
- Elderly Healthy Subjects, Adult Healthy Subjects, Lemborexant, Respiratory Safety, Peripheral Oxygen Saturation, Total Sleep Time
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- Eisai Inc.Industry (pharma, biotech, devices)
- Collaborators
- Purdue Pharma LP
- Study start
- 21 Feb 2018 (actual)
- Primary completion
- 3 Aug 2018 (actual)
- Study completion
- 3 Aug 2018 (actual)
- First posted
- 21 Mar 2018 (actual)
- Results
- Posted 18 Jan 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| HV Cohort,Sequence A:Placebo,Lemborexant 10mg,Lemborexant 25mg | Experimental | Drug: Placebo, Drug: Lemborexant 10 mg, Drug: Lemborexant 25 mgEligible healthy adult and elderly participants will receive lemborexant-matched placebo (3 matched tablets) on the night of Day 1 of Treatment Period 1, followed by lemborexant 10 mg (1 lemborexant 10 mg tablet and 2 matching placebo tablets) on the night of Day 1 of Treatment Period 2, and then lemborexant 25 mg (2 lemborexant 10 mg tablets and 1 lemborexant 5 mg tablet) on the night of Day 1 of Treatment Period 3. A washout period of 14 days was maintained between each Treatment Period. |
| HV Cohort,Sequence B:Lemborexant 10mg,Lemborexant 25mg,Placebo | Experimental | Drug: Placebo, Drug: Lemborexant 10 mg, Drug: Lemborexant 25 mgEligible healthy adult and elderly participants will receive lemborexant 10 mg (1 lemborexant 10 mg tablet and 2 matching placebo tablets) on the night of Day 1 of Treatment Period 1, followed by lemborexant 25 mg (2 lemborexant 10 mg tablets and 1 lemborexant 5 mg tablet) on the night of Day 1 of Treatment Period 2, and then lemborexant-matched placebo (3 matched tablets) on the night of Day 1 of Treatment Period 3. A washout period of 14 days was maintained between each Treatment Period. |
| HV Cohort,Sequence C:Lemborexant 25mg,Placebo,Lemborexant 10mg | Experimental | Drug: Placebo, Drug: Lemborexant 10 mg, Drug: Lemborexant 25 mgEligible healthy adult and elderly participants will receive lemborexant 25 mg (2 lemborexant 10 mg tablet and 1 lemborexant 5 mg tablet) on the night of Day 1 of Treatment Period 1, followed by lemborexant-matched placebo (3 matched tablets) on the night of Day 1 of Treatment Period 2, and then lemborexant 10 mg (1 lemborexant 10 mg tablet and 2 matching placebo tablets) on the night of Day 1 of Treatment Period 3. A washout period of 14 days was maintained between each Treatment Period. |
| OSA Cohort, Sequence D: Placebo, Lemborexant 10mg | Experimental | Drug: Placebo, Drug: Lemborexant 10 mgEligible adult and elderly participants with mild OSA will receive one lemborexant-matched placebo tablet on the night of Day 1 through Day 8 of Treatment Period 1, followed by one lemborexant 10 mg tablet on the night of Day 1 through Day 8 of Treatment Period 2. A washout period of 14 days was maintained between each Treatment Period. |
| OSA Cohort, Sequence E: Lemborexant 10mg, Placebo | Experimental | Drug: Placebo, Drug: Lemborexant 10 mgEligible adult and elderly participants with mild OSA will receive one lemborexant 10 mg tablet on the night of Day 1 through Day 8 of Treatment Period 1, followed by one lemborexant-matched placebo tablet on the night of Day 1 through Day 8 of Treatment Period 2. A washout period of 14 days was maintained between each Treatment Period. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Male or female, age ≥18 years and ≤90 years at the time of informed consent
- Voluntary agreement and ability to provide written informed consent
- Reports habitually sleeping for at least 5.5 hours per night
- Agrees to stay in bed for 7 hours per night for the duration of treatment
- Reports habitual bedtime between 21:00 and 01:00
Key exclusion criteria (32 listed)
- 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 a parasomnia or parasomnia observed on the Screening PSG that in the investigator's opinion makes the participant unsuitable for the study
- Periodic Limb Movement with Arousal Index (PLMAI) as measured on the Screening PSG:
- History of or suspected drug or alcohol use disorder within approximately 2 previous years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboHV: Lemborexant-matched oral placebo will be administered at bedtime in the clinic (within 5 minutes of lights off). | Drug | HV Cohort,Sequence A:Placebo,Lemborexant 10mg,Lemborexant 25mg, HV Cohort,Sequence B:Lemborexant 10mg,Lemborexant 25mg,Placebo, HV Cohort,Sequence C:Lemborexant 25mg,Placebo,Lemborexant 10mg |
| Lemborexant 10 mgHV: 10 mg oral lemborexant will be administered at bedtime in the clinic (within 5 minutes of lights off). | Drug | HV Cohort,Sequence A:Placebo,Lemborexant 10mg,Lemborexant 25mg, HV Cohort,Sequence B:Lemborexant 10mg,Lemborexant 25mg,Placebo, HV Cohort,Sequence C:Lemborexant 25mg,Placebo,Lemborexant 10mg |
| Lemborexant 25 mgHV: 25 mg oral lemborexant will be administered at bedtime in the clinic (within 5 minutes of lights off). | Drug | HV Cohort,Sequence A:Placebo,Lemborexant 10mg,Lemborexant 25mg, HV Cohort,Sequence B:Lemborexant 10mg,Lemborexant 25mg,Placebo, HV Cohort,Sequence C:Lemborexant 25mg,Placebo,Lemborexant 10mg |
| PlaceboOSA: 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 | OSA Cohort, Sequence D: Placebo, Lemborexant 10mg, OSA Cohort, Sequence E: Lemborexant 10mg, Placebo |
| Lemborexant 10 mgOSA: 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. | Drug | OSA Cohort, Sequence D: Placebo, Lemborexant 10mg, OSA Cohort, Sequence E: Lemborexant 10mg, Placebo |
Primary outcome
HV Cohort: Peripheral Oxygen Saturation (SpO2) During Total Sleep Time (TST) on Day 1 of Treatment
Time frame: Day 1
SpO2 is an estimate of the amount of oxygen in the blood. It is the percentage of hemoglobin containing oxygen compared to the total amount of hemoglobin in the blood (that is, oxygenated hemoglobin versus oxygenated and non-oxygenated hemoglobin). SpO2 was monitored by noninvasive method known as transmissive pulse oximetry. TST was defined as the total time asleep in minutes using polysomnography (PSG).
OSA Cohort: Apnea-Hypopnea Index (AHI) on Day 8 of Treatment
Time frame: Day 8
The AHI is the number of apneas and hypopneas per hour of sleep. AHI less than 5 is considered normal. An AHI from 5 to 14 denotes mild sleep apnea, 15 to 30 is moderate, while a greater than 30 AHI is considered severe.
7 secondary outcomes
HV Cohort: AHI on Day 1 of Treatment
Time frame: Day 1
OSA Cohort: AHI on Day 1 of Treatment
Time frame: Day 1
HV Cohort: Percentage of TST During Which SpO2 Was Less Than (<) 90 Percent (%), 85 % and 80 % on Day 1 of Treatment
Time frame: Day 1
HV Cohort: Percentage of Participants With at Least One Incident of SpO2 <90% for at Least 30 Seconds During TST on Day 1 of Treatment
Time frame: Day 1
OSA Cohort: SpO2 During TST on Day 1 and Day 8 of Treatment
Time frame: Day 1 and Day 8
OSA Cohort: Percentage of TST During Which the SpO2 is <90%, 85% and 80 % on Day 1 and Day 8 of Treatment
Time frame: Day 1 and Day 8
OSA Cohort: Percentage of Participants With at Least One Incident of SpO2 <90% for at Least 30 Seconds During TST on Day 1 and Day 8 of Treatment
Time frame: Day 1 and Day 8
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40848323Khullar A, Boulos MI, Mak MSB, Moline M, Cheng JY, Hall N. Effect of lemborexant on sleep parameters and architecture in adult and elderly participants with mild-to-severe obstructive sleep apnea. Sleep Med. 2025 Oct;134:106757. doi: 10.1016/j.sleep.2025.106757. Epub 2025 Aug 18.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Lemborexant 10 mg and Lemborexant 25 mg in people with Obstructive Sleep Apnea and Healthy Subjects, run by Eisai Inc. at 11 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Jan 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HV Cohort: Peripheral Oxygen Saturation (SpO2) During Total Sleep Time (TST) on Day 1 of Treatment (time frame: Day 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03471871, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2020.