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| Name | Class |
|---|---|
| Purdue Pharma LP | INDUSTRY |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | HV: Lemborexant-matched oral placebo will be administered at bedtime in the clinic (within 5 minutes of lights off). |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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. | Day 8 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 1 |
| OSA Cohort: AHI on Day 1 of Treatment |
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Inclusion Criteria:
Participants must meet all of the following criteria to be included in this study:
Additional Inclusion Criteria (Healthy Volunteer [HV] Cohort):
Additional Inclusion Criteria (Obstructive Sleep Apnea [OSA] Cohort):
Exclusion Criteria:
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
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):
Additional Exclusion Criteria (OSA Cohort):
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PACT | Glendale | Arizona | 85306 | United States | ||
| Pulmonary Associates, PA |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40848323 | Derived | 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. |
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In healthy volunteer (HV) cohort, 39 participants were screened and enrolled, of which 22 were screen failures, 17 were randomized to receive treatment. In obstructive sleep apnea (OSA) cohort, 107 participants were screened and enrolled, of which 68 were screen failures, 39 were randomized to receive treatment. Total participants enrolled=146
Participants took part in the study at 8 investigative sites in the United States from February 21, 2018 to August 3, 2018.
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| ID | Title | Description |
|---|---|---|
| FG000 | HV Cohort,Sequence A:Placebo,Lemborexant 10mg,Lemborexant 25mg | Eligible healthy adult and elderly participants received lemborexant-matched placebo (3 placebo tablets), orally, once, in the evening (within 5 minutes of lights off) of Day 1 of Treatment Period 1, followed by lemborexant 10 mg (milligram) (1 lemborexant 10 mg tablet and 2 matching placebo tablets [to maintain blind]), orally, once, in the evening (within 5 minutes of lights off) of Day 1 of Treatment Period 2, and then lemborexant 25 mg (2 lemborexant 10 mg tablets and 1 lemborexant 5 mg tablet), orally, once, in the evening (within 5 minutes of lights off) of Day 1 of Treatment Period 3. A washout period of 14 days was maintained between each treatment period. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Treatment Period 1(HV:1 Day, OSA:8 Days) |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 12, 2018 | Jan 31, 2020 |
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|
| 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. |
|
| 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. |
|
| Lemborexant 10 mg | Drug | HV: 10 mg oral lemborexant will be administered at bedtime in the clinic (within 5 minutes of lights off). |
|
| Lemborexant 25 mg | Drug | HV: 25 mg oral lemborexant will be administered at bedtime in the clinic (within 5 minutes of lights off). |
|
| Placebo | Drug | 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 mg | Drug | 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. |
|
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. |
| 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. | 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. | 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. | 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. | 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. | Day 1 and Day 8 |
| Phoenix |
| Arizona |
| 85006 |
| United States |
| Pacific Research Network. LLC | San Diego | California | 92103 | United States |
| PAB Clinical Research | Brandon | Florida | 33511 | United States |
| Research Centers of America | Hollywood | Florida | 33024 | United States |
| Neurotrials Research, Inc | Atlanta | Georgia | 30342 | United States |
| The Center for Sleep & Wake Disorders | Chevy Chase | Maryland | 20815 | United States |
| Advarra | Columbia | Maryland | 21046 | United States |
| Clinilabs Drug Development | New York | New York | 10019 | United States |
| CTI Clinical Research Center | Cincinnati | Ohio | 45212 | United States |
| Community Research | Cincinnati | Ohio | 45227 | United States |
| FG001 | HV Cohort,Sequence B:Lemborexant 10mg,Lemborexant 25mg,Placebo | Eligible healthy adult and elderly participants received lemborexant 10 mg (1 lemborexant 10 mg tablet and 2 matching placebo tablets [to maintain blind]), orally, once, in the evening (within 5 minutes of lights off) of Day 1 of Treatment Period 1, followed by lemborexant 25 mg (2 lemborexant 10 mg tablets and 1 lemborexant 5 mg tablet), orally, once, in the evening (within 5 minutes of lights off) of Day 1 of Treatment Period 2, and then lemborexant-matched placebo (3 placebo tablets), orally, once, in the evening (within 5 minutes of lights off) of Day 1 of Treatment Period 3. A washout period of 14 days was maintained between each treatment period. |
| FG002 | HV Cohort,Sequence C:Lemborexant 25mg,Placebo,Lemborexant 10mg | Eligible healthy adult and elderly participants received lemborexant 25 mg (2 lemborexant 10 mg tablets and 1 lemborexant 5 mg tablet), orally, once, in the evening (within 5 minutes of lights off) of Day 1 of Treatment Period 1, followed by lemborexant-matched placebo (3 placebo tablets), orally, once, in the evening (within 5 minutes of lights off) of Day 1 of Treatment Period 2, and then lemborexant 10 mg (1 lemborexant 10 mg tablet and 2 matching placebo tablets [to maintain blind]), orally, once, in the evening (within 5 minutes of lights off) of Day 1 of Treatment Period 3. A washout period of 14 days was maintained between each treatment period. |
| FG003 | OSA Cohort, Sequence D: Placebo, Lemborexant 10mg | Eligible adult and elderly participants with mild OSA received one lemborexant-matched placebo, tablet, orally, once, in the evening (within 5 minutes of lights off) of Day 1 through Day 8 of Treatment Period 1, followed by one lemborexant 10 mg, tablet, orally, once, in the evening (within 5 minutes of lights off) of Day 1 through Day 8 of Treatment Period 2. A washout period of 14 days was maintained between each treatment period. |
| FG004 | OSA Cohort, Sequence E: Lemborexant 10mg, Placebo | Eligible adult and elderly participants with mild OSA received one lemborexant 10 mg, tablet, orally, once in the evening of Day 1 through Day 8 of Treatment Period 1, followed by one lemborexant-matched placebo, tablet, orally, once, in the evening of Day 1 through Day 8 of Treatment Period 2. A washout period of 14 days was maintained between each treatment period. |
| Treated |
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| COMPLETED |
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| NOT COMPLETED |
|
|
| Washout Period 1 (14 Days) |
|
| Treatment Period 2(HV:1 Day, OSA:8 Days) |
|
|
| Washout Period 2 (14 Days) |
|
| Treatment Period 3: ( HV:1 Day) |
|
| Follow Up (14 Days for Both HV and OSA) |
|
|
Baseline characteristics data has been presented as per study cohorts (HV and OSA) involved in the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | HV Cohort | Eligible healthy adult and elderly participants received lemborexant-matched placebo (3 placebo tablets), lemborexant 10 mg (1 lemborexant 10 mg tablet and 2 matching placebo tablets [to maintain blind]) or lemborexant 25 mg (2 lemborexant 10 mg tablets and 1 lemborexant 5 mg tablet), orally, once, in the evening (within 5 minutes of lights off) of Day 1 in the respective Treatment Period 1, 2 or 3. A washout period of 14 days was maintained between each treatment period. |
| BG001 | OSA Cohort | Eligible adult and elderly participants with mild OSA received one lemborexant-matched placebo or one lemborexant 10 mg, tablets, orally, once, in the evening (within 5 minutes of lights off) of Day 1 through Day 8 in the respective Treatment Period 1 or 2. A washout period of 14 days was maintained between each treatment period. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Pharmacodynamic (PD) analysis set included group of participants who received at least 1 dose of study drug in each treatment periods and who had sufficient PD data to derive at least 1 primary PD parameter. | Posted | Mean | Standard Deviation | percentage of oxygen saturation | Day 1 |
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| Primary | 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. | PD analysis set included group of participants who received at least 1 dose of study drug in each treatment periods and who had sufficient PD data to derive at least 1 primary PD parameter. Here, overall number of participants analyzed signifies participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | events (apnea plus hyponea) per hour | Day 8 |
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| Secondary | 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. | PD analysis set included group of participants who received at least 1 dose of study drug in each treatment periods and who had sufficient PD data to derive at least 1 primary PD parameter. | Posted | Mean | Standard Deviation | events (apnea plus hyponea) per hour | Day 1 |
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| Secondary | 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. | PD analysis set included group of participants who received at least 1 dose of study drug in each treatment periods and who had sufficient PD data to derive at least 1 primary PD parameter. Here, overall number of participants analyzed signifies participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | events (apnea plus hyponea) per hour | Day 1 |
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| Secondary | 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. | PD analysis set included group of participants who received at least 1 dose of study drug in each treatment periods and who had sufficient PD data to derive at least 1 primary PD parameter. | Posted | Mean | Standard Deviation | percentage of TST | Day 1 |
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| Secondary | 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. | PD analysis set included group of participants who received at least 1 dose of study drug in each treatment periods and who had sufficient PD data to derive at least 1 primary PD parameter. | Posted | Number | percentage of participant | Day 1 |
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| Secondary | 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. | PD analysis set included group of participants who received at least 1 dose of study drug in each treatment periods and who had sufficient PD data to derive at least 1 primary PD parameter. Here, 'number analyzed' signifies participants who were evaluable for analysis at the specified timepoints. | Posted | Mean | Standard Deviation | percentage of oxygen saturation | Day 1 and Day 8 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | PD analysis set included group of participants who received at least 1 dose of study drug in each treatment periods and who had sufficient PD data to derive at least 1 primary PD parameter. Here, 'number analyzed' signifies participants who were evaluable for analysis at the specified timepoints. | Posted | Mean | Standard Deviation | percentage of TST | Day 1 and Day 8 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | PD analysis set included group of participants who received at least 1 dose of study drug in each treatment periods and who had sufficient PD data to derive at least 1 primary PD parameter. | Posted | Number | percentage of participant | Day 1 and Day 8 |
|
Baseline up to end of follow up visit (up to 67 days)
Safety analysis set included group of participants who received study drug and had at least 1 postdose safety assessment.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | HV Cohort: Placebo | Eligible healthy adult and elderly participants received lemborexant-matched placebo (3 placebo tablets), orally, once, in the evening (within 5 minutes of lights off) of Day 1 in the respective Treatment Period 1, 2 or 3. | 0 | 16 | 0 | 16 | 1 | 16 |
| EG001 | HV Cohort: Lemborexant 10 mg | Eligible healthy adult and elderly participants received lemborexant 10 mg (1 lemborexant 10 mg tablet and 2 matching placebo tablets [to maintain blind]), orally, once, in the evening (within 5 minutes of lights off) of Day 1 in the respective Treatment Period 1, 2 or 3. | 0 | 16 | 0 | 16 | 1 | 16 |
| EG002 | HV Cohort: Lemborexant 25 mg | Eligible healthy adult and elderly participants received lemborexant 25 mg (2 lemborexant 10 mg tablets and 1 lemborexant 5 mg tablet), orally, once, in the evening (within 5 minutes of lights off) of Day 1 in the respective Treatment Period 1, 2 or 3. | 0 | 17 | 0 | 17 | 4 | 17 |
| EG003 | OSA Cohort: Placebo | Eligible adult and elderly participants with mild OSA received one lemborexant-matched placebo, tablet, orally, once, in the evening (within 5 minutes of lights off) of Day 1 through Day 8 in the respective Treatment Period 1 or 2. | 0 | 38 | 0 | 38 | 5 | 38 |
| EG004 | OSA Cohort: Lemborexant 10 mg | Eligible adult and elderly participants with mild OSA received one lemborexant 10 mg, tablet, orally, once, in the evening (within 5 minutes of lights off) of Day 1 through Day 8 in the respective Treatment Period 1 or 2. | 0 | 38 | 0 | 38 | 6 | 38 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Photopsia | Eye disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Seasonal allergy | Immune system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Vaginal infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Endometriosis | Reproductive system and breast disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 21.0 | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Eisai Medical Information | Eisai Inc. | +1-888-274-2378 | esi_medinfo@eisai.com |
| Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 5, 2018 | Jan 31, 2020 | SAP_003.pdf |
| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000634104 | lemborexant |
Not provided
Not provided
Not provided
| Did Return to Clinic |
|
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Mixed effect model |
SPO2 was analyzed by mixed effect model, which included fixed effects for sequence, period, treatment a random effect for participant within sequence. |
| 0.176 |
P-Value was at the 0.05 level of significance. |
| LS mean difference |
| -0.29 |
| 2-Sided |
| 95 |
| -0.72 |
| 0.14 |
| Other |
| Counts |
|---|
| Participants |
|
|
|
|
|
|
| Counts |
|---|
| Participants |
|
|
|
| HV Cohort: Lemborexant 25 mg |
Eligible healthy adult and elderly participants received lemborexant 25 mg (2 lemborexant 10 mg tablets and 1 lemborexant 5 mg tablet), orally, once, in the evening (within 5 minutes of lights off) of Day 1 in the respective Treatment Period 1, 2 or 3. |
|
|
|
| HV Cohort: Lemborexant 25 mg |
Eligible healthy adult and elderly participants received lemborexant 25 mg (2 lemborexant 10 mg tablets and 1 lemborexant 5 mg tablet), orally, once, in the evening (within 5 minutes of lights off) of Day 1 in the respective Treatment Period 1, 2 or 3. |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|