Study to Evaluate the Respiratory Safety of Lemborexant in Adult and Elderly Healthy Subjects and Adult and Elderly Subjects With Mild Obstructive Sleep Apnea
Condition: Obstructive Sleep Apnea; Healthy Subjects
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Interventional
Phase: Phase 1

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.
    

Intervention name(s): Placebo; Lemborexant 10 mg; Lemborexant 25 mg; Placebo; Lemborexant 10 mg
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): HV: Lemborexant-matched oral placebo will be administered at bedtime in the clinic (within 5 minutes of lights off).; HV: 10 mg oral lemborexant will be administered at bedtime in the clinic (within 5 minutes of lights off).; HV: 25 mg oral lemborexant will be administered at bedtime in the clinic (within 5 minutes of lights off).; 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.; 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.
Intervention MeSH terms: Lemborexant
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: Elderly Healthy Subjects; Adult Healthy Subjects; Lemborexant; Respiratory Safety; Peripheral Oxygen Saturation; Total Sleep Time