A 2-Part Single Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of E2006
Condition: Insomnia
MeSH terms: Sleep Initiation and Maintenance Disorders
Intervention: E2006 1.0 mg; E2006 2.5 mg; E2006 5.0 mg; E2006 10.0 mg; E2006 25.0 mg; E2006 50.0 mg; E2006 100 mg; E2006 200 mg; Zolpidem 10 mg; E2006 Matched Placebo or Zolpidem Matched Placebo; E2006 Matched Placebo
Intervention description: E2006 1.0 mg capsule.; E2006 2.5 mg capsule.; E2006 5.0 mg (2 capsules of 2.5 mg each).; E2006 10.0 mg capsule.; E2006 25.0 mg (2 capsules of 10 mg each and 2 capsules of 2.5 mg each).; E2006 50.0 mg capsule.; E2006 100 mg (2 capsules of 50 mg each).; E2006 200 mg (4 capsules of 50 mg each).; Zolpidem 10 mg immediate release tablet.; E2006-matched placebo capsules or zolpidem-matched placebo tablets.; E2006-matched placebo capsule.
Intervention MeSH terms: Zolpidem; Lemborexant
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 122.0
Sex: All
Minimum age: 18 Years
Maximum age: 64 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Part A: The purpose of this study is to evaluate the safety and tolerability of single oral
      doses of E2006 administered in the morning to healthy male and female subjects.

      Part B: The purpose of this study is to evaluate selected pharmacodynamic (PD) parameters
      (e.g., polysomnographically defined sleep measures) with regard to dose response in subjects
      with primary insomnia following single oral dosing of E2006 in the evening approximately 30
      minutes prior to the sleep period, compared with 10 mg zolpidem and placebo.
    

Eligibility criteria:

        Key Inclusion Criteria:

        Healthy Subjects:

          -  With habitual time in bed > 7 hours, with lights out 2200 to 2400 and lights on 0600
             to 0800

          -  Who report typical sleep latency of </= 30 minutes

          -  With typical total sleep time (TST) >/= 420 minutes

        Primary Insomnia Subjects:

          -  Otherwise healthy adult male and female subjects with a diagnosis of primary insomnia
             (as defined by the Diagnostic and Statistical Manual of Mental Disorders-IV-Text
             Revision [DSM-IV-TR]) present at the time of Screening for at least 3 months

          -  With a score of > 15 on the Insomnia Severity Index (ISI) at Screening

          -  Who report taking >/= 30 minutes to fall asleep on at least 3 nights per week for the
             past month

          -  Who report 6.5 hours sleep or less on at least 3 nights per week for the past month

          -  With mean latency to persistent sleep (LPS) on both baseline nights of >/= 20 minutes
             with neither night < 15 minutes

          -  With mean wake after sleep onset (WASO) >/= 20 minutes on both baseline nights, with
             neither night < 15 minutes or mean TST > 420 minutes

        Key Exclusion Criteria:

          -  With a current history of sleep disorders (e.g., obstructive sleep apnea, restless leg
             syndrome [RLS], narcolepsy, or circadian rhythm disorder) other than primary insomnia
             (for Part B)

          -  Subjects with any clinically abnormal symptom or organ impairment found in medical
             history, symptoms/signs, vital signs, ECG finding, or laboratory test results which
             require medical treatment

          -  All females must be of non-childbearing potential

          -  With a known history of significant neurological or serious psychiatric illness