A Study to Evaluate the Efficacy, Safety, and Tolerability of JNJ-42847922 in Participants With Insomnia Disorder
Condition: Insomnia Disorders
MeSH terms: Sleep Initiation and Maintenance Disorders
Intervention: Placebo; JNJ-42847922, 5 mg; JNJ-42847922, 10 mg; JNJ-42847922, 20 mg; Zolpidem
Intervention description: Matching placebo will be administered once daily based upon dosing group.; JNJ-42847922 will be administered as 5 mg (2*2.5 mg capsule) oral capsules once daily.; JNJ-42847922 will be administered as 10 mg oral capsule once daily.; JNJ-42847922 will be administered as 20 mg oral capsule once daily.; Zolpidem will be administered as 5 mg or 10 mg (2*5mg capsule) oral capsule once daily based upon the local labeling information.
Intervention MeSH terms: Zolpidem
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 365.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No

Summary:

      The purpose of this 2 month phase 2b study is to investigate the dose response of 3 doses of
      JNJ-42847922 (Seltorexant) (5,10 and 20 mg) compared to placebo and zolpidem on sleep onset
      and maintenance and to further document safety and tolerability of JNJ-42847922 (Seltorexant)
      upon multiple (14 days) dose administration in participants with insomnia disorder.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participant must be a man or women of non-childbearing potential (WONCBP), 18 to 85
             years of age, inclusive, on the day of signing informed consent. A WONCBP is defined
             as: a).Postmenopausal: A postmenopausal state is defined as no menses for 12 months
             without an alternative medical cause. b). Permanently sterile: Permanent sterilization
             methods include hysterectomy, bilateral salpingectomy, bilateral tubal
             occlusion/ligation procedures, and bilateral oophorectomy. c). If reproductive status
             is questionable, additional evaluation should be considered

          -  Participant must meet Diagnostic and Statistical Manual of Mental Disorders (5th
             edition) (DSM-5) criteria for insomnia disorder

          -  Participant must have an Insomnia Severity Index (ISI) total score greater than or
             equal to (>=) 15 at screening

          -  Participant must have an self-reported sleep onset latency (sSOL) >=45 minutes and a
             subjective wake after sleep onset (sWASO) >= 60 minutes on at least 3 nights over any
             7-day period during Part 1 of screening, using the Consensus Sleep Diary - Morning
             Administration (CSD-M), prior to screening polysomnography (PSG) assessments

          -  Participant must demonstrate a 2-night mean latency to persistent sleep (LPS) of >= 25
             minutes (with neither night less than [<] 20 minutes), a 2 night mean wake after sleep
             onset (WASO) >= 30 minutes, and a 2 night mean total sleep time (TST) less than or
             equal to (=<) 6.5 hours, with neither night greater than (>) 7 hours

          -  Participant must be otherwise healthy or present with stable, well-controlled, chronic
             conditions on the basis of physical examination, medical history, vital signs, 12-lead
             electrocardiogram (ECG), and clinical laboratory tests performed at screening

        Exclusion Criteria:

          -  Has history of or current clinically significant and/or unstable liver (moderate or
             severe hepatic impairment [Child-Pugh Score {>=} 7]) or renal insufficiency (severe
             renal impairment [estimated creatinine clearance below 30 {milliliter per minute}
             mL/min]; serum creatinine >2 [milligram per deciliter] mg/dL); significant and/or
             unstable cardiac, vascular, pulmonary (example, acute or severe respiratory failure),
             gastrointestinal, endocrine, neurologic (example, myasthenia gravis, narcolepsy),
             hematologic, rheumatologic, immunologic, or metabolic disturbances. Organic brain
             disease, epilepsy, dementia, narcolepsy, narrow angle glaucoma and known or suspected
             mental retardation are exclusionary. Any clinically relevant medical condition that is
             likely to result in deterioration of the participant's condition or affect the
             participant's safety during the study (eg, medically frail participant with history of
             hospitalization due to fractures) or could potentially alter the absorption,
             metabolism, or excretion of the study drug is exclusionary

          -  Has uncontrolled hypertension (supine systolic blood pressure >150 millimeter of
             mercury (mm Hg) in adult participants or >160 mm Hg in elderly participants or supine
             diastolic blood pressure >90 mm Hg, despite diet, exercise, or a stable dose of
             allowed antihypertensive therapy) at screening or Day 1. (A participant with
             hypertension may be included if the participant's hypertension has been controlled for
             at least 3 months prior to screening, and the dosage of any antihypertensive
             medication has been stable for the past 3 months)

          -  Has clinically significant abnormal values for hematology, clinical chemistry, or
             urinalysis at screening. Participants with non-insulin dependent diabetes mellitus who
             are adequately controlled (hemoglobin A1c [HbA1c] =< 8 percent [%]) may be eligible to
             participate if otherwise medically healthy. It is expected that laboratory values will
             generally be within the normal range, though minor deviations, which are not
             considered to be of clinical significance to both the investigator and the sponsor's
             Safety Physician, are acceptable

          -  Has clinically significant ECG abnormalities at screening or Day 1 prior to
             randomization defined as:

               1. QT interval corrected according to Fridericia's formula: >= 450 millisecond
                  (msec) (males); >= 470 msec (females).

               2. Evidence of 2nd and 3rd degree atrioventricular block, or 1st degree
                  atrioventricular block with PR interval >210 msec, left bundle branch block.

               3. Features of new ischemia.

               4. Other clinically important arrhythmia

          -  Has significant hypersomnia not related to night time insomnia (based on clinical
             judgment of the investigator)

          -  Regularly naps more than 3 times per week

          -  Has a current diagnosis or recent history of psychotic disorder, major depressive
             disorder (MDD), bipolar disorder, or posttraumatic stress disorder, or other
             psychiatric condition that, in the investigator's opinion, would interfere with the
             participant's ability to participate in the trial

          -  Has a current or recent history of serious suicidal ideation within the past 6 months,
             corresponding to a positive response on item 4 (active suicidal ideation with some
             intent to act, without specific plan) or item 5 (active suicidal ideation with
             specific plan and intent) for ideation on the Columbia Suicide Severity Rating Scale
             (C-SSRS), or a history of suicidal behavior within the past year, as validated by the
             C-SSRS at screening or Day 1. Participants with a prior suicide attempt of any sort,
             or prior serious suicidal ideation/plan within the past 6 months, should be carefully
             screened for current suicidal ideation and only participants with non-serious items
             (1-3 of the suicidal ideation section of the C-SSRS) may be included at the discretion
             of the investigator

          -  Has insomnia related to restless leg syndrome (RLS) (defined as periodic leg movement
             [PLM]-arousal index of >=10 PLM-related electroencephalograph (EEG) arousals per hour
             of sleep for adult participants or >15 for elderly participants), sleep breathing
             disorder (defined as an apnea hypopnea index >=10 cumulative apneas and hypopneas per
             hour of EEG sleep for adult participants or >15 for elderly participants), or
             parasomnias. These disorders will be ruled out by the first PSG recording during Part
             2 of screening

          -  Has known allergies, hypersensitivity, intolerance, lack of response, or any
             contraindication to JNJ-42847922 or zolpidem or their excipients

          -  Plans to father a child while enrolled in this study or within 3 months after the last
             dose of study drug; and/or, Is pregnant, or breastfeeding, while enrolled in this
             study or within 1 month after the last dose of study drug