A Study to Evaluate the Efficacy, Safety, and Tolerability of JNJ-42847922 in Participants With Insomnia Disorder



Status:Recruiting
Conditions:Insomnia Sleep Studies
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:18 - 85
Updated:2/13/2019
Start Date:November 23, 2017
End Date:April 24, 2019
Contact:Study Contact
Email:JNJ.CT@sylogent.com
Phone:844-434-4210

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A Multicenter, Double-Blind, Randomized, Parallel-Group, Active- and Placebo-Controlled Polysomnography Study to Evaluate the Efficacy, Safety, and Tolerability of JNJ-42847922 in Subjects With Insomnia Disorder

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.


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
We found this trial at
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860 Peachwood Drive
DeLand, Florida 32720
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1100 Johnson Ferry Road
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2128 W Flagler St # 201
Miami, Florida 33144
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104 SE 1st Avenue
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1897 Palm Beach Lakes Boulevard
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28 Alkerstraat
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811 Juniper St NE
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Lauderhill, Florida 33319
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640 George Washington Highway
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Little Rock, Arkansas 72211
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1801 Coral Way
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Mooresville, North Carolina 28117
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180 Wingo Way
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3555 NW 58th St # 800
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