A Study to Evaluate the Efficacy, Safety, and Tolerability of JNJ-42847922 in Participants with Insomnia Disorder
- Conditions
- Insomnia Disorder
- Registration Number
- JPRN-jRCT2080223787
- Lead Sponsor
- Janssen Pharmaceutical K.K.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 360
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 (5thedition) (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
- 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, gastrointestinal, endocrine, neurologic (example, myasthenia gravis, narcolepsy), hematologic, rheumatologic, immunologic, or metabolic disturbances. Organic brain disease, epilepsy, dementia, 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:
a) QT interval corrected according to Fridericia's formula: >= 450 millisecond (msec) (males); >= 470 msec (females).
b) Evidence of 2nd and 3rd degree atrioventricular block, or 1st degree atrioventricular
block with PR interval >210 msec, left bundle branch block.
c) Features of new ischemia.
d) 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method efficacy<br>Change from Baseline in Latency to Persistent Sleep (LPS) as Measured by Polysomnography (PSG) on Night 1
- Secondary Outcome Measures
Name Time Method efficacy<br>Change from Baseline in Wake After Sleep Onset (WASO) Over the First 6 Hours as Measured by PSG on Night 1<br><br>efficacy<br>Change from Baseline in LPS on Night 13 of JNJ-42847922 Compared with Placebo<br><br>efficacy<br>Change from Baseline in WASO Over the First 6 Hours on Night 13 of JNJ-42847922 Compared with Placebo<br><br>efficacy<br>Change from Baseline in Total Sleep Time (TST) on Nights 1 and 13 of JNJ-42847922 Compared with Placebo and Zolpidem<br><br>efficacy<br>Change from Baseline in Sleep Efficiency (SE) on Nights 1 and 13 of JNJ-42847922 Compared with Placebo and Zolpidem<br><br>safety<br>Change from Baseline in LPS on Nights 1 and 13 of JNJ-42847922 Compared with Zolpidem<br><br>pharmacokinetics<br>Change from Baseline in WASO Over the First 6 Hours on Nights 1 and 13 of JNJ-42847922 Compared with Zolpidem