The purpose of this study is to see if JNJ-42847922 is useful for treating patients with insomnia without any other psychiatric disease. The safety of JNJ-42847922 will also be studied.
ID
Source
Brief title
Condition
- Sleep disorders and disturbances
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- Latency to persistent sleep (minutes)
- Total sleep time (minutes)
- Wake After Sleep Onset (minutes)
- Wake during total sleep period (minutes)
- Wake after final awakening (minutes)
- Sleep efficiency (%)
- Total time spent in deep sleep (duration of slow wave sleep) (minutes)
Secondary outcome
PSG secondary endpoints
- Time in bed (minutes)
- Sleep onset latency (minutes)
- Number of awakenings (#)
- Time to first awakening after sleep onset (minutes)
- REML (minutes)
- Duration of REM sleep (minutes)
- Duration of Stage 1 Sleep (minutes)
- Duration of Stage 2 Sleep (minutes)
- Number of REM blocs (#)
Safety
- ECG
- Vital signs
- Blood chemistry / hematology
Suicidal assessment by C-SSRS Questionnaire
Sleep questionnaires:
Bond and Lader Visual Analogue Scale
Karolinska Sleepiness Scale
Leeds Sleep Evaluation Questionnaire
Background summary
JNJ-42847922 is a potent and selective antagonist of the human orexin-2
receptor (OX2R) that is being developed for the treatment of insomnia and major
depressive disorder (MDD). In rats, JNJ-42847922 quickly and reversibly binds
to OX2R in the brain after oral administration and reduces sleep latency and
increases total sleep duration whilst not affecting Rapid Eye Movement (REM)
sleep. JNJ-42847922 induced dose-related somnolence in healthy subjects after
daytime administration and decreased the latency to persistent sleep (LPS) and
increased the total sleep time (TST) in MDD patients with insomnia after
nighttime administration of a single dose of 10 mg or higher.
Study objective
The purpose of this study is to see if JNJ-42847922 is useful for treating
patients with insomnia without any other psychiatric disease. The safety of
JNJ-42847922 will also be studied.
Study design
This study is a multi-center, randomized, placebo-controlled, double-blind,
2-way cross-over study with JNJ-42847922 in 26 healthy male and female subjects
with insomnia disorder without psychiatric comorbidity.
Intervention
Subjects will receive during each study period one of the following treatments
for 5 days once a day:
-40 mg JNJ-42847922
-placebo
Study burden and risks
Subjects will receive 40 mg JNJ-42847922 and placebo q.d. for 5 days in two
treatment sequences. JNJ-42487922 has been administered to healthy male and
female subjects for 10 days up to 60 mg [42847922EDI1003] and was well
tolerated. JNJ-42847922 causes somnolence/sedation when administered at
daytime. When administered in the evening, JNJ-42847922 increases SE, decreases
LPS and increases TST [42847922EDI1002] at all doses tested (10, 20, and 40
mg). None of the doses tested significantly affected WASO or the number of
awakenings in the latter study which may be related to study design (phase
advanced sleep time), population (MDD), and the limited sample size.
A 40 mg JNJ-42847922 dose level is selected for this study because it has been
demonstrated to be well tolerated, offers some slight benefit on sleep
parameters versus a 20 mg dose level, and to optimize our ability to detect, if
present, an effect on WASO.
Turnhoutseweg 30
Beerse 2340
BE
Turnhoutseweg 30
Beerse 2340
BE
Listed location countries
Age
Inclusion criteria
Healthy male and female participants aged between 18 and 65 years, inclusive
- Body mass index (BMI) between 18 and 30 kilogram per square meters (kg/m^2) inclusive (BMI = weight/height^2)
- Insomnia Severity Index (ISI) score more than or equal to 15 at screening
- Insomnia: at screening participants will report both difficulties with sleep onset and sleep maintenance. Insomnia will furthermore objectively be established prior to enrollment per PSG recorded over 3 consecutive nights. Participants will sleep for 3 consecutive nights in the sleep center. First and second night data will be used to exclude any participant with restless leg syndrome, apnea, parasomnias or other sleepdisorders. On the second and third night participants are required to meet objective inclusion criteria: 2-night mean LPS of >= 30 minutes with no night < 20 minutes, and on both nights TST =< 6 hours and wake after sleep onset (WASO) >30 minutes
- Participants must be healthy /medically stable on the basis of clinical laboratory tests, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening and baseline
Exclusion criteria
Participant has current signs/symptoms of, liver or renal insufficiency; hypothyroidism or hyperthyroidism, significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, or metabolic disturbances. Participants with non-insulin dependent diabetes mellitus who are adequately controlled (not on insulin) may participate in the study
- History of epilepsy or fits or unexplained black-outs
- Clinically significant abnormal values for hematology, clinical chemistry or urinalysis at screening or admission
- Clinically significant abnormal physical and neurological examination, vital signs or 12-lead ECG at screening or baseline
- Smoking >10 cigarettes/daily
- Insomnia related to restless leg syndrome, sleep breathing disorder, narcolepsy, obstructive sleep apnea/hypopnea, central sleep apnea, sleep-related hypoventilation, circadian rhythm sleep-wake disorders, substance/medication-induced sleep disorder or parasomnias
- Night-shift worker or significantly shifted diurnal activity pattern
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2015-001672-22-NL |
| CCMO | NL54083.056.15 |