A Randomized, Placebo-controlled, 2-way Crossover, Double-blind Study to Evaluate the Efficacy, Safety and Tolerability of JNJ-42847922 in Subjects With Insomnia Disorder Without Psychiatric Comorbidity
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 28
- 主要终点
- Sleep Efficiency by Polysomnography
研究概览
简要总结
The primary purpose of this study is to investigate the effect of JNJ-42847922 (change versus placebo) on sleep efficiency (SE) measured by polysomnography (PSG) after single and multiple dose administration to participants with insomnia disorder without psychiatric comorbidity.
详细描述
This is a multi-center, randomized (study medication assigned to participants by chance), placebo-controlled, double-blind (neither physician nor participant knows the identity of the assigned treatment), 2-way cross-over study of JNJ-42847922 participants with insomnia disorder without psychiatric comorbidity. The study consists of following phases: screening (28 days prior to Day 1), a double-blind treatment phase (consists of 5-day treatments, either JNJ-42847922 or placebo in subsequent 2-treatment periods, each separated with washout period of 5 to 9 days), and a follow-up examination (7 to 14 days after last dose administration). Participants' safety will be monitored throughout the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 sleep disorders. 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
排除标准
- •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
研究组 & 干预措施
JNJ-42847922 then Placebo
Participants receive 2*20 milligram (mg) tablet of JNJ-42847922 orally once daily from Day 1 to Day 5 of period 1. After a washout period of 5 to 9 days participants will receive matching placebo from Day 1 to Day 5 of period 2.
干预措施: JNJ-42847922 (Drug)
JNJ-42847922 then Placebo
Participants receive 2*20 milligram (mg) tablet of JNJ-42847922 orally once daily from Day 1 to Day 5 of period 1. After a washout period of 5 to 9 days participants will receive matching placebo from Day 1 to Day 5 of period 2.
干预措施: Placebo (Drug)
Placebo then JNJ-42847922
Participants will receive matching placebo from Day 1 to Day 5 of period 1. After a washout period of 5 to 9 days participants will receive 2*20 mg tablet of JNJ-42847922 orally once daily from Day 1 to Day 5 of period 2.
干预措施: JNJ-42847922 (Drug)
Placebo then JNJ-42847922
Participants will receive matching placebo from Day 1 to Day 5 of period 1. After a washout period of 5 to 9 days participants will receive 2*20 mg tablet of JNJ-42847922 orally once daily from Day 1 to Day 5 of period 2.
干预措施: Placebo (Drug)
结局指标
主要结局
Sleep Efficiency by Polysomnography
时间窗: up to Night 5
The total sleep time divided by the total time in bed (that is, the number of minutes from the beginning of the Polysomnography recording to the end of the recording).
次要结局
- Total Sleep Time by Polysomnography(up to Night 5)
- Wake Time After Sleep Onset by Polysomnography(up to Night 5)
- Number of Awakenings After Persistent Sleep by Polysomnography(up to Night 5)
- Total Time Spent in Deep Sleep by Polysomnography(up to Night 5)
- Mean Latency to Persistent Sleep by Polysomnography(up to Night 5)
- Subjective assessment of sleep by Questionnaire(up to Night 5)
- Next Morning Residual Effects by Bond and Lader Visual Analogue Scale(up to Night 5)
- Leeds Sleep Evaluation Questionnaire (LSEQ) Score(up to Night 5)
- Next Morning Residual Effects by cognitive test battery(up to Night 5)
- Next Morning Residual Effects by Karolinska Sleepiness Scale(up to Night 5)
- Number of Participants with Adverse Events (AEs) and Serious AEs(up to Night 5)