A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Single-Dose Study of TAK-375 in Healthy Adult Volunteers in a Sleep Lab Model of Transient Insomnia
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 289
- 主要终点
- Latency to Persistent Sleep from 1 night of polysomnography (PSG) recording in a sleep laboratory.
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of Ramelteon, once daily (QD), in healthy subjects within a sleep lab.
详细描述
Insomnia is characterized by difficulties initiating and maintaining sleep, or of non-restorative and non-refreshing sleep. Transient insomnia affects approximately one-third to one-half of the US population, based on the results of 2 surveys of representative samples of the adult US population conducted by the Gallup Organization in which respondents were asked if they had "ever had difficulty sleeping." Based on reports of "regular" or "frequent" sleep difficulty, results from the same studies suggest that approximately one-tenth of the US population experiences chronic insomnia. The ideal treatment for insomnia would reduce the latency to onset of sleep and increase total sleep time, without a negative impact on sleep architecture and without safety concerns or next-day effects.
Ramelteon is a selective melatonin-1 receptor agonist under global development by Takeda Chemical Industries, Ltd., for the treatment of transient and chronic insomnia and for the treatment of Circadian Rhythm Sleep Disorders.
This study is being conducted to evaluate the safety and efficacy of a single dose of Ramelteon in normal healthy subjects in a sleep lab model of transient insomnia. Participation is this study is anticipated to be about 3 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •Any history of insomnia.
- •Spent one or more nights in a sleep laboratory.
- •Epworth Sleepiness Scale score of greater than
- •Known hypersensitivity to Ramelteon or related compounds, including melatonin.
- •Previously participated in a study involving Ramelteon.
- •Participated in any other investigational study and/or taken any investigational drug within 30 days or five half-lives prior to Day 1, whichever is longer.
- •Sleep schedule changes required by employment (ie, shift work) within three months preceding Day 1 or has flown across greater than three time zones within seven days prior to screening.
- •Participated in a weight loss program or substantially altered their exercise routine within 30 days prior to Day
- •History of seizures, sleep apnea, chronic obstructive pulmonary disease, restless leg syndrome, schizophrenia, bipolar disorder, mental retardation, or cognitive disorder.
- •History of a psychiatric disorder (including anxiety or depression) within the past 12 months.
- •History of drug addiction or drug abuse within the past 12 months.
- •Any physical or psychiatric disorder that may be associated with sleep disturbance.
- •History of alcohol abuse within the past 12 months, as defined in Diagnostic and Statistical Manual of Mental Disorders, 4th Edition Revised and/or regularly consumes 4 or more alcoholic drinks per day.
- •Current significant neurological, hepatic, renal, endocrine, cardiovascular, gastrointestinal, pulmonary, hematologic or metabolic disease.
- •Uses tobacco products during nightly awakenings.
- •Any clinically important abnormal finding as determined by a medical history, physical examination, electrocardiogram, or clinical laboratory tests, as determined by the investigator.
- •Positive hepatitis panel.
- •Positive urine drug screen including alcohol at screening or a positive breathalyzer test at check-in.
- •Any additional condition(s) that in the investigator's opinion would
- •affect sleep-wake function
- •prohibit the subject from completing the study
- •not be in the best interest of the subject.
- •Is required to take or continues taking any disallowed medication, prescription medication, herbal treatment or over-the counter medication, including:
- •Anxiolytics
- •Hypnotics
- •Antidepressants
- •Anticonvulsants
- •Sedating H1 antihistamines
- •Systemic steroids
- •Respiratory stimulants (eg, theophylline)
- •Decongestants
- •Over-the-counter and prescription stimulants
- •Over-the-counter and prescription diet aids
- •Central nervous system active drugs
- •Narcotic analgesics
- •All beta blockers
- •St. John's Wort
- •Kava-kava
- •gingko biloba
研究组 & 干预措施
Placebo
干预措施: Placebo (Drug)
Ramelteon 8 mg QD
干预措施: Ramelteon (Drug)
Ramelteon 16 mg QD
干预措施: Ramelteon (Drug)
结局指标
主要结局
Latency to Persistent Sleep from 1 night of polysomnography (PSG) recording in a sleep laboratory.
时间窗: Day 1
次要结局
- Stage 3/4 Nonrapid Eye Movement (NREM) Sleep(Day 2.)
- Latency to Rapid Eye Movement (REM) Sleep(Day 2.)
- Wake Time after Persistent Sleep Onset.(Days 1 and 2.)
- Subjective Sleep Latency.(Day 2)
- Subjective Ease of Falling Back to Sleep after Awakening.(Day 2)
- Total Sleep Time.(Days 1 and 2.)
- Sleep Efficiency.(Days 1 and 2.)
- Subjective Total Sleep Time.(Day 2)
- Number of Awakenings after Persistent Sleep.(Days 1 and 2.)
- Subjective Sleep Quality.(Day 2)
- Subjective Wake Time after Sleep Onset.(Day 2)
- Stage 1 Nonrapid Eye Movement (NREM) Sleep(Day 2.)
- Subjective Number of Awakenings.(Day 2)
- Stage 2 Nonrapid Eye Movement (NREM) Sleep(Day 2.)
- Percentage of Total Sleep Time in REM Sleep(Day 2.)