NCT03284931已完成1 期
A Randomized, Double-Blind, Multiple Dose, 3-way Crossover, Exploratory Study to Assess the Pharmacodynamic Effects of SAGE-217 Capsules in Healthy Adults Using a 5-hour Phase Advance Model of Insomnia
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Biogen
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Sleep efficiency, as determined by polysomnography (PSG)
研究概览
简要总结
This study will assess the pharmacodynamic effects of SAGE-217 in approximately 42 healthy adult subjects using an insomnia model.
详细描述
Subjects are expected to complete Treatment Periods 1, 2 and 3, followed by an optional open-label administration of SAGE-217 for pharmacokinetic purposes (Treatment Period 4).
This study was previously posted by Sage Therapeutics. In November 2023, sponsorship of the trial was transferred to Biogen.
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
- Triple (Participant, 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
- •Subject is willing and able to participate in the study, including all assessments, planned inpatient stays and all follow-up visits
- •Subject is a healthy, ambulatory volunteer
- •Subject meets sleep Qualification criteria
排除标准
- •Subject has a medical history of suicidal behavior, epilepsy, eating disorders, sleep disorders, or circadian rhythm disorders
- •Subject has worked a night shift or flown >1 time zone within 30 days prior to Screening
研究组 & 干预措施
SAGE-217 high dose
Experimental
SAGE-217
干预措施: SAGE-217 high dose (Drug)
SAGE-217 low dose
Experimental
SAGE-217
干预措施: SAGE-217 low dose (Drug)
Placebo
Placebo Comparator
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Sleep efficiency, as determined by polysomnography (PSG)
时间窗: 16 days
次要结局
- Safety and tolerability, as assessed by vital signs(29 days)
- Safety and tolerability, as assessed by clinical laboratory data(29 days)
- Safety and tolerability, as assessed by ECG(29 days)
- Safety and tolerability, as assessed by adverse events(36 days)
- Safety and tolerability, as assessed by Columbia Suicide Severity Rating Scale (C-SSRS)(29 days)
研究者
研究点 (1)
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