NCT03489772已完成1 期
A Randomized, Placebo-Controlled, Double-Blind Study of Escalating Single Doses of ITI-214 in Healthy Volunteers to Determine Central Nervous System Engagement, Safety and Tolerability
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- BOLD MRI signals in the anterior insula during the extinction phase of a Fear Conditioning task
研究概览
简要总结
This is a single site, randomized, double-blind, placebo-controlled, within-subjects study design in healthy volunteers. Escalating single doses of ITI-214 will be evaluated using functional magnetic resonance imaging (fMRI) to determine central nervous system engagement. Safety and tolerability also will be assessed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male or female, 18 - 45 years
- •Fluent and literate in English and able to provide written informed consent
- •BMI between 18.5 and 38.0 kg/m2 and minimum body weight of 50 kg
排除标准
- •Recent exposure to any investigational product
- •Previous exposure to relevant fMRI task(s)
- •Considered medically unsuitable for participation
- •Has any contraindication for BOLD fMRI
研究组 & 干预措施
1 mg ITI-214
Experimental
Single dose
干预措施: ITI-214 (Drug)
10 mg ITI-214
Experimental
Single dose
干预措施: ITI-214 (Drug)
Placebo
Placebo Comparator
Single dose
干预措施: Placebo (Drug)
结局指标
主要结局
BOLD MRI signals in the anterior insula during the extinction phase of a Fear Conditioning task
时间窗: 1-3 hours post-dose
Changes in brain activation
BOLD MRI signals in the inferior frontal gyrus during the Stop Signal Task
时间窗: 1-3 hours post-dose
Changes in brain activation
次要结局
- BOLD fMRI signals elicited by the Stop versus Go signal(1-3 hours post-dose)
- BOLD fMRI signals elicited by fear conditioning stimulus(1-3 hours post-dose)
- Number of subjects with reported or observed treatment-related adverse events(0-5 hours post-dose)
研究者
研究点 (1)
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