NCT02266966已完成1 期
Effect of F2695 on Brain Activity Measured by Functional Magnetic Resonance Imaging
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
- 17
- 试验地点
- 1
- 主要终点
- Motor system cortical areas activation magnitude during a paced motor task.
研究概览
简要总结
The aim of this functional Magnetic Resonance Imaging (MRI) study is to assess the effect of single dose of F2695 at 75mg on modulation of the cerebral motor network.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Male right-handed*, healthy volunteers 18 to 40 years of age. Having signed and dated an informed consent form
排除标准
- •Any significant disease or history of any clinically important drug allergy. Acute disease state within 7 days. History of drug abuse within 1 year. History or current excessive use of alcohol and / or positive alcohol screen. History of narrow angle glaucoma, seizures or epilepsy or brain injury. History of Gluten sensitivity, Gluten intolerance (celiac disease), Wheat allergy or Wheat intolerance.
- •History of obstructive voiding symptoms, including urinary retention.
研究组 & 干预措施
F2695
Experimental
Single dose - 2 capsules / Day on Day 1 and Day 8
干预措施: F2695 (Drug)
placebo
Placebo Comparator
Single dose - 2 capsules / Day on Day 1 and Day 8
干预措施: Placebo (Drug)
结局指标
主要结局
Motor system cortical areas activation magnitude during a paced motor task.
时间窗: 1 day (Period 1/Day +1, Period 2/Day +8)
1. Location coordinates (x,y,z), 2. Voxel cluster size expressed in terms number of voxels, 3. Intensity as measured with a Z-score
次要结局
- Incidence of adverse events (AEs) as a measure of safety and tolerability(up to 2 weeks)
研究者
研究点 (1)
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