NCT00526968已完成1 期
A Double Blind, Placebo Controlled Study to Investigate the Role of NMDA Receptor NR2B Subunit Selective Antagonism on Cognitive Functions and Neurophysiology in Healthy Subjects as Measured With MRI
Evotec Neurosciences GmbH1 个研究点 分布在 1 个国家目标入组 19 人开始时间: 2007年9月最近更新:
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
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Change in fMRI BOLD signal under baseline conditions and during activation by cognitive tasks
研究概览
简要总结
The purpose of this study is to investigate the neurophysiological changes following single doses of EVT 101 using fMRI during rest and during cognitive tasks in young healthy male subjects.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy Male volunteers
- •Body Mass Index between 19 and 29
排除标准
- •Subjects who received any prescribed medication within 5 half lives or 14 days of the first dose administration whichever is the longer
- •Subjects who have received any prescribed CNS medication or any medication known to chronically alter drug absorption or elimination processes within 30 days of first dose administration
- •Participation in a clinical trial of an investigational drug within the past 4 months or of a marketed drug within the past 3 months
- •History of allergy to NMDA antagonists or other clinically significant drug allergy
- •Supine blood pressure and heart rate of higher than 140/90 mmHg and 90 bpm respectively or lower than 80/40 mmHg and 40 bpm
- •Consumption of more than 21 units of alcohol per week or history of alcoholism or drug/chemical abuse
- •Smokers of more than 5 cigarettes or equivalent per day
- •Subjects who cannot complete the neuropsychological test battery
- •Any clinically significant health deficit
研究组 & 干预措施
1
Experimental
EVT 101 8 mg capsule
干预措施: EVT 101 (Drug)
2
Experimental
EVT 101 15 mg capsule
干预措施: EVT 101 (Drug)
3
Placebo Comparator
Matching placebo capsule
干预措施: placebo (Drug)
结局指标
主要结局
Change in fMRI BOLD signal under baseline conditions and during activation by cognitive tasks
时间窗: 2-hours post dose
Change in regional cerebral blood flow (determined with ASL-MRI)after drug compared with placebo
时间窗: 2-hours post dose
Performance scores in the cognitive tests
时间窗: 2-hours post dose
次要结局
- Safety, tolerability, adverse events, safety laboratory tests, ECG, vital signs(Up to 24 hours post dose and 5-7 days post last dose)
研究者
研究点 (1)
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