NCT01130909终止1 期
A Phase I, Randomized, Double-Blind, Four-way Cross-over Study in Healthy Subjects to Assess Quantitative Electroencephalography (qEEG) Parameters After the Administration of Ketamine, Two Doses of AZD6765 and Placebo
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- AstraZeneca
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- qEEG assessed through the gamma bands
研究概览
简要总结
This study will provide data to support preclinical to clinical translation by aligning preclinical and clinical efficacy assay with dose dependent changes in EEG.
详细描述
A Phase I, Randomized, Double-Blind, Four-way Cross-over Study in Healthy Subjects to Assess Quantitative Electroencephalography (qEEG) parameters after the administration of ketamine, two doses of AZD6765 and Placebo
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 30 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •BMI 18-30 Non-smoker for at least 4 weeks
排除标准
- •Any clinically relevant acute or chronic disease
- •History of substance abuse Hypersensitivity to ketamine
研究组 & 干预措施
AZD6765 75 mg
Experimental
干预措施: AZD6765 (Drug)
AZD6765 150 mg
Experimental
干预措施: AZD6765 (Drug)
Ketamine 0.5 mg/kg
Active Comparator
干预措施: Ketamine (Drug)
125 mL sterile NaCl 0.9%
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
qEEG assessed through the gamma bands
时间窗: Day 1 of each treatment period at Predose, 0.25h, 1h, 1.25h, 3h and 8h
次要结局
- Pupil Size - to assess the relationship between qEEG and pupil size(Day 1 of each treatment period at Predose, 0.25h, 1h, 1.25h, 3h, and 8h)
- Electronystagmography - to assess the relationship between qEEG and spontaneous nystagmus.(Day 1 of each treatment period at Predose, 1h, 3h, and 8h)
- Bond/Lader scales and eVAS - to assess the subject's alertness, calmness and contentment(Day 1 of each treatment period at Predose, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, and 8h)
研究者
研究点 (1)
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