NCT02935725已完成1 期
A Phase 1, Single-centre, Double-blind, Placebocontrolled Crossover Study to Assess the pharmacoMRI Effects of AUT00206 in Healthy Male Participants
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
- 22
- 试验地点
- 1
- 主要终点
- Significant difference in BOLD phMRI signals after dosing with AUT00206 vs placebo
研究概览
简要总结
A Phase 1, Single-centre, Double-blind, Placebo controlled Crossover Study to Assess the pharmacoMRI Effects of AUT00206 in Healthy Male Participants
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, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Male aged 18 to 45 years, inclusive at Visit
- •Healthy on the basis of medical history, psychiatric history, physical examination, vital signs, 12-lead electrocardiogram (ECG), haematology, blood chemistry and urinalysis within 6 weeks of Visit
- •Right-handed.
- •Not a regular smoker (maximum 5 cigarettes per week or equivalent).
排除标准
- •History of, or current condition of, migraine headaches or has undergone operations to the head.
- •History of significant claustrophobia.
研究组 & 干预措施
High dose AUT00206 2000 mg + Ketamine
Experimental
High dose AUT00206 (2000 mg) + ketamine
干预措施: High dose AUT00206 2000 mg (Drug)
High dose AUT00206 2000 mg + Ketamine
Experimental
High dose AUT00206 (2000 mg) + ketamine
干预措施: Ketamine (Drug)
Low dose AUT00206 800 mg + Ketamine
Experimental
Low dose AUT00206 (800 mg) + ketamine
干预措施: Ketamine (Drug)
Low dose AUT00206 800 mg + Ketamine
Experimental
Low dose AUT00206 (800 mg) + ketamine
干预措施: Low dose AUT00206 800mg (Drug)
Placebo + Ketamine
Placebo Comparator
Placebo + ketamine
干预措施: Placebo (Drug)
Placebo + Ketamine
Placebo Comparator
Placebo + ketamine
干预措施: Ketamine (Drug)
Placebo + Saline
Placebo Comparator
Placebo + saline
干预措施: Placebo (Drug)
Placebo + Saline
Placebo Comparator
Placebo + saline
干预措施: Saline (Other)
结局指标
主要结局
Significant difference in BOLD phMRI signals after dosing with AUT00206 vs placebo
时间窗: 15 Weeks
次要结局
未报告次要终点
研究者
研究点 (1)
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