NCT00692042已完成1 期
A Phase I, First Time in Man, Single-Centre, Randomised, Double-Blind (Within Panels), Placebo-Controller Study to Investigate Safety, Tolerability and Pharmacokinetics of AZD1704 After Administration of Oral Single Ascending Doses in Healthy Volunteers
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
- AstraZeneca
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- To investigate the safety and tolerability of AZD1704 following single ascending doses in healthy volunteers.
研究概览
简要总结
The primary aim for this study is to investigate the safety and tolerability of the AZD1704, first time in man.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteers, man or woman of non child-bearing potential
- •Provision of signed informed consent.
排除标准
- •History of somatic disease/condition that may interfere with the objectives ot the study, as judged by the Investigator. History of seizures, with the exception of single occasions fever induced seizures in childhood.
- •History of previous or ongoing psychiatric disease/condition including psychosis, affective disorder, anxiety disorder, borderline state and personality disorder according to the criteria in the DSM of Mental Disorder, 4th edition
- •History of use of antipsychotic, antidepressant or anxiolytic drugs for the treatment of psychiatric disease or symptoms, prescribed as well as non-prescribed use.
研究组 & 干预措施
1
Experimental
干预措施: AZD1704 (Drug)
结局指标
主要结局
To investigate the safety and tolerability of AZD1704 following single ascending doses in healthy volunteers.
时间窗: At screening, during residential period (daily) and at follow-up
次要结局
- To investigate the subjective CNS effects of specific adjectives (stimulated, anxious, sedated, down and high) rated on visual analogue mood scale (VAMS).(During residential period (daily))
研究者
研究点 (1)
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