NCT00931541已完成1 期
A Phase I, Single Centre, Double-blind, Randomised, Placebo-controlled, Parallel-group Study to Assess the Safety, Tolerability and Pharmacokinetics of Oral AZD6088 After Single Ascending Doses in Healthy Male and Non-Fertile Female 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
- 35
- 试验地点
- 1
- 主要终点
- Safety variables (vital signs, ECG, EEG, safety laboratory values, body temp)
研究概览
简要总结
The aims of the study are to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of AZD6088 following single ascending dose administration in healthy male and non-fertile females.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Caucasian male and non-fertile female healthy volunteers aged ≥18 to ≤55 years with suitable veins for cannulation or repeated venipuncture.
- •Clinically normal physical findings including supine BP, pulse rate, ECG and laboratory assessments in relation to age, as judged by the investigator.
- •Normal and suitable EEG, as judged by a neurologist
排除标准
- •History of any clinically significant disease or disorder which for instance includes CNS disorder or CV disorder.
- •Any clinically significant abnormalities in clinical chemistry, haematology or urinalysis results as judged by the investigator.
- •Any clinically important abnormalities in the ECG.
研究组 & 干预措施
A
Experimental
AZD6088 oral solution
干预措施: AZD6088 (Drug)
B
Experimental
Placebo oral solution
干预措施: Placebo (Drug)
结局指标
主要结局
Safety variables (vital signs, ECG, EEG, safety laboratory values, body temp)
时间窗: Sampling occasions during all visits.
次要结局
- Pharmacokinetics(Intense PK-sampling during 3 pre-defined study days for PK profiling.)
- Pharmacodynamics(Sampling occasions during 3 pre-defined study days.)
研究者
研究点 (1)
Loading locations...
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