NCT00729443已完成1 期
A Single-Centre, Placebo-Controlled, Randomized, Double-Blind Study to Evaluate the Safety, Tolerability and Pharmacokinetics of AZD3241 Following Administration of Single Ascending (Part A) and Fractionated Ascending (Part B) Oral Doses to Young 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
- 64
- 试验地点
- 1
- 主要终点
- General tolerability and safety variables
研究概览
简要总结
The study is carried out in order to investigate safety, tolerability and pharmacokinetics after administrating single and fractionated doses of AZD3241 to healthy volunteers
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 49 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Provision of informed consent
- •Body Mass Index (BMI) 19 to 30 kg/m2 inclusive
- •Clinically normal physical findings, including BP, pulse rate, ECG and laboratory findings, as judged by the investigator
排除标准
- •Clinically significant illness within the 2 weeks prior to the administration of the investigational product
- •Heart rate (resting, recumbent) <50 bmp or >85 bmp
- •History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity as judged by the investigator
研究组 & 干预措施
1
Experimental
干预措施: AZD3241 (Drug)
2
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
General tolerability and safety variables
时间窗: 2 weeks
次要结局
- pk(approximately 48 hour)
研究者
研究点 (1)
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