NCT00754715已完成1 期
A Phase I, Single-Centre, Randomised, Double-Blind, Placebo-Controlled Parallel-Group Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD2516 in Young and Elderly Healthy Volunteers After Oral Single Ascending Doses
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
- 72
- 试验地点
- 1
- 主要终点
- Safety and tolerability of AZD2516 by assessment of serious adverse events, ECGs, vital signs and laboratory variables
研究概览
简要总结
The primary purpose of this study is to assess the safety and tolerability of AZD2516 following administration of a single dose.
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
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy white males or non-fertile females between 20 to 45 years and 65 to 80 years old.
- •Weight between 50 to 100 kg and a body mass index (BMI) between 19 to 28 kg/m2
排除标准
- •History of previous or ongoing psychiatric disease.
- •Abnormalities in ECG that may interfere with interpretation of data.
研究组 & 干预措施
AZD2516
Experimental
干预措施: AZD2516 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Safety and tolerability of AZD2516 by assessment of serious adverse events, ECGs, vital signs and laboratory variables
时间窗: From first to last visit
次要结局
- Safety and tolerability of AZD2516 by assessment of non-serious adverse events(Collected from start of residential period until last visit.)
- Determine the single ascending dose pharmacokinetics of AZD2516(PK sampling taken at defined timepoints during residential period)
研究者
研究点 (1)
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