NCT00972049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 After Oral Single Ascending Doses of AZD2516 in Young and Elderly Japanese Healthy Subjects
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
- 40
- 试验地点
- 1
- 主要终点
- Safety and tolerability of AZD2516 in Japanese healthy subjects by assessment of adverse events, vital signs, laboratory variables and ECG
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 to Japanese healthy subjects.
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
- •Weight between 45 to 100 kg and a body mass index (BMI) between 19 to 28 kg/m2
- •Japanese males aged between 20 to 45 years old (young) and Japanese males or females aged between 65 to 80 years old (elderly)
排除标准
- •History of previous or ongoing somatic or psychiatric disease/condition
- •Abnormalities in ECG that may interfere with interpretation of data.
研究组 & 干预措施
1
Experimental
Capsule administered once orally
干预措施: AZD2516 (Drug)
2
Placebo Comparator
Capsule administered once orally
干预措施: Placebo (Drug)
结局指标
主要结局
Safety and tolerability of AZD2516 in Japanese healthy subjects by assessment of adverse events, vital signs, laboratory variables and ECG
时间窗: Assessments taken at visit 1 (enrolment), defined time points pre dose and post dose during visit 2 (residential period): days -1 through to day 3 and follow up visit 3
次要结局
- Investigate the single ascending dose pharmacokinetics of AZD2516 in Japanese subjects(Blood sampling at defined timepoints during residential period and follow-up)
研究者
研究点 (1)
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