NCT00997308已完成1 期
A Phase I, Randomised, Double-blind, Placebo-controlled, Parallel Group, Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD1446 in Healthy Elderly Male and Female Volunteers During 4 Weeks of Treatment
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
- 97
- 试验地点
- 1
- 主要终点
- To assess the safety and tolerability of AZD1446 dosed for 4 weeks as compared to placebo in healthy elderly male and female volunteers. Safety and tolerability outcomes include adverse events, clinical chemistry and vitals (pulse and blood pressure).
研究概览
简要总结
This study is designed to evaluate the safety, tolerability and pharmacokinetics (PK) of two doses of AZD1446 or placebo in subjects when given for 4 weeks.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 65 Years 至 85 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or non-fertile female, elderly Subjects, aged ≥65 to ≤85
- •Body mass index (BMI) between 18 and 30 kg/m2
- •Clinically normal findings on physical examination
排除标准
- •History of any clinically significant disease or disorder
- •History of severe allergy/hypersensitivity reactions including severe food allergy as judged by the investigator.
研究组 & 干预措施
AZD1446 High
Experimental
High dose of AZD1446
干预措施: AZD1446 (Drug)
AZD1446 Low
Experimental
Low dose of AZD1446
干预措施: AZD1446 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
To assess the safety and tolerability of AZD1446 dosed for 4 weeks as compared to placebo in healthy elderly male and female volunteers. Safety and tolerability outcomes include adverse events, clinical chemistry and vitals (pulse and blood pressure).
时间窗: During the whole study period, Study days 1-68 (30 days of enrolment , study day 1-28 and follow up visit study days 35-38).
次要结局
- To determine the PK of AZD1446 dosed for 4 weeks in healthy elderly male and female volunteers. PK parameters include renal clearance, AUC (0-24)ss and T1/2 eff.(PK sampling taken at defined timepoints during the treatment period (study days 1-28))
研究者
研究点 (1)
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