NCT00803855已完成1 期
A Phase I, Randomised, Double-Blind, Placebo-Controlled, Parallel-Group Single Ascending Dose Study to Asses the Safety, Tolerability, Pharmacokinetics of AZD1446 Including an Open Food Effect Panel 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
- 110
- 试验地点
- 1
- 主要终点
- Safety and tolerability of AZD1446 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 AZD1446 following single dose administration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •physical healthy volunteers
- •weight between 50 to 100 kg and a body mass index (BMI) between 19 and 30 kg/m2
排除标准
- •History of any clinically significant disease or disorder.
- •History of severe allergy/hypersensitivity reactions
研究组 & 干预措施
AZD1446 Oral or placebo
Experimental
Single oral administration of AZD1446 or placebo
干预措施: AZD1446 (Drug)
AZD1446 Oral, with or without food
Experimental
Single oral administration of AZD1446 with or without food
干预措施: AZD1446 (Drug)
结局指标
主要结局
Safety and tolerability of AZD1446 by assessment of serious adverse events, ECGs, vital signs and laboratory variables
时间窗: From first to last visit
次要结局
- Determine the single ascending dose pharmacokinetics of AZD1446(PK sampling taken at defined timepoints during residential period)
- Determine the single dose of AZD1446 on food interaction(From first to last visit)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
Study to Assess Safety, Tolerability and Pharmacokinetics After Single and Multiple Doses of AZD1446 to Japanese SubjectHealthyNCT01021189AstraZeneca97
已完成
1 期
Study to Investigate Safety, Tolerability and Pharmacokinetics With Single and Multiple Ascending Doses of AZD1446HealthyNCT00902993AstraZeneca80
终止
1 期
Assess Safety, Tolerability and Pharmacokinetic (PK) of AZD1704 in Healthy Japanese Male and Non-Fertile Female VolunteersHealthy VolunteersNCT00736788AstraZeneca16
已完成
1 期
Study to Evaluate Safety, Tolerability and Pharmacokinetics (PK) (Including Food Effect) of Oral Doses of AZD5847 in Healthy VolunteersHealthyNCT01037725AstraZeneca64
已完成
1 期
Phase I Study in Healthy Volunteers to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD4017 After Repeated Ascending Oral DosesDiabetes Mellitus Type 2NCT00841048AstraZeneca107