NCT00755378已完成1 期
Phase I, Single-Center, Randomized, Double-Blind, Placebo Controlled Single-Ascending Dose, First Time Into Man Study to Assess the Safety, Tolerability, and PK of AZD8529 in Healthy Subjects Part B: A Randomized, Open Label Study to Assess the Effect of Food on AZD 8529
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
- 58
- 试验地点
- 1
- 主要终点
- To assess the safety and tolerability of single dose administration of AZD8529 when given orally to healthy male subjects and female subjects of non-childbearing potential.
研究概览
简要总结
This is a study to evaluate safety, tolerability, PK and PD effects of orally administered AZD8529 after single ascending doses
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male or female subjects aged 18 to 45 years (inclusive) on Day
- •Female subjects must be of non-child bearing potential.
排除标准
- •Has received another new chemical entity (defined as a compound which has not been approved for marketing) or has participated in any other clinical study that included drug treatment within 3 months of the first administration of investigational prod
- •Plasma donation within one month of screening or any blood donation/blood loss > 500mL during the 3 months prior to screening
- •Clinically relevant abnormalities in physical examinations, vital signs, ECG, clinical chemistry, hematology or urinalysis
研究组 & 干预措施
1
Experimental
干预措施: AZD8529 (Drug)
2
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
To assess the safety and tolerability of single dose administration of AZD8529 when given orally to healthy male subjects and female subjects of non-childbearing potential.
时间窗: at each visit, at least daily, during the study.
次要结局
- To asses the effect of food on the safety and pharmacokinetic profile of AZD8529.(Safety assessments and blood and urine samples will be taken throughout the study.)
- To characterize the pharmacokinetics of AZD8529 in plasma and urine.(Blood and urine samples will be taken during the study.)
研究者
研究点 (1)
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