NCT00765492已完成1 期
A Phase I, Single-Center, Randomized, Double-Blind, Placebo-Controlled, Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD8529 When Given as Single and Multiple Ascending Oral Doses in 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
- 47
- 主要终点
- To assess the safety and tolerability of multiple 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 multiple 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
- •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 30months 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 multiple dose administration of AZD8529 when given orally to healthy male subjects and female subjects of non-childbearing potential.
时间窗: each visit, at least daily, during the study.
次要结局
- To characterize the pharmacokinetics of AZD8529 in plasma(Blood samples will be taken during the study.)
研究者
相似试验
已完成
1 期
AZD8529 Single Ascending Dose StudyHealthy VolunteerNCT00755378AstraZeneca58
已完成
1 期
AZD6280 Multiple Ascending Dose StudyHealthy VolunteerNCT00681317AstraZeneca48
已完成
1 期
AZD7325 Multiple Ascending Dose StudyHealthy VolunteerNCT00681915AstraZeneca48
已完成
1 期
A Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD0914Gonococcal (GC) InfectionNCT01929629AstraZeneca100
终止
1 期
A First Time in Man Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD1979 in Healthy MalesHealthy SubjectsNCT02072993AstraZeneca116