NCT00696865已完成1 期
A Phase I, Single-Center, Randomized, Double-Blind, Placebo-Controlled, Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD2624 When Given in Multiple Ascending Oral Doses in Young Healthy Male Japanese 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
- 30
- 试验地点
- 1
- 主要终点
- To assess the safety and tolerability of multiple ascending oral doses of AZD2624 in young healthy male Japanese subjects compared to placebo by assessment of adverse events, vital signs, physical examinations, laboratory parameters, ECGs and EEGs
研究概览
简要总结
This multiple ascending dose study will evaluate safety and tolerability after repeated ascending doses of AZD2624
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
- 20 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy young male Japanese volunteers
排除标准
- •Significant illness, as judged by the investigator, within 2 weeks of screening visit or Day 1
- •Enrollment in another concurrent investigational study or intake of an investigational drug within 4 months prior to the screening visit or Day 1
- •Blood loss in excess of 200 mL within 30 days of screening visit or Day 1, in excess of 400 mL within 90 days of screening visit or Day 1, or in excess of 1200 mL within 1 year of screening visit or Day 1
- •Clinically relevant abnormalities in physical examinations, vital signs, clinical chemistry, hematology or urinalysis as judged by the investigator at screening or pre first dose
研究组 & 干预措施
1
Experimental
干预措施: AZD2624 (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 ascending oral doses of AZD2624 in young healthy male Japanese subjects compared to placebo by assessment of adverse events, vital signs, physical examinations, laboratory parameters, ECGs and EEGs
时间窗: All assessments are made at each visit, at least daily, during the study.
次要结局
- Identification of genes that influence the disposition, efficacy, safety and tolerability of AZD2624(A single blood sample will be obtained)
- To evaluate and characterize the pharmacokinetics of AZD2624 and its metabolites when given orally in multiple ascending doses of AZD2624 to young healthy male Japanese subjects by assessment of drug concentration in plasma(Blood samples will be taken before and after study drug administration.)
研究者
研究点 (1)
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