NCT00904800已完成1 期
A Single-blind, Randomised, Placebo-controlled, Parallel-group, Single Centre Phase I Study to Assess the Safety, Tolerability and Pharmacokinetics of Extended-release Tablets AZD0837 After Single and Repeated Oral Administration to 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
- 36
- 试验地点
- 1
- 主要终点
- To investigate the safety and tolerability of AZD0837 after single and repeated oral dosing of AZD0837 extended release (ER) tablet, in Japanese healthy subjects.
研究概览
简要总结
This phase I study will evaluate safety and tolerability after repeated doses of AZD0837.
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
- Single (Participant)
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 male Japanese subject aged between 20 to 45 years inclusive
排除标准
- •Acute illness (including ongoing or history of liver disease), trauma or surgical procedures within two weeks before Visit 1 or pre first dose in Visit 2
- •Intake of another investigational drug within 4 months before Visit 1 or pre first dose in Visit 2
- •Blood donation and/or sampling in excess of 200 mL of whole blood within the preceding 4 weeks, 400 mL of whole blood within the preceding 12 weeks and/or 1200 mL of whole blood within the preceding 12 months, before Visit 1 or pre first dose in Visit 2
研究组 & 干预措施
1
Experimental
Low dose
干预措施: AZD0837 (Drug)
2
Experimental
Middle dose
干预措施: AZD0837 (Drug)
3
Experimental
High dose
干预措施: AZD0837 (Drug)
4
Placebo Comparator
placebo
干预措施: Placebo (Drug)
结局指标
主要结局
To investigate the safety and tolerability of AZD0837 after single and repeated oral dosing of AZD0837 extended release (ER) tablet, in Japanese healthy subjects.
时间窗: All assessments are made at each visit, at least daily, during the study.
次要结局
- To investigate the pharmacokinetics (PK) of AZD0837, AR H069927XX and AR-H067637XX after single and repeated oral dosing of AZD0837 ER tablet, in Japanese healthy subjects.(Blood samples will be taken before and after study drug administration.)
研究者
研究点 (1)
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