NCT00434785已完成1 期
An Ascending, Multiple Dose Study of the Safety, Tolerability, and Pharmacokinetics of AGG-523 Administered Orally to Healthy Male Japanese Subjects.
Wyeth is now a wholly owned subsidiary of Pfizer1 个研究点 分布在 1 个国家开始时间: 2007年2月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 试验地点
- 1
- 主要终点
- To assess the safety and PK profile
研究概览
简要总结
To assess the safety and tolerability of ascending, multiple oral doses of AGG-523 in healthy Japanese subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Men aged 20 to 40 years, inclusive, at screening; sexually active men must agree to use a medically acceptable form of contraception during the study and continue for 12 weeks after test article administration.
- •Body mass index (BMI) in the range of 17.6 to 26.4 Kgm2, and body weight >45 kg.
- •Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs, and 12 lead ECG.
排除标准
- 未提供
结局指标
主要结局
To assess the safety and PK profile
次要结局
未报告次要终点
研究者
研究点 (1)
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