NCT00550381已完成1 期
Ascending Single-Dose Study of the Safety, Tolerability, and Pharmacokinetics of HKI-357 Administered Orally to Healthy Subjects
Wyeth is now a wholly owned subsidiary of Pfizer0 个研究点目标入组 72 人开始时间: 2008年1月最近更新:
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
- 入组人数
- 72
- 主要终点
- Safety, tolerability, PK
研究概览
简要总结
The purpose of this study is to assess the safety, tolerability, and pharmacokinetics of single doses of HKI-357 administered to healthy 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 (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
1
Placebo Comparator
10mg
干预措施: HKI-357 (Drug)
2
Placebo Comparator
20mg
干预措施: HKI-357 (Drug)
3
Placebo Comparator
40mg
干预措施: HKI-357 (Drug)
4
Placebo Comparator
80mg
干预措施: HKI-357 (Drug)
5
Placebo Comparator
160mg
干预措施: HKI-357 (Drug)
6
Placebo Comparator
240mg
干预措施: HKI-357 (Drug)
7
Placebo Comparator
400mg
干预措施: HKI-357 (Drug)
8
Placebo Comparator
640mg
干预措施: HKI-357 (Drug)
9
Placebo Comparator
960mg
干预措施: HKI-357 (Drug)
10
Placebo Comparator
placebo
干预措施: HKI-357 (Drug)
结局指标
主要结局
Safety, tolerability, PK
时间窗: 5 days
次要结局
未报告次要终点
研究者
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