NCT00437437已完成1 期
Phase I Study to Determine the Effect of a High Fat Meal on the Pharmacokinetics of BMS-540215, the Active Metabolite of Brivanib Alaninate in Subjects With Advanced or Metastatic Solid Tumors
Bristol-Myers Squibb3 个研究点 分布在 1 个国家目标入组 29 人开始时间: 2000年5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
- 29
- 试验地点
- 3
- 主要终点
- To determine the effect on pharmacokinetics of BMS-540215, the active metabolite of brivanib alaninate, when administered following a high fat meal versus administration in a fasted state
研究概览
简要总结
The purpose of this trial is to determine the effect of food versus a fasted state on single-dose pharmacokinetics of BMS-540215, the active metabolite of Brivanib alaninate
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologic/cytologic diagnosis of advanced or metastatic solid tumors
- •4/6 weeks since prior therapy
排除标准
- •Brain metastases
- •Second primary malignancy
- •Thromboembolic disease requiring full anticoagulation within 6 months
- •Inability to swallow or absorb oral therapy
研究组 & 干预措施
1
Experimental
干预措施: Brivanib (Drug)
结局指标
主要结局
To determine the effect on pharmacokinetics of BMS-540215, the active metabolite of brivanib alaninate, when administered following a high fat meal versus administration in a fasted state
时间窗: throughout the study
次要结局
- To assess safety and tolerability of Brivanib alaninate when administered in a fasted state, or following a high fat meal(throughout the study)
研究者
研究点 (3)
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