NCT00860275已完成1 期
A Study of the Effect of Concomitant Administration of Ketoconazole or Fluconazole on the Pharmacokinetics of BMS-708163 in Healthy Subjects
Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2009年4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
- 30
- 试验地点
- 1
- 主要终点
- PK profile of BMS-708163
研究概览
简要总结
The purpose of the study is to determine if the concomitant administration of either ketoconazole or fluconazole with BMS-708163 will affect the PK of BMS-708163 and to assess safety and tolerability of BMS-708163
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
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male and postmenopausal female subjects 18-55 yrs old inclusive
- •Premenopausal women
排除标准
- 未提供
研究组 & 干预措施
BMS-708163 / Ketoconazole
Active Comparator
干预措施: BMS-708163 (Drug)
BMS-708163 / Ketoconazole
Active Comparator
干预措施: BMS-708163 + Ketoconazole (Drug)
BMS-708163 / Ketoconazole
Active Comparator
干预措施: Ketoconazole (Drug)
BMS-708163 / Fluconazole
Active Comparator
干预措施: BMS-708163 (Drug)
BMS-708163 / Fluconazole
Active Comparator
干预措施: Fluconazole (Drug)
BMS-708163 / Fluconazole
Active Comparator
干预措施: BMS-708163 + Fluconazole (Drug)
结局指标
主要结局
PK profile of BMS-708163
时间窗: Within 14 days after dose
次要结局
- Safety and tolerability of BMS-708163 when administered alone and with either ketoconazole or fluconazole(During the entire study period)
研究者
研究点 (1)
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