NCT01002079已完成1 期
A Study of the Effect of Concomitant Administration of Rifampin 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 20 人开始时间: 2010年8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
- 20
- 试验地点
- 1
- 主要终点
- BMS-708163 alone and with rifampin: BMS-708163 single dose PK parameters (Cmax, Tmax, T-HALF, AUC(0-T), AUC(INF), CLT/F and molar AUCmet/AUCparent ratios will be assessed without rifampin (Day 1) and with rifampin (Day 13)
研究概览
简要总结
The purpose of the study is to determine if the concomitant administration of rifampin with BMS-708163 will affect the Pharmacokinetics of BMS-708163 and to assess safety and tolerability of co-administration BMS-708163 and rifampin
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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
排除标准
- •Women of childbearing potential
- •Tuberculosis
研究组 & 干预措施
BMS-708163
Experimental
干预措施: BMS-708163 (Drug)
Rifampin
Other
干预措施: Rifampin (Drug)
Rifampin + BMS-708163
Experimental
干预措施: BMS-708163 (Drug)
Rifampin + BMS-708163
Experimental
干预措施: Rifampin (Drug)
结局指标
主要结局
BMS-708163 alone and with rifampin: BMS-708163 single dose PK parameters (Cmax, Tmax, T-HALF, AUC(0-T), AUC(INF), CLT/F and molar AUCmet/AUCparent ratios will be assessed without rifampin (Day 1) and with rifampin (Day 13)
时间窗: Within 30 days after dose
次要结局
- BMS-708163 alone and with rifampin: Safety and tolerability (AE's, ECG, vital signs, safety labs)(Within 30 days after dose)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
2 期
A Study to Assess the Pharmacokinetics of Ramucirumab (IMC-1121B) in Combination With FOLFIRISolid TumorsNCT01634555Eli Lilly and Company29
已完成
1 期
Drug Interaction Study With a Potential Alzheimer's Disease CompoundAlzheimer DiseaseNCT00726726Bristol-Myers Squibb22
已完成
1 期
A Study to Evaluate the Effect of Rifampin on the Single-dose Pharmacokinetics (PK) of BMS-986141 in Healthy SubjectsAtherothrombotic DiseasesNCT02957448Bristol-Myers Squibb16
已完成
2 期
A Study of Ramucirumab and Docetaxel in Participants With Solid TumorsMalignant Solid TumorNCT01567163Eli Lilly and Company22
已完成
1 期
Study Evaluating The Potential Effect Of Rifampin On The Pharmacokinetics Of NeratinibHealthy SubjectsNCT00864487Puma Biotechnology, Inc.24