NCT01251835撤回1 期
A Phase 1, Open Label, Fixed Sequence Design, Multiple Dose Study To Assess The Effect Of Rifampin On The Pharmacokinetics Of Sitaxsentan In Healthy Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 发起方
- Pfizer
- 主要终点
- Comparison of Area Under the Curve of sitaxsentan co-administered with rifampin versus sitaxsentan administered alone.
研究概览
简要总结
This study will assess how rifampin will affect the blood levels of sitaxsentan. Safety of sitaxsentan given alone and with rifampin will also be assessed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male subjects and/or women of non-child bearing potential.
- •Subjects between the ages of 21 and 55 years, inclusive.
- •Signed informed consent.
排除标准
- •Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease.
- •Has hepatic dysfunction.
- •Has history of excessive alcohol and tobacco use.
研究组 & 干预措施
Sitaxsentan
Active Comparator
干预措施: Sitaxsentan alone (Drug)
Sitaxsentan plus Rifampin
Experimental
干预措施: Sitaxsentan (Drug)
Sitaxsentan plus Rifampin
Experimental
干预措施: Rifampin (Drug)
结局指标
主要结局
Comparison of Area Under the Curve of sitaxsentan co-administered with rifampin versus sitaxsentan administered alone.
时间窗: 24 hours
Comparison of Peak Plasma Concentrations of sitaxsentan co-administered with rifampin versus sitaxsentan administered alone.
时间窗: 24 hours
次要结局
未报告次要终点
研究者
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