NCT00969813已完成1 期
A Phase 1, Non-Randomized, Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics, Safety and Tolerability of CP-690,550 in Subjects With Hepatic Impairment and Normal Hepatic Function
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
- Pfizer
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Pharmacokinetics of CP-690,550 in subjects with hepatic impairment compared to subjects with normal hepatic function
研究概览
简要总结
This study is designed to evaluate how CP-690,550 is handled by the body in healthy volunteers who have mild and moderate hepatic impairment compared to healthy volunteers with normal hepatic function. This study will also evaluate the safety and tolerability of CP-690,550.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteers who have normal liver function, and subjects who have either mild or moderate liver impairment.
排除标准
- •Subjects with severe liver impairment
- •Subjects who have weakened immune systems
研究组 & 干预措施
Mild hepatic impairment
Experimental
干预措施: CP-690,550 (Drug)
Moderate hepatic impairment
Experimental
干预措施: CP-690,550 (Drug)
Normal hepatic function
Experimental
干预措施: CP-690,550 (Drug)
结局指标
主要结局
Pharmacokinetics of CP-690,550 in subjects with hepatic impairment compared to subjects with normal hepatic function
时间窗: 3 days
次要结局
- Safety and tolerability of CP-690,550 in subjects with hepatic impairment compared to subjects with normal hepatic function(10-14 days)
研究者
研究点 (1)
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