NCT01202240已完成1 期
A Phase 1, Open Label, Fixed-Sequence Study To Estimate The Effect Of Ketoconazole On The Pharmacokinetics Of Tasocitinib (CP-690,550) In Healthy Volunteers
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
- 12
- 试验地点
- 1
- 主要终点
- AUCinf of tasocitinib (CP-690,550)
研究概览
简要总结
Estimate the effect of oral ketoconazole administration (400 mg once daily over 3 days) on the pharmacokinetics (process by which the drug is absorbed, distributed, metabolized, and eliminated by the body) of single 10 mg dose of tasocitinib (CP-690,550) in normal healthy volunteers.
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/or female (non-childbearing potential) subjects between the ages of 18 and 55 years
排除标准
- •Clinically significant disease
- •Recent history of serious infection
研究组 & 干预措施
Tasocitinib (CP-690,550) plus Ketoconazole
Experimental
干预措施: Tasocitinib (CP-690,55) plus Ketoconazole (Drug)
结局指标
主要结局
AUCinf of tasocitinib (CP-690,550)
时间窗: 5 days
次要结局
- AUClast, Cmax, and Tmax of tasocitinib (CP-690,550)(5 days)
- Safety: laboratory tests, AE reporting and vital signs(5 days)
研究者
研究点 (1)
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