A Phase 1, Randomized, 2-Period, 2-Sequence, Open Label, Single Dose, Cross-Over Study To Evaluate The Effect Of Food On Pharmacokinetics Of Tasocitinib (CP-690,550) Tablets In Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- AUCinf and Cmax of tasocitinib (CP-690,550).
研究概览
简要总结
In this study, a 10 mg tasocitinib (CP-690,550) tablet will be administered to healthy subjects on two separate dosing occasions. On one occasion the tasocitinib (CP-690,550) tablet will be administered in a fasting condition; On the other occasion the tasocitinib (CP-690,550) tablet will be administered in a fed condition following a standard breakfast meal. The amount of tasocitinib (CP-690,550) in the blood will be measured at various times over 24 hours following each dosing occasion and compared to evaluate for any differences.
详细描述
To evaluate the effect of food on the pharmacokinetics of tasocitinib (CP-690,550).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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 and/or female (non-childbearing potential) subjects between the ages of 21 and 55 years.
- •Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight for males>50 kg (110 lbs). For females, total body weight >45 kg (99 lbs).
- •No evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis (TB)
排除标准
- •Evidence or history of any clinically significant illness, medical condition, or disease.
- •Evidence or history of any clinically significant infections within the past 3 months.
- •Use of tobacco- or nicotine-containing products in excess of the equivalent of 5 cigarettes per day.
研究组 & 干预措施
Sequence 1
干预措施: Treatment A (Drug)
Sequence 1
干预措施: Treatment B (Drug)
Sequence 2
干预措施: Treatment B (Drug)
Sequence 2
干预措施: Treatment A (Drug)
结局指标
主要结局
AUCinf and Cmax of tasocitinib (CP-690,550).
时间窗: PK blood samples out to 24 hours post dose in each of two periods.
次要结局
- AUClast, Tmax, and t1/2 of tasocitinib (CP-690,550).(PK blood samples out to 24 hours post dose in each of two periods.)
- Safety: Laboratory tests.(Pre-dose on Day O of Period 1 and post-dose on Day 2 of Period 2.)
- Safety:Vital signs.(Prior to dosing in Period 1 and 2.)
- Safety: AE reporting.(Continuous)