A Phase 1, Open Label, Single Dose, Randomized, Cross Over Study To Estimate The Absolute Oral Bioavailability Of CP-690,550 In Healthy Subjects
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
In this study, a 10 mg dose of CP-690,550 will be given to study subjects on two separate occasions by two different routes of administration: One time by mouth in tablet form and one time by vein (intravenous form). The amount of CP-690,550 available in the blood following administration by vein will be measured and is expected to reflect the maximum amount possible for the 10 mg CP-690,550 dose. The amount of CP-690,550 that is achieved in the blood following oral tablet administration will also be measured and compared to that achieved following administration by vein in order to estimate how much of the maximum amount possible is actually absorbed into the blood following administration by mouth as a tablet.
详细描述
To estimate the absolute bioavailability of a 10 mg oral dose of tasocitinib (CP-690,550) compared to a 10 mg intravenous dose of tasocitinib (CP-690,550) in healthy subjects.
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, inclusive
- •Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 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
Treatment A: Tasocitinib 10 mg oral tablet
干预措施: Tasocitinib 10 mg oral tablet (Drug)
Treatment B: Tasocitinib 10 mg IV Infusion
干预措施: Tasocitinib 10 mg IV Infusion (Drug)
结局指标
主要结局
AUCinf of tasocitinib (CP 690,550)
时间窗: PK blood samples out to 12 hours post dose
次要结局
- AUClast, Cmax, Tmax, and t½, CL (IV dose only) and Vss (IV dose only) of tasocitinib (CP 690,550).(PK blood samples out to 12 hours postdose)
- Safety Laboratory tests: hematology, chemistry, urine testing(Safety Laboratory testing performed out to 2 days post last dose)
- Vital Signs: Blood pressure, heart rate, oral temperature(Vital signs out to 2 days post last dose)
- AE Reporting(Throughout study)