A Phase 1, Randomized, Open Label, Partial Crossover Study To Evaluate The Pharmacokinetics (PK) And Safety Of Three Modified Release (MR) And One Immediate Release (IR) Formulations Of Tofacitinib (CP-690,550) In Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- AUCinf: Area under the plasma concentration-time profile from time 0 exprapolated to infinite time
研究概览
简要总结
This study will explore the drug behavior and safety following a single dose of three different 22 milligram tofacitinib (CP-690,550) modified-release formulations in 30 healthy volunteers. These formulations will be compared to 10 milligram tofacitinib (CP-690-550) in an immediate-release formulation.
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 healthy females subjects who are of non-childbearing potential.
排除标准
- •Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease;
- •Clinically significant infections within the past 3 months
研究组 & 干预措施
Treatment A
tofacitinib (CP-690,550) modified-release formulation A-Fed
干预措施: tofacitinib (CP-690,550) modified-release formulation A (Drug)
Treatment B
tofacitinib (CP-690,550) modified-release formulation B1-Fed
干预措施: tofacitinib (CP-690,550) modified-release formulation B1 (Drug)
Treatment C
tofacitinib (CP-690,550) modified-release formulation A-Fasted
干预措施: tofacitinib (CP-690,550) modified-release formulation A (Drug)
Treatment D
tofacitinib (CP-690,550) modified-release formulation B1-Fasted
干预措施: tofacitinib (CP-690,550) modified-release formulation B1 (Drug)
Treatment E
tofacitinib (CP-690,550) modified-release formulation B2-Fasted
干预措施: tofacitinib (CP-690,550) modified-release formulation B2 (Drug)
Treatment F
tofacitinib (CP-690,550) immediate-release formulation-Fasted
干预措施: tofacitinib (CP-690,550) immediate-release formulation (Drug)
结局指标
主要结局
AUCinf: Area under the plasma concentration-time profile from time 0 exprapolated to infinite time
时间窗: 72 hours post dose
AUClast: Area under the plasma concentration-time profile from time 0 to the last with quantifiable concentration
时间窗: 72 hours post dose
Cmax: Maximum plasma concentration of tofacitinib (CP-690,550)
时间窗: 72 hours post dose
Tmax: Amount of time tofacitinib (CP-690,550) is at maximum plasma concentration
时间窗: 72 hours post dose
t1/2: The time required for one half of the total amount of tofacitinib (CP-690,550) to be removed from the plasma
时间窗: 72 hours post dose
次要结局
- Frel: Relative bioavailability (Frel) of tofacitinib (CP-690,550) in the modified-release formulations compared to the immediate release formulation(24 hours post dose)