A Phase 1, Randomized, Open Label, Single Dose, 2-Period Crossover Study To Evaluate The Effect Of Food On The Pharmacokinetics Of Tofacitinib Modified Release (MR) 11 Mg Tablets In Healthy Western And Japanese Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Area under the curve from time zero to infinity
研究概览
简要总结
This study will evaluate the drug behavior and safety of a single dose of the 11 milligram tofacitinib (CP-690,550) modified-release formulation in 24 healthy volunteers when taken after eating a high fat meal (the effect of food). This will be compared to the drug behavior and safety of a single dose of the 11 milligram tofacitinib (CP-690,550) modified-release formulation when taken after a 10 hour fast.
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
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male volunteers and/or healthy females volunteers of non-childbearing potential who are 18 to 55 years of age;
- •Healthy volunteers who are of Japanese or Western descent;
- •Healthy volunteers with no evidence of active or latent or inadequately treated tuberculosis.
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
tofacitinib MR 11 mg Fed
tofacitinib modified release (MR) 11 mg tablet administered with food.
干预措施: tofacitinib modified-release (MR) formulation (Drug)
tofacitinib MR 11 mg Fasting
tofacitinib modified release (MR) 11 mg tablet administered without food.
干预措施: tofacitinib modified-release (MR) formulation (Drug)
结局指标
主要结局
Area under the curve from time zero to infinity
时间窗: 48 hours post dose
Area under the curve from time zero to infinity
Area under the plasma concentration-time profile from time zero to time of the last quantifiable concentration
时间窗: 48 hours post dose
Area under the plasma concentration-time profile from time zero to time of the last quantifiable concentration
Maximum Observed Plasma Concentration (Cmax)
时间窗: 48 hours post dose
Maximum Observed Plasma Concentration (Cmax)
次要结局
- Time to Reach Maximum Observed Plasma Concentration (Tmax)(48 hours post dose)
- Plasma Decay Half-Life (t1/2)(48 hours post dose)