A Phase 1, Open Label, Randomized, Single Dose, Cross-Over Study To Evaluate The Effect Of Food On PF-04447943 Pharmacokinetics In Healthy Adult Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Pharmacokinetic endpoints include plasma PF-04447943 area under the curve (AUC), maximum plasma concentration (Cmax) and time of maximum plasma concentration (Tmax).
研究概览
简要总结
The purpose of the study is to compare the plasma drug levels of PF-04447943 when taken as a 35 mg tablet after a high fat meal compared to when taken after fasting. Healthy adult volunteers will receive a single dose of the drug once when fasted and again when fed. The safety and tolerability of the drug will be monitored.
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
- 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 subjects, not of child bearing potential.
- •Age 18-55 inclusive
- •Total body weight >50 kg.
排除标准
- •Evidence or history of clinical significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic diseases
- •History of orthostatic blood pressure changes or orthostatic symptoms
- •Greater than 7 drinks of alcohol per week for women and greater than 14 drinks per week for men
- •Smoking more than 5 cigarettes per day
研究组 & 干预措施
Sequence 1
干预措施: PF-04447943 (Drug)
Sequence 2
干预措施: PF-04447943 (Drug)
结局指标
主要结局
Pharmacokinetic endpoints include plasma PF-04447943 area under the curve (AUC), maximum plasma concentration (Cmax) and time of maximum plasma concentration (Tmax).
时间窗: Up to 96 hours after drug administration
Safety endpoints include vital signs, ECGs, clinical laboratory tests, clinical evaluations and examinations, and adverse events.
时间窗: Up to 96 hours after drug administration
次要结局
- No secondary outcomes(No secondary outcomes)