A Phase 1, Cross-over, Randomized, Single-dose Open Label Study To Determine The Effect Of Food On The Pharmacokinetics Of Orally Administered Pf-06372865 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
- 12
- 试验地点
- 1
- 主要终点
- Maximum Observed Plasma Concentration (Cmax)
研究概览
简要总结
This study has been designed to investigate the effect of high fat food on the pharmacokinetics of PF-06372865 when administered to healthy subjects as single oral doses.
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 and/or female subjects of non-childbearing potential between the ages of 18 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);
排除标准
- •Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease
- •Screening supine blood pressure > 140 mm Hg (systolic) or >90 mm Hg (diastolic), following at least 5 minutes of supine rest.
- •Any condition possibly affecting drug absorption: current or recent (within one year) gastrointestinal disease; a history of malabsorption, esophageal reflux, irritable bowel syndrome; frequent (more than once a week) occurrence of heartburn; or any surgical intervention (e.g., cholecysectomy) which would be expected to influence the absorption of drugs.
研究组 & 干预措施
fasted condition
干预措施: PF-06372865 (Drug)
fed condition
干预措施: PF-06372865 (Drug)
结局指标
主要结局
Maximum Observed Plasma Concentration (Cmax)
时间窗: basline to 48 hours
Time to Reach Maximum Observed Plasma Concentration (Tmax)
时间窗: basline to 48 hours
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)]
时间窗: basline to 48 hours
AUC (0 - 8)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - 8). It is obtained from AUC (0 - t) plus AUC (t - 8).
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
时间窗: basline to 48 hours
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)
Plasma Decay Half-Life (t1/2)
时间窗: basline to 48 hours
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
次要结局
- Change from Baseline in Systolic Blood Pressure(basline to 48 hours)
- Change from Baseline in Diastolic Blood Pressure(basline to 48 hours)
- Change from baseline in heart rate(basline to 48 hours)