A Phase 1, Randomized, Open-Label, Single Dose, 2-Cohort Crossover Study To Determine The Effect Of Food On The Pharmacokinetics Of Orally Administered PH-797804 In Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Pharmacokinetics: peak plasma concentration
研究概览
简要总结
The purpose of this study is to investigate the effect of food on the time course of PH-797804 concentration in the blood following dosing by oral immediate release tablet 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 female subjects of non-child bearing potential between the ages of 21 and 55 years (inclusive). Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurements, 12-lead ECG and clinical laboratory tests.
- •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 (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
- •A positive urine drug screen.
- •History of regular alcohol consumption exceeding 21 drinks/week for males.
研究组 & 干预措施
PH-797804 1 mg Fasted
Subjects will receive a single 1 mg dose in the fasted state
干预措施: PH-797804 (Drug)
PH-797804 1 mg Fed
Subjects will receive a single 1 mg dose following a high-fat meal
干预措施: PH-797804 (Drug)
PH-797804 10 mg Fasted
Subjects will receive a single 10 mg dose in the fasted state
干预措施: PH-797804 (Drug)
PH-797804 10 mg Fed
Subjects will receive a single 10 mg dose following a high-fat meal
干预措施: PH-797804 (Drug)
PH-797804 24 mg Fed
Subjects will receive a single 24 mg dose following a high-fat meal
干预措施: PH-797804 (Drug)
结局指标
主要结局
Pharmacokinetics: peak plasma concentration
时间窗: 0,1,2,3,4,6,8,12,24,48,72,96,144,192,264,312 hours post-dose
Pharmacokinetics: time to peak plasma concentration
时间窗: 0,1,2,3,4,6,8,12,24,48,72,96,144,192,264,312 hours post-dose
Pharmacokinetics: area under the plasma concentration-time curve
时间窗: 0,1,2,3,4,6,8,12,24,48,72,96,144,192,264,312 hours post-dose
Pharmacokinetics: terminal plasma half-life
时间窗: 0,1,2,3,4,6,8,12,24,48,72,96,144,192,264,312 hours post-dose
次要结局
未报告次要终点