An Exploratory, Open Label, Fixed Sequence Study To Investigate The Pharmacokinetics Of Single Intravenous And Oral Micro Doses Of PF-06273588 In Healthy Male Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Pharmacokinetics : time of peak plasma concentration
研究概览
简要总结
To investigate the pharmacokinetics of PF-06273588 following administration of a micro-dose via both intravenous and oral routes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 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
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male subjects between the ages of 18 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
50 microgram PF-06273588 intravenous
Subjects will receive a single intravenous microdose of PF-06273588 in period one
干预措施: PF-06273588 (Drug)
50 microgram PF-06273588 oral
Subjects will receive a single oral microdose of PF-06273588 in period two
干预措施: PF-06273588 (Drug)
结局指标
主要结局
Pharmacokinetics : time of peak plasma concentration
时间窗: 3 days
The number of participants with Adverse Events as a measure of Safety and tolerability.
时间窗: 3 days
Pharmacokinetics : peak plasma concentration
时间窗: 3 days
Pharmacokinetics : area under plasma concentration-time curve
时间窗: 3 days
Pharmacokinetics : Terminal plasma half life
时间窗: 3 days
Pharmacokinetics : Plasma Clearance
时间窗: 3 days
Pharmacokinetics : plasma volume of distribution
时间窗: 3 days
Pharmacokinetics : oral bioavailability
时间窗: 3 days
次要结局
未报告次要终点