An Exploratory, Open Label, Randomized, Parallel Group Study To Investigate The Pharmacokinetics Of Single Intravenous And Oral Micro Doses Of PF-05186462, PF-05089771, PF-05241328 And PF-05150122 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
- 40
- 试验地点
- 1
- 主要终点
- Safety and tolerability (heart rate, blood pressure, QTcF, clinical chemistry)
研究概览
简要总结
The purpose of this study is to calculate the pharmacokinetics (concentration of compound in and rate of excretion from the blood) following a very low dose of compound which will not have any pharmacological activity and to monitor for the safety and tolerability of each of the compounds in the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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 50 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 measurement, 12-lead ECG and clinical laboratory tests)
- •Body Mass Index (BMI) of 17.5 to 30.5kg/m2l and a total body weight of between 50 and 100kg inclusive.
- •Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the trial.
排除标准
- •Evidence or history of clinically significant haematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, genitourinary, psychiatric, neurologic or allergic disease (including drug allergies, but excluding untreated, symptomatic, seasonal allergies at time of dosing)
- •History of febrile illness within 5 days prior to the first dose a positive urine drug screen
研究组 & 干预措施
Intravenous: PF-05186462
干预措施: PF-05186462 (Drug)
Oral: PF-05186462
干预措施: PF-05186462 (Drug)
Intravenous: PF-05089771
干预措施: PF-05089771 (Drug)
Oral: PF-05089771
干预措施: PF-05089771 (Drug)
Intravenous: PF-05150122
干预措施: PF-05150122 (Drug)
Oral: PF-05150122
干预措施: PF-05150122 (Drug)
Intravenous: PF-05241328
干预措施: PF-05241328 (Drug)
Oral: PF-05241328
干预措施: PF-05241328 (Drug)
结局指标
主要结局
Safety and tolerability (heart rate, blood pressure, QTcF, clinical chemistry)
时间窗: up to 3 days post dose
pharmacokinetics of each of the four compounds measuring Clearance, volume of distribution, elimination half life and area under the effect curve
时间窗: up to 3 days post dose
次要结局
- safety and tolerability of each of the four compounds (heart rate, blood pressure, QTcF, clinical chemistry)(up to 3 days post dose)