NCT02142920已完成1 期
A Phase One, Open-Label Single-Radiolabeled Dose Study To Investigate The Metabolism, And Excretion Of [14c]-PF-05212384 In Healthy Male Volunteers
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Maximum Observed Plasma Concentration (Cmax)
研究概览
简要总结
The purpose of the study is to characterize how PF-05212384 is metabolized in the body following a single intravenous dose of radioactively labeled drug ([14C]-PF-05212384).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male subjects between the ages of 30- 65 years vasectomised or >40 with no desire to father children in the near future (12 months), 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 35 kg/m2; and a total body weight >50 kg (110 lbs).
- •Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.
- •Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
- •Subjects agree to use an adequate method of contraception
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 or history of drug or alcohol abuse in the past 2 years.
研究组 & 干预措施
[14C] PF 05212384
Experimental
Receive PF-05212384 89 mg Dose
干预措施: PF-05212384 (Drug)
结局指标
主要结局
Maximum Observed Plasma Concentration (Cmax)
时间窗: 0.5 hours
Time to Reach Maximum Observed Plasma Concentration (Tmax)
时间窗: 0.5 hours
次要结局
- Area under the Concentration-Time Curve (AUC)(9 days)
- Systemic Clearance (CL)(9 days)
- Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)(9 Days)
- Plasma Decay Half-Life (t1/2)(9 days)
- Volume of Distribution at Steady State (Vss)(9 days)
研究者
研究点 (1)
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