An Open Label, Single-Period, Phase 1 Study To Evaluate The Pharmacokinetics, Excretion, Mass Balance And Metabolism Of [14c]-PF-04991532 In Healthy Adult Male Subjects
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
- Mass Balance: Urinary and fecal excretion of radioactivity over time expressed as a percentage of the total radioactive dose administered.
研究概览
简要总结
The purpose of this study is to evaluate the excretion balance, metabolic profile and the routes of excretion of [14C]PF-04991532 in healthy adult male subjects.
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
- 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 measurement, 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).
- •An informed consent document signed and dated by the subject.
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) or clinical findings at Screening.
- •History of irregular bowel movements (eg, irritable bowel syndrome or frequent episodes of diarrhea or constipation).
- •Any condition possibly affecting drug absorption (eg, appendectomy, gastrectomy).
研究组 & 干预措施
1
干预措施: PF-04991532 (Drug)
结局指标
主要结局
Mass Balance: Urinary and fecal excretion of radioactivity over time expressed as a percentage of the total radioactive dose administered.
时间窗: 0-168 hrs
Metabolic Profiling/identification and determination of relative abundance of PF-04991532 and the metabolites of PF-04991532 in plasma, urine, and feces.
时间窗: 0-168 hrs
radioactivity AUC
时间窗: 0-168 hrs
plasma PF-04991532 AUC
时间窗: 0-168 hrs
radioactivity Cmax
时间窗: 0-168 hrs
plasma PF-04991532 Cmax
时间窗: 0-168 hrs
plasma PF-04991532 Tmax
时间窗: 0-168 hrs
radioactivity Tmax
时间窗: 0-168 hrs
plasma PF-04991532 t1/2
时间窗: 0-168 hrs
radioactivity t1/2
时间窗: 0-168 hrs
次要结局
未报告次要终点