A Phase I Single Oral Dose (100 mg) Trial to Characterize the Excretion Balance of 14c-radiolabeled BIRB 796 BS and to Determine Its Metabolites in Normal Male Subjects

Boehringer Ingelheim0 个研究点目标入组 6 人开始时间: 2002年10月最近更新: 2014年8月8日

适应症

试验速览

阶段: 1 期
状态: 已完成
发起方: Boehringer Ingelheim
入组人数: 6
主要终点: AUC0-∞ of 14C-BIRB 796BS in blood

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

Study to characterize the pharmacokinetics of 14C-radiolabeled BIRB 796 BS and its metabolites including excretion and mass balance of parent compound and radioactivity; to isolate, identify and quantify major radiolabeled metabolites of BIRB 796 in plasma, urine and feces

研究设计

研究类型: Interventional
分配方式: Na
干预模型: Single Group
主要目的: Treatment
盲法: None

入排标准

年龄范围: 18 Years 至 45 Years（Adult）
性别: Male
接受健康志愿者: 是

入选标准

•Healthy male subjects as determined by results of screening. Health is confirmed by medical history, physical examination, laboratory testing and 12-lead electrocardiogram (ECG)
•Signed written informed consent in accordance with Good Clinical Practice
•Age ≥ 18 and ≤ 45 years
•Subjects within 10% of the normal height: weight range defined by the Metropolitan Life Insurance Company Tables

排除标准

•Any finding of the medical examination (including blood pressure, pulse rate, and ECG) deviating from normal and of clinical relevance
•History of clinically significant disease including metabolic, endocrinologic, immunological, hepatic, renal, gastrointestinal, respiratory, cardiovascular, psychiatric or neurological
•History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
•Subjects with a history of drug abuse or alcoholism
•Chronic or relevant acute (within 1 month of screening) infections
•Subjects who have taken prescription within one month or over-the-counter drugs within two weeks of the start of the trial
•Participation in another trial with an investigational drug (≤ 2 months prior to administration or during trial)
•Inability to refrain from smoking on trial days
•Blood donation > 400 mL (within 1 month prior to administration or during the trial)
•Any laboratory value outside 10% of the reference range of clinical relevance (but not exclusive to) total white cell count ≥ 10 x 10**9/L, any hemoglobin < 12 mg/dl or >15 mg/dl. Protein on urine dipstick
•Positive urine drug screen, positive HIV or Hepatitis C antibodies
•History of any familial bleeding disorder