Excretion Balance of 14c-radiolabeled BIRB 796 BS in Normal Male Subjects

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Male

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Boehringer Ingelheim

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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