Status:
COMPLETED
Excretion Balance of 14c-radiolabeled BIRB 796 BS in Normal Male Subjects
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Healthy
Eligibility:
MALE
18-45 years
Phase:
PHASE1
Brief 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 quant...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT02211885
Start Date
October 1 2002
Last Update
August 8 2014
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