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

Boehringer Ingelheim

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: 14C-BIRB 796 BS

Study type

Interventional

Funder types

Industry

Identifiers

NCT02211885

1175.6

Details and patient eligibility

About

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

Enrollment

6 patients

Sex

Male

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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