Excretion Balance of 14c-radiolabeled BIRB 796 BS in Normal Male Subjects
Phase 1
Completed
- Conditions
- Healthy
- Registration Number
- NCT02211885
- Lead Sponsor
- Boehringer Ingelheim
- 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 quantify major radiolabeled metabolites of BIRB 796 in plasma, urine and feces
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 6
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method AUC0-∞ of 14C-BIRB 796BS in blood up to 96 hours after drug administration tmax of 14C-BIRB 796BS in blood up to 96 hours after drug administration t1/2 of 14C-BIRB 796BS in blood up to 96 hours after drug administration Cmax of BIRB 796BS in plasma up to 96 hours after drug administration AUC0-∞ of BIRB 796BS in plasma up to 96 hours after drug administration tmax of BIRB 796BS in plasma up to 96 hours after drug administration t1/2 of BIRB 796BS in plasma up to 96 hours after drug administration Cumulative amount of 14C-BIRB 796 BS radioactivity excreted in feces (percent of dose) up to 5 days Cumulative amount of 14C-BIRB 796 BS radioactivity excreted in urine (percent of dose) up to 5 days Maximum observed Concentration (Cmax) of 14C-BIRB 796BS in plasma up to 96 hours after drug administration Area under the Concentration versus time curve from time 0 to infinity (AUC0-∞) of 14C-BIRB 796BS in plasma up to 96 hours after drug administration Time To The Maximum Concentration (tmax) of 14C-BIRB 796BS in plasma up to 96 hours after drug administration Elimination Half-Life (t1/2) of 14C-BIRB 796BS in plasma up to 96 hours after drug administration Erythrocyte-plasma partition ratio of 14C-radioactivity up to 5 days Cmax of 14C-BIRB 796BS in blood up to 96 hours after drug administration Quantification of radiolabeled metabolites in urine (percent of dose) up to 5 days Quantification of radiolabeled metabolites in feces (percent of dose) up to 5 days Quantification of radiolabeled metabolites in plasma (percent of dose) up to 96 hours after drug administration
- Secondary Outcome Measures
Name Time Method Excretion of 14C-radioactivity in saliva (percent of dose) up to 24 hours after drug administration Excretion of 14C-radioactivity in expired air (percent of dose) up to 48 hours after drug administration