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

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Healthy

Intervention / Treatment
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* Drug: 14C-BIRB 796 BS


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: 14C-BIRB 796 BS|14C-radiolabeled BIRB 796 BS|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |