Clinical trial NCT02211885: Excretion Balance of 14c-radiolabeled BIRB 796 BS in Normal Male Subjects
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-08-08
Enrollment: 6
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: Cumulative amount of 14C-BIRB 796 BS radioactivity excreted in feces (percent of dose)
timeFrame: up to 5 days
measure: Cumulative amount of 14C-BIRB 796 BS radioactivity excreted in urine (percent of dose)
timeFrame: up to 5 days
measure: Maximum observed Concentration (Cmax) of 14C-BIRB 796BS in plasma
timeFrame: up to 96 hours after drug administration
measure: Area under the Concentration versus time curve from time 0 to infinity (AUC0-∞) of 14C-BIRB 796BS in plasma
timeFrame: up to 96 hours after drug administration
measure: Time To The Maximum Concentration (tmax) of 14C-BIRB 796BS in plasma
timeFrame: up to 96 hours after drug administration
measure: Elimination Half-Life (t1/2) of 14C-BIRB 796BS in plasma
timeFrame: up to 96 hours after drug administration
measure: Erythrocyte-plasma partition ratio of 14C-radioactivity
timeFrame: up to 5 days
measure: Cmax of 14C-BIRB 796BS in blood
timeFrame: up to 96 hours after drug administration
measure: AUC0-∞ of 14C-BIRB 796BS in blood
timeFrame: up to 96 hours after drug administration
measure: tmax of 14C-BIRB 796BS in blood
timeFrame: up to 96 hours after drug administration
measure: t1/2 of 14C-BIRB 796BS in blood
timeFrame: up to 96 hours after drug administration
measure: Cmax of BIRB 796BS in plasma
timeFrame: up to 96 hours after drug administration
measure: AUC0-∞ of BIRB 796BS in plasma
timeFrame: up to 96 hours after drug administration
measure: tmax of BIRB 796BS in plasma
timeFrame: up to 96 hours after drug administration
measure: t1/2 of BIRB 796BS in plasma
timeFrame: up to 96 hours after drug administration
measure: Quantification of radiolabeled metabolites in urine (percent of dose)
timeFrame: up to 5 days
measure: Quantification of radiolabeled metabolites in feces (percent of dose)
timeFrame: up to 5 days
measure: Quantification of radiolabeled metabolites in plasma (percent of dose)
timeFrame: up to 96 hours after drug administration
Secondary outcomes:
measure: Excretion of 14C-radioactivity in saliva (percent of dose)
timeFrame: up to 24 hours after drug administration
measure: Excretion of 14C-radioactivity in expired air (percent of dose)
timeFrame: up to 48 hours after drug administration
Other outcomes:
Locations:
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