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

NCT ID: NCT02211885

Last Updated: 2014-08-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-10-31

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

Conditions

Healthy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

14C-BIRB 796 BS

14C-radiolabeled BIRB 796 BS

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

1175.6

Identifier Type: -

Identifier Source: org_study_id