<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02211885</url>
  </required_header>
  <id_info>
    <org_study_id>1175.6</org_study_id>
    <nct_id>NCT02211885</nct_id>
  </id_info>
  <brief_title>Excretion Balance of 14c-radiolabeled BIRB 796 BS in Normal Male Subjects</brief_title>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boehringer Ingelheim</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boehringer Ingelheim</source>
  <brief_summary>
    <textblock>
      Study to characterize the pharmacokinetics of 14C-radiolabeled BIRB 796 BS and its&#xD;
      metabolites including excretion and mass balance of parent compound and radioactivity; to&#xD;
      isolate, identify and quantify major radiolabeled metabolites of BIRB 796 in plasma, urine&#xD;
      and feces&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2002</start_date>
  <primary_completion_date type="Actual">November 2002</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Cumulative amount of 14C-BIRB 796 BS radioactivity excreted in feces (percent of dose)</measure>
    <time_frame>up to 5 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Cumulative amount of 14C-BIRB 796 BS radioactivity excreted in urine (percent of dose)</measure>
    <time_frame>up to 5 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Maximum observed Concentration (Cmax) of 14C-BIRB 796BS in plasma</measure>
    <time_frame>up to 96 hours after drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Area under the Concentration versus time curve from time 0 to infinity (AUC0-∞) of 14C-BIRB 796BS in plasma</measure>
    <time_frame>up to 96 hours after drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Time To The Maximum Concentration (tmax) of 14C-BIRB 796BS in plasma</measure>
    <time_frame>up to 96 hours after drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Elimination Half-Life (t1/2) of 14C-BIRB 796BS in plasma</measure>
    <time_frame>up to 96 hours after drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Erythrocyte-plasma partition ratio of 14C-radioactivity</measure>
    <time_frame>up to 5 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Cmax of 14C-BIRB 796BS in blood</measure>
    <time_frame>up to 96 hours after drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>AUC0-∞ of 14C-BIRB 796BS in blood</measure>
    <time_frame>up to 96 hours after drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>tmax of 14C-BIRB 796BS in blood</measure>
    <time_frame>up to 96 hours after drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>t1/2 of 14C-BIRB 796BS in blood</measure>
    <time_frame>up to 96 hours after drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Cmax of BIRB 796BS in plasma</measure>
    <time_frame>up to 96 hours after drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>AUC0-∞ of BIRB 796BS in plasma</measure>
    <time_frame>up to 96 hours after drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>tmax of BIRB 796BS in plasma</measure>
    <time_frame>up to 96 hours after drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>t1/2 of BIRB 796BS in plasma</measure>
    <time_frame>up to 96 hours after drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Quantification of radiolabeled metabolites in urine (percent of dose)</measure>
    <time_frame>up to 5 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Quantification of radiolabeled metabolites in feces (percent of dose)</measure>
    <time_frame>up to 5 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Quantification of radiolabeled metabolites in plasma (percent of dose)</measure>
    <time_frame>up to 96 hours after drug administration</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Excretion of 14C-radioactivity in saliva (percent of dose)</measure>
    <time_frame>up to 24 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Excretion of 14C-radioactivity in expired air (percent of dose)</measure>
    <time_frame>up to 48 hours after drug administration</time_frame>
  </secondary_outcome>
  <enrollment type="Actual">6</enrollment>
  <condition>Healthy</condition>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>14C-BIRB 796 BS</intervention_name>
    <description>14C-radiolabeled BIRB 796 BS</description>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy male subjects as determined by results of screening. Health is confirmed by&#xD;
             medical history, physical examination, laboratory testing and 12-lead&#xD;
             electrocardiogram (ECG)&#xD;
&#xD;
          -  Signed written informed consent in accordance with Good Clinical Practice&#xD;
&#xD;
          -  Age ≥ 18 and ≤ 45 years&#xD;
&#xD;
          -  Subjects within 10% of the normal height: weight range defined by the Metropolitan&#xD;
             Life Insurance Company Tables&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any finding of the medical examination (including blood pressure, pulse rate, and ECG)&#xD;
             deviating from normal and of clinical relevance&#xD;
&#xD;
          -  History of clinically significant disease including metabolic, endocrinologic,&#xD;
             immunological, hepatic, renal, gastrointestinal, respiratory, cardiovascular,&#xD;
             psychiatric or neurological&#xD;
&#xD;
          -  History of allergy/hypersensitivity (including drug allergy) which is deemed relevant&#xD;
             to the trial as judged by the investigator&#xD;
&#xD;
          -  Subjects with a history of drug abuse or alcoholism&#xD;
&#xD;
          -  Chronic or relevant acute (within 1 month of screening) infections&#xD;
&#xD;
          -  Subjects who have taken prescription within one month or over-the-counter drugs within&#xD;
             two weeks of the start of the trial&#xD;
&#xD;
          -  Participation in another trial with an investigational drug (≤ 2 months prior to&#xD;
             administration or during trial)&#xD;
&#xD;
          -  Inability to refrain from smoking on trial days&#xD;
&#xD;
          -  Blood donation &gt; 400 mL (within 1 month prior to administration or during the trial)&#xD;
&#xD;
          -  Any laboratory value outside 10% of the reference range of clinical relevance (but not&#xD;
             exclusive to) total white cell count ≥ 10 x 10**9/L, any hemoglobin &lt; 12 mg/dl or &gt;15&#xD;
             mg/dl. Protein on urine dipstick&#xD;
&#xD;
          -  Positive urine drug screen, positive HIV or Hepatitis C antibodies&#xD;
&#xD;
          -  History of any familial bleeding disorder&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <link>
    <url>http://trials.boehringer-ingelheim.com</url>
    <description>Related Info</description>
  </link>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>August 7, 2014</study_first_submitted>
  <study_first_submitted_qc>August 7, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 8, 2014</study_first_posted>
  <last_update_submitted>August 7, 2014</last_update_submitted>
  <last_update_submitted_qc>August 7, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 8, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02211885
org study id: 1175.6
nct id: NCT02211885
lead sponsor: 
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
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Cumulative amount of 14C-BIRB 796 BS radioactivity excreted in feces (percent of dose)
time frame: up to 5 days
measure: Cumulative amount of 14C-BIRB 796 BS radioactivity excreted in urine (percent of dose)
time frame: up to 5 days
measure: Maximum observed Concentration (Cmax) of 14C-BIRB 796BS in plasma
time frame: 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
time frame: up to 96 hours after drug administration
measure: Time To The Maximum Concentration (tmax) of 14C-BIRB 796BS in plasma
time frame: up to 96 hours after drug administration
measure: Elimination Half-Life (t1/2) of 14C-BIRB 796BS in plasma
time frame: up to 96 hours after drug administration
measure: Erythrocyte-plasma partition ratio of 14C-radioactivity
time frame: up to 5 days
measure: Cmax of 14C-BIRB 796BS in blood
time frame: up to 96 hours after drug administration
measure: AUC0-∞ of 14C-BIRB 796BS in blood
time frame: up to 96 hours after drug administration
measure: tmax of 14C-BIRB 796BS in blood
time frame: up to 96 hours after drug administration
measure: t1/2 of 14C-BIRB 796BS in blood
time frame: up to 96 hours after drug administration
measure: Cmax of BIRB 796BS in plasma
time frame: up to 96 hours after drug administration
measure: AUC0-∞ of BIRB 796BS in plasma
time frame: up to 96 hours after drug administration
measure: tmax of BIRB 796BS in plasma
time frame: up to 96 hours after drug administration
measure: t1/2 of BIRB 796BS in plasma
time frame: up to 96 hours after drug administration
measure: Quantification of radiolabeled metabolites in urine (percent of dose)
time frame: up to 5 days
measure: Quantification of radiolabeled metabolites in feces (percent of dose)
time frame: up to 5 days
measure: Quantification of radiolabeled metabolites in plasma (percent of dose)
time frame: up to 96 hours after drug administration
measure: Excretion of 14C-radioactivity in saliva (percent of dose)
time frame: up to 24 hours after drug administration
measure: Excretion of 14C-radioactivity in expired air (percent of dose)
time frame: up to 48 hours after drug administration
intervention type: Drug
intervention name: 14C-BIRB 796 BS
description: 14C-radiolabeled BIRB 796 BS
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
url: http://trials.boehringer-ingelheim.com
description: Related Info
responsible party type: Sponsor