<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/NCT02215772</url>
  </required_header>
  <id_info>
    <org_study_id>1246.14</org_study_id>
    <nct_id>NCT02215772</nct_id>
  </id_info>
  <brief_title>Metabolism and Pharmacokinetics of [14C]-BI 44370 BS Administered as an Oral Solution in Healthy Male Volunteers</brief_title>
  <official_title>A Phase I Trial to Investigate the Metabolism and Pharmacokinetics of an Open Label Single Dose of 200 mg [14C]-BI 44370 BS Administered as an Oral Solution in Healthy Male Volunteers</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 investigate the basic pharmacokinetics of BI 44370 BS, its metabolite CD 10419 BS,&#xD;
      and 14C-radioactivity including mass balance, excretion pathways, and metabolism following a&#xD;
      single oral administration of 200 mg [14C]BI 44370 BS to healthy male volunteers and to&#xD;
      evaluate safety and tolerability following a single oral administration of 200 mg [14C]BI&#xD;
      44370 BS to healthy male volunteers&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2008</start_date>
  <primary_completion_date type="Actual">October 2008</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>Individual time course profiles of [14C]-radioactivity in whole blood, plasma, urine</measure>
    <time_frame>up to day 15</time_frame>
    <description>in nmoleq/L</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Individual time course profiles of [14C]-radioactivity in faeces</measure>
    <time_frame>up to day 15</time_frame>
    <description>in nmoleq/kg</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Individual time course profiles of BI 44370 BS (and its glucuronide CD 10419 BS) in plasma and urine</measure>
    <time_frame>up to 15 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Rate and extent of excretion mass balance based on the total radioactivity in urine and faeces</measure>
    <time_frame>up to 15 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Cblood cells/Cplasma ratio of [14C]-radioactivity</measure>
    <time_frame>up to 12 hours after drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Cblood /Cplasma ratio of [14C]-radioactivity</measure>
    <time_frame>up to 144 hours after drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Identification of major metabolites in plasma, urine, and faeces</measure>
    <time_frame>up to day 15</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Cmax (maximum concentration of the analyte(s) in plasma)</measure>
    <time_frame>up to 144 hours after drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>tmax (time from dosing to the maximum concentration of the analyte(s) in plasma)</measure>
    <time_frame>up to 144 hours after drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>AUC0-tz (area under the concentration-time curve of the analyte(s) in plasma over the time interval from 0 to the time of the last quantifiable data point)</measure>
    <time_frame>up to 144 hours after drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>AUC0-inf. (area under the concentration-time curve of the analyte(s) in plasma over the time interval from 0 to infinity)</measure>
    <time_frame>up to 144 hours after drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>λz (terminal rate constant in plasma)</measure>
    <time_frame>up to 144 hours after drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>t1/2 (terminal half-life of the analyte(s) in plasma)</measure>
    <time_frame>up to 144 hours after drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>MRTpo (mean residence time of the analyte(s) in the body after oral administration)</measure>
    <time_frame>up to 144 hours after drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>CL/F (total clearance of the analyte in plasma after oral administration)</measure>
    <time_frame>up to 144 hours after drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Vz/F (apparent volume of distribution during the terminal phase λz following an oral dose)</measure>
    <time_frame>up to 144 hours after drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Ae0-tz (amount of analyte that is eliminated in urine within the time interval zero to tz, additionally excretion within each sampling interval will be calculated)</measure>
    <time_frame>up to 15 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>fe0-tz (fraction of analyte excreted in urine within the time interval zero to tz in % of dose, additionally excretion within each sampling interval will be calculated)</measure>
    <time_frame>up to 15 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Aefaeces,0-tz (amount of analyte excreted in faeces within the time interval zero to tz, additionally excretion within each sampling interval will be calculated)</measure>
    <time_frame>up to 15 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>fefaeces,0-tz (fraction of analyte excreted in faeces within the time interval zero to tz in % of dose, additionally excretion within each sampling interval will be calculated)</measure>
    <time_frame>up to 15 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>CLR,t1-t2 (renal clearance of analyte from the within the time interval t1 to t2)</measure>
    <time_frame>up to 15 days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of patients with clinically relevant findings in vital signs</measure>
    <time_frame>up to 23 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with clinically relevant findings in 12-lead electrocardiogram (ECG)</measure>
    <time_frame>up to 23 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with clinically relevant laboratory findings</measure>
    <time_frame>up to 23 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with adverse events</measure>
    <time_frame>up to up to 44 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of global tolerability on a 4-point scale</measure>
    <time_frame>day 15</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">8</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>BI 44370 BS</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>200 mg containing 2.43 megabecquerel (MBq) 14C-radioactivity</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BI 44370 BS</intervention_name>
    <arm_group_label>BI 44370 BS</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy males according to the following criteria based upon a complete medical&#xD;
             history, including the physical examination, vital signs (blood pressure (BP), pulse&#xD;
             rate (PR)), 12-lead ECG, clinical laboratory tests&#xD;
&#xD;
          -  Age ≥18 and ≤65 years&#xD;
&#xD;
          -  Body mass index (BMI) ≥18.0 and BMI ≤30.0 kg/m2&#xD;
&#xD;
          -  Signed and dated written informed consent prior to admission to the study in&#xD;
             accordance with Good Clinical Practice (GCP) and the local legislation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any finding of the medical examination (including BP, PR and ECG) deviating from&#xD;
             normal and of clinical relevance&#xD;
&#xD;
          -  Any evidence of a clinically relevant concomitant disease&#xD;
&#xD;
          -  Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic,&#xD;
             immunological or hormonal disorders&#xD;
&#xD;
          -  Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or&#xD;
             neurological disorders&#xD;
&#xD;
          -  History of relevant orthostatic hypotension, fainting spells or blackouts&#xD;
&#xD;
          -  Chronic, or relevant acute infections&#xD;
&#xD;
          -  History of relevant allergy/hypersensitivity (including allergy to study drug or its&#xD;
             excipients)&#xD;
&#xD;
          -  Intake of drugs with a long half-life (&gt; 24 hours) within at least one month or less&#xD;
             than 10 half-lives of the respective drug prior to administration or during the trial&#xD;
&#xD;
          -  Use of drugs which might reasonably influence the results of the trial based on the&#xD;
             knowledge at the time of protocol preparation within 10 days prior to administration&#xD;
             until after the last sample from Visit 2 is collected&#xD;
&#xD;
          -  Participation in another trial with an investigational drug within two months prior to&#xD;
             administration or during the trial&#xD;
&#xD;
          -  Smoker (&gt; 10 cigarettes or &gt; 3 cigars or &gt; 3 pipes/day)&#xD;
&#xD;
          -  Inability to refrain from smoking during the stay in the trial centre&#xD;
&#xD;
          -  Alcohol abuse (more than on average 2 units of alcoholic beverages per day or more&#xD;
             than 14 units per week (1 unit equals 1 pint [285 mL] of beer or lager, 1 glass [125&#xD;
             mL] of wine, 25 mL shot of 40% spirit))&#xD;
&#xD;
          -  Drug abuse&#xD;
&#xD;
          -  Blood donation (more than 100 mL within 60 days prior to study drug administration or&#xD;
             during the trial)&#xD;
&#xD;
          -  Excessive physical activities (within one week prior to administration or during the&#xD;
             trial until follow-up examination)&#xD;
&#xD;
          -  Any laboratory value outside the reference range that is of clinical relevance&#xD;
&#xD;
          -  Inability to comply with dietary regimen of study centre&#xD;
&#xD;
          -  A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a&#xD;
             QTc interval &gt;450 ms)&#xD;
&#xD;
          -  Veins unsuitable for blood sampling&#xD;
&#xD;
          -  PR interval &gt;220 ms or QRS interval &gt;120 ms&#xD;
&#xD;
          -  Exposure to radiation for diagnostic reasons (except dental X-rays and plain X-rays of&#xD;
             thorax and bony skeleton (excluding spinal column)), during work or during&#xD;
             participation in a medical trial in the previous year&#xD;
&#xD;
          -  Irregular defecation pattern (less than once per 2 days)&#xD;
&#xD;
          -  Not willing to use adequate contraception (condoms use plus another form of&#xD;
             contraception e.g. spermicide, oral contraceptive taken by female partner,&#xD;
             sterilisation, intrauterine device) during the whole study period from the time of the&#xD;
             first intake of study drug until three months after the last intake&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 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 12, 2014</study_first_submitted>
  <study_first_submitted_qc>August 12, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 13, 2014</study_first_posted>
  <last_update_submitted>August 12, 2014</last_update_submitted>
  <last_update_submitted_qc>August 12, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 13, 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/NCT02215772
org study id: 1246.14
nct id: NCT02215772
lead sponsor: 
Study to investigate the basic pharmacokinetics of BI 44370 BS, its metabolite CD 10419 BS,
      and 14C-radioactivity including mass balance, excretion pathways, and metabolism following a
      single oral administration of 200 mg [14C]BI 44370 BS to healthy male volunteers and to
      evaluate safety and tolerability following a single oral administration of 200 mg [14C]BI
      44370 BS to healthy male volunteers
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Individual time course profiles of [14C]-radioactivity in whole blood, plasma, urine
time frame: up to day 15
description: in nmoleq/L
measure: Individual time course profiles of [14C]-radioactivity in faeces
time frame: up to day 15
description: in nmoleq/kg
measure: Individual time course profiles of BI 44370 BS (and its glucuronide CD 10419 BS) in plasma and urine
time frame: up to 15 days
measure: Rate and extent of excretion mass balance based on the total radioactivity in urine and faeces
time frame: up to 15 days
measure: Cblood cells/Cplasma ratio of [14C]-radioactivity
time frame: up to 12 hours after drug administration
measure: Cblood /Cplasma ratio of [14C]-radioactivity
time frame: up to 144 hours after drug administration
measure: Identification of major metabolites in plasma, urine, and faeces
time frame: up to day 15
measure: Cmax (maximum concentration of the analyte(s) in plasma)
time frame: up to 144 hours after drug administration
measure: tmax (time from dosing to the maximum concentration of the analyte(s) in plasma)
time frame: up to 144 hours after drug administration
measure: AUC0-tz (area under the concentration-time curve of the analyte(s) in plasma over the time interval from 0 to the time of the last quantifiable data point)
time frame: up to 144 hours after drug administration
measure: AUC0-inf. (area under the concentration-time curve of the analyte(s) in plasma over the time interval from 0 to infinity)
time frame: up to 144 hours after drug administration
measure: λz (terminal rate constant in plasma)
time frame: up to 144 hours after drug administration
measure: t1/2 (terminal half-life of the analyte(s) in plasma)
time frame: up to 144 hours after drug administration
measure: MRTpo (mean residence time of the analyte(s) in the body after oral administration)
time frame: up to 144 hours after drug administration
measure: CL/F (total clearance of the analyte in plasma after oral administration)
time frame: up to 144 hours after drug administration
measure: Vz/F (apparent volume of distribution during the terminal phase λz following an oral dose)
time frame: up to 144 hours after drug administration
measure: Ae0-tz (amount of analyte that is eliminated in urine within the time interval zero to tz, additionally excretion within each sampling interval will be calculated)
time frame: up to 15 days
measure: fe0-tz (fraction of analyte excreted in urine within the time interval zero to tz in % of dose, additionally excretion within each sampling interval will be calculated)
time frame: up to 15 days
measure: Aefaeces,0-tz (amount of analyte excreted in faeces within the time interval zero to tz, additionally excretion within each sampling interval will be calculated)
time frame: up to 15 days
measure: fefaeces,0-tz (fraction of analyte excreted in faeces within the time interval zero to tz in % of dose, additionally excretion within each sampling interval will be calculated)
time frame: up to 15 days
measure: CLR,t1-t2 (renal clearance of analyte from the within the time interval t1 to t2)
time frame: up to 15 days
measure: Number of patients with clinically relevant findings in vital signs
time frame: up to 23 days
measure: Number of patients with clinically relevant findings in 12-lead electrocardiogram (ECG)
time frame: up to 23 days
measure: Number of patients with clinically relevant laboratory findings
time frame: up to 23 days
measure: Number of patients with adverse events
time frame: up to up to 44 days
measure: Assessment of global tolerability on a 4-point scale
time frame: day 15
arm group label: BI 44370 BS
arm group type: Experimental
description: 200 mg containing 2.43 megabecquerel (MBq) 14C-radioactivity
intervention type: Drug
intervention name: BI 44370 BS
arm group label: BI 44370 BS
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
url: http://trials.boehringer-ingelheim.com
description: Related Info
responsible party type: Sponsor