<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/NCT02264028</url>
  </required_header>
  <id_info>
    <org_study_id>503.209</org_study_id>
    <nct_id>NCT02264028</nct_id>
  </id_info>
  <brief_title>Metabolism and Pharmacokinetics of [14C]-DK-AH 269 CL in 12 Healthy Male Volunteers</brief_title>
  <official_title>Metabolism and Pharmacokinetics of [14C]-DK-AH 269 CL After Administration of Single Doses of 5 mg [14C]-DK-AH 269 CL Intravenously and 10 mg [14C]-DK-AH 269 CL as Oral Solution in a Parallel-group Design in 12 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>
      -  To investigate absorption, metabolism and excretion of [14C]-DK-AH 269 CL after oral and&#xD;
           intravenous administration in healthy volunteers&#xD;
&#xD;
        -  To assess the safety and tolerability of DK-AH 269 CL after oral and intravenous&#xD;
           administration to healthy volunteers&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>March 2004</start_date>
  <primary_completion_date type="Actual">April 2004</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Maximum measured concentration of the analytes in plasma (Cmax)</measure>
    <time_frame>Up to 96 hours after start of treatment</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Area under the concentration-time curve of the analytes in plasma (AUC)</measure>
    <time_frame>Up to 96 hours after start of treatment</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Time from dosing to the maximum concentration of the analytes in plasma (tmax)</measure>
    <time_frame>Up to 96 hours after start of treatment</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Terminal rate constant of the analytes in plasma (λz)</measure>
    <time_frame>Up to 96 hours after start of treatment</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Terminal half-life of the analytes in plasma (t1/2)</measure>
    <time_frame>Up to 96 hours after start of treatment</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Mean residence time of the analytes in the body after intravenous administration (MRT)</measure>
    <time_frame>Up to 96 hours after start of treatment</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Mean residence time of the analytes in the body after oral administration (MRTpo)</measure>
    <time_frame>Up to 96 hours after start of treatment</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Apparent clearance of the analytes in plasma following extravascular administration (CL/F)</measure>
    <time_frame>Up to 96 hours after start of treatment</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Total clearance of the analytes in plasma following intravascular administration (CL)</measure>
    <time_frame>Up to 96 hours after start of treatment</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Apparent volume of distribution of the analytes during the terminal phase λz following extravascular administration (Vz/F)</measure>
    <time_frame>Up to 96 hours after start of treatment</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Volume of distribution at steady state (Vss)</measure>
    <time_frame>Up to 96 hours after start of treatment</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Fraction of analytes eliminated in urine from 0 to the time of the last quantifiable data point (fe0-tz)</measure>
    <time_frame>Up to 120 hours after start of treatment</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Fraction of analytes eliminated in faeces from 0 to the time of the last quantifiable data point (fefaeces,0-tz)</measure>
    <time_frame>Up to 120 hours after start of treatment</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Renal clearance of the analytes from 0 to the time of the last quantifiable data point (CLR,0-tz)</measure>
    <time_frame>Up to 120 hours after start of treatment</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Fraction of dose absorbed, based on radioactivity data (Fa)</measure>
    <time_frame>Up to 96 hours after start of treatment</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Absolute bioavailability of the analytes after oral administration (F)</measure>
    <time_frame>Up to 96 hours after start of treatment</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Ratio of CBlood cells/Cplasma [14C]-radioactivity</measure>
    <time_frame>Up to 96 hours after start of treatment</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of patients with clinically significant findings in vital signs</measure>
    <time_frame>up to 12 days after last drug administration</time_frame>
    <description>blood pressure, heart rate</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of patients with clinically significant findings in 12-lead ECG</measure>
    <time_frame>up to 12 days after last drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of patients with clinically significant findings in 2-lead ECG (telemetry)</measure>
    <time_frame>up to 90 minutes after start of treatment</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Clinically significant changes from baseline in physical examination</measure>
    <time_frame>Pre-dose, and 12 days after last drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Occurrence of visual phenomena</measure>
    <time_frame>up to 120 hours after start of treatment</time_frame>
    <description>questionnaire</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of patients with clinically significant findings in clinical laboratory tests</measure>
    <time_frame>up to 12 days after last drug administration</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>[14C]-DK-AH 269 CL intravenous</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>[14C]-DK-AH 269 CL oral</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>[14C]-DK-AH 269 CL, solution for infusion</intervention_name>
    <arm_group_label>[14C]-DK-AH 269 CL intravenous</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>[14C]-DK-AH 269 CL, drinking solution</intervention_name>
    <arm_group_label>[14C]-DK-AH 269 CL oral</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  50 to 65 years of age&#xD;
&#xD;
          -  Body Mass Index (BMI) of 19.9 to 29.9 kg/m2&#xD;
&#xD;
          -  Resting heart rate (HR) (after 5 min. in the supine position) of more than 55 bpm&#xD;
&#xD;
          -  All volunteers will have given their written informed consent prior to admission to&#xD;
             the study in accordance with Good Clinical Practice (GCP) and the local legislation.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any finding at the medical examination (including BP, HR and ECG) deviating from&#xD;
             normal and of clinical relevance&#xD;
&#xD;
          -  Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic,&#xD;
             hematological/oncological, immunological or hormonal disorders&#xD;
&#xD;
          -  Diseases of the central nervous system or psychiatric disorders or neurological&#xD;
             disorders&#xD;
&#xD;
          -  History of relevant orthostatic hypotension, fainting spells or blackouts&#xD;
&#xD;
          -  Chronic or relevant acute infections&#xD;
&#xD;
          -  History of allergy/hypersensitivity (including drug allergy) which is deemed relevant&#xD;
             to the trial as judged by the investigator&#xD;
&#xD;
          -  Intake of drugs with a long half-life (&gt; 24 hours) within ten half-lives of the&#xD;
             respective drug before enrolment in the study&#xD;
&#xD;
          -  Use of any drugs which might influence the results of the trial within two weeks prior&#xD;
             to administration or during the trial&#xD;
&#xD;
          -  Participation in another trial with an investigational drug (≤ two months prior to&#xD;
             administration or during the trial)&#xD;
&#xD;
          -  Smoker (&gt; 10 cigarettes or &gt; 3 cigars of &gt; 3 pipes/day)&#xD;
&#xD;
          -  Inability to refrain from smoking on trial days&#xD;
&#xD;
          -  Alcohol abuse (&gt; 60 g/day)&#xD;
&#xD;
          -  Drug abuse&#xD;
&#xD;
          -  Blood donation (≥ 100 mL within 2 months prior to administration or during the trial)&#xD;
&#xD;
          -  Excessive physical activities (within the last week before the study)&#xD;
&#xD;
          -  Any laboratory value outside the reference range and of clinical relevance&#xD;
&#xD;
          -  Inability to comply with dietary regimen of study centre&#xD;
&#xD;
        Not necessarily clinically relevant abnormalities, but specific exclusion criteria for the&#xD;
        drugs under study or for the study:&#xD;
&#xD;
          -  Subjects at increased risk for development of cardiac arrhythmia (e.g. family history&#xD;
             of long QT syndrome or sudden cardiac death)&#xD;
&#xD;
          -  ECG: PR interval &gt; 210 ms&#xD;
&#xD;
          -  HR at rest ≤ 55 beats per minute (bpm)&#xD;
&#xD;
          -  Relevant ophthalmological disease&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>50 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>October 2014</verification_date>
  <study_first_submitted>October 13, 2014</study_first_submitted>
  <study_first_submitted_qc>October 13, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 15, 2014</study_first_posted>
  <last_update_submitted>October 13, 2014</last_update_submitted>
  <last_update_submitted_qc>October 13, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 15, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pharmaceutical Solutions</mesh_term>
  </intervention_browse>
  <!-- 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/NCT02264028
org study id: 503.209
nct id: NCT02264028
lead sponsor: 
-  To investigate absorption, metabolism and excretion of [14C]-DK-AH 269 CL after oral and
           intravenous administration in healthy volunteers

        -  To assess the safety and tolerability of DK-AH 269 CL after oral and intravenous
           administration to healthy volunteers
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Maximum measured concentration of the analytes in plasma (Cmax)
time frame: Up to 96 hours after start of treatment
measure: Area under the concentration-time curve of the analytes in plasma (AUC)
time frame: Up to 96 hours after start of treatment
measure: Time from dosing to the maximum concentration of the analytes in plasma (tmax)
time frame: Up to 96 hours after start of treatment
measure: Terminal rate constant of the analytes in plasma (λz)
time frame: Up to 96 hours after start of treatment
measure: Terminal half-life of the analytes in plasma (t1/2)
time frame: Up to 96 hours after start of treatment
measure: Mean residence time of the analytes in the body after intravenous administration (MRT)
time frame: Up to 96 hours after start of treatment
measure: Mean residence time of the analytes in the body after oral administration (MRTpo)
time frame: Up to 96 hours after start of treatment
measure: Apparent clearance of the analytes in plasma following extravascular administration (CL/F)
time frame: Up to 96 hours after start of treatment
measure: Total clearance of the analytes in plasma following intravascular administration (CL)
time frame: Up to 96 hours after start of treatment
measure: Apparent volume of distribution of the analytes during the terminal phase λz following extravascular administration (Vz/F)
time frame: Up to 96 hours after start of treatment
measure: Volume of distribution at steady state (Vss)
time frame: Up to 96 hours after start of treatment
measure: Fraction of analytes eliminated in urine from 0 to the time of the last quantifiable data point (fe0-tz)
time frame: Up to 120 hours after start of treatment
measure: Fraction of analytes eliminated in faeces from 0 to the time of the last quantifiable data point (fefaeces,0-tz)
time frame: Up to 120 hours after start of treatment
measure: Renal clearance of the analytes from 0 to the time of the last quantifiable data point (CLR,0-tz)
time frame: Up to 120 hours after start of treatment
measure: Fraction of dose absorbed, based on radioactivity data (Fa)
time frame: Up to 96 hours after start of treatment
measure: Absolute bioavailability of the analytes after oral administration (F)
time frame: Up to 96 hours after start of treatment
measure: Ratio of CBlood cells/Cplasma [14C]-radioactivity
time frame: Up to 96 hours after start of treatment
measure: Number of patients with clinically significant findings in vital signs
time frame: up to 12 days after last drug administration
description: blood pressure, heart rate
measure: Number of patients with clinically significant findings in 12-lead ECG
time frame: up to 12 days after last drug administration
measure: Number of patients with clinically significant findings in 2-lead ECG (telemetry)
time frame: up to 90 minutes after start of treatment
measure: Clinically significant changes from baseline in physical examination
time frame: Pre-dose, and 12 days after last drug administration
measure: Occurrence of visual phenomena
time frame: up to 120 hours after start of treatment
description: questionnaire
measure: Number of patients with clinically significant findings in clinical laboratory tests
time frame: up to 12 days after last drug administration
arm group label: [14C]-DK-AH 269 CL intravenous
arm group type: Active Comparator
arm group label: [14C]-DK-AH 269 CL oral
arm group type: Experimental
intervention type: Drug
intervention name: [14C]-DK-AH 269 CL, solution for infusion
arm group label: [14C]-DK-AH 269 CL intravenous
intervention type: Drug
intervention name: [14C]-DK-AH 269 CL, drinking solution
arm group label: [14C]-DK-AH 269 CL oral
criteria: 
gender: Male
minimum age: 50 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
url: http://trials.boehringer-ingelheim.com
description: Related Info
responsible party type: Sponsor
mesh term: Pharmaceutical Solutions