<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/NCT02248259</url>
  </required_header>
  <id_info>
    <org_study_id>1289.23</org_study_id>
    <nct_id>NCT02248259</nct_id>
  </id_info>
  <brief_title>Drug Drug Interaction Trial With Strong CYP3A4 Inhibitor (Itraconazole) in CYP2C19 Extensive Metabolizers and Poor Metabolizers</brief_title>
  <official_title>Open-label, Randomised, Two-way Crossover Study to Assess the Effect of Once Daily Itraconazole on the Pharmacokinetics of BI 409306 After a Single Oral Dose in Healthy Male Volunteers Genotyped as Poor and Extensive Metabolizers of CYP2C19</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boehringer Ingelheim</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boehringer Ingelheim</source>
  <brief_summary>
    <textblock>
      The objective of the current study is to evaluate the effect of once daily itraconazole on&#xD;
      the pharmacokinetics of BI 409306 in poor (PM) and extensive metabolisers (EM) of CYP2C19.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2014</start_date>
  <completion_date type="Actual">January 2015</completion_date>
  <primary_completion_date type="Actual">January 2015</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>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>AUC0-infinity (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)</measure>
    <time_frame>up to 72 hours after start of drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Cmax (maximum measured concentration of the analyte in plasma)</measure>
    <time_frame>up to 72 hours after start of drug administration</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>AUC0-tz ((area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable plasma concentration)</measure>
    <time_frame>up to 72 hours after start of drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>tmax (time from dosing to the maximum concentration of the analyte in plasma)</measure>
    <time_frame>up to 72 hours after start of drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>t1/2 (terminal half-life of the analyte in plasma)</measure>
    <time_frame>up to 72 hours after start of drug administration</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">25</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Reference treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single oral dose of BI 409306</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Test treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single oral dose of BI 409306 and Administration of Itraconazole</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BI 409306</intervention_name>
    <description>Oral single dose of BI 409306</description>
    <arm_group_label>Test treatment</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Itraconazole</intervention_name>
    <description>Oral dose, twice daily on Day -3, once daily on Day -2 to Day 2 of Itraconazole</description>
    <arm_group_label>Test treatment</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BI 409306</intervention_name>
    <description>Oral single dose</description>
    <arm_group_label>Reference treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
        - Healthy CYP2C19 genotyped male volunteers according to the following criteria: Based upon&#xD;
        a complete medical history, including the physical examination, vital signs (BP, PR,&#xD;
        respiratory rate, body temperature), 12-lead ECG, ophthalmologic exam, clinical laboratory&#xD;
        tests&#xD;
&#xD;
          -  Korean ethnicity according to the following criteria: be a current Korean passport or&#xD;
             national identification card holder, and have parents and grandparents who were all&#xD;
             born in Korea&#xD;
&#xD;
          -  Age 20 or older than 20 and 45 or younger than 45 years&#xD;
&#xD;
          -  BMI (Body Mass Index) 18.5 or more than 18.5 and BMI 25 or less than 25 kg/m2&#xD;
&#xD;
          -  Signed and dated written informed consent prior to admission to the study in&#xD;
             accordance with GCP and the local legislation.&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  Any finding of the medical examination (including BP, PR, respiratory rate, body&#xD;
             temperature and ECG) deviating from 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;
          -  Surgery of the gastrointestinal tract (except appendectomy, hernia surgery)&#xD;
&#xD;
          -  Diseases of the central nervous system (including but not limited to any kind of&#xD;
             seizures, migraine, stroke or psychiatric disorders) within the past 6 month&#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 drug or its&#xD;
             excipients)&#xD;
&#xD;
          -  Intake of drugs with a long half-life (longer than 24 hours) within at least one month&#xD;
             or less than 10 half-lives of the respective drug prior to administration or during&#xD;
             the trial&#xD;
&#xD;
          -  Use of drugs which might reasonably influence the results of the trial or that prolong&#xD;
             the QT/QTc interval based on the knowledge at the time of protocol preparation within&#xD;
             10 days prior to administration or during the trial&#xD;
&#xD;
          -  Participation in another trial with an investigational drug within two months prior to&#xD;
             administration or during the trial&#xD;
&#xD;
          -  Smoker (more than 10 cigarettes or more than 3 cigars or more than 3 pipes/day)&#xD;
&#xD;
          -  Inability to refrain from smoking on trial days&#xD;
&#xD;
          -  Alcohol abuse (more than 20 g/day)&#xD;
&#xD;
          -  Drug abuse&#xD;
&#xD;
          -  Blood donation (more than 100 mL within four weeks prior to administration or during&#xD;
             the trial)&#xD;
&#xD;
          -  Excessive physical activities (within one week prior to administration or during the&#xD;
             trial)&#xD;
&#xD;
          -  Any laboratory value outside the reference range that is of clinical relevance&#xD;
&#xD;
          -  Inability to comply with dietary regimen of trial site&#xD;
&#xD;
          -  A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a&#xD;
             QTc interval more than 450 ms)&#xD;
&#xD;
          -  A history of additional risk factors for Torsade des Pointes (e.g., heart failure,&#xD;
             hypokalemia, family history of Long QT Syndrome)&#xD;
&#xD;
          -  Abnormality on color vision test or any other finding on ophthalmologic exam that is&#xD;
             clinically deemed to potentially interfere with the safety assessment of this trial&#xD;
&#xD;
          -  Subjects who do not agree to minimize the risk of female partners becoming pregnant&#xD;
             from the first dosing day until two month after the study completion. Acceptable&#xD;
             methods of contraception comprises barrier contraception and a medically accepted&#xD;
             contraceptive method for the female partner (intra-uterine device with spermicide,&#xD;
             hormonal contraceptive since at least two month)&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Boehringer Ingelheim</last_name>
    <role>Study Chair</role>
    <affiliation>Boehringer Ingelheim</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>1289.23.8201 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>January 2015</verification_date>
  <study_first_submitted>September 22, 2014</study_first_submitted>
  <study_first_submitted_qc>September 22, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 25, 2014</study_first_posted>
  <last_update_submitted>January 22, 2015</last_update_submitted>
  <last_update_submitted_qc>January 22, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 26, 2015</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>Itraconazole</mesh_term>
    <mesh_term>BI 409306</mesh_term>
  </intervention_browse>
  <pending_results>
    <submitted>August 10, 2023</submitted>
  </pending_results>
  <!-- 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/NCT02248259
org study id: 1289.23
nct id: NCT02248259
lead sponsor: 
The objective of the current study is to evaluate the effect of once daily itraconazole on
      the pharmacokinetics of BI 409306 in poor (PM) and extensive metabolisers (EM) of CYP2C19.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: AUC0-infinity (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
time frame: up to 72 hours after start of drug administration
measure: Cmax (maximum measured concentration of the analyte in plasma)
time frame: up to 72 hours after start of drug administration
measure: AUC0-tz ((area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable plasma concentration)
time frame: up to 72 hours after start of drug administration
measure: tmax (time from dosing to the maximum concentration of the analyte in plasma)
time frame: up to 72 hours after start of drug administration
measure: t1/2 (terminal half-life of the analyte in plasma)
time frame: up to 72 hours after start of drug administration
arm group label: Reference treatment
arm group type: Experimental
description: Single oral dose of BI 409306
arm group label: Test treatment
arm group type: Experimental
description: Single oral dose of BI 409306 and Administration of Itraconazole
intervention type: Drug
intervention name: BI 409306
description: Oral single dose of BI 409306
arm group label: Test treatment
intervention type: Drug
intervention name: Itraconazole
description: Oral dose, twice daily on Day -3, once daily on Day -2 to Day 2 of Itraconazole
arm group label: Test treatment
intervention type: Drug
intervention name: BI 409306
description: Oral single dose
arm group label: Reference treatment
criteria: 
gender: Male
minimum age: 20 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Boehringer Ingelheim
role: Study Chair
affiliation: Boehringer Ingelheim
facility: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Itraconazole
mesh term: BI 409306
submitted: August 10, 2023