xml: <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/NCT06028464</url>
    </required_header>
    <id_info>
      <org_study_id>1479-0011</org_study_id>
      <secondary_id>2022-503046-50-00</secondary_id>
      <nct_id>NCT06028464</nct_id>
    </id_info>
    <brief_title>A Study in Healthy Men to Test Whether Carbamazepine Influences the Amount of BI 1810631 in the Blood</brief_title>
    <official_title>The Effect of Multiple Doses of Carbamazepine on the Pharmacokinetics of a Single Oral Dose of BI 1810631 in Healthy Male Subjects (an Open-label, Two-period, Fixed-sequence Trial)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Boehringer Ingelheim</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Boehringer Ingelheim</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The main objective of this trial is to investigate the effect of multiple oral doses of the&#xD;
        strong CYP3A inducer carbamazepine on the pharmacokinetics of a single dose of BI 1810631 in&#xD;
        plasma.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 11, 2023</start_date>
    <completion_date type="Anticipated">November 24, 2023</completion_date>
    <primary_completion_date type="Anticipated">November 24, 2023</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>Sequential Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)</measure>
      <time_frame>Up to 8 days</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Maximum measured concentration of the analyte in plasma (Cmax)</measure>
      <time_frame>Up to 8 days</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz)</measure>
      <time_frame>Up to 8 days</time_frame>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">16</enrollment>
    <condition>Healthy</condition>
    <arm_group>
      <arm_group_label>BI 1810631 (reference) and BI 1810631 + carbamazepine (test)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>BI 1810631</intervention_name>
      <description>BI 1810631</description>
      <arm_group_label>BI 1810631 (reference) and BI 1810631 + carbamazepine (test)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Carbamazepine</intervention_name>
      <description>Carbamazepine</description>
      <arm_group_label>BI 1810631 (reference) and BI 1810631 + carbamazepine (test)</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Healthy male subjects according to the assessment of the investigator, as based on a&#xD;
               complete medical history including a physical examination, vital signs (Blood Pressure&#xD;
               (BP), Pulse rate (PR)), 12-lead Electrocardiogram (ECG), and clinical laboratory tests&#xD;
  &#xD;
            -  Age of 18 to 55 years (inclusive)&#xD;
  &#xD;
            -  Body mass index (BMI) of 18.5 to 29.9 kg/m2 (inclusive)&#xD;
  &#xD;
            -  Signed and dated written informed consent in accordance with ICH-GCP and local&#xD;
               legislation prior to admission to the trial&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Any finding in the medical examination (including BP, PR or ECG, the neurological&#xD;
               examination, or the skin inspection) deviating from normal and assessed as clinically&#xD;
               relevant by the investigator&#xD;
  &#xD;
            -  Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg,&#xD;
               diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the&#xD;
               range of 50 to 90 bpm&#xD;
  &#xD;
            -  Any laboratory value outside the reference range that the investigator considers to be&#xD;
               of clinical relevance&#xD;
  &#xD;
            -  Any evidence of a concomitant disease assessed as clinically relevant by the&#xD;
               investigator&#xD;
  &#xD;
            -  Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic,&#xD;
               immunological or hormonal disorders&#xD;
  &#xD;
            -  Cholecystectomy or other surgery of the gastrointestinal tract that could interfere&#xD;
               with the pharmacokinetics of the trial medication (except appendectomy or simple&#xD;
               hernia repair)&#xD;
  &#xD;
            -  Diseases of the central nervous system (including but not limited to any kind of&#xD;
               seizures or stroke), and other relevant neurological or psychiatric disorders&#xD;
  &#xD;
            -  History of relevant orthostatic hypotension, fainting spells, or blackouts&#xD;
  &#xD;
            -  Further exclusion criteria apply&#xD;
        </textblock>
      </criteria>
      <gender>Male</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>55 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Boehringer Ingelheim</last_name>
      <phone>1-800-243-0127</phone>
      <email>clintriage.rdg@boehringer-ingelheim.com</email>
    </overall_contact>
    <link>
      <url>http://www.mystudywindow.com</url>
      <description>Related Info</description>
    </link>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 30, 2023</study_first_submitted>
    <study_first_submitted_qc>September 1, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 8, 2023</study_first_posted>
    <last_update_submitted>September 1, 2023</last_update_submitted>
    <last_update_submitted_qc>September 1, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 8, 2023</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>Carbamazepine</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization).&#xD;
  For more details refer to:&#xD;
  https://www.mystudywindow.com/msw/datatransparency</ipd_description>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06028464
  org study id: 1479-0011
  secondary id: 2022-503046-50-00
  nct id: NCT06028464
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The main objective of this trial is to investigate the effect of multiple oral doses of the
        strong CYP3A inducer carbamazepine on the pharmacokinetics of a single dose of BI 1810631 in
        plasma.
  allocation: N/A
  intervention model: Sequential Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)
  time frame: Up to 8 days
  measure: Maximum measured concentration of the analyte in plasma (Cmax)
  time frame: Up to 8 days
  measure: Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz)
  time frame: Up to 8 days
  arm group label: BI 1810631 (reference) and BI 1810631 + carbamazepine (test)
  arm group type: Experimental
  intervention type: Drug
  intervention name: BI 1810631
  description: BI 1810631
  arm group label: BI 1810631 (reference) and BI 1810631 + carbamazepine (test)
  intervention type: Drug
  intervention name: Carbamazepine
  description: Carbamazepine
  arm group label: BI 1810631 (reference) and BI 1810631 + carbamazepine (test)
  criteria: 
  gender: Male
  minimum age: 18 Years
  maximum age: 55 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Boehringer Ingelheim
  phone: 1-800-243-0127
  email: clintriage.rdg@boehringer-ingelheim.com
  url: http://www.mystudywindow.com
  description: Related Info
  responsible party type: Sponsor
  mesh term: Carbamazepine
  sharing ipd: No
  ipd description: Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization).
  For more details refer to:
  https://www.mystudywindow.com/msw/datatransparency