<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/NCT03793621</url>
  </required_header>
  <id_info>
    <org_study_id>1407-0015</org_study_id>
    <nct_id>NCT03793621</nct_id>
  </id_info>
  <brief_title>This Study is Done in Healthy Japanese Volunteers. It Looks at How Different Doses of BI 730357 Are Taken up in the Body and How Well They Are Tolerated</brief_title>
  <official_title>Safety, Tolerability, and Pharmacokinetics of Single Rising Oral Doses of BI 730357 in Japanese Healthy Male Subjects (Double-blind, Randomised, Placebo-controlled, Parallel Group Design)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boehringer Ingelheim</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boehringer Ingelheim</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <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 safety and tolerability of BI 730357&#xD;
      in Japanese healthy male subjects following oral administration of single rising doses.&#xD;
&#xD;
      Secondary objectives are the explorations of the pharmacokinetic(s) (PK), including dose&#xD;
      proportionality as well as investigation of linearity of BI 730357 after single dose&#xD;
      administration.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 21, 2019</start_date>
  <completion_date type="Actual">April 26, 2019</completion_date>
  <primary_completion_date type="Actual">April 26, 2019</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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants With Drug-related Adverse Events</measure>
    <time_frame>Up to 7 days after drug administration.</time_frame>
    <description>Number of participants with trial drug-related adverse events.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Area Under the Concentration-time Curve of BI 730357 in Plasma Over the Time Interval From 0 Extrapolated to Infinity</measure>
    <time_frame>Within 3 hours before drug administration and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 34, 48, 72, 96 and 168 hours after drug administration.</time_frame>
    <description>Area under the concentration-time curve of BI 730357 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum Measured Concentration of BI 730357 in Plasma</measure>
    <time_frame>Within 3 hours before drug administration and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 34, 48, 72, 96 and 168 hours after drug administration.</time_frame>
    <description>Maximum measured concentration of BI 730357 in plasma (Cmax).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>BI 730357</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BI 730357</intervention_name>
    <description>single rising oral dose</description>
    <arm_group_label>BI 730357</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>single rising oral dose</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy male subjects according to the investigator's assessment, based on a complete&#xD;
             medical history including a physical examination, vital signs (Blood Pressure (BP),&#xD;
             Pulse Rate (PR), Respiratory Rate (RR), body temperature), 12-lead Electrocardiogram&#xD;
             (ECG), and clinical laboratory tests&#xD;
&#xD;
          -  Japanese ethnicity, according to the following criteria:&#xD;
&#xD;
             -- born in Japan, have lived outside of Japan &lt;10 years, and have parents and&#xD;
             grandparents who are Japanese&#xD;
&#xD;
          -  Age of 20 to 45 years (inclusive) at screening&#xD;
&#xD;
          -  Body Mass Index (BMI) of 18.5 to 25.0 kg/m2 (inclusive) at screening&#xD;
&#xD;
          -  Signed and dated written informed consent in accordance with International Council for&#xD;
             Harmonisation - Good Clinical Practice (ICH-GCP) and local legislation prior to&#xD;
             admission to the trial&#xD;
&#xD;
          -  Male subject who agree to minimize the risk of female partners becoming pregnant by&#xD;
             fulfilling any of the following criteria starting from participation to this trial and&#xD;
             until 90 days after the trial completion:&#xD;
&#xD;
               -  Use of adequate contraception, e.g., any of the following methods plus condom:&#xD;
&#xD;
                  --- combined oral contraceptives, intrauterine device.&#xD;
&#xD;
               -  Vasectomised (vasectomy at least 1 year prior to enrolment)&#xD;
&#xD;
               -  Surgical sterilised (including hysterectomy) of the subject's female partner&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any finding in the medical examination (including Blood Pressure (BP), Pulse Rate (PR)&#xD;
             or Electrocardiogram (ECG)) is deviating from normal and judged as clinically relevant&#xD;
             by the investigator&#xD;
&#xD;
          -  Repeated measurement of systolic BP outside the range of 90 to 140 mmHg, diastolic BP&#xD;
             outside the range of 50 to 90 mmHg, or PR outside the range of 45 to 90 beats per&#xD;
             minute (bpm) at screening&#xD;
&#xD;
          -  Any laboratory value outside the reference range that the investigator considers to be&#xD;
             of clinical relevance at screening&#xD;
&#xD;
          -  Any evidence of a concomitant disease judged as clinically relevant by the&#xD;
             investigator&#xD;
&#xD;
          -  Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic,&#xD;
             immunological or hormonal disorders&#xD;
&#xD;
          -  Cholecystectomy and/or surgery of the gastrointestinal tract that could interfere with&#xD;
             the pharmacokinetics of the trial medication (except appendectomy and simple hernia&#xD;
             repair)&#xD;
&#xD;
          -  Diseases of the Central Nervous System (CNS) (including but not limited to any kind of&#xD;
             seizures or stroke), and other relevant neurological or psychiatric disorders,&#xD;
             including but not limited to mood disorders and any history of suicidality&#xD;
&#xD;
          -  History of relevant orthostatic hypotension, fainting spells, or blackouts&#xD;
&#xD;
          -  Chronic or relevant acute infections including human immunodeficiency virus (HIV),&#xD;
             viral hepatitis, syphilis and/or tuberculosis&#xD;
&#xD;
          -  History of relevant allergy or hypersensitivity (including allergy to the trial&#xD;
             medication or its excipients)&#xD;
&#xD;
          -  Use of drugs within 30 days or 5 half-lives, whichever is longer, prior to&#xD;
             administration of trial medication, if that might reasonably influence the results of&#xD;
             the trial (including potential for QT/QTc interval prolongation)&#xD;
&#xD;
          -  Participation in another trial where an investigational drug has been administered&#xD;
             within 60 days prior to planned administration of trial medication, or current&#xD;
             participation in another trial involving administration of investigational drug&#xD;
&#xD;
          -  Previous exposure to BI 730357&#xD;
&#xD;
          -  Smoker (more than 10 cigarettes or 3 cigars or 3 pipes per day)&#xD;
&#xD;
          -  Inability to refrain from smoking on specified trial days&#xD;
&#xD;
          -  Alcohol abuse (consumption of more than 30 g per day for males)&#xD;
&#xD;
          -  Drug abuse or positive drug screening&#xD;
&#xD;
          -  Whole blood donation of more than 200 mL within 30 days or 400 mL within 12 weeks, or&#xD;
             plasmapheresis and platelet apheresis within 2 weeks prior to administration of trial&#xD;
             medication, or intended donation during the trial&#xD;
&#xD;
          -  Intention to perform excessive physical activities within one week prior to&#xD;
             administration of trial medication or during the trial&#xD;
&#xD;
          -  Inability to comply with dietary regimen of trial site&#xD;
&#xD;
          -  A marked baseline prolongation of QT/QTc interval (such as QTc intervals that are&#xD;
             repeatedly greater than 450 mseconds) or any other relevant ECG finding at screening&#xD;
&#xD;
          -  A history of additional risk factors for Torsades de Pointes (such as heart failure,&#xD;
             hypokalemia, or family history of Long QT Syndrome)&#xD;
&#xD;
          -  Subject is assessed as unsuitable for inclusion by the investigator, for instance,&#xD;
             because considered not able to understand and comply with study requirements, or has a&#xD;
             condition that would not allow safe participation in the study&#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>
  <location>
    <facility>
      <name>SOUSEIKAI Sumida Hospital</name>
      <address>
        <city>Tokyo, Sumida-ku</city>
        <zip>130-0004</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <link>
    <url>https://www.mystudywindow.com</url>
    <description>Related Info</description>
  </link>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>January 3, 2019</study_first_submitted>
  <study_first_submitted_qc>January 3, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 4, 2019</study_first_posted>
  <results_first_submitted>August 12, 2022</results_first_submitted>
  <results_first_submitted_qc>August 12, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">July 12, 2023</results_first_posted>
  <last_update_submitted>August 12, 2022</last_update_submitted>
  <last_update_submitted_qc>August 12, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 12, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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, except for the following exclusions:&#xD;
1. studies in products where Boehringer Ingelheim is not the license holder; 2. studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; 3. studies conducted in a single center or targeting rare diseases (because of limitations with anonymization). For more details refer to: http://trials.boehringer-ingelheim.com/</ipd_description>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>December 13, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/21/NCT03793621/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>May 7, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/21/NCT03793621/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Investigation of safety and tolerability of BI730357 in healthy subjects following oral administration of single rising doses of 50, 100, and 200mg. The trial was designed as double-blind, randomised within dose group, and placebo-controlled within parallel dose group.</recruitment_details>
      <pre_assignment_details>All participants were screened for eligibility to participate in the trial. Participants attended specialist sites which would then ensure that all participants met all inclusion/exclusion criteria. Participants were not to be entered to trial treatment if any of the specific entry criteria were not met.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Placebo</title>
          <description>Placebo film-coated tablet (1 for 50 milligram (mg) group, 1 for 100 mg group, 2 for 200 mg group), administered as single oral dose with ~240 milliliter of water after an overnight fast of at least 10 hours. Subjects receiving placebo were equally distributed across dose groups.</description>
        </group>
        <group group_id="P2">
          <title>50 mg BI 730357 Single Dose</title>
          <description>1 film-coated tablet (50 milligram) of BI 730357, administered as single oral dose with ~240 milliliter of water after an overnight fast of at least 10 hours.</description>
        </group>
        <group group_id="P3">
          <title>100 mg BI 730357 Single Dose</title>
          <description>1 film-coated tablet (100 milligram) of BI 730357, administered as single oral dose with ~240 milliliter of water after an overnight fast of at least 10 hours.</description>
        </group>
        <group group_id="P4">
          <title>200 mg BI 730357 Single Dose</title>
          <description>2 film-coated tablets (100 milligram each) of BI 730357, administered as single oral dose with ~240 milliliter of water after an overnight fast of at least 10 hours.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="6"/>
                <participants group_id="P4" count="6"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="6"/>
                <participants group_id="P4" count="6"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Treated Set (TS), which included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.</population>
      <group_list>
        <group group_id="B1">
          <title>Placebo</title>
          <description>Placebo film-coated tablet (1 for 50 milligram (mg) group, 1 for 100 mg group, 2 for 200 mg group), administered as single oral dose with ~240 milliliter of water after an overnight fast of at least 10 hours. Subjects receiving placebo were equally distributed across dose groups.</description>
        </group>
        <group group_id="B2">
          <title>50 mg BI 730357 Single Dose</title>
          <description>1 film-coated tablet (50 milligram) of BI 730357, administered as single oral dose with ~240 milliliter of water after an overnight fast of at least 10 hours.</description>
        </group>
        <group group_id="B3">
          <title>100 mg BI 730357 Single Dose</title>
          <description>1 film-coated tablet (100 milligram) of BI 730357, administered as single oral dose with ~240 milliliter of water after an overnight fast of at least 10 hours.</description>
        </group>
        <group group_id="B4">
          <title>200 mg BI 730357 Single Dose</title>
          <description>2 film-coated tablets (100 milligram each) of BI 730357, administered as single oral dose with ~240 milliliter of water after an overnight fast of at least 10 hours.</description>
        </group>
        <group group_id="B5">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="6"/>
            <count group_id="B2" value="6"/>
            <count group_id="B3" value="6"/>
            <count group_id="B4" value="6"/>
            <count group_id="B5" value="24"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="29.7" spread="7.6"/>
                    <measurement group_id="B2" value="22.2" spread="1.8"/>
                    <measurement group_id="B3" value="26.8" spread="7.3"/>
                    <measurement group_id="B4" value="32.8" spread="7.3"/>
                    <measurement group_id="B5" value="27.9" spread="7.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="6"/>
                    <measurement group_id="B4" value="6"/>
                    <measurement group_id="B5" value="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="6"/>
                    <measurement group_id="B4" value="6"/>
                    <measurement group_id="B5" value="24"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="6"/>
                    <measurement group_id="B4" value="6"/>
                    <measurement group_id="B5" value="24"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Drug-related Adverse Events</title>
        <description>Number of participants with trial drug-related adverse events.</description>
        <time_frame>Up to 7 days after drug administration.</time_frame>
        <population>Treated Set (TS):&#xD;
All subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subject received.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo film-coated tablet (1 for 50 milligram (mg) group, 1 for 100 mg group, 2 for 200 mg group), administered as single oral dose with ~240 milliliter of water after an overnight fast of at least 10 hours. Subjects receiving placebo were equally distributed across dose groups.</description>
          </group>
          <group group_id="O2">
            <title>50 mg BI 730357 Single Dose</title>
            <description>1 film-coated tablet (50 milligram) of BI 730357, administered as single oral dose with ~240 milliliter of water after an overnight fast of at least 10 hours.</description>
          </group>
          <group group_id="O3">
            <title>100 mg BI 730357 Single Dose</title>
            <description>1 film-coated tablet (100 milligram) of BI 730357, administered as single oral dose with ~240 milliliter of water after an overnight fast of at least 10 hours.</description>
          </group>
          <group group_id="O4">
            <title>200 mg BI 730357 Single Dose</title>
            <description>2 film-coated tablets (100 milligram each) of BI 730357, administered as single oral dose with ~240 milliliter of water after an overnight fast of at least 10 hours.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Drug-related Adverse Events</title>
          <description>Number of participants with trial drug-related adverse events.</description>
          <population>Treated Set (TS):&#xD;
All subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subject received.</population>
          <units>Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="6"/>
                <count group_id="O4" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Area Under the Concentration-time Curve of BI 730357 in Plasma Over the Time Interval From 0 Extrapolated to Infinity</title>
        <description>Area under the concentration-time curve of BI 730357 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞).</description>
        <time_frame>Within 3 hours before drug administration and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 34, 48, 72, 96 and 168 hours after drug administration.</time_frame>
        <population>Pharmacokinetics analysis set (PKS): All subjects in the treated set (TS) who provided at least one PK endpoint that was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. Only participants with non-missing results are reported.</population>
        <group_list>
          <group group_id="O1">
            <title>50 mg BI 730357 Single Dose</title>
            <description>1 film-coated tablet (50 milligram) of BI 730357, administered as single oral dose with ~240 milliliter of water after an overnight fast of at least 10 hours.</description>
          </group>
          <group group_id="O2">
            <title>100 mg BI 730357 Single Dose</title>
            <description>1 film-coated tablet (100 milligram) of BI 730357, administered as single oral dose with ~240 milliliter of water after an overnight fast of at least 10 hours.</description>
          </group>
          <group group_id="O3">
            <title>200 mg BI 730357 Single Dose</title>
            <description>2 film-coated tablets (100 milligram each) of BI 730357, administered as single oral dose with ~240 milliliter of water after an overnight fast of at least 10 hours.</description>
          </group>
        </group_list>
        <measure>
          <title>Area Under the Concentration-time Curve of BI 730357 in Plasma Over the Time Interval From 0 Extrapolated to Infinity</title>
          <description>Area under the concentration-time curve of BI 730357 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞).</description>
          <population>Pharmacokinetics analysis set (PKS): All subjects in the treated set (TS) who provided at least one PK endpoint that was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. Only participants with non-missing results are reported.</population>
          <units>Hours*Nanomoles per Litre (h*nmol/L)</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7160" spread="14.3"/>
                    <measurement group_id="O2" value="13000" spread="48.6"/>
                    <measurement group_id="O3" value="13200" spread="53.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Maximum Measured Concentration of BI 730357 in Plasma</title>
        <description>Maximum measured concentration of BI 730357 in plasma (Cmax).</description>
        <time_frame>Within 3 hours before drug administration and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 34, 48, 72, 96 and 168 hours after drug administration.</time_frame>
        <population>Pharmacokinetics analysis set (PKS): All subjects in the treated set (TS) who provided at least one PK endpoint that was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability.</population>
        <group_list>
          <group group_id="O1">
            <title>50 mg BI 730357 Single Dose</title>
            <description>1 film-coated tablet (50 milligram) of BI 730357, administered as single oral dose with ~240 milliliter of water after an overnight fast of at least 10 hours.</description>
          </group>
          <group group_id="O2">
            <title>100 mg BI 730357 Single Dose</title>
            <description>1 film-coated tablet (100 milligram) of BI 730357, administered as single oral dose with ~240 milliliter of water after an overnight fast of at least 10 hours.</description>
          </group>
          <group group_id="O3">
            <title>200 mg BI 730357 Single Dose</title>
            <description>2 film-coated tablets (100 milligram each) of BI 730357, administered as single oral dose with ~240 milliliter of water after an overnight fast of at least 10 hours.</description>
          </group>
        </group_list>
        <measure>
          <title>Maximum Measured Concentration of BI 730357 in Plasma</title>
          <description>Maximum measured concentration of BI 730357 in plasma (Cmax).</description>
          <population>Pharmacokinetics analysis set (PKS): All subjects in the treated set (TS) who provided at least one PK endpoint that was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability.</population>
          <units>Nanomoles per Litre (nmol/L)</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="346" spread="23.0"/>
                    <measurement group_id="O2" value="451" spread="34.8"/>
                    <measurement group_id="O3" value="515" spread="48.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>[Serious and Other Adverse Events]: Up to 7 days after drug administration. [All-cause mortality]: From drug administration until end of trial, up to 13 days.</time_frame>
      <desc>Adverse events are reported based on treated set (TS). This set included all subjects who were randomized and treated with at least 1 dose of trial drug. The TS was used for safety analyses.</desc>
      <group_list>
        <group group_id="E1">
          <title>Placebo</title>
          <description>Placebo film-coated tablet (1 for 50 milligram (mg) group, 1 for 100 mg group, 2 for 200 mg group), administered as single oral dose with ~240 milliliter of water after an overnight fast of at least 10 hours. Subjects receiving placebo were equally distributed across dose groups.</description>
        </group>
        <group group_id="E2">
          <title>50 mg BI 730357 Single Dose</title>
          <description>1 film-coated tablet (50 milligram) of BI 730357, administered as single oral dose with ~240 milliliter of water after an overnight fast of at least 10 hours.</description>
        </group>
        <group group_id="E3">
          <title>100 mg BI 730357 Single Dose</title>
          <description>1 film-coated tablet (100 milligram) of BI 730357, administered as single oral dose with ~240 milliliter of water after an overnight fast of at least 10 hours.</description>
        </group>
        <group group_id="E4">
          <title>200 mg BI 730357 Single Dose</title>
          <description>2 film-coated tablets (100 milligram each) of BI 730357, administered as single oral dose with ~240 milliliter of water after an overnight fast of at least 10 hours.</description>
        </group>
        <group group_id="E5">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 22.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Appendicitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Boehringer Ingelheim, Call Centre</name_or_title>
      <organization>Boehringer Ingelheim</organization>
      <phone>1-800-243-0127</phone>
      <email>clintriage.rdg@boehringer-ingelheim.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03793621
org study id: 1407-0015
nct id: NCT03793621
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The main objective of this trial is to investigate the safety and tolerability of BI 730357
      in Japanese healthy male subjects following oral administration of single rising doses.

      Secondary objectives are the explorations of the pharmacokinetic(s) (PK), including dose
      proportionality as well as investigation of linearity of BI 730357 after single dose
      administration.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Number of Participants With Drug-related Adverse Events
time frame: Up to 7 days after drug administration.
description: Number of participants with trial drug-related adverse events.
measure: Area Under the Concentration-time Curve of BI 730357 in Plasma Over the Time Interval From 0 Extrapolated to Infinity
time frame: Within 3 hours before drug administration and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 34, 48, 72, 96 and 168 hours after drug administration.
description: Area under the concentration-time curve of BI 730357 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞).
measure: Maximum Measured Concentration of BI 730357 in Plasma
time frame: Within 3 hours before drug administration and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 34, 48, 72, 96 and 168 hours after drug administration.
description: Maximum measured concentration of BI 730357 in plasma (Cmax).
arm group label: BI 730357
arm group type: Experimental
arm group label: Placebo
arm group type: Placebo Comparator
intervention type: Drug
intervention name: BI 730357
description: single rising oral dose
arm group label: BI 730357
intervention type: Drug
intervention name: Placebo
description: single rising oral dose
arm group label: Placebo
criteria: 
gender: Male
minimum age: 20 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Japan
url: https://www.mystudywindow.com
description: Related Info
responsible party type: Sponsor
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, except for the following exclusions:
1. studies in products where Boehringer Ingelheim is not the license holder; 2. studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; 3. studies conducted in a single center or targeting rare diseases (because of limitations with anonymization). For more details refer to: http://trials.boehringer-ingelheim.com/
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 