<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/NCT03302091</url>
  </required_header>
  <id_info>
    <org_study_id>1386-0002</org_study_id>
    <secondary_id>2017-002180-18</secondary_id>
    <nct_id>NCT03302091</nct_id>
  </id_info>
  <brief_title>A Study in People With Normal Kidney Function and People With Reduced Kidney Function to Test How BI 1467335 is Processed in the Body</brief_title>
  <official_title>Pharmacokinetics, Safety and Tolerability After Multiple Dose Administration of BI 1467335 in Subjects With Moderate Renal Impairment and Subjects With Normal Renal Function (a Mono-centric, Open-label Study in Matched-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 primary objective of the current study is to investigate the influence of moderate renal&#xD;
      impairment on the pharmacokinetics of multiple doses in comparison to a matched control group&#xD;
      with normal renal function.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 17, 2017</start_date>
  <completion_date type="Actual">August 16, 2018</completion_date>
  <primary_completion_date type="Actual">August 16, 2018</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel 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 BI 1467335 in Plasma Over the Time Interval From 0 to 24 Hours After Administration of the First Dose (AUC0-24)</measure>
    <time_frame>Pharmacokinetic (PK) samples were taken 2.00 hours (h) before dosing and 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00 and 23.917 h after dosing on day 1.</time_frame>
    <description>Area under the concentration-time curve of BI 1467335 in plasma over the time interval from 0 to 24 hours after administration of the first dose AUC 0-24.&#xD;
Standard Error presented is actually geometric Standard Error. PKS-stat including participants data for AUC(0-24). The pharmacokinetic (PK) analysis set (PKS) included all subjects in the TS who provided at least one PK parameter that was defined as primary or secondary endpoint and who were not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Maximum Measured Concentration of BI 1467335 in Plasma After Administration of the First Dose (Cmax)</measure>
    <time_frame>Pharmacokinetic (PK) samples were taken 2.00 h before dosing and 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00 and 23.917 h after dosing on day 1.</time_frame>
    <description>Maximum measured concentration of BI 1467335 in plasma after administration of the first dose (Cmax).&#xD;
Standard Error presented is actually geometric Standard Error.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Area Under the Concentration-time Curve of BI 1467335 in Plasma Over the Dosing Interval After Administration of the 28th Dose (AUCτ,28)</measure>
    <time_frame>Pharmacokinetic samples were taken 0.0833 h before last dose and 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00 and 24.00 h after dosing on day 28.</time_frame>
    <description>Area under the concentration-time curve of BI 1467335 in plasma over the dosing interval after administration of the 28th dose (AUCτ,28).&#xD;
Standard Error presented is actually geometric Standard Error. As per the protocol, day is counted as &quot;Day 1 = 0:00&quot;.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Maximum Measured Concentration of BI 1467335 in Plasma Following Administration of the 28th Dose (Cmax,28)</measure>
    <time_frame>Pharmacokinetic samples were taken 0.0833 h before last dose and 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00 and 24.00 h after dosing on day 28.</time_frame>
    <description>Maximum measured concentration of BI 1467335 in plasma following administration of the 28th dose (Cmax,28).&#xD;
Standard Error presented is actually geometric Standard Error. As per the protocol, day is counted as &quot;Day 1 = 0:00&quot;.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Area Under the Concentration-time Curve of BI 1467335 in Plasma Over the Dosing Interval After Administration of the 14th Dose (AUCτ,14)</measure>
    <time_frame>Pharmacokinetic samples were taken 0.0833 h before dosing and 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00 and 23.917 h after dosing on day 14.</time_frame>
    <description>Area under the concentration-time curve of BI 1467335 in plasma over the dosing interval after administration of the 14th dose (AUCτ,14).&#xD;
Standard Error presented is actually geometric Standard Error. As per the protocol, day is counted as &quot;Day 1 = 0:00&quot;.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum Measured Concentration of BI 1467335 in Plasma Following Administration of the 14th Dose (Cmax,14)</measure>
    <time_frame>Pharmacokinetic samples were taken 0.0833 h before dosing and 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00 and 23.917 h after dosing on day 14.</time_frame>
    <description>Maximum measured concentration of BI 1467335 in plasma following administration of the 14th dose (Cmax,14).&#xD;
Standard Error presented is actually geometric Standard Error. As per the protocol, day is counted as &quot;Day 1 = 0:00&quot;.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Renal Insufficiency</condition>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>BI 1467335 Normal (R)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants with normal renal function.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>BI 1467335 Moderate (T)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants with moderate renal impairment.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BI 1467335</intervention_name>
    <description>28 day treatment period</description>
    <arm_group_label>BI 1467335 Moderate (T)</arm_group_label>
    <arm_group_label>BI 1467335 Normal (R)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Despite of moderate renal impairment (Group 1) healthy male or female subjects&#xD;
             according to the assessment of the investigator, based on a complete medical history&#xD;
             including a physical examination, vital signs (Blood pressure (BP), Pulse rate (PR)),&#xD;
             12-lead Electrocardiogram (ECG), and clinical laboratory tests&#xD;
&#xD;
          -  Estimated glomerular filtration rate (eGFR) based on CKD-EPI formula for Group 1&#xD;
             between 30 and 59 mL/min/1.73m2 and for Group 2 ≥ 90 mL/min/1.73m2&#xD;
&#xD;
          -  Age of 18 to 79 years (incl.)&#xD;
&#xD;
          -  BMI of 18.5 to 34 kg/m2 (incl.)&#xD;
&#xD;
          -  Signed and dated written informed consent prior to admission to the study in&#xD;
             accordance with Good Clinical Practice (GCP) and local legislation&#xD;
&#xD;
          -  Male subjects, or female subjects who meet any of the following criteria (according to&#xD;
             the CTFG Recommendations related to contraception and pregnancy testing in clinical&#xD;
             trials, methods with a failure rate of less than 1% per year) starting from at least&#xD;
             30 days before the first administration of trial medication and until 30 days after&#xD;
             trial completion, e.g.:&#xD;
&#xD;
               -  Use of adequate contraception, e.g. any of the following methods plus condom:&#xD;
                  implants, injectables, combined oral or vaginal contraceptives (inhibition of&#xD;
                  ovulation)&#xD;
&#xD;
               -  Hormonal intrauterine device&#xD;
&#xD;
               -  Sexually abstinent (defined as refraining from heterosexual intercourse during&#xD;
                  the entire period of risk)&#xD;
&#xD;
               -  A vasectomised sexual partner (provided that vasectomy was performed at least 1&#xD;
                  year prior to enrolment and the vasectomised partner has received medical&#xD;
                  assessment of the surgical success)&#xD;
&#xD;
               -  Surgically sterilised (including bilateral tubal occlusion, hysterectomy)&#xD;
&#xD;
               -  Postmenopausal, defined as at least 1 year of spontaneous amenorrhea (in&#xD;
                  questionable cases a blood sample with simultaneous levels of FSH above 40 U/L&#xD;
                  and estradiol below 30 ng/L is confirmatory)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Healthy subjects&#xD;
&#xD;
          -  Any finding in the medical examination (including BP, PR or ECG) is deviating from&#xD;
             normal and judged as clinically 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 judged as clinically relevant by the&#xD;
             investigator&#xD;
&#xD;
          -  Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic,&#xD;
             immunological or hormonal disorders&#xD;
&#xD;
          -  Estimated glomerular filtration rate (eGFR) calculated by CKD-EPI formula &lt; 90&#xD;
             mL/min/1.73m2&#xD;
&#xD;
        Subjects with moderate renal impairment&#xD;
&#xD;
          -  Subject with significant diseases other than moderate renal impairment. A significant&#xD;
             disease is defined as a disease which in the opinion of the investigator:&#xD;
&#xD;
               -  puts the subjects at risk because of participation in the study&#xD;
&#xD;
               -  may influence the results of the study&#xD;
&#xD;
               -  may influence the subject's ability to participate in the study&#xD;
&#xD;
               -  is not in a stable condition Diabetic or hypertensive subjects can be entered in&#xD;
                  this trial if the disease is not significant according to these criteria.&#xD;
&#xD;
          -  Any finding of the medical examination (including BP, PR and ECG) of clinical&#xD;
             relevance&#xD;
&#xD;
          -  Moderate and severe concurrent liver function impairment (e.g. due to hepatorenal&#xD;
             syndrome) or biliary obstruction&#xD;
&#xD;
          -  Clinically relevant laboratory abnormalities (except for renal function tests or&#xD;
             deviation of clinical laboratory values that are related to renal impairment)&#xD;
&#xD;
          -  eGFR calculated by CKD-EPI formula ≥ 60 mL/min/1.73m2 and &lt; 30 mL/min/1.73m2&#xD;
&#xD;
        For all subjects&#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 (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;
          -  Chronic or relevant acute infections&#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 prior to administration of trial medication if that might&#xD;
             reasonably influence the results of the trial (incl. QT/QTc interval prolongation)&#xD;
&#xD;
          -  Participation in another trial where an investigational drug has been administered&#xD;
             within 30 days prior to planned administration of trial medication or longer if&#xD;
             required by local regulation, or within 5-half-lives of the investigational agent&#xD;
             taken (whichever is longer), or current participation in another trial involving&#xD;
             administration of investigational drug&#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 20 g per day for females and 30 g per day for&#xD;
             males)&#xD;
&#xD;
          -  Drug abuse or positive drug screening&#xD;
&#xD;
          -  Blood donation of more than 100 mL within 30 days 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 ms in males or repeatedly greater than 470 ms in females)&#xD;
             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;
&#xD;
        Female subjects will not be allowed to participate if any of the following applies:&#xD;
&#xD;
          -  Positive pregnancy test, pregnancy or plans to become pregnant within 30 days after&#xD;
             study completion&#xD;
&#xD;
          -  Lactation period&#xD;
&#xD;
        Male subjects will not be allowed to participate if any of the following applies:&#xD;
&#xD;
        - Male subjects with WOCBP partner who are unwilling to use male contraception (condom or&#xD;
        sexual abstinence) from the first administration of trial medication until 30 days after&#xD;
        last administration of trial medication&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>79 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>CRS Clinical Research Services Kiel GmbH</name>
      <address>
        <city>Kiel</city>
        <zip>24105</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <link>
    <url>http://www.mystudywindow.com</url>
    <description>Related Info</description>
  </link>
  <verification_date>May 2021</verification_date>
  <study_first_submitted>September 29, 2017</study_first_submitted>
  <study_first_submitted_qc>October 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 4, 2017</study_first_posted>
  <results_first_submitted>May 11, 2021</results_first_submitted>
  <results_first_submitted_qc>May 11, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">June 4, 2021</results_first_posted>
  <last_update_submitted>May 11, 2021</last_update_submitted>
  <last_update_submitted_qc>May 11, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">June 4, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Renal Insufficiency</mesh_term>
  </condition_browse>
  <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>March 15, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/91/NCT03302091/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>October 10, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/91/NCT03302091/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>This was open-label, multiple-dose and matched-group design. 20 participants entered (ten in each of the two groups). Participants with moderate renal impairment were assigned to the moderate group and individually matched participants with normal renal function were assigned to the normal group.</recruitment_details>
      <pre_assignment_details>All participants were screened for eligibility to participate in the trial. Participants attended a specialist site which would then ensure that they (the participants) met all strictly implemented inclusion/exclusion criteria. Participants were not to be assigned to treatment groups if any one of the specific entry criteria were violated.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>BI 1467335 Normal (R)</title>
          <description>Participants with normal renal function were administered 10 milligram (mg) (5 mg X2) BI 1467335 film coated tablet orally with 240 milliliter (mL) water after an overnight fast of at least 10 hour (h) once daily over 28 days.</description>
        </group>
        <group group_id="P2">
          <title>BI 1467335 Moderate (T)</title>
          <description>Participants with moderate renal impairment were administered 10 milligram (mg) (5 mg X2) BI 1467335 film coated tablet orally with 240 milliliter (mL) water after an overnight fast of at least 10 hour (h) once daily over 28 days.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
                <participants group_id="P2" count="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
                <participants group_id="P2" count="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Treated Set (TS): The TS included all subjects who were documented to have taken at least one dose of trial medication. This is the full analysis set population in the sense of International council for harmonisation - efficacy guideline 9: statistical principles for clinical trials (ICH-E9).</population>
      <group_list>
        <group group_id="B1">
          <title>BI 1467335 Normal (R)</title>
          <description>Participants with normal renal function were administered 10 milligram (mg) (5 mg X2) BI 1467335 film coated tablet orally with 240 milliliter (mL) water after an overnight fast of at least 10 hour (h) once daily over 28 days.</description>
        </group>
        <group group_id="B2">
          <title>BI 1467335 Moderate (T)</title>
          <description>Participants with moderate renal impairment were administered 10 milligram (mg) (5 mg X2) BI 1467335 film coated tablet orally with 240 milliliter (mL) water after an overnight fast of at least 10 hour (h) once daily over 28 days.</description>
        </group>
        <group group_id="B3">
          <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="10"/>
            <count group_id="B2" value="10"/>
            <count group_id="B3" value="20"/>
          </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="67.5" spread="9.5"/>
                    <measurement group_id="B2" value="68.7" spread="10.9"/>
                    <measurement group_id="B3" value="68.1" spread="10.0"/>
                  </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="4"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="8"/>
                  </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="12"/>
                  </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_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="20"/>
                  </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_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_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </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_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_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="20"/>
                  </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_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_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Area Under the Concentration-time Curve of BI 1467335 in Plasma Over the Time Interval From 0 to 24 Hours After Administration of the First Dose (AUC0-24)</title>
        <description>Area under the concentration-time curve of BI 1467335 in plasma over the time interval from 0 to 24 hours after administration of the first dose AUC 0-24.&#xD;
Standard Error presented is actually geometric Standard Error. PKS-stat including participants data for AUC(0-24). The pharmacokinetic (PK) analysis set (PKS) included all subjects in the TS who provided at least one PK parameter that was defined as primary or secondary endpoint and who were not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability.</description>
        <time_frame>Pharmacokinetic (PK) samples were taken 2.00 hours (h) before dosing and 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00 and 23.917 h after dosing on day 1.</time_frame>
        <population>PK statistical analysis set (PKS-stat) included all subjects from PK set who built a subject pair of renally impaired subject and her/his matching healthy volunteer control and provided at least one primary or secondary PK parameter and who were 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>BI 1467335 Normal (R)</title>
            <description>Participants with normal renal function were administered 10 milligram (mg) (5 mg X2) BI 1467335 film coated tablet orally with 240 milliliter (mL) water after an overnight fast of at least 10 hour (h) once daily over 28 days.</description>
          </group>
          <group group_id="O2">
            <title>BI 1467335 Moderate (T)</title>
            <description>Participants with moderate renal impairment were administered 10 milligram (mg) (5 mg X2) BI 1467335 film coated tablet orally with 240 milliliter (mL) water after an overnight fast of at least 10 hour (h) once daily over 28 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Area Under the Concentration-time Curve of BI 1467335 in Plasma Over the Time Interval From 0 to 24 Hours After Administration of the First Dose (AUC0-24)</title>
          <description>Area under the concentration-time curve of BI 1467335 in plasma over the time interval from 0 to 24 hours after administration of the first dose AUC 0-24.&#xD;
Standard Error presented is actually geometric Standard Error. PKS-stat including participants data for AUC(0-24). The pharmacokinetic (PK) analysis set (PKS) included all subjects in the TS who provided at least one PK parameter that was defined as primary or secondary endpoint and who were not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability.</description>
          <population>PK statistical analysis set (PKS-stat) included all subjects from PK set who built a subject pair of renally impaired subject and her/his matching healthy volunteer control and provided at least one primary or secondary PK parameter and who were not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability.</population>
          <units>nanomole*hour/Liter (nmol*h/L)</units>
          <param>Geometric Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.97" spread="1.31"/>
                    <measurement group_id="O2" value="7.88" spread="1.31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The statistical model used for the analyses of the primary endpoints was an ANOVA (analysis of variance) model on the logarithmic scale including the effect &quot;degree of renal impairment&quot; as a fixed effect as well as subject pair as a random effect.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Adjusted gMean ratio (T/R)%</param_type>
            <param_value>198.50</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>96.5</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>101.83</ci_lower_limit>
            <ci_upper_limit>386.94</ci_upper_limit>
            <estimate_desc>Standard deviation is actually intra individual geometric coefficient of variation (%).</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Maximum Measured Concentration of BI 1467335 in Plasma After Administration of the First Dose (Cmax)</title>
        <description>Maximum measured concentration of BI 1467335 in plasma after administration of the first dose (Cmax).&#xD;
Standard Error presented is actually geometric Standard Error.</description>
        <time_frame>Pharmacokinetic (PK) samples were taken 2.00 h before dosing and 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00 and 23.917 h after dosing on day 1.</time_frame>
        <population>PK statistical analysis set (PKS-stat) included all subjects from PK set who built a subject pair of renally impaired subject and her/his matching healthy volunteer control and provided at least one primary or secondary PK parameter and who were 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>BI 1467335 Normal (R)</title>
            <description>Participants with normal renal function were administered 10 milligram (mg) (5 mg X2) BI 1467335 film coated tablet orally with 240 milliliter (mL) water after an overnight fast of at least 10 hour (h) once daily over 28 days.</description>
          </group>
          <group group_id="O2">
            <title>BI 1467335 Moderate (T)</title>
            <description>Participants with moderate renal impairment were administered 10 milligram (mg) (5 mg X2) BI 1467335 film coated tablet orally with 240 milliliter (mL) water after an overnight fast of at least 10 hour (h) once daily over 28 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Maximum Measured Concentration of BI 1467335 in Plasma After Administration of the First Dose (Cmax)</title>
          <description>Maximum measured concentration of BI 1467335 in plasma after administration of the first dose (Cmax).&#xD;
Standard Error presented is actually geometric Standard Error.</description>
          <population>PK statistical analysis set (PKS-stat) included all subjects from PK set who built a subject pair of renally impaired subject and her/his matching healthy volunteer control and provided at least one primary or secondary PK parameter and who were not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability.</population>
          <units>nanomole/Liter (nmol/L)</units>
          <param>Geometric Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
                <count group_id="O2" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.03" spread="1.24"/>
                    <measurement group_id="O2" value="6.01" spread="1.24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The statistical model used for the analyses of the primary endpoints was an ANOVA (analysis of variance) model on the logarithmic scale including the effect &quot;degree of renal impairment&quot; as a fixed effect as well as subject pair as a random effect.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Adjusted gMean ratio (T/R)%</param_type>
            <param_value>198.42</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>77.5</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>116.56</ci_lower_limit>
            <ci_upper_limit>337.78</ci_upper_limit>
            <estimate_desc>Standard deviation is actually intra individual geometric coefficient of variation (%).</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Area Under the Concentration-time Curve of BI 1467335 in Plasma Over the Dosing Interval After Administration of the 28th Dose (AUCτ,28)</title>
        <description>Area under the concentration-time curve of BI 1467335 in plasma over the dosing interval after administration of the 28th dose (AUCτ,28).&#xD;
Standard Error presented is actually geometric Standard Error. As per the protocol, day is counted as &quot;Day 1 = 0:00&quot;.</description>
        <time_frame>Pharmacokinetic samples were taken 0.0833 h before last dose and 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00 and 24.00 h after dosing on day 28.</time_frame>
        <population>PK statistical analysis set (PKS-stat) included all subjects from PK set who built a subject pair of renally impaired subject and her/his matching healthy volunteer control and provided at least one primary or secondary PK parameter and who were 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>BI 1467335 Normal (R)</title>
            <description>Participants with normal renal function were administered 10 milligram (mg) (5 mg X2) BI 1467335 film coated tablet orally with 240 milliliter (mL) water after an overnight fast of at least 10 hour (h) once daily over 28 days.</description>
          </group>
          <group group_id="O2">
            <title>BI 1467335 Moderate (T)</title>
            <description>Participants with moderate renal impairment were administered 10 milligram (mg) (5 mg X2) BI 1467335 film coated tablet orally with 240 milliliter (mL) water after an overnight fast of at least 10 hour (h) once daily over 28 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Area Under the Concentration-time Curve of BI 1467335 in Plasma Over the Dosing Interval After Administration of the 28th Dose (AUCτ,28)</title>
          <description>Area under the concentration-time curve of BI 1467335 in plasma over the dosing interval after administration of the 28th dose (AUCτ,28).&#xD;
Standard Error presented is actually geometric Standard Error. As per the protocol, day is counted as &quot;Day 1 = 0:00&quot;.</description>
          <population>PK statistical analysis set (PKS-stat) included all subjects from PK set who built a subject pair of renally impaired subject and her/his matching healthy volunteer control and provided at least one primary or secondary PK parameter and who were not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability.</population>
          <units>nanomole*hours/Liter (nmol*h/L)</units>
          <param>Geometric Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
                <count group_id="O2" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="692.42" spread="1.23"/>
                    <measurement group_id="O2" value="1566.88" spread="1.23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The statistical model used for the analyses of the primary endpoints was an ANOVA (analysis of variance) model on the logarithmic scale including the effect &quot;degree of renal impairment&quot; as a fixed effect as well as subject pair as a random effect.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Adjusted gMean ratio (T/R)%</param_type>
            <param_value>226.29</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>47.5</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>156.35</ci_lower_limit>
            <ci_upper_limit>327.53</ci_upper_limit>
            <estimate_desc>Standard deviation is actually intra individual geometric coefficient of variation (%).</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Maximum Measured Concentration of BI 1467335 in Plasma Following Administration of the 28th Dose (Cmax,28)</title>
        <description>Maximum measured concentration of BI 1467335 in plasma following administration of the 28th dose (Cmax,28).&#xD;
Standard Error presented is actually geometric Standard Error. As per the protocol, day is counted as &quot;Day 1 = 0:00&quot;.</description>
        <time_frame>Pharmacokinetic samples were taken 0.0833 h before last dose and 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00 and 24.00 h after dosing on day 28.</time_frame>
        <population>PK statistical analysis set (PKS-stat) included all subjects from PK set who built a subject pair of renally impaired subject and her/his matching healthy volunteer control and provided at least one primary or secondary PK parameter and who were 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>BI 1467335 Normal (R)</title>
            <description>Participants with normal renal function were administered 10 milligram (mg) (5 mg X2) BI 1467335 film coated tablet orally with 240 milliliter (mL) water after an overnight fast of at least 10 hour (h) once daily over 28 days.</description>
          </group>
          <group group_id="O2">
            <title>BI 1467335 Moderate (T)</title>
            <description>Participants with moderate renal impairment were administered 10 milligram (mg) (5 mg X2) BI 1467335 film coated tablet orally with 240 milliliter (mL) water after an overnight fast of at least 10 hour (h) once daily over 28 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Maximum Measured Concentration of BI 1467335 in Plasma Following Administration of the 28th Dose (Cmax,28)</title>
          <description>Maximum measured concentration of BI 1467335 in plasma following administration of the 28th dose (Cmax,28).&#xD;
Standard Error presented is actually geometric Standard Error. As per the protocol, day is counted as &quot;Day 1 = 0:00&quot;.</description>
          <population>PK statistical analysis set (PKS-stat) included all subjects from PK set who built a subject pair of renally impaired subject and her/his matching healthy volunteer control and provided at least one primary or secondary PK parameter and who were not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability.</population>
          <units>nanomole/Liter (nmol/L)</units>
          <param>Geometric Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
                <count group_id="O2" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100.57" spread="1.13"/>
                    <measurement group_id="O2" value="141.20" spread="1.13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The statistical model used for the analyses of the primary endpoints was an ANOVA (analysis of variance) model on the logarithmic scale including the effect &quot;degree of renal impairment&quot; as a fixed effect as well as subject pair as a random effect.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Adjusted gMean ratio (T/R)%</param_type>
            <param_value>140.40</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>32.8</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>108.06</ci_lower_limit>
            <ci_upper_limit>182.43</ci_upper_limit>
            <estimate_desc>Standard deviation is actually intra individual geometric coefficient of variation (%).</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Area Under the Concentration-time Curve of BI 1467335 in Plasma Over the Dosing Interval After Administration of the 14th Dose (AUCτ,14)</title>
        <description>Area under the concentration-time curve of BI 1467335 in plasma over the dosing interval after administration of the 14th dose (AUCτ,14).&#xD;
Standard Error presented is actually geometric Standard Error. As per the protocol, day is counted as &quot;Day 1 = 0:00&quot;.</description>
        <time_frame>Pharmacokinetic samples were taken 0.0833 h before dosing and 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00 and 23.917 h after dosing on day 14.</time_frame>
        <population>PK statistical analysis set (PKS-stat) included all subjects from PK set who built a subject pair of renally impaired subject and her/his matching healthy volunteer control and provided at least one primary or secondary PK parameter and who were 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>BI 1467335 Normal (R)</title>
            <description>Participants with normal renal function were administered 10 milligram (mg) (5 mg X2) BI 1467335 film coated tablet orally with 240 milliliter (mL) water after an overnight fast of at least 10 hour (h) once daily over 28 days.</description>
          </group>
          <group group_id="O2">
            <title>BI 1467335 Moderate (T)</title>
            <description>Participants with moderate renal impairment were administered 10 milligram (mg) (5 mg X2) BI 1467335 film coated tablet orally with 240 milliliter (mL) water after an overnight fast of at least 10 hour (h) once daily over 28 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Area Under the Concentration-time Curve of BI 1467335 in Plasma Over the Dosing Interval After Administration of the 14th Dose (AUCτ,14)</title>
          <description>Area under the concentration-time curve of BI 1467335 in plasma over the dosing interval after administration of the 14th dose (AUCτ,14).&#xD;
Standard Error presented is actually geometric Standard Error. As per the protocol, day is counted as &quot;Day 1 = 0:00&quot;.</description>
          <population>PK statistical analysis set (PKS-stat) included all subjects from PK set who built a subject pair of renally impaired subject and her/his matching healthy volunteer control and provided at least one primary or secondary PK parameter and who were not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability.</population>
          <units>nanomole*hour/Liter (nmol*h/L)</units>
          <param>Geometric Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
                <count group_id="O2" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="321.23" spread="1.34"/>
                    <measurement group_id="O2" value="532.06" spread="1.34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The statistical model used for the analyses of the primary endpoints was an ANOVA (analysis of variance) model on the logarithmic scale including the effect &quot;degree of renal impairment&quot; as a fixed effect as well as subject pair as a random effect.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Adjusted gMean ratio (T/R)%</param_type>
            <param_value>165.63</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>56.6</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>107.51</ci_lower_limit>
            <ci_upper_limit>255.17</ci_upper_limit>
            <estimate_desc>Standard deviation is actually intra individual geometric coefficient of variation (%).</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Maximum Measured Concentration of BI 1467335 in Plasma Following Administration of the 14th Dose (Cmax,14)</title>
        <description>Maximum measured concentration of BI 1467335 in plasma following administration of the 14th dose (Cmax,14).&#xD;
Standard Error presented is actually geometric Standard Error. As per the protocol, day is counted as &quot;Day 1 = 0:00&quot;.</description>
        <time_frame>Pharmacokinetic samples were taken 0.0833 h before dosing and 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00 and 23.917 h after dosing on day 14.</time_frame>
        <population>PK statistical analysis set (PKS-stat) included all subjects from PK set who built a subject pair of renally impaired subject and her/his matching healthy volunteer control and provided at least one primary or secondary PK parameter and who were 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>BI 1467335 Normal (R)</title>
            <description>Participants with normal renal function were administered 10 milligram (mg) (5 mg X2) BI 1467335 film coated tablet orally with 240 milliliter (mL) water after an overnight fast of at least 10 hour (h) once daily over 28 days.</description>
          </group>
          <group group_id="O2">
            <title>BI 1467335 Moderate (T)</title>
            <description>Participants with moderate renal impairment were administered 10 milligram (mg) (5 mg X2) BI 1467335 film coated tablet orally with 240 milliliter (mL) water after an overnight fast of at least 10 hour (h) once daily over 28 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Maximum Measured Concentration of BI 1467335 in Plasma Following Administration of the 14th Dose (Cmax,14)</title>
          <description>Maximum measured concentration of BI 1467335 in plasma following administration of the 14th dose (Cmax,14).&#xD;
Standard Error presented is actually geometric Standard Error. As per the protocol, day is counted as &quot;Day 1 = 0:00&quot;.</description>
          <population>PK statistical analysis set (PKS-stat) included all subjects from PK set who built a subject pair of renally impaired subject and her/his matching healthy volunteer control and provided at least one primary or secondary PK parameter and who were not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability.</population>
          <units>nanomole/Liter (nmol/L)</units>
          <param>Geometric Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
                <count group_id="O2" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="73.41" spread="1.16"/>
                    <measurement group_id="O2" value="94.28" spread="1.16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The statistical model used for the analyses of the primary endpoints was an ANOVA (analysis of variance) model on the logarithmic scale including the effect &quot;degree of renal impairment&quot; as a fixed effect as well as subject pair as a random effect.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Adjusted gMean ratio (T/R)%</param_type>
            <param_value>128.44</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>31.7</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>99.64</ci_lower_limit>
            <ci_upper_limit>165.57</ci_upper_limit>
            <estimate_desc>Standard deviation is actually intra individual geometric coefficient of variation (%).</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From first day of study drug administration until End of trial (EOT), up to 41 days.</time_frame>
      <desc>The treated set (TS) included all subjects who were documented to have taken at least one dose of trial medication. This is the full analysis set population in the sense of ICH-E9.</desc>
      <group_list>
        <group group_id="E1">
          <title>BI 1467335 Normal (R)</title>
          <description>Participants with normal renal function were administered 10 milligram (mg) (5 mg X2) BI 1467335 film coated tablet orally with 240 milliliter (mL) water after an overnight fast of at least 10 hour (h) once daily over 28 days.</description>
        </group>
        <group group_id="E2">
          <title>BI 1467335 Moderate (T)</title>
          <description>Participants with moderate renal impairment were administered 10 milligram (mg) (5 mg X2) BI 1467335 film coated tablet orally with 240 milliliter (mL) water after an overnight fast of at least 10 hour (h) once daily over 28 days.</description>
        </group>
      </group_list>
      <serious_events>
        <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="10"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 21.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="10"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Rash pruritic</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </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 Center</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/NCT03302091
org study id: 1386-0002
secondary id: 2017-002180-18
nct id: NCT03302091
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The primary objective of the current study is to investigate the influence of moderate renal
      impairment on the pharmacokinetics of multiple doses in comparison to a matched control group
      with normal renal function.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Area Under the Concentration-time Curve of BI 1467335 in Plasma Over the Time Interval From 0 to 24 Hours After Administration of the First Dose (AUC0-24)
time frame: Pharmacokinetic (PK) samples were taken 2.00 hours (h) before dosing and 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00 and 23.917 h after dosing on day 1.
description: Area under the concentration-time curve of BI 1467335 in plasma over the time interval from 0 to 24 hours after administration of the first dose AUC 0-24.
Standard Error presented is actually geometric Standard Error. PKS-stat including participants data for AUC(0-24). The pharmacokinetic (PK) analysis set (PKS) included all subjects in the TS who provided at least one PK parameter that was defined as primary or secondary endpoint and who were not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability.
measure: Maximum Measured Concentration of BI 1467335 in Plasma After Administration of the First Dose (Cmax)
time frame: Pharmacokinetic (PK) samples were taken 2.00 h before dosing and 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00 and 23.917 h after dosing on day 1.
description: Maximum measured concentration of BI 1467335 in plasma after administration of the first dose (Cmax).
Standard Error presented is actually geometric Standard Error.
measure: Area Under the Concentration-time Curve of BI 1467335 in Plasma Over the Dosing Interval After Administration of the 28th Dose (AUCτ,28)
time frame: Pharmacokinetic samples were taken 0.0833 h before last dose and 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00 and 24.00 h after dosing on day 28.
description: Area under the concentration-time curve of BI 1467335 in plasma over the dosing interval after administration of the 28th dose (AUCτ,28).
Standard Error presented is actually geometric Standard Error. As per the protocol, day is counted as "Day 1 = 0:00".
measure: Maximum Measured Concentration of BI 1467335 in Plasma Following Administration of the 28th Dose (Cmax,28)
time frame: Pharmacokinetic samples were taken 0.0833 h before last dose and 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00 and 24.00 h after dosing on day 28.
description: Maximum measured concentration of BI 1467335 in plasma following administration of the 28th dose (Cmax,28).
Standard Error presented is actually geometric Standard Error. As per the protocol, day is counted as "Day 1 = 0:00".
measure: Area Under the Concentration-time Curve of BI 1467335 in Plasma Over the Dosing Interval After Administration of the 14th Dose (AUCτ,14)
time frame: Pharmacokinetic samples were taken 0.0833 h before dosing and 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00 and 23.917 h after dosing on day 14.
description: Area under the concentration-time curve of BI 1467335 in plasma over the dosing interval after administration of the 14th dose (AUCτ,14).
Standard Error presented is actually geometric Standard Error. As per the protocol, day is counted as "Day 1 = 0:00".
measure: Maximum Measured Concentration of BI 1467335 in Plasma Following Administration of the 14th Dose (Cmax,14)
time frame: Pharmacokinetic samples were taken 0.0833 h before dosing and 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00 and 23.917 h after dosing on day 14.
description: Maximum measured concentration of BI 1467335 in plasma following administration of the 14th dose (Cmax,14).
Standard Error presented is actually geometric Standard Error. As per the protocol, day is counted as "Day 1 = 0:00".
arm group label: BI 1467335 Normal (R)
arm group type: Experimental
description: Participants with normal renal function.
arm group label: BI 1467335 Moderate (T)
arm group type: Experimental
description: Participants with moderate renal impairment.
intervention type: Drug
intervention name: BI 1467335
description: 28 day treatment period
arm group label: BI 1467335 Moderate (T)
arm group label: BI 1467335 Normal (R)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 79 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Germany
url: http://www.mystudywindow.com
description: Related Info
responsible party type: Sponsor
mesh term: Renal Insufficiency
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 