<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/NCT02976519</url>
  </required_header>
  <id_info>
    <org_study_id>1363.2</org_study_id>
    <secondary_id>2016-001504-31</secondary_id>
    <nct_id>NCT02976519</nct_id>
  </id_info>
  <brief_title>BI 443651 Multiple Rising Dose in Healthy Volunteers Followed by a Cross-over in CF Subjects</brief_title>
  <official_title>A Phase Ib, Multicentre, Double Blind, Randomized, Two-part Study, First Part Multiple Rising Dose and Second Part Two-way Cross-over, to Assess Safety, Tolerability, Efficacy and Pharmacokinetics of BI 443651 Compared to Placebo Via Respimat® in Healthy Volunteers and CF Subjects.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boehringer Ingelheim</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boehringer Ingelheim</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this study is to investigate the safety, tolerability, and pharmacokinetics&#xD;
      of BI 443651 in male and female healthy volunteers and subjects with Cystic Fibrosis (CF).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 15, 2017</start_date>
  <completion_date type="Actual">August 29, 2018</completion_date>
  <primary_completion_date type="Actual">August 29, 2018</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>Percentage of Participants With Treatment-emergent Adverse Events (TEAE) Over the Treatment Period in Part 1 and Part 2</measure>
    <time_frame>Up to 44 days (for Part 1) or 51 days (for Part 2) (Please check the measure description for detailed timeframe)</time_frame>
    <description>Percentage of participants with treatment-emergent adverse events (TEAE) over the treatment period in Part 1 and Part 2. For Part 1: From the first dose of study medication up to 30 days after the day of last intake of study medication, up to 44 days. For Part 2: From the first dose of study medication up to 30 days after the day of last intake of study medication, up to 51 days.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Maximum Measured Concentration of the BI 443651 in Plasma After the Administration of the First Dose (Cmax) on Day 1 and Over the Time Interval From 0 to 12 h After the 13th Dose (Cmax,13) on Day 7, in Part 1</measure>
    <time_frame>Day 1 and Day 7 (Please check the measure description for detailed timeframe)</time_frame>
    <description>Maximum measured concentration of the BI 443651 in plasma after the administration of the first dose (Cmax) on day 1 and over the time interval from 0 to 12 h after the 13th dose (Cmax,13) on day 7, in Part 1. Pharmacokinetic samples were collected at 00:15 hours:minutes (h:m) pre-dose and at 00:15, 00:30, 00:45, 1:00, 2:00, 4:00, 6:00, 8:00 and 11:45 h:m after first drug administration on day 1 (for Cmax) and after last drug administration on day 7 (for Cmax,13).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area Under the Concentration-time Curve of the BI 443651 in Plasma Over the Time Interval From 0 to 12 Hours After the Administration of the First Dose (AUC0-12) on Day 1 and After the 13th Dose (AUC0-12,13) on Day 7 in Part 1</measure>
    <time_frame>Day 1 and Day 7 (Please check the measure description for detailed timeframe)</time_frame>
    <description>Area under the concentration-time curve of the BI 443651 in plasma over the time interval from 0 to 12 hours (h) after the administration of the first dose (AUC0-12) on day 1 and after the 13th dose (AUC0-12,13) on day 7 in Part 1. Pharmacokinetic samples were collected at 00:15 h:m pre-dose and at 00:15, 00:30, 00:45, 1:00, 2:00, 4:00, 6:00, 8:00 and 11:45 h:m after first drug administration on day 1 (for AUC0-12) and after last drug administration on day 7 (for AUC0-12,13).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">64</enrollment>
  <condition>Cystic Fibrosis</condition>
  <arm_group>
    <arm_group_label>BI 443651</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 443651</intervention_name>
    <description>twice daily</description>
    <arm_group_label>BI 443651</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>twice daily</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
        Healthy volunteers:&#xD;
&#xD;
          -  Signed informed consent&#xD;
&#xD;
          -  Healthy male or female subjects&#xD;
&#xD;
          -  - Women of childbearing potential (WOCBP) should only be dosed after a confirmed&#xD;
             menstrual period and/or with a progesterone level at Day -5 to Day -3 that&#xD;
             demonstrates a dip from baseline, indicating a menstrual bleed prior to dosing.&#xD;
&#xD;
          -  Age of 18 to 55 years (incl.)&#xD;
&#xD;
          -  Body mass index (BMI) of 18.5 to 32.0 kg/m2 (incl.)&#xD;
&#xD;
          -  Forced expiratory volume in 1 second (FEV1) and forced vital capacity (FVC) of equal&#xD;
             or greater than 80% of predicted normal, at screening and prior to randomisation&#xD;
&#xD;
        Cystic Fibrosis (Cross over part):&#xD;
&#xD;
          -  Signed informed consent&#xD;
&#xD;
          -  Males or females with a documented diagnosis of cystic fibrosis&#xD;
&#xD;
          -  Women of childbearing potential (WOCBP) should only be dosed after a confirmed&#xD;
             menstrual period and/or with a progesterone level at Day -5 to Day -3, that&#xD;
             demonstrates a dip from baseline, indicating a menstrual bleed prior to dosing. For CF&#xD;
             subjects of child bearing potential this must confirmed prior to second treatment&#xD;
             period.&#xD;
&#xD;
          -  Age 18 to 55 years (each inclusive)&#xD;
&#xD;
          -  BMI of 18 to 32.0 kg/m2 (incl.)&#xD;
&#xD;
          -  Pre-bronchodilator FEV1 &gt;/= to 70% of predicted normal at screening and prior to&#xD;
             randomisation&#xD;
&#xD;
          -  Clinical stability as defined by no evidence of acute upper or lower respiratory tract&#xD;
             infection; no pulmonary exacerbation requiring use of i.v. / oral / inhaled&#xD;
             antibiotics, or oral corticosteroids; no change in pulmonary disease therapy; if on&#xD;
             cycling antibiotics, these must be initiated within 2 weeks prior to randomisation; no&#xD;
             acute (serious or non-serious) illness not related to cystic fibrosis; no infection&#xD;
             with an organism associated with more rapid decline in pulmonary function (eg,&#xD;
             Burkholderia cenocepacia, B dolosa, or Mycobacterium abscessus).&#xD;
&#xD;
          -  Able to perform technically acceptable pulmonary functions test (PFTs)&#xD;
&#xD;
          -  Further inclusion criteria apply.&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  Any evidence of a concomitant disease judged as clinically relevant by the&#xD;
             investigator including gastrointestinal, hepatic, renal, respiratory, cardiovascular,&#xD;
             metabolic, immunological, dermatologic, hematologic, neurological and psychiatric,&#xD;
             oncological, coagulation or hormonal disorders as determined by medical history,&#xD;
             examination, and clinical investigations at screening that may, in the opinion of the&#xD;
             investigator, result in any of the following:&#xD;
&#xD;
               -  Put the subject at risk because of participation in the study.&#xD;
&#xD;
               -  Influence the results of the study.&#xD;
&#xD;
               -  Cast doubt on the subject's ability to participate in the study.&#xD;
&#xD;
          -  Chronic or relevant acute infections.&#xD;
&#xD;
          -  History of relevant orthostatic hypotension, fainting spells, or blackouts&#xD;
&#xD;
          -  History of myocardial infarction; history of acute coronary syndrome&#xD;
&#xD;
          -  History of and/or active life-threatening cardiac arrhythmia, as assessed by the&#xD;
             investigator&#xD;
&#xD;
          -  Major surgery (major according to the investigator's assessment)&#xD;
&#xD;
          -  History of chronic kidney disease (estimate glomerular filtration rate (EGFR) &lt;59&#xD;
             mls/min including corrections as per ethnicity)&#xD;
&#xD;
          -  History of relevant allergy or hypersensitivity (including allergy to the trial&#xD;
             medication or its excipients)&#xD;
&#xD;
          -  Unsuitable veins for venipuncture (for instance, veins which are difficult to locate,&#xD;
             access or puncture, veins with a tendency to rupture during or after puncture) as&#xD;
             assessed by the investigator&#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;
          -  Any laboratory value outside the reference range that the investigator considers to be&#xD;
             of clinical relevance, specifically volunteers with serum potassium &gt; upper limit of&#xD;
             normal should be excluded; Safety laboratory screening and Day -7 to Day -3,&#xD;
             evaluation can be repeated twice during screening.&#xD;
&#xD;
          -  For healthy volunteers, repeated measurement (i.e. &gt; 2 measurements) of systolic blood&#xD;
             pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the&#xD;
             range of 50 to 90 mmHg. Volunteers will be excluded with a pulse rate outside the&#xD;
             range of 45 to 90 bpm.&#xD;
&#xD;
          -  A marked baseline prolongation of mean QT/QTcF interval (such as QTcF intervals that&#xD;
             are repeatedly greater than 450 ms in males or repeatedly greater than 470 ms in&#xD;
             females) or any other relevant ECG finding at screening or prior to randomisation&#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;
          -  Within 10 days prior to administration of trial medication, use of drugs that might&#xD;
             reasonably influence the results of the trial or that might prolong the QT/QTcF&#xD;
             interval&#xD;
&#xD;
          -  Intake of drugs with a long half-life (more than 24hrs) within 30 days or less than 10&#xD;
             half-lives of the respective drug prior to administration of trial medication unless&#xD;
             this is allowed medications.&#xD;
&#xD;
          -  CF subjects treated with non-permitted concomitant medication. Specifically&#xD;
             medications causing changes in serum potassium are restricted&#xD;
&#xD;
          -  Current or previous participation in another interventional trial, including where an&#xD;
             investigational drug has been or will be administered within 60 days or 5 half-lives&#xD;
             (whichever is longer) prior to screening&#xD;
&#xD;
          -  For healthy volunteers and CF subjects: current smokers or ex-smokers of less than 12&#xD;
             months and/or with a pack year history of more than 5 years&#xD;
&#xD;
          -  Further exclusion criteria apply&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Boehringer Ingelheim</last_name>
    <role>Study Chair</role>
    <affiliation>Boehringer Ingelheim</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Charité - Universitätsmedizin Berlin</name>
      <address>
        <city>Berlin</city>
        <zip>13353</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IKF Pneumologie GmbH &amp; Co. KG</name>
      <address>
        <city>Frankfurt</city>
        <zip>60596</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lungenärztliche Praxis</name>
      <address>
        <city>München-Pasing</city>
        <zip>81241</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Celerion Inc</name>
      <address>
        <city>Belfast</city>
        <zip>BT9 6AD</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Medicines Evaluation Unit</name>
      <address>
        <city>Manchester</city>
        <zip>M23 9QZ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
    <country>United Kingdom</country>
  </location_countries>
  <link>
    <url>http://trials.boehringer-ingelheim.com/</url>
    <description>Related Info</description>
  </link>
  <verification_date>November 2019</verification_date>
  <study_first_submitted>November 25, 2016</study_first_submitted>
  <study_first_submitted_qc>November 25, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 29, 2016</study_first_posted>
  <results_first_submitted>November 7, 2019</results_first_submitted>
  <results_first_submitted_qc>November 7, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">November 27, 2019</results_first_posted>
  <last_update_submitted>November 7, 2019</last_update_submitted>
  <last_update_submitted_qc>November 7, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">November 27, 2019</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>Cystic Fibrosis</mesh_term>
  </condition_browse>
  <provided_document_section>
    <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>September 18, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/19/NCT02976519/SAP_000.pdf</document_url>
    </provided_document>
    <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>November 9, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/19/NCT02976519/Prot_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>The trial was conducted in 2 parts. The first part was a multiple rising dose (MRD) trial in healthy participants. The second part followed a cross-over design with respect to placebo and BI 443651 treatment in participants with cystic fibrosis. Both parts were randomised, placebo-controlled, and double-blinded.</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 they (all participants) met all inclusion/exclusion criteria. Participants were not to be randomized to trial treatment if any one of the specific entry criteria were not met.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Placebo Matching BI 443651</title>
          <description>Healthy participants were treated with placebo matching to BI 443651 via Respimat® inhaler twice daily for 6.5 days in Part 1.</description>
        </group>
        <group group_id="P2">
          <title>BI 443651 100 Microgram (μg)</title>
          <description>Healthy participants were treated with BI 443651 100 μg dose via Respimat® inhaler twice daily for 6.5 days in Part 1.</description>
        </group>
        <group group_id="P3">
          <title>BI 443651 400 μg</title>
          <description>Healthy participants were treated with BI 443651 400 μg dose via Respimat® inhaler twice daily for 6.5 days in Part 1.</description>
        </group>
        <group group_id="P4">
          <title>BI 443651 1200 μg</title>
          <description>Healthy participants were treated with BI 443651 1200 μg dose via Respimat® inhaler twice daily for 6.5 days in Part 1.</description>
        </group>
        <group group_id="P5">
          <title>BI 443651 1800 μg</title>
          <description>Healthy participants were treated with BI 443651 1800 μg dose via Respimat® inhaler twice daily for 6.5 days in Part 1.</description>
        </group>
        <group group_id="P6">
          <title>BI 443651 600 μg/ Placebo Matching BI 443651</title>
          <description>Participants suffering from cystic fibrosis were treated with 600 μg BI 443651 dose in period 1 and followed by placebo matching to BI 443651 in period 2, both administered via Respimat® inhaler twice daily for 13.5 days treatment periods separated by a wash-out period of at least 30 days between drug administrations in Part 2.</description>
        </group>
        <group group_id="P7">
          <title>Placebo Matching BI 443651/ BI 443651 600 μg</title>
          <description>Participants suffering from cystic fibrosis were treated with placebo matching to BI 443651 in period 1 and followed by 600 μg BI 443651 dose in period 2, both administered via Respimat® inhaler twice daily for 13.5 days treatment periods separated by a wash-out period of at least 30 days between drug administrations in Part 2.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Treatment Period 1 (Part 1 and Part 2)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="8"/>
                <participants group_id="P3" count="8"/>
                <participants group_id="P4" count="8"/>
                <participants group_id="P5" count="8"/>
                <participants group_id="P6" count="12"/>
                <participants group_id="P7" count="12"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="7"/>
                <participants group_id="P3" count="8"/>
                <participants group_id="P4" count="7"/>
                <participants group_id="P5" count="8"/>
                <participants group_id="P6" count="12"/>
                <participants group_id="P7" count="12"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</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="1"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Wash-out Period (Part 2 Only)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</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 group_id="P5" count="0"/>
                <participants group_id="P6" count="12"/>
                <participants group_id="P7" count="12"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>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 group_id="P5" count="0"/>
                <participants group_id="P6" count="12"/>
                <participants group_id="P7" 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 group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="2"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Reason not listed</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 group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</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 group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Treatment Period 2 (Part 2 Only)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</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 group_id="P5" count="0"/>
                <participants group_id="P6" count="12"/>
                <participants group_id="P7" count="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>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 group_id="P5" count="0"/>
                <participants group_id="P6" count="12"/>
                <participants group_id="P7" count="9"/>
              </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 group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</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 group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Treated set (TS): The TS included all randomised subjects who had been treated with at least 1 dose of trial medication.</population>
      <group_list>
        <group group_id="B1">
          <title>Placebo Matching BI 443651</title>
          <description>Healthy participants were treated with placebo matching to BI 443651 via Respimat® inhaler twice daily for 6.5 days in Part 1.</description>
        </group>
        <group group_id="B2">
          <title>BI 443651 100 Microgram (μg)</title>
          <description>Healthy participants were treated with BI 443651 100 μg dose via Respimat® inhaler twice daily for 6.5 days in Part 1.</description>
        </group>
        <group group_id="B3">
          <title>BI 443651 400 μg</title>
          <description>Healthy participants were treated with BI 443651 400 μg dose via Respimat® inhaler twice daily for 6.5 days in Part 1.</description>
        </group>
        <group group_id="B4">
          <title>BI 443651 1200 μg</title>
          <description>Healthy participants were treated with BI 443651 1200 μg dose via Respimat® inhaler twice daily for 6.5 days in Part 1.</description>
        </group>
        <group group_id="B5">
          <title>BI 443651 1800 μg</title>
          <description>Healthy participants were treated with BI 443651 1800 μg dose via Respimat® inhaler twice daily for 6.5 days in Part 1.</description>
        </group>
        <group group_id="B6">
          <title>BI 443651 600 μg/ Placebo Matching BI 443651</title>
          <description>Participants suffering from cystic fibrosis were treated with 600 μg BI 443651 dose in period 1 and followed by placebo matching to BI 443651 in period 2, both administered via Respimat® inhaler twice daily for 13.5 days treatment periods separated by a wash-out period of at least 30 days between drug administrations in Part 2.</description>
        </group>
        <group group_id="B7">
          <title>Placebo Matching BI 443651/ BI 443651 600 μg</title>
          <description>Participants suffering from cystic fibrosis were treated with placebo matching to BI 443651 in period 1 and followed by 600 μg BI 443651 dose in period 2, both administered via Respimat® inhaler twice daily for 13.5 days treatment periods separated by a wash-out period of at least 30 days between drug administrations in Part 2.</description>
        </group>
        <group group_id="B8">
          <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="8"/>
            <count group_id="B2" value="8"/>
            <count group_id="B3" value="8"/>
            <count group_id="B4" value="8"/>
            <count group_id="B5" value="8"/>
            <count group_id="B6" value="12"/>
            <count group_id="B7" value="12"/>
            <count group_id="B8" value="64"/>
          </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="36.8" spread="7.9"/>
                    <measurement group_id="B2" value="39.1" spread="10.2"/>
                    <measurement group_id="B3" value="38.9" spread="9.4"/>
                    <measurement group_id="B4" value="32.1" spread="8.1"/>
                    <measurement group_id="B5" value="41.1" spread="10.4"/>
                    <measurement group_id="B6" value="38.3" spread="12.4"/>
                    <measurement group_id="B7" value="34.0" spread="8.1"/>
                    <measurement group_id="B8" value="37.1" spread="9.7"/>
                  </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 group_id="B6" value="3"/>
                    <measurement group_id="B7" value="5"/>
                    <measurement group_id="B8" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="8"/>
                    <measurement group_id="B4" value="8"/>
                    <measurement group_id="B5" value="8"/>
                    <measurement group_id="B6" value="9"/>
                    <measurement group_id="B7" value="7"/>
                    <measurement group_id="B8" value="56"/>
                  </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 group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="8"/>
                    <measurement group_id="B4" value="8"/>
                    <measurement group_id="B5" value="8"/>
                    <measurement group_id="B6" value="12"/>
                    <measurement group_id="B7" value="12"/>
                    <measurement group_id="B8" value="64"/>
                  </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 group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" 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 group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" 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 group_id="B4" value="2"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="2"/>
                  </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 group_id="B6" value="0"/>
                    <measurement group_id="B7" value="1"/>
                    <measurement group_id="B8" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="7"/>
                    <measurement group_id="B4" value="5"/>
                    <measurement group_id="B5" value="8"/>
                    <measurement group_id="B6" value="12"/>
                    <measurement group_id="B7" value="11"/>
                    <measurement group_id="B8" value="56"/>
                  </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 group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" 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 group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With Treatment-emergent Adverse Events (TEAE) Over the Treatment Period in Part 1 and Part 2</title>
        <description>Percentage of participants with treatment-emergent adverse events (TEAE) over the treatment period in Part 1 and Part 2. For Part 1: From the first dose of study medication up to 30 days after the day of last intake of study medication, up to 44 days. For Part 2: From the first dose of study medication up to 30 days after the day of last intake of study medication, up to 51 days.</description>
        <time_frame>Up to 44 days (for Part 1) or 51 days (for Part 2) (Please check the measure description for detailed timeframe)</time_frame>
        <population>TS</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo Matching BI 443651</title>
            <description>Healthy participants were treated with placebo matching to BI 443651 via Respimat® inhaler twice daily for 6.5 days in Part 1.</description>
          </group>
          <group group_id="O2">
            <title>BI 443651 100 Microgram (μg)</title>
            <description>Healthy participants were treated with BI 443651 100 μg dose via Respimat® inhaler twice daily for 6.5 days in Part 1.</description>
          </group>
          <group group_id="O3">
            <title>BI 443651 400 μg</title>
            <description>Healthy participants were treated with BI 443651 400 μg dose via Respimat® inhaler twice daily for 6.5 days in Part 1.</description>
          </group>
          <group group_id="O4">
            <title>BI 443651 1200 μg</title>
            <description>Healthy participants were treated with BI 443651 1200 μg dose via Respimat® inhaler twice daily for 6.5 days in Part 1.</description>
          </group>
          <group group_id="O5">
            <title>BI 443651 1800 μg</title>
            <description>Healthy participants were treated with BI 443651 1800 μg dose via Respimat® inhaler twice daily for 6.5 days in Part 1.</description>
          </group>
          <group group_id="O6">
            <title>Placebo Matching BI 443651 600 μg</title>
            <description>Participants suffering from cystic fibrosis were treated with placebo matching to BI 443651 600 μg dose via Respimat® twice daily for 13.5 days in Part 2.</description>
          </group>
          <group group_id="O7">
            <title>BI 443651 600 μg</title>
            <description>Participants suffering from cystic fibrosis were treated with BI 443651 600 μg dose via Respimat® twice daily for 13.5 days in Part 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Treatment-emergent Adverse Events (TEAE) Over the Treatment Period in Part 1 and Part 2</title>
          <description>Percentage of participants with treatment-emergent adverse events (TEAE) over the treatment period in Part 1 and Part 2. For Part 1: From the first dose of study medication up to 30 days after the day of last intake of study medication, up to 44 days. For Part 2: From the first dose of study medication up to 30 days after the day of last intake of study medication, up to 51 days.</description>
          <population>TS</population>
          <units>Percentage of participants (%)</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="8"/>
                <count group_id="O3" value="8"/>
                <count group_id="O4" value="8"/>
                <count group_id="O5" value="8"/>
                <count group_id="O6" value="24"/>
                <count group_id="O7" value="22"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="37.5"/>
                    <measurement group_id="O2" value="62.5"/>
                    <measurement group_id="O3" value="87.5"/>
                    <measurement group_id="O4" value="100.0"/>
                    <measurement group_id="O5" value="87.5"/>
                    <measurement group_id="O6" value="58.3"/>
                    <measurement group_id="O7" value="59.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Maximum Measured Concentration of the BI 443651 in Plasma After the Administration of the First Dose (Cmax) on Day 1 and Over the Time Interval From 0 to 12 h After the 13th Dose (Cmax,13) on Day 7, in Part 1</title>
        <description>Maximum measured concentration of the BI 443651 in plasma after the administration of the first dose (Cmax) on day 1 and over the time interval from 0 to 12 h after the 13th dose (Cmax,13) on day 7, in Part 1. Pharmacokinetic samples were collected at 00:15 hours:minutes (h:m) pre-dose and at 00:15, 00:30, 00:45, 1:00, 2:00, 4:00, 6:00, 8:00 and 11:45 h:m after first drug administration on day 1 (for Cmax) and after last drug administration on day 7 (for Cmax,13).</description>
        <time_frame>Day 1 and Day 7 (Please check the measure description for detailed timeframe)</time_frame>
        <population>Pharmacokinetic (PK) set (PKS): The PKS included all subjects in the TS who provided at least 1 PK parameter that was not excluded.</population>
        <group_list>
          <group group_id="O1">
            <title>BI 443651 100 Microgram (μg)</title>
            <description>Healthy participants were treated with BI 443651 100 μg dose via Respimat® inhaler twice daily for 6.5 days in Part 1.</description>
          </group>
          <group group_id="O2">
            <title>BI 443651 400 μg</title>
            <description>Healthy participants were treated with BI 443651 400 μg dose via Respimat® inhaler twice daily for 6.5 days in Part 1.</description>
          </group>
          <group group_id="O3">
            <title>BI 443651 1200 μg</title>
            <description>Healthy participants were treated with BI 443651 1200 μg dose via Respimat® inhaler twice daily for 6.5 days in Part 1.</description>
          </group>
          <group group_id="O4">
            <title>BI 443651 1800 μg</title>
            <description>Healthy participants were treated with BI 443651 1800 μg dose via Respimat® inhaler twice daily for 6.5 days in Part 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Maximum Measured Concentration of the BI 443651 in Plasma After the Administration of the First Dose (Cmax) on Day 1 and Over the Time Interval From 0 to 12 h After the 13th Dose (Cmax,13) on Day 7, in Part 1</title>
          <description>Maximum measured concentration of the BI 443651 in plasma after the administration of the first dose (Cmax) on day 1 and over the time interval from 0 to 12 h after the 13th dose (Cmax,13) on day 7, in Part 1. Pharmacokinetic samples were collected at 00:15 hours:minutes (h:m) pre-dose and at 00:15, 00:30, 00:45, 1:00, 2:00, 4:00, 6:00, 8:00 and 11:45 h:m after first drug administration on day 1 (for Cmax) and after last drug administration on day 7 (for Cmax,13).</description>
          <population>Pharmacokinetic (PK) set (PKS): The PKS included all subjects in the TS who provided at least 1 PK parameter that was not excluded.</population>
          <units>picomole (pmol)/Litre (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="8"/>
                <count group_id="O2" value="7"/>
                <count group_id="O3" value="8"/>
                <count group_id="O4" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Cmax</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="7"/>
                    <count group_id="O3" value="8"/>
                    <count group_id="O4" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="158" spread="60.8"/>
                    <measurement group_id="O2" value="782" spread="46.8"/>
                    <measurement group_id="O3" value="3400" spread="64.7"/>
                    <measurement group_id="O4" value="6320" spread="48.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cmax,13</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="7"/>
                    <count group_id="O3" value="7"/>
                    <count group_id="O4" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="250" spread="31.9"/>
                    <measurement group_id="O2" value="745" spread="70.3"/>
                    <measurement group_id="O3" value="4000" spread="27.2"/>
                    <measurement group_id="O4" value="6060" spread="70.6"/>
                  </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>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Cmax. The basic model used for the investigation of dose proportionality was a power model (regression model applied to log-transformed data) that described the functional relationship between the dose and PK endpoints.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Slope</param_type>
            <param_value>1.2705</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.0801</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.1067</ci_lower_limit>
            <ci_upper_limit>1.4343</ci_upper_limit>
            <estimate_desc>Based on the estimate for slope parameter (β), a 2-sided 95% confidence interval (CI) for the slope was computed. Standard error of the mean is actually standard error of slope.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Cmax,13. The basic model used for the investigation of dose proportionality was a power model (regression model applied to log-transformed data) that described the functional relationship between the dose and PK endpoints.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Slope</param_type>
            <param_value>1.1361</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.0859</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.9598</ci_lower_limit>
            <ci_upper_limit>1.3123</ci_upper_limit>
            <estimate_desc>Based on the estimate for slope parameter (β), a 2-sided 95% CI for the slope was computed. Standard error of the mean is actually standard error of slope.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Area Under the Concentration-time Curve of the BI 443651 in Plasma Over the Time Interval From 0 to 12 Hours After the Administration of the First Dose (AUC0-12) on Day 1 and After the 13th Dose (AUC0-12,13) on Day 7 in Part 1</title>
        <description>Area under the concentration-time curve of the BI 443651 in plasma over the time interval from 0 to 12 hours (h) after the administration of the first dose (AUC0-12) on day 1 and after the 13th dose (AUC0-12,13) on day 7 in Part 1. Pharmacokinetic samples were collected at 00:15 h:m pre-dose and at 00:15, 00:30, 00:45, 1:00, 2:00, 4:00, 6:00, 8:00 and 11:45 h:m after first drug administration on day 1 (for AUC0-12) and after last drug administration on day 7 (for AUC0-12,13).</description>
        <time_frame>Day 1 and Day 7 (Please check the measure description for detailed timeframe)</time_frame>
        <population>PKS</population>
        <group_list>
          <group group_id="O1">
            <title>BI 443651 100 Microgram (μg)</title>
            <description>Healthy participants were treated with BI 443651 100 μg dose via Respimat® inhaler twice daily for 6.5 days in Part 1.</description>
          </group>
          <group group_id="O2">
            <title>BI 443651 400 μg</title>
            <description>Healthy participants were treated with BI 443651 400 μg dose via Respimat® inhaler twice daily for 6.5 days in Part 1.</description>
          </group>
          <group group_id="O3">
            <title>BI 443651 1200 μg</title>
            <description>Healthy participants were treated with BI 443651 1200 μg dose via Respimat® inhaler twice daily for 6.5 days in Part 1.</description>
          </group>
          <group group_id="O4">
            <title>BI 443651 1800 μg</title>
            <description>Healthy participants were treated with BI 443651 1800 μg dose via Respimat® inhaler twice daily for 6.5 days in Part 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Area Under the Concentration-time Curve of the BI 443651 in Plasma Over the Time Interval From 0 to 12 Hours After the Administration of the First Dose (AUC0-12) on Day 1 and After the 13th Dose (AUC0-12,13) on Day 7 in Part 1</title>
          <description>Area under the concentration-time curve of the BI 443651 in plasma over the time interval from 0 to 12 hours (h) after the administration of the first dose (AUC0-12) on day 1 and after the 13th dose (AUC0-12,13) on day 7 in Part 1. Pharmacokinetic samples were collected at 00:15 h:m pre-dose and at 00:15, 00:30, 00:45, 1:00, 2:00, 4:00, 6:00, 8:00 and 11:45 h:m after first drug administration on day 1 (for AUC0-12) and after last drug administration on day 7 (for AUC0-12,13).</description>
          <population>PKS</population>
          <units>pmol*h/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="8"/>
                <count group_id="O2" value="7"/>
                <count group_id="O3" value="8"/>
                <count group_id="O4" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>AUC0-12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="7"/>
                    <count group_id="O3" value="8"/>
                    <count group_id="O4" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="409" spread="50.5"/>
                    <measurement group_id="O2" value="1980" spread="47.7"/>
                    <measurement group_id="O3" value="9150" spread="59.6"/>
                    <measurement group_id="O4" value="16200" spread="43.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AUC0-12,13</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="7"/>
                    <count group_id="O3" value="7"/>
                    <count group_id="O4" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="868" spread="35.3"/>
                    <measurement group_id="O2" value="2260" spread="54.0"/>
                    <measurement group_id="O3" value="12200" spread="37.6"/>
                    <measurement group_id="O4" value="18400" spread="54.6"/>
                  </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>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>AUC0-12. The basic model used for the investigation of dose proportionality was a power model (regression model applied to log-transformed data) that described the functional relationship between the dose and PK endpoints.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Slope</param_type>
            <param_value>1.2743</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.0739</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.1231</ci_lower_limit>
            <ci_upper_limit>1.4255</ci_upper_limit>
            <estimate_desc>Based on the estimate for slope parameter (β), a 2-sided 95% CI for the slope was computed. Standard error of the mean is actually standard error of slope.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>AUC0-12,13. The basic model used for the investigation of dose proportionality was a power model (regression model applied to log-transformed data) that described the functional relationship between the dose and PK endpoints.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Slope</param_type>
            <param_value>1.0924</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.0793</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.9296</ci_lower_limit>
            <ci_upper_limit>1.2551</ci_upper_limit>
            <estimate_desc>Based on the estimate for slope parameter (β), a 2-sided 95% CI for the slope was computed. Standard error of the mean is actually standard error of slope.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From the first dose of study medication until 30 days after the day of last intake of study medication, up to 37 days (for Part 1) and up to 44 days (for Part 2).</time_frame>
      <desc>Treated set (TS): The TS included all randomised subjects who had been treated with at least 1 dose of trial medication.</desc>
      <group_list>
        <group group_id="E1">
          <title>Placebo Matching BI 443651</title>
          <description>Healthy participants were treated with placebo matching to BI 443651 via Respimat® inhaler twice daily for 6.5 days in Part 1.</description>
        </group>
        <group group_id="E2">
          <title>BI 443651 100 Microgram (μg)</title>
          <description>Healthy participants were treated with BI 443651 100 μg dose via Respimat® inhaler twice daily for 6.5 days in Part 1.</description>
        </group>
        <group group_id="E3">
          <title>BI 443651 400 μg</title>
          <description>Healthy participants were treated with BI 443651 400 μg dose via Respimat® inhaler twice daily for 6.5 days in Part 1.</description>
        </group>
        <group group_id="E4">
          <title>BI 443651 1200 μg</title>
          <description>Healthy participants were treated with BI 443651 1200 μg dose via Respimat® inhaler twice daily for 6.5 days in Part 1.</description>
        </group>
        <group group_id="E5">
          <title>BI 443651 1800 μg</title>
          <description>Healthy participants were treated with BI 443651 1800 μg dose via Respimat® inhaler twice daily for 6.5 days in Part 1.</description>
        </group>
        <group group_id="E6">
          <title>Placebo Matching BI 443651 600 μg</title>
          <description>Participants suffering from cystic fibrosis were treated with placebo matching to BI 443651 600 μg dose via Respimat® twice daily for 13.5 days in Part 2.</description>
        </group>
        <group group_id="E7">
          <title>BI 443651 600 μg</title>
          <description>Participants suffering from cystic fibrosis were treated with BI 443651 600 μg dose via Respimat® twice daily for 13.5 days in Part 2.</description>
        </group>
      </group_list>
      <serious_events>
        <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, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Supraventricular tachycardia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Infective pulmonary exacerbation of cystic fibrosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </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="3" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="8"/>
                <counts group_id="E3" subjects_affected="7" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="8" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="7" subjects_at_risk="8"/>
                <counts group_id="E6" subjects_affected="8" subjects_at_risk="24"/>
                <counts group_id="E7" subjects_affected="9" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Toothache</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Medical device site rash</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E6" subjects_affected="6" subjects_at_risk="24"/>
                <counts group_id="E7" subjects_affected="5" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Anal abscess</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Rhinitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Viral infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Skin abrasion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dysgeusia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="4" subjects_at_risk="8"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="8"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="24"/>
                <counts group_id="E7" subjects_affected="3" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="5" subjects_at_risk="8"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E7" subjects_affected="3" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Dry throat</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Dysphonia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Nasal congestion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Rhinorrhoea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </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/NCT02976519
org study id: 1363.2
secondary id: 2016-001504-31
nct id: NCT02976519
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The objective of this study is to investigate the safety, tolerability, and pharmacokinetics
      of BI 443651 in male and female healthy volunteers and subjects with Cystic Fibrosis (CF).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Percentage of Participants With Treatment-emergent Adverse Events (TEAE) Over the Treatment Period in Part 1 and Part 2
time frame: Up to 44 days (for Part 1) or 51 days (for Part 2) (Please check the measure description for detailed timeframe)
description: Percentage of participants with treatment-emergent adverse events (TEAE) over the treatment period in Part 1 and Part 2. For Part 1: From the first dose of study medication up to 30 days after the day of last intake of study medication, up to 44 days. For Part 2: From the first dose of study medication up to 30 days after the day of last intake of study medication, up to 51 days.
measure: Maximum Measured Concentration of the BI 443651 in Plasma After the Administration of the First Dose (Cmax) on Day 1 and Over the Time Interval From 0 to 12 h After the 13th Dose (Cmax,13) on Day 7, in Part 1
time frame: Day 1 and Day 7 (Please check the measure description for detailed timeframe)
description: Maximum measured concentration of the BI 443651 in plasma after the administration of the first dose (Cmax) on day 1 and over the time interval from 0 to 12 h after the 13th dose (Cmax,13) on day 7, in Part 1. Pharmacokinetic samples were collected at 00:15 hours:minutes (h:m) pre-dose and at 00:15, 00:30, 00:45, 1:00, 2:00, 4:00, 6:00, 8:00 and 11:45 h:m after first drug administration on day 1 (for Cmax) and after last drug administration on day 7 (for Cmax,13).
measure: Area Under the Concentration-time Curve of the BI 443651 in Plasma Over the Time Interval From 0 to 12 Hours After the Administration of the First Dose (AUC0-12) on Day 1 and After the 13th Dose (AUC0-12,13) on Day 7 in Part 1
time frame: Day 1 and Day 7 (Please check the measure description for detailed timeframe)
description: Area under the concentration-time curve of the BI 443651 in plasma over the time interval from 0 to 12 hours (h) after the administration of the first dose (AUC0-12) on day 1 and after the 13th dose (AUC0-12,13) on day 7 in Part 1. Pharmacokinetic samples were collected at 00:15 h:m pre-dose and at 00:15, 00:30, 00:45, 1:00, 2:00, 4:00, 6:00, 8:00 and 11:45 h:m after first drug administration on day 1 (for AUC0-12) and after last drug administration on day 7 (for AUC0-12,13).
arm group label: BI 443651
arm group type: Experimental
arm group label: Placebo
arm group type: Placebo Comparator
intervention type: Drug
intervention name: BI 443651
description: twice daily
arm group label: BI 443651
intervention type: Drug
intervention name: Placebo
description: twice daily
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Boehringer Ingelheim
role: Study Chair
affiliation: Boehringer Ingelheim
facility: 
facility: 
facility: 
facility: 
facility: 
country: Germany
country: United Kingdom
url: http://trials.boehringer-ingelheim.com/
description: Related Info
responsible party type: Sponsor
mesh term: Cystic Fibrosis
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 