<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/NCT01681277</url>
  </required_header>
  <id_info>
    <org_study_id>1314.2</org_study_id>
    <secondary_id>2012-002536-82</secondary_id>
    <nct_id>NCT01681277</nct_id>
  </id_info>
  <brief_title>Safety, Tolerability and Pharmacokinetics of Multiple Rising Doses of BI 113608 in Healthy Male Volunteers</brief_title>
  <official_title>Safety, Tolerability and Pharmacokinetics of Multiple Rising Doses of BI 113608 Powder for Oral Solution in Healthy Male Volunteers q.d. or b.i.d. for 14 Days (a Randomised, Double-blind, Placebo-controlled Within Dose Groups Phase I Trial)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boehringer Ingelheim</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boehringer Ingelheim</source>
  <brief_summary>
    <textblock>
      The objective of the current trial is to evaluate safety, tolerability and pharmacokinetics&#xD;
      of multiple rising doses of BI 113608 in healthy male volunteers&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">May 2013</completion_date>
  <primary_completion_date type="Actual">May 2013</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>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Participants With Drug-related Adverse Events</measure>
    <time_frame>From administration of study drug until end-of-study, up to 17 days</time_frame>
    <description>Percentage of participants with drug-related adverse events</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Clinically Relevant Abnormalities for Clinical Laboratory Evaluation, Vital Signs, and ECG Recordings</measure>
    <time_frame>From administration of study drug until end-of-study, up to 17 days</time_frame>
    <description>Number of participants with Clinically relevant abnormalities for clinical laboratory tests (haematology, clinical chemistry and urinalysis), vital signs (blood pressure (BP), pulse rate (PR), respiratory rate (RR), body temperature), and 12- lead electrocardiogram (ECG)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cmax,ss</measure>
    <time_frame>311.917h before dose and 312.25h. 312.5h, 312.75h, 313h, 313.5h, 314h, 314.5h, 315h, 316h, 318h, 320h, 322h, 324h, 328h, 336h after last dose. The time 324h for the b.i.d treatment and 336h for the q.d. treatment.</time_frame>
    <description>Maximum measured concentration of the analyte in plasma at steady state (Cmax,ss).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tmax,ss</measure>
    <time_frame>311.917h before dose and 312.25h. 312.5h, 312.75h, 313h, 313.5h, 314h, 314.5h, 315h, 316h, 318h, 320h, 322h, 324h, 328h, 336h after last dose. The time 324h for the b.i.d treatment and 336h for the q.d. treatment.</time_frame>
    <description>Time from last dosing to maximum concentration of the analyte in plasma at steady state (tmax,ss).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AUCtau,ss</measure>
    <time_frame>311.917h before dose and 312.25h. 312.5h, 312.75h, 313h, 313.5h, 314h, 314.5h, 315h, 316h, 318h, 320h, 322h, 324h, 328h, 336h after last dose. The time 324h for the b.i.d treatment and 336h for the q.d. treatment.</time_frame>
    <description>Area under the concentration-time curve of the analyte BI 113608 in plasma at steady state over a uniform dosing interval t (AUCtau,ss).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>t1/2,ss</measure>
    <time_frame>311.917h before dose and 312.25h. 312.5h, 312.75h, 313h, 313.5h, 314h, 314.5h, 315h, 316h, 318h, 320h, 322h, 324h, 328h, 336h, 360h, 384h after last dose.</time_frame>
    <description>Terminal half-life of the analyte in plasma at steady state (t1/2,ss).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>RA,Cmax</measure>
    <time_frame>-2h,0.25h,0.5h,0.75h,1h,1.5h,2h,2.5h,3h,4h,6h,8h,10h,12h,16h,23.917h and 311.917h before dose and 312.25h. 312.5h, 312.75h, 313h, 313.5h, 314h, 314.5h, 315h, 316h, 318h, 320h, 322h, 324h, 328h, 336h after single and multiple dose.</time_frame>
    <description>Accumulation ratio of the analyte in plasma at steady state after multiple oral administration over a uniform dosing interval t, expressed as ratio of Cmax at steady state and after single dose (RA,Cmax).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>RA,AUC</measure>
    <time_frame>-2h,0.25h,0.5h,0.75h,1h,1.5h,2h,2.5h,3h,4h,6h,8h,10h,12h,16h,23.917h and 311.917h before dose and 312.25h. 312.5h, 312.75h, 313h, 313.5h, 314h, 314.5h, 315h, 316h, 318h, 320h, 322h, 324h, 328h, 336h after single and multiple dose.</time_frame>
    <description>Accumulation ratio of the analyte in plasma at steady state after multiple dose administration over a uniform dosing interval t, expressed as ratio of AUC at steady state and after single dose (RA,AUC).</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">48</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>BI 113608 high dose bid</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>powder in the bottle for oral solution, oral administration with 240 ml water</description>
  </arm_group>
  <arm_group>
    <arm_group_label>BI 113608 low dose bid</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>powder in the bottle for oral solution, oral administration with 240 ml water</description>
  </arm_group>
  <arm_group>
    <arm_group_label>BI 113608 medium dose bid</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>powder in the bottle for oral solution, oral administration with 240 ml water</description>
  </arm_group>
  <arm_group>
    <arm_group_label>BI 113608 high dose qd</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>powder in the bottle for oral solution, oral administration with 240 ml water</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BI 113608 PIB bid</intervention_name>
    <description>powder for oral solution</description>
    <arm_group_label>BI 113608 medium dose bid</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo to BI 113608 PIB bid</intervention_name>
    <description>powder for oral solution</description>
    <arm_group_label>BI 113608 low dose bid</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo to BI 113608 PIB bid</intervention_name>
    <description>powder for oral solution</description>
    <arm_group_label>BI 113608 medium dose bid</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo to BI 113608 PIB qd</intervention_name>
    <description>powder for oral solution</description>
    <arm_group_label>BI 113608 high dose qd</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo to BI 113608 PIB bid</intervention_name>
    <description>powder for oral solution</description>
    <arm_group_label>BI 113608 high dose bid</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BI 113608 PIB bid</intervention_name>
    <description>powder for oral solution</description>
    <arm_group_label>BI 113608 high dose bid</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BI 113608 PIB bid</intervention_name>
    <description>powder for oral solution</description>
    <arm_group_label>BI 113608 low dose bid</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BI 113608 PIB qd</intervention_name>
    <description>powder for oral solution</description>
    <arm_group_label>BI 113608 high dose qd</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
        1. healthy male subjects&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
        1. Any relevant deviation from healthy conditions&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 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>Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Mannheim</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <link>
    <url>http://trials.boehringer-ingelheim.com</url>
    <description>Related Info</description>
  </link>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>September 5, 2012</study_first_submitted>
  <study_first_submitted_qc>September 5, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 7, 2012</study_first_posted>
  <results_first_submitted>November 23, 2016</results_first_submitted>
  <results_first_submitted_qc>November 23, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">January 20, 2017</results_first_posted>
  <last_update_submitted>November 23, 2016</last_update_submitted>
  <last_update_submitted_qc>November 23, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 20, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Placebo</title>
          <description>Subjects were orally administered matching placebo to BI 113608 (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1 and Day 14 for all dose group, twice daily dose (b.i.d.) on Days 2 to 13 for dose group 1 to 3 and a single morning dose (q.d.) for group 4.</description>
        </group>
        <group group_id="P2">
          <title>BI 113608 25 mg Bid (DG1)</title>
          <description>Dose Group (DG) 1: Subjects were orally administered with daily dose of BI 113608 50 mg (25 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days (b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.</description>
        </group>
        <group group_id="P3">
          <title>BI 113608 50 mg Bid (DG2)</title>
          <description>DG 2: Subjects were orally administered with daily dose of BI 113608 100 mg (50 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.</description>
        </group>
        <group group_id="P4">
          <title>BI 113608 100 mg Bid (DG3)</title>
          <description>DG 3: Subjects were orally administered with daily dose of BI 113608 200 mg (100 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.</description>
        </group>
        <group group_id="P5">
          <title>BI 113608 100 mg qd (DG4)</title>
          <description>DG 4: Subjects were orally administered with daily dose of BI 113608 100 mg (100 mg q.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1 to Day 14.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
                <participants group_id="P2" count="9"/>
                <participants group_id="P3" count="9"/>
                <participants group_id="P4" count="9"/>
                <participants group_id="P5" count="9"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="11"/>
                <participants group_id="P2" count="9"/>
                <participants group_id="P3" count="9"/>
                <participants group_id="P4" count="9"/>
                <participants group_id="P5" count="9"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <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_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <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_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Treated Set (TS): This set included all subjects who were dispensed study medication and were documented to have taken at least one dose of study drug. The TS included all 48 treated subjects.</population>
      <group_list>
        <group group_id="B1">
          <title>Placebo</title>
          <description>Subjects were orally administered matching placebo to BI 113608 (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1 and Day 14 for all dose group, twice daily dose (b.i.d.) on Days 2 to 13 for dose group 1 to 3 and a single morning dose (q.d.) for group 4.</description>
        </group>
        <group group_id="B2">
          <title>BI 113608 25 mg Bid (DG1)</title>
          <description>Dose Group (DG) 1: Subjects were orally administered with daily dose of BI 113608 50 mg (25 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days (b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.</description>
        </group>
        <group group_id="B3">
          <title>BI 113608 50 mg Bid (DG2)</title>
          <description>DG 2: Subjects were orally administered with daily dose of BI 113608 100 mg (50 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.</description>
        </group>
        <group group_id="B4">
          <title>BI 113608 100 mg Bid (DG3)</title>
          <description>DG 3: Subjects were orally administered with daily dose of BI 113608 200 mg (100 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.</description>
        </group>
        <group group_id="B5">
          <title>BI 113608 100 mg qd (DG4)</title>
          <description>DG 4: Subjects were orally administered with daily dose of BI 113608 100 mg (100 mg q.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1 to Day 14.</description>
        </group>
        <group group_id="B6">
          <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="12"/>
            <count group_id="B2" value="9"/>
            <count group_id="B3" value="9"/>
            <count group_id="B4" value="9"/>
            <count group_id="B5" value="9"/>
            <count group_id="B6" value="48"/>
          </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="40.9" spread="7.0"/>
                    <measurement group_id="B2" value="40.9" spread="7.0"/>
                    <measurement group_id="B3" value="44.2" spread="5.7"/>
                    <measurement group_id="B4" value="43.8" spread="4.6"/>
                    <measurement group_id="B5" value="40.1" spread="8.0"/>
                    <measurement group_id="B6" value="41.9" spread="6.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Gender</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="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="9"/>
                    <measurement group_id="B4" value="9"/>
                    <measurement group_id="B5" value="9"/>
                    <measurement group_id="B6" value="48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With Drug-related Adverse Events</title>
        <description>Percentage of participants with drug-related adverse events</description>
        <time_frame>From administration of study drug until end-of-study, up to 17 days</time_frame>
        <population>Treated set</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Subjects were orally administered matching placebo to BI 113608 (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1 and Day 14 for all dose group, twice daily dose (b.i.d.) on Days 2 to 13 for dose group 1 to 3 and a single morning dose (q.d.) for group 4.</description>
          </group>
          <group group_id="O2">
            <title>BI 113608 25 mg Bid (DG1)</title>
            <description>Dose Group (DG) 1: Subjects were orally administered with daily dose of BI 113608 50 mg (25 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days (b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.</description>
          </group>
          <group group_id="O3">
            <title>BI 113608 50 mg Bid (DG2)</title>
            <description>DG 2: Subjects were orally administered with daily dose of BI 113608 100 mg (50 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.</description>
          </group>
          <group group_id="O4">
            <title>BI 113608 100 mg Bid (DG3)</title>
            <description>DG 3: Subjects were orally administered with daily dose of BI 113608 200 mg (100 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.</description>
          </group>
          <group group_id="O5">
            <title>BI 113608 100 mg qd (DG4)</title>
            <description>DG 4: Subjects were orally administered with daily dose of BI 113608 100 mg (100 mg q.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1 to Day 14.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Drug-related Adverse Events</title>
          <description>Percentage of participants with drug-related adverse events</description>
          <population>Treated set</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="12"/>
                <count group_id="O2" value="9"/>
                <count group_id="O3" value="9"/>
                <count group_id="O4" value="9"/>
                <count group_id="O5" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33.3"/>
                    <measurement group_id="O2" value="33.3"/>
                    <measurement group_id="O3" value="22.2"/>
                    <measurement group_id="O4" value="88.9"/>
                    <measurement group_id="O5" value="77.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Clinically Relevant Abnormalities for Clinical Laboratory Evaluation, Vital Signs, and ECG Recordings</title>
        <description>Number of participants with Clinically relevant abnormalities for clinical laboratory tests (haematology, clinical chemistry and urinalysis), vital signs (blood pressure (BP), pulse rate (PR), respiratory rate (RR), body temperature), and 12- lead electrocardiogram (ECG)</description>
        <time_frame>From administration of study drug until end-of-study, up to 17 days</time_frame>
        <population>Treated Set (TS)</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Subjects were orally administered matching placebo to BI 113608 (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1 and Day 14 for all dose group, twice daily dose (b.i.d.) on Days 2 to 13 for dose group 1 to 3 and a single morning dose (q.d.) for group 4.</description>
          </group>
          <group group_id="O2">
            <title>BI 113608 25 mg Bid (DG1)</title>
            <description>Dose Group (DG) 1: Subjects were orally administered with daily dose of BI 113608 50 mg (25 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days (b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.</description>
          </group>
          <group group_id="O3">
            <title>BI 113608 50 mg Bid (DG2)</title>
            <description>DG 2: Subjects were orally administered with daily dose of BI 113608 100 mg (50 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.</description>
          </group>
          <group group_id="O4">
            <title>BI 113608 100 mg Bid (DG3)</title>
            <description>DG 3: Subjects were orally administered with daily dose of BI 113608 200 mg (100 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.</description>
          </group>
          <group group_id="O5">
            <title>BI 113608 100 mg qd (DG4)</title>
            <description>DG 4: Subjects were orally administered with daily dose of BI 113608 100 mg (100 mg q.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1 to Day 14.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Clinically Relevant Abnormalities for Clinical Laboratory Evaluation, Vital Signs, and ECG Recordings</title>
          <description>Number of participants with Clinically relevant abnormalities for clinical laboratory tests (haematology, clinical chemistry and urinalysis), vital signs (blood pressure (BP), pulse rate (PR), respiratory rate (RR), body temperature), and 12- lead electrocardiogram (ECG)</description>
          <population>Treated Set (TS)</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="9"/>
                <count group_id="O3" value="9"/>
                <count group_id="O4" value="9"/>
                <count group_id="O5" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Cmax,ss</title>
        <description>Maximum measured concentration of the analyte in plasma at steady state (Cmax,ss).</description>
        <time_frame>311.917h before dose and 312.25h. 312.5h, 312.75h, 313h, 313.5h, 314h, 314.5h, 315h, 316h, 318h, 320h, 322h, 324h, 328h, 336h after last dose. The time 324h for the b.i.d treatment and 336h for the q.d. treatment.</time_frame>
        <population>PK analysis set (PKS): This set included all subjects of the TS who provided at least one observation for at least one secondary PK endpoint without important protocol violations.</population>
        <group_list>
          <group group_id="O1">
            <title>BI 113608 25 mg Bid (DG1)</title>
            <description>Dose Group (DG) 1: Subjects were orally administered with daily dose of BI 113608 50 mg (25 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days (b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.</description>
          </group>
          <group group_id="O2">
            <title>BI 113608 50 mg Bid (DG2)</title>
            <description>DG 2: Subjects were orally administered with daily dose of BI 113608 100 mg (50 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.</description>
          </group>
          <group group_id="O3">
            <title>BI 113608 100 mg Bid (DG3)</title>
            <description>DG 3: Subjects were orally administered with daily dose of BI 113608 200 mg (100 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.</description>
          </group>
          <group group_id="O4">
            <title>BI 113608 100 mg qd (DG4)</title>
            <description>DG 4: Subjects were orally administered with daily dose of BI 113608 100 mg (100 mg q.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1 to Day 14.</description>
          </group>
        </group_list>
        <measure>
          <title>Cmax,ss</title>
          <description>Maximum measured concentration of the analyte in plasma at steady state (Cmax,ss).</description>
          <population>PK analysis set (PKS): This set included all subjects of the TS who provided at least one observation for at least one secondary PK endpoint without important protocol violations.</population>
          <units>nmol/L</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="9"/>
                <count group_id="O3" value="9"/>
                <count group_id="O4" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="119" spread="58.2"/>
                    <measurement group_id="O2" value="261" spread="40.3"/>
                    <measurement group_id="O3" value="648" spread="27.7"/>
                    <measurement group_id="O4" value="549" spread="41.7"/>
                  </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>This was non confirmatory testing (Single dose). Dose proportionality of BI 113608 for Cmax,ss was analysed.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Slope</param_type>
            <param_value>1.2208</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.1386</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.9354</ci_lower_limit>
            <ci_upper_limit>1.5062</ci_upper_limit>
            <estimate_desc>Dose proportionality was explored using the power model (ANCOVA). The perfect dose proportionality would correspond to a slope β of 1.&#xD;
PK endpoints on the log-transformed scale. Standard Error of the mean is actually the Standard Error of the slope</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Tmax,ss</title>
        <description>Time from last dosing to maximum concentration of the analyte in plasma at steady state (tmax,ss).</description>
        <time_frame>311.917h before dose and 312.25h. 312.5h, 312.75h, 313h, 313.5h, 314h, 314.5h, 315h, 316h, 318h, 320h, 322h, 324h, 328h, 336h after last dose. The time 324h for the b.i.d treatment and 336h for the q.d. treatment.</time_frame>
        <population>PKS</population>
        <group_list>
          <group group_id="O1">
            <title>BI 113608 25 mg Bid (DG1)</title>
            <description>Dose Group (DG) 1: Subjects were orally administered with daily dose of BI 113608 50 mg (25 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days (b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.</description>
          </group>
          <group group_id="O2">
            <title>BI 113608 50 mg Bid (DG2)</title>
            <description>DG 2: Subjects were orally administered with daily dose of BI 113608 100 mg (50 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.</description>
          </group>
          <group group_id="O3">
            <title>BI 113608 100 mg Bid (DG3)</title>
            <description>DG 3: Subjects were orally administered with daily dose of BI 113608 200 mg (100 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.</description>
          </group>
          <group group_id="O4">
            <title>BI 113608 100 mg qd (DG4)</title>
            <description>DG 4: Subjects were orally administered with daily dose of BI 113608 100 mg (100 mg q.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1 to Day 14.</description>
          </group>
        </group_list>
        <measure>
          <title>Tmax,ss</title>
          <description>Time from last dosing to maximum concentration of the analyte in plasma at steady state (tmax,ss).</description>
          <population>PKS</population>
          <units>h</units>
          <param>Median</param>
          <dispersion>Full Range</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 group_id="O3" value="9"/>
                <count group_id="O4" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.500" lower_limit="0.250" upper_limit="0.500"/>
                    <measurement group_id="O2" value="0.500" lower_limit="0.250" upper_limit="2.00"/>
                    <measurement group_id="O3" value="0.750" lower_limit="0.500" upper_limit="1.00"/>
                    <measurement group_id="O4" value="0.750" lower_limit="0.250" upper_limit="4.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>AUCtau,ss</title>
        <description>Area under the concentration-time curve of the analyte BI 113608 in plasma at steady state over a uniform dosing interval t (AUCtau,ss).</description>
        <time_frame>311.917h before dose and 312.25h. 312.5h, 312.75h, 313h, 313.5h, 314h, 314.5h, 315h, 316h, 318h, 320h, 322h, 324h, 328h, 336h after last dose. The time 324h for the b.i.d treatment and 336h for the q.d. treatment.</time_frame>
        <population>PKS</population>
        <group_list>
          <group group_id="O1">
            <title>BI 113608 25 mg Bid (DG1)</title>
            <description>Dose Group (DG) 1: Subjects were orally administered with daily dose of BI 113608 50 mg (25 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days (b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.</description>
          </group>
          <group group_id="O2">
            <title>BI 113608 50 mg Bid (DG2)</title>
            <description>DG 2: Subjects were orally administered with daily dose of BI 113608 100 mg (50 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.</description>
          </group>
          <group group_id="O3">
            <title>BI 113608 100 mg Bid (DG3)</title>
            <description>DG 3: Subjects were orally administered with daily dose of BI 113608 200 mg (100 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.</description>
          </group>
          <group group_id="O4">
            <title>BI 113608 100 mg qd (DG4)</title>
            <description>DG 4: Subjects were orally administered with daily dose of BI 113608 100 mg (100 mg q.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1 to Day 14.</description>
          </group>
        </group_list>
        <measure>
          <title>AUCtau,ss</title>
          <description>Area under the concentration-time curve of the analyte BI 113608 in plasma at steady state over a uniform dosing interval t (AUCtau,ss).</description>
          <population>PKS</population>
          <units>nmol*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="9"/>
                <count group_id="O2" value="9"/>
                <count group_id="O3" value="9"/>
                <count group_id="O4" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="491" spread="48.5"/>
                    <measurement group_id="O2" value="1290" spread="29.0"/>
                    <measurement group_id="O3" value="3030" spread="32.2"/>
                    <measurement group_id="O4" value="2290" spread="20.0"/>
                  </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>This was non confirmatory testing (Single dose). Dose proportionality of BI 113608 for AUCt,ss was analysed.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Slope</param_type>
            <param_value>1.3135</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.1206</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.0652</ci_lower_limit>
            <ci_upper_limit>1.5618</ci_upper_limit>
            <estimate_desc>Dose proportionality was explored using the power model (ANCOVA). The perfect dose proportionality would correspond to a slope β of 1.&#xD;
PK endpoints on the log-transformed scale. Standard Error of the mean is actually the Standard Error of the slope</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>t1/2,ss</title>
        <description>Terminal half-life of the analyte in plasma at steady state (t1/2,ss).</description>
        <time_frame>311.917h before dose and 312.25h. 312.5h, 312.75h, 313h, 313.5h, 314h, 314.5h, 315h, 316h, 318h, 320h, 322h, 324h, 328h, 336h, 360h, 384h after last dose.</time_frame>
        <population>PKS</population>
        <group_list>
          <group group_id="O1">
            <title>BI 113608 25 mg Bid (DG1)</title>
            <description>Dose Group (DG) 1: Subjects were orally administered with daily dose of BI 113608 50 mg (25 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days (b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.</description>
          </group>
          <group group_id="O2">
            <title>BI 113608 50 mg Bid (DG2)</title>
            <description>DG 2: Subjects were orally administered with daily dose of BI 113608 100 mg (50 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.</description>
          </group>
          <group group_id="O3">
            <title>BI 113608 100 mg Bid (DG3)</title>
            <description>DG 3: Subjects were orally administered with daily dose of BI 113608 200 mg (100 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.</description>
          </group>
          <group group_id="O4">
            <title>BI 113608 100 mg qd (DG4)</title>
            <description>DG 4: Subjects were orally administered with daily dose of BI 113608 100 mg (100 mg q.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1 to Day 14.</description>
          </group>
        </group_list>
        <measure>
          <title>t1/2,ss</title>
          <description>Terminal half-life of the analyte in plasma at steady state (t1/2,ss).</description>
          <population>PKS</population>
          <units>h</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="9"/>
                <count group_id="O2" value="9"/>
                <count group_id="O3" value="9"/>
                <count group_id="O4" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.0" spread="15.4"/>
                    <measurement group_id="O2" value="12.9" spread="22.8"/>
                    <measurement group_id="O3" value="12.9" spread="14.7"/>
                    <measurement group_id="O4" value="13.1" spread="15.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>RA,Cmax</title>
        <description>Accumulation ratio of the analyte in plasma at steady state after multiple oral administration over a uniform dosing interval t, expressed as ratio of Cmax at steady state and after single dose (RA,Cmax).</description>
        <time_frame>-2h,0.25h,0.5h,0.75h,1h,1.5h,2h,2.5h,3h,4h,6h,8h,10h,12h,16h,23.917h and 311.917h before dose and 312.25h. 312.5h, 312.75h, 313h, 313.5h, 314h, 314.5h, 315h, 316h, 318h, 320h, 322h, 324h, 328h, 336h after single and multiple dose.</time_frame>
        <population>PKS</population>
        <group_list>
          <group group_id="O1">
            <title>BI 113608 25 mg Bid (DG1)</title>
            <description>Dose Group (DG) 1: Subjects were orally administered with daily dose of BI 113608 50 mg (25 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days (b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.</description>
          </group>
          <group group_id="O2">
            <title>BI 113608 50 mg Bid (DG2)</title>
            <description>DG 2: Subjects were orally administered with daily dose of BI 113608 100 mg (50 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.</description>
          </group>
          <group group_id="O3">
            <title>BI 113608 100 mg Bid (DG3)</title>
            <description>DG 3: Subjects were orally administered with daily dose of BI 113608 200 mg (100 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.</description>
          </group>
          <group group_id="O4">
            <title>BI 113608 100 mg qd (DG4)</title>
            <description>DG 4: Subjects were orally administered with daily dose of BI 113608 100 mg (100 mg q.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1 to Day 14.</description>
          </group>
        </group_list>
        <measure>
          <title>RA,Cmax</title>
          <description>Accumulation ratio of the analyte in plasma at steady state after multiple oral administration over a uniform dosing interval t, expressed as ratio of Cmax at steady state and after single dose (RA,Cmax).</description>
          <population>PKS</population>
          <units>Ratio</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="9"/>
                <count group_id="O2" value="9"/>
                <count group_id="O3" value="9"/>
                <count group_id="O4" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.36" spread="54.0"/>
                    <measurement group_id="O2" value="1.15" spread="23.6"/>
                    <measurement group_id="O3" value="1.09" spread="34.3"/>
                    <measurement group_id="O4" value="0.915" spread="38.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>RA,AUC</title>
        <description>Accumulation ratio of the analyte in plasma at steady state after multiple dose administration over a uniform dosing interval t, expressed as ratio of AUC at steady state and after single dose (RA,AUC).</description>
        <time_frame>-2h,0.25h,0.5h,0.75h,1h,1.5h,2h,2.5h,3h,4h,6h,8h,10h,12h,16h,23.917h and 311.917h before dose and 312.25h. 312.5h, 312.75h, 313h, 313.5h, 314h, 314.5h, 315h, 316h, 318h, 320h, 322h, 324h, 328h, 336h after single and multiple dose.</time_frame>
        <population>PKS</population>
        <group_list>
          <group group_id="O1">
            <title>BI 113608 25 mg Bid (DG1)</title>
            <description>Dose Group (DG) 1: Subjects were orally administered with daily dose of BI 113608 50 mg (25 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days (b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.</description>
          </group>
          <group group_id="O2">
            <title>BI 113608 50 mg Bid (DG2)</title>
            <description>DG 2: Subjects were orally administered with daily dose of BI 113608 100 mg (50 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.</description>
          </group>
          <group group_id="O3">
            <title>BI 113608 100 mg Bid (DG3)</title>
            <description>DG 3: Subjects were orally administered with daily dose of BI 113608 200 mg (100 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.</description>
          </group>
          <group group_id="O4">
            <title>BI 113608 100 mg qd (DG4)</title>
            <description>DG 4: Subjects were orally administered with daily dose of BI 113608 100 mg (100 mg q.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1 to Day 14.</description>
          </group>
        </group_list>
        <measure>
          <title>RA,AUC</title>
          <description>Accumulation ratio of the analyte in plasma at steady state after multiple dose administration over a uniform dosing interval t, expressed as ratio of AUC at steady state and after single dose (RA,AUC).</description>
          <population>PKS</population>
          <units>Ratio</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="9"/>
                <count group_id="O2" value="9"/>
                <count group_id="O3" value="9"/>
                <count group_id="O4" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.29" spread="29.9"/>
                    <measurement group_id="O2" value="1.48" spread="13.0"/>
                    <measurement group_id="O3" value="1.37" spread="14.5"/>
                    <measurement group_id="O4" value="1.05" spread="15.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From administration of study drug until end-of-study, up to 17 days</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Placebo</title>
          <description>Subjects were orally administered matching placebo to BI 113608 (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1 and Day 14 for all dose group, twice daily dose (b.i.d.) on Days 2 to 13 for dose group 1 to 3 and a single morning dose (q.d.) for group 4.</description>
        </group>
        <group group_id="E2">
          <title>BI 113608 25 mg Bid (DG1)</title>
          <description>Dose Group (DG) 1: Subjects were orally administered with daily dose of BI 113608 50 mg (25 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days (b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.</description>
        </group>
        <group group_id="E3">
          <title>BI 113608 50 mg Bid (DG2)</title>
          <description>DG 2: Subjects were orally administered with daily dose of BI 113608 100 mg (50 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.</description>
        </group>
        <group group_id="E4">
          <title>BI 113608 100 mg Bid (DG3)</title>
          <description>DG 3: Subjects were orally administered with daily dose of BI 113608 200 mg (100 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.</description>
        </group>
        <group group_id="E5">
          <title>BI 113608 100 mg qd (DG4)</title>
          <description>DG 4: Subjects were orally administered with daily dose of BI 113608 100 mg (100 mg q.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1 to Day 14.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 16.0</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="5" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="8" subjects_at_risk="9"/>
                <counts group_id="E5" subjects_affected="7" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Palpitations</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Lacrimation increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="9"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Dry mouth</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="9"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Anal haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Flatulence</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Feeling of relaxation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Sensation of pressure</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Spinal pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Thirst</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Folliculitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="8" subjects_at_risk="9"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Oral herpes</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Rhinitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Excoriation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Body temperature increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Decreased appetite</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="9"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Hyperaesthesia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Facial paresis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Paraesthesia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Oliguria</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Epistaxis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="9"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Oropharyngeal pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="9"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Nasal dryness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Rhinorrhoea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Throat irritation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Dry skin</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="9"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="9"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Skin irritation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Eczema</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Skin hyperpigmentation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
              </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/NCT01681277
org study id: 1314.2
secondary id: 2012-002536-82
nct id: NCT01681277
lead sponsor: 
The objective of the current trial is to evaluate safety, tolerability and pharmacokinetics
      of multiple rising doses of BI 113608 in healthy male volunteers
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: Double
measure: Percentage of Participants With Drug-related Adverse Events
time frame: From administration of study drug until end-of-study, up to 17 days
description: Percentage of participants with drug-related adverse events
measure: Number of Participants With Clinically Relevant Abnormalities for Clinical Laboratory Evaluation, Vital Signs, and ECG Recordings
time frame: From administration of study drug until end-of-study, up to 17 days
description: Number of participants with Clinically relevant abnormalities for clinical laboratory tests (haematology, clinical chemistry and urinalysis), vital signs (blood pressure (BP), pulse rate (PR), respiratory rate (RR), body temperature), and 12- lead electrocardiogram (ECG)
measure: Cmax,ss
time frame: 311.917h before dose and 312.25h. 312.5h, 312.75h, 313h, 313.5h, 314h, 314.5h, 315h, 316h, 318h, 320h, 322h, 324h, 328h, 336h after last dose. The time 324h for the b.i.d treatment and 336h for the q.d. treatment.
description: Maximum measured concentration of the analyte in plasma at steady state (Cmax,ss).
measure: Tmax,ss
time frame: 311.917h before dose and 312.25h. 312.5h, 312.75h, 313h, 313.5h, 314h, 314.5h, 315h, 316h, 318h, 320h, 322h, 324h, 328h, 336h after last dose. The time 324h for the b.i.d treatment and 336h for the q.d. treatment.
description: Time from last dosing to maximum concentration of the analyte in plasma at steady state (tmax,ss).
measure: AUCtau,ss
time frame: 311.917h before dose and 312.25h. 312.5h, 312.75h, 313h, 313.5h, 314h, 314.5h, 315h, 316h, 318h, 320h, 322h, 324h, 328h, 336h after last dose. The time 324h for the b.i.d treatment and 336h for the q.d. treatment.
description: Area under the concentration-time curve of the analyte BI 113608 in plasma at steady state over a uniform dosing interval t (AUCtau,ss).
measure: t1/2,ss
time frame: 311.917h before dose and 312.25h. 312.5h, 312.75h, 313h, 313.5h, 314h, 314.5h, 315h, 316h, 318h, 320h, 322h, 324h, 328h, 336h, 360h, 384h after last dose.
description: Terminal half-life of the analyte in plasma at steady state (t1/2,ss).
measure: RA,Cmax
time frame: -2h,0.25h,0.5h,0.75h,1h,1.5h,2h,2.5h,3h,4h,6h,8h,10h,12h,16h,23.917h and 311.917h before dose and 312.25h. 312.5h, 312.75h, 313h, 313.5h, 314h, 314.5h, 315h, 316h, 318h, 320h, 322h, 324h, 328h, 336h after single and multiple dose.
description: Accumulation ratio of the analyte in plasma at steady state after multiple oral administration over a uniform dosing interval t, expressed as ratio of Cmax at steady state and after single dose (RA,Cmax).
measure: RA,AUC
time frame: -2h,0.25h,0.5h,0.75h,1h,1.5h,2h,2.5h,3h,4h,6h,8h,10h,12h,16h,23.917h and 311.917h before dose and 312.25h. 312.5h, 312.75h, 313h, 313.5h, 314h, 314.5h, 315h, 316h, 318h, 320h, 322h, 324h, 328h, 336h after single and multiple dose.
description: Accumulation ratio of the analyte in plasma at steady state after multiple dose administration over a uniform dosing interval t, expressed as ratio of AUC at steady state and after single dose (RA,AUC).
arm group label: BI 113608 high dose bid
arm group type: Experimental
description: powder in the bottle for oral solution, oral administration with 240 ml water
arm group label: BI 113608 low dose bid
arm group type: Experimental
description: powder in the bottle for oral solution, oral administration with 240 ml water
arm group label: BI 113608 medium dose bid
arm group type: Experimental
description: powder in the bottle for oral solution, oral administration with 240 ml water
arm group label: BI 113608 high dose qd
arm group type: Experimental
description: powder in the bottle for oral solution, oral administration with 240 ml water
intervention type: Drug
intervention name: BI 113608 PIB bid
description: powder for oral solution
arm group label: BI 113608 medium dose bid
intervention type: Drug
intervention name: Placebo to BI 113608 PIB bid
description: powder for oral solution
arm group label: BI 113608 low dose bid
intervention type: Drug
intervention name: Placebo to BI 113608 PIB bid
description: powder for oral solution
arm group label: BI 113608 medium dose bid
intervention type: Drug
intervention name: Placebo to BI 113608 PIB qd
description: powder for oral solution
arm group label: BI 113608 high dose qd
intervention type: Drug
intervention name: Placebo to BI 113608 PIB bid
description: powder for oral solution
arm group label: BI 113608 high dose bid
intervention type: Drug
intervention name: BI 113608 PIB bid
description: powder for oral solution
arm group label: BI 113608 high dose bid
intervention type: Drug
intervention name: BI 113608 PIB bid
description: powder for oral solution
arm group label: BI 113608 low dose bid
intervention type: Drug
intervention name: BI 113608 PIB qd
description: powder for oral solution
arm group label: BI 113608 high dose qd
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Boehringer Ingelheim
role: Study Chair
affiliation: Boehringer Ingelheim
facility: 
country: Germany
url: http://trials.boehringer-ingelheim.com
description: Related Info
responsible party type: Sponsor
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 