<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/NCT03004404</url>
  </required_header>
  <id_info>
    <org_study_id>1407.1</org_study_id>
    <secondary_id>2016-003047-11</secondary_id>
    <nct_id>NCT03004404</nct_id>
  </id_info>
  <brief_title>To Assess Safety, Tolerability and Pharmacokinetics of BI 730357 in Healthy Male Volunteers</brief_title>
  <official_title>A Partially Randomised, Single-blind, Placebo-controlled Trial to Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Doses of BI 730357 Administered as Oral Solution and Tablets to Healthy Subjects, and a Randomized, Open-label, Single-dose, Three-way Cross-over Bioavailability Comparison of BI 730357 as Tablet Versus Oral Solution and Tablet With and Without Food</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 primary objective of the Single Rising Dose (SRD) part (trial part 1) is to investigate&#xD;
      the safety and tolerability of BI 730357 in healthy subjects following oral administration of&#xD;
      single rising doses after fasting and/or non-fasting conditions. The secondary objective is&#xD;
      the exploration of the pharmacokinetics (PK) including dose proportionality, and&#xD;
      pharmacodynamics of BI 730357 after single dosing.&#xD;
&#xD;
      The objective of the Bioavailability (BA) part (trial part 2) will be to explore the relative&#xD;
      bioavailability of tablet fasted versus oral solution fasted and the influence of food on the&#xD;
      bioavailability of tablet fasted versus tablet fed.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 12, 2017</start_date>
  <completion_date type="Actual">August 15, 2017</completion_date>
  <primary_completion_date type="Actual">August 15, 2017</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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Subjects With Drug-related Adverse Events (AEs)</measure>
    <time_frame>SRD 1-7, 10: From first drug administration until end of trial (EOT), up to 13 days. SRD 8-9: From first drug administration until end of trial (EOT), up to 27 days. BA: From first drug administration until end of trial (EOT), up to 41 days.</time_frame>
    <description>Percentage of subjects with adverse reactions, assessed by investigator-defined drug-related adverse events (AEs) are reported.&#xD;
Fed1 means intake of continental breakfast; fed2 means intake of high-fat breakfast. The 400 mg tablet fed1 and fed2 treatments were administered to the same participants.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Area Under the Concentration-time Curve of BI 730357 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-inf)</measure>
    <time_frame>SRD &amp; BA Part: Within 3 hours (h) prior administration, and 0.5h, 1.0h, 1.5h, 2.0h, 2.5h, 3.0h, 4.0h, 5.0h, 6.0h, 8.0h, 10.0h, 12.0h, 24.0h, 34.0h, 48.0h, 72.0h, 96.0h and 168.0h after drug administration</time_frame>
    <description>Area under the concentration-time curve of BI 730357 in plasma over the time interval from 0 extrapolated to infinity is reported.&#xD;
Fed1 means intake of continental breakfast; fed2 means intake of high-fat breakfast. The 400 mg tablet fed1 and fed2 treatments were administered to the same subjects.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum Measured Concentration of BI 730357 in Plasma (Cmax)</measure>
    <time_frame>SRD &amp; BA Part: Within 3 hours (h) prior administration, and 0.5h, 1.0h, 1.5h, 2.0h, 2.5h, 3.0h, 4.0h, 5.0h, 6.0h, 8.0h, 10.0h, 12.0h, 24.0h, 34.0h, 48.0h, 72.0h, 96.0h and 168.0h after drug administration</time_frame>
    <description>Maximum measured concentration of BI 730357 in plasma is reported.&#xD;
Fed1 means intake of continental breakfast; Fed2 means intake of high-fat breakfast. The 400 mg tablet fed1 and fed2 treatments were administered to the same subjects.</description>
  </secondary_outcome>
  <number_of_arms>16</number_of_arms>
  <enrollment type="Actual">84</enrollment>
  <condition>Healthy Volunteers</condition>
  <arm_group>
    <arm_group_label>SRD part-Dose group 1: BI 730357 PfOS 2 mg Fasted</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants were administered on Day 1 a single oral dose of 2 milligram (mg) of BI 730357 powder for reconstitution of an oral solution (PfoS) reconstituted in solvent for oral solution 2 milliliter (mL) (Macrogol 400 (Polyethylene glycol 400) together with about 240 milliliter (mL) of water in fasted state.&#xD;
One authorized employee of the trial site was witness of the administration of the trial medication.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>This arm comprises all placebo treated participants in trial part SRD, regardless of the dose group in which they were treated. Participants of the first cohort of each dose group (DG) were not randomized. In the second cohort of each DG participants were assigned to active treatment or placebo in a 3:1 allocation ratio.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SRD part-Dose group 2: BI 730357 PfOS 8 mg Fasted</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants were administered on Day 1 a single oral dose of 8 milligram (mg) of BI 730357 powder for reconstitution of an oral solution (PfoS) reconstituted in solvent for oral solution 8 milliliter (mL) (Macrogol 400 (Polyethylene glycol 400) together with about 240 milliliter (mL) of water in fasted state.&#xD;
One authorized employee of the trial site was witness of the administration of the trial medication.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SRD part-Dose group 3: BI 730357 tablet 25 mg Fasted</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants were administered on Day 1 a single oral dose of 25 milligram (mg) of BI 730357 film-coated tablet together with about 240 milliliter (mL) of water in fasted state. One authorized employee of the trial site was witness of the administration of the trial medication.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SRD part-Dose group 4: BI 730357 tablet 50 mg Fasted</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants were administered on Day 1 a single oral dose of 50 milligram (mg) of BI 730357 film-coated tablet together with about 240 milliliter (mL) of water in fasted state. One authorized employee of the trial site was witness of the administration of the trial medication.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SRD part-Dose group 5: BI 730357 tablet(s) 100 mg Fasted</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants were administered on Day 1 a single oral dose of 100 milligram (mg) of BI 730357 film-coated tablets (2x50mg) together with about 240 milliliter (mL) of water in fasted state. One authorized employee of the trial site was witness of the administration of the trial medication.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SRD part-Dose group 6: BI 730357 tablet(s) 200 mg Fasted</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants were administered on Day 1 a single oral dose of 200 milligram (mg) of BI 730357 film-coated tablets (4x50mg) together with about 240 milliliter (mL) of water in fasted state. One authorized employee of the trial site was witness of the administration of the trial medication.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SRD part-Dose group 7: BI 730357 tablet(s) 400 mg Fasted</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants were administered on Day 1 a single oral dose of 200 milligram (mg) of BI 730357 film-coated tablets (8x50mg) together with about 240 milliliter (mL) of water in fasted state. One authorized employee of the trial site was witness of the administration of the trial medication.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SRD part-Dose group 8-9: BI 730357 tablet(s) 400 mg Fed</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The same participants conformed the Dose group (DG) 8 and DG 9. DG 8: Participants were administered on Day 1 a single oral dose of 200 milligram (mg) of BI 730357 film-coated tablets (8x50mg) together with about 240 milliliter (mL) of water, 30 minutes (min) prior dose administration the participants consumed a standard continental breakfast.&#xD;
DG 9: Participants were administered on Day 1 a single oral dose of 200 milligram (mg) of BI 730357 film-coated tablets (8x50mg) together with about 240 milliliter (mL) of water, 30 minutes (min) prior dose administration the participants consumed a standard high fat breakfast.&#xD;
Both treatment periods were separated by a wash-out phase of at least 14 days between drug administration of DG 8 and DG 9. One authorized employee of the trial site was witness of the administration of the trial medication.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SRD part-Dose group 10: BI 730357 tablet(s) 800 mg Fed</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants were administered on Day 1 a single oral dose of 200 milligram (mg) of BI 730357 film-coated tablets (16x50mg) together with about 240 milliliter (mL) of water, 30 minutes (min) prior dose administration the participants consumed a standard high fat breakfast. One authorized employee of the trial site was witness of the administration of the trial medication.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>BA Part: R/T2/T1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants were orally administered 25 mg of BI 730357 as film-coated tablet (Reference treatment R) in fasted state.&#xD;
Followed by 25 mg of BI 730357 film-coated tablet in a fed state (test treatment T2), a high-fat, high-calorie breakfast was served 30 min before dose administration.&#xD;
Participants received 25 mg of BI 730357 powder for reconstitution of an oral solution (PfOS) reconstituted in solvent for oral solution 2.5 milliliter (mL) (Macrogol 400 (Polyethylene glycol 400) (test treatment T1) in fasted state.&#xD;
The 3 treatments were administered with 240 mL of water and were separated by a washout period of at least 8 days. One authorized employee of the trial site was witness of the administration of the trial medication.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>BA Part: R/T1/T2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants were orally administered 25 mg of BI 730357 as film-coated tablet (Reference treatment R) in fasted state.&#xD;
Participants received 25 mg of BI 730357 powder for reconstitution of an oral solution (PfOS) reconstituted in solvent for oral solution 2.5 milliliter (mL) (Macrogol 400 (Polyethylene glycol 400) (test treatment T1) in fasted state.&#xD;
Followed by 25 mg of BI 730357 film-coated tablet in a fed state (test treatment T2), a high-fat, high-calorie breakfast was served 30 min before dose administration.&#xD;
The 3 treatments were administered with 240 mL of water and were separated by a washout period of at least 8 days. One authorized employee of the trial site was witness of the administration of the trial medication.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>BA Part: T2/R/T1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants were orally administered 25 mg of BI 730357 film-coated tablet in a fed state (test treatment T2), a high-fat, high-calorie breakfast was served 30 min before dose administration.&#xD;
Followed by 25 mg of BI 730357 as film-coated tablet (Reference treatment R) in fasted state.&#xD;
Participants received 25 mg of BI 730357 powder for reconstitution of an oral solution (PfOS) reconstituted in solvent for oral solution 2.5 milliliter (mL) (Macrogol 400 (Polyethylene glycol 400) (test treatment T1) in fasted state.&#xD;
The 3 treatments were administered with 240 mL of water and were separated by a washout period of at least 8 days. One authorized employee of the trial site was witness of the administration of the trial medication.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>BA Part: T2/T1/R</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants were orally administered 25 mg of BI 730357 film-coated tablet in a fed state (test treatment T2), a high-fat, high-calorie breakfast was served 30 min before dose administration.&#xD;
Participants received 25 mg of BI 730357 powder for reconstitution of an oral solution (PfOS) reconstituted in solvent for oral solution 2.5 milliliter (mL) (Macrogol 400 (Polyethylene glycol 400) (test treatment T1) in fasted state.&#xD;
Followed by 25 mg of BI 730357 as film-coated tablet (Reference treatment R) in fasted state.&#xD;
The 3 treatments were administered with 240 mL of water and were separated by a washout period of at least 8 days. One authorized employee of the trial site was witness of the administration of the trial medication.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>BA Part: T1/R/T2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants received 25 mg of BI 730357 powder for reconstitution of an oral solution (PfOS) reconstituted in solvent for oral solution 2.5 milliliter (mL) (Macrogol 400 (Polyethylene glycol 400) (test treatment T1) in fasted state.&#xD;
Followed by 25 mg of BI 730357 as film-coated tablet (Reference treatment R) in fasted state.&#xD;
Participants were orally administered 25 mg of BI 730357 film-coated tablet in a fed state (test treatment T2), a high-fat, high-calorie breakfast was served 30 min before dose administration.&#xD;
The 3 treatments were administered with 240 mL of water and were separated by a washout period of at least 8 days. One authorized employee of the trial site was witness of the administration of the trial medication.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>BA Part: T1/T2/R</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>BA Part: T1/T2/R Participants received 25 mg of BI 730357 powder for reconstitution of an oral solution (PfOS) reconstituted in solvent for oral solution 2.5 milliliter (mL) (Macrogol 400 (Polyethylene glycol 400) (test treatment T1) in fasted state.&#xD;
Participants were orally administered 25 mg of BI 730357 film-coated tablet in a fed state (test treatment T2), a high-fat, high-calorie breakfast was served 30 min before dose administration.&#xD;
Followed by 25 mg of BI 730357 as film-coated tablet (Reference treatment R) in fasted state.&#xD;
The 3 treatments were administered with 240 mL of water and were separated by a washout period of at least 8 days. One authorized employee of the trial site was witness of the administration of the trial medication.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BI 730357</intervention_name>
    <description>powder for reconstitution of an oral solution (PfoS)</description>
    <arm_group_label>BA Part: R/T1/T2</arm_group_label>
    <arm_group_label>BA Part: R/T2/T1</arm_group_label>
    <arm_group_label>BA Part: T1/R/T2</arm_group_label>
    <arm_group_label>BA Part: T1/T2/R</arm_group_label>
    <arm_group_label>BA Part: T2/R/T1</arm_group_label>
    <arm_group_label>BA Part: T2/T1/R</arm_group_label>
    <arm_group_label>SRD part-Dose group 1: BI 730357 PfOS 2 mg Fasted</arm_group_label>
    <arm_group_label>SRD part-Dose group 2: BI 730357 PfOS 8 mg Fasted</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BI 730357</intervention_name>
    <description>BI 730357 film-coated tablet</description>
    <arm_group_label>BA Part: R/T1/T2</arm_group_label>
    <arm_group_label>BA Part: R/T2/T1</arm_group_label>
    <arm_group_label>BA Part: T1/R/T2</arm_group_label>
    <arm_group_label>BA Part: T1/T2/R</arm_group_label>
    <arm_group_label>BA Part: T2/R/T1</arm_group_label>
    <arm_group_label>BA Part: T2/T1/R</arm_group_label>
    <arm_group_label>SRD part-Dose group 10: BI 730357 tablet(s) 800 mg Fed</arm_group_label>
    <arm_group_label>SRD part-Dose group 3: BI 730357 tablet 25 mg Fasted</arm_group_label>
    <arm_group_label>SRD part-Dose group 4: BI 730357 tablet 50 mg Fasted</arm_group_label>
    <arm_group_label>SRD part-Dose group 5: BI 730357 tablet(s) 100 mg Fasted</arm_group_label>
    <arm_group_label>SRD part-Dose group 6: BI 730357 tablet(s) 200 mg Fasted</arm_group_label>
    <arm_group_label>SRD part-Dose group 7: BI 730357 tablet(s) 400 mg Fasted</arm_group_label>
    <arm_group_label>SRD part-Dose group 8-9: BI 730357 tablet(s) 400 mg Fed</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy male according to the Investigator's assessment, based on a complete medical&#xD;
             history including a physical examination, vital signs (Blood Pressure (BP), Pulse Rate&#xD;
             (PR)), 12-lead Electrocardiogram (ECG), and clinical laboratory tests&#xD;
&#xD;
          -  Age of 18 to 45 years (incl.)&#xD;
&#xD;
          -  Body Mass index (BMI) of 18.5 to 29.9 kg/m2 (incl.)&#xD;
&#xD;
          -  Signed and dated written informed consent prior to admission to the study in&#xD;
             accordance with Good Clinical Practice (GCP) and local legislation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any finding in the medical examination (including Blood Pressure (BP), Pulse Rate (PR)&#xD;
             or Electrocardiogram (ECG)) is deviating from normal and judged as clinically relevant&#xD;
             by the Investigator&#xD;
&#xD;
          -  Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg,&#xD;
             diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the&#xD;
             range of 50 to 90 beats per minute (bpm)&#xD;
&#xD;
          -  Any laboratory value outside the reference range that the Investigator considers to be&#xD;
             of clinical relevance&#xD;
&#xD;
          -  Any evidence of a concomitant disease judged as clinically relevant by the&#xD;
             Investigator&#xD;
&#xD;
          -  Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic,&#xD;
             immunological or hormonal disorders&#xD;
&#xD;
          -  Cholecystectomy and/or surgery of the gastrointestinal tract that could interfere with&#xD;
             the pharmacokinetics of the trial medication (except appendectomy and simple hernia&#xD;
             repair)&#xD;
&#xD;
          -  Diseases of the central nervous system (including but not limited to any kind of&#xD;
             seizures or stroke), and other relevant neurological or psychiatric disorders&#xD;
&#xD;
          -  History of relevant orthostatic hypotension, fainting spells, or blackouts&#xD;
&#xD;
          -  Chronic or relevant acute infections&#xD;
&#xD;
          -  History of relevant allergy or hypersensitivity (including allergy to the trial&#xD;
             medication or its excipients)&#xD;
&#xD;
          -  Use of drugs within 30 days prior to administration of trial medication if that might&#xD;
             reasonably influence the results of the trial (incl. QT/QTc (corrected QT) interval&#xD;
             prolongation)&#xD;
&#xD;
          -  Participation in another trial where an investigational drug has been administered&#xD;
             within 60 days prior to planned administration of trial medication, or current&#xD;
             participation in another trial involving administration of investigational drug&#xD;
&#xD;
          -  Smoker (more than 10 cigarettes or 3 cigars or 3 pipes per day)&#xD;
&#xD;
          -  Inability to refrain from smoking on specified trial days&#xD;
&#xD;
          -  Alcohol abuse (consumption of more 30 g per day for males)&#xD;
&#xD;
          -  Drug abuse or positive drug screening&#xD;
&#xD;
          -  Blood donation of more than 100 mL within 30 days prior to administration of trial&#xD;
             medication or intended donation during the trial&#xD;
&#xD;
          -  Intention to perform excessive physical activities within one week prior to&#xD;
             administration of trial medication or during the trial&#xD;
&#xD;
          -  Inability to comply with dietary regimen of trial site&#xD;
&#xD;
          -  A marked baseline prolongation of QT/QTc interval (such as QTc intervals that are&#xD;
             repeatedly greater than 450 ms) or any other relevant ECG finding at screening&#xD;
&#xD;
          -  A history of additional risk factors for Torsades de Pointes (such as heart failure,&#xD;
             hypokalemia, or family history of Long QT Syndrome)&#xD;
&#xD;
          -  Subject is assessed as unsuitable for inclusion by the Investigator, for instance,&#xD;
             because considered not able to understand and comply with study requirements, or has a&#xD;
             condition that would not allow safe participation in the study&#xD;
&#xD;
        In addition, the following trial-specific exclusion criteria apply:&#xD;
&#xD;
        - Male subjects with Women of childbearing potential (WOCBP) partner who are unwilling to&#xD;
        use male contraception (condom or sexual abstinence) from the first administration of trial&#xD;
        medication until 30 days after last administration of trial medication&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 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>Humanpharmakologisches Zentrum Biberach</name>
      <address>
        <city>Biberach</city>
        <zip>88397</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <link>
    <url>https://www.mystudywindow.com</url>
    <description>Related Info</description>
  </link>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>December 23, 2016</study_first_submitted>
  <study_first_submitted_qc>December 23, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 28, 2016</study_first_posted>
  <results_first_submitted>August 12, 2022</results_first_submitted>
  <results_first_submitted_qc>August 11, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">August 16, 2023</results_first_posted>
  <last_update_submitted>August 11, 2023</last_update_submitted>
  <last_update_submitted_qc>August 11, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 16, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization).&#xD;
For more details refer to:&#xD;
https://www.mystudywindow.com/msw/datatransparency</ipd_description>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>May 5, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/04/NCT03004404/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>September 22, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/04/NCT03004404/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>This study had two parts, single rising dose (SRD): partially randomized, single-blind, placebo-controlled, parallel group design to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of BI 730357. Bioavailability/food effect (BA/FE) part: Single dose, randomised, open-label, intra-individual three-way crossover to investigate the relative BA of the tablet formulation versus oral solution as well as the influence of food on the bioavailability of the tablet formulation.</recruitment_details>
      <pre_assignment_details>All subjects were screened for eligibility to participate in trial. Subjects attended specialist sites to ensure that they (the subjects) met all implemented inclusion/exclusion criteria. Subjects were not to be randomised to trial drug if any of the specific entry criteria was violated.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Placebo</title>
          <description>This arm comprises all placebo treated participants in trial part SRD, regardless of the dose group in which they were treated. Participants of the first cohort of each dose group (DG) were not randomized. In the second cohort of each DG participants were assigned to active treatment or placebo in a 3:1 allocation ratio.&#xD;
Participants were administered on Day 1 a single oral dose of matching placebo, for dose group (DG) 1-2 the matching placebo was solvent for oral solution containing Macrogol 400 (Polyethylene glycol 400) on a volume identical to dose group of active treatment, for DG 3-7 the matching placebo were single oral film-coated tablet(s) with about 240 milliliter (mL) of water on fasted state. For DG 8-10 the matching placebo were single oral film-coated tablet(s) with about 240 milliliter (mL) of water on fed state, 30 minutes (min) prior dose administration the participants consumed a standard high fat breakfast/continental breakfast depending on dose group. One authorized employee of the trial site was witness of the administration of the trial medication.</description>
        </group>
        <group group_id="P2">
          <title>SRD Part-Dose Group 1: BI 730357 PfOS 2 mg Fasted</title>
          <description>Participants were administered on Day 1 a single oral dose of 2 milligram (mg) of BI 730357 powder for reconstitution of an oral solution (PfoS) reconstituted in solvent for oral solution 2 milliliter (mL) (Macrogol 400 (Polyethylene glycol 400) together with about 240 milliliter (mL) of water in fasted state.&#xD;
One authorized employee of the trial site was witness of the administration of the trial medication.</description>
        </group>
        <group group_id="P3">
          <title>SRD Part-Dose Group 2: BI 730357 PfOS 8 mg Fasted</title>
          <description>Participants were administered on Day 1 a single oral dose of 8 milligram (mg) of BI 730357 powder for reconstitution of an oral solution (PfoS) reconstituted in solvent for oral solution 8 milliliter (mL) (Macrogol 400 (Polyethylene glycol 400) together with about 240 milliliter (mL) of water in fasted state.&#xD;
One authorized employee of the trial site was witness of the administration of the trial medication.</description>
        </group>
        <group group_id="P4">
          <title>SRD Part-Dose Group 3: BI 730357 Tablet 25 mg Fasted</title>
          <description>Participants were administered on Day 1 a single oral dose of 25 milligram (mg) of BI 730357 film-coated tablet together with about 240 milliliter (mL) of water in fasted state. One authorized employee of the trial site was witness of the administration of the trial medication.</description>
        </group>
        <group group_id="P5">
          <title>SRD Part-Dose Group 4: BI 730357 Tablet 50 mg Fasted</title>
          <description>Participants were administered on Day 1 a single oral dose of 50 milligram (mg) of BI 730357 film-coated tablet together with about 240 milliliter (mL) of water in fasted state. One authorized employee of the trial site was witness of the administration of the trial medication.</description>
        </group>
        <group group_id="P6">
          <title>SRD Part-Dose Group 5: BI 730357 Tablet(s) 100 mg Fasted</title>
          <description>Participants were administered on Day 1 a single oral dose of 100 milligram (mg) of BI 730357 film-coated tablets (2x50mg) together with about 240 milliliter (mL) of water in fasted state. One authorized employee of the trial site was witness of the administration of the trial medication.</description>
        </group>
        <group group_id="P7">
          <title>SRD Part-Dose Group 6: BI 730357 Tablet(s) 200 mg Fasted</title>
          <description>Participants were administered on Day 1 a single oral dose of 200 milligram (mg) of BI 730357 film-coated tablets (4x50mg) together with about 240 milliliter (mL) of water in fasted state. One authorized employee of the trial site was witness of the administration of the trial medication.</description>
        </group>
        <group group_id="P8">
          <title>SRD Part-Dose Group 7: BI 730357 Tablet(s) 400 mg Fasted</title>
          <description>Participants were administered on Day 1 a single oral dose of 200 milligram (mg) of BI 730357 film-coated tablets (8x50mg) together with about 240 milliliter (mL) of water in fasted state. One authorized employee of the trial site was witness of the administration of the trial medication.</description>
        </group>
        <group group_id="P9">
          <title>SRD Part-Dose Group 8-9: BI 730357 Tablet(s) 400 mg Fed</title>
          <description>The same participants conformed the Dose group (DG) 8 and DG 9. DG 8: Participants were administered on Day 1 a single oral dose of 200 milligram (mg) of BI 730357 film-coated tablets (8x50mg) together with about 240 milliliter (mL) of water, 30 minutes (min) prior dose administration the participants consumed a standard continental breakfast.&#xD;
DG 9: Participants were administered on Day 1 a single oral dose of 200 milligram (mg) of BI 730357 film-coated tablets (8x50mg) together with about 240 milliliter (mL) of water, 30 minutes (min) prior dose administration the participants consumed a standard high fat breakfast.&#xD;
Both treatment periods were separated by a wash-out phase of at least 14 days between drug administration of DG 8 and DG 9. One authorized employee of the trial site was witness of the administration of the trial medication.</description>
        </group>
        <group group_id="P10">
          <title>SRD Part-Dose Group 10: BI 730357 Tablet(s) 800 mg Fed</title>
          <description>Participants were administered on Day 1 a single oral dose of 200 milligram (mg) of BI 730357 film-coated tablets (16x50mg) together with about 240 milliliter (mL) of water, 30 minutes (min) prior dose administration the participants consumed a standard high fat breakfast. One authorized employee of the trial site was witness of the administration of the trial medication.</description>
        </group>
        <group group_id="P11">
          <title>BA Part: R/T2/T1</title>
          <description>Participants were orally administered 25 mg of BI 730357 as film-coated tablet (Reference treatment R) in fasted state.&#xD;
Followed by 25 mg of BI 730357 film-coated tablet in a fed state (test treatment T2), a high-fat, high-calorie breakfast was served 30 min before dose administration.&#xD;
Participants received 25 mg of BI 730357 powder for reconstitution of an oral solution (PfOS) reconstituted in solvent for oral solution 2.5 milliliter (mL) (Macrogol 400 (Polyethylene glycol 400) (test treatment T1) in fasted state.&#xD;
The 3 treatments were administered with 240 mL of water and were separated by a washout period of at least 8 days. One authorized employee of the trial site was witness of the administration of the trial medication.</description>
        </group>
        <group group_id="P12">
          <title>BA Part: R/T1/T2</title>
          <description>Participants were orally administered 25 mg of BI 730357 as film-coated tablet (Reference treatment R) in fasted state.&#xD;
Participants received 25 mg of BI 730357 powder for reconstitution of an oral solution (PfOS) reconstituted in solvent for oral solution 2.5 milliliter (mL) (Macrogol 400 (Polyethylene glycol 400) (test treatment T1) in fasted state.&#xD;
Followed by 25 mg of BI 730357 film-coated tablet in a fed state (test treatment T2), a high-fat, high-calorie breakfast was served 30 min before dose administration.&#xD;
The 3 treatments were administered with 240 mL of water and were separated by a washout period of at least 8 days. One authorized employee of the trial site was witness of the administration of the trial medication.</description>
        </group>
        <group group_id="P13">
          <title>BA Part: T2/R/T1</title>
          <description>Participants were orally administered 25 mg of BI 730357 film-coated tablet in a fed state (test treatment T2), a high-fat, high-calorie breakfast was served 30 min before dose administration.&#xD;
Followed by 25 mg of BI 730357 as film-coated tablet (Reference treatment R) in fasted state.&#xD;
Participants received 25 mg of BI 730357 powder for reconstitution of an oral solution (PfOS) reconstituted in solvent for oral solution 2.5 milliliter (mL) (Macrogol 400 (Polyethylene glycol 400) (test treatment T1) in fasted state.&#xD;
The 3 treatments were administered with 240 mL of water and were separated by a washout period of at least 8 days. One authorized employee of the trial site was witness of the administration of the trial medication.</description>
        </group>
        <group group_id="P14">
          <title>BA Part: T2/T1/R</title>
          <description>Participants were orally administered 25 mg of BI 730357 film-coated tablet in a fed state (test treatment T2), a high-fat, high-calorie breakfast was served 30 min before dose administration.&#xD;
Participants received 25 mg of BI 730357 powder for reconstitution of an oral solution (PfOS) reconstituted in solvent for oral solution 2.5 milliliter (mL) (Macrogol 400 (Polyethylene glycol 400) (test treatment T1) in fasted state.&#xD;
Followed by 25 mg of BI 730357 as film-coated tablet (Reference treatment R) in fasted state.&#xD;
The 3 treatments were administered with 240 mL of water and were separated by a washout period of at least 8 days. One authorized employee of the trial site was witness of the administration of the trial medication.</description>
        </group>
        <group group_id="P15">
          <title>BA Part: T1/R/T2</title>
          <description>Participants received 25 mg of BI 730357 powder for reconstitution of an oral solution (PfOS) reconstituted in solvent for oral solution 2.5 milliliter (mL) (Macrogol 400 (Polyethylene glycol 400) (test treatment T1) in fasted state.&#xD;
Followed by 25 mg of BI 730357 as film-coated tablet (Reference treatment R) in fasted state.&#xD;
Participants were orally administered 25 mg of BI 730357 film-coated tablet in a fed state (test treatment T2), a high-fat, high-calorie breakfast was served 30 min before dose administration.&#xD;
The 3 treatments were administered with 240 mL of water and were separated by a washout period of at least 8 days. One authorized employee of the trial site was witness of the administration of the trial medication.</description>
        </group>
        <group group_id="P16">
          <title>BA Part: T1/T2/R</title>
          <description>Participants received 25 mg of BI 730357 powder for reconstitution of an oral solution (PfOS) reconstituted in solvent for oral solution 2.5 milliliter (mL) (Macrogol 400 (Polyethylene glycol 400) (test treatment T1) in fasted state.&#xD;
Participants were orally administered 25 mg of BI 730357 film-coated tablet in a fed state (test treatment T2), a high-fat, high-calorie breakfast was served 30 min before dose administration.&#xD;
Followed by 25 mg of BI 730357 as film-coated tablet (Reference treatment R) in fasted state.&#xD;
The 3 treatments were administered with 240 mL of water and were separated by a washout period of at least 8 days. One authorized employee of the trial site was witness of the administration of the trial medication.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Period 1</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="18"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="6"/>
                <participants group_id="P4" count="6"/>
                <participants group_id="P5" count="6"/>
                <participants group_id="P6" count="6"/>
                <participants group_id="P7" count="6"/>
                <participants group_id="P8" count="6"/>
                <participants group_id="P9" count="6"/>
                <participants group_id="P10" count="6"/>
                <participants group_id="P11" count="2"/>
                <participants group_id="P12" count="2"/>
                <participants group_id="P13" count="2"/>
                <participants group_id="P14" count="2"/>
                <participants group_id="P15" count="2"/>
                <participants group_id="P16" count="2"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="18"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="6"/>
                <participants group_id="P4" count="6"/>
                <participants group_id="P5" count="6"/>
                <participants group_id="P6" count="6"/>
                <participants group_id="P7" count="6"/>
                <participants group_id="P8" count="6"/>
                <participants group_id="P9" count="6"/>
                <participants group_id="P10" count="6"/>
                <participants group_id="P11" count="2"/>
                <participants group_id="P12" count="2"/>
                <participants group_id="P13" count="2"/>
                <participants group_id="P14" count="2"/>
                <participants group_id="P15" count="2"/>
                <participants group_id="P16" count="2"/>
              </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="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
                <participants group_id="P12" count="0"/>
                <participants group_id="P13" count="0"/>
                <participants group_id="P14" count="0"/>
                <participants group_id="P15" count="0"/>
                <participants group_id="P16" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Period 2</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="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="6"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="2"/>
                <participants group_id="P12" count="2"/>
                <participants group_id="P13" count="2"/>
                <participants group_id="P14" count="2"/>
                <participants group_id="P15" count="2"/>
                <participants group_id="P16" count="2"/>
              </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="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="5"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="2"/>
                <participants group_id="P12" count="2"/>
                <participants group_id="P13" count="2"/>
                <participants group_id="P14" count="2"/>
                <participants group_id="P15" count="2"/>
                <participants group_id="P16" count="1"/>
              </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="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="1"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
                <participants group_id="P12" count="0"/>
                <participants group_id="P13" count="0"/>
                <participants group_id="P14" count="0"/>
                <participants group_id="P15" count="0"/>
                <participants group_id="P16" 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="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="1"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
                <participants group_id="P12" count="0"/>
                <participants group_id="P13" count="0"/>
                <participants group_id="P14" count="0"/>
                <participants group_id="P15" count="0"/>
                <participants group_id="P16" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Period 3</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="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="2"/>
                <participants group_id="P12" count="2"/>
                <participants group_id="P13" count="2"/>
                <participants group_id="P14" count="2"/>
                <participants group_id="P15" count="2"/>
                <participants group_id="P16" count="1"/>
              </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="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="2"/>
                <participants group_id="P12" count="2"/>
                <participants group_id="P13" count="2"/>
                <participants group_id="P14" count="2"/>
                <participants group_id="P15" count="2"/>
                <participants group_id="P16" count="1"/>
              </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="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
                <participants group_id="P12" count="0"/>
                <participants group_id="P13" count="0"/>
                <participants group_id="P14" count="0"/>
                <participants group_id="P15" count="0"/>
                <participants group_id="P16" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Treated Set (TS): The Treated set (TS) included all subjects from the Randomised set (RS) who were documented to have taken at least 1 dose of trial medication. The TS for the SRD part included 72 subjects. The TS for the BA part included all 12 treated subjects.</population>
      <group_list>
        <group group_id="B1">
          <title>Placebo</title>
          <description>This arm comprises all placebo treated participants in trial part SRD, regardless of the dose group in which they were treated. Participants of the first cohort of each dose group (DG) were not randomized. In the second cohort of each DG participants were assigned to active treatment or placebo in a 3:1 allocation ratio.&#xD;
Participants were administered on Day 1 a single oral dose of matching placebo, for dose group (DG) 1-2 the matching placebo was solvent for oral solution containing Macrogol 400 (Polyethylene glycol 400) on a volume identical to dose group of active treatment, for DG 3-7 the matching placebo were single oral film-coated tablet(s) with about 240 milliliter (mL) of water on fasted state. For DG 8-10 the matching placebo were single oral film-coated tablet(s) with about 240 milliliter (mL) of water on fed state, 30 minutes (min) prior dose administration the participants consumed a standard high fat breakfast/continental breakfast depending on dose group. One authorized employee of the trial site was witness of the administration of the trial medication.</description>
        </group>
        <group group_id="B2">
          <title>SRD Part-Dose Group 1: BI 730357 PfOS 2 mg Fasted</title>
          <description>Participants were administered on Day 1 a single oral dose of 2 milligram (mg) of BI 730357 powder for reconstitution of an oral solution (PfoS) reconstituted in solvent for oral solution 2 milliliter (mL) (Macrogol 400 (Polyethylene glycol 400) together with about 240 milliliter (mL) of water in fasted state.&#xD;
One authorized employee of the trial site was witness of the administration of the trial medication.</description>
        </group>
        <group group_id="B3">
          <title>SRD Part-Dose Group 2: BI 730357 PfOS 8 mg Fasted</title>
          <description>Participants were administered on Day 1 a single oral dose of 8 milligram (mg) of BI 730357 powder for reconstitution of an oral solution (PfoS) reconstituted in solvent for oral solution 8 milliliter (mL) (Macrogol 400 (Polyethylene glycol 400) together with about 240 milliliter (mL) of water in fasted state.&#xD;
One authorized employee of the trial site was witness of the administration of the trial medication.</description>
        </group>
        <group group_id="B4">
          <title>SRD Part-Dose Group 3: BI 730357 Tablet 25 mg Fasted</title>
          <description>Participants were administered on Day 1 a single oral dose of 25 milligram (mg) of BI 730357 film-coated tablet together with about 240 milliliter (mL) of water in fasted state. One authorized employee of the trial site was witness of the administration of the trial medication.</description>
        </group>
        <group group_id="B5">
          <title>SRD Part-Dose Group 4: BI 730357 Tablet 50 mg Fasted</title>
          <description>Participants were administered on Day 1 a single oral dose of 50 milligram (mg) of BI 730357 film-coated tablet together with about 240 milliliter (mL) of water in fasted state. One authorized employee of the trial site was witness of the administration of the trial medication.</description>
        </group>
        <group group_id="B6">
          <title>SRD Part-Dose Group 5: BI 730357 Tablet(s) 100 mg Fasted</title>
          <description>Participants were administered on Day 1 a single oral dose of 100 milligram (mg) of BI 730357 film-coated tablets (2x50mg) together with about 240 milliliter (mL) of water in fasted state. One authorized employee of the trial site was witness of the administration of the trial medication.</description>
        </group>
        <group group_id="B7">
          <title>SRD Part-Dose Group 6: BI 730357 Tablet(s) 200 mg Fasted</title>
          <description>Participants were administered on Day 1 a single oral dose of 200 milligram (mg) of BI 730357 film-coated tablets (4x50mg) together with about 240 milliliter (mL) of water in fasted state. One authorized employee of the trial site was witness of the administration of the trial medication.</description>
        </group>
        <group group_id="B8">
          <title>SRD Part-Dose Group 7: BI 730357 Tablet(s) 400 mg Fasted</title>
          <description>Participants were administered on Day 1 a single oral dose of 200 milligram (mg) of BI 730357 film-coated tablets (8x50mg) together with about 240 milliliter (mL) of water in fasted state. One authorized employee of the trial site was witness of the administration of the trial medication.</description>
        </group>
        <group group_id="B9">
          <title>SRD Part-Dose Group 8-9: BI 730357 Tablet(s) 400 mg Fed</title>
          <description>The same participants conformed the Dose group (DG) 8 and DG 9. DG 8: Participants were administered on Day 1 a single oral dose of 200 milligram (mg) of BI 730357 film-coated tablets (8x50mg) together with about 240 milliliter (mL) of water, 30 minutes (min) prior dose administration the participants consumed a standard continental breakfast.&#xD;
DG 9: Participants were administered on Day 1 a single oral dose of 200 milligram (mg) of BI 730357 film-coated tablets (8x50mg) together with about 240 milliliter (mL) of water, 30 minutes (min) prior dose administration the participants consumed a standard high fat breakfast.&#xD;
Both treatment periods were separated by a wash-out phase of at least 14 days between drug administration of DG 8 and DG 9. One authorized employee of the trial site was witness of the administration of the trial medication.</description>
        </group>
        <group group_id="B10">
          <title>SRD Part-Dose Group 10: BI 730357 Tablet(s) 800 mg Fed</title>
          <description>Participants were administered on Day 1 a single oral dose of 200 milligram (mg) of BI 730357 film-coated tablets (16x50mg) together with about 240 milliliter (mL) of water, 30 minutes (min) prior dose administration the participants consumed a standard high fat breakfast. One authorized employee of the trial site was witness of the administration of the trial medication.</description>
        </group>
        <group group_id="B11">
          <title>BA Part</title>
          <description>In the BA part of the trial, subjects were randomised to 6 treatment sequences. All subjects were administered BI 730357 as tablet in fasted condition (R), as oral solution in fasted condition (T1), and as tablet after a standardised high-fat breakfast (T2). The 3 treatments were separated by a wash-out period of at least 8 days between trial drug administrations. One authorized employee of the trial site was witness of the administration of the trial medication.</description>
        </group>
        <group group_id="B12">
          <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="18"/>
            <count group_id="B2" value="6"/>
            <count group_id="B3" value="6"/>
            <count group_id="B4" value="6"/>
            <count group_id="B5" value="6"/>
            <count group_id="B6" value="6"/>
            <count group_id="B7" value="6"/>
            <count group_id="B8" value="6"/>
            <count group_id="B9" value="6"/>
            <count group_id="B10" value="6"/>
            <count group_id="B11" value="12"/>
            <count group_id="B12" value="84"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <population>Treated set</population>
          <units>Years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="32.3" spread="6.3"/>
                    <measurement group_id="B2" value="36.8" spread="4.5"/>
                    <measurement group_id="B3" value="33.0" spread="6.5"/>
                    <measurement group_id="B4" value="30.7" spread="6.7"/>
                    <measurement group_id="B5" value="30.2" spread="8.7"/>
                    <measurement group_id="B6" value="31.3" spread="5.0"/>
                    <measurement group_id="B7" value="30.2" spread="7.9"/>
                    <measurement group_id="B8" value="34.5" spread="5.9"/>
                    <measurement group_id="B9" value="30.8" spread="7.0"/>
                    <measurement group_id="B10" value="31.7" spread="5.5"/>
                    <measurement group_id="B11" value="35.3" spread="8.6"/>
                    <measurement group_id="B12" value="32.6" spread="6.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <population>Treated Set</population>
          <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 group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="0"/>
                    <measurement group_id="B10" value="0"/>
                    <measurement group_id="B11" value="0"/>
                    <measurement group_id="B12" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="6"/>
                    <measurement group_id="B4" value="6"/>
                    <measurement group_id="B5" value="6"/>
                    <measurement group_id="B6" value="6"/>
                    <measurement group_id="B7" value="6"/>
                    <measurement group_id="B8" value="6"/>
                    <measurement group_id="B9" value="6"/>
                    <measurement group_id="B10" value="6"/>
                    <measurement group_id="B11" value="12"/>
                    <measurement group_id="B12" value="84"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <description>TS</description>
          <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 group_id="B9" value="0"/>
                    <measurement group_id="B10" value="0"/>
                    <measurement group_id="B11" value="0"/>
                    <measurement group_id="B12" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="6"/>
                    <measurement group_id="B4" value="6"/>
                    <measurement group_id="B5" value="6"/>
                    <measurement group_id="B6" value="6"/>
                    <measurement group_id="B7" value="6"/>
                    <measurement group_id="B8" value="6"/>
                    <measurement group_id="B9" value="6"/>
                    <measurement group_id="B10" value="6"/>
                    <measurement group_id="B11" value="12"/>
                    <measurement group_id="B12" value="84"/>
                  </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 group_id="B9" value="0"/>
                    <measurement group_id="B10" value="0"/>
                    <measurement group_id="B11" value="0"/>
                    <measurement group_id="B12" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <population>Treated Set</population>
          <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 group_id="B9" value="0"/>
                    <measurement group_id="B10" value="0"/>
                    <measurement group_id="B11" value="0"/>
                    <measurement group_id="B12" 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="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 group_id="B9" value="0"/>
                    <measurement group_id="B10" value="0"/>
                    <measurement group_id="B11" value="0"/>
                    <measurement group_id="B12" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement 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 group_id="B9" value="0"/>
                    <measurement group_id="B10" value="0"/>
                    <measurement group_id="B11" value="0"/>
                    <measurement group_id="B12" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <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 group_id="B9" value="0"/>
                    <measurement group_id="B10" value="0"/>
                    <measurement group_id="B11" value="0"/>
                    <measurement group_id="B12" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="6"/>
                    <measurement group_id="B4" value="6"/>
                    <measurement group_id="B5" value="6"/>
                    <measurement group_id="B6" value="6"/>
                    <measurement group_id="B7" value="6"/>
                    <measurement group_id="B8" value="6"/>
                    <measurement group_id="B9" value="6"/>
                    <measurement group_id="B10" value="6"/>
                    <measurement group_id="B11" value="12"/>
                    <measurement group_id="B12" value="83"/>
                  </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 group_id="B9" value="0"/>
                    <measurement group_id="B10" value="0"/>
                    <measurement group_id="B11" value="0"/>
                    <measurement group_id="B12" 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 group_id="B9" value="0"/>
                    <measurement group_id="B10" value="0"/>
                    <measurement group_id="B11" value="0"/>
                    <measurement group_id="B12" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Subjects With Drug-related Adverse Events (AEs)</title>
        <description>Percentage of subjects with adverse reactions, assessed by investigator-defined drug-related adverse events (AEs) are reported.&#xD;
Fed1 means intake of continental breakfast; fed2 means intake of high-fat breakfast. The 400 mg tablet fed1 and fed2 treatments were administered to the same participants.</description>
        <time_frame>SRD 1-7, 10: From first drug administration until end of trial (EOT), up to 13 days. SRD 8-9: From first drug administration until end of trial (EOT), up to 27 days. BA: From first drug administration until end of trial (EOT), up to 41 days.</time_frame>
        <population>Treated set (TS): This subject set included all subjects from the Randomised set (RS) who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>This arm comprises all placebo treated participants in trial part SRD, regardless of the dose group in which they were treated. Participants of the first cohort of each dose group (DG) were not randomized. In the second cohort of each DG participants were assigned to active treatment or placebo in a 3:1 allocation ratio.&#xD;
Participants were administered on Day 1 a single oral dose of matching placebo, for dose group (DG) 1-2 the matching placebo was solvent for oral solution containing Macrogol 400 (Polyethylene glycol 400) on a volume identical to dose group of active treatment, for DG 3-7 the matching placebo were single oral film-coated tablet(s) with about 240 milliliter (mL) of water on fasted state. For DG 8-10 the matching placebo were single oral film-coated tablet(s) with about 240 milliliter (mL) of water on fed state, 30 minutes (min) prior dose administration the participants consumed a standard high fat breakfast/continental breakfast depending on dose group. One authorized employee of the trial site was witness of the administration of the trial medication.</description>
          </group>
          <group group_id="O2">
            <title>SRD Part-Dose Group 1: BI 730357 PfOS 2 mg Fasted</title>
            <description>Participants were administered on Day 1 a single oral dose of 2 milligram (mg) of BI 730357 powder for reconstitution of an oral solution (PfoS) reconstituted in solvent for oral solution 2 milliliter (mL) (Macrogol 400 (Polyethylene glycol 400) together with about 240 milliliter (mL) of water in fasted state.&#xD;
One authorized employee of the trial site was witness of the administration of the trial medication.</description>
          </group>
          <group group_id="O3">
            <title>SRD Part-Dose Group 2: BI 730357 PfOS 8 mg Fasted</title>
            <description>Participants were administered on Day 1 a single oral dose of 8 milligram (mg) of BI 730357 powder for reconstitution of an oral solution (PfoS) reconstituted in solvent for oral solution 8 milliliter (mL) (Macrogol 400 (Polyethylene glycol 400) together with about 240 milliliter (mL) of water in fasted state.&#xD;
One authorized employee of the trial site was witness of the administration of the trial medication.</description>
          </group>
          <group group_id="O4">
            <title>SRD Part-Dose Group 3: BI 730357 Tablet 25 mg Fasted</title>
            <description>Participants were administered on Day 1 a single oral dose of 25 milligram (mg) of BI 730357 film-coated tablet together with about 240 milliliter (mL) of water in fasted state. One authorized employee of the trial site was witness of the administration of the trial medication.</description>
          </group>
          <group group_id="O5">
            <title>SRD Part-Dose Group 4: BI 730357 Tablet 50 mg Fasted</title>
            <description>Participants were administered on Day 1 a single oral dose of 50 milligram (mg) of BI 730357 film-coated tablet together with about 240 milliliter (mL) of water in fasted state. One authorized employee of the trial site was witness of the administration of the trial medication.</description>
          </group>
          <group group_id="O6">
            <title>SRD Part-Dose Group 5: BI 730357 Tablet(s) 100 mg Fasted</title>
            <description>Participants were administered on Day 1 a single oral dose of 100 milligram (mg) of BI 730357 film-coated tablets (2x50mg) together with about 240 milliliter (mL) of water in fasted state. One authorized employee of the trial site was witness of the administration of the trial medication.</description>
          </group>
          <group group_id="O7">
            <title>SRD Part-Dose Group 6: BI 730357 Tablet(s) 200 mg Fasted</title>
            <description>Participants were administered on Day 1 a single oral dose of 200 milligram (mg) of BI 730357 film-coated tablets (4x50mg) together with about 240 milliliter (mL) of water in fasted state. One authorized employee of the trial site was witness of the administration of the trial medication.</description>
          </group>
          <group group_id="O8">
            <title>SRD Part-Dose Group 7: BI 730357 Tablet(s) 400 mg Fasted</title>
            <description>Participants were administered on Day 1 a single oral dose of 200 milligram (mg) of BI 730357 film-coated tablets (8x50mg) together with about 240 milliliter (mL) of water in fasted state. One authorized employee of the trial site was witness of the administration of the trial medication.</description>
          </group>
          <group group_id="O9">
            <title>SRD Part-Dose Group 8: BI 730357 Tablets(s) 400 mg Fed1</title>
            <description>Participants were administered on Day 1 a single oral dose of 200 milligram (mg) of BI 730357 film-coated tablets (8x50mg) together with about 240 milliliter (mL) of water, 30 minutes (min) prior dose administration the participants consumed a standard continental breakfast. One authorized employee of the trial site was witness of the administration of the trial medication.</description>
          </group>
          <group group_id="O10">
            <title>SRD Part-Dose Group 9: BI 730357 Tablets(s) 400 mg Fed2</title>
            <description>Participants were administered on Day 1 of period 2 a single oral dose of 200 milligram (mg) of BI 730357 film-coated tablets (8x50mg) together with about 240 milliliter (mL) of water, 30 minutes (min) prior dose administration the participants consumed a standard high fat breakfast. One authorized employee of the trial site was witness of the administration of the trial medication.</description>
          </group>
          <group group_id="O11">
            <title>SRD Part-Dose Group 10: BI 730357 Tablet(s) 800 mg Fed</title>
            <description>Participants were administered on Day 1 a single oral dose of 200 milligram (mg) of BI 730357 film-coated tablets (16x50mg) together with about 240 milliliter (mL) of water, 30 minutes (min) prior dose administration the participants consumed a standard high fat breakfast. One authorized employee of the trial site was witness of the administration of the trial medication.</description>
          </group>
          <group group_id="O12">
            <title>BA Part: BI 730357 Tablet 25 mg Fasted (R)</title>
            <description>Participants were orally administered 25 mg of BI 730357 as film-coated tablet (Reference treatment R) together with about 240 mL of water in fasted state. One authorized employee of the trial site was witness of the administration of the trial medication.</description>
          </group>
          <group group_id="O13">
            <title>BA Part: BI 730357 PfOS 25 mg Fasted (T1)</title>
            <description>Participants received 25 mg of BI 730357 powder for reconstitution of an oral solution (PfOS) reconstituted in solvent for oral solution 2.5 milliliter (mL) (Macrogol 400 (Polyethylene glycol 400) (test treatment T1) together with about 240 mL of water in fasted state. One authorized employee of the trial site was witness of the administration of the trial medication.</description>
          </group>
          <group group_id="O14">
            <title>BA Part: BI 730357 Tablet 25 mg Fed (T2)</title>
            <description>Participants were orally administered 25 mg of BI 730357 film-coated tablet in a fed state (test treatment T2) together with about 240 mL of water, a high-fat, high-calorie breakfast was served 30 min before dose administration. One authorized employee of the trial site was witness of the administration of the trial medication.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Subjects With Drug-related Adverse Events (AEs)</title>
          <description>Percentage of subjects with adverse reactions, assessed by investigator-defined drug-related adverse events (AEs) are reported.&#xD;
Fed1 means intake of continental breakfast; fed2 means intake of high-fat breakfast. The 400 mg tablet fed1 and fed2 treatments were administered to the same participants.</description>
          <population>Treated set (TS): This subject set included all subjects from the Randomised set (RS) who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.</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="18"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="6"/>
                <count group_id="O4" value="6"/>
                <count group_id="O5" value="6"/>
                <count group_id="O6" value="6"/>
                <count group_id="O7" value="6"/>
                <count group_id="O8" value="6"/>
                <count group_id="O9" value="6"/>
                <count group_id="O10" value="5"/>
                <count group_id="O11" value="6"/>
                <count group_id="O12" value="11"/>
                <count group_id="O13" value="12"/>
                <count group_id="O14" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.6"/>
                    <measurement group_id="O2" value="0.0"/>
                    <measurement group_id="O3" value="16.7"/>
                    <measurement group_id="O4" value="0.0"/>
                    <measurement group_id="O5" value="0.0"/>
                    <measurement group_id="O6" value="16.7"/>
                    <measurement group_id="O7" value="16.7"/>
                    <measurement group_id="O8" value="0.0"/>
                    <measurement group_id="O9" value="0.0"/>
                    <measurement group_id="O10" value="20.0"/>
                    <measurement group_id="O11" value="0.0"/>
                    <measurement group_id="O12" value="0.0"/>
                    <measurement group_id="O13" value="0.0"/>
                    <measurement group_id="O14" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Area Under the Concentration-time Curve of BI 730357 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-inf)</title>
        <description>Area under the concentration-time curve of BI 730357 in plasma over the time interval from 0 extrapolated to infinity is reported.&#xD;
Fed1 means intake of continental breakfast; fed2 means intake of high-fat breakfast. The 400 mg tablet fed1 and fed2 treatments were administered to the same subjects.</description>
        <time_frame>SRD &amp; BA Part: Within 3 hours (h) prior administration, and 0.5h, 1.0h, 1.5h, 2.0h, 2.5h, 3.0h, 4.0h, 5.0h, 6.0h, 8.0h, 10.0h, 12.0h, 24.0h, 34.0h, 48.0h, 72.0h, 96.0h and 168.0h after drug administration</time_frame>
        <population>Pharmacokinetic set (PKS): The PKS included all subjects who were treated with BI 730357 and who provided at least 1 secondary PK endpoint (AUC0-∞ or Cmax) that was not excluded due to a protocol violation relevant to the evaluation of PK or due to PK non-evaluability.</population>
        <group_list>
          <group group_id="O1">
            <title>SRD Part-Dose Group 1: BI 730357 PfOS 2 mg Fasted</title>
            <description>Participants were administered on Day 1 a single oral dose of 2 milligram (mg) of BI 730357 powder for reconstitution of an oral solution (PfoS) reconstituted in solvent for oral solution 2 milliliter (mL) (Macrogol 400 (Polyethylene glycol 400) together with about 240 milliliter (mL) of water in fasted state.&#xD;
One authorized employee of the trial site was witness of the administration of the trial medication.</description>
          </group>
          <group group_id="O2">
            <title>SRD Part-Dose Group 2: BI 730357 PfOS 8 mg Fasted</title>
            <description>Participants were administered on Day 1 a single oral dose of 8 milligram (mg) of BI 730357 powder for reconstitution of an oral solution (PfoS) reconstituted in solvent for oral solution 8 milliliter (mL) (Macrogol 400 (Polyethylene glycol 400) together with about 240 milliliter (mL) of water in fasted state.&#xD;
One authorized employee of the trial site was witness of the administration of the trial medication.</description>
          </group>
          <group group_id="O3">
            <title>SRD Part-Dose Group 3: BI 730357 Tablet 25 mg Fasted</title>
            <description>Participants were administered on Day 1 a single oral dose of 25 milligram (mg) of BI 730357 film-coated tablet together with about 240 milliliter (mL) of water in fasted state. One authorized employee of the trial site was witness of the administration of the trial medication.</description>
          </group>
          <group group_id="O4">
            <title>SRD Part-Dose Group 4: BI 730357 Tablet 50 mg Fasted</title>
            <description>Participants were administered on Day 1 a single oral dose of 50 milligram (mg) of BI 730357 film-coated tablet together with about 240 milliliter (mL) of water in fasted state. One authorized employee of the trial site was witness of the administration of the trial medication.</description>
          </group>
          <group group_id="O5">
            <title>SRD Part-Dose Group 5: BI 730357 Tablet(s) 100 mg Fasted</title>
            <description>Participants were administered on Day 1 a single oral dose of 100 milligram (mg) of BI 730357 film-coated tablets (2x50mg) together with about 240 milliliter (mL) of water in fasted state. One authorized employee of the trial site was witness of the administration of the trial medication.</description>
          </group>
          <group group_id="O6">
            <title>SRD Part-Dose Group 6: BI 730357 Tablet(s) 200 mg Fasted</title>
            <description>Participants were administered on Day 1 a single oral dose of 200 milligram (mg) of BI 730357 film-coated tablets (4x50mg) together with about 240 milliliter (mL) of water in fasted state. One authorized employee of the trial site was witness of the administration of the trial medication.</description>
          </group>
          <group group_id="O7">
            <title>SRD Part-Dose Group 7: BI 730357 Tablet(s) 400 mg Fasted</title>
            <description>Participants were administered on Day 1 a single oral dose of 200 milligram (mg) of BI 730357 film-coated tablets (8x50mg) together with about 240 milliliter (mL) of water in fasted state. One authorized employee of the trial site was witness of the administration of the trial medication.</description>
          </group>
          <group group_id="O8">
            <title>SRD Part-Dose Group 8: BI 730357 Tablets(s) 400 mg Fed1</title>
            <description>Participants were administered on Day 1 a single oral dose of 200 milligram (mg) of BI 730357 film-coated tablets (8x50mg) together with about 240 milliliter (mL) of water, 30 minutes (min) prior dose administration the participants consumed a standard continental breakfast. One authorized employee of the trial site was witness of the administration of the trial medication.</description>
          </group>
          <group group_id="O9">
            <title>SRD Part-Dose Group 9: BI 730357 Tablets(s) 400 mg Fed2</title>
            <description>Participants were administered on Day 1 a single oral dose of 200 milligram (mg) of BI 730357 film-coated tablets (8x50mg) together with about 240 milliliter (mL) of water, 30 minutes (min) prior dose administration the participants consumed a standard high fat breakfast. One authorized employee of the trial site was witness of the administration of the trial medication.</description>
          </group>
          <group group_id="O10">
            <title>SRD Part-Dose Group 10: BI 730357 Tablet(s) 800 mg Fed</title>
            <description>Participants were administered on Day 1 a single oral dose of 200 milligram (mg) of BI 730357 film-coated tablets (16x50mg) together with about 240 milliliter (mL) of water, 30 minutes (min) prior dose administration the participants consumed a standard high fat breakfast. One authorized employee of the trial site was witness of the administration of the trial medication.</description>
          </group>
          <group group_id="O11">
            <title>BA Part: BI 730357 Tablet 25 mg Fasted (R)</title>
            <description>Participants were orally administered 25 mg of BI 730357 as film-coated tablet (Reference treatment R) together with about 240 mL of water in fasted state. One authorized employee of the trial site was witness of the administration of the trial medication.</description>
          </group>
          <group group_id="O12">
            <title>BA Part: BI 730357 PfOS 25 mg Fasted (T1)</title>
            <description>Participants received 25 mg of BI 730357 powder for reconstitution of an oral solution (PfOS) reconstituted in solvent for oral solution 2.5 milliliter (mL) (Macrogol 400 (Polyethylene glycol 400) (test treatment T1) together with about 240 mL of water in fasted state. One authorized employee of the trial site was witness of the administration of the trial medication.</description>
          </group>
          <group group_id="O13">
            <title>BA Part: BI 730357 Tablet 25 mg Fed (T2)</title>
            <description>Participants were orally administered 25 mg of BI 730357 film-coated tablet in a fed state (test treatment T2) together with about 240 mL of water, a high-fat, high-calorie breakfast was served 30 min before dose administration. One authorized employee of the trial site was witness of the administration of the trial medication.</description>
          </group>
        </group_list>
        <measure>
          <title>Area Under the Concentration-time Curve of BI 730357 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-inf)</title>
          <description>Area under the concentration-time curve of BI 730357 in plasma over the time interval from 0 extrapolated to infinity is reported.&#xD;
Fed1 means intake of continental breakfast; fed2 means intake of high-fat breakfast. The 400 mg tablet fed1 and fed2 treatments were administered to the same subjects.</description>
          <population>Pharmacokinetic set (PKS): The PKS included all subjects who were treated with BI 730357 and who provided at least 1 secondary PK endpoint (AUC0-∞ or Cmax) that was not excluded due to a protocol violation relevant to the evaluation of PK or due to PK non-evaluability.</population>
          <units>nanomol*hour/liter (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="6"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="6"/>
                <count group_id="O4" value="6"/>
                <count group_id="O5" value="6"/>
                <count group_id="O6" value="6"/>
                <count group_id="O7" value="6"/>
                <count group_id="O8" value="6"/>
                <count group_id="O9" value="5"/>
                <count group_id="O10" value="6"/>
                <count group_id="O11" value="11"/>
                <count group_id="O12" value="12"/>
                <count group_id="O13" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="399.0" spread="35.0"/>
                    <measurement group_id="O2" value="1550.0" spread="27.8"/>
                    <measurement group_id="O3" value="3730.0" spread="36.4"/>
                    <measurement group_id="O4" value="6990.0" spread="52.7"/>
                    <measurement group_id="O5" value="10700.0" spread="60.2"/>
                    <measurement group_id="O6" value="18300.0" spread="28.0"/>
                    <measurement group_id="O7" value="30800.0" spread="36.8"/>
                    <measurement group_id="O8" value="44800.0" spread="41.5"/>
                    <measurement group_id="O9" value="50700.0" spread="57.5"/>
                    <measurement group_id="O10" value="77900.0" spread="38.3"/>
                    <measurement group_id="O11" value="4240.0" spread="45.0"/>
                    <measurement group_id="O12" value="5390.0" spread="43.8"/>
                    <measurement group_id="O13" value="5370.0" spread="44.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
              <group_id>O5</group_id>
              <group_id>O6</group_id>
              <group_id>O7</group_id>
            </group_id_list>
            <groups_desc>In the SRD part of the trial, dose proportionality for AUC0-inf was assessed in the 25 mg to 400 mg dose groups (BI 730357 tablets administered under fasted conditions) using a power model (regression model applied to log-transformed data).</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Slope</param_type>
            <param_value>0.7480</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.0743</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.5959</ci_lower_limit>
            <ci_upper_limit>0.9001</ci_upper_limit>
            <estimate_desc>Standard error of the mean is actually standard error of the slope. Based on the estimate for the slope parameter, a two sided 95% confidence interval for the slope was computed. Perfect dose proportionality would correspond to a slope of 1.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O8</group_id>
              <group_id>O9</group_id>
            </group_id_list>
            <groups_desc>Relative bioavailability of AUC0-inf for the SRD part was performed to test the effect of food intake on the PK of 400 mg BI 730357 tablets. The intra-individual comparison of fed conditions was done using an Analysis of Variance (ANOVA) model on the logarithmic scale.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Ratio T/R</param_type>
            <param_value>118.71</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.11</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>94.57</ci_lower_limit>
            <ci_upper_limit>149.03</ci_upper_limit>
            <estimate_desc>Standard error of the mean is the geometric standard error of the mean. The geometric mean ratio was calculated as: tablet 400mg fed1 (T)/400mg fed2(R), T/R.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O11</group_id>
              <group_id>O12</group_id>
            </group_id_list>
            <groups_desc>Estimation of relative bioavailability of AUC0-inf was based on ANOVA model on the logarithmic scale, included effects: 'sequence', 'period' and 'treatment' as fixed and 'subjects within sequences' as random</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Geometric mean ratio T1/R (%)</param_type>
            <param_value>124.79</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.036</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>116.858</ci_lower_limit>
            <ci_upper_limit>133.255</ci_upper_limit>
            <estimate_desc>Standard error of the mean is actually geometric standard error of the mean. The geometric mean ratio was calculated as: oral solution in fasted state (test treatment T1)/tablet in fasted state (reference treatment R), T1/R.</estimate_desc>
            <other_analysis_desc>Relative bioavailability of BI 730357 for Oral solution (PfOS) fasted (T1) vs. tablet fasted (R) was assessed by the point estimators (geometric means) of the intra-subject ratio of Auc0-inf and their two-sided 90% confidence intervals . No hypothesis was tested.</other_analysis_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O11</group_id>
              <group_id>O13</group_id>
            </group_id_list>
            <groups_desc>Estimation of relative bioavailability of AUC0-inf was based on ANOVA model on the logarithmic scale, included effects: 'sequence', 'period' and 'treatment' as fixed and 'subjects within sequences' as random</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Geometric mean ratio T2/R (%)</param_type>
            <param_value>125.17</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.06</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>112.89</ci_lower_limit>
            <ci_upper_limit>138.80</ci_upper_limit>
            <estimate_desc>Standard error of the mean is actually geometric standard error of the mean. The geometric mean ratio was calculated as: tablet in fed state (test treatment T2)/tablet in fasted state (reference treatment R), T2/R.</estimate_desc>
            <other_analysis_desc>Relative bioavailability of BI 730357 for tablet fed (T2) vs. tablet fasted (R) was assessed by the point estimators (geometric means) of the intra-subject ratio of AUC0-inf and their two-sided 90% confidence intervals . No hypothesis was tested.</other_analysis_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Maximum Measured Concentration of BI 730357 in Plasma (Cmax)</title>
        <description>Maximum measured concentration of BI 730357 in plasma is reported.&#xD;
Fed1 means intake of continental breakfast; Fed2 means intake of high-fat breakfast. The 400 mg tablet fed1 and fed2 treatments were administered to the same subjects.</description>
        <time_frame>SRD &amp; BA Part: Within 3 hours (h) prior administration, and 0.5h, 1.0h, 1.5h, 2.0h, 2.5h, 3.0h, 4.0h, 5.0h, 6.0h, 8.0h, 10.0h, 12.0h, 24.0h, 34.0h, 48.0h, 72.0h, 96.0h and 168.0h after drug administration</time_frame>
        <population>Pharmacokinetic set (PKS): The PKS included all subjects who were treated with BI 730357 and who provided at least 1 secondary PK endpoint (AUC0-∞ or Cmax) that was not excluded due to a protocol violation relevant to the evaluation of PK or due to PK non-evaluability.</population>
        <group_list>
          <group group_id="O1">
            <title>SRD Part-Dose Group 1: BI 730357 PfOS 2 mg Fasted</title>
            <description>Participants were administered on Day 1 a single oral dose of 2 milligram (mg) of BI 730357 powder for reconstitution of an oral solution (PfoS) reconstituted in solvent for oral solution 2 milliliter (mL) (Macrogol 400 (Polyethylene glycol 400) together with about 240 milliliter (mL) of water in fasted state.&#xD;
One authorized employee of the trial site was witness of the administration of the trial medication.</description>
          </group>
          <group group_id="O2">
            <title>SRD Part-Dose Group 2: BI 730357 PfOS 8 mg Fasted</title>
            <description>Participants were administered on Day 1 a single oral dose of 8 milligram (mg) of BI 730357 powder for reconstitution of an oral solution (PfoS) reconstituted in solvent for oral solution 8 milliliter (mL) (Macrogol 400 (Polyethylene glycol 400) together with about 240 milliliter (mL) of water in fasted state.&#xD;
One authorized employee of the trial site was witness of the administration of the trial medication.</description>
          </group>
          <group group_id="O3">
            <title>SRD Part-Dose Group 3: BI 730357 Tablet 25 mg Fasted</title>
            <description>Participants were administered on Day 1 a single oral dose of 25 milligram (mg) of BI 730357 film-coated tablet together with about 240 milliliter (mL) of water in fasted state. One authorized employee of the trial site was witness of the administration of the trial medication.</description>
          </group>
          <group group_id="O4">
            <title>SRD Part-Dose Group 4: BI 730357 Tablet 50 mg Fasted</title>
            <description>Participants were administered on Day 1 a single oral dose of 50 milligram (mg) of BI 730357 film-coated tablet together with about 240 milliliter (mL) of water in fasted state. One authorized employee of the trial site was witness of the administration of the trial medication.</description>
          </group>
          <group group_id="O5">
            <title>SRD Part-Dose Group 5: BI 730357 Tablet(s) 100 mg Fasted</title>
            <description>Participants were administered on Day 1 a single oral dose of 100 milligram (mg) of BI 730357 film-coated tablets (2x50mg) together with about 240 milliliter (mL) of water in fasted state. One authorized employee of the trial site was witness of the administration of the trial medication.</description>
          </group>
          <group group_id="O6">
            <title>SRD Part-Dose Group 6: BI 730357 Tablet(s) 200 mg Fasted</title>
            <description>Participants were administered on Day 1 a single oral dose of 200 milligram (mg) of BI 730357 film-coated tablets (4x50mg) together with about 240 milliliter (mL) of water in fasted state. One authorized employee of the trial site was witness of the administration of the trial medication.</description>
          </group>
          <group group_id="O7">
            <title>SRD Part-Dose Group 7: BI 730357 Tablet(s) 400 mg Fasted</title>
            <description>Participants were administered on Day 1 a single oral dose of 200 milligram (mg) of BI 730357 film-coated tablets (8x50mg) together with about 240 milliliter (mL) of water in fasted state. One authorized employee of the trial site was witness of the administration of the trial medication.</description>
          </group>
          <group group_id="O8">
            <title>SRD Part-Dose Group 8: BI 730357 Tablets(s) 400 mg Fed1</title>
            <description>Participants were administered on Day 1 a single oral dose of 200 milligram (mg) of BI 730357 film-coated tablets (8x50mg) together with about 240 milliliter (mL) of water, 30 minutes (min) prior dose administration the participants consumed a standard continental breakfast. One authorized employee of the trial site was witness of the administration of the trial medication.</description>
          </group>
          <group group_id="O9">
            <title>SRD Part-Dose Group 9: BI 730357 Tablets(s) 400 mg Fed2</title>
            <description>Participants were administered on Day 1 a single oral dose of 200 milligram (mg) of BI 730357 film-coated tablets (8x50mg) together with about 240 milliliter (mL) of water, 30 minutes (min) prior dose administration the participants consumed a standard high fat breakfast. One authorized employee of the trial site was witness of the administration of the trial medication.</description>
          </group>
          <group group_id="O10">
            <title>SRD Part-Dose Group 10: BI 730357 Tablet(s) 800 mg Fed</title>
            <description>Participants were administered on Day 1 a single oral dose of 200 milligram (mg) of BI 730357 film-coated tablets (16x50mg) together with about 240 milliliter (mL) of water, 30 minutes (min) prior dose administration the participants consumed a standard high fat breakfast. One authorized employee of the trial site was witness of the administration of the trial medication.</description>
          </group>
          <group group_id="O11">
            <title>BA Part: BI 730357 Tablet 25 mg Fasted (R)</title>
            <description>Participants were orally administered 25 mg of BI 730357 as film-coated tablet (Reference treatment R) together with about 240 mL of water in fasted state. One authorized employee of the trial site was witness of the administration of the trial medication.</description>
          </group>
          <group group_id="O12">
            <title>BA Part: BI 730357 PfOS 25 mg Fasted (T1)</title>
            <description>Participants received 25 mg of BI 730357 powder for reconstitution of an oral solution (PfOS) reconstituted in solvent for oral solution 2.5 milliliter (mL) (Macrogol 400 (Polyethylene glycol 400) (test treatment T1) together with about 240 mL of water in fasted state. One authorized employee of the trial site was witness of the administration of the trial medication.</description>
          </group>
          <group group_id="O13">
            <title>BA Part: BI 730357 Tablet 25 mg Fed (T2)</title>
            <description>Participants were orally administered 25 mg of BI 730357 film-coated tablet in a fed state (test treatment T2) together with about 240 mL of water, a high-fat, high-calorie breakfast was served 30 min before dose administration. One authorized employee of the trial site was witness of the administration of the trial medication.</description>
          </group>
        </group_list>
        <measure>
          <title>Maximum Measured Concentration of BI 730357 in Plasma (Cmax)</title>
          <description>Maximum measured concentration of BI 730357 in plasma is reported.&#xD;
Fed1 means intake of continental breakfast; Fed2 means intake of high-fat breakfast. The 400 mg tablet fed1 and fed2 treatments were administered to the same subjects.</description>
          <population>Pharmacokinetic set (PKS): The PKS included all subjects who were treated with BI 730357 and who provided at least 1 secondary PK endpoint (AUC0-∞ or Cmax) that was not excluded due to a protocol violation relevant to the evaluation of PK or due to PK non-evaluability.</population>
          <units>nanomol / liter (nmol/L)</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="6"/>
                <count group_id="O4" value="6"/>
                <count group_id="O5" value="6"/>
                <count group_id="O6" value="6"/>
                <count group_id="O7" value="6"/>
                <count group_id="O8" value="6"/>
                <count group_id="O9" value="5"/>
                <count group_id="O10" value="6"/>
                <count group_id="O11" value="11"/>
                <count group_id="O12" value="12"/>
                <count group_id="O13" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32.9" spread="39.4"/>
                    <measurement group_id="O2" value="154.0" spread="28.9"/>
                    <measurement group_id="O3" value="103.0" spread="31.7"/>
                    <measurement group_id="O4" value="173.0" spread="41.9"/>
                    <measurement group_id="O5" value="284.0" spread="30.7"/>
                    <measurement group_id="O6" value="433.0" spread="27.6"/>
                    <measurement group_id="O7" value="755.0" spread="37.4"/>
                    <measurement group_id="O8" value="1270.0" spread="17.5"/>
                    <measurement group_id="O9" value="1900.0" spread="30.2"/>
                    <measurement group_id="O10" value="2470.0" spread="15.7"/>
                    <measurement group_id="O11" value="133.0" spread="31.4"/>
                    <measurement group_id="O12" value="380.0" spread="27.4"/>
                    <measurement group_id="O13" value="235.0" spread="28.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
              <group_id>O5</group_id>
              <group_id>O6</group_id>
              <group_id>O7</group_id>
            </group_id_list>
            <groups_desc>In the SRD part of the trial, dose proportionality for Cmax was assessed in the 25 mg to 400 mg dose groups (BI 730357 tablets administered under fasted conditions) using a power model (regression model applied to log-transformed data).</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Slope</param_type>
            <param_value>0.7065</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.0587</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.5863</ci_lower_limit>
            <ci_upper_limit>0.8267</ci_upper_limit>
            <estimate_desc>Standard error of the mean is actually standard error of the slope. Based on the estimate for the slope parameter, a two sided 95% confidence interval for the slope was computed. Perfect dose proportionality would correspond to a slope of 1</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O8</group_id>
              <group_id>O9</group_id>
            </group_id_list>
            <groups_desc>Relative bioavailability of the Cmax for the SRD part was performed to test the effect of food intake on the PK of 400 mg BI 730357 tablets. The intra-individual comparison of fed conditions was done using an ANOVA model on the logarithmic scale.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Ratio T/R</param_type>
            <param_value>151.22</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.107</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>122.781</ci_lower_limit>
            <ci_upper_limit>186.248</ci_upper_limit>
            <estimate_desc>Standard error of the mean is the geometric standard error of the mean. The geometric mean ratio was calculated as: tablet 400mg fed1 (T)/400mg fed2(R), T/R.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O11</group_id>
              <group_id>O12</group_id>
            </group_id_list>
            <groups_desc>Estimation of relative bioavailability of Cmax based on ANOVA model on the logarithmic scale, included effects: 'sequence', 'period' and 'treatment' as fixed and 'subjects within sequences' as random</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Geometric mean ratio T1/R (%)</param_type>
            <param_value>293.21</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.069</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>259.044</ci_lower_limit>
            <ci_upper_limit>331.891</ci_upper_limit>
            <estimate_desc>Standard error of the mean is the geometric standard error of the mean. The geometric mean ratio was calculated as: oral solution in fasted state (test treatment T1)/tablet in fasted state (reference treatment R), T1/R.</estimate_desc>
            <other_analysis_desc>Relative bioavailability of BI 730357 for Oral solution (PfOS) fasted (T1) vs. tablet fasted (R) was assessed by the point estimators (geometric means) of the intra-subject ratio of Cmax and their two-sided 90% confidence intervals . No hypothesis was tested.</other_analysis_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O11</group_id>
              <group_id>O13</group_id>
            </group_id_list>
            <groups_desc>Estimation of relative bioavailability of Cmax was based on ANOVA model on the logarithmic scale, included effects: 'sequence', 'period' and 'treatment' as fixed and 'subjects within sequences' as random</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Geometric mean ratio T2/R (%)</param_type>
            <param_value>180.53</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.059</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>162.369</ci_lower_limit>
            <ci_upper_limit>200.732</ci_upper_limit>
            <estimate_desc>Standard error of the mean is the geometric standard error of the mean. The geometric mean ratio was calculated as: tablet in fed state (test treatment T2)/tablet in fasted state (reference treatment R), T2/R.</estimate_desc>
            <other_analysis_desc>Relative bioavailability of BI 730357 for tablet fasted (T2) vs. tablet fasted (R) was assessed by the point estimators (geometric means) of the intra-subject ratio of Cmax and their two-sided 90% confidence intervals . No hypothesis was tested.</other_analysis_desc>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>SRD 1-7, 9-10: From first drug administration until end of trial (EOT), up to 13 days. SRD 8: From first drug administration until end of trial (EOT), up to 14 days. BA per treatment: From first drug administration until end of trial (EOT), up to 14 days.</time_frame>
      <desc>Treated set (TS): This subject set included all subjects from the Randomised set (RS) who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.</desc>
      <group_list>
        <group group_id="E1">
          <title>Placebo</title>
          <description>This arm comprises all placebo treated participants in trial part SRD, regardless of the dose group in which they were treated. Participants of the first cohort of each dose group (DG) were not randomized. In the second cohort of each DG participants were assigned to active treatment or placebo in a 3:1 allocation ratio.&#xD;
Participants were administered on Day 1 a single oral dose of matching placebo, for dose group (DG) 1-2 the matching placebo was solvent for oral solution containing Macrogol 400 (Polyethylene glycol 400) on a volume identical to dose group of active treatment, for DG 3-7 the matching placebo were single oral film-coated tablet(s) with about 240 milliliter (mL) of water on fasted state. For DG 8-10 the matching placebo were single oral film-coated tablet(s) with about 240 milliliter (mL) of water on fed state, 30 minutes (min) prior dose administration the participants consumed a standard high fat breakfast/continental breakfast depending on dose group. One authorized employee of the trial site was witness of the administration of the trial medication.</description>
        </group>
        <group group_id="E2">
          <title>SRD Part-Dose Group 1: BI 730357 PfOS 2 mg Fasted</title>
          <description>Participants were administered on Day 1 a single oral dose of 2 milligram (mg) of BI 730357 powder for reconstitution of an oral solution (PfoS) reconstituted in solvent for oral solution 2 milliliter (mL) (Macrogol 400 (Polyethylene glycol 400) together with about 240 milliliter (mL) of water in fasted state.&#xD;
One authorized employee of the trial site was witness of the administration of the trial medication.</description>
        </group>
        <group group_id="E3">
          <title>SRD Part-Dose Group 2: BI 730357 PfOS 8 mg Fasted</title>
          <description>Participants were administered on Day 1 a single oral dose of 8 milligram (mg) of BI 730357 powder for reconstitution of an oral solution (PfoS) reconstituted in solvent for oral solution 8 milliliter (mL) (Macrogol 400 (Polyethylene glycol 400) together with about 240 milliliter (mL) of water in fasted state.&#xD;
One authorized employee of the trial site was witness of the administration of the trial medication.</description>
        </group>
        <group group_id="E4">
          <title>SRD Part-Dose Group 3: BI 730357 Tablet 25 mg Fasted</title>
          <description>Participants were administered on Day 1 a single oral dose of 25 milligram (mg) of BI 730357 film-coated tablet together with about 240 milliliter (mL) of water in fasted state. One authorized employee of the trial site was witness of the administration of the trial medication.</description>
        </group>
        <group group_id="E5">
          <title>SRD Part-Dose Group 4: BI 730357 Tablet 50 mg Fasted</title>
          <description>Participants were administered on Day 1 a single oral dose of 50 milligram (mg) of BI 730357 film-coated tablet together with about 240 milliliter (mL) of water in fasted state. One authorized employee of the trial site was witness of the administration of the trial medication.</description>
        </group>
        <group group_id="E6">
          <title>SRD Part-Dose Group 5: BI 730357 Tablet(s) 100 mg Fasted</title>
          <description>Participants were administered on Day 1 a single oral dose of 100 milligram (mg) of BI 730357 film-coated tablets (2x50mg) together with about 240 milliliter (mL) of water in fasted state. One authorized employee of the trial site was witness of the administration of the trial medication.</description>
        </group>
        <group group_id="E7">
          <title>SRD Part-Dose Group 6: BI 730357 Tablet(s) 200 mg Fasted</title>
          <description>Participants were administered on Day 1 a single oral dose of 200 milligram (mg) of BI 730357 film-coated tablets (4x50mg) together with about 240 milliliter (mL) of water in fasted state. One authorized employee of the trial site was witness of the administration of the trial medication.</description>
        </group>
        <group group_id="E8">
          <title>SRD Part-Dose Group 7: BI 730357 Tablet(s) 400 mg Fasted</title>
          <description>Participants were administered on Day 1 a single oral dose of 200 milligram (mg) of BI 730357 film-coated tablets (8x50mg) together with about 240 milliliter (mL) of water in fasted state. One authorized employee of the trial site was witness of the administration of the trial medication.</description>
        </group>
        <group group_id="E9">
          <title>SRD Part-Dose Group 8: BI 730357 Tablets(s) 400 mg Fed1</title>
          <description>Participants were administered on Day 1 a single oral dose of 200 milligram (mg) of BI 730357 film-coated tablets (8x50mg) together with about 240 milliliter (mL) of water, 30 minutes (min) prior dose administration the participants consumed a standard continental breakfast. One authorized employee of the trial site was witness of the administration of the trial medication.</description>
        </group>
        <group group_id="E10">
          <title>SRD Part-Dose Group 9: BI 730357 Tablets(s) 400 mg Fed2</title>
          <description>Participants were administered on Day 1 of period 2 a single oral dose of 200 milligram (mg) of BI 730357 film-coated tablets (8x50mg) together with about 240 milliliter (mL) of water, 30 minutes (min) prior dose administration the participants consumed a standard high fat breakfast. One authorized employee of the trial site was witness of the administration of the trial medication.</description>
        </group>
        <group group_id="E11">
          <title>SRD Part-Dose Group 10: BI 730357 Tablet(s) 800 mg Fed</title>
          <description>Participants were administered on Day 1 a single oral dose of 200 milligram (mg) of BI 730357 film-coated tablets (16x50mg) together with about 240 milliliter (mL) of water, 30 minutes (min) prior dose administration the participants consumed a standard high fat breakfast. One authorized employee of the trial site was witness of the administration of the trial medication.</description>
        </group>
        <group group_id="E12">
          <title>BA Part: BI 730357 Tablet 25 mg Fasted (R)</title>
          <description>Participants were orally administered 25 mg of BI 730357 as film-coated tablet (Reference treatment R) together with about 240 mL of water in fasted state. One authorized employee of the trial site was witness of the administration of the trial medication.</description>
        </group>
        <group group_id="E13">
          <title>BA Part: BI 730357 PfOS 25 mg Fasted (T1)</title>
          <description>Participants received 25 mg of BI 730357 powder for reconstitution of an oral solution (PfOS) reconstituted in solvent for oral solution 2.5 milliliter (mL) (Macrogol 400 (Polyethylene glycol 400) (test treatment T1) together with about 240 mL of water in fasted state. One authorized employee of the trial site was witness of the administration of the trial medication.</description>
        </group>
        <group group_id="E14">
          <title>BA Part: BI 730357 Tablet 25 mg Fed (T2)</title>
          <description>Participants were orally administered 25 mg of BI 730357 film-coated tablet in a fed state (test treatment T2) together with about 240 mL of water, a high-fat, high-calorie breakfast was served 30 min before dose administration. One authorized employee of the trial site was witness of the administration of the trial medication.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 20.0</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="18"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="4" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="3" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="5" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="3" subjects_at_risk="5"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="2" subjects_at_risk="11"/>
                <counts group_id="E13" subjects_affected="2" subjects_at_risk="12"/>
                <counts group_id="E14" subjects_affected="3" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal discomfort</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Toothache</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="12"/>
              </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="0" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Vessel puncture site haematoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Gastroenteritis viral</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Gastrointestinal infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Rhinitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Viral upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" subjects_affected="1" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Arthropod bite</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Burns second degree</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Scratch</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Heart rate increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Paraesthesia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Product Issues</title>
            <event_list>
              <event>
                <sub_title>Device failure</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E13" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="12"/>
              </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="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Nasal congestion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Oropharyngeal pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E13" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Dermatitis contact</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Dry skin</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Erythema</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Petechiae</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </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/NCT03004404
org study id: 1407.1
secondary id: 2016-003047-11
nct id: NCT03004404
lead sponsor: 
The primary objective of the Single Rising Dose (SRD) part (trial part 1) is to investigate
      the safety and tolerability of BI 730357 in healthy subjects following oral administration of
      single rising doses after fasting and/or non-fasting conditions. The secondary objective is
      the exploration of the pharmacokinetics (PK) including dose proportionality, and
      pharmacodynamics of BI 730357 after single dosing.

      The objective of the Bioavailability (BA) part (trial part 2) will be to explore the relative
      bioavailability of tablet fasted versus oral solution fasted and the influence of food on the
      bioavailability of tablet fasted versus tablet fed.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Percentage of Subjects With Drug-related Adverse Events (AEs)
time frame: SRD 1-7, 10: From first drug administration until end of trial (EOT), up to 13 days. SRD 8-9: From first drug administration until end of trial (EOT), up to 27 days. BA: From first drug administration until end of trial (EOT), up to 41 days.
description: Percentage of subjects with adverse reactions, assessed by investigator-defined drug-related adverse events (AEs) are reported.
Fed1 means intake of continental breakfast; fed2 means intake of high-fat breakfast. The 400 mg tablet fed1 and fed2 treatments were administered to the same participants.
measure: Area Under the Concentration-time Curve of BI 730357 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-inf)
time frame: SRD & BA Part: Within 3 hours (h) prior administration, and 0.5h, 1.0h, 1.5h, 2.0h, 2.5h, 3.0h, 4.0h, 5.0h, 6.0h, 8.0h, 10.0h, 12.0h, 24.0h, 34.0h, 48.0h, 72.0h, 96.0h and 168.0h after drug administration
description: Area under the concentration-time curve of BI 730357 in plasma over the time interval from 0 extrapolated to infinity is reported.
Fed1 means intake of continental breakfast; fed2 means intake of high-fat breakfast. The 400 mg tablet fed1 and fed2 treatments were administered to the same subjects.
measure: Maximum Measured Concentration of BI 730357 in Plasma (Cmax)
time frame: SRD & BA Part: Within 3 hours (h) prior administration, and 0.5h, 1.0h, 1.5h, 2.0h, 2.5h, 3.0h, 4.0h, 5.0h, 6.0h, 8.0h, 10.0h, 12.0h, 24.0h, 34.0h, 48.0h, 72.0h, 96.0h and 168.0h after drug administration
description: Maximum measured concentration of BI 730357 in plasma is reported.
Fed1 means intake of continental breakfast; Fed2 means intake of high-fat breakfast. The 400 mg tablet fed1 and fed2 treatments were administered to the same subjects.
arm group label: SRD part-Dose group 1: BI 730357 PfOS 2 mg Fasted
arm group type: Experimental
description: Participants were administered on Day 1 a single oral dose of 2 milligram (mg) of BI 730357 powder for reconstitution of an oral solution (PfoS) reconstituted in solvent for oral solution 2 milliliter (mL) (Macrogol 400 (Polyethylene glycol 400) together with about 240 milliliter (mL) of water in fasted state.
One authorized employee of the trial site was witness of the administration of the trial medication.
arm group label: Placebo
arm group type: Placebo Comparator
description: This arm comprises all placebo treated participants in trial part SRD, regardless of the dose group in which they were treated. Participants of the first cohort of each dose group (DG) were not randomized. In the second cohort of each DG participants were assigned to active treatment or placebo in a 3:1 allocation ratio.
arm group label: SRD part-Dose group 2: BI 730357 PfOS 8 mg Fasted
arm group type: Experimental
description: Participants were administered on Day 1 a single oral dose of 8 milligram (mg) of BI 730357 powder for reconstitution of an oral solution (PfoS) reconstituted in solvent for oral solution 8 milliliter (mL) (Macrogol 400 (Polyethylene glycol 400) together with about 240 milliliter (mL) of water in fasted state.
One authorized employee of the trial site was witness of the administration of the trial medication.
arm group label: SRD part-Dose group 3: BI 730357 tablet 25 mg Fasted
arm group type: Experimental
description: Participants were administered on Day 1 a single oral dose of 25 milligram (mg) of BI 730357 film-coated tablet together with about 240 milliliter (mL) of water in fasted state. One authorized employee of the trial site was witness of the administration of the trial medication.
arm group label: SRD part-Dose group 4: BI 730357 tablet 50 mg Fasted
arm group type: Experimental
description: Participants were administered on Day 1 a single oral dose of 50 milligram (mg) of BI 730357 film-coated tablet together with about 240 milliliter (mL) of water in fasted state. One authorized employee of the trial site was witness of the administration of the trial medication.
arm group label: SRD part-Dose group 5: BI 730357 tablet(s) 100 mg Fasted
arm group type: Experimental
description: Participants were administered on Day 1 a single oral dose of 100 milligram (mg) of BI 730357 film-coated tablets (2x50mg) together with about 240 milliliter (mL) of water in fasted state. One authorized employee of the trial site was witness of the administration of the trial medication.
arm group label: SRD part-Dose group 6: BI 730357 tablet(s) 200 mg Fasted
arm group type: Experimental
description: Participants were administered on Day 1 a single oral dose of 200 milligram (mg) of BI 730357 film-coated tablets (4x50mg) together with about 240 milliliter (mL) of water in fasted state. One authorized employee of the trial site was witness of the administration of the trial medication.
arm group label: SRD part-Dose group 7: BI 730357 tablet(s) 400 mg Fasted
arm group type: Experimental
description: Participants were administered on Day 1 a single oral dose of 200 milligram (mg) of BI 730357 film-coated tablets (8x50mg) together with about 240 milliliter (mL) of water in fasted state. One authorized employee of the trial site was witness of the administration of the trial medication.
arm group label: SRD part-Dose group 8-9: BI 730357 tablet(s) 400 mg Fed
arm group type: Experimental
description: The same participants conformed the Dose group (DG) 8 and DG 9. DG 8: Participants were administered on Day 1 a single oral dose of 200 milligram (mg) of BI 730357 film-coated tablets (8x50mg) together with about 240 milliliter (mL) of water, 30 minutes (min) prior dose administration the participants consumed a standard continental breakfast.
DG 9: Participants were administered on Day 1 a single oral dose of 200 milligram (mg) of BI 730357 film-coated tablets (8x50mg) together with about 240 milliliter (mL) of water, 30 minutes (min) prior dose administration the participants consumed a standard high fat breakfast.
Both treatment periods were separated by a wash-out phase of at least 14 days between drug administration of DG 8 and DG 9. One authorized employee of the trial site was witness of the administration of the trial medication.
arm group label: SRD part-Dose group 10: BI 730357 tablet(s) 800 mg Fed
arm group type: Experimental
description: Participants were administered on Day 1 a single oral dose of 200 milligram (mg) of BI 730357 film-coated tablets (16x50mg) together with about 240 milliliter (mL) of water, 30 minutes (min) prior dose administration the participants consumed a standard high fat breakfast. One authorized employee of the trial site was witness of the administration of the trial medication.
arm group label: BA Part: R/T2/T1
arm group type: Experimental
description: Participants were orally administered 25 mg of BI 730357 as film-coated tablet (Reference treatment R) in fasted state.
Followed by 25 mg of BI 730357 film-coated tablet in a fed state (test treatment T2), a high-fat, high-calorie breakfast was served 30 min before dose administration.
Participants received 25 mg of BI 730357 powder for reconstitution of an oral solution (PfOS) reconstituted in solvent for oral solution 2.5 milliliter (mL) (Macrogol 400 (Polyethylene glycol 400) (test treatment T1) in fasted state.
The 3 treatments were administered with 240 mL of water and were separated by a washout period of at least 8 days. One authorized employee of the trial site was witness of the administration of the trial medication.
arm group label: BA Part: R/T1/T2
arm group type: Experimental
description: Participants were orally administered 25 mg of BI 730357 as film-coated tablet (Reference treatment R) in fasted state.
Participants received 25 mg of BI 730357 powder for reconstitution of an oral solution (PfOS) reconstituted in solvent for oral solution 2.5 milliliter (mL) (Macrogol 400 (Polyethylene glycol 400) (test treatment T1) in fasted state.
Followed by 25 mg of BI 730357 film-coated tablet in a fed state (test treatment T2), a high-fat, high-calorie breakfast was served 30 min before dose administration.
The 3 treatments were administered with 240 mL of water and were separated by a washout period of at least 8 days. One authorized employee of the trial site was witness of the administration of the trial medication.
arm group label: BA Part: T2/R/T1
arm group type: Experimental
description: Participants were orally administered 25 mg of BI 730357 film-coated tablet in a fed state (test treatment T2), a high-fat, high-calorie breakfast was served 30 min before dose administration.
Followed by 25 mg of BI 730357 as film-coated tablet (Reference treatment R) in fasted state.
Participants received 25 mg of BI 730357 powder for reconstitution of an oral solution (PfOS) reconstituted in solvent for oral solution 2.5 milliliter (mL) (Macrogol 400 (Polyethylene glycol 400) (test treatment T1) in fasted state.
The 3 treatments were administered with 240 mL of water and were separated by a washout period of at least 8 days. One authorized employee of the trial site was witness of the administration of the trial medication.
arm group label: BA Part: T2/T1/R
arm group type: Experimental
description: Participants were orally administered 25 mg of BI 730357 film-coated tablet in a fed state (test treatment T2), a high-fat, high-calorie breakfast was served 30 min before dose administration.
Participants received 25 mg of BI 730357 powder for reconstitution of an oral solution (PfOS) reconstituted in solvent for oral solution 2.5 milliliter (mL) (Macrogol 400 (Polyethylene glycol 400) (test treatment T1) in fasted state.
Followed by 25 mg of BI 730357 as film-coated tablet (Reference treatment R) in fasted state.
The 3 treatments were administered with 240 mL of water and were separated by a washout period of at least 8 days. One authorized employee of the trial site was witness of the administration of the trial medication.
arm group label: BA Part: T1/R/T2
arm group type: Experimental
description: Participants received 25 mg of BI 730357 powder for reconstitution of an oral solution (PfOS) reconstituted in solvent for oral solution 2.5 milliliter (mL) (Macrogol 400 (Polyethylene glycol 400) (test treatment T1) in fasted state.
Followed by 25 mg of BI 730357 as film-coated tablet (Reference treatment R) in fasted state.
Participants were orally administered 25 mg of BI 730357 film-coated tablet in a fed state (test treatment T2), a high-fat, high-calorie breakfast was served 30 min before dose administration.
The 3 treatments were administered with 240 mL of water and were separated by a washout period of at least 8 days. One authorized employee of the trial site was witness of the administration of the trial medication.
arm group label: BA Part: T1/T2/R
arm group type: Experimental
description: BA Part: T1/T2/R Participants received 25 mg of BI 730357 powder for reconstitution of an oral solution (PfOS) reconstituted in solvent for oral solution 2.5 milliliter (mL) (Macrogol 400 (Polyethylene glycol 400) (test treatment T1) in fasted state.
Participants were orally administered 25 mg of BI 730357 film-coated tablet in a fed state (test treatment T2), a high-fat, high-calorie breakfast was served 30 min before dose administration.
Followed by 25 mg of BI 730357 as film-coated tablet (Reference treatment R) in fasted state.
The 3 treatments were administered with 240 mL of water and were separated by a washout period of at least 8 days. One authorized employee of the trial site was witness of the administration of the trial medication.
intervention type: Drug
intervention name: Placebo
description: Placebo
arm group label: Placebo
intervention type: Drug
intervention name: BI 730357
description: powder for reconstitution of an oral solution (PfoS)
arm group label: BA Part: R/T1/T2
arm group label: BA Part: R/T2/T1
arm group label: BA Part: T1/R/T2
arm group label: BA Part: T1/T2/R
arm group label: BA Part: T2/R/T1
arm group label: BA Part: T2/T1/R
arm group label: SRD part-Dose group 1: BI 730357 PfOS 2 mg Fasted
arm group label: SRD part-Dose group 2: BI 730357 PfOS 8 mg Fasted
intervention type: Drug
intervention name: BI 730357
description: BI 730357 film-coated tablet
arm group label: BA Part: R/T1/T2
arm group label: BA Part: R/T2/T1
arm group label: BA Part: T1/R/T2
arm group label: BA Part: T1/T2/R
arm group label: BA Part: T2/R/T1
arm group label: BA Part: T2/T1/R
arm group label: SRD part-Dose group 10: BI 730357 tablet(s) 800 mg Fed
arm group label: SRD part-Dose group 3: BI 730357 tablet 25 mg Fasted
arm group label: SRD part-Dose group 4: BI 730357 tablet 50 mg Fasted
arm group label: SRD part-Dose group 5: BI 730357 tablet(s) 100 mg Fasted
arm group label: SRD part-Dose group 6: BI 730357 tablet(s) 200 mg Fasted
arm group label: SRD part-Dose group 7: BI 730357 tablet(s) 400 mg Fasted
arm group label: SRD part-Dose group 8-9: BI 730357 tablet(s) 400 mg Fed
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Boehringer Ingelheim
role: Study Chair
affiliation: Boehringer Ingelheim
facility: 
country: Germany
url: https://www.mystudywindow.com
description: Related Info
responsible party type: Sponsor
sharing ipd: No
ipd description: Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization).
For more details refer to:
https://www.mystudywindow.com/msw/datatransparency
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 