<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/NCT02225626</url>
  </required_header>
  <id_info>
    <org_study_id>1333.44</org_study_id>
    <secondary_id>2014-001960-37</secondary_id>
    <nct_id>NCT02225626</nct_id>
  </id_info>
  <brief_title>Effect of Food on the Pharmacokinetics of BI 1060469 (Formulation Tablet) in Healthy Male Subjects</brief_title>
  <official_title>Effect of Food on the Pharmacokinetics of BI 1060469 (Formulation Tablet) in Healthy Male Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boehringer Ingelheim</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boehringer Ingelheim</source>
  <brief_summary>
    <textblock>
      Effect of food on the pharmacokinetics of BI 1060469 (formulation tablet) in healthy male&#xD;
      subjects as well as to investigate pharmacokinetics, safety and tolerability&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">December 2014</completion_date>
  <primary_completion_date type="Actual">November 2014</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>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>AUC 0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point)</measure>
    <time_frame>up to 6 days after last drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Cmax (maximum measured concentration of the analyte in plasma)</measure>
    <time_frame>up to 6 days after last drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Frequency of subjects with drug-related adverse events</measure>
    <time_frame>up to 7 days after last drug administration</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>AUC0-infinity (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)</measure>
    <time_frame>up to 6 days after last drug administration</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">16</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>BI 1060469 fed</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>tablet, oral administration with 240 mL water 30 minutes after subject is served a standardised high-caloric high-fat administr</description>
  </arm_group>
  <arm_group>
    <arm_group_label>BI 1060469 fasted</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>tablet, oral administration with 240 mL of water after an overnight fast of at least 10 h</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BI 1060469</intervention_name>
    <description>tablet, oral administration with 240 mL of water after an overnight fast of at least 10 h</description>
    <arm_group_label>BI 1060469 fasted</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BI 1060469</intervention_name>
    <description>tablet, oral administration with 240 mL water 30 minutes after subject is served a standardised high-caloric high-fat administration</description>
    <arm_group_label>BI 1060469 fed</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Other: standard breakfast</intervention_name>
    <description>tablet, oral administration with 240 mL water 30 minutes after subject is served a standardised high-caloric high-fat administration</description>
    <arm_group_label>BI 1060469 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 ECG, and clinical laboratory tests&#xD;
&#xD;
          -  Age of 18 to 50 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 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 greater than 140 mmHg or diastolic&#xD;
             blood pressure greater than 90 mmHg&#xD;
&#xD;
          -  Any laboratory value outside the reference range that the investigator considers to be&#xD;
             of clinical relevance&#xD;
&#xD;
          -  Repeated measurement of pulse rate &lt; 50 bpm and &gt; 90 bpm at screening&#xD;
&#xD;
          -  Serum creatinine laboratory value outside the normal range&#xD;
&#xD;
          -  estimated glomerular filtration rate (eGFR) according to CKD-EPI-Creatinine Formula &lt;&#xD;
             90 ml/ min&#xD;
&#xD;
          -  Current or history of relevant kidney, urinary tract diseases or abnormalities (i.e.&#xD;
             nephrolithiasis, hydronephrosis, acute or chronic nephritis, renal injury, renal&#xD;
             failure, infections)&#xD;
&#xD;
          -  Any evidence of a concomitant disease judged as clinically relevant by the&#xD;
             investigator Repeated measurement of pulse rate &lt; 50 bpm and &gt; 90 bpm at screening&#xD;
&#xD;
          -  Serum creatinine laboratory value outside the normal range&#xD;
&#xD;
          -  estimated glomerular filtration rate (eGFR) according to CKD-EPI-Creatinine Formula &lt;&#xD;
             90 ml/ min&#xD;
&#xD;
          -  Current or history of relevant kidney, urinary tract diseases or abnormalities (i.e.&#xD;
             nephrolithiasis, hydronephrosis, acute or chronic nephritis, renal injury, renal&#xD;
             failure, infections)&#xD;
&#xD;
          -  Any evidence of a concomitant disease judged as clinically relevant by the&#xD;
             investigator&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Boehringer Ingelheim</last_name>
    <role>Study Chair</role>
    <affiliation>Boehringer Ingelheim</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>1333.44.1 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Ingelheim</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>May 2015</verification_date>
  <study_first_submitted>August 25, 2014</study_first_submitted>
  <study_first_submitted_qc>August 25, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 26, 2014</study_first_posted>
  <last_update_submitted>May 10, 2015</last_update_submitted>
  <last_update_submitted_qc>May 10, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 12, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT02225626
org study id: 1333.44
secondary id: 2014-001960-37
nct id: NCT02225626
lead sponsor: 
Effect of food on the pharmacokinetics of BI 1060469 (formulation tablet) in healthy male
      subjects as well as to investigate pharmacokinetics, safety and tolerability
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: AUC 0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point)
time frame: up to 6 days after last drug administration
measure: Cmax (maximum measured concentration of the analyte in plasma)
time frame: up to 6 days after last drug administration
measure: Frequency of subjects with drug-related adverse events
time frame: up to 7 days after last drug administration
measure: AUC0-infinity (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
time frame: up to 6 days after last drug administration
arm group label: BI 1060469 fed
arm group type: Experimental
description: tablet, oral administration with 240 mL water 30 minutes after subject is served a standardised high-caloric high-fat administr
arm group label: BI 1060469 fasted
arm group type: Experimental
description: tablet, oral administration with 240 mL of water after an overnight fast of at least 10 h
intervention type: Drug
intervention name: BI 1060469
description: tablet, oral administration with 240 mL of water after an overnight fast of at least 10 h
arm group label: BI 1060469 fasted
intervention type: Drug
intervention name: BI 1060469
description: tablet, oral administration with 240 mL water 30 minutes after subject is served a standardised high-caloric high-fat administration
arm group label: BI 1060469 fed
intervention type: Drug
intervention name: Other: standard breakfast
description: tablet, oral administration with 240 mL water 30 minutes after subject is served a standardised high-caloric high-fat administration
arm group label: BI 1060469 fed
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Boehringer Ingelheim
role: Study Chair
affiliation: Boehringer Ingelheim
facility: 
country: Germany
responsible party type: Sponsor