<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/NCT02222168</url>
  </required_header>
  <id_info>
    <org_study_id>1289.22</org_study_id>
    <secondary_id>2014-001934-28</secondary_id>
    <nct_id>NCT02222168</nct_id>
  </id_info>
  <brief_title>Pharmacokinetics of BI 409306 After a High Fat, High Caloric Meal and After a Single Oral Dose Given at Bed Time in Healthy Volunteers</brief_title>
  <official_title>Open, Randomised, Two-way Crossover Study to Assess the Effect of a High Fat, High Caloric Meal on the Pharmacokinetics of BI 409306, Followed by a Fixed Sequence Period to Investigate the Pharmacokinetics of BI 409306 After a Single Oral Dose Given at Bed Time in Healthy Male and Female Volunteers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boehringer Ingelheim</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boehringer Ingelheim</source>
  <brief_summary>
    <textblock>
      To evaluate the effect of food on the pharmacokinetics of BI 409306 and to investigate the&#xD;
      pharmacokinetics of BI 409306 when given at bed time.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">October 2014</completion_date>
  <primary_completion_date type="Actual">October 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>Cmax (maximum measured concentration of the analyte in plasma)</measure>
    <time_frame>8 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>AUC0-tz (area under the concentration-time curve of the analyte in plasma from time 0 to time of last quantifiable data point)</measure>
    <time_frame>8 weeks</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>8 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">18</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>1 BI 409306</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>tablet, fasted, oral administration with 240 ml water</description>
  </arm_group>
  <arm_group>
    <arm_group_label>2 BI 409306</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>tablet, fed, oral administration with 240 ml water</description>
  </arm_group>
  <arm_group>
    <arm_group_label>3 BI 409306</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>tablet, oral administration with 240 ml water at bed time</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BI 409306</intervention_name>
    <description>medium dose, oral administration</description>
    <arm_group_label>2 BI 409306</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BI 409306</intervention_name>
    <description>medium dose, oral administration</description>
    <arm_group_label>3 BI 409306</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BI 409306</intervention_name>
    <description>medium dose, oral administration</description>
    <arm_group_label>1 BI 409306</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          1. Healthy male and female volunteers&#xD;
&#xD;
          2. Age 18 (incl.) to 50 (incl.) years&#xD;
&#xD;
          3. Body mass index (BMI) range: 18.5 (incl.) to 29.9 (incl.) kg/m2&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          1. Any evidence of a clinically relevant concomitant disease&#xD;
&#xD;
          2. Any finding of the medical examination (including BP, PR and ECG) deviating from&#xD;
             normal and of clinical relevance&#xD;
&#xD;
          3. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic,&#xD;
             immunological or hormonal disorders&#xD;
&#xD;
          4. Surgery of the gastrointestinal tract (except appendectomy)&#xD;
&#xD;
          5. Diseases of the central nervous system (including but not limited to any kind of&#xD;
             seizures, stroke or psychiatric disorders)&#xD;
&#xD;
          6. History or evidence of relevant orthostatic reaction, fainting spells or blackouts,&#xD;
             occurrence of syncopes, brady- or tachycardia in the anamnesis.&#xD;
&#xD;
          7. Positive pregnancy test&#xD;
&#xD;
          8. No adequate contraception during the study and until 1 month of study completion, i.e.&#xD;
             intrauterine device (IUD), sexual abstinence (for at least 1 month prior to&#xD;
             enrolment), or surgical sterilisation (incl. hysterectomy). Females, who are not&#xD;
             surgically sterile will be asked to additionally use barrier contraception methods&#xD;
             (e.g. condom, diaphragm with spermicide)&#xD;
      </textblock>
    </criteria>
    <gender>All</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>1289.22.1 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Berlin</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <reference>
    <citation>Unable to connect to PubMed to validate , last attempt on November 19, 2014 at 10:17 AM EST</citation>
  </reference>
  <verification_date>November 2014</verification_date>
  <study_first_submitted>August 20, 2014</study_first_submitted>
  <study_first_submitted_qc>August 20, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 21, 2014</study_first_posted>
  <last_update_submitted>November 19, 2014</last_update_submitted>
  <last_update_submitted_qc>November 19, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 20, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>BI 409306</mesh_term>
  </intervention_browse>
  <pending_results>
    <submitted>August 10, 2023</submitted>
  </pending_results>
  <!-- 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/NCT02222168
org study id: 1289.22
secondary id: 2014-001934-28
nct id: NCT02222168
lead sponsor: 
To evaluate the effect of food on the pharmacokinetics of BI 409306 and to investigate the
      pharmacokinetics of BI 409306 when given at bed time.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Cmax (maximum measured concentration of the analyte in plasma)
time frame: 8 weeks
measure: AUC0-tz (area under the concentration-time curve of the analyte in plasma from time 0 to time of last quantifiable data point)
time frame: 8 weeks
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: 8 weeks
arm group label: 1 BI 409306
arm group type: Experimental
description: tablet, fasted, oral administration with 240 ml water
arm group label: 2 BI 409306
arm group type: Experimental
description: tablet, fed, oral administration with 240 ml water
arm group label: 3 BI 409306
arm group type: Experimental
description: tablet, oral administration with 240 ml water at bed time
intervention type: Drug
intervention name: BI 409306
description: medium dose, oral administration
arm group label: 2 BI 409306
intervention type: Drug
intervention name: BI 409306
description: medium dose, oral administration
arm group label: 3 BI 409306
intervention type: Drug
intervention name: BI 409306
description: medium dose, oral administration
arm group label: 1 BI 409306
criteria: 
gender: All
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
citation: Unable to connect to PubMed to validate , last attempt on November 19, 2014 at 10:17 AM EST
responsible party type: Sponsor
mesh term: BI 409306
submitted: August 10, 2023