<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/NCT01707940</url>
  </required_header>
  <id_info>
    <org_study_id>1313.7</org_study_id>
    <secondary_id>2012-003225-21</secondary_id>
    <nct_id>NCT01707940</nct_id>
  </id_info>
  <brief_title>Bioavailability of BI 144807 Given Alone and in Combination With Ketoconazole in Healthy Male Volunteers</brief_title>
  <official_title>Relative Bioavailability of a Single Oral Dose of BI 144807 (Oral Solution) When Administered Alone or in Combination With Multiple Oral Doses of Ketoconazole (200 mg Tablet) in Healthy Male Subjects (an Open-label, Two-period, Fixed-sequence Trial)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boehringer Ingelheim</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boehringer Ingelheim</source>
  <brief_summary>
    <textblock>
      This trial investigates the influence of oral ketoconazole on the pharmacokinetics and safety&#xD;
      of BI 144807.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">December 2012</completion_date>
  <primary_completion_date type="Actual">December 2012</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity</measure>
    <time_frame>0 to 48 hours after administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Maximum measured concentration of the analyte in plasma</measure>
    <time_frame>0 to 48 hours after administration</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>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>0 to 48 hours after administration</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>BI 144807</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>subjects receive an oral single dose of BI 144807</description>
  </arm_group>
  <arm_group>
    <arm_group_label>BI 144807 plus Ketoconazole</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>subjects receive bid ketoconazole plus an oral single dose of BI 144807</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ketoconazole</intervention_name>
    <description>Ketoconazole 400 mg / day</description>
    <arm_group_label>BI 144807 plus Ketoconazole</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BI 144807</intervention_name>
    <description>BI144807 oral solution, intermediate dose</description>
    <arm_group_label>BI 144807</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BI 144807</intervention_name>
    <description>BI144807 oral solution, intermediate dose</description>
    <arm_group_label>BI 144807 plus Ketoconazole</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
        1. healthy male subjects&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
        1. any relevant deviation from healthy conditions&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Boehringer Ingelheim</last_name>
    <role>Study Chair</role>
    <affiliation>Boehringer Ingelheim</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>1313.7.1 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Biberach</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>May 2013</verification_date>
  <study_first_submitted>October 15, 2012</study_first_submitted>
  <study_first_submitted_qc>October 15, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 16, 2012</study_first_posted>
  <last_update_submitted>May 15, 2013</last_update_submitted>
  <last_update_submitted_qc>May 15, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 16, 2013</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>Ketoconazole</mesh_term>
  </intervention_browse>
  <!-- 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/NCT01707940
org study id: 1313.7
secondary id: 2012-003225-21
nct id: NCT01707940
lead sponsor: 
This trial investigates the influence of oral ketoconazole on the pharmacokinetics and safety
      of BI 144807.
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity
time frame: 0 to 48 hours after administration
measure: Maximum measured concentration of the analyte in plasma
time frame: 0 to 48 hours after administration
measure: 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: 0 to 48 hours after administration
arm group label: BI 144807
arm group type: Experimental
description: subjects receive an oral single dose of BI 144807
arm group label: BI 144807 plus Ketoconazole
arm group type: Experimental
description: subjects receive bid ketoconazole plus an oral single dose of BI 144807
intervention type: Drug
intervention name: Ketoconazole
description: Ketoconazole 400 mg / day
arm group label: BI 144807 plus Ketoconazole
intervention type: Drug
intervention name: BI 144807
description: BI144807 oral solution, intermediate dose
arm group label: BI 144807
intervention type: Drug
intervention name: BI 144807
description: BI144807 oral solution, intermediate dose
arm group label: BI 144807 plus Ketoconazole
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
mesh term: Ketoconazole