<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/NCT02211937</url>
  </required_header>
  <id_info>
    <org_study_id>1224.2</org_study_id>
    <nct_id>NCT02211937</nct_id>
  </id_info>
  <brief_title>Relative Oral Bioavailability of BI 44847 as Suspension Compared to Tablet and the Influence of Food Anf of BI 44847 as Solution Compared to Tablet in Healthy Male Volunteers</brief_title>
  <official_title>Relative Oral Bioavailability of 400 mg BI 44847 as Suspension Compared to 400 mg BI 44847 as Tablet and the Influence of Food (Standardised High Fat Breakfast) on the Tablet in a Single Dose, Open-label, Randomised Three-way Crossover Trial and Relative Oral Bioavailability of 40 mg BI 44847 as Solution Compared to 40 mg BI 44847 as Tablet in Healthy Male Volunteers in a Single Dose, Open-label, Randomised Two-way Crossover 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>
      Study to investigate the relative oral bioavailability of 400 mg BI 44847 as suspension vs.&#xD;
      400 mg BI 44847 as tablet, to investigate a food effect on the 400 mg tablet pharmacokinetic&#xD;
      (PK) and to investigate relative oral bioavailability of 40 mg BI 44847 as solution vs. 40 mg&#xD;
      BI 44847 as tablet.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2007</start_date>
  <primary_completion_date type="Actual">March 2007</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 concentration of the analyte in plasma)</measure>
    <time_frame>up to 48 hours after drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point)</measure>
    <time_frame>up to 48 hours after drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>AUC0-∞ (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 48 hours after drug administration</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>λz (terminal rate constant in plasma)</measure>
    <time_frame>up to 48 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>t1/2 (terminal half-life of the analyte in plasma)</measure>
    <time_frame>up to 48 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MRTpo (mean residence time of the analyte in the body after po administration)</measure>
    <time_frame>up to 48 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CL/F (total clearance of the analyte in the plasma after extravascular administration)</measure>
    <time_frame>up to 48 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose)</measure>
    <time_frame>up to 48 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Aet1-t2 (amount of analyte that is eliminated in urine from the time point t1 to time point t2)</measure>
    <time_frame>up to 48 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>fet1-t2 (fraction of analyte eliminated in urine from time point t1 to time point t2)</measure>
    <time_frame>up to 48 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CLR,t1-t2 (renal clearance of the analyte from the time point t1 until the time point t2)</measure>
    <time_frame>up to 48 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>%AUCtz-∞ (the percentage of the AUC0-∞ that is obtained by extrapolation)</measure>
    <time_frame>up to 48 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>tmax (time from dosing to maximum concentration)</measure>
    <time_frame>up to 48 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with clinically relevant changes in vital signs</measure>
    <time_frame>up to 3 days after last drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with clinically relevant findings in 12-lead electrocardiogram (ECG)</measure>
    <time_frame>up to 3 days after last drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with adverse events</measure>
    <time_frame>up to 3 days after last drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of tolerability by investigator on a 4-point scale</measure>
    <time_frame>day 3</time_frame>
  </secondary_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Actual">25</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Treatment A</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>BI 44847 suspension high dose, fasted</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment B</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>BI 44847 tablet high dose, fasted</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment C</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>BI 44847 tablet high dose, fed</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment D</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>BI 44847 solution low dose, fasted</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment E</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>BI 44847 tablet low dose, fasted</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BI 44847 solution, low dose</intervention_name>
    <arm_group_label>Treatment D</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BI 44847 suspension, high dose</intervention_name>
    <arm_group_label>Treatment A</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BI 44847 tablet, low dose</intervention_name>
    <arm_group_label>Treatment E</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BI 44847 tablet, high dose</intervention_name>
    <arm_group_label>Treatment B</arm_group_label>
    <arm_group_label>Treatment C</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>high fat breakfast</intervention_name>
    <arm_group_label>Treatment C</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy males according to the following criteria based upon a complete medical&#xD;
             history, including the physical examination, vital signs (BP, PR), 12-lead ECG,&#xD;
             clinical laboratory tests&#xD;
&#xD;
          -  Age ≥ 21 and Age ≤ 50 years&#xD;
&#xD;
          -  BMI ≥ 18.5 and BMI ≤ 29.9 kg/m2 (Body Mass Index)&#xD;
&#xD;
          -  Signed and dated written informed consent prior to admission to the study in&#xD;
             accordance with Good Clinical Practice and the local legislation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any finding of the medical examination (including BP, PR and ECG) deviating from&#xD;
             normal and of clinical relevance&#xD;
&#xD;
          -  Any evidence of a clinically relevant concomitant disease&#xD;
&#xD;
          -  Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic,&#xD;
             immunological or hormonal disorders&#xD;
&#xD;
          -  Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or&#xD;
             neurological 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/hypersensitivity (including allergy to drug or its&#xD;
             excipients)&#xD;
&#xD;
          -  Intake of drugs with a long half-life (&gt; 24 hours) within at least one month or less&#xD;
             than 10 half-lives of the respective drug prior to administration or during the trial&#xD;
&#xD;
          -  Use of drugs which might reasonably influence the results of the trial based on the&#xD;
             knowledge at the time of protocol preparation within 10 days prior to administration&#xD;
             or during the trial&#xD;
&#xD;
          -  Participation in another trial with an investigational drug within two months prior to&#xD;
             administration or during the trial&#xD;
&#xD;
          -  Smoker (&gt; 10 cigarettes or &gt; 3 cigars or &gt; 3 pipes/day)&#xD;
&#xD;
          -  Inability to refrain from smoking on trial days&#xD;
&#xD;
          -  Alcohol abuse (more than 60 g/day)&#xD;
&#xD;
          -  Drug abuse&#xD;
&#xD;
          -  Blood donation (more than 100 mL) within four weeks prior to administration or during&#xD;
             the trial&#xD;
&#xD;
          -  Excessive physical activities (within one week prior to administration or during the&#xD;
             trial)&#xD;
&#xD;
          -  Any laboratory value outside the reference range that is of clinical relevance&#xD;
&#xD;
          -  Inability to comply with dietary regimen of study centre&#xD;
&#xD;
          -  Any ECG value outside of the reference range and of clinical relevance including, but&#xD;
             not limited to QRS interval &gt; 120 ms. A marked baseline prolongation of QT/QTc&#xD;
             interval (e.g., repeated demonstration of a QTc interval &gt; 450 ms or QT&gt; 500 ms)&#xD;
&#xD;
          -  A history of additional risk factors for torsade de pointes (e.g., heart failure,&#xD;
             hypokalemia, family history of Long QT Syndrome)&#xD;
&#xD;
          -  The use of concomitant medications that prolong the QT/QTc interval&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <link>
    <url>http://trials.boehringer-ingelheim.com</url>
    <description>Related Info</description>
  </link>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>August 7, 2014</study_first_submitted>
  <study_first_submitted_qc>August 7, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 8, 2014</study_first_posted>
  <last_update_submitted>August 7, 2014</last_update_submitted>
  <last_update_submitted_qc>August 7, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 8, 2014</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/NCT02211937
org study id: 1224.2
nct id: NCT02211937
lead sponsor: 
Study to investigate the relative oral bioavailability of 400 mg BI 44847 as suspension vs.
      400 mg BI 44847 as tablet, to investigate a food effect on the 400 mg tablet pharmacokinetic
      (PK) and to investigate relative oral bioavailability of 40 mg BI 44847 as solution vs. 40 mg
      BI 44847 as tablet.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Cmax (maximum concentration of the analyte in plasma)
time frame: up to 48 hours after drug administration
measure: AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point)
time frame: up to 48 hours after drug administration
measure: AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
time frame: up to 48 hours after drug administration
measure: λz (terminal rate constant in plasma)
time frame: up to 48 hours after drug administration
measure: t1/2 (terminal half-life of the analyte in plasma)
time frame: up to 48 hours after drug administration
measure: MRTpo (mean residence time of the analyte in the body after po administration)
time frame: up to 48 hours after drug administration
measure: CL/F (total clearance of the analyte in the plasma after extravascular administration)
time frame: up to 48 hours after drug administration
measure: Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose)
time frame: up to 48 hours after drug administration
measure: Aet1-t2 (amount of analyte that is eliminated in urine from the time point t1 to time point t2)
time frame: up to 48 hours after drug administration
measure: fet1-t2 (fraction of analyte eliminated in urine from time point t1 to time point t2)
time frame: up to 48 hours after drug administration
measure: CLR,t1-t2 (renal clearance of the analyte from the time point t1 until the time point t2)
time frame: up to 48 hours after drug administration
measure: %AUCtz-∞ (the percentage of the AUC0-∞ that is obtained by extrapolation)
time frame: up to 48 hours after drug administration
measure: tmax (time from dosing to maximum concentration)
time frame: up to 48 hours after drug administration
measure: Number of patients with clinically relevant changes in vital signs
time frame: up to 3 days after last drug administration
measure: Number of patients with clinically relevant findings in 12-lead electrocardiogram (ECG)
time frame: up to 3 days after last drug administration
measure: Number of patients with adverse events
time frame: up to 3 days after last drug administration
measure: Assessment of tolerability by investigator on a 4-point scale
time frame: day 3
arm group label: Treatment A
arm group type: Active Comparator
description: BI 44847 suspension high dose, fasted
arm group label: Treatment B
arm group type: Experimental
description: BI 44847 tablet high dose, fasted
arm group label: Treatment C
arm group type: Experimental
description: BI 44847 tablet high dose, fed
arm group label: Treatment D
arm group type: Active Comparator
description: BI 44847 solution low dose, fasted
arm group label: Treatment E
arm group type: Experimental
description: BI 44847 tablet low dose, fasted
intervention type: Drug
intervention name: BI 44847 solution, low dose
arm group label: Treatment D
intervention type: Drug
intervention name: BI 44847 suspension, high dose
arm group label: Treatment A
intervention type: Drug
intervention name: BI 44847 tablet, low dose
arm group label: Treatment E
intervention type: Drug
intervention name: BI 44847 tablet, high dose
arm group label: Treatment B
arm group label: Treatment C
intervention type: Other
intervention name: high fat breakfast
arm group label: Treatment C
criteria: 
gender: Male
minimum age: 21 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
url: http://trials.boehringer-ingelheim.com
description: Related Info
responsible party type: Sponsor