<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/NCT02259972</url>
  </required_header>
  <id_info>
    <org_study_id>1272.1</org_study_id>
    <nct_id>NCT02259972</nct_id>
  </id_info>
  <brief_title>Safety, Tolerability and Pharmacokinetics of Single Rising Oral Doses of BI 113823 Powder in Bottle (PiB) and Tablet in Healthy Male Volunteers</brief_title>
  <official_title>Investigation of Safety, Tolerability and Pharmacokinetics of Single Rising Oral Doses of 5 to 800 mg BI 113823 Powder in Bottle (PiB) and Tablet Administered to Healthy Male Volunteers in a Partially Randomised and Double Blinded, Placebo Controlled Phase I Trial. Including Intra-individual Open Comparisons of PiB and Tablet (Fasted and Fed).</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 investigate the safety, tolerability, and pharmacokinetics incl. dose proportionality of&#xD;
      BI 113823, as well as the relative bioavailability of PiB vs. tablet and tablet fasted vs.&#xD;
      fed (food effect for the tablet).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2010</start_date>
  <primary_completion_date type="Actual">June 2010</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>Double</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of participants with clinically significant findings on physical examination</measure>
    <time_frame>up to 14 days after last drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of participants with clinically significant findings in vital signs</measure>
    <time_frame>up to 14 days after last drug administration</time_frame>
    <description>blood pressure (BP), pulse rate (PR)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of participants with clinically significant findings in 12-lead electrocardiogram (ECG)</measure>
    <time_frame>up to 14 days after last drug administration</time_frame>
    <description>special attention to QRS prolongation</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of participants with clinically significant findings in laboratory tests</measure>
    <time_frame>up to 14 days after last drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of participants with adverse events</measure>
    <time_frame>up to 14 days after last drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Assessment of tolerability by investigator on a 4-point scale</measure>
    <time_frame>up to 14 days after last drug administration</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cmax (maximum measured concentration of the analyte in plasma)</measure>
    <time_frame>up to 72 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>tmax (time from dosing to maximum measured concentration)</measure>
    <time_frame>up to 72 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_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 72 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AUC0-tz (area under the concentration-time curve of metformin in plasma over the time interval from 0 to the time of the last quantifiable data point)</measure>
    <time_frame>up to 72 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>λz (terminal rate constant in plasma)</measure>
    <time_frame>up to 72 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 72 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MRToral (mean residence time of the analyte in the body after oral administration)</measure>
    <time_frame>up to 72 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CL/F (total/apparent clearance of the analyte in plasma after extravascular administration)</measure>
    <time_frame>up to 72 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 72 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Aet1-t2 (amount of analyte eliminated in urine from the time point t1 to time point t2)</measure>
    <time_frame>up to 72 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 72 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 72 hours after drug administration</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">63</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>BI 113823 solution</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>single rising doses, dose group 5 twice (fed and fasted)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>BI 113823 tablet</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>dose group 5 only</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BI 113823 solution</intervention_name>
    <arm_group_label>BI 113823 solution</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BI 113823 tablet</intervention_name>
    <arm_group_label>BI 113823 tablet</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>High fat, high calorie breakfast</intervention_name>
    <description>only for dose group 5</description>
    <arm_group_label>BI 113823 solution</arm_group_label>
    <arm_group_label>BI 113823 tablet</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. 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;
          2. Age ≥18 and Age ≤45 years&#xD;
&#xD;
          3. BMI ≥18.5 and BMI ≤29.9 kg/m2 (Body Mass Index)&#xD;
&#xD;
          4. Signed and dated written informed consent prior to admission to the study in&#xD;
             accordance with GCP and the local legislation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Any finding of the medical examination (including BP, PR and ECG) deviating from&#xD;
             normal and of clinical relevance&#xD;
&#xD;
          2. Any evidence of a clinically relevant concomitant disease&#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 (such as epilepsy) or psychiatric disorders or&#xD;
             neurological disorders&#xD;
&#xD;
          6. History of relevant orthostatic hypotension, fainting spells or blackouts&#xD;
&#xD;
          7. Chronic or relevant acute infections&#xD;
&#xD;
          8. History of relevant allergy/hypersensitivity (including allergy to drug or its&#xD;
             excipients)&#xD;
&#xD;
          9. 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&#xD;
&#xD;
         10. Use of drugs which might reasonably influence the results of the trial or that prolong&#xD;
             the QT/QTc interval based on the knowledge at the time of protocol preparation within&#xD;
             10 days prior to administration&#xD;
&#xD;
         11. Participation in another trial with an investigational drug within two months prior to&#xD;
             administration or during the trial&#xD;
&#xD;
         12. Smoker (&gt; 10 cigarettes or &gt; 3 cigars or &gt; 3 pipes/day)&#xD;
&#xD;
         13. Inability to refrain from smoking on trial days&#xD;
&#xD;
         14. Alcohol abuse (more than 30 g/day)&#xD;
&#xD;
         15. Drug abuse&#xD;
&#xD;
         16. Blood donation (more than 100 mL within four weeks prior to administration)&#xD;
&#xD;
         17. Excessive physical activities (within one week prior to administration)&#xD;
&#xD;
         18. Any laboratory value outside the reference range that is of clinical relevance&#xD;
&#xD;
         19. Inability to comply with dietary regimen of trial site&#xD;
&#xD;
         20. Bradycardia &lt; 50/min, PR interval &gt; 200 ms, QRS interval &gt; 110 ms, QTcB &gt; 450 ms, or&#xD;
             QT (uncorrected) &gt; 470 ms or any other relevant ECG findings at screening&#xD;
&#xD;
         21. A history of additional risk factors for Torsades des Pointes (e.g., heart failure,&#xD;
             hypokalemia, family history of Long QT Syndrome)&#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>
  <link>
    <url>http://trials.boehringer-ingelheim.com</url>
    <description>Related Info</description>
  </link>
  <verification_date>October 2014</verification_date>
  <study_first_submitted>October 7, 2014</study_first_submitted>
  <study_first_submitted_qc>October 7, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 9, 2014</study_first_posted>
  <last_update_submitted>October 7, 2014</last_update_submitted>
  <last_update_submitted_qc>October 7, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 9, 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/NCT02259972
org study id: 1272.1
nct id: NCT02259972
lead sponsor: 
To investigate the safety, tolerability, and pharmacokinetics incl. dose proportionality of
      BI 113823, as well as the relative bioavailability of PiB vs. tablet and tablet fasted vs.
      fed (food effect for the tablet).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double
measure: Number of participants with clinically significant findings on physical examination
time frame: up to 14 days after last drug administration
measure: Number of participants with clinically significant findings in vital signs
time frame: up to 14 days after last drug administration
description: blood pressure (BP), pulse rate (PR)
measure: Number of participants with clinically significant findings in 12-lead electrocardiogram (ECG)
time frame: up to 14 days after last drug administration
description: special attention to QRS prolongation
measure: Number of participants with clinically significant findings in laboratory tests
time frame: up to 14 days after last drug administration
measure: Number of participants with adverse events
time frame: up to 14 days after last drug administration
measure: Assessment of tolerability by investigator on a 4-point scale
time frame: up to 14 days after last drug administration
measure: Cmax (maximum measured concentration of the analyte in plasma)
time frame: up to 72 hours after drug administration
measure: tmax (time from dosing to maximum measured concentration)
time frame: up to 72 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 72 hours after drug administration
measure: AUC0-tz (area under the concentration-time curve of metformin in plasma over the time interval from 0 to the time of the last quantifiable data point)
time frame: up to 72 hours after drug administration
measure: λz (terminal rate constant in plasma)
time frame: up to 72 hours after drug administration
measure: t1/2 (terminal half-life of the analyte in plasma)
time frame: up to 72 hours after drug administration
measure: MRToral (mean residence time of the analyte in the body after oral administration)
time frame: up to 72 hours after drug administration
measure: CL/F (total/apparent clearance of the analyte in plasma after extravascular administration)
time frame: up to 72 hours after drug administration
measure: Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose)
time frame: up to 72 hours after drug administration
measure: Aet1-t2 (amount of analyte eliminated in urine from the time point t1 to time point t2)
time frame: up to 72 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 72 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 72 hours after drug administration
arm group label: BI 113823 solution
arm group type: Experimental
description: single rising doses, dose group 5 twice (fed and fasted)
arm group label: BI 113823 tablet
arm group type: Experimental
description: dose group 5 only
arm group label: Placebo
arm group type: Placebo Comparator
intervention type: Drug
intervention name: BI 113823 solution
arm group label: BI 113823 solution
intervention type: Drug
intervention name: BI 113823 tablet
arm group label: BI 113823 tablet
intervention type: Drug
intervention name: Placebo
arm group label: Placebo
intervention type: Other
intervention name: High fat, high calorie breakfast
description: only for dose group 5
arm group label: BI 113823 solution
arm group label: BI 113823 tablet
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
url: http://trials.boehringer-ingelheim.com
description: Related Info
responsible party type: Sponsor