<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/NCT02211924</url>
  </required_header>
  <id_info>
    <org_study_id>1224.11</org_study_id>
    <nct_id>NCT02211924</nct_id>
  </id_info>
  <brief_title>Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Oral Doses of BI 44847 Administered to Healthy Male Subjects</brief_title>
  <official_title>Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Oral Doses (50 mg to 800 mg) of BI 44847 as Tablet(s) Administered to Healthy Male Subjects. A Randomised, Placebo-controlled (Within Dose Groups) and Double-blinded 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 safety, tolerability, pharmacokinetics and pharmacodynamics of BI 44847&#xD;
      in Japanese healthy volunteers&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2007</start_date>
  <primary_completion_date type="Actual">September 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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of patients with clinically relevant changes in vital signs</measure>
    <time_frame>up to day 7</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of patients with clinically relevant finding in 12-lead electrocardiogram (ECG)</measure>
    <time_frame>up to day 7</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of patients with clinically relevant changes in laboratory parameters</measure>
    <time_frame>up to day 7</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of patients with adverse events</measure>
    <time_frame>up to 5 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cmax (maximum concentration of the analyte in plasma)</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>AUC0-inf. (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>
  </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>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>
  </secondary_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>Area under the plasma glucose concentration time curve</measure>
    <time_frame>up to 12 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total amount of glucose excreted in the urine</measure>
    <time_frame>up to 48 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum glucose concentration in plasma</measure>
    <time_frame>up to 12 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum glucose concentration in urine</measure>
    <time_frame>up to 48 hours after drug administration</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">48</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>BI 44847</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>single rising dose</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 44847</intervention_name>
    <arm_group_label>BI 44847</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects will be healthy male volunteers who meet the criteria below:&#xD;
&#xD;
               -  Persons without clinically remarkable findings or clinically evident&#xD;
                  complications based on their concurrent illness, past medical history, physical&#xD;
                  examination, vital signs (blood pressure, pulse rate, and body temperature),&#xD;
                  12-lead ECG, and laboratory test results&#xD;
&#xD;
               -  Persons who are 20 or older and 35 or younger&#xD;
&#xD;
               -  Persons with a BMI 18.5 kg/m2 or more and 25.0 kg/m2 less&#xD;
&#xD;
               -  Persons who are willing to participate in this trial before study initiation and&#xD;
                  who give their written consent in accordance with Good Clinical Practice&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any finding of the medical examination (including BP, Pulse Rate (PR) and ECG)&#xD;
             deviating from 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 any drugs within 10 days prior to administration or during the trial&#xD;
&#xD;
          -  Participation in another trial with an investigational drug within four months prior&#xD;
             to 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 19. A history of additional&#xD;
             risk factors for torsade de pointes (e.g., heart failure, hypokalemia, family history&#xD;
             of long QT syndrome)&#xD;
&#xD;
          -  The use of concomitant medications that prolong the QT/QTc interval&#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&#xD;
&#xD;
          -  Elevated urinary glucose levels at screening (&gt;15 mg/dl)&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>35 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/NCT02211924
org study id: 1224.11
nct id: NCT02211924
lead sponsor: 
Study to investigate safety, tolerability, pharmacokinetics and pharmacodynamics of BI 44847
      in Japanese healthy volunteers
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double
measure: Number of patients with clinically relevant changes in vital signs
time frame: up to day 7
measure: Number of patients with clinically relevant finding in 12-lead electrocardiogram (ECG)
time frame: up to day 7
measure: Number of patients with clinically relevant changes in laboratory parameters
time frame: up to day 7
measure: Number of patients with adverse events
time frame: up to 5 weeks
measure: Cmax (maximum concentration of the analyte in plasma)
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: AUC0-inf. (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: %AUCtz-∞ (the percentage of the AUC0-∞ that is obtained by extrapolation)
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: 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: Area under the plasma glucose concentration time curve
time frame: up to 12 hours after drug administration
measure: Total amount of glucose excreted in the urine
time frame: up to 48 hours after drug administration
measure: Maximum glucose concentration in plasma
time frame: up to 12 hours after drug administration
measure: Maximum glucose concentration in urine
time frame: up to 48 hours after drug administration
arm group label: BI 44847
arm group type: Experimental
description: single rising dose
arm group label: Placebo
arm group type: Placebo Comparator
intervention type: Drug
intervention name: BI 44847
arm group label: BI 44847
intervention type: Drug
intervention name: Placebo
arm group label: Placebo
criteria: 
gender: Male
minimum age: 20 Years
maximum age: 35 Years
healthy volunteers: Accepts Healthy Volunteers
url: http://trials.boehringer-ingelheim.com
description: Related Info
responsible party type: Sponsor