<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/NCT02211950</url>
  </required_header>
  <id_info>
    <org_study_id>1224.22</org_study_id>
    <nct_id>NCT02211950</nct_id>
  </id_info>
  <brief_title>Relative Bioavailability of BI 44847 in Different Ethnic Groups and Evaluation of Effect of Diet and Acarbose Coadministration on Bioavailability Following Oral Administration of 200 mg BI 44847 in Healthy Male Volunteers</brief_title>
  <official_title>Evaluation of Relative Bioavailability of BI 44847 in Different Ethnic Groups (Subjects of White, Asian, and African Origin), and Evaluation of Effect of Diet and Acarbose Coadministration on Bioavailability Following Oral Administration of 200 mg BI 44847 in Healthy Male Volunteers. An Open-label, Single-dose, Parallel Group, Phase 1 Study (Group 1 With Additional Crossover Aspects)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boehringer Ingelheim</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boehringer Ingelheim</source>
  <brief_summary>
    <textblock>
      The objectives were to investigate the relative bioavailability of BI 44847 in different&#xD;
      racial groups (white, Asian, and African subjects) and to investigate the effect of different&#xD;
      types of diet and acarbose coadministration on the bioavailability of BI 44847 in white&#xD;
      subjects.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2008</start_date>
  <primary_completion_date type="Actual">December 2008</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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>AUC0-∞ (area under the concentration time curve of the analyte in plasma in plasma over the time interval from 0 to infinity)</measure>
    <time_frame>up to 48 hours after drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>AUC0-48 (area under the concentration time curve of the analyte in plasma over the time interval from 0 to 48 h)</measure>
    <time_frame>up to 48 hours after drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>AUC0-12 (area under the concentration time curve of the analyte in plasma over the time interval from 0 to 12 h)</measure>
    <time_frame>up to 48 hours after drug administration</time_frame>
  </primary_outcome>
  <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>
  <secondary_outcome>
    <measure>tmax (time from dosing to maximum concentration of the analyte in plasma)</measure>
    <time_frame>up to 48 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>λz (terminal rate constant in plasma after single dose</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 after single dose)</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 single dose)</measure>
    <time_frame>up to 48 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CL/F (apparent clearance of the analyte in the plasma after extravascular administration after single dose)</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 after single dose following extravascular administration)</measure>
    <time_frame>up to 48 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AUCt1-t2 (area under the concentration time curve of analyte in plasma over the time interval t1 to t2)</measure>
    <time_frame>up to 24 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Aet1-t2 (amount of drug that is eliminated in urine from the time point t1 to time point t2)</measure>
    <time_frame>up to 24 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>fet1-t2 (fraction of drug eliminated in urine from time point t1 to time point t2)</measure>
    <time_frame>up to 24 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CLR,t1-t2 (renal clearance of the drug from the time point t1 until the time point t2)</measure>
    <time_frame>up to 24 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Amount of glucose excreted in urine</measure>
    <time_frame>up to 24 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with adverse events</measure>
    <time_frame>up to 48 hours after last administration of study drug</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with clinically relevant changes in laboratory tests</measure>
    <time_frame>up to 48 hours after last administration of study drug</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with clinically relevant changes in Electrocardiogram (ECG)</measure>
    <time_frame>up to 48 hours after last administration of study drug</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with clinically relevant changes in vital signs</measure>
    <time_frame>up to 48 hours after last administration of study drug</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of global tolerability by investigator on a 4-point scale</measure>
    <time_frame>48 hours after last administration of study drug</time_frame>
  </secondary_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Actual">37</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Treatment A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>single dose BI 44847 administered to white subjects</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment B</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>100 mg acarbose for 2 days, on the second day a single dose BI 44847 administered to white subjects</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment C</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>single dose BI 44847 after a Japanese diet of 6 days administered to white subjects</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment D</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>single dose BI 44847 administered to asian subjects</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment E</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>single dose BI 44847 administered to african subjects</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BI 44847</intervention_name>
    <arm_group_label>Treatment A</arm_group_label>
    <arm_group_label>Treatment B</arm_group_label>
    <arm_group_label>Treatment C</arm_group_label>
    <arm_group_label>Treatment D</arm_group_label>
    <arm_group_label>Treatment E</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Acarbose</intervention_name>
    <arm_group_label>Treatment B</arm_group_label>
    <other_name>Glucobay</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Japanese diet</intervention_name>
    <arm_group_label>Treatment C</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy male subjects determined by results of screening&#xD;
&#xD;
          -  Age 18 - 40 years&#xD;
&#xD;
          -  Body Mass Index 18 - 25 kg/m2, at least 45 kg&#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;
          -  Significant gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic,&#xD;
             immunological or hormonal disorders as judged by the investigator&#xD;
&#xD;
          -  Relevant gastrointestinal tract surgery&#xD;
&#xD;
          -  Diseases of the central nervous system (such as epilepsy, seizures) or psychiatric&#xD;
             disorders or relevant neurological disorders&#xD;
&#xD;
          -  History of relevant orthostatic hypotension, fainting spells or blackouts; systolic&#xD;
             blood pressure greater than 140 mm Hg, diastolic blood pressure greater than 90 mm Hg,&#xD;
             pulse rate out of 45 to 90 beats per minute&#xD;
&#xD;
          -  Chronic or relevant acute infections&#xD;
&#xD;
          -  History of allergy/hypersensitivity (including drug allergies) that are deemed&#xD;
             relevant to the trial as judged by the investigator&#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 within 10 days prior to administration or during the trial of drugs which might&#xD;
             reasonably influence the results of the trial based on the knowledge at the time of&#xD;
             protocol preparation&#xD;
&#xD;
          -  Participation in another trial with an investigational drug within 2 months after a&#xD;
             multiple dose study or within 1 month after a single dose study&#xD;
&#xD;
          -  Smoker (more than 10 cigarettes or 3 cigars or 3 pipes per day)&#xD;
&#xD;
          -  Inability to refrain from smoking when confined to the study site on trial days&#xD;
&#xD;
          -  Alcohol abuse (more than 60 g/day in males, more than 40 g/day in females)&#xD;
&#xD;
          -  Drug abuse, in the investigator's judgment upon review of the patient's history and&#xD;
             urine screening for abused substances&#xD;
&#xD;
          -  Veins unsuited for iv puncture on either arm (e.g. veins which are difficult to&#xD;
             locate, access or puncture, veins with a tendency to rupture during or after puncture)&#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 48 hours prior to trial or during the trial)&#xD;
&#xD;
          -  Any laboratory value outside the reference range that is of clinical relevance&#xD;
             according to the assessment of the investigator&#xD;
&#xD;
          -  Inability to comply with dietary regimen of study centre&#xD;
&#xD;
          -  Subjects not able to understand and comply with protocol requirements, instructions&#xD;
             and protocol-stated restrictions&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 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>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acarbose</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/NCT02211950
org study id: 1224.22
nct id: NCT02211950
lead sponsor: 
The objectives were to investigate the relative bioavailability of BI 44847 in different
      racial groups (white, Asian, and African subjects) and to investigate the effect of different
      types of diet and acarbose coadministration on the bioavailability of BI 44847 in white
      subjects.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: AUC0-∞ (area under the concentration time curve of the analyte in plasma in plasma over the time interval from 0 to infinity)
time frame: up to 48 hours after drug administration
measure: AUC0-48 (area under the concentration time curve of the analyte in plasma over the time interval from 0 to 48 h)
time frame: up to 48 hours after drug administration
measure: AUC0-12 (area under the concentration time curve of the analyte in plasma over the time interval from 0 to 12 h)
time frame: up to 48 hours after drug administration
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 of the analyte in plasma)
time frame: up to 48 hours after drug administration
measure: λz (terminal rate constant in plasma after single dose
time frame: up to 48 hours after drug administration
measure: t1/2 (terminal half-life of the analyte in plasma after single dose)
time frame: up to 48 hours after drug administration
measure: MRTpo (mean residence time of the analyte in the body after single dose)
time frame: up to 48 hours after drug administration
measure: CL/F (apparent clearance of the analyte in the plasma after extravascular administration after single dose)
time frame: up to 48 hours after drug administration
measure: Vz/F (apparent volume of distribution during the terminal phase λz after single dose following extravascular administration)
time frame: up to 48 hours after drug administration
measure: AUCt1-t2 (area under the concentration time curve of analyte in plasma over the time interval t1 to t2)
time frame: up to 24 hours after drug administration
measure: Aet1-t2 (amount of drug that is eliminated in urine from the time point t1 to time point t2)
time frame: up to 24 hours after drug administration
measure: fet1-t2 (fraction of drug eliminated in urine from time point t1 to time point t2)
time frame: up to 24 hours after drug administration
measure: CLR,t1-t2 (renal clearance of the drug from the time point t1 until the time point t2)
time frame: up to 24 hours after drug administration
measure: Amount of glucose excreted in urine
time frame: up to 24 hours after drug administration
measure: Number of patients with adverse events
time frame: up to 48 hours after last administration of study drug
measure: Number of patients with clinically relevant changes in laboratory tests
time frame: up to 48 hours after last administration of study drug
measure: Number of patients with clinically relevant changes in Electrocardiogram (ECG)
time frame: up to 48 hours after last administration of study drug
measure: Number of patients with clinically relevant changes in vital signs
time frame: up to 48 hours after last administration of study drug
measure: Assessment of global tolerability by investigator on a 4-point scale
time frame: 48 hours after last administration of study drug
arm group label: Treatment A
arm group type: Experimental
description: single dose BI 44847 administered to white subjects
arm group label: Treatment B
arm group type: Experimental
description: 100 mg acarbose for 2 days, on the second day a single dose BI 44847 administered to white subjects
arm group label: Treatment C
arm group type: Experimental
description: single dose BI 44847 after a Japanese diet of 6 days administered to white subjects
arm group label: Treatment D
arm group type: Experimental
description: single dose BI 44847 administered to asian subjects
arm group label: Treatment E
arm group type: Experimental
description: single dose BI 44847 administered to african subjects
intervention type: Drug
intervention name: BI 44847
arm group label: Treatment A
arm group label: Treatment B
arm group label: Treatment C
arm group label: Treatment D
arm group label: Treatment E
intervention type: Drug
intervention name: Acarbose
arm group label: Treatment B
other name: Glucobay
intervention type: Other
intervention name: Japanese diet
arm group label: Treatment C
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
url: http://trials.boehringer-ingelheim.com
description: Related Info
responsible party type: Sponsor
mesh term: Acarbose