<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/NCT02183467</url>
  </required_header>
  <id_info>
    <org_study_id>1218.32</org_study_id>
    <nct_id>NCT02183467</nct_id>
  </id_info>
  <brief_title>Effect of BI 1356 as Single Dose on the QT Interval in Healthy Female and Male Subjects</brief_title>
  <official_title>Assessment of the Effect of 5 mg and 100 mg of BI 1356 as Single Dose on the QT Interval in Healthy Female and Male Subjects. A Randomised, Placebo Controlled, Double-blind, Four-way Crossover Study With Moxifloxacin as Positive Control</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boehringer Ingelheim</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boehringer Ingelheim</source>
  <brief_summary>
    <textblock>
      Assessment of the effect of BI 1356 or Placebo on prolongation of the QT interval&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2008</start_date>
  <primary_completion_date type="Actual">June 2008</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>Double</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline of the QTcI interval (individually heart rate-corrected QT interval length)</measure>
    <time_frame>Pre-dose and 1 to 4 hours following administration</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mean of the QTcI change from baseline of all electrocardiograms (ECGs) taken from 1 hour to 24 hours after dosing</measure>
    <time_frame>up to 24 hours following administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from mean baseline of the QTcI at any point in time between 1 and 24 hours after dosing</measure>
    <time_frame>up to 24 hours following administration</time_frame>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">44</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>BI 1356, low dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>BI 1356, high dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Moxifloxacin</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BI 1356, low dose</intervention_name>
    <arm_group_label>BI 1356, low dose</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BI 1356, high dose</intervention_name>
    <arm_group_label>BI 1356, high dose</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>Drug</intervention_type>
    <intervention_name>Moxifloxacin</intervention_name>
    <arm_group_label>Moxifloxacin</arm_group_label>
    <other_name>Avalox®</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy males and females, 21 to 50 years of age&#xD;
&#xD;
          -  Body mass index (BMI) ranging from 18.5 to 29.9 kg/m2&#xD;
&#xD;
          -  Signed written informed consent prior to admission to the study in accordance with&#xD;
             Good Clinical Practice and the local legislation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any finding of the medical examination (including blood pressure, pulse rate and ECG)&#xD;
             deviating from normal and of clinical relevance&#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 orthostatic hypotension, fainting spells or blackouts&#xD;
&#xD;
          -  Chronic or relevant acute infections&#xD;
&#xD;
          -  History of allergy/hypersensitivity (including drug allergy) which is deemed relevant&#xD;
             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 ten half-lives of the respective drug before enrolment in the study or during the&#xD;
             study&#xD;
&#xD;
          -  Use of any drugs which might influence the results of the trial up to 7 days prior to&#xD;
             enrolment in the study or during the study&#xD;
&#xD;
          -  Participation in another trial with an investigational drug (≤ 60 days prior to&#xD;
             administration or during the trial)&#xD;
&#xD;
          -  Heavy smoker (&gt; 10 cigarettes or &gt; 3 cigars of &gt; 3 pipes/day)&#xD;
&#xD;
          -  Inability to refrain from smoking on trial days&#xD;
&#xD;
          -  Alcohol abuse (&gt; 60 g/day)&#xD;
&#xD;
          -  Drug abuse&#xD;
&#xD;
          -  Blood donation (≥ 100 mL within four weeks prior to administration or during the&#xD;
             trial)&#xD;
&#xD;
          -  Any deviation of a laboratory value that is considered to be of clinical relevance&#xD;
&#xD;
          -  Excessive physical activities within the last week before the trial or during the&#xD;
             trial&#xD;
&#xD;
          -  Hypersensitivity to Moxifloxacin or related drugs of these classes&#xD;
&#xD;
          -  Supine blood pressure at screening of systolic &lt; 100 mmHg and diastolic &lt; 60 mmHg&#xD;
&#xD;
          -  Heart rate at screening of &gt; 80 bpm or &lt; 40 bpm&#xD;
&#xD;
          -  Any screening ECG value outside of the reference range of clinical relevance&#xD;
             including, but not limited to PR interval &gt; 220 ms, QRS interval &gt; 115 ms, QTcB or&#xD;
             QTcF &gt; 450 ms, or QT (uncorrected) &gt; 470 ms&#xD;
&#xD;
          -  Subjects involved in passenger transport or operation of dangerous machines&#xD;
&#xD;
        For Female subjects:&#xD;
&#xD;
          -  Pregnancy or positive pregnancy test, or planning to become pregnant during the study&#xD;
             or within 1 month of study completion Pregnancy&#xD;
&#xD;
          -  No adequate contraception during the study and until 1 month of study completion, i.e.&#xD;
             implants, injectables, combined oral contraceptives, IUD [intrauterine device], sexual&#xD;
             abstinence (for at least 1 month prior to enrolment), vasectomised partner (vasectomy&#xD;
             performed at least 1 year prior to enrolment), or surgical sterilisation (incl.&#xD;
             hysterectomy). Females, who have not a vasectomised partner, are not sexually&#xD;
             abstinent or surgically sterile will be asked to additionally use barrier&#xD;
             contraception methods (e.g. condom, diaphragm with spermicide)&#xD;
&#xD;
          -  Lactation period&#xD;
      </textblock>
    </criteria>
    <gender>All</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/content/dam/internet/opu/clinicaltrial/com_EN/results/1218/1218.32_U09-1067-01.pdf</url>
    <description>Related Info</description>
  </link>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 4, 2014</study_first_submitted>
  <study_first_submitted_qc>July 4, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 8, 2014</study_first_posted>
  <last_update_submitted>July 4, 2014</last_update_submitted>
  <last_update_submitted_qc>July 4, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 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>Linagliptin</mesh_term>
    <mesh_term>Moxifloxacin</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/NCT02183467
org study id: 1218.32
nct id: NCT02183467
lead sponsor: 
Assessment of the effect of BI 1356 or Placebo on prolongation of the QT interval
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Double
measure: Change from baseline of the QTcI interval (individually heart rate-corrected QT interval length)
time frame: Pre-dose and 1 to 4 hours following administration
measure: Mean of the QTcI change from baseline of all electrocardiograms (ECGs) taken from 1 hour to 24 hours after dosing
time frame: up to 24 hours following administration
measure: Change from mean baseline of the QTcI at any point in time between 1 and 24 hours after dosing
time frame: up to 24 hours following administration
arm group label: BI 1356, low dose
arm group type: Experimental
arm group label: BI 1356, high dose
arm group type: Experimental
arm group label: Placebo
arm group type: Placebo Comparator
arm group label: Moxifloxacin
arm group type: Active Comparator
intervention type: Drug
intervention name: BI 1356, low dose
arm group label: BI 1356, low dose
intervention type: Drug
intervention name: BI 1356, high dose
arm group label: BI 1356, high dose
intervention type: Drug
intervention name: Placebo
arm group label: Placebo
intervention type: Drug
intervention name: Moxifloxacin
arm group label: Moxifloxacin
other name: Avalox®
criteria: 
gender: All
minimum age: 21 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
url: http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/1218/1218.32_U09-1067-01.pdf
description: Related Info
responsible party type: Sponsor
mesh term: Linagliptin
mesh term: Moxifloxacin