<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/NCT02256735</url>
  </required_header>
  <id_info>
    <org_study_id>1207.22</org_study_id>
    <nct_id>NCT02256735</nct_id>
  </id_info>
  <brief_title>Study to Investigate the Effect of KUC 7483 CL on the QT/QTc Interval of the ECG in Comparison to Placebo and Moxifloxacin in Healthy Male and Female Volunteers</brief_title>
  <official_title>A Double-blinded, Randomised, Placebo Controlled, Five-way Crossover Study With One Positive Control (Open-label) (Moxifloxacin) to Assess the Influence of Oral Single Dose KUC 7483 BS (40 mg, 80 mg, 160 mg, 320 mg) on the QT/QTc Interval of the ECG in Healthy Male and Female Volunteers</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 effect of Ritobegron CL (KUC 7483 CL) on the QT/QTc interval of the&#xD;
      ECG in comparison to placebo and moxifloxacin&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2005</start_date>
  <primary_completion_date type="Actual">December 2005</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>Change from baseline in mean time-matched QTcI</measure>
    <time_frame>up to 2 hours following drug administration</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in mean time-matched QTcI</measure>
    <time_frame>up to 8 hours following drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Occurrence of uncorrected QT interval</measure>
    <time_frame>up to 8 hours following drug administration</time_frame>
    <description>QT interval &lt;=500 ms, &gt; 500 ms</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Occurrence of the QTcI interval</measure>
    <time_frame>up to 8 hours following drug administration</time_frame>
    <description>QTcI interval &lt;= 450 ms, &gt;450 ms, &gt;480 ms or &gt;500 ms</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline of the QTcI interval</measure>
    <time_frame>up to 8 hours following drug administration</time_frame>
    <description>QTcI interval &lt; 30 ms, ≤ 60 ms</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in Heart Rate (HR)</measure>
    <time_frame>up to 6 hours following drug administration</time_frame>
    <description>increase ≥25 % or decrease HR by ≥25 %</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cmax (maximum measured concentration of the analyte in plasma)</measure>
    <time_frame>up to 8 hours following drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>tmax (time from dosing to the maximum concentration of the analyte in plasma)</measure>
    <time_frame>up to 8 hours following drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AUC0-6 (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 6 hours)</measure>
    <time_frame>up to 6 hours following drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AUC0-8 (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 8 hours) for moxifloxacin</measure>
    <time_frame>up to 8 hours following drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of subjects with adverse events</measure>
    <time_frame>up to 17 days after last drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of subjects with abnormal changes in laboratory parameters</measure>
    <time_frame>up to 17 days after last drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of subjects with abnormal changes in 12-lead ECG</measure>
    <time_frame>up to 17 days after last drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with clinically significant changes in vital signs</measure>
    <time_frame>up to 17 days after last drug administration</time_frame>
    <description>Blood pressure, pulse rate</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of tolerability by investigator on a 4-point scale</measure>
    <time_frame>17 days after last drug administration</time_frame>
  </secondary_outcome>
  <number_of_arms>6</number_of_arms>
  <enrollment type="Actual">39</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Treatment A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment B</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment C</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment D</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>Treatment A</intervention_name>
    <description>Ritobegron Cl (KUC 7483 CL) tablets low dose</description>
    <arm_group_label>Treatment A</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Treatment B</intervention_name>
    <arm_group_label>Treatment B</arm_group_label>
    <other_name>Ritobegron Cl (KUC 7483 CL) tablets medium 1 dose</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Treatment C</intervention_name>
    <arm_group_label>Treatment C</arm_group_label>
    <other_name>Ritobegron Cl (KUC 7483 CL) tablets medium 2 dose</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Treatment D</intervention_name>
    <arm_group_label>Treatment D</arm_group_label>
    <other_name>Ritobegron Cl (KUC 7483 CL) tablets high dose</other_name>
  </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>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy males or females&#xD;
&#xD;
          -  Age 30 to 60 years&#xD;
&#xD;
          -  Body mass index (BMI) within 18.5 to 29.9 kg/m2&#xD;
&#xD;
          -  In accordance with Good Clinical Practice (GCP) and the local legislation all&#xD;
             volunteers are to have given their written informed consent prior to admission to the&#xD;
             study&#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, clinically relevant electrolyte disturbances&#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 clinically 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; 24:00 hours) within at least one month or&#xD;
             less than ten half-lives of the respective drug before enrolment in the study or&#xD;
             during the 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 (within two months prior&#xD;
             to administration or during the trial)&#xD;
&#xD;
          -  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;
          -  Drug abuse&#xD;
&#xD;
          -  Blood donation (&gt; 100 mL within four weeks prior to administration or during the&#xD;
             trial)&#xD;
&#xD;
          -  Any laboratory value outside the reference range if indicative of underlying disease&#xD;
             or poor health&#xD;
&#xD;
          -  Excessive physical activities within the last week before the trial or during the&#xD;
             trial&#xD;
&#xD;
          -  Hypersensitivity to treatment medication, moxifloxacin and/or related drugs of these&#xD;
             classes&#xD;
&#xD;
          -  Previous tendon disease related to quinolone treatment&#xD;
&#xD;
          -  Congenital or documented acquired QT- prolongation, previous history of symptomatic&#xD;
             arrhythmias&#xD;
&#xD;
          -  Heart rate at screening of &gt; 80 bpm or &lt; 45 bpm&#xD;
&#xD;
          -  Any screening ECG value outside of the reference range of clinical relevance&#xD;
             including, but not limited to Pulse rate (PR) interval &gt; 220 ms, QRS interval &gt; 115&#xD;
             ms, QTcB &gt; 450 ms, or QT (uncorrected) &gt; 470 ms&#xD;
&#xD;
        For Female Subjects:&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Positive pregnancy test&#xD;
&#xD;
          -  No adequate contraception (adequate contraception e.g. sterilization, Intrauterine&#xD;
             pessary (IUP), oral contraceptives)&#xD;
&#xD;
          -  Inability to maintain this adequate contraception during the whole study period&#xD;
&#xD;
          -  Lactation period&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>60 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 2, 2014</study_first_submitted>
  <study_first_submitted_qc>October 2, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 6, 2014</study_first_posted>
  <last_update_submitted>October 2, 2014</last_update_submitted>
  <last_update_submitted_qc>October 2, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 6, 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>Moxifloxacin</mesh_term>
    <mesh_term>p-Hydroxyamphetamine</mesh_term>
    <mesh_term>Ritobegron</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/NCT02256735
org study id: 1207.22
nct id: NCT02256735
lead sponsor: 
Study to investigate the effect of Ritobegron CL (KUC 7483 CL) on the QT/QTc interval of the
      ECG in comparison to placebo and moxifloxacin
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double
measure: Change from baseline in mean time-matched QTcI
time frame: up to 2 hours following drug administration
measure: Change from baseline in mean time-matched QTcI
time frame: up to 8 hours following drug administration
measure: Occurrence of uncorrected QT interval
time frame: up to 8 hours following drug administration
description: QT interval <=500 ms, > 500 ms
measure: Occurrence of the QTcI interval
time frame: up to 8 hours following drug administration
description: QTcI interval <= 450 ms, >450 ms, >480 ms or >500 ms
measure: Change from baseline of the QTcI interval
time frame: up to 8 hours following drug administration
description: QTcI interval < 30 ms, ≤ 60 ms
measure: Change from baseline in Heart Rate (HR)
time frame: up to 6 hours following drug administration
description: increase ≥25 % or decrease HR by ≥25 %
measure: Cmax (maximum measured concentration of the analyte in plasma)
time frame: up to 8 hours following drug administration
measure: tmax (time from dosing to the maximum concentration of the analyte in plasma)
time frame: up to 8 hours following drug administration
measure: AUC0-6 (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 6 hours)
time frame: up to 6 hours following drug administration
measure: AUC0-8 (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 8 hours) for moxifloxacin
time frame: up to 8 hours following drug administration
measure: Number of subjects with adverse events
time frame: up to 17 days after last drug administration
measure: Number of subjects with abnormal changes in laboratory parameters
time frame: up to 17 days after last drug administration
measure: Number of subjects with abnormal changes in 12-lead ECG
time frame: up to 17 days after last drug administration
measure: Number of patients with clinically significant changes in vital signs
time frame: up to 17 days after last drug administration
description: Blood pressure, pulse rate
measure: Assessment of tolerability by investigator on a 4-point scale
time frame: 17 days after last drug administration
arm group label: Treatment A
arm group type: Experimental
arm group label: Treatment B
arm group type: Experimental
arm group label: Treatment C
arm group type: Experimental
arm group label: Treatment D
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: Treatment A
description: Ritobegron Cl (KUC 7483 CL) tablets low dose
arm group label: Treatment A
intervention type: Drug
intervention name: Treatment B
arm group label: Treatment B
other name: Ritobegron Cl (KUC 7483 CL) tablets medium 1 dose
intervention type: Drug
intervention name: Treatment C
arm group label: Treatment C
other name: Ritobegron Cl (KUC 7483 CL) tablets medium 2 dose
intervention type: Drug
intervention name: Treatment D
arm group label: Treatment D
other name: Ritobegron Cl (KUC 7483 CL) tablets high dose
intervention type: Drug
intervention name: Placebo
arm group label: Placebo
intervention type: Drug
intervention name: Moxifloxacin
arm group label: Moxifloxacin
criteria: 
gender: All
minimum age: 30 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
url: http://trials.boehringer-ingelheim.com
description: Related Info
responsible party type: Sponsor
mesh term: Moxifloxacin
mesh term: p-Hydroxyamphetamine
mesh term: Ritobegron