<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/NCT02264015</url>
  </required_header>
  <id_info>
    <org_study_id>503.204</org_study_id>
    <nct_id>NCT02264015</nct_id>
  </id_info>
  <brief_title>Pharmacodynamic Effects, Safety and Tolerability of Cilobradine, to Healthy Male and Female Volunteers, With an Intra-individual Comparison to Moxifloxacin in a Subset of Volunteers</brief_title>
  <official_title>Pharmacodynamic Effects, Safety and Tolerability of 2 mg and 5 mg Cilobradine, Administered p.o. Once Daily Over 14 Days to Healthy Male and Female Volunteers in a Randomised, Placebo-controlled, Double Blind Study, With an Open-label Uncontrolled Intra-individual Comparison to 400 mg Moxifloxacin Single Dose in a Subset of 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>
      Incidence of visual phenomena, heart rate at rest, safety (with particular emphasis on QT&#xD;
      analysis of ECGs), and pharmacokinetic parameters&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2004</start_date>
  <primary_completion_date type="Actual">May 2004</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>Incidence of visual phenomena</measure>
    <time_frame>Up to 12 days after last scheduled study day</time_frame>
    <description>Reported as adverse events</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in heart rate at rest</measure>
    <time_frame>Pre dose, up to 12 hours after drug administration</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Investigator assessed tolerability on a 4 point scale</measure>
    <time_frame>Up to 12 days after last scheduled study day</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with abnormal findings in physical examination</measure>
    <time_frame>Up to 12 days after last scheduled study day</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with clinically significant changes in vital signs</measure>
    <time_frame>Up to 12 days after last scheduled study day</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with adverse events</measure>
    <time_frame>Up to 12 days after last scheduled study day</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Characteristics of visual phenomena on a special questionnaire</measure>
    <time_frame>Up to 12 days after last scheduled study day</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with abnormal changes in clinical laboratory parameters</measure>
    <time_frame>Up to 12 days after last scheduled study day</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with abnormal findings in electrocardiogram (ECG)</measure>
    <time_frame>Up to 12 days after last scheduled study day</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area under the concentration-time curve of the analyte in plasma from zero time to 24 hours (AUC0-24)</measure>
    <time_frame>Up to 24 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum plasma concentration following the first dose (Cmax)</measure>
    <time_frame>Up to 24 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time from first dose to the maximum plasma concentration (tmax)</measure>
    <time_frame>Up to 24 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Terminal half-life (t1/2)</measure>
    <time_frame>Up to 24 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean residence time of the analyte in the body after oral administration (MRTpo)</measure>
    <time_frame>Up to 24 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Apparent clearance of the analyte in plasma following extravascular administration (CL/F)</measure>
    <time_frame>Up to 24 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Apparent volume of distribution during the terminal phase λz following extravascular administration (Vz/F)</measure>
    <time_frame>Up to 24 hours after drug administration</time_frame>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">125</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Cilobradine low</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>
  <arm_group>
    <arm_group_label>Cilobradine high</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cilobradine, low, film-coated tablets</intervention_name>
    <arm_group_label>Cilobradine low</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cilobradine, high, film-coated tablets</intervention_name>
    <arm_group_label>Cilobradine high</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo, film-coated tablets</intervention_name>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Moxifloxacin, film-coated tablets</intervention_name>
    <arm_group_label>Moxifloxacin</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Healthy males and females according to the following criteria:&#xD;
&#xD;
             Based upon a complete medical history, including the physical examination, vital signs&#xD;
             (blood pressure (BP), pulse rate (PR)), 12-lead Electrocardiogram (ECG), clinical&#xD;
             laboratory tests&#xD;
&#xD;
             1.1 No finding deviating from normal and of clinical relevance&#xD;
&#xD;
             1.2 No evidence of a clinically relevant concomitant disease&#xD;
&#xD;
          2. Age ≥21 and Age ≤55 years&#xD;
&#xD;
          3. BMI ≥18.5 and BMI &lt; 30 kg/m2 (Body Mass Index)&#xD;
&#xD;
          4. Resting Heart rate (HR) (after 10 min. in the supine position) of equal or more than&#xD;
             60 bpm&#xD;
&#xD;
          5. Females: post-menopausal or those who have had a hysterectomy (plus a negative&#xD;
             pregnancy test)&#xD;
&#xD;
          6. Signed and dated written informed consent prior to admission to the study in&#xD;
             accordance with Good Clinical Practice (GCP) and the local legislation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic,&#xD;
             immunological, ophthalmological, or hormonal disorders&#xD;
&#xD;
          2. Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or&#xD;
             neurological disorders&#xD;
&#xD;
          3. History of relevant orthostatic hypotension, fainting spells or blackouts&#xD;
&#xD;
          4. Chronic or relevant acute infections&#xD;
&#xD;
          5. History of allergy/hypersensitivity (including drug allergy) which is deemed relevant&#xD;
             to the trial as judged by the investigator&#xD;
&#xD;
          6. 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;
          7. Use of drugs which might reasonably influence the results of the trial based on the&#xD;
             knowledge at the time of protocol preparation within 10 days prior to administration&#xD;
             or during the trial&#xD;
&#xD;
          8. Participation in another trial with an investigational drug within two months prior to&#xD;
             administration or during the trial&#xD;
&#xD;
          9. Smoker (more than 10 cigarettes or 3 cigars or 3 pipes/day)&#xD;
&#xD;
         10. Inability to refrain from smoking on trial days&#xD;
&#xD;
         11. Alcohol abuse&#xD;
&#xD;
         12. Drug abuse&#xD;
&#xD;
         13. Blood donation (more than 100 mL within four weeks prior to administration or during&#xD;
             the trial)&#xD;
&#xD;
         14. Excessive physical activities (within one week prior to administration or during the&#xD;
             trial)&#xD;
&#xD;
         15. Any laboratory value outside the reference range that is of clinical relevance.&#xD;
&#xD;
             Exclusion criteria specific for this study:&#xD;
&#xD;
         16. Subjects at increased risk for development of cardiac arrhythmia (e.g. family history&#xD;
             of long QT syndrome or sudden cardiac death)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>55 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 13, 2014</study_first_submitted>
  <study_first_submitted_qc>October 13, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 15, 2014</study_first_posted>
  <last_update_submitted>October 13, 2014</last_update_submitted>
  <last_update_submitted_qc>October 13, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 15, 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>
  </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/NCT02264015
org study id: 503.204
nct id: NCT02264015
lead sponsor: 
Incidence of visual phenomena, heart rate at rest, safety (with particular emphasis on QT
      analysis of ECGs), and pharmacokinetic parameters
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double
measure: Incidence of visual phenomena
time frame: Up to 12 days after last scheduled study day
description: Reported as adverse events
measure: Change in heart rate at rest
time frame: Pre dose, up to 12 hours after drug administration
measure: Investigator assessed tolerability on a 4 point scale
time frame: Up to 12 days after last scheduled study day
measure: Number of participants with abnormal findings in physical examination
time frame: Up to 12 days after last scheduled study day
measure: Number of participants with clinically significant changes in vital signs
time frame: Up to 12 days after last scheduled study day
measure: Number of participants with adverse events
time frame: Up to 12 days after last scheduled study day
measure: Characteristics of visual phenomena on a special questionnaire
time frame: Up to 12 days after last scheduled study day
measure: Number of participants with abnormal changes in clinical laboratory parameters
time frame: Up to 12 days after last scheduled study day
measure: Number of participants with abnormal findings in electrocardiogram (ECG)
time frame: Up to 12 days after last scheduled study day
measure: Area under the concentration-time curve of the analyte in plasma from zero time to 24 hours (AUC0-24)
time frame: Up to 24 hours after drug administration
measure: Maximum plasma concentration following the first dose (Cmax)
time frame: Up to 24 hours after drug administration
measure: Time from first dose to the maximum plasma concentration (tmax)
time frame: Up to 24 hours after drug administration
measure: Terminal half-life (t1/2)
time frame: Up to 24 hours after drug administration
measure: Mean residence time of the analyte in the body after oral administration (MRTpo)
time frame: Up to 24 hours after drug administration
measure: Apparent clearance of the analyte in plasma following extravascular administration (CL/F)
time frame: Up to 24 hours after drug administration
measure: Apparent volume of distribution during the terminal phase λz following extravascular administration (Vz/F)
time frame: Up to 24 hours after drug administration
arm group label: Cilobradine low
arm group type: Experimental
arm group label: Placebo
arm group type: Placebo Comparator
arm group label: Moxifloxacin
arm group type: Active Comparator
arm group label: Cilobradine high
arm group type: Experimental
intervention type: Drug
intervention name: Cilobradine, low, film-coated tablets
arm group label: Cilobradine low
intervention type: Drug
intervention name: Cilobradine, high, film-coated tablets
arm group label: Cilobradine high
intervention type: Drug
intervention name: Placebo, film-coated tablets
arm group label: Placebo
intervention type: Drug
intervention name: Moxifloxacin, film-coated tablets
arm group label: Moxifloxacin
criteria: 
gender: All
minimum age: 21 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
url: http://trials.boehringer-ingelheim.com
description: Related Info
responsible party type: Sponsor
mesh term: Moxifloxacin