<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/NCT02259764</url>
  </required_header>
  <id_info>
    <org_study_id>1207.6</org_study_id>
    <nct_id>NCT02259764</nct_id>
  </id_info>
  <brief_title>Safety, Tolerability and Pharmacokinetics of Single Rising Oral Doses of KUC 7483 CL Tablets in Healthy Male Volunteers</brief_title>
  <official_title>Safety, Tolerability and Pharmacokinetics of Single Rising Oral Doses (400, 440 and 480 mg) of KUC 7483 CL Tablets in Healthy Male Volunteers. A Double-blind at Each Dose Level, Randomised, Placebo Controlled Study</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 and pharmacokinetics of KUC 7483 CL&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2004</start_date>
  <primary_completion_date type="Actual">September 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>Number of subjects with abnormal findings in physical examination</measure>
    <time_frame>up to 8 days after last drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of subjects with abnormal changes in laboratory parameters</measure>
    <time_frame>up to 8 days after last drug administration</time_frame>
    <description>special parameters, Tropanin I, insulin, C-Peptide, glucagon, free fatty acids, lactate, potassium, cAMP and faecal occult blood testing</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of subjects with clinically significant changes in vital signs</measure>
    <time_frame>up to 8 days after last drug administration</time_frame>
    <description>Blood Pressure, Pulse Rate, Respiratory Rate, body temperature, orthostatic testing</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of subjects with clinically significant changes in 12-lead ECG (electrocardiogram)</measure>
    <time_frame>up to 8 days after last drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of subjects with adverse events</measure>
    <time_frame>up to 8 days after last drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Assessment of tolerability by investigator on a 4-point scale</measure>
    <time_frame>8 days after last drug administration</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cmax (maximum measured 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 the maximum concentration of the analyte in plasma)</measure>
    <time_frame>up to 48 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AUC0-∞ (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>AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point)</measure>
    <time_frame>up to 48 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>λ z (terminal rate constant of the analyte 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 oral administration)</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)</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 the analyte that is eliminated in urine from the time point t1 until time point t2)</measure>
    <time_frame>up to 48 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>fet1-t2 (fraction of administered drug excreted unchanged in urine from the time point t1 until 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 determined from the time point t1 until time point t2)</measure>
    <time_frame>up to 48 hours after drug administration</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>KUC 7483 CL - single rising dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Treatment 1: KUC 7483 CL - low dose&#xD;
Treatment 2: KUC 7483 CL - medium dose&#xD;
Treatment 3: KUC 7483 CL - high dose&#xD;
In treatment 3 the same subjects as in treatment 2 received drug immediately after the ingestion of a standardized high fat meal</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>KUC 7483 CL - single rising dose</intervention_name>
    <arm_group_label>KUC 7483 CL - single rising 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>Other</intervention_type>
    <intervention_name>standardized high fat meal</intervention_name>
    <arm_group_label>KUC 7483 CL - single rising dose</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Healthy males according to the following criteria:&#xD;
&#xD;
             Based upon a complete medical history, including the physical examination, vital signs&#xD;
             (BP, PR), 12-lead ECG, clinical 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 ≥ 30 and Age ≤ 60 years&#xD;
&#xD;
          3. BMI ≥ 18.5 and BMI ≤ 29.9 kg/m2 (Body Mass Index)&#xD;
&#xD;
          4. 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;
          -  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 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 10 half-lives of the respective drug prior to administration or during the trial&#xD;
&#xD;
          -  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;
          -  Participation in another trial with an investigational drug within two months prior to&#xD;
             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;
          -  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 of clinical relevance&#xD;
&#xD;
        The clinical relevance of study parameters will be assessed by the investigator or his&#xD;
        deputy&#xD;
      </textblock>
    </criteria>
    <gender>Male</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 6, 2014</study_first_submitted>
  <study_first_submitted_qc>October 6, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 9, 2014</study_first_posted>
  <last_update_submitted>October 6, 2014</last_update_submitted>
  <last_update_submitted_qc>October 6, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 9, 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/NCT02259764
org study id: 1207.6
nct id: NCT02259764
lead sponsor: 
Study to investigate safety, tolerability and pharmacokinetics of KUC 7483 CL
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double
measure: Number of subjects with abnormal findings in physical examination
time frame: up to 8 days after last drug administration
measure: Number of subjects with abnormal changes in laboratory parameters
time frame: up to 8 days after last drug administration
description: special parameters, Tropanin I, insulin, C-Peptide, glucagon, free fatty acids, lactate, potassium, cAMP and faecal occult blood testing
measure: Number of subjects with clinically significant changes in vital signs
time frame: up to 8 days after last drug administration
description: Blood Pressure, Pulse Rate, Respiratory Rate, body temperature, orthostatic testing
measure: Number of subjects with clinically significant changes in 12-lead ECG (electrocardiogram)
time frame: up to 8 days after last drug administration
measure: Number of subjects with adverse events
time frame: up to 8 days after last drug administration
measure: Assessment of tolerability by investigator on a 4-point scale
time frame: 8 days after last drug administration
measure: Cmax (maximum measured concentration of the analyte in plasma)
time frame: up to 48 hours after drug administration
measure: tmax (time from dosing to the maximum concentration of the analyte in plasma)
time frame: up to 48 hours after drug administration
measure: AUC0-∞ (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: AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point)
time frame: up to 48 hours after drug administration
measure: λ z (terminal rate constant of the analyte 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 oral administration)
time frame: up to 48 hours after drug administration
measure: CL/F (apparent 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 the analyte that is eliminated in urine from the time point t1 until time point t2)
time frame: up to 48 hours after drug administration
measure: fet1-t2 (fraction of administered drug excreted unchanged in urine from the time point t1 until time point t2)
time frame: up to 48 hours after drug administration
measure: CLR,t1-t2 (renal clearance of the analyte determined from the time point t1 until time point t2)
time frame: up to 48 hours after drug administration
arm group label: KUC 7483 CL - single rising dose
arm group type: Experimental
description: Treatment 1: KUC 7483 CL - low dose
Treatment 2: KUC 7483 CL - medium dose
Treatment 3: KUC 7483 CL - high dose
In treatment 3 the same subjects as in treatment 2 received drug immediately after the ingestion of a standardized high fat meal
arm group label: Placebo
arm group type: Placebo Comparator
intervention type: Drug
intervention name: KUC 7483 CL - single rising dose
arm group label: KUC 7483 CL - single rising dose
intervention type: Drug
intervention name: Placebo
arm group label: Placebo
intervention type: Other
intervention name: standardized high fat meal
arm group label: KUC 7483 CL - single rising dose
criteria: 
gender: Male
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