<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/NCT02259933</url>
  </required_header>
  <id_info>
    <org_study_id>1207.3</org_study_id>
    <nct_id>NCT02259933</nct_id>
  </id_info>
  <brief_title>Safety, Tolerability and Pharmacokinetics of KUC 7483 CL Tablets in Healthy Male Volunteers</brief_title>
  <official_title>A Double-blind (at Each Dose Level), Randomised, Placebo Controlled Study to Evaluate Safety, Tolerability and Pharmacokinetics of Increasing Repeated Oral Doses of KUC 7483 CL Tablets (Dosage: 40, 120, 180 mg b.i.d.) Over 7 Days in Healthy Male 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 safety, tolerability and pharmacokinetics of KUC 7483 CL after repeated&#xD;
      dosing&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>February 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>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 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 clinically significant changes in vital signs</measure>
    <time_frame>up to 8 days after last drug administration</time_frame>
    <description>Blood Pressure, Pulse Rate, body temperature, orthostatic testing</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of subjects with clinically significant changes in laboratory tests</measure>
    <time_frame>up to 8 days after last drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in salivary secretion</measure>
    <time_frame>pre-dose and 2, 4 and 8 hours after drug administration on days 1 and 7</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in residual urine volume</measure>
    <time_frame>pre-dose and 2, 4 and 8 hours after drug administration on days 1 and 7</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 5-point scale</measure>
    <time_frame>within 8 days after last drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of subjects with clinically significant changes in special laboratory parameters</measure>
    <time_frame>up to day 8</time_frame>
    <description>Tropanin I, Insulin, C-Peptide, Glucagon, free fatty acids and faecal occult blood testing, Potassium, Lactate and cAMP</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Maximum measured concentration of the analyte in plasma (Cmax)</measure>
    <time_frame>up to day 9</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time from dosing to the maximum concentration of the analyte in plasma (Tmax)</measure>
    <time_frame>up to day 9</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area under the concentration-time curve of the analyte in plasma (AUC)</measure>
    <time_frame>up to day 9</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Terminal rate constant of the analyte constant in plasma (λz)</measure>
    <time_frame>up to day 9</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Terminal half-life of the analyte in plasma (t1/2)</measure>
    <time_frame>up to day 9</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 day 9</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Apparent clearance of the analyte in the plasma after extravascular administration (CL/F)</measure>
    <time_frame>up to day 9</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Apparent volume of distribution during the terminal phase λz following an extravascular dose (Vz/F)</measure>
    <time_frame>up to day 9</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Amount of the analyte that is eliminated in urine from the time point t1 until time point t2 (Aet1-t2)</measure>
    <time_frame>up to day 9</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fraction of administered drug excreted in urine from the time point t1 until time point t2 (fet1-t2)</measure>
    <time_frame>up to day 9</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Renal clearance of the analyte determined from the time point t1 until time point t2 (CLR,t1-t2)</measure>
    <time_frame>up to day 9</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Minimum concentration of the analyte in plasma at steady state (Cmin,ss )</measure>
    <time_frame>up to day 9</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Accumulation ratio (RA)</measure>
    <time_frame>up to day 9</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Linearity index (LI)</measure>
    <time_frame>up to day 9</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">35</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>KUC 7483 CL</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>increasing repeated oral doses</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</intervention_name>
    <arm_group_label>KUC 7483 CL</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Placebo</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;
               -  No finding deviating from normal and of clinical relevance&#xD;
&#xD;
               -  No evidence of a clinically relevant concomitant disease&#xD;
&#xD;
          2. Age ≥21 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 and the local legislation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic,&#xD;
             immunological 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 (&gt; 10 cigarettes or &gt; 3 cigars of &gt; 3 pipes/day)&#xD;
&#xD;
         10. Inability to refrain from smoking on trial days&#xD;
&#xD;
         11. Alcohol abuse (more than 60 g/day)&#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 of clinical relevance&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>21 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 7, 2014</study_first_submitted>
  <study_first_submitted_qc>October 7, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 9, 2014</study_first_posted>
  <last_update_submitted>October 7, 2014</last_update_submitted>
  <last_update_submitted_qc>October 7, 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/NCT02259933
org study id: 1207.3
nct id: NCT02259933
lead sponsor: 
Study to investigate safety, tolerability and pharmacokinetics of KUC 7483 CL after repeated
      dosing
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 clinically significant changes in 12-lead ECG (electrocardiogram)
time frame: up to 8 days after last drug administration
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, body temperature, orthostatic testing
measure: Number of subjects with clinically significant changes in laboratory tests
time frame: up to 8 days after last drug administration
measure: Changes in salivary secretion
time frame: pre-dose and 2, 4 and 8 hours after drug administration on days 1 and 7
measure: Changes in residual urine volume
time frame: pre-dose and 2, 4 and 8 hours after drug administration on days 1 and 7
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 5-point scale
time frame: within 8 days after last drug administration
measure: Number of subjects with clinically significant changes in special laboratory parameters
time frame: up to day 8
description: Tropanin I, Insulin, C-Peptide, Glucagon, free fatty acids and faecal occult blood testing, Potassium, Lactate and cAMP
measure: Maximum measured concentration of the analyte in plasma (Cmax)
time frame: up to day 9
measure: Time from dosing to the maximum concentration of the analyte in plasma (Tmax)
time frame: up to day 9
measure: Area under the concentration-time curve of the analyte in plasma (AUC)
time frame: up to day 9
measure: Terminal rate constant of the analyte constant in plasma (λz)
time frame: up to day 9
measure: Terminal half-life of the analyte in plasma (t1/2)
time frame: up to day 9
measure: Mean residence time of the analyte in the body after oral administration (MRTpo)
time frame: up to day 9
measure: Apparent clearance of the analyte in the plasma after extravascular administration (CL/F)
time frame: up to day 9
measure: Apparent volume of distribution during the terminal phase λz following an extravascular dose (Vz/F)
time frame: up to day 9
measure: Amount of the analyte that is eliminated in urine from the time point t1 until time point t2 (Aet1-t2)
time frame: up to day 9
measure: Fraction of administered drug excreted in urine from the time point t1 until time point t2 (fet1-t2)
time frame: up to day 9
measure: Renal clearance of the analyte determined from the time point t1 until time point t2 (CLR,t1-t2)
time frame: up to day 9
measure: Minimum concentration of the analyte in plasma at steady state (Cmin,ss )
time frame: up to day 9
measure: Accumulation ratio (RA)
time frame: up to day 9
measure: Linearity index (LI)
time frame: up to day 9
arm group label: KUC 7483 CL
arm group type: Experimental
description: increasing repeated oral doses
arm group label: Placebo
arm group type: Placebo Comparator
intervention type: Drug
intervention name: KUC 7483 CL
arm group label: KUC 7483 CL
intervention type: Drug
intervention name: Placebo
arm group label: Placebo
criteria: 
gender: Male
minimum age: 21 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
url: http://trials.boehringer-ingelheim.com
description: Related Info
responsible party type: Sponsor