<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/NCT02215018</url>
  </required_header>
  <id_info>
    <org_study_id>1246.1</org_study_id>
    <nct_id>NCT02215018</nct_id>
  </id_info>
  <brief_title>Safety, Tolerability and Pharmacokinetics of BI 44370 TA Oral Drinking Solution in Healthy Male Volunteers</brief_title>
  <official_title>Safety, Tolerability and Pharmacokinetics of BI 44370 TA Oral Drinking Solution in Healthy Male Volunteers (Dose Range: 5 - 800 mg). A Double-blind (Within Dose Groups), Randomised, Placebo-controlled Within Dose Groups, Single Rising Dose Study, Including Re-dosing at 100 mg and 500 mg (Solution) and at 200 mg (Four 50 mg Tablets)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boehringer Ingelheim</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boehringer Ingelheim</source>
  <brief_summary>
    <textblock>
      To evaluate the safety, tolerability and pharmacokinetics of single rising oral doses of BI&#xD;
      44370 TA in healthy male volunteers, to compare a drinking solution vs. a tablet formulation&#xD;
      and to assess intra-individual pharmacokinetic (PK) variability by re-dosing two further&#xD;
      doses.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>April 2007</start_date>
  <primary_completion_date type="Actual">August 2007</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 patients with adverse events</measure>
    <time_frame>up to 10 days after last drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of patients with clinically significant findings in vital signs</measure>
    <time_frame>up to 10 days after last drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of patients with clinically significant findings in laboratory tests</measure>
    <time_frame>up to 10 days after last drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of patients with clinically significant findings in ECG</measure>
    <time_frame>up to 10 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>up to 10 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 72 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>tmax (time from dosing to maximum measured concentration)</measure>
    <time_frame>up to 72 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 72 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>%AUCtz-∞ (the percentage of the AUC0-∞ that is obtained by extrapolation)</measure>
    <time_frame>up to 72 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 time of the last quantifiable data point)</measure>
    <time_frame>up to 72 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AUCt1-t2 (area under the concentration-time curve of the analyte in plasma over the time interval t1 to t2)</measure>
    <time_frame>up to 72 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>tz (time of last measurable concentration of the analyte in plasma)</measure>
    <time_frame>up to 72 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 72 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MRTp.o. (mean residence time of the analyte in the body after oral administration)</measure>
    <time_frame>up to 72 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CL/F (total/apparent clearance of the analyte in plasma after extravascular administration)</measure>
    <time_frame>up to 72 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vz/F (apparent volume of distribution during the terminal phase tz following an extravascular dose)</measure>
    <time_frame>up to 72 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>λz (the terminal rate constant)</measure>
    <time_frame>up to 72 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Aet1/t2 (total quantity of analyte excreted in the urine in the time interval from t1 to t2)</measure>
    <time_frame>up to 24 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>fet1/t2 (the fractional excretion of the analyte in the time interval from t1 to t2)</measure>
    <time_frame>up to 24 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CLR,t1/t2 (the renal clearance of the analyte in the time interval from t1 to t2)</measure>
    <time_frame>up to 24 hours after drug administration</time_frame>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">56</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>BI 44370 TA solution</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>BI 44370 TA tablet</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo solution</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo tablet</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BI 44370 TA solution</intervention_name>
    <arm_group_label>BI 44370 TA solution</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BI 44370 TA tablet</intervention_name>
    <arm_group_label>BI 44370 TA tablet</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo solution</intervention_name>
    <arm_group_label>Placebo solution</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo tablet</intervention_name>
    <arm_group_label>Placebo tablet</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, RR and body temperature), 12-lead ECG, clinical laboratory tests&#xD;
&#xD;
          2. Age ≥21 and Age ≤50 years&#xD;
&#xD;
          3. Body Mass Index (BMI) ≥18.5 and BMI ≤29.9 kg/m2&#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;
          1. Any finding of the medical examination (including Blood Pressure (BP), Pulse Rate&#xD;
             (PR), Respiratory rate (RR) , body temperature and Electrocardiogram(ECG)) deviating&#xD;
             from normal and of clinical relevance&#xD;
&#xD;
          2. Any evidence of a clinically relevant concomitant disease&#xD;
&#xD;
          3. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic,&#xD;
             immunological or hormonal disorders&#xD;
&#xD;
          4. Surgery of the gastrointestinal tract (except appendectomy)&#xD;
&#xD;
          5. Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or&#xD;
             neurological disorders&#xD;
&#xD;
          6. History of relevant orthostatic hypotension, fainting spells or blackouts&#xD;
&#xD;
          7. Chronic or relevant acute infections&#xD;
&#xD;
          8. History of relevant allergy/hypersensitivity (including allergy to drug or its&#xD;
             excipients)&#xD;
&#xD;
          9. 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;
         10. Use of drugs which might reasonably influence the results of the trial or that prolong&#xD;
             the QT/QTc interval based on the knowledge at the time of protocol preparation within&#xD;
             10 days prior to administration or during the trial&#xD;
&#xD;
         11. Participation in another trial with an investigational drug within two months prior to&#xD;
             administration or during the trial&#xD;
&#xD;
         12. Smoker (&gt; 10 cigarettes or &gt; 3 cigars or &gt; 3 pipes/day)&#xD;
&#xD;
         13. Inability to refrain from smoking on trial days&#xD;
&#xD;
         14. Alcohol abuse (more than 60 g/day)&#xD;
&#xD;
         15. Drug abuse&#xD;
&#xD;
         16. Blood donation (more than 100 mL within four weeks prior to administration or during&#xD;
             the trial)&#xD;
&#xD;
         17. Excessive physical activities (within one week prior to administration or during the&#xD;
             trial)&#xD;
&#xD;
         18. Any laboratory value outside the reference range that is of clinical relevance&#xD;
&#xD;
         19. Inability to comply with dietary regimen of trial site&#xD;
&#xD;
         20. A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a&#xD;
             QTc interval &gt;450 ms);&#xD;
&#xD;
         21. A history of additional risk factors for Torsade des Pointes (e.g., heart failure,&#xD;
             hypokalemia, family history of Long QT Syndrome)&#xD;
&#xD;
         22. Not willing to use adequate contraception (condom use plus another form of&#xD;
             contraception e.g. spermicide, oral contraceptive taken by female partner,&#xD;
             sterilisation, intrauterine device) during the whole study period from the time of the&#xD;
             first intake of study drug until three months after the last intake&#xD;
      </textblock>
    </criteria>
    <gender>Male</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</url>
    <description>Related Info</description>
  </link>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>August 12, 2014</study_first_submitted>
  <study_first_submitted_qc>August 12, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 13, 2014</study_first_posted>
  <last_update_submitted>August 12, 2014</last_update_submitted>
  <last_update_submitted_qc>August 12, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 13, 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>Pharmaceutical Solutions</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/NCT02215018
org study id: 1246.1
nct id: NCT02215018
lead sponsor: 
To evaluate the safety, tolerability and pharmacokinetics of single rising oral doses of BI
      44370 TA in healthy male volunteers, to compare a drinking solution vs. a tablet formulation
      and to assess intra-individual pharmacokinetic (PK) variability by re-dosing two further
      doses.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double
measure: Number of patients with adverse events
time frame: up to 10 days after last drug administration
measure: Number of patients with clinically significant findings in vital signs
time frame: up to 10 days after last drug administration
measure: Number of patients with clinically significant findings in laboratory tests
time frame: up to 10 days after last drug administration
measure: Number of patients with clinically significant findings in ECG
time frame: up to 10 days after last drug administration
measure: Assessment of tolerability by investigator on a 4-point scale
time frame: up to 10 days after last drug administration
measure: Cmax (maximum measured concentration of the analyte in plasma)
time frame: up to 72 hours after drug administration
measure: tmax (time from dosing to maximum measured concentration)
time frame: up to 72 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 72 hours after drug administration
measure: %AUCtz-∞ (the percentage of the AUC0-∞ that is obtained by extrapolation)
time frame: up to 72 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 time of the last quantifiable data point)
time frame: up to 72 hours after drug administration
measure: AUCt1-t2 (area under the concentration-time curve of the analyte in plasma over the time interval t1 to t2)
time frame: up to 72 hours after drug administration
measure: tz (time of last measurable concentration of the analyte in plasma)
time frame: up to 72 hours after drug administration
measure: t1/2 (terminal half-life of the analyte in plasma)
time frame: up to 72 hours after drug administration
measure: MRTp.o. (mean residence time of the analyte in the body after oral administration)
time frame: up to 72 hours after drug administration
measure: CL/F (total/apparent clearance of the analyte in plasma after extravascular administration)
time frame: up to 72 hours after drug administration
measure: Vz/F (apparent volume of distribution during the terminal phase tz following an extravascular dose)
time frame: up to 72 hours after drug administration
measure: λz (the terminal rate constant)
time frame: up to 72 hours after drug administration
measure: Aet1/t2 (total quantity of analyte excreted in the urine in the time interval from t1 to t2)
time frame: up to 24 hours after drug administration
measure: fet1/t2 (the fractional excretion of the analyte in the time interval from t1 to t2)
time frame: up to 24 hours after drug administration
measure: CLR,t1/t2 (the renal clearance of the analyte in the time interval from t1 to t2)
time frame: up to 24 hours after drug administration
arm group label: BI 44370 TA solution
arm group type: Experimental
arm group label: BI 44370 TA tablet
arm group type: Experimental
arm group label: Placebo solution
arm group type: Placebo Comparator
arm group label: Placebo tablet
arm group type: Placebo Comparator
intervention type: Drug
intervention name: BI 44370 TA solution
arm group label: BI 44370 TA solution
intervention type: Drug
intervention name: BI 44370 TA tablet
arm group label: BI 44370 TA tablet
intervention type: Drug
intervention name: Placebo solution
arm group label: Placebo solution
intervention type: Drug
intervention name: Placebo tablet
arm group label: Placebo tablet
criteria: 
gender: Male
minimum age: 21 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
url: http://trials.boehringer-ingelheim.com
description: Related Info
responsible party type: Sponsor
mesh term: Pharmaceutical Solutions