<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/NCT02229838</url>
  </required_header>
  <id_info>
    <org_study_id>1178.1</org_study_id>
    <nct_id>NCT02229838</nct_id>
  </id_info>
  <brief_title>Safety/Tolerability, Pharmacokinetics, and Pharmacodynamics of BIBB 1464 MS in Healthy Male Subjects, Combined With Preliminary Evaluation of Relative Bioavailability and Effect of Food</brief_title>
  <official_title>Safety/Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Oral Doses of 0.25 mg, 0.75 mg, 2 mg, 6 mg, and 10 mg BIBB 1464 MS (Tablet) in Healthy Male Subjects, Combined With Preliminary Evaluation of Relative Bioavailability and Effect of Food of the Dose of 0.75 mg or 2 mg or 6 mg (Two-stage Trial Design With Randomised Double Blind Placebo Controlled Rising Dose Phase and Subsequent Randomised, Open Parallel Group Phase)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boehringer Ingelheim</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boehringer Ingelheim</source>
  <brief_summary>
    <textblock>
      Safety, pharmacodynamics and pharmacokinetics of 0.25, 0.75, 2.0, 6.0, and 10 mg BIBB 1464&#xD;
      p.o once daily in a rising dose group-comparison (placebo controlled, double blind,&#xD;
      randomized per dose level).&#xD;
&#xD;
      Relative Bioavailability of 0.75 mg or 2 mg or 6 mg ( tablet vs. solution, intraindividual&#xD;
      comparison), preliminary assessment of food effects (interindividual comparison)&#xD;
&#xD;
      Two-stage Trial Design With Randomised Double Blind Placebo Controlled Rising Dose Phase and&#xD;
      Subsequent Randomised, Open Parallel Group Phase).&#xD;
&#xD;
      MS (Tablet) in Healthy Male Subjects, Combined With Preliminary Evaluation of Relative&#xD;
      Bioavailability and Effect of Food of the Dose of 0.75 mg or 2 mg or 6 mg (Two-stage Trial&#xD;
      Design With Randomised Double Blind Placebo Controlled Rising Dose Phase and Subsequent&#xD;
      Randomised, Open Parallel Group Phase).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 1999</start_date>
  <primary_completion_date type="Actual">September 1999</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>Maximum drug plasma concentration (Cmax)</measure>
    <time_frame>Up to 38 hours after drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Time to reach the maximum concentration of the analyte in plasma (tmax)</measure>
    <time_frame>Up to 38 hours after drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Total area under the plasma drug concentration-time curve (AUC)</measure>
    <time_frame>Up to 38 hours after drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Apparent terminal half-life of the analyte in plasma (t1/2)</measure>
    <time_frame>Up to 38 hours after drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Total plasma clearance divided by the systemic availability factor (CL/f)</measure>
    <time_frame>Up to 38 hours after drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Dose normalized AUC0-38h ( NAUC0-38h)</measure>
    <time_frame>Up to 38 h after drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Mean residence time, total (MRTtot)</measure>
    <time_frame>Up to 38 hours after drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of patients with adverse events</measure>
    <time_frame>Up to 72 hours after last drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of patients with clinical significant findings in vital signs</measure>
    <time_frame>Up to 38 hours after drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of patients with clinical significant findings in electrocardiogram (ECG)</measure>
    <time_frame>Up to 38 hours after drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of patients with clinical significant findings in physical examination</measure>
    <time_frame>Up to 38 hours after drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Investigator assessed tolerability on a 4 point scale</measure>
    <time_frame>Up to 38 hours after drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Monoepoxysqualene (MES) plasma concentration</measure>
    <time_frame>Up to 38 hours after drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Amount of drug excreted in urine</measure>
    <time_frame>Up to 38 h after drug administration</time_frame>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">73</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>BIBB 1464 MS single rising dose fed</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>BIBB 1464 MS tablet fasted</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>BIBB 1464 MS solution fasted</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>BIBB 1464 MS placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BIBB 1464 MS tablet</intervention_name>
    <arm_group_label>BIBB 1464 MS single rising dose fed</arm_group_label>
    <arm_group_label>BIBB 1464 MS tablet fasted</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BIBB 1464 MS solution</intervention_name>
    <arm_group_label>BIBB 1464 MS solution fasted</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BIBB 1464 MS placebo</intervention_name>
    <arm_group_label>BIBB 1464 MS placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Standard dinner</intervention_name>
    <arm_group_label>BIBB 1464 MS single rising dose fed</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy subjects as determined by results of screening&#xD;
&#xD;
          -  Signed written informed consent in accordance with good clinical practice (GCP) and&#xD;
             local legislation&#xD;
&#xD;
          -  Age &gt; 18 and &lt; 55 years&#xD;
&#xD;
          -  Broca &gt; - 20% and &lt; + 20%&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any findings 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 (including thyroid) disorder&#xD;
&#xD;
          -  Surgery of the gastro-intestinal tract (except appendectomy)&#xD;
&#xD;
          -  Disease of the central nervous system (such as epilepsy) or psychiatric disorders&#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) (&lt;= 1 month prior to administration&#xD;
             or during the trial)&#xD;
&#xD;
          -  Use of any drugs which might influence the result of the trial (&lt;= 10 days prior to&#xD;
             administration or during the trial)&#xD;
&#xD;
          -  Participation in another trial with an investigational drug (&lt;= 2 month prior to&#xD;
             administration or during the trial)&#xD;
&#xD;
          -  Smoker (&gt; 10 cigarettes or &gt; 3 cigars or &gt;3 pipes/day)&#xD;
&#xD;
          -  Inability to refrain from smoking during the period of the study&#xD;
&#xD;
          -  Known alcohol (&gt;60 g/day) or drug abuse&#xD;
&#xD;
          -  Blood donation (&lt;=1 month prior to administration)&#xD;
&#xD;
          -  Excessive physical activities (&lt;5 days prior to administration)&#xD;
&#xD;
          -  Any laboratory value outside the normal range of clinical relevance&#xD;
&#xD;
          -  History of hemorrhagic diatheses&#xD;
&#xD;
          -  History of gastro-intestinal ulcer, perforation or bleeding&#xD;
&#xD;
          -  History of bronchial asthma&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>54 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 28, 2014</study_first_submitted>
  <study_first_submitted_qc>August 28, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 1, 2014</study_first_posted>
  <last_update_submitted>August 28, 2014</last_update_submitted>
  <last_update_submitted_qc>August 28, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 1, 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/NCT02229838
org study id: 1178.1
nct id: NCT02229838
lead sponsor: 
Safety, pharmacodynamics and pharmacokinetics of 0.25, 0.75, 2.0, 6.0, and 10 mg BIBB 1464
      p.o once daily in a rising dose group-comparison (placebo controlled, double blind,
      randomized per dose level).

      Relative Bioavailability of 0.75 mg or 2 mg or 6 mg ( tablet vs. solution, intraindividual
      comparison), preliminary assessment of food effects (interindividual comparison)

      Two-stage Trial Design With Randomised Double Blind Placebo Controlled Rising Dose Phase and
      Subsequent Randomised, Open Parallel Group Phase).

      MS (Tablet) in Healthy Male Subjects, Combined With Preliminary Evaluation of Relative
      Bioavailability and Effect of Food of the Dose of 0.75 mg or 2 mg or 6 mg (Two-stage Trial
      Design With Randomised Double Blind Placebo Controlled Rising Dose Phase and Subsequent
      Randomised, Open Parallel Group Phase).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double
measure: Maximum drug plasma concentration (Cmax)
time frame: Up to 38 hours after drug administration
measure: Time to reach the maximum concentration of the analyte in plasma (tmax)
time frame: Up to 38 hours after drug administration
measure: Total area under the plasma drug concentration-time curve (AUC)
time frame: Up to 38 hours after drug administration
measure: Apparent terminal half-life of the analyte in plasma (t1/2)
time frame: Up to 38 hours after drug administration
measure: Total plasma clearance divided by the systemic availability factor (CL/f)
time frame: Up to 38 hours after drug administration
measure: Dose normalized AUC0-38h ( NAUC0-38h)
time frame: Up to 38 h after drug administration
measure: Mean residence time, total (MRTtot)
time frame: Up to 38 hours after drug administration
measure: Number of patients with adverse events
time frame: Up to 72 hours after last drug administration
measure: Number of patients with clinical significant findings in vital signs
time frame: Up to 38 hours after drug administration
measure: Number of patients with clinical significant findings in electrocardiogram (ECG)
time frame: Up to 38 hours after drug administration
measure: Number of patients with clinical significant findings in physical examination
time frame: Up to 38 hours after drug administration
measure: Investigator assessed tolerability on a 4 point scale
time frame: Up to 38 hours after drug administration
measure: Monoepoxysqualene (MES) plasma concentration
time frame: Up to 38 hours after drug administration
measure: Amount of drug excreted in urine
time frame: Up to 38 h after drug administration
arm group label: BIBB 1464 MS single rising dose fed
arm group type: Experimental
arm group label: BIBB 1464 MS tablet fasted
arm group type: Experimental
arm group label: BIBB 1464 MS solution fasted
arm group type: Active Comparator
arm group label: BIBB 1464 MS placebo
arm group type: Placebo Comparator
intervention type: Drug
intervention name: BIBB 1464 MS tablet
arm group label: BIBB 1464 MS single rising dose fed
arm group label: BIBB 1464 MS tablet fasted
intervention type: Drug
intervention name: BIBB 1464 MS solution
arm group label: BIBB 1464 MS solution fasted
intervention type: Drug
intervention name: BIBB 1464 MS placebo
arm group label: BIBB 1464 MS placebo
intervention type: Other
intervention name: Standard dinner
arm group label: BIBB 1464 MS single rising dose fed
criteria: 
gender: Male
minimum age: 19 Years
maximum age: 54 Years
healthy volunteers: Accepts Healthy Volunteers
url: http://trials.boehringer-ingelheim.com
description: Related Info
responsible party type: Sponsor