<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/NCT02264119</url>
  </required_header>
  <id_info>
    <org_study_id>509.119</org_study_id>
    <nct_id>NCT02264119</nct_id>
  </id_info>
  <brief_title>Influence of Pantoprazole on the Pharmacokinetics of Fradafiban After Multiple Oral Doses of Lefradafiban in Healthy Subjects</brief_title>
  <official_title>Influence of 40 mg Pantoprazole Per Day on the Pharmacokinetics of Fradafiban After Multiple Oral Doses of 20 mg Lefradafiban Tid as Acid Free Tablet and Sachet Over 5 Days in Healthy Subjects. A 4-way Crossover Randomized Open Trial.</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 assess the absorption of 20 mg Lefradafiban in two formulations, each under&#xD;
      physiological conditions and with 40 mg Pantoprazole&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>April 1998</start_date>
  <primary_completion_date type="Actual">July 1998</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>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Area under the concentration-time curve of the analyte in plasma at steady state, 13th dosing interval (AUCss,13)</measure>
    <time_frame>Up to 168 hours after first drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Maximum concentration of the analyte in plasma at steady state, 13th dosing interval (Cmax,ss,13)</measure>
    <time_frame>Up to 168 hours after first drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Pre-dose concentration of the analyte in plasma at steady state, 13th dosing interval (Cpre,ss,13)</measure>
    <time_frame>Up to 168 hours after first drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Amount of the analyte eliminated unchanged in the urine per dosing interval (Ae% (i=1,...,13))</measure>
    <time_frame>Up to 168 hours after first drug administration</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pre-dose concentration lf the analyte in plasma for the i-th dosing interval (Cpre,i (i=1,4,7,10,11,12))</measure>
    <time_frame>Up to 168 hours after first drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma concentration of the analyte at 2 hours post-dose for the i-th dosing interval (C2h,i (i=10,11,12))</measure>
    <time_frame>up to 2 hours after each dosing interval</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Terminal half life of the analyte in plasma (t1/2)</measure>
    <time_frame>Up to 168 hours after first drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent swing of peak/trough concentrations of the analyte in plasma for the i-th dosing interval (%Swing,i)</measure>
    <time_frame>Up to 168 hours after first drug administration</time_frame>
    <description>Calculated: (C2h,i - Cpre,i) / Cpre,i * 100% (i=10,11,12)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent peak-trough fluctuation for the 13th dosing interval (%PTF13)</measure>
    <time_frame>Up to 168 hours after first drug administration</time_frame>
    <description>Calculated: (Cmax,ss,13 - Cpre,ss,13) * 8h / AUCss,13 * 100%)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent fluctuation of area under the plasma concentration-time curve (AUCfluc,13)</measure>
    <time_frame>Up to 168 hours after first drug administration</time_frame>
    <description>Calculated: (AUCabove,13 - AUCbelow,13) / AUCabove,13</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fibrinogen receptor occupancy levels</measure>
    <time_frame>Up to 168 hours after first drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of subjects with adverse events</measure>
    <time_frame>Up to 3 days after last drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of subjects with clinically significant findings in vital signs</measure>
    <time_frame>Up to 3 days after last drug administration</time_frame>
    <description>systolic and diastolic blood pressure, pulse rate</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of subjects with clinically significant findings in laboratory tests</measure>
    <time_frame>Up to 3 days after last drug administration</time_frame>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Lefradafiban tablet with Pantoprazole</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Lefradafiban tablet without Pantoprazole</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Lefradafiban double chamber sachet with Pantoprazole</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Lefradafiban double chamber sachet without Pantoprazole</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lefradafiban tablet</intervention_name>
    <arm_group_label>Lefradafiban tablet with Pantoprazole</arm_group_label>
    <arm_group_label>Lefradafiban tablet without Pantoprazole</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Pantoprazole tablet</intervention_name>
    <arm_group_label>Lefradafiban double chamber sachet with Pantoprazole</arm_group_label>
    <arm_group_label>Lefradafiban tablet with Pantoprazole</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Lefradafiban double chamber sachet</intervention_name>
    <arm_group_label>Lefradafiban double chamber sachet with Pantoprazole</arm_group_label>
    <arm_group_label>Lefradafiban double chamber sachet without Pantoprazole</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy male 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 ≥ 18 and ≤ 60 years, planned stratification: age &lt; 40 years (4 subjects) and ≥ 40&#xD;
             years (8 subjects)&#xD;
&#xD;
          -  Broca ≥ - 20 % and ≤ + 20 %&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Use of any drugs which might influence the results of the trial within 10 days prior&#xD;
             to administration or during the trial&#xD;
&#xD;
          -  Intake of drugs with a long half-life (&gt; 24 hours) within 1 month prior to&#xD;
             administration&#xD;
&#xD;
          -  Participation in another trial with an investigational drug within 2 months prior to&#xD;
             administration or during the trial&#xD;
&#xD;
          -  Drug abuse&#xD;
&#xD;
          -  Alcohol abuse (&gt; 60 g/day)&#xD;
&#xD;
          -  Smoker (&gt; 10 cigarettes or 3 cigars or 3 pipes/day) or inability to refrain from&#xD;
             smoking on study days&#xD;
&#xD;
          -  Excessive physical activities within 5 days prior to administration or during the&#xD;
             trial&#xD;
&#xD;
          -  Blood donation within 1 month prior to administration or during the trial&#xD;
&#xD;
          -  History or current gastrointestinal, hepatic, renal, respiratory, cardiovascular,&#xD;
             metabolic, immunological, hormonal disorders&#xD;
&#xD;
          -  Chronic or relevant acute infections&#xD;
&#xD;
          -  Diseases of the central nervous system (such as epilepsy) or psychiatric disorders&#xD;
&#xD;
          -  History of&#xD;
&#xD;
               -  Allergy/hypersensitivity (including drug allergy) which is deemed relevant to the&#xD;
                  trial as judged by the investigator&#xD;
&#xD;
               -  Any bleeding disorder including prolonged or habitual bleeding&#xD;
&#xD;
               -  Other hematologic disease&#xD;
&#xD;
               -  Cerebral bleeding (e.g. after a car accident)&#xD;
&#xD;
          -  Recent surgical procedures&#xD;
&#xD;
          -  Thrombocytes &lt; 150000/µ&#xD;
&#xD;
          -  Any finding of the medical examination (including blood pressure, pulse rate and ECG)&#xD;
             deviating from normal and of clinical relevance&#xD;
&#xD;
          -  Any laboratory value outside the clinically accepted reference range&#xD;
&#xD;
          -  Other disease or abnormality of clinical relevance&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 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 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>Pantoprazole</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/NCT02264119
org study id: 509.119
nct id: NCT02264119
lead sponsor: 
Study to assess the absorption of 20 mg Lefradafiban in two formulations, each under
      physiological conditions and with 40 mg Pantoprazole
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Area under the concentration-time curve of the analyte in plasma at steady state, 13th dosing interval (AUCss,13)
time frame: Up to 168 hours after first drug administration
measure: Maximum concentration of the analyte in plasma at steady state, 13th dosing interval (Cmax,ss,13)
time frame: Up to 168 hours after first drug administration
measure: Pre-dose concentration of the analyte in plasma at steady state, 13th dosing interval (Cpre,ss,13)
time frame: Up to 168 hours after first drug administration
measure: Amount of the analyte eliminated unchanged in the urine per dosing interval (Ae% (i=1,...,13))
time frame: Up to 168 hours after first drug administration
measure: Pre-dose concentration lf the analyte in plasma for the i-th dosing interval (Cpre,i (i=1,4,7,10,11,12))
time frame: Up to 168 hours after first drug administration
measure: Plasma concentration of the analyte at 2 hours post-dose for the i-th dosing interval (C2h,i (i=10,11,12))
time frame: up to 2 hours after each dosing interval
measure: Terminal half life of the analyte in plasma (t1/2)
time frame: Up to 168 hours after first drug administration
measure: Percent swing of peak/trough concentrations of the analyte in plasma for the i-th dosing interval (%Swing,i)
time frame: Up to 168 hours after first drug administration
description: Calculated: (C2h,i - Cpre,i) / Cpre,i * 100% (i=10,11,12)
measure: Percent peak-trough fluctuation for the 13th dosing interval (%PTF13)
time frame: Up to 168 hours after first drug administration
description: Calculated: (Cmax,ss,13 - Cpre,ss,13) * 8h / AUCss,13 * 100%)
measure: Percent fluctuation of area under the plasma concentration-time curve (AUCfluc,13)
time frame: Up to 168 hours after first drug administration
description: Calculated: (AUCabove,13 - AUCbelow,13) / AUCabove,13
measure: Fibrinogen receptor occupancy levels
time frame: Up to 168 hours after first drug administration
measure: Number of subjects with adverse events
time frame: Up to 3 days after last drug administration
measure: Number of subjects with clinically significant findings in vital signs
time frame: Up to 3 days after last drug administration
description: systolic and diastolic blood pressure, pulse rate
measure: Number of subjects with clinically significant findings in laboratory tests
time frame: Up to 3 days after last drug administration
arm group label: Lefradafiban tablet with Pantoprazole
arm group type: Experimental
arm group label: Lefradafiban tablet without Pantoprazole
arm group type: Active Comparator
arm group label: Lefradafiban double chamber sachet with Pantoprazole
arm group type: Experimental
arm group label: Lefradafiban double chamber sachet without Pantoprazole
arm group type: Active Comparator
intervention type: Drug
intervention name: Lefradafiban tablet
arm group label: Lefradafiban tablet with Pantoprazole
arm group label: Lefradafiban tablet without Pantoprazole
intervention type: Drug
intervention name: Pantoprazole tablet
arm group label: Lefradafiban double chamber sachet with Pantoprazole
arm group label: Lefradafiban tablet with Pantoprazole
intervention type: Device
intervention name: Lefradafiban double chamber sachet
arm group label: Lefradafiban double chamber sachet with Pantoprazole
arm group label: Lefradafiban double chamber sachet without Pantoprazole
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
url: http://trials.boehringer-ingelheim.com
description: Related Info
responsible party type: Sponsor
mesh term: Pantoprazole