<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/NCT02214927</url>
  </required_header>
  <id_info>
    <org_study_id>1234.12</org_study_id>
    <nct_id>NCT02214927</nct_id>
  </id_info>
  <brief_title>Pharmacokinetics and Relative Bioavailability of 11634 Immediate Release Tablet in Healthy Male Volunteers</brief_title>
  <official_title>Relative Bioavailability of 10 mg BI 11634 Immediate Release Tablet (IR) Compared to 10 mg of Oral Solution Following Oral Administration in Healthy Male Volunteers (Open-label, Single-dose, Intra-individual Comparison); Determination of Pharmacokinetics of 5 mg, 10 mg and 25 mg IR-tablet Formulation (Open-label, Single Dose)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boehringer Ingelheim</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boehringer Ingelheim</source>
  <brief_summary>
    <textblock>
      -  Characterisation of the relative bioavailability of the IR-tablet vs. oral drinking&#xD;
           solution (no primary endpoint in a statistical sense)&#xD;
&#xD;
        -  Safety and tolerability of the IR-tablet formulation and solution&#xD;
&#xD;
        -  PK profile of the single ascending doses of the IR-tablet formulation (including&#xD;
           analysis of dose proportionality)&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>May 2007</start_date>
  <primary_completion_date type="Actual">July 2007</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of subjects with adverse events</measure>
    <time_frame>up to 10 days after drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of subjects with clinically significant findings in vital signs (blood pressure, pulse rate)</measure>
    <time_frame>up to 10 days after drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of subjects with clinically significant findings in ECG</measure>
    <time_frame>up to 10 days after drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of subjects with clinically significant findings in laboratory tests</measure>
    <time_frame>up to 10 days after 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 drug administration</time_frame>
  </primary_outcome>
  <primary_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 24 hours after drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Cmax (maximum measured concentration of the analyte in plasma)</measure>
    <time_frame>up to 24 hours after drug administration</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>tmax (time from dosing to maximum measured concentration)</measure>
    <time_frame>up to 24 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 up to the last quantifiable data point)</measure>
    <time_frame>up to 24 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>λz (terminal rate constant in plasma)</measure>
    <time_frame>up to 24 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 24 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CL/F (apparent clearance of the analyte in plasma after extravascular administration)</measure>
    <time_frame>up to 24 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 24 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Activated partial thromboplastin time (aPTT) ratios between groups</measure>
    <time_frame>up to 24 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum aPTT prolongation</measure>
    <time_frame>up to 24 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>% inhibition of endogenous Factor Xa</measure>
    <time_frame>up to 24 hours after drug administration</time_frame>
    <description>by Russel's Viper Venom test (RVV)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum international normalized ratio (INR)</measure>
    <time_frame>up to 24 hours after drug administration</time_frame>
    <description>compared between groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent inhibition of thrombin generation by BI 11634</measure>
    <time_frame>up to 24 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent peak inhibition of thrombin generation</measure>
    <time_frame>up to 24 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to maximum inhibition of thrombin generation BI 11634</measure>
    <time_frame>up to 24 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent prolongation of lag time</measure>
    <time_frame>up to 24 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area under the inhibition of the endogenous thrombin generation-time curve</measure>
    <time_frame>up to 24 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum prolongation of blood coagulation time</measure>
    <time_frame>up to 24 hours after drug administration</time_frame>
    <description>by HepTest® (Haemachem Inc.) and COAMATIC® Heparin test (Chromogenix)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>t1/2 (terminal half-life of the analyte in plasma)</measure>
    <time_frame>up to 24 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>BI 11634 single rising dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>tablet</description>
  </arm_group>
  <arm_group>
    <arm_group_label>BI 11634 cross-over</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>sequence: 1. tablet 2. drinking solution</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BI 11634 tablet</intervention_name>
    <arm_group_label>BI 11634 cross-over</arm_group_label>
    <arm_group_label>BI 11634 single rising dose</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BI 11634 drinking solution</intervention_name>
    <arm_group_label>BI 11634 cross-over</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy Caucasian males according to the following criteria, based upon a complete&#xD;
             medical history, including the physical examination, vital signs (blood pressure,&#xD;
             pulse rate), 12-lead ECG, clinical laboratory tests&#xD;
&#xD;
          -  Age ≥18 and ≤50 years&#xD;
&#xD;
          -  Haemoglobin within the normal ranges&#xD;
&#xD;
          -  Body Mass Index (BMI) ≥18.5 and BMI ≤29.9 kg/m2&#xD;
&#xD;
          -  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;
          -  Relevant gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic,&#xD;
             immunological or hormonal disorders&#xD;
&#xD;
          -  Relevant surgery of gastrointestinal tract&#xD;
&#xD;
          -  History of any bleeding disorder or acute and chronic blood coagulation defect, for&#xD;
             the subject itself or any person of his family as far as known&#xD;
&#xD;
          -  History of gastric ulcera and cholecystectomy&#xD;
&#xD;
          -  Occult blood in faeces&#xD;
&#xD;
          -  Relevant diseases of the central nervous system (such as epilepsy) or psychiatric&#xD;
             disorders or neurological disorders&#xD;
&#xD;
          -  History of relevant orthostatic hypotension, fainting spells or blackouts&#xD;
&#xD;
          -  Relevant chronic or 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;
          -  Use of acetylsalicylic acid or any other non-steroidal anti-inflammatory drugs (NSAID)&#xD;
             within 2 weeks of study start until the end of study&#xD;
&#xD;
          -  Participation in another trial with an investigational drug within two months prior to&#xD;
             administration or during the trial&#xD;
&#xD;
          -  Alcohol abuse (more than 40 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 that is of clinical relevance&#xD;
&#xD;
          -  Vulnerable subjects (e.g. persons kept in detention)&#xD;
&#xD;
          -  Inability to understand and comply with protocol requirements, instructions and&#xD;
             protocol-stated restrictions, the nature, scope and possible consequences of the study&#xD;
&#xD;
          -  Subjects (including those who have had a vasectomy) who do not agree to use two&#xD;
             methods of contraception, including barrier contraception (latex condoms with&#xD;
             spermicide plus intrauterine device) when engaging in sexual activity with women of&#xD;
             child bearing potential during the study and for 60 days after completion of the study&#xD;
&#xD;
          -  Subjects with a history within the past six weeks of closed-head or torso trauma or&#xD;
             deceleration injury such as an automobile accident or fall from a significant height&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 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>
  <!-- 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/NCT02214927
org study id: 1234.12
nct id: NCT02214927
lead sponsor: 
-  Characterisation of the relative bioavailability of the IR-tablet vs. oral drinking
           solution (no primary endpoint in a statistical sense)

        -  Safety and tolerability of the IR-tablet formulation and solution

        -  PK profile of the single ascending doses of the IR-tablet formulation (including
           analysis of dose proportionality)
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of subjects with adverse events
time frame: up to 10 days after drug administration
measure: Number of subjects with clinically significant findings in vital signs (blood pressure, pulse rate)
time frame: up to 10 days after drug administration
measure: Number of subjects with clinically significant findings in ECG
time frame: up to 10 days after drug administration
measure: Number of subjects with clinically significant findings in laboratory tests
time frame: up to 10 days after drug administration
measure: Assessment of tolerability by investigator on a 4-point scale
time frame: up to 10 days 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 24 hours after drug administration
measure: Cmax (maximum measured concentration of the analyte in plasma)
time frame: up to 24 hours after drug administration
measure: tmax (time from dosing to maximum measured concentration)
time frame: up to 24 hours after drug administration
measure: AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 up to the last quantifiable data point)
time frame: up to 24 hours after drug administration
measure: λz (terminal rate constant in plasma)
time frame: up to 24 hours after drug administration
measure: MRTpo (mean residence time of the analyte in the body after oral administration)
time frame: up to 24 hours after drug administration
measure: CL/F (apparent clearance of the analyte in plasma after extravascular administration)
time frame: up to 24 hours after drug administration
measure: Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose)
time frame: up to 24 hours after drug administration
measure: Activated partial thromboplastin time (aPTT) ratios between groups
time frame: up to 24 hours after drug administration
measure: Maximum aPTT prolongation
time frame: up to 24 hours after drug administration
measure: % inhibition of endogenous Factor Xa
time frame: up to 24 hours after drug administration
description: by Russel's Viper Venom test (RVV)
measure: Maximum international normalized ratio (INR)
time frame: up to 24 hours after drug administration
description: compared between groups
measure: Percent inhibition of thrombin generation by BI 11634
time frame: up to 24 hours after drug administration
measure: Percent peak inhibition of thrombin generation
time frame: up to 24 hours after drug administration
measure: Time to maximum inhibition of thrombin generation BI 11634
time frame: up to 24 hours after drug administration
measure: Percent prolongation of lag time
time frame: up to 24 hours after drug administration
measure: Area under the inhibition of the endogenous thrombin generation-time curve
time frame: up to 24 hours after drug administration
measure: Maximum prolongation of blood coagulation time
time frame: up to 24 hours after drug administration
description: by HepTest® (Haemachem Inc.) and COAMATIC® Heparin test (Chromogenix)
measure: t1/2 (terminal half-life of the analyte in plasma)
time frame: up to 24 hours after drug administration
arm group label: BI 11634 single rising dose
arm group type: Experimental
description: tablet
arm group label: BI 11634 cross-over
arm group type: Experimental
description: sequence: 1. tablet 2. drinking solution
intervention type: Drug
intervention name: BI 11634 tablet
arm group label: BI 11634 cross-over
arm group label: BI 11634 single rising dose
intervention type: Drug
intervention name: BI 11634 drinking solution
arm group label: BI 11634 cross-over
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
url: http://trials.boehringer-ingelheim.com
description: Related Info
responsible party type: Sponsor