<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/NCT02227030</url>
  </required_header>
  <id_info>
    <org_study_id>1180.1</org_study_id>
    <nct_id>NCT02227030</nct_id>
  </id_info>
  <brief_title>Tolerability and Pharmacokinetics of BIIB 722 CL Drinking Solution and of BIIB 722 CL Filmcoated Tablet in Healthy Subjects</brief_title>
  <official_title>Tolerability and Pharmacokinetics of Single Oral Administration of 10, 20, 50, 100, 200 and 300 mg BIIB 722 CL (Calculated as Free Base) as Drinking Solution and of 200, 450, 600 and 750 mg BIIB 722 CL as Filmcoated Tablet in Healthy Subjects. An Open Study With Rising Doses, Partly Uncontrolled Intra-individual Comparison, Placebo Randomised Double Blind at Each Dose Level.</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 and pharmacokinetics after oral single rising doses of BIIB 722 CL&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>April 2000</start_date>
  <primary_completion_date type="Actual">September 2000</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>Double</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Area under the concentration-time curve of the analyte in plasma (AUC)</measure>
    <time_frame>up to 96 hours after drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Maximum measured concentration of the analyte in plasma (Cmax)</measure>
    <time_frame>up to 96 hours after drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Time from dosing to the maximum concentration of the analyte in plasma (tmax)</measure>
    <time_frame>up to 96 hours after drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Total mean residence time of the analyte in the body (MRTtot)</measure>
    <time_frame>up to 96 hours after drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Total clearance of the analyte in plasma (CLtot/f)</measure>
    <time_frame>up to 96 hours after drug administration</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of subjects with adverse events</measure>
    <time_frame>up to 96 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of subjects with clinically significant findings in vital functions</measure>
    <time_frame>up to 96 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of subjects with clinically significant findings in laboratory tests</measure>
    <time_frame>up to 96 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Thrombocytic Na-H exchange (NHE-1) inhibition by AUC of pH recovery</measure>
    <time_frame>up to 24 hours after drug administration</time_frame>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">71</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>BIIB 722 CL single rising dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>BIIB 722 CL cross over</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>BIIB 722 CL solution</intervention_name>
    <arm_group_label>BIIB 722 CL cross over</arm_group_label>
    <arm_group_label>BIIB 722 CL single rising dose</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BIIB 722 CL tablet</intervention_name>
    <arm_group_label>BIIB 722 CL cross over</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;
          -  Healthy males&#xD;
&#xD;
          -  18 to 55 years of age&#xD;
&#xD;
          -  Broca index &gt;= -20% and &lt;= +20%&#xD;
&#xD;
          -  Written informed consent according to Good Clinical Practice (GCP) and local&#xD;
             legislation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any finding of the medical examination (including blood pressure, pulse rate and&#xD;
             Electrocardiogram (ECG)) deviating from normal and of clinical relevance&#xD;
&#xD;
          -  History or current gastrointestinal hepatic, renal, respiratory, cardiovascular,&#xD;
             metabolic, immunologic, hormonal disorders&#xD;
&#xD;
          -  History of orthostatic hypotension, fainting spells or blackouts&#xD;
&#xD;
          -  Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or&#xD;
             neurological 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) within 1 month prior to&#xD;
             administration&#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;
          -  Participation in another trial with an investigational drug within 2 months prior to&#xD;
             administration or during trial&#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;
          -  Alcohol abuse (&gt; 60g/day)&#xD;
&#xD;
          -  Drug abuse&#xD;
&#xD;
          -  Blood donation within 1 month prior to administration or during the trial&#xD;
&#xD;
          -  Excessive physical activities within 5 days prior to administration or during the&#xD;
             trial&#xD;
&#xD;
          -  Any laboratory value outside the clinically accepted reference range&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 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 26, 2014</study_first_submitted>
  <study_first_submitted_qc>August 26, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 27, 2014</study_first_posted>
  <last_update_submitted>August 26, 2014</last_update_submitted>
  <last_update_submitted_qc>August 26, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 27, 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/NCT02227030
org study id: 1180.1
nct id: NCT02227030
lead sponsor: 
Safety and pharmacokinetics after oral single rising doses of BIIB 722 CL
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Double
measure: Area under the concentration-time curve of the analyte in plasma (AUC)
time frame: up to 96 hours after drug administration
measure: Maximum measured concentration of the analyte in plasma (Cmax)
time frame: up to 96 hours after drug administration
measure: Time from dosing to the maximum concentration of the analyte in plasma (tmax)
time frame: up to 96 hours after drug administration
measure: Total mean residence time of the analyte in the body (MRTtot)
time frame: up to 96 hours after drug administration
measure: Total clearance of the analyte in plasma (CLtot/f)
time frame: up to 96 hours after drug administration
measure: Number of subjects with adverse events
time frame: up to 96 hours after drug administration
measure: Number of subjects with clinically significant findings in vital functions
time frame: up to 96 hours after drug administration
measure: Number of subjects with clinically significant findings in laboratory tests
time frame: up to 96 hours after drug administration
measure: Thrombocytic Na-H exchange (NHE-1) inhibition by AUC of pH recovery
time frame: up to 24 hours after drug administration
arm group label: BIIB 722 CL single rising dose
arm group type: Experimental
arm group label: BIIB 722 CL cross over
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: BIIB 722 CL solution
arm group label: BIIB 722 CL cross over
arm group label: BIIB 722 CL single rising dose
intervention type: Drug
intervention name: BIIB 722 CL tablet
arm group label: BIIB 722 CL cross over
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: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
url: http://trials.boehringer-ingelheim.com
description: Related Info
responsible party type: Sponsor
mesh term: Pharmaceutical Solutions