<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/NCT02224079</url>
  </required_header>
  <id_info>
    <org_study_id>1180.3</org_study_id>
    <nct_id>NCT02224079</nct_id>
  </id_info>
  <brief_title>Safety, Tolerability and Pharmacokinetics of Single Rising Doses of BIIB 722 CL and HPβCD in Young Healthy Male Volunteers</brief_title>
  <official_title>Safety, Tolerability and Preliminary Pharmacokinetics of Single Rising Doses of 1 mg, 2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg, 25 mg, 37.5 mg, 50 mg, 75 mg, 100 mg, 125 mg and 150 mg BIIB 722 CL (Calculated as 'Free Base') and HPβCD Given as Intravenous Infusion Over 30 Minutes to Young Healthy Male Subjects. A Single-centre, Single-blind, Placebo-controlled, Randomised Study.</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 safety, tolerability and pharmacokinetics (PK) of single intravenous (i.v.)&#xD;
      doses of BIIB 722 CL&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>April 2002</start_date>
  <primary_completion_date type="Actual">June 2002</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>Single</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of subjects with adverse events</measure>
    <time_frame>up to 12 days after drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of subjects with clinically significant findings in vital signs</measure>
    <time_frame>up to 12 days after drug administration</time_frame>
    <description>blood pressure, pulse rate, respiratory rate, oral body temperature</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of subjects with clinically significant findings in ECG</measure>
    <time_frame>up to 12 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 12 days after drug administration</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Plasma concentration time profiles</measure>
    <time_frame>up to 96 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum measured concentration of the analyte in plasma (Cmax)</measure>
    <time_frame>up to 96 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_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>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area under the concentration-time curve of the analyte in plasma from time zero to a specified point in time (AUC0-t)</measure>
    <time_frame>up to 96 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Terminal half-life of the analyte in plasma (t1/2)</measure>
    <time_frame>up to 96 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean residence time of the analyte in the body (MRT)</measure>
    <time_frame>up to 96 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total clearance of the analyte in plasma (CL)</measure>
    <time_frame>up to 96 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Apparent volume of distribution at steady state (Vss)</measure>
    <time_frame>up to 96 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Amount of drug excreted into urine (Ae)</measure>
    <time_frame>up to 72 hours after drug administration</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>BIIB 722 CL</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BIIB 722 CL</intervention_name>
    <arm_group_label>BIIB 722 CL</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Hydroxypropyl-beta-cyclodextrin (HPβCD)</description>
    <arm_group_label>BIIB 722 CL</arm_group_label>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy males&#xD;
&#xD;
          -  21 to 50 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 or hormonal disorders&#xD;
&#xD;
          -  Diseases of the central nervous system or psychiatric disorders or neurological&#xD;
             disorders&#xD;
&#xD;
          -  History of orthostatic hypotension, fainting spells or blackouts&#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 at least one month or less&#xD;
             than ten half-lives of the respective drug before enrolment in the study&#xD;
&#xD;
          -  Use of any drugs, which might influence the results of the trial within two weeks&#xD;
             prior to administration or during the trial&#xD;
&#xD;
          -  Participation in another trial with an investigational drug (&lt;= two months prior to&#xD;
             administration or during trial)&#xD;
&#xD;
          -  Smoker (&gt; 10 cigarettes or &gt; 3 cigars or &gt; 3 pipes/day)&#xD;
&#xD;
          -  Inability to refrain from smoking on study days&#xD;
&#xD;
          -  Alcohol abuse (&gt; 60 g/day)&#xD;
&#xD;
          -  Drug abuse&#xD;
&#xD;
          -  Blood donation (&gt;= 100 mL within four weeks prior to administration or during the&#xD;
             trial)&#xD;
&#xD;
          -  Excessive physical activities (within the last week before the study)&#xD;
&#xD;
          -  Any laboratory value outside the reference range of clinical relevance&#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 21, 2014</study_first_submitted>
  <study_first_submitted_qc>August 21, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 25, 2014</study_first_posted>
  <last_update_submitted>August 21, 2014</last_update_submitted>
  <last_update_submitted_qc>August 21, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 25, 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/NCT02224079
org study id: 1180.3
nct id: NCT02224079
lead sponsor: 
Study to assess safety, tolerability and pharmacokinetics (PK) of single intravenous (i.v.)
      doses of BIIB 722 CL
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single
measure: Number of subjects with adverse events
time frame: up to 12 days after drug administration
measure: Number of subjects with clinically significant findings in vital signs
time frame: up to 12 days after drug administration
description: blood pressure, pulse rate, respiratory rate, oral body temperature
measure: Number of subjects with clinically significant findings in ECG
time frame: up to 12 days after drug administration
measure: Number of subjects with clinically significant findings in laboratory tests
time frame: up to 12 days after drug administration
measure: Plasma concentration time profiles
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: Area under the concentration-time curve of the analyte in plasma from time zero to a specified point in time (AUC0-t)
time frame: up to 96 hours after drug administration
measure: Terminal half-life of the analyte in plasma (t1/2)
time frame: up to 96 hours after drug administration
measure: Mean residence time of the analyte in the body (MRT)
time frame: up to 96 hours after drug administration
measure: Total clearance of the analyte in plasma (CL)
time frame: up to 96 hours after drug administration
measure: Apparent volume of distribution at steady state (Vss)
time frame: up to 96 hours after drug administration
measure: Amount of drug excreted into urine (Ae)
time frame: up to 72 hours after drug administration
arm group label: BIIB 722 CL
arm group type: Experimental
arm group label: Placebo
arm group type: Placebo Comparator
intervention type: Drug
intervention name: BIIB 722 CL
arm group label: BIIB 722 CL
intervention type: Drug
intervention name: Placebo
description: Hydroxypropyl-beta-cyclodextrin (HPβCD)
arm group label: BIIB 722 CL
arm group label: Placebo
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