<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/NCT02223507</url>
  </required_header>
  <id_info>
    <org_study_id>600.6</org_study_id>
    <nct_id>NCT02223507</nct_id>
  </id_info>
  <brief_title>Single Dose Followed by Maintenance Dose Tolerance Study of BIIR 561 CL in Healthy Elderly Male and Female Volunteers</brief_title>
  <official_title>A Single-blind, Placebo-controlled Single Dose Tolerance Study in Healthy Elderly Male and Female Volunteers After Intravenous Administration of BIIR 561 CL as Loading Dose (Dosage: 75 mg/h, Infusion Time 1 Hour) Followed by Maintenance Dose (Dosage: 40 mg/h and 75 mg/h, Infusion Time 5 Hours)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boehringer Ingelheim</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boehringer Ingelheim</source>
  <brief_summary>
    <textblock>
      The objective of the present study was to obtain information about the safety, tolerability&#xD;
      and pharmacokinetics of BIIR 561 CL after continuous intravenous administration of two&#xD;
      increasing doses in healthy elderly volunteers, following the infusion schema of a loading&#xD;
      dose (1 hour) and a maintenance dose (5 hours)&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 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>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 8 days after drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of subjects with clinically significant findings in vital functions</measure>
    <time_frame>up to 8 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 8 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 8 days after drug administration</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Maximum drug plasma concentration (Cmax)</measure>
    <time_frame>up to 32 hours after first drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Cmax (tmax)</measure>
    <time_frame>up to 32 hours after first drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Terminal half-life (t1/2)</measure>
    <time_frame>up to 32 hours after first drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area under the plasma concentration-time curve from zero to the last time points with a quantifiable plasma concentration (AUC0-tf)</measure>
    <time_frame>up to 32 hours after first drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area under the plasma concentration-time curve extrapolated to infinity (AUC0-inf)</measure>
    <time_frame>up to 32 hours after first drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean residence time (MRT)</measure>
    <time_frame>up to 32 hours after first drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma clearance (CL)</measure>
    <time_frame>up to 32 hours after first drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Volume of distribution (Vz)</measure>
    <time_frame>up to 32 hours after first drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Volume of distribution at steady state (Vss)</measure>
    <time_frame>up to 32 hours after first drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Amount excreted into urine (Ae)</measure>
    <time_frame>up to 32 hours after first drug administration</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment>13</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>BIIR 561 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>BIIR 561 CL</intervention_name>
    <arm_group_label>BIIR 561 CL</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy male and female volunteers&#xD;
&#xD;
          -  Age &gt;= 60 years&#xD;
&#xD;
          -  Broca index from -25% to +25%&#xD;
&#xD;
          -  Written informed consent prior to admission to the study&#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;
          -  Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic,&#xD;
             immunological or hormonal disorders (exclusion: substitution therapy regarding thyroid&#xD;
             gland and/or ovaries)&#xD;
&#xD;
          -  Diseases of the central nervous system (CNS) (such as epilepsy) or psychiatric&#xD;
             disorders or neurological disorders and medical history of such diseases or disorders&#xD;
&#xD;
          -  History of orthostatic hypotension, fainting spells or blackouts&#xD;
&#xD;
          -  Chronic or relevant acute infections&#xD;
&#xD;
          -  Allergy/hypersensitivity (including drug allergy) which is deemed relevant to the&#xD;
             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;
          -  Intake of any drugs which might influence the results of the trial (&lt;= one week prior&#xD;
             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 the trial&#xD;
&#xD;
          -  Smoker (&gt; 10 cigarettes or &gt; 3 cigars or &gt; 3 pipes/day)&#xD;
&#xD;
          -  Inability to refrain from smoking on trial days&#xD;
&#xD;
          -  Alcohol abuse (&gt; 30g/day for males, &gt; 24 g for females)&#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>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>N/A</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 22, 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 22, 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/NCT02223507
org study id: 600.6
nct id: NCT02223507
lead sponsor: 
The objective of the present study was to obtain information about the safety, tolerability
      and pharmacokinetics of BIIR 561 CL after continuous intravenous administration of two
      increasing doses in healthy elderly volunteers, following the infusion schema of a loading
      dose (1 hour) and a maintenance dose (5 hours)
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single
measure: Number of subjects with adverse events
time frame: up to 8 days after drug administration
measure: Number of subjects with clinically significant findings in vital functions
time frame: up to 8 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 8 days after drug administration
measure: Number of subjects with clinically significant findings in laboratory tests
time frame: up to 8 days after drug administration
measure: Maximum drug plasma concentration (Cmax)
time frame: up to 32 hours after first drug administration
measure: Time to Cmax (tmax)
time frame: up to 32 hours after first drug administration
measure: Terminal half-life (t1/2)
time frame: up to 32 hours after first drug administration
measure: Area under the plasma concentration-time curve from zero to the last time points with a quantifiable plasma concentration (AUC0-tf)
time frame: up to 32 hours after first drug administration
measure: Area under the plasma concentration-time curve extrapolated to infinity (AUC0-inf)
time frame: up to 32 hours after first drug administration
measure: Mean residence time (MRT)
time frame: up to 32 hours after first drug administration
measure: Plasma clearance (CL)
time frame: up to 32 hours after first drug administration
measure: Volume of distribution (Vz)
time frame: up to 32 hours after first drug administration
measure: Volume of distribution at steady state (Vss)
time frame: up to 32 hours after first drug administration
measure: Amount excreted into urine (Ae)
time frame: up to 32 hours after first drug administration
arm group label: BIIR 561 CL
arm group type: Experimental
arm group label: Placebo
arm group type: Placebo Comparator
intervention type: Drug
intervention name: BIIR 561 CL
arm group label: BIIR 561 CL
intervention type: Drug
intervention name: Placebo
arm group label: Placebo
criteria: 
gender: All
minimum age: 60 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
url: http://trials.boehringer-ingelheim.com
description: Related Info
responsible party type: Sponsor