<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/NCT01723618</url>
  </required_header>
  <id_info>
    <org_study_id>Cardoz-005</org_study_id>
    <nct_id>NCT01723618</nct_id>
  </id_info>
  <brief_title>Pharmacokinetics of CRD007 in Patients With Abdominal Aorta Aneurisms.</brief_title>
  <official_title>An Open-label, Randomised, Uncontrolled Trial Investigating the Pharmacokinetics of CRD007 After Single Dose Administration to Subjects With Abdominal Aortic Aneurysm (AAA)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>RSPR Pharma AB</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>RSPR Pharma AB</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the study is to determine the plasma levels of CRD007 in patients with&#xD;
      abdominal aortic aneurysms after the administration of single doses of tablets containing 10,&#xD;
      25 and 40 mg CRD007.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">November 2012</completion_date>
  <primary_completion_date type="Actual">November 2012</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>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pharmacokinetics - maximum plasma concentration (Cmax)</measure>
    <time_frame>Pre-dose and until 12 hours post-dose</time_frame>
    <description>Plasma concentrations of CRD007 will be measured and standard pharmacokinetic parameters as Cmax will be measured</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacokinetics - time to maximum plasma concentration (tmax)</measure>
    <time_frame>Pre-dose til 12 hours post-dose</time_frame>
    <description>Plasma concentrations of CRD007 will be measured and standard pharmacokinetic parameters as tmax will be measured.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacokinetics - Area under the plasma concentration curve (AUC)</measure>
    <time_frame>Pre-dose until 12 hours post-dose</time_frame>
    <description>Plasma concentrations of CRD007 will be measured and standard pharmacokinetic parameters as AUC will be measured.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacokinetics - elimination half life (t1/2)</measure>
    <time_frame>pre-dose until 12 hours post-dose</time_frame>
    <description>Plasma concentrations of CRD007 will be measured and standard pharmacokinetic parameters as t1/2 will be measured</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Dose linearity</measure>
    <time_frame>Pre-dose and until 12 hours post-dose</time_frame>
    <description>Evaluation of dose linearity in the dose range 10 - 40 mg</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Potential for accumulation</measure>
    <time_frame>Pre-dose untill 12 hours post-dose</time_frame>
    <description>To estimate the accumulation of CRD007 in the dose range 10 - 40 mg</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">18</enrollment>
  <condition>Abdominal Aortic Aneurisms</condition>
  <arm_group>
    <arm_group_label>CRD007 10 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>CRD007, 10 mg tablet, single dose</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CRD007 25 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>CRD007, 25 mg tablet, single dose</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CRD007 40 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>CRD007, 40 mg tablet, single dose</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>CRD007</intervention_name>
    <arm_group_label>CRD007 10 mg</arm_group_label>
    <arm_group_label>CRD007 25 mg</arm_group_label>
    <arm_group_label>CRD007 40 mg</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Infra-renal abdominal aortic aneurysm&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Significant concurrent disease or medical conditions that are deemed to interfere with&#xD;
             the pharmacokinetics or the safety of CRD007 conduct of the trial&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nikolaj F Groendal, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Vascular Surgery Viborg Hospital Heiberg Allé 4 DK-8800 Viborg Denmark</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Vascular Surgery Viborg Hospital</name>
      <address>
        <city>Viborg</city>
        <zip>8800</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>November 2012</verification_date>
  <study_first_submitted>November 1, 2012</study_first_submitted>
  <study_first_submitted_qc>November 6, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 8, 2012</study_first_posted>
  <last_update_submitted>November 28, 2012</last_update_submitted>
  <last_update_submitted_qc>November 28, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 29, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Aneurysm</mesh_term>
    <mesh_term>Aortic Aneurysm</mesh_term>
    <mesh_term>Aortic Aneurysm, Abdominal</mesh_term>
  </condition_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/NCT01723618
org study id: Cardoz-005
nct id: NCT01723618
lead sponsor: 
has dmc: No
The purpose of the study is to determine the plasma levels of CRD007 in patients with
      abdominal aortic aneurysms after the administration of single doses of tablets containing 10,
      25 and 40 mg CRD007.
allocation: Randomized
intervention model: Parallel Assignment
masking: None (Open Label)
measure: Pharmacokinetics - maximum plasma concentration (Cmax)
time frame: Pre-dose and until 12 hours post-dose
description: Plasma concentrations of CRD007 will be measured and standard pharmacokinetic parameters as Cmax will be measured
measure: Pharmacokinetics - time to maximum plasma concentration (tmax)
time frame: Pre-dose til 12 hours post-dose
description: Plasma concentrations of CRD007 will be measured and standard pharmacokinetic parameters as tmax will be measured.
measure: Pharmacokinetics - Area under the plasma concentration curve (AUC)
time frame: Pre-dose until 12 hours post-dose
description: Plasma concentrations of CRD007 will be measured and standard pharmacokinetic parameters as AUC will be measured.
measure: Pharmacokinetics - elimination half life (t1/2)
time frame: pre-dose until 12 hours post-dose
description: Plasma concentrations of CRD007 will be measured and standard pharmacokinetic parameters as t1/2 will be measured
measure: Dose linearity
time frame: Pre-dose and until 12 hours post-dose
description: Evaluation of dose linearity in the dose range 10 - 40 mg
measure: Potential for accumulation
time frame: Pre-dose untill 12 hours post-dose
description: To estimate the accumulation of CRD007 in the dose range 10 - 40 mg
arm group label: CRD007 10 mg
arm group type: Experimental
description: CRD007, 10 mg tablet, single dose
arm group label: CRD007 25 mg
arm group type: Experimental
description: CRD007, 25 mg tablet, single dose
arm group label: CRD007 40 mg
arm group type: Experimental
description: CRD007, 40 mg tablet, single dose
intervention type: Drug
intervention name: CRD007
arm group label: CRD007 10 mg
arm group label: CRD007 25 mg
arm group label: CRD007 40 mg
criteria: 
gender: All
minimum age: 50 Years
maximum age: N/A
healthy volunteers: No
last name: Nikolaj F Groendal, MD
role: Principal Investigator
affiliation: Department of Vascular Surgery Viborg Hospital Heiberg Allé 4 DK-8800 Viborg Denmark
facility: 
country: Denmark
responsible party type: Sponsor
mesh term: Aneurysm
mesh term: Aortic Aneurysm
mesh term: Aortic Aneurysm, Abdominal