<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/NCT01715259</url>
  </required_header>
  <id_info>
    <org_study_id>CR016951</org_study_id>
    <secondary_id>COU-AA-012</secondary_id>
    <nct_id>NCT01715259</nct_id>
  </id_info>
  <brief_title>A Pharmacokinetic Study of Abiraterone Acetate in Male Participants With Impaired Renal Function Compared to Individuals With Normal Renal Function</brief_title>
  <official_title>A Phase 1 Single Dose Open-Label Reduced/Staged Pharmacokinetic Study of Abiraterone Acetate in Male Subjects With Impaired Renal Function Compared to Matched Control Subjects With Normal Renal Function</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cougar Biotechnology, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cougar Biotechnology, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine the pharmacokinetic (how the drug concentrations&#xD;
      change over time) profile of abiraterone acetate 1000 mg when administered as a single dose&#xD;
      in male participants with impaired renal function compared to individuals with normal renal&#xD;
      function.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is an open-label (identity of assigned study drug will be known) pharmacokinetics study&#xD;
      evaluating a single dose of abiraterone acetate 1000 mg administered in male participants&#xD;
      with end-stage renal disease compared to matched-control (matched for age and body mass&#xD;
      index) participants with normal renal function. There will be approximately 8 participants in&#xD;
      each cohort (group). The total study duration for each participant will be 36 days.&#xD;
      Abiraterone acetate 1000 mg will be administered orally (by mouth) as a single dose in the&#xD;
      fasted state on Day 1. No food will be ingested for 4 hours post-dose. Participants will be&#xD;
      confined to the clinical research center from the day prior to dosing (Day -1) to Day 5 and&#xD;
      will return to the clinic on Days 8, 15, and 22 for follow up. Serial pharmacokinetic samples&#xD;
      will be collected and safety will be monitored throughout the study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2009</start_date>
  <completion_date type="Actual">January 2010</completion_date>
  <primary_completion_date type="Actual">January 2010</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Maximum observed plasma concentration of abiraterone</measure>
    <time_frame>Within 0.5 hour prior to dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hours post-dose</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Time to maximum plasma concentration of abiraterone</measure>
    <time_frame>Within 0.5 hour prior to dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hours post-dose</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Area under the concentration-time curve from time 0 to the last measurable plasma concentration of abiraterone</measure>
    <time_frame>Within 0.5 hour prior to dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hours post-dose</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Area under the concentration-time curve from time 0 to infinity of abiraterone</measure>
    <time_frame>Within 0.5 hour prior to dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hours post-dose</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Terminal phase rate constant of abiraterone</measure>
    <time_frame>Within 0.5 hour prior to dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hours post-dose</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Terminal plasma elimination half-life of abiraterone</measure>
    <time_frame>Within 0.5 hour prior to dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hours post-dose</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Oral clearance of abiraterone</measure>
    <time_frame>Within 0.5 hour prior to dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hours post-dose</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Apparent volume of distribution of abiraterone</measure>
    <time_frame>Within 0.5 hour prior to dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hours post-dose</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of participants affected by an adverse event</measure>
    <time_frame>Up to Day 22</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">16</enrollment>
  <condition>Renal Insufficiency</condition>
  <arm_group>
    <arm_group_label>Abiraterone acetate</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Abiraterone acetate: participants with end-stage renal disease</intervention_name>
    <description>abiraterone acetate 1000 mg (4 x 250 mg tablets) taken by mouth as a single dose in the fasted state on Day 1</description>
    <arm_group_label>Abiraterone acetate</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Abiraterone acetate: matched control participants with normal renal function</intervention_name>
    <description>abiraterone acetate 1000 mg (4 x 250 mg tablets) taken by mouth as a single dose in the fasted state on Day 1</description>
    <arm_group_label>Abiraterone acetate</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        All participants:&#xD;
&#xD;
          -  Non-smokers or light smokers&#xD;
&#xD;
          -  Body Mass Index of 18-38 kg/m2 inclusive&#xD;
&#xD;
          -  Negative drug test, at screening and Day -1, for breathalyzer alcohol and drugs of&#xD;
             abuse&#xD;
&#xD;
          -  Negative HIV antibody test at screening&#xD;
&#xD;
          -  Clinical laboratory values within protocol-defined parameters&#xD;
&#xD;
          -  Agrees to protocol-defined use of effective contraception&#xD;
&#xD;
          -  Participants may have concurrent stable medical conditions and may be included if the&#xD;
             deemed condition(s) will not introduce an additional risk factor and will not&#xD;
             interfere with the study objectives and procedures&#xD;
&#xD;
        Patients with renal impairment must additionally meet the following criteria:&#xD;
&#xD;
          -  Must have protocol-defined criteria of end-stage renal disease, moderate or mild renal&#xD;
             impairment&#xD;
&#xD;
          -  Evidence of stable renal impairment&#xD;
&#xD;
        Control participants with normal renal function must additionally meet the following&#xD;
        criteria:&#xD;
&#xD;
        - Must be in good health&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        All participants:&#xD;
&#xD;
          -  Medical history of malignancy except non-melanoma skin cancer&#xD;
&#xD;
          -  Participation in any other investigational study drug trial in which receipt of an&#xD;
             investigational study drug occurred within 5 half-lives of that drug or 30 days prior&#xD;
             to dosing with abiraterone acetate, whichever is longer&#xD;
&#xD;
          -  History of alcoholism or drug abuse within the past 12 months&#xD;
&#xD;
          -  Significant history or clinical manifestation as determined by the Investigator of any&#xD;
             significant metabolic, allergic, dermatological, hepatic, hematological, pulmonary,&#xD;
             cardiovascular, immunologic, neurological, psychiatric or gastrointestinal conditions,&#xD;
             surgery or resection that would potentially alter absorption and/or excretion of&#xD;
             orally administered drugs&#xD;
&#xD;
          -  Clinically significant arrhythmias and/or history or presence of a clinically&#xD;
             significantly abnormal electrocardiogram&#xD;
&#xD;
          -  Acute illness, especially any active and uncontrolled infection&#xD;
&#xD;
          -  Not willing to refrain from strenuous exercise from 48-hours prior to Day -1 and&#xD;
             during the period of confinement at the clinical site&#xD;
&#xD;
          -  Not willing to abstain from consuming: grapefruit- or caffeine-containing foods or&#xD;
             beverages for 72 hours prior to Day -1 and alcohol-containing foods or beverages for&#xD;
             24 hours prior to Day -1&#xD;
&#xD;
          -  Donation of blood or significant loss of blood within 56 days prior to Day 1 or&#xD;
             planned donation of blood or plasma from screening through 30 days after Day 1,&#xD;
             inclusive&#xD;
&#xD;
          -  The use of any prescription or over-the-counter (OTC) preparation known to&#xD;
             significantly inhibit or induce liver enzymes involved in drug metabolism within 30&#xD;
             days prior to Day 1&#xD;
&#xD;
          -  Use of any prescription medications/products or any OTC, non-prescription preparations&#xD;
             unrelated to existing allowable stable medical conditions within 5 half-lives of that&#xD;
             product or 7 days prior to dosing with abiraterone acetate, whichever is longer&#xD;
&#xD;
          -  Any acute or chronic condition that, in the opinion of the Investigator, would limit&#xD;
             the individual's ability to complete and/or participate in this clinical study&#xD;
&#xD;
        Patients with renal impairment who meet any of the following criteria will be excluded from&#xD;
        the study:&#xD;
&#xD;
          -  Acute or exacerbating renal disease, fluctuating or rapidly deteriorating renal&#xD;
             function as indicated by widely varying or worsening of signs of renal impairment&#xD;
             within 2 weeks of Day 1&#xD;
&#xD;
          -  Hypertension (systolic blood pressure [BP] &gt;180 or diastolic BP &gt;100)&#xD;
&#xD;
        Control participants with normal renal function who meet any of the following criteria will&#xD;
        be excluded from the study:&#xD;
&#xD;
          -  Hypertension (systolic BP &gt;=160 or diastolic BP &gt;=95)&#xD;
&#xD;
          -  Any significant laboratory results consistent with renal impairment&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Cougar Biotechnology, Inc. Clinical Trial</last_name>
    <role>Study Director</role>
    <affiliation>Cougar Biotechnology, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2012</verification_date>
  <study_first_submitted>October 24, 2012</study_first_submitted>
  <study_first_submitted_qc>October 24, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 26, 2012</study_first_posted>
  <last_update_submitted>November 16, 2012</last_update_submitted>
  <last_update_submitted_qc>November 16, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 19, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Renal insufficiency</keyword>
  <keyword>Renal impairment</keyword>
  <keyword>End-stage renal disease</keyword>
  <keyword>Abiraterone acetate</keyword>
  <keyword>Pharmacokinetics</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Renal Insufficiency</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Abiraterone Acetate</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/NCT01715259
org study id: CR016951
secondary id: COU-AA-012
nct id: NCT01715259
lead sponsor: 
has dmc: No
The purpose of this study is to determine the pharmacokinetic (how the drug concentrations
      change over time) profile of abiraterone acetate 1000 mg when administered as a single dose
      in male participants with impaired renal function compared to individuals with normal renal
      function.
This is an open-label (identity of assigned study drug will be known) pharmacokinetics study
      evaluating a single dose of abiraterone acetate 1000 mg administered in male participants
      with end-stage renal disease compared to matched-control (matched for age and body mass
      index) participants with normal renal function. There will be approximately 8 participants in
      each cohort (group). The total study duration for each participant will be 36 days.
      Abiraterone acetate 1000 mg will be administered orally (by mouth) as a single dose in the
      fasted state on Day 1. No food will be ingested for 4 hours post-dose. Participants will be
      confined to the clinical research center from the day prior to dosing (Day -1) to Day 5 and
      will return to the clinic on Days 8, 15, and 22 for follow up. Serial pharmacokinetic samples
      will be collected and safety will be monitored throughout the study.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Maximum observed plasma concentration of abiraterone
time frame: Within 0.5 hour prior to dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hours post-dose
measure: Time to maximum plasma concentration of abiraterone
time frame: Within 0.5 hour prior to dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hours post-dose
measure: Area under the concentration-time curve from time 0 to the last measurable plasma concentration of abiraterone
time frame: Within 0.5 hour prior to dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hours post-dose
measure: Area under the concentration-time curve from time 0 to infinity of abiraterone
time frame: Within 0.5 hour prior to dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hours post-dose
measure: Terminal phase rate constant of abiraterone
time frame: Within 0.5 hour prior to dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hours post-dose
measure: Terminal plasma elimination half-life of abiraterone
time frame: Within 0.5 hour prior to dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hours post-dose
measure: Oral clearance of abiraterone
time frame: Within 0.5 hour prior to dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hours post-dose
measure: Apparent volume of distribution of abiraterone
time frame: Within 0.5 hour prior to dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hours post-dose
measure: Number of participants affected by an adverse event
time frame: Up to Day 22
arm group label: Abiraterone acetate
arm group type: Experimental
intervention type: Drug
intervention name: Abiraterone acetate: participants with end-stage renal disease
description: abiraterone acetate 1000 mg (4 x 250 mg tablets) taken by mouth as a single dose in the fasted state on Day 1
arm group label: Abiraterone acetate
intervention type: Drug
intervention name: Abiraterone acetate: matched control participants with normal renal function
description: abiraterone acetate 1000 mg (4 x 250 mg tablets) taken by mouth as a single dose in the fasted state on Day 1
arm group label: Abiraterone acetate
criteria: 
gender: Male
minimum age: 40 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Cougar Biotechnology, Inc. Clinical Trial
role: Study Director
affiliation: Cougar Biotechnology, Inc.
facility: 
country: United States
responsible party type: Sponsor
mesh term: Renal Insufficiency
mesh term: Abiraterone Acetate