<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/NCT01678573</url>
  </required_header>
  <id_info>
    <org_study_id>CR100668</org_study_id>
    <secondary_id>ABI-PRO-1016</secondary_id>
    <nct_id>NCT01678573</nct_id>
  </id_info>
  <brief_title>A Study to Evaluate the Pharmacokinetics of Abiraterone in Healthy Chinese Male Participants</brief_title>
  <official_title>A Single-Dose, Randomized, Open-Label, Three-Way Crossover Study to Evaluate the Pharmacokinetics of Abiraterone in Chinese Healthy Male Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Janssen Research &amp; Development, LLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Janssen Research &amp; Development, LLC</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the pharmacokinetics (how the drug concentrations&#xD;
      change over time) of abiraterone acetate after oral administration of abiraterone acetate at&#xD;
      different dose levels of 250, 500, and 1000 mg in healthy Chinese male participants under&#xD;
      fasted conditions.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is an open-label (all people know the identity of the intervention), randomized (the&#xD;
      treatment sequence is assigned by chance), 3-way crossover study (method used to switch&#xD;
      participants from one dose level to another in a clinical study) of single doses of&#xD;
      abiraterone acetate in healthy Chinese male participants. The study consists of 3 phases:&#xD;
      screening, open-label treatment, and follow up phases. After screening, randomly assigned&#xD;
      participants will receive different dose levels of abiraterone acetate (Treatment A = 250 mg;&#xD;
      Treatment B = 500 mg; and Treatment C = 1000 mg) on Day 1 in each of the 3 treatment periods&#xD;
      according to a randomized schedule under fasted conditions (Sequence 1 = ABC; Sequence 2 =&#xD;
      BAC; and Sequence 3 = CBA). Each treatment period will be separated by a washout period&#xD;
      (period when participant is not receiving any study medication) of at least 7 days. In the&#xD;
      follow-up phase, study-related adverse events will be monitored by the investigator. Serial&#xD;
      blood samples for pharmacokinetic analysis will be collected and safety will be monitored&#xD;
      throughout the study. The total study duration will be approximately 42 days.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2012</start_date>
  <completion_date type="Actual">September 2012</completion_date>
  <primary_completion_date type="Actual">September 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>Crossover 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>Pre-dose and up to 96 hours post-dose each treatment period</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Time to reach the maximum observed plasma concentration of abiraterone</measure>
    <time_frame>Pre-dose and up to 96 hours post-dose each treatment period</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration of abiraterone</measure>
    <time_frame>Pre-dose and up to 96 hours post-dose each treatment period</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Area under the plasma concentration-time curve extrapolated to infinite time of abiraterone</measure>
    <time_frame>Pre-dose and up to 96 hours post-dose each treatment period</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Apparent terminal elimination rate constant of abiraterone</measure>
    <time_frame>Pre-dose and up to 96 hours post-dose each treatment period</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Apparent terminal elimination half-life of abiraterone</measure>
    <time_frame>Pre-dose and up to 96 hours post-dose each treatment period</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of participants with adverse events</measure>
    <time_frame>Up to 42 days</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">15</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Sequence 1: abiraterone acetate</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Randomly assigned participants in Sequence 1 will receive different dose levels of abiraterone acetate (Treatment A = 250 mg; Treatment B = 500 mg; and Treatment C = 1000 mg) on Day 1 in each of the 3 treatment periods according to the randomized schedule &quot;ABC&quot; under fasted conditions.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sequence 2: abiraterone acetate</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Randomly assigned participants in Sequence 2 will receive different dose levels of abiraterone acetate (Treatment A = 250 mg; Treatment B = 500 mg; and Treatment C = 1000 mg) on Day 1 in each of the 3 treatment periods according to the randomized schedule &quot;BAC&quot; under fasted conditions.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sequence 3: abiraterone acetate</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Randomly assigned participants in Sequence 3 will receive different dose levels of abiraterone acetate (Treatment A = 250 mg; Treatment B = 500 mg; and Treatment C = 1000 mg) on Day 1 in each of the 3 treatment periods according to the randomized schedule &quot;CBA&quot; under fasted conditions.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Treatment A: abiraterone acetate</intervention_name>
    <description>250 mg/day tablet administered orally on Day 1 of each treatment period.</description>
    <arm_group_label>Sequence 1: abiraterone acetate</arm_group_label>
    <arm_group_label>Sequence 2: abiraterone acetate</arm_group_label>
    <arm_group_label>Sequence 3: abiraterone acetate</arm_group_label>
    <other_name>ZYTIGA</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Treatment B: abiraterone acetate</intervention_name>
    <description>500 mg/day tablets administered orally on Day 1 of each treatment period.</description>
    <arm_group_label>Sequence 1: abiraterone acetate</arm_group_label>
    <arm_group_label>Sequence 2: abiraterone acetate</arm_group_label>
    <arm_group_label>Sequence 3: abiraterone acetate</arm_group_label>
    <other_name>ZYTIGA</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Treatment C: abiraterone acetate</intervention_name>
    <description>1000 mg/day tablets administered orally on Day 1 of each treatment period.</description>
    <arm_group_label>Sequence 1: abiraterone acetate</arm_group_label>
    <arm_group_label>Sequence 2: abiraterone acetate</arm_group_label>
    <arm_group_label>Sequence 3: abiraterone acetate</arm_group_label>
    <other_name>ZYTIGA</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Body mass index within 18 to 27 kg/m2 (inclusive) and body weight above 50 kg at&#xD;
             screening&#xD;
&#xD;
          -  Protocol-defined laboratory and electrocardiogram parameters&#xD;
&#xD;
          -  Negative test results for selected medications and substances of abuse and negative&#xD;
             exhaled carbon monoxide test at check-in day of each period&#xD;
&#xD;
          -  Agrees to protocol-defined use of effective contraception&#xD;
&#xD;
          -  Willing to be confined at the clinical research facility for time period specified in&#xD;
             the protocol&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Significant history or current manifestation of any significant metabolic, allergic,&#xD;
             dermatological, hepatic, renal, hematologic, pulmonary, cardiovascular,&#xD;
             gastrointestinal, neurological, or psychiatric disorder&#xD;
&#xD;
          -  History of hypersensitivity reaction to the study medication or related compounds or&#xD;
             excipients used in the formulation&#xD;
&#xD;
          -  Confirmed hepatitis A, B, or C infection or human immunodeficiency virus (HIV) 1 or&#xD;
             HIV-2 infection at screening&#xD;
&#xD;
          -  Serum testosterone level of &lt;200 ng/dL&#xD;
&#xD;
          -  Use of any tobacco or nicotine-containing products&#xD;
&#xD;
          -  Known or suspected use of illicit drugs in the last year&#xD;
&#xD;
          -  Protocol contraindicated medications/preparations (prescription and non-prescription)&#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>
  <overall_official>
    <last_name>Janssen Research &amp; Development, LLC Clinical Trial</last_name>
    <role>Study Director</role>
    <affiliation>Janssen Research &amp; Development, LLC</affiliation>
  </overall_official>
  <location>
    <facility>
      <address>
        <city>Beijing</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>September 2013</verification_date>
  <study_first_submitted>August 31, 2012</study_first_submitted>
  <study_first_submitted_qc>August 31, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 5, 2012</study_first_posted>
  <last_update_submitted>September 5, 2013</last_update_submitted>
  <last_update_submitted_qc>September 5, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 6, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Healthy</keyword>
  <keyword>Pharmacokinetics</keyword>
  <keyword>Abiraterone acetate</keyword>
  <keyword>Abiraterone</keyword>
  <keyword>JNJ-212082</keyword>
  <keyword>Zytiga</keyword>
  <keyword>Chinese</keyword>
  <keyword>Fasted</keyword>
  <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/NCT01678573
org study id: CR100668
secondary id: ABI-PRO-1016
nct id: NCT01678573
lead sponsor: 
has dmc: Yes
The purpose of this study is to evaluate the pharmacokinetics (how the drug concentrations
      change over time) of abiraterone acetate after oral administration of abiraterone acetate at
      different dose levels of 250, 500, and 1000 mg in healthy Chinese male participants under
      fasted conditions.
This is an open-label (all people know the identity of the intervention), randomized (the
      treatment sequence is assigned by chance), 3-way crossover study (method used to switch
      participants from one dose level to another in a clinical study) of single doses of
      abiraterone acetate in healthy Chinese male participants. The study consists of 3 phases:
      screening, open-label treatment, and follow up phases. After screening, randomly assigned
      participants will receive different dose levels of abiraterone acetate (Treatment A = 250 mg;
      Treatment B = 500 mg; and Treatment C = 1000 mg) on Day 1 in each of the 3 treatment periods
      according to a randomized schedule under fasted conditions (Sequence 1 = ABC; Sequence 2 =
      BAC; and Sequence 3 = CBA). Each treatment period will be separated by a washout period
      (period when participant is not receiving any study medication) of at least 7 days. In the
      follow-up phase, study-related adverse events will be monitored by the investigator. Serial
      blood samples for pharmacokinetic analysis will be collected and safety will be monitored
      throughout the study. The total study duration will be approximately 42 days.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Maximum observed plasma concentration of abiraterone
time frame: Pre-dose and up to 96 hours post-dose each treatment period
measure: Time to reach the maximum observed plasma concentration of abiraterone
time frame: Pre-dose and up to 96 hours post-dose each treatment period
measure: Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration of abiraterone
time frame: Pre-dose and up to 96 hours post-dose each treatment period
measure: Area under the plasma concentration-time curve extrapolated to infinite time of abiraterone
time frame: Pre-dose and up to 96 hours post-dose each treatment period
measure: Apparent terminal elimination rate constant of abiraterone
time frame: Pre-dose and up to 96 hours post-dose each treatment period
measure: Apparent terminal elimination half-life of abiraterone
time frame: Pre-dose and up to 96 hours post-dose each treatment period
measure: Number of participants with adverse events
time frame: Up to 42 days
arm group label: Sequence 1: abiraterone acetate
arm group type: Experimental
description: Randomly assigned participants in Sequence 1 will receive different dose levels of abiraterone acetate (Treatment A = 250 mg; Treatment B = 500 mg; and Treatment C = 1000 mg) on Day 1 in each of the 3 treatment periods according to the randomized schedule "ABC" under fasted conditions.
arm group label: Sequence 2: abiraterone acetate
arm group type: Experimental
description: Randomly assigned participants in Sequence 2 will receive different dose levels of abiraterone acetate (Treatment A = 250 mg; Treatment B = 500 mg; and Treatment C = 1000 mg) on Day 1 in each of the 3 treatment periods according to the randomized schedule "BAC" under fasted conditions.
arm group label: Sequence 3: abiraterone acetate
arm group type: Experimental
description: Randomly assigned participants in Sequence 3 will receive different dose levels of abiraterone acetate (Treatment A = 250 mg; Treatment B = 500 mg; and Treatment C = 1000 mg) on Day 1 in each of the 3 treatment periods according to the randomized schedule "CBA" under fasted conditions.
intervention type: Drug
intervention name: Treatment A: abiraterone acetate
description: 250 mg/day tablet administered orally on Day 1 of each treatment period.
arm group label: Sequence 1: abiraterone acetate
arm group label: Sequence 2: abiraterone acetate
arm group label: Sequence 3: abiraterone acetate
other name: ZYTIGA
intervention type: Drug
intervention name: Treatment B: abiraterone acetate
description: 500 mg/day tablets administered orally on Day 1 of each treatment period.
arm group label: Sequence 1: abiraterone acetate
arm group label: Sequence 2: abiraterone acetate
arm group label: Sequence 3: abiraterone acetate
other name: ZYTIGA
intervention type: Drug
intervention name: Treatment C: abiraterone acetate
description: 1000 mg/day tablets administered orally on Day 1 of each treatment period.
arm group label: Sequence 1: abiraterone acetate
arm group label: Sequence 2: abiraterone acetate
arm group label: Sequence 3: abiraterone acetate
other name: ZYTIGA
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Janssen Research & Development, LLC Clinical Trial
role: Study Director
affiliation: Janssen Research & Development, LLC
facility: 
country: China
responsible party type: Sponsor
mesh term: Abiraterone Acetate