<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/NCT02230046</url>
  </required_header>
  <id_info>
    <org_study_id>CR105286</org_study_id>
    <secondary_id>212082PCR1007</secondary_id>
    <nct_id>NCT02230046</nct_id>
  </id_info>
  <brief_title>Bioequivalence Study of Abiraterone Acetate Coated and Uncoated Tablet Formulations in Healthy Male Participants</brief_title>
  <official_title>A Single-Dose, Open-Label, Randomized, 3-Way Crossover Pivotal Study to Assess the Bioequivalence of 2 Abiraterone Acetate Coated Tablet Formulations With Respect to the Current Commercial Abiraterone Acetate Uncoated Tablet Formulation Under Fasted Conditions in 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>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine the bioequivalence (equivalence of pharmacokinetic&#xD;
      parameters) of 2 abiraterone acetate coated tablet formulations with respect to the current&#xD;
      commercial abiraterone acetate uncoated tablet formulation under fasted (without eating or&#xD;
      drinking) conditions in healthy male participants.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a Phase 1, randomized (study medication assigned to participants by chance),&#xD;
      open-label (all people know the identity of the intervention), single-center, single-dose and&#xD;
      3-way Crossover (the same medications provided to all participants but in different sequence)&#xD;
      pivotal study to determine the bioequivalence of 2 abiraterone acetate coated tablet&#xD;
      formulations with respect to the current commercial abiraterone acetate uncoated tablet&#xD;
      formulation. Approximately 102 healthy male participants will participate in this study.&#xD;
      Participants will be randomly assigned to 1 of 6 treatment sequences. The study will consist&#xD;
      of 3 parts: Screening Phase (within 21 days before the first study drug administration of the&#xD;
      first period), an open-label treatment Phase consisting of 3 single-dose treatment periods&#xD;
      (45 days) and follow-up Phase (5 to 7 days after the last study procedure). The total study&#xD;
      duration for each participant will be from 45 days to a maximum of 61 days. Participants will&#xD;
      receive a single oral 1000 milligram (mg) dose of abiraterone acetate under fasted conditions&#xD;
      either as Treatment A (current commercial formulation, uncoated), Treatment B (current&#xD;
      commercial formulation, coated) or Treatment C (new composition, coated). Bioequivalence will&#xD;
      be primarily evaluated by pharmacokinetic parameters. Participants' safety will be monitored&#xD;
      throughout the study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2014</start_date>
  <completion_date type="Actual">November 2014</completion_date>
  <primary_completion_date type="Actual">November 2014</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 Plasma Concentration (Cmax) of abiraterone acetate</measure>
    <time_frame>Pre-dose; 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours post-dose on Day 1 of each period</time_frame>
    <description>The Cmax is the maximum observed plasma concentration of abiraterone acetate.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Area Under the Plasma Concentration-Time Curve From Time 0 to Time of the Last Quantifiable Concentration (AUC [0-last]) of abiraterone acetate</measure>
    <time_frame>Pre-dose; 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours post-dose on Day 1 of each period</time_frame>
    <description>The AUC (0-last) is the area under the plasma abiraterone acetate concentration-time curve from time zero to time of the last quantifiable concentration.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Area Under the Plasma Concentration-Time Curve From Time 0 to Infinite Time (AUC [0-infinity]) of abiraterone acetate</measure>
    <time_frame>Pre-dose; 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours post-dose on Day 1 of each period</time_frame>
    <description>The AUC (0-infinity) is the area under the plasma abiraterone acetate concentration-time curve from time 0 to infinite time, calculated as the sum of AUC (0-last) and C(last)/lambda(z), in which AUC(0-last) is area under the plasma abiraterone acetate concentration-time curve from time zero to time of the last quantifiable concentration, C(last) is the last observed quantifiable concentration and lambda(z) is elimination rate constant.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time to Reach the Maximum Plasma Concentration (Tmax) of abiraterone acetate</measure>
    <time_frame>Pre-dose; 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours post-dose on Day 1 of each period</time_frame>
    <description>The Tmax is the time to reach the maximum observed plasma concentration of abiraterone acetate.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Area Under the Plasma Concentration-Time Curve Extrapolated From Last Measurable Concentration to Infinite Time (%AUC, ext) of abiraterone acetate</measure>
    <time_frame>Pre-dose; 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours post-dose on Day 1 of each period</time_frame>
    <description>Percentage of area under the plasma abiraterone acetate concentration-time curve extrapolated from last measurable concentration to infinite time (%AUC, ext) is calculated using formula: ((AUC [0-infinity] minus- AUC [0-last)]/AUC [0-infinity])*100.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Elimination Half-Life (t 1/2, Lambda) of abiraterone acetate</measure>
    <time_frame>Pre-dose; 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours post-dose on Day 1 of each period</time_frame>
    <description>Elimination half-life (t 1/2, Lambda) is associated with the terminal slope (lambda [z]) of the semi logarithmic drug concentration-time curve, calculated as 0.693/lambda(z).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate Constant (Lambda [z]) of abiraterone acetate</measure>
    <time_frame>Pre-dose; 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours post-dose on Day 1 of each period</time_frame>
    <description>Lambda (z) is the first-order rate constant associated with the terminal portion of the curve, determined as the negative slope of the terminal log-linear phase of the drug concentration-time curve.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Last Quantifiable Plasma Concentration (T [last]) of abiraterone acetate</measure>
    <time_frame>Pre-dose; 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours post-dose on Day 1 of each period</time_frame>
    <description>Time to last quantifiable plasma concentration of abiraterone acetate will be observed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)</measure>
    <time_frame>Screening up to follow-up (5 to 7 days after last dose administration)</time_frame>
    <description>An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.</description>
  </secondary_outcome>
  <number_of_arms>6</number_of_arms>
  <enrollment type="Actual">102</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Sequence 1 (ABC)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive a single oral 1000 milligram [mg] dose of abiraterone acetate in all 3 periods under fasted conditions as: Treatment A (current commercial formulation, 4*250 mg uncoated tablets) in Period 1, Treatment B (current commercial formulation, 4*250 mg coated tablets) in Period 2 and Treatment C (new composition, 2*500 mg coated tablets) in Period 3.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sequence 2 (BCA)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive a single oral 1000 milligram [mg] dose of abiraterone acetate in all 3 periods under fasted conditions as: Treatment B (current commercial formulation, 4*250 mg coated tablets) in Period 1, Treatment C (new composition, 2*500 mg coated tablets) in Period 2 and Treatment A (current commercial formulation, 4*250 mg uncoated tablets) in Period 3.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sequence 3 (CAB)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive a single oral 1000 milligram [mg] dose of abiraterone acetate in all 3 periods under fasted conditions as: Treatment C (new composition, 2*500 mg coated tablets) in Period 1, Treatment A (current commercial formulation, 4*250 mg uncoated tablets) in Period 2 and Treatment B (current commercial formulation, 4*250 mg coated tablets) in Period 3.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sequence 4 (ACB)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive a single oral 1000 milligram [mg] dose of abiraterone acetate in all 3 periods under fasted conditions as: Treatment A (current commercial formulation, 4*250 mg uncoated tablets) in Period 1, Treatment C (new composition, 2*500 mg coated tablets) in Period 2 and Treatment B (current commercial formulation, 4*250 mg coated tablets) in Period 3.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sequence 5 (BAC)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive a single oral 1000 milligram [mg] dose of abiraterone acetate in all 3 periods under fasted conditions as: Treatment B (current commercial formulation, 4*250 mg coated tablets) in Period 1, Treatment A (current commercial formulation, 4*250 mg uncoated tablets) in Period 2 and Treatment C (new composition, 2*500 mg coated tablets) in Period 3.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sequence 6 (CBA)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive a single oral 1000 milligram [mg] dose of abiraterone acetate in all 3 periods under fasted conditions as: Treatment C (new composition, 2*500 mg coated tablets) in Period 1, Treatment B (current commercial formulation, 4*250 mg coated tablets) in Period 2 and Treatment A (current commercial formulation, 4*250 mg uncoated tablets) in Period 3.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Abiraterone acetate (Treatment A)</intervention_name>
    <description>Participants will receive a single oral 1000 mg dose of abiraterone acetate as Treatment A (current commercial formulation, 4*250 mg uncoated tablets) under fasted conditions on Day 1 of period as specified in the protocol.</description>
    <arm_group_label>Sequence 1 (ABC)</arm_group_label>
    <arm_group_label>Sequence 2 (BCA)</arm_group_label>
    <arm_group_label>Sequence 3 (CAB)</arm_group_label>
    <arm_group_label>Sequence 4 (ACB)</arm_group_label>
    <arm_group_label>Sequence 5 (BAC)</arm_group_label>
    <arm_group_label>Sequence 6 (CBA)</arm_group_label>
    <other_name>JNJ-212082</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Abiraterone acetate (Treatment B)</intervention_name>
    <description>Participants will receive a single oral 1000 mg dose of abiraterone acetate as Treatment B (current commercial formulation, 4*250 mg coated tablets) under fasted conditions on Day 1 of period as specified in the protocol.</description>
    <arm_group_label>Sequence 1 (ABC)</arm_group_label>
    <arm_group_label>Sequence 2 (BCA)</arm_group_label>
    <arm_group_label>Sequence 3 (CAB)</arm_group_label>
    <arm_group_label>Sequence 4 (ACB)</arm_group_label>
    <arm_group_label>Sequence 5 (BAC)</arm_group_label>
    <arm_group_label>Sequence 6 (CBA)</arm_group_label>
    <other_name>JNJ-212082</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Abiraterone acetate (Treatment B)</intervention_name>
    <description>Participants will receive a single oral 1000 mg dose of abiraterone acetate as Treatment C (new composition, 2*500 mg coated tablets) under fasted conditions on Day 1 of period as specified in the protocol.</description>
    <arm_group_label>Sequence 1 (ABC)</arm_group_label>
    <arm_group_label>Sequence 2 (BCA)</arm_group_label>
    <arm_group_label>Sequence 3 (CAB)</arm_group_label>
    <arm_group_label>Sequence 4 (ACB)</arm_group_label>
    <arm_group_label>Sequence 5 (BAC)</arm_group_label>
    <arm_group_label>Sequence 6 (CBA)</arm_group_label>
    <other_name>JNJ-212082</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  If sexually active, participants must always use a condom during the study and for 1&#xD;
             week after last intake of study drug. If sexually active with a pregnant woman or&#xD;
             woman of child-bearing potential, participants must agree to abstain from intercourse&#xD;
             during the study and for 1 week after last intake of study drug. Participants should&#xD;
             not donate sperm during the study and for 1 week after receiving the last dose of&#xD;
             study drug&#xD;
&#xD;
          -  Body mass index (BMI; weight [kilogram(kg)]/height^2 [meter square (m^2)]) between&#xD;
             18.5 and 30.0 kg/m^2, (inclusive), and body weight not less than 50 kg&#xD;
&#xD;
          -  Blood pressure (after the participants is supine for 5 minutes) between 90 and 140&#xD;
             millimeter of mercury (mmHg) systolic, inclusive, and no higher than 90 mmHg diastolic&#xD;
             at Screening&#xD;
&#xD;
          -  A 12-lead electrocardiogram (ECG) consistent with normal cardiac conduction and&#xD;
             function at Screening as specified in the protocol&#xD;
&#xD;
          -  Non-smoker, no history of smoking or use of nicotine-containing substances within the&#xD;
             previous 2 months, as determined by medical history or participant's verbal report&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of or current clinically significant medical illness including (but not&#xD;
             limited to) cardiac arrhythmias or other cardiac disease, hematologic disease,&#xD;
             coagulation disorders (including any abnormal bleeding or blood dyscrasias), lipid&#xD;
             abnormalities, significant pulmonary disease, including bronchospastic respiratory&#xD;
             disease, diabetes mellitus, renal or hepatic insufficiency, thyroid disease,&#xD;
             neurologic or psychiatric disease, infection, or any other illness that the&#xD;
             investigator considers should exclude the participants or that could interfere with&#xD;
             the interpretation of the study results&#xD;
&#xD;
          -  Clinically significant abnormal values for hematology or clinical chemistry at&#xD;
             Screening&#xD;
&#xD;
          -  Presence of sexual dysfunction (abnormal libido, erectile dysfunction, etc.) or any&#xD;
             medical condition that would affect sexual function&#xD;
&#xD;
          -  Use of any prescription or nonprescription medication (including vitamins and herbal&#xD;
             supplements), except for acetaminophen, within 14 days before the first dose of the&#xD;
             study drug is scheduled through study completion&#xD;
&#xD;
          -  History of, or a reason to believe a participants has a history of drug or alcohol&#xD;
             abuse within the past 5 years&#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>Tempe</city>
        <state>Arizona</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2016</verification_date>
  <study_first_submitted>August 29, 2014</study_first_submitted>
  <study_first_submitted_qc>September 2, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 3, 2014</study_first_posted>
  <last_update_submitted>January 18, 2016</last_update_submitted>
  <last_update_submitted_qc>January 18, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 20, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Healthy,</keyword>
  <keyword>Abiraterone Acetate,</keyword>
  <keyword>Bioequivalence.</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/NCT02230046
org study id: CR105286
secondary id: 212082PCR1007
nct id: NCT02230046
lead sponsor: 
has dmc: No
The purpose of this study is to determine the bioequivalence (equivalence of pharmacokinetic
      parameters) of 2 abiraterone acetate coated tablet formulations with respect to the current
      commercial abiraterone acetate uncoated tablet formulation under fasted (without eating or
      drinking) conditions in healthy male participants.
This is a Phase 1, randomized (study medication assigned to participants by chance),
      open-label (all people know the identity of the intervention), single-center, single-dose and
      3-way Crossover (the same medications provided to all participants but in different sequence)
      pivotal study to determine the bioequivalence of 2 abiraterone acetate coated tablet
      formulations with respect to the current commercial abiraterone acetate uncoated tablet
      formulation. Approximately 102 healthy male participants will participate in this study.
      Participants will be randomly assigned to 1 of 6 treatment sequences. The study will consist
      of 3 parts: Screening Phase (within 21 days before the first study drug administration of the
      first period), an open-label treatment Phase consisting of 3 single-dose treatment periods
      (45 days) and follow-up Phase (5 to 7 days after the last study procedure). The total study
      duration for each participant will be from 45 days to a maximum of 61 days. Participants will
      receive a single oral 1000 milligram (mg) dose of abiraterone acetate under fasted conditions
      either as Treatment A (current commercial formulation, uncoated), Treatment B (current
      commercial formulation, coated) or Treatment C (new composition, coated). Bioequivalence will
      be primarily evaluated by pharmacokinetic parameters. Participants' safety will be monitored
      throughout the study.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Maximum Plasma Concentration (Cmax) of abiraterone acetate
time frame: Pre-dose; 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours post-dose on Day 1 of each period
description: The Cmax is the maximum observed plasma concentration of abiraterone acetate.
measure: Area Under the Plasma Concentration-Time Curve From Time 0 to Time of the Last Quantifiable Concentration (AUC [0-last]) of abiraterone acetate
time frame: Pre-dose; 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours post-dose on Day 1 of each period
description: The AUC (0-last) is the area under the plasma abiraterone acetate concentration-time curve from time zero to time of the last quantifiable concentration.
measure: Area Under the Plasma Concentration-Time Curve From Time 0 to Infinite Time (AUC [0-infinity]) of abiraterone acetate
time frame: Pre-dose; 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours post-dose on Day 1 of each period
description: The AUC (0-infinity) is the area under the plasma abiraterone acetate concentration-time curve from time 0 to infinite time, calculated as the sum of AUC (0-last) and C(last)/lambda(z), in which AUC(0-last) is area under the plasma abiraterone acetate concentration-time curve from time zero to time of the last quantifiable concentration, C(last) is the last observed quantifiable concentration and lambda(z) is elimination rate constant.
measure: Time to Reach the Maximum Plasma Concentration (Tmax) of abiraterone acetate
time frame: Pre-dose; 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours post-dose on Day 1 of each period
description: The Tmax is the time to reach the maximum observed plasma concentration of abiraterone acetate.
measure: Percentage of Area Under the Plasma Concentration-Time Curve Extrapolated From Last Measurable Concentration to Infinite Time (%AUC, ext) of abiraterone acetate
time frame: Pre-dose; 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours post-dose on Day 1 of each period
description: Percentage of area under the plasma abiraterone acetate concentration-time curve extrapolated from last measurable concentration to infinite time (%AUC, ext) is calculated using formula: ((AUC [0-infinity] minus- AUC [0-last)]/AUC [0-infinity])*100.
measure: Elimination Half-Life (t 1/2, Lambda) of abiraterone acetate
time frame: Pre-dose; 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours post-dose on Day 1 of each period
description: Elimination half-life (t 1/2, Lambda) is associated with the terminal slope (lambda [z]) of the semi logarithmic drug concentration-time curve, calculated as 0.693/lambda(z).
measure: Rate Constant (Lambda [z]) of abiraterone acetate
time frame: Pre-dose; 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours post-dose on Day 1 of each period
description: Lambda (z) is the first-order rate constant associated with the terminal portion of the curve, determined as the negative slope of the terminal log-linear phase of the drug concentration-time curve.
measure: Time to Last Quantifiable Plasma Concentration (T [last]) of abiraterone acetate
time frame: Pre-dose; 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours post-dose on Day 1 of each period
description: Time to last quantifiable plasma concentration of abiraterone acetate will be observed.
measure: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
time frame: Screening up to follow-up (5 to 7 days after last dose administration)
description: An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
arm group label: Sequence 1 (ABC)
arm group type: Experimental
description: Participants will receive a single oral 1000 milligram [mg] dose of abiraterone acetate in all 3 periods under fasted conditions as: Treatment A (current commercial formulation, 4*250 mg uncoated tablets) in Period 1, Treatment B (current commercial formulation, 4*250 mg coated tablets) in Period 2 and Treatment C (new composition, 2*500 mg coated tablets) in Period 3.
arm group label: Sequence 2 (BCA)
arm group type: Experimental
description: Participants will receive a single oral 1000 milligram [mg] dose of abiraterone acetate in all 3 periods under fasted conditions as: Treatment B (current commercial formulation, 4*250 mg coated tablets) in Period 1, Treatment C (new composition, 2*500 mg coated tablets) in Period 2 and Treatment A (current commercial formulation, 4*250 mg uncoated tablets) in Period 3.
arm group label: Sequence 3 (CAB)
arm group type: Experimental
description: Participants will receive a single oral 1000 milligram [mg] dose of abiraterone acetate in all 3 periods under fasted conditions as: Treatment C (new composition, 2*500 mg coated tablets) in Period 1, Treatment A (current commercial formulation, 4*250 mg uncoated tablets) in Period 2 and Treatment B (current commercial formulation, 4*250 mg coated tablets) in Period 3.
arm group label: Sequence 4 (ACB)
arm group type: Experimental
description: Participants will receive a single oral 1000 milligram [mg] dose of abiraterone acetate in all 3 periods under fasted conditions as: Treatment A (current commercial formulation, 4*250 mg uncoated tablets) in Period 1, Treatment C (new composition, 2*500 mg coated tablets) in Period 2 and Treatment B (current commercial formulation, 4*250 mg coated tablets) in Period 3.
arm group label: Sequence 5 (BAC)
arm group type: Experimental
description: Participants will receive a single oral 1000 milligram [mg] dose of abiraterone acetate in all 3 periods under fasted conditions as: Treatment B (current commercial formulation, 4*250 mg coated tablets) in Period 1, Treatment A (current commercial formulation, 4*250 mg uncoated tablets) in Period 2 and Treatment C (new composition, 2*500 mg coated tablets) in Period 3.
arm group label: Sequence 6 (CBA)
arm group type: Experimental
description: Participants will receive a single oral 1000 milligram [mg] dose of abiraterone acetate in all 3 periods under fasted conditions as: Treatment C (new composition, 2*500 mg coated tablets) in Period 1, Treatment B (current commercial formulation, 4*250 mg coated tablets) in Period 2 and Treatment A (current commercial formulation, 4*250 mg uncoated tablets) in Period 3.
intervention type: Drug
intervention name: Abiraterone acetate (Treatment A)
description: Participants will receive a single oral 1000 mg dose of abiraterone acetate as Treatment A (current commercial formulation, 4*250 mg uncoated tablets) under fasted conditions on Day 1 of period as specified in the protocol.
arm group label: Sequence 1 (ABC)
arm group label: Sequence 2 (BCA)
arm group label: Sequence 3 (CAB)
arm group label: Sequence 4 (ACB)
arm group label: Sequence 5 (BAC)
arm group label: Sequence 6 (CBA)
other name: JNJ-212082
intervention type: Drug
intervention name: Abiraterone acetate (Treatment B)
description: Participants will receive a single oral 1000 mg dose of abiraterone acetate as Treatment B (current commercial formulation, 4*250 mg coated tablets) under fasted conditions on Day 1 of period as specified in the protocol.
arm group label: Sequence 1 (ABC)
arm group label: Sequence 2 (BCA)
arm group label: Sequence 3 (CAB)
arm group label: Sequence 4 (ACB)
arm group label: Sequence 5 (BAC)
arm group label: Sequence 6 (CBA)
other name: JNJ-212082
intervention type: Drug
intervention name: Abiraterone acetate (Treatment B)
description: Participants will receive a single oral 1000 mg dose of abiraterone acetate as Treatment C (new composition, 2*500 mg coated tablets) under fasted conditions on Day 1 of period as specified in the protocol.
arm group label: Sequence 1 (ABC)
arm group label: Sequence 2 (BCA)
arm group label: Sequence 3 (CAB)
arm group label: Sequence 4 (ACB)
arm group label: Sequence 5 (BAC)
arm group label: Sequence 6 (CBA)
other name: JNJ-212082
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: United States
responsible party type: Sponsor
mesh term: Abiraterone Acetate