<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/NCT03802682</url>
  </required_header>
  <id_info>
    <org_study_id>CR108562</org_study_id>
    <secondary_id>2018-003774-27</secondary_id>
    <secondary_id>56021927PCR1024</secondary_id>
    <nct_id>NCT03802682</nct_id>
  </id_info>
  <brief_title>A Study of Apalutamide Administered Orally as Whole Tablets and as a Mixture in Applesauce in Healthy Participants</brief_title>
  <official_title>A Randomized, Open-label, Two-way, Crossover Study to Evaluate the Relative Bioavailability of Apalutamide Administered Orally as Whole Tablets and as a Mixture in Applesauce in Healthy 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>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine the bioavailability of apalutamide tablets&#xD;
      administered orally as dispersed tablets mixed in applesauce relative to whole tablets under&#xD;
      fasting conditions in healthy male participants.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 11, 2019</start_date>
  <completion_date type="Actual">April 11, 2019</completion_date>
  <primary_completion_date type="Actual">April 11, 2019</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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Maximum Plasma Concentration (Cmax)</measure>
    <time_frame>Day 1: Predose, 30 minutes, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, and 168 hours postdose</time_frame>
    <description>Cmax is the maximum observed plasma concentration.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Area Under the Plasma Concentration-time Curve From Time 0 to 72 hours (h) (AUC [0-72h]</measure>
    <time_frame>Day 1: Predose, 30 minutes, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, and 168 hours postdose</time_frame>
    <description>AUC(0-72h) is area under plasma concentration-time curve from time zero to 72 hours.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Area Under the Plasma Concentration-time Curve From Time 0 to 168 hours (AUC[0-168h])</measure>
    <time_frame>Day 1: Predose, 30 minutes, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, and 168 hours postdose</time_frame>
    <description>AUC(0-168h) is area under plasma concentration-time curve from time zero to 168 hours.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Adverse Events as a Measure of Safety and Tolerability</measure>
    <time_frame>Approximately 84 days</time_frame>
    <description>An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Treatment Sequence AB</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive a single dose of apalutamide 240 milligram (mg) (4*60 mg tablets) swallowed whole under fasted conditions on Day 1 of Treatment Period 1 (Treatment A [reference]) followed by a single dose of apalutamide 240 mg (4*60 mg tablets) as a dispersed mixture in applesauce under fasted conditions on Day 1 of Treatment Period 2 (Treatment B [test]). Study treatment periods will be separated by a washout interval of at least 42 days and no more than 56 days between doses.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment Sequence BA</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive a single dose of apalutamide 240 mg (4*60 mg tablets) as a dispersed mixture in applesauce under fasted conditions on Day 1 of Treatment Period 1 (Treatment B [test]) followed by a single dose of apalutamide 240 mg (4*60 mg tablets) swallowed whole under fasted conditions on Day 1 of Treatment Period 2 (Treatment A [reference]). Study treatment periods will be separated by a washout interval of at least 42 days and no more than 56 days between doses.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Apalutamide</intervention_name>
    <description>Participants will receive apalutamide 240 mg as a whole tablets administered orally (Treatment A) or as a dispersed mixture in applesauce (Treatment B) under fasted condition.</description>
    <arm_group_label>Treatment Sequence AB</arm_group_label>
    <arm_group_label>Treatment Sequence BA</arm_group_label>
    <other_name>JNJ-56021927 and ARN-509</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Must agree not to donate sperm for the purpose of reproduction during the study and&#xD;
             for a minimum of 3 months after receiving the last dose of study drug&#xD;
&#xD;
          -  Body mass index (BMI; weight [Kilogram{kg}/height^2 [meter {m}^2]) between 18 and 30&#xD;
             kg/m^2 (inclusive), and body weight not less than 50 kg&#xD;
&#xD;
          -  Blood pressure (after the participant is sitting for at least 5 minutes) between 90&#xD;
             and 140 millimeters of Mercury (mmHg) systolic, inclusive, and no higher than 90 mmHg&#xD;
             diastolic. If blood pressure is out of range, up to 2 repeated assessments are&#xD;
             permitted&#xD;
&#xD;
          -  Nonsmoker within the last 2 months (calculated from the first dosing)&#xD;
&#xD;
          -  A 12-lead Electrocardiogram (ECG) at screening consistent with normal cardiac&#xD;
             conduction and function, including: (1) Sinus rhythm; (2) Pulse rate between 40 and&#xD;
             100 beats per minute (bpm); (3) QTc interval less than or equal to (&lt;=) 450&#xD;
             milliseconds (ms) (corrected Fridericia; QTcF); (4) QRS interval of less than (&lt;) 120&#xD;
             ms; (5) PR interval &lt;210 ms; and (6) Morphology consistent with healthy cardiac&#xD;
             conduction and function&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Clinically significant abnormal values for hematology or clinical chemistry at&#xD;
             screening or at admission to the study center as deemed appropriate by the&#xD;
             investigator&#xD;
&#xD;
          -  Clinically significant abnormal physical examination, vital signs, or 12 lead&#xD;
             electrocardiogram (ECG) at screening or at admission to the study center as deemed&#xD;
             appropriate by the investigator&#xD;
&#xD;
          -  Has a history of significant multiple and/or severe allergies, or has had an&#xD;
             anaphylactic reaction or significant intolerability to prescription or&#xD;
             non-prescription drugs or food including to excipients of apalutamide or to apple or&#xD;
             applesauce&#xD;
&#xD;
          -  History of malignancy within 5 years before screening (exceptions are squamous and&#xD;
             basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy,&#xD;
             which is considered cured with minimal risk of recurrence)&#xD;
&#xD;
          -  Use of any prescription or nonprescription medication (including vitamins and herbal&#xD;
             supplements), except for paracetamol, within 14 days before the first dose of the&#xD;
             study drug is scheduled until completion of the study&#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>
      <name>Clinical Pharmacology Unit</name>
      <address>
        <city>Merksem</city>
        <zip>2170</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <link>
    <url>https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217051&amp;amp;parentIdentifier=CR108562&amp;amp;attachmentIdentifier=9e043bf8-0e10-4797-9adb-2079ca785ec7&amp;amp;fileName=REDACTED_56021927PCR1024_CSR_Synopsis.pdf&amp;amp;versionIdentifier=</url>
    <description>A Randomized, Open-label, Two-way, Crossover Study to Evaluate the Relative Bioavailability of Apalutamide Administered Orally as Whole Tablets and as a Mixture in Applesauce in Healthy Subjects</description>
  </link>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>January 11, 2019</study_first_submitted>
  <study_first_submitted_qc>January 11, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 14, 2019</study_first_posted>
  <last_update_submitted>August 7, 2020</last_update_submitted>
  <last_update_submitted_qc>August 7, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 10, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>The data sharing policy of the Janssen Pharmaceutical Companies of Johnson &amp; Johnson is available at www.janssen.com/clinical-trials/transparency.&#xD;
As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu</ipd_description>
    <ipd_url>https://www.janssen.com/clinical-trials/transparency</ipd_url>
  </patient_data>
  <!-- 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/NCT03802682
org study id: CR108562
secondary id: 2018-003774-27
secondary id: 56021927PCR1024
nct id: NCT03802682
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
The purpose of this study is to determine the bioavailability of apalutamide tablets
      administered orally as dispersed tablets mixed in applesauce relative to whole tablets under
      fasting conditions in healthy male participants.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Other
masking: None (Open Label)
measure: Maximum Plasma Concentration (Cmax)
time frame: Day 1: Predose, 30 minutes, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, and 168 hours postdose
description: Cmax is the maximum observed plasma concentration.
measure: Area Under the Plasma Concentration-time Curve From Time 0 to 72 hours (h) (AUC [0-72h]
time frame: Day 1: Predose, 30 minutes, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, and 168 hours postdose
description: AUC(0-72h) is area under plasma concentration-time curve from time zero to 72 hours.
measure: Area Under the Plasma Concentration-time Curve From Time 0 to 168 hours (AUC[0-168h])
time frame: Day 1: Predose, 30 minutes, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, and 168 hours postdose
description: AUC(0-168h) is area under plasma concentration-time curve from time zero to 168 hours.
measure: Number of Participants With Adverse Events as a Measure of Safety and Tolerability
time frame: Approximately 84 days
description: An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
arm group label: Treatment Sequence AB
arm group type: Experimental
description: Participants will receive a single dose of apalutamide 240 milligram (mg) (4*60 mg tablets) swallowed whole under fasted conditions on Day 1 of Treatment Period 1 (Treatment A [reference]) followed by a single dose of apalutamide 240 mg (4*60 mg tablets) as a dispersed mixture in applesauce under fasted conditions on Day 1 of Treatment Period 2 (Treatment B [test]). Study treatment periods will be separated by a washout interval of at least 42 days and no more than 56 days between doses.
arm group label: Treatment Sequence BA
arm group type: Experimental
description: Participants will receive a single dose of apalutamide 240 mg (4*60 mg tablets) as a dispersed mixture in applesauce under fasted conditions on Day 1 of Treatment Period 1 (Treatment B [test]) followed by a single dose of apalutamide 240 mg (4*60 mg tablets) swallowed whole under fasted conditions on Day 1 of Treatment Period 2 (Treatment A [reference]). Study treatment periods will be separated by a washout interval of at least 42 days and no more than 56 days between doses.
intervention type: Drug
intervention name: Apalutamide
description: Participants will receive apalutamide 240 mg as a whole tablets administered orally (Treatment A) or as a dispersed mixture in applesauce (Treatment B) under fasted condition.
arm group label: Treatment Sequence AB
arm group label: Treatment Sequence BA
other name: JNJ-56021927 and ARN-509
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: Belgium
url: https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217051&amp;parentIdentifier=CR108562&amp;attachmentIdentifier=9e043bf8-0e10-4797-9adb-2079ca785ec7&amp;fileName=REDACTED_56021927PCR1024_CSR_Synopsis.pdf&amp;versionIdentifier=
description: A Randomized, Open-label, Two-way, Crossover Study to Evaluate the Relative Bioavailability of Apalutamide Administered Orally as Whole Tablets and as a Mixture in Applesauce in Healthy Subjects
responsible party type: Sponsor
sharing ipd: Yes
ipd description: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency.
As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
ipd url: https://www.janssen.com/clinical-trials/transparency