<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/NCT04448964</url>
  </required_header>
  <id_info>
    <org_study_id>CR108803</org_study_id>
    <secondary_id>2020-000565-17</secondary_id>
    <secondary_id>70033093THR1005</secondary_id>
    <nct_id>NCT04448964</nct_id>
  </id_info>
  <brief_title>A Study of JNJ-70033093 in Healthy Participants</brief_title>
  <official_title>A Randomized, Open-Label, 3-way Cross-over (Part 1) and 2-way Cross-over (Part 2) Study in Healthy Participants to Evaluate the Relative Bioavailability and the Food Effect of an Oral Tablet Formulation Relative to a Capsule Formulation of JNJ-70033093</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Janssen Research &amp; Development, LLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Bristol-Myers Squibb</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </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 evaluate the pharmacokinetics (PK) and relative&#xD;
      bioavailability of a single dose of JNJ-70033093 spray dried dispersion (SDD) tablets&#xD;
      compared with JNJ-70033093 SDD granule capsules in healthy participants under fasting&#xD;
      conditions in Part 1 and 2 and to assess the effect of food on the bioavailability of a&#xD;
      single dose of JNJ-70033093 SDD tablets in Part 1.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 26, 2020</start_date>
  <completion_date type="Actual">November 14, 2020</completion_date>
  <primary_completion_date type="Actual">November 14, 2020</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>Part 1 and 2: Maximum Observed Plasma Concentration (Cmax) of JNJ-70033093</measure>
    <time_frame>Up to 72 hours post dose</time_frame>
    <description>Cmax is defined as maximum observed plasma concentration after administration of JNJ-70033093.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 1 and 2: Area Under the Plasma Concentration-time Curve from Time Zero to Time of Last Quantifiable Concentration (AUC [0-last]) of JNJ-70033093</measure>
    <time_frame>Up to 72 hours post dose</time_frame>
    <description>AUC (0-last) is defined as area under the plasma concentration-time curve from time 0 to time of last quantifiable concentration after administration of JNJ-70033093.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 1 and 2: Area Under the Plasma Concentration-time Curve from Time Zero to Infinity (AUC [0-inf]) of JNJ-70033093</measure>
    <time_frame>Up to 72 hours post dose</time_frame>
    <description>AUC (0-inf) is defined as area under the plasma concentration-time curve from time 0 to infinity after administration of JNJ-70033093.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 1 and 2: Time to Reach Maximum Observed Plasma Concentration (Tmax) of JNJ-70033093</measure>
    <time_frame>Up to 72 hours post dose</time_frame>
    <description>Tmax is defined time to reach the maximum observed plasma concentration.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 1 and 2: Apparent Elimination Half-life (t1/2) of JNJ-70033093</measure>
    <time_frame>Up to 72 hours post dose</time_frame>
    <description>Apparent elimination half-life associated with the terminal slope lambda(z) of the semilogarithmic drug concentration-time curve.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Part 1 and 2: Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability</measure>
    <time_frame>Up to 2 Months</time_frame>
    <description>An AE is any untoward medical occurrence in a clinical study participant administered a investigational or non-investigational medicinal product. An AE does not necessarily have a causal relationship with the treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part 1 and 2: Number of Participants with Clinically Significant Changes in Vital Signs</measure>
    <time_frame>Up to 2 Months</time_frame>
    <description>Number of participants with clinically significant changes in vital signs including temperature (axillary), pulse rate, respiratory rate, blood pressure will be reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part 1 and 2: Number of Participants with Abnormalities in Electrocardiogram (ECG)</measure>
    <time_frame>Up to 2 Months</time_frame>
    <description>Number of participants with abnormalities in ECG will be reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part 1 and 2: Number of Participants with Clinically Significant Changes in Physical Examination</measure>
    <time_frame>Up to 2 Months</time_frame>
    <description>Number of participants with clinically significant changes in physical examination including height and body weight will be reported.</description>
  </secondary_outcome>
  <number_of_arms>8</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Part 1: Treatment Sequence ABC</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive a single dose of JNJ-70033093 spray-dried dispersion (SDD) tablet under fasted conditions (Treatment A) in Treatment Period 1, followed by JNJ-70033093 SDD tablet in fed conditions (Treatment B) in Treatment Period 2, and then JNJ-70033093 SDD granule capsule under fasted conditions (Treatment C) in Treatment Period 3 on Day 1 of each Period during Part 1. There will be a wash-out period of at least 5 days and up to 2 weeks between Day 1 of each treatment period.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part 1: Treatment Sequence BCA</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive Treatment B in Treatment Period 1, followed by Treatment C in Treatment Period 2, and then Treatment A in Treatment Period 3 on Day 1 of each Period during Part 1. There will be a wash-out period of at least 5 days and up to 2 weeks between Day 1 of each treatment period.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part 1: Treatment Sequence CAB</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive Treatment C in Treatment Period 1, followed by Treatment A in Treatment Period 2, and then Treatment B in Treatment Period 3 on Day 1 of each Period during Part 1. There will be a wash-out period of at least 5 days and up to 2 weeks between Day 1 of each treatment period.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part 1: Treatment Sequence ACB</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive Treatment A in Treatment Period 1, followed by Treatment C in Treatment Period 2, and then Treatment B in Treatment Period 3 on Day 1 of each Period during Part 1. There will be a wash-out period of at least 5 days and up to 2 weeks between Day 1 of each treatment period.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part 1: Treatment Sequence BAC</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive Treatment B in Treatment Period 1, followed by Treatment A in Treatment Period 2, and then Treatment C in Treatment Period 3 on Day 1 of each Period during Part 1. There will be a wash-out period of at least 5 days and up to 2 weeks between Day 1 of each treatment period.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part 1: Treatment Sequence CBA</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive Treatment C in Treatment Period 1, followed by Treatment B in Treatment Period 2, and then Treatment A in Treatment Period 3 on Day 1 of each Period during Part 1. There will be a wash-out period of at least 5 days and up to 2 weeks between Day 1 of each treatment period.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part 2: Treatment Sequence DE</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive Treatment D (single dose of JNJ-70033093 SDD tablet in fed conditions) in Treatment Period 1, and then Treatment E (single dose of JNJ-70033093 SDD granule capsule under fasted conditions) in Treatment Period 2 on Day 1 of each Period during Part 2. There will be a wash-out period of at least 5 days and up to 2 weeks between Day 1 of each treatment period.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part 2: Treatment Sequence ED</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive Treatment E in Treatment Period 1, and then Treatment D in Treatment Period 2 on Day 1 of each Period during Part 2. There will be a wash-out period of at least 5 days and up to 2 weeks between Day 1 of each treatment period.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>JNJ-70033093</intervention_name>
    <description>JNJ-70033093 will be administered orally as per assigned treatment sequence.</description>
    <arm_group_label>Part 1: Treatment Sequence ABC</arm_group_label>
    <arm_group_label>Part 1: Treatment Sequence ACB</arm_group_label>
    <arm_group_label>Part 1: Treatment Sequence BAC</arm_group_label>
    <arm_group_label>Part 1: Treatment Sequence BCA</arm_group_label>
    <arm_group_label>Part 1: Treatment Sequence CAB</arm_group_label>
    <arm_group_label>Part 1: Treatment Sequence CBA</arm_group_label>
    <arm_group_label>Part 2: Treatment Sequence DE</arm_group_label>
    <arm_group_label>Part 2: Treatment Sequence ED</arm_group_label>
    <other_name>BMS-986177</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy on the basis of physical examination, medical history, vital signs, and&#xD;
             12-lead electrocardiogram (ECG) performed at screening and on Day -1 of Treatment&#xD;
             Period 1. If there are abnormalities, the investigator may decide that the&#xD;
             abnormalities or deviations from normal are not clinically significant, in which case&#xD;
             the participant may be included&#xD;
&#xD;
          -  Healthy on the basis of safety laboratory tests performed at screening and on Day -1&#xD;
             of Period 1. If the results of the safety laboratory tests are outside the normal&#xD;
             reference ranges, the participant may be included only if the investigator judges the&#xD;
             abnormalities or deviations from normal to be not clinically significant&#xD;
&#xD;
          -  If a woman, must have a negative highly sensitive serum (beta-human chorionic&#xD;
             gonadotropin [beta-hCG]) at screening and urine pregnancy test on Day 1 of each&#xD;
             treatment period&#xD;
&#xD;
          -  Body mass index (BMI) between 18.0 and 30.0 kilogram per meter square (kg/m^2,&#xD;
             inclusive (BMI = weight/height^2), and body weight not less than 50 kg at screening&#xD;
&#xD;
          -  After being supine for 5 minutes, systolic blood pressure between 90 and 140&#xD;
             millimeter of Mercury (mmHg), inclusive; and no higher than 90 mmHg diastolic blood&#xD;
             pressure at screening and on Day -1 of Treatment Period 1&#xD;
&#xD;
          -  Must sign an ICF indicating that they understand the purpose of, and procedures&#xD;
             required for the study and is willing to participate in the study&#xD;
&#xD;
          -  Before randomization, a woman must be either: a.) Not of childbearing potential&#xD;
             (Postmenopausal- no menses for 12 months without an alternative medical cause and&#xD;
             Permanently sterile- include hysterectomy, bilateral salpingectomy, bilateral tubal&#xD;
             occlusion/ligation procedures, and bilateral oophorectomy); b.) of childbearing&#xD;
             potential and practicing a highly effective method of contraception for at least 3&#xD;
             months prior to the study entry and agrees to remain on a highly effective method of&#xD;
             contraception throughout the study and for at least 34 days after the last dose of&#xD;
             study drug&#xD;
&#xD;
          -  During the study, a man who is sexually active with a woman of childbearing potential&#xD;
             or with a woman who is pregnant must agree to use a barrier method of contraception&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of any known illness that, in the opinion of the investigator, might confound&#xD;
             the results of the study or pose an additional risk in administering study drug to the&#xD;
             participant or that could prevent, limit or confound the protocol specified&#xD;
             assessments.&#xD;
&#xD;
          -  History of any clinically significant drug or food allergies (such as anaphylaxis or&#xD;
             hepatotoxicity) and known allergy to the study drugs or any of the excipients of the&#xD;
             formulation&#xD;
&#xD;
          -  History of allergy to or unwillingness to consume any component of the standardized&#xD;
             high-fat breakfast menu to be provided in this study&#xD;
&#xD;
          -  Use of any systemic strong cytochrome P450 P glycoprotein ([CYP] 3A4/P-gp) inducers&#xD;
             (example, [rifampin]) or inhibitors (example, [itraconazole]) within 4 weeks before&#xD;
             the first dose of the study drug&#xD;
&#xD;
          -  Participants with current hepatitis B infection (confirmed by hepatitis B surface&#xD;
             antigen [HBsAg]), or hepatitis C infection (confirmed by hepatitis C virus [HCV]&#xD;
             antibody), or human immunodeficiency virus type 1 (HIV-1) or human immunodeficiency&#xD;
             virus type 2 (HIV-2) infection at study screening&#xD;
&#xD;
          -  Clinically significant abnormal values for hematology, coagulation, clinical chemistry&#xD;
             or urinalysis at screening or on Day -1 of Treatment Period 1 as determined by the&#xD;
             investigator or appropriate designee&#xD;
&#xD;
          -  Use of any prescription or nonprescription medication (including vitamins and herbal&#xD;
             supplements), except for hormonal contraceptives, hormone replacement therapy and&#xD;
             paracetamol (acetaminophen) within 14 days before the first dose of the study drug&#xD;
             until completion of the study&#xD;
&#xD;
          -  Any of the following on a 12-lead electrocardiogram (ECG) and the assessment of QT&#xD;
             interval, confirmed by repeat at screening and Day -1 of Treatment Period 1: a.) Heart&#xD;
             rate greater than (&gt;) 100 beats per minute (bpm); b.) PR &gt; 210 milliseconds (ms); c.)&#xD;
             QRS &gt; 120 ms; d.) QT corrected according to Fridericia's formula (QTcF) &gt; 450 ms for&#xD;
             male and &gt; 470 ms for female&#xD;
      </textblock>
    </criteria>
    <gender>All</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>
  <verification_date>December 2020</verification_date>
  <study_first_submitted>June 25, 2020</study_first_submitted>
  <study_first_submitted_qc>June 25, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 26, 2020</study_first_posted>
  <last_update_submitted>December 11, 2020</last_update_submitted>
  <last_update_submitted_qc>December 11, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">December 14, 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. 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/NCT04448964
org study id: CR108803
secondary id: 2020-000565-17
secondary id: 70033093THR1005
nct id: NCT04448964
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
The purpose of this study is to evaluate the pharmacokinetics (PK) and relative
      bioavailability of a single dose of JNJ-70033093 spray dried dispersion (SDD) tablets
      compared with JNJ-70033093 SDD granule capsules in healthy participants under fasting
      conditions in Part 1 and 2 and to assess the effect of food on the bioavailability of a
      single dose of JNJ-70033093 SDD tablets in Part 1.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Other
masking: None (Open Label)
measure: Part 1 and 2: Maximum Observed Plasma Concentration (Cmax) of JNJ-70033093
time frame: Up to 72 hours post dose
description: Cmax is defined as maximum observed plasma concentration after administration of JNJ-70033093.
measure: Part 1 and 2: Area Under the Plasma Concentration-time Curve from Time Zero to Time of Last Quantifiable Concentration (AUC [0-last]) of JNJ-70033093
time frame: Up to 72 hours post dose
description: AUC (0-last) is defined as area under the plasma concentration-time curve from time 0 to time of last quantifiable concentration after administration of JNJ-70033093.
measure: Part 1 and 2: Area Under the Plasma Concentration-time Curve from Time Zero to Infinity (AUC [0-inf]) of JNJ-70033093
time frame: Up to 72 hours post dose
description: AUC (0-inf) is defined as area under the plasma concentration-time curve from time 0 to infinity after administration of JNJ-70033093.
measure: Part 1 and 2: Time to Reach Maximum Observed Plasma Concentration (Tmax) of JNJ-70033093
time frame: Up to 72 hours post dose
description: Tmax is defined time to reach the maximum observed plasma concentration.
measure: Part 1 and 2: Apparent Elimination Half-life (t1/2) of JNJ-70033093
time frame: Up to 72 hours post dose
description: Apparent elimination half-life associated with the terminal slope lambda(z) of the semilogarithmic drug concentration-time curve.
measure: Part 1 and 2: Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability
time frame: Up to 2 Months
description: An AE is any untoward medical occurrence in a clinical study participant administered a investigational or non-investigational medicinal product. An AE does not necessarily have a causal relationship with the treatment.
measure: Part 1 and 2: Number of Participants with Clinically Significant Changes in Vital Signs
time frame: Up to 2 Months
description: Number of participants with clinically significant changes in vital signs including temperature (axillary), pulse rate, respiratory rate, blood pressure will be reported.
measure: Part 1 and 2: Number of Participants with Abnormalities in Electrocardiogram (ECG)
time frame: Up to 2 Months
description: Number of participants with abnormalities in ECG will be reported.
measure: Part 1 and 2: Number of Participants with Clinically Significant Changes in Physical Examination
time frame: Up to 2 Months
description: Number of participants with clinically significant changes in physical examination including height and body weight will be reported.
arm group label: Part 1: Treatment Sequence ABC
arm group type: Experimental
description: Participants will receive a single dose of JNJ-70033093 spray-dried dispersion (SDD) tablet under fasted conditions (Treatment A) in Treatment Period 1, followed by JNJ-70033093 SDD tablet in fed conditions (Treatment B) in Treatment Period 2, and then JNJ-70033093 SDD granule capsule under fasted conditions (Treatment C) in Treatment Period 3 on Day 1 of each Period during Part 1. There will be a wash-out period of at least 5 days and up to 2 weeks between Day 1 of each treatment period.
arm group label: Part 1: Treatment Sequence BCA
arm group type: Experimental
description: Participants will receive Treatment B in Treatment Period 1, followed by Treatment C in Treatment Period 2, and then Treatment A in Treatment Period 3 on Day 1 of each Period during Part 1. There will be a wash-out period of at least 5 days and up to 2 weeks between Day 1 of each treatment period.
arm group label: Part 1: Treatment Sequence CAB
arm group type: Experimental
description: Participants will receive Treatment C in Treatment Period 1, followed by Treatment A in Treatment Period 2, and then Treatment B in Treatment Period 3 on Day 1 of each Period during Part 1. There will be a wash-out period of at least 5 days and up to 2 weeks between Day 1 of each treatment period.
arm group label: Part 1: Treatment Sequence ACB
arm group type: Experimental
description: Participants will receive Treatment A in Treatment Period 1, followed by Treatment C in Treatment Period 2, and then Treatment B in Treatment Period 3 on Day 1 of each Period during Part 1. There will be a wash-out period of at least 5 days and up to 2 weeks between Day 1 of each treatment period.
arm group label: Part 1: Treatment Sequence BAC
arm group type: Experimental
description: Participants will receive Treatment B in Treatment Period 1, followed by Treatment A in Treatment Period 2, and then Treatment C in Treatment Period 3 on Day 1 of each Period during Part 1. There will be a wash-out period of at least 5 days and up to 2 weeks between Day 1 of each treatment period.
arm group label: Part 1: Treatment Sequence CBA
arm group type: Experimental
description: Participants will receive Treatment C in Treatment Period 1, followed by Treatment B in Treatment Period 2, and then Treatment A in Treatment Period 3 on Day 1 of each Period during Part 1. There will be a wash-out period of at least 5 days and up to 2 weeks between Day 1 of each treatment period.
arm group label: Part 2: Treatment Sequence DE
arm group type: Experimental
description: Participants will receive Treatment D (single dose of JNJ-70033093 SDD tablet in fed conditions) in Treatment Period 1, and then Treatment E (single dose of JNJ-70033093 SDD granule capsule under fasted conditions) in Treatment Period 2 on Day 1 of each Period during Part 2. There will be a wash-out period of at least 5 days and up to 2 weeks between Day 1 of each treatment period.
arm group label: Part 2: Treatment Sequence ED
arm group type: Experimental
description: Participants will receive Treatment E in Treatment Period 1, and then Treatment D in Treatment Period 2 on Day 1 of each Period during Part 2. There will be a wash-out period of at least 5 days and up to 2 weeks between Day 1 of each treatment period.
intervention type: Drug
intervention name: JNJ-70033093
description: JNJ-70033093 will be administered orally as per assigned treatment sequence.
arm group label: Part 1: Treatment Sequence ABC
arm group label: Part 1: Treatment Sequence ACB
arm group label: Part 1: Treatment Sequence BAC
arm group label: Part 1: Treatment Sequence BCA
arm group label: Part 1: Treatment Sequence CAB
arm group label: Part 1: Treatment Sequence CBA
arm group label: Part 2: Treatment Sequence DE
arm group label: Part 2: Treatment Sequence ED
other name: BMS-986177
criteria: 
gender: All
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
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