<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/NCT04453189</url>
  </required_header>
  <id_info>
    <org_study_id>CR108812</org_study_id>
    <secondary_id>2020-000380-23</secondary_id>
    <secondary_id>64417184RSV1004</secondary_id>
    <nct_id>NCT04453189</nct_id>
  </id_info>
  <brief_title>A Study to Assess the Effects of Acid-Reducing Agent(s) on JNJ-64417184 in Healthy Participants</brief_title>
  <official_title>A Phase 1, Open-label, Randomized, 2-Way Crossover Study to Assess the Effects of Acid-Reducing Agent(s) on the Pharmacokinetics of a Single Oral Dose of JNJ-64417184 in Healthy Adult Participants</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>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary purpose of this study is to evaluate the effect of multiple-dose administration&#xD;
      of lansoprazole on the single-dose pharmacokinetics (PK) of JNJ-64417184 in healthy adult&#xD;
      participants; and to evaluate the effect of time-separated, multiple-dose administration of&#xD;
      famotidine on the single-dose PK of JNJ-64417184 in healthy adult participants (optional).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 20, 2020</start_date>
  <completion_date type="Actual">September 14, 2020</completion_date>
  <primary_completion_date type="Actual">September 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>Maximum Observed Plasma Analyte Concentration (Cmax) of JNJ-64417184</measure>
    <time_frame>Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 18, 24, 36, 48, 72, 96, 120 hours and up to follow-up 1 (up to 120 hours in case of dropout; at the time of dropout or the following morning)</time_frame>
    <description>Cmax is defined as the maximum observed plasma analyte concentration.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Area Under the Plasma Analyte Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration (AUC[0-last]) of JNJ-64417184</measure>
    <time_frame>Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 18, 24, 36, 48, 72, 96, 120 hours and up to follow-up 1 (up to 120 hours in case of dropout; at the time of dropout or the following morning)</time_frame>
    <description>AUC(0-last) is defined as the area under the plasma analyte concentration-time curve from time 0 to time of the last quantifiable (non-below quantification limit [non-BQL]) concentration calculated by linear-linear trapezoidal summation.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Area Under the Plasma Analyte Concentration-time Curve From Time 0 to Infinite Time (AUC[0-infinity]) of JNJ-64417184</measure>
    <time_frame>Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 18, 24, 36, 48, 72, 96, 120 hours and up to follow-up 1 (up to 120 hours in case of dropout; at the time of dropout or the following morning)</time_frame>
    <description>Area under the plasma analyte concentration-time curve from time 0 to infinite time, calculated as AUC (0-last) + C (0-last)/lambda(z), where C (0-last) is the last observed measurable (non BQL) plasma analyte concentration; AUC (0-last) is the area under the plasma analyte concentration-time curve from time 0 to time of the last quantifiable (non-below quantification limit [non-BQL]) concentration and lambda(z) is the terminal phase rate constant. Extrapolations of more than 20.00 percent (%) of the total AUC are reported as approximations.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants with Adverse Event as a Measure of Safety and Tolerability</measure>
    <time_frame>Up to 2.5 months</time_frame>
    <description>An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non investigational) product. An AE does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non investigational) product, whether or not related to that medicinal (investigational or non investigational) product.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants with Clinically Significant Changes in Vital Signs</measure>
    <time_frame>Up to 2.5 years</time_frame>
    <description>Number of participants with clinically significant abnormalities in vital signs (Systolic and diastolic blood pressure and pulse rate) will be assessed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants with Clinically Significant Abnormalities in Laboratory Parameters</measure>
    <time_frame>Up to 2.5 years</time_frame>
    <description>Number of participants with clinically significant abnormalities in laboratory parameters (Hematology Panel, biochemistry panel, coagulation and urinalysis) will be assessed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants with Clinically Significant Abnormalities in Electrocardiogram</measure>
    <time_frame>Up to 2.5 years</time_frame>
    <description>Number of participants with clinically significant abnormalities in electrocardiogram will be assessed.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">14</enrollment>
  <condition>Healthy Participants</condition>
  <arm_group>
    <arm_group_label>Treatment Sequence: AB(Part 1) followed by C(Part 2-Optional)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will received Treatment A (single dose of JNJ-64417184 in fed condition on Day 1) in period 1 followed by Treatment B (lansoprazole on Day 1 to 4 under fasted condition and 2 hours before single dose of JNJ-64417184 in fed condition on Day 5) in period 2 of part 1. There will be a washout period of 7 days between each treatment. Participants will receive Treatment C: optional (famotidine under fasted conditions administered 12 hours before and 12 hours after a single dose of JNJ-64417184 under fed conditions on Day 1) in Part 2, Period 3.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment Sequence: BA(Part 1) followed by C(Part 2-Optional)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive Treatment B in period 1 followed by Treatment A in period 2, Part 1. There will be a washout period of 7 days between each treatment. Participants will receive Treatment C: optional (famotidine under fasted conditions administered 12 hours before and 12 hours after a single dose of JNJ-64417184 under fed conditions on Day 1) in Part 2, Period 3.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>JNJ-64417184</intervention_name>
    <description>Participants will receive single dose of JNJ-64417184 in fed condition on Day 1 in assigned treatment sequence.</description>
    <arm_group_label>Treatment Sequence: AB(Part 1) followed by C(Part 2-Optional)</arm_group_label>
    <arm_group_label>Treatment Sequence: BA(Part 1) followed by C(Part 2-Optional)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lansoprazole</intervention_name>
    <description>Participants will receive lansoprazole once daily in fasted condition on Day 1 to 4 under fasted condition and 2 hours before single dose of JNJ-64417184 in fed condition on Day 5 in assigned treatment sequence.</description>
    <arm_group_label>Treatment Sequence: AB(Part 1) followed by C(Part 2-Optional)</arm_group_label>
    <arm_group_label>Treatment Sequence: BA(Part 1) followed by C(Part 2-Optional)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Famotidine</intervention_name>
    <description>Participant will receive famotidine in fasted condition on Day 1 in assigned treatment sequence.</description>
    <arm_group_label>Treatment Sequence: AB(Part 1) followed by C(Part 2-Optional)</arm_group_label>
    <arm_group_label>Treatment Sequence: BA(Part 1) followed by C(Part 2-Optional)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Must have a body mass index (BMI) between 18.0 and 30.0 kilograms per square meters&#xD;
             [kg/m^2]), extremes included, and body weight not less than 50.0 kilograms (kg) at&#xD;
             screening&#xD;
&#xD;
          -  Healthy on the basis of physical examination, medical and surgical history, and vital&#xD;
             signs performed at screening&#xD;
&#xD;
          -  Healthy on the basis of clinical laboratory tests performed at screening&#xD;
&#xD;
          -  Must have a normal 12-lead Electrocardiogram (ECG) (triplicate) at screening,&#xD;
             including: normal sinus rhythm (heart rate between 45 and 100 beats per minute [bpm],&#xD;
             extremes included); QT interval corrected for heart rate (QTc) according to Fridericia&#xD;
             (QTcF) less than or equal to (&lt;=) 450 milliseconds (ms) for male participants and &lt;=&#xD;
             470 ms for female participants; QRS interval less than (&lt;) 120 ms; PR interval &lt;= 200&#xD;
             ms. If the results of the ECG are outside the normal ranges, the participant may be&#xD;
             included only if the investigator judges the deviations from normal ECG to be not&#xD;
             clinically significant or to be appropriate and reasonable for the population under&#xD;
             study. This determination must be recorded in the participant's source documents and&#xD;
             initialed by the investigator&#xD;
&#xD;
          -  Must sign an informed consent form (ICF) indicating he or she understands the purpose&#xD;
             of, and procedures required for, the study and is willing to participate in the study,&#xD;
             before starting any screening activities&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of liver or renal dysfunction (calculated creatinine clearance/estimated&#xD;
             glomerular filtration rate (eGFR) &lt;60 milliliter per minute (mL/min) at screening,&#xD;
             calculated by the Modification of Diet in Renal Disease [MDRD] formula), significant&#xD;
             cardiac, vascular, pulmonary, gastrointestinal (such as significant diarrhea, gastric&#xD;
             stasis, or constipation that in the investigator's opinion could influence drug&#xD;
             absorption or bioavailability), endocrine, neurologic, hematologic, rheumatologic,&#xD;
             psychiatric, neoplastic, or metabolic disturbances&#xD;
&#xD;
          -  Past history of clinically significant cardiac arrhythmias (for example, extrasystoli,&#xD;
             tachycardia at rest), history of risk factors for Torsade de Pointes syndrome (for&#xD;
             example, hypokalemia, family history of long QT Syndrome)&#xD;
&#xD;
          -  Any evidence of clinically significant heart block or bundle branch block at screening&#xD;
&#xD;
          -  Current human immunodeficiency virus type 1 (HIV-1) or HIV-2 infection (confirmed by&#xD;
             antibodies) at screening&#xD;
&#xD;
          -  History of hepatitis A, B, or C infection, or current hepatitis A infection (confirmed&#xD;
             by hepatitis A antibody immunoglobulin M [IgM]), or hepatitis B virus (HBV) infection&#xD;
             (confirmed by hepatitis B surface antigen), or HCV infection (confirmed by hepatitis C&#xD;
             virus [HCV] antibody) at screening&#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>PRA Health Sciences Onderzoekscentrum Groningen, locatie Martini</name>
      <address>
        <city>Groningen</city>
        <zip>9728 NZ</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>June 29, 2020</study_first_submitted>
  <study_first_submitted_qc>June 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 1, 2020</study_first_posted>
  <last_update_submitted>November 16, 2020</last_update_submitted>
  <last_update_submitted_qc>November 16, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 17, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lansoprazole</mesh_term>
    <mesh_term>Dexlansoprazole</mesh_term>
    <mesh_term>Famotidine</mesh_term>
  </intervention_browse>
  <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/NCT04453189
org study id: CR108812
secondary id: 2020-000380-23
secondary id: 64417184RSV1004
nct id: NCT04453189
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The primary purpose of this study is to evaluate the effect of multiple-dose administration
      of lansoprazole on the single-dose pharmacokinetics (PK) of JNJ-64417184 in healthy adult
      participants; and to evaluate the effect of time-separated, multiple-dose administration of
      famotidine on the single-dose PK of JNJ-64417184 in healthy adult participants (optional).
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Other
masking: None (Open Label)
measure: Maximum Observed Plasma Analyte Concentration (Cmax) of JNJ-64417184
time frame: Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 18, 24, 36, 48, 72, 96, 120 hours and up to follow-up 1 (up to 120 hours in case of dropout; at the time of dropout or the following morning)
description: Cmax is defined as the maximum observed plasma analyte concentration.
measure: Area Under the Plasma Analyte Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration (AUC[0-last]) of JNJ-64417184
time frame: Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 18, 24, 36, 48, 72, 96, 120 hours and up to follow-up 1 (up to 120 hours in case of dropout; at the time of dropout or the following morning)
description: AUC(0-last) is defined as the area under the plasma analyte concentration-time curve from time 0 to time of the last quantifiable (non-below quantification limit [non-BQL]) concentration calculated by linear-linear trapezoidal summation.
measure: Area Under the Plasma Analyte Concentration-time Curve From Time 0 to Infinite Time (AUC[0-infinity]) of JNJ-64417184
time frame: Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 18, 24, 36, 48, 72, 96, 120 hours and up to follow-up 1 (up to 120 hours in case of dropout; at the time of dropout or the following morning)
description: Area under the plasma analyte concentration-time curve from time 0 to infinite time, calculated as AUC (0-last) + C (0-last)/lambda(z), where C (0-last) is the last observed measurable (non BQL) plasma analyte concentration; AUC (0-last) is the area under the plasma analyte concentration-time curve from time 0 to time of the last quantifiable (non-below quantification limit [non-BQL]) concentration and lambda(z) is the terminal phase rate constant. Extrapolations of more than 20.00 percent (%) of the total AUC are reported as approximations.
measure: Number of Participants with Adverse Event as a Measure of Safety and Tolerability
time frame: Up to 2.5 months
description: An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non investigational) product. An AE does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non investigational) product, whether or not related to that medicinal (investigational or non investigational) product.
measure: Number of Participants with Clinically Significant Changes in Vital Signs
time frame: Up to 2.5 years
description: Number of participants with clinically significant abnormalities in vital signs (Systolic and diastolic blood pressure and pulse rate) will be assessed.
measure: Number of Participants with Clinically Significant Abnormalities in Laboratory Parameters
time frame: Up to 2.5 years
description: Number of participants with clinically significant abnormalities in laboratory parameters (Hematology Panel, biochemistry panel, coagulation and urinalysis) will be assessed.
measure: Number of Participants with Clinically Significant Abnormalities in Electrocardiogram
time frame: Up to 2.5 years
description: Number of participants with clinically significant abnormalities in electrocardiogram will be assessed.
arm group label: Treatment Sequence: AB(Part 1) followed by C(Part 2-Optional)
arm group type: Experimental
description: Participants will received Treatment A (single dose of JNJ-64417184 in fed condition on Day 1) in period 1 followed by Treatment B (lansoprazole on Day 1 to 4 under fasted condition and 2 hours before single dose of JNJ-64417184 in fed condition on Day 5) in period 2 of part 1. There will be a washout period of 7 days between each treatment. Participants will receive Treatment C: optional (famotidine under fasted conditions administered 12 hours before and 12 hours after a single dose of JNJ-64417184 under fed conditions on Day 1) in Part 2, Period 3.
arm group label: Treatment Sequence: BA(Part 1) followed by C(Part 2-Optional)
arm group type: Experimental
description: Participants will receive Treatment B in period 1 followed by Treatment A in period 2, Part 1. There will be a washout period of 7 days between each treatment. Participants will receive Treatment C: optional (famotidine under fasted conditions administered 12 hours before and 12 hours after a single dose of JNJ-64417184 under fed conditions on Day 1) in Part 2, Period 3.
intervention type: Drug
intervention name: JNJ-64417184
description: Participants will receive single dose of JNJ-64417184 in fed condition on Day 1 in assigned treatment sequence.
arm group label: Treatment Sequence: AB(Part 1) followed by C(Part 2-Optional)
arm group label: Treatment Sequence: BA(Part 1) followed by C(Part 2-Optional)
intervention type: Drug
intervention name: Lansoprazole
description: Participants will receive lansoprazole once daily in fasted condition on Day 1 to 4 under fasted condition and 2 hours before single dose of JNJ-64417184 in fed condition on Day 5 in assigned treatment sequence.
arm group label: Treatment Sequence: AB(Part 1) followed by C(Part 2-Optional)
arm group label: Treatment Sequence: BA(Part 1) followed by C(Part 2-Optional)
intervention type: Drug
intervention name: Famotidine
description: Participant will receive famotidine in fasted condition on Day 1 in assigned treatment sequence.
arm group label: Treatment Sequence: AB(Part 1) followed by C(Part 2-Optional)
arm group label: Treatment Sequence: BA(Part 1) followed by C(Part 2-Optional)
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: Netherlands
responsible party type: Sponsor
mesh term: Lansoprazole
mesh term: Dexlansoprazole
mesh term: Famotidine
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