<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/NCT03002779</url>
  </required_header>
  <id_info>
    <org_study_id>CR108210</org_study_id>
    <secondary_id>53718678RSV1008</secondary_id>
    <secondary_id>2016-002664-14</secondary_id>
    <nct_id>NCT03002779</nct_id>
  </id_info>
  <brief_title>A Study to Characterize the Absorption, Metabolism, and Excretion of 14C-JNJ-53718678 After a Single Oral Dose in Healthy Male Participants</brief_title>
  <official_title>A Phase 1, Open Label Study to Characterize the Absorption, Metabolism and Excretion of 14C-JNJ-53718678 After a Single Dose in Healthy Adult 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>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the study is to determine the routes of excretion for JNJ-53718678 and its&#xD;
      metabolites, to explore the metabolic pathways of JNJ-53718678, and to determine the chemical&#xD;
      structure of predominant metabolites in healthy adult male participants after a single oral&#xD;
      dose of 500 milligram (mg) 14C-JNJ-53718678.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 26, 2017</start_date>
  <completion_date type="Actual">March 20, 2017</completion_date>
  <primary_completion_date type="Actual">March 10, 2017</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mass Balance of JNJ-53718678 in Healthy Adult Male Participants.</measure>
    <time_frame>Up to Day 10</time_frame>
    <description>Total mass balance calculated by D(dose) urine, total (percent [%]) + D feces, total (%) + D duodenal, total (%) where D urine, total is the total percentage of the dose excreted into urine, calculated as 100 * (Ae total [total amount excreted into urine, calculated by adding the amounts of the individual intervals together] /Dose); D feces,total is the total percentage of the dose excreted into feces, calculated as 100 * (Ae total [total amount excreted into feces, calculated by adding the amounts of the individual stools together]/Dose) and D duodenal, total is defined as total percentage of the dose collected in all duodenal samples collectively, calculated as % of dose.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Metabolic profiles of JNJ-53718678 in plasma, duodenal fluid, urine, and feces samples with radio high-performance liquid chromatography analysis</measure>
    <time_frame>Up to Day 6</time_frame>
    <description>Metabolite profiling will be performed with radio high-performance liquid chromatography.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Adverse Events as a Measure of Safety and Tolerability</measure>
    <time_frame>Throughout the study duration (up to 24 days)</time_frame>
    <description>Safety and Tolerability</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">6</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>JNJ-53718678</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>JNJ-53718678</intervention_name>
    <description>Participants will receive a single 500 milligram (mg) dose of 14C-JNJ-53718678 as an oral liquid solution containing 14C-labeled and unlabeled JNJ-53718678 corresponding to a radioactivity dose.</description>
    <arm_group_label>JNJ-53718678</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  A male participant: a) Must be sexually abstinent (defined as refraining from sexual&#xD;
             intercourse from Day 1 (day of dosing) until 90 days after study drug administration),&#xD;
             OR b) Who is sexually active (either heterosexual, including with a pregnant woman, or&#xD;
             homosexual) must agree to use a barrier method of contraception (eg, condom) from Day&#xD;
             1 (day of dosing) until 90 days after study drug administration, AND c) Who is&#xD;
             sexually active with a woman of childbearing potential must agree to use a barrier&#xD;
             method of contraception (eg, condom) from Day 1 (day of dosing) until 90 days after&#xD;
             study drug administration, in conjunction with this female partner using a highly&#xD;
             effective contraceptive (such as implantable progestogen-only hormone contraception&#xD;
             associated with inhibition of ovulation; intrauterine device; intrauterine&#xD;
             hormone-releasing system, combined [estrogen- and progestogen- containing] hormonal&#xD;
             contraception associated with inhibition of ovulation: oral, intravaginal, or&#xD;
             transdermal; progestogen-only hormone contraception associated with inhibition of&#xD;
             ovulation: oral or injectable) d) Must agree not to donate sperm from Day 1 (day of&#xD;
             dosing) until 90 days after study drug administration&#xD;
&#xD;
          -  Participant must have a body mass index (BMI; weight in kg divided by the square of&#xD;
             height in meters) of 18.0 to 30.0 kilogram per square meter (kg/m^2)&#xD;
&#xD;
          -  Participant must have a blood pressure (after the participant is supine for 5 minutes)&#xD;
             between 90 and 140 millimeter of mercury (mmHg) systolic, inclusive, and no higher&#xD;
             than 90 mmHg diastolic&#xD;
&#xD;
          -  Participant must have a normal 12-lead electrocardiogram (ECG) (based on the mean&#xD;
             value of triplicate ECG parameters), consistent with normal cardiac conduction and&#xD;
             function at screening, including: a) normal sinus rhythm (heart rate between 45 and 90&#xD;
             beats per minute (bpm), extremes included); b)mean QT interval corrected for heart&#xD;
             rate according to Fridericia formula (QTcF) interval lesser than or equal to (&lt;=)450&#xD;
             millisecond (ms); c) mean QRS interval of &lt;110 ms; d) mean PR interval &lt;200 ms; e)&#xD;
             morphology consistent with healthy cardiac conduction and function&#xD;
&#xD;
          -  Participants must be healthy on the basis of a medical evaluation that reveals the&#xD;
             absence of any clinically relevant abnormality and includes a physical examination&#xD;
             (including height and body weight measurement and skin examination), medical history,&#xD;
             vital signs (systolic and diastolic blood pressure, pulse rate, orthostatic blood&#xD;
             pressure changes, respiratory rate, and body temperature), creatinine clearance (below&#xD;
             60 milliliter per minute (mL/min) at screening using Cockroft-Gault equation), and the&#xD;
             results of blood biochemistry, blood coagulation, and hematology tests, and a&#xD;
             urinalysis performed at screening, on Day -1, or predose on Day 1, whichever is&#xD;
             applicable. If there are abnormalities, with the exception of those described in the&#xD;
             in- and exclusion criteria, the participant may be included only if the investigator&#xD;
             judges the abnormalities or deviations from normal to be not clinically significant.&#xD;
             This determination must be recorded in the participant's source documents and&#xD;
             initialed by the investigator&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participants with a removed gallbladder, or with a history of upper gastrointestinal&#xD;
             (stomach, duodenum) surgery, or with a recent (less than 3 months prior to screening)&#xD;
             episode of gallbladder stones&#xD;
&#xD;
          -  Participants with a history of heart arrhythmias (extrasystoles, tachycardia at rest)&#xD;
             or history of risk factors for Torsade de Pointes syndrome (example, hypokalemia,&#xD;
             family history of long QT syndrome)&#xD;
&#xD;
          -  Participant has intolerance to xylocaine, lactose, or midazolam&#xD;
&#xD;
          -  Participant has a history of hepatitis A antibody immunoglobulin M (IgM), hepatitis B&#xD;
             virus surface antigen (HBsAg), or hepatitis C virus antibody (anti-HCV) positive, or&#xD;
             other clinically active liver disease, or tests positive for hepatitis A antibody IgM,&#xD;
             HBsAg or anti HCV at screening&#xD;
&#xD;
          -  Participant has a history of human immunodeficiency virus (HIV) antibody positive, or&#xD;
             tests positive for HIV at screening&#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>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>May 2017</verification_date>
  <study_first_submitted>November 30, 2016</study_first_submitted>
  <study_first_submitted_qc>December 21, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 26, 2016</study_first_posted>
  <last_update_submitted>May 29, 2017</last_update_submitted>
  <last_update_submitted_qc>May 29, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">May 31, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT03002779
org study id: CR108210
secondary id: 53718678RSV1008
secondary id: 2016-002664-14
nct id: NCT03002779
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
The purpose of the study is to determine the routes of excretion for JNJ-53718678 and its
      metabolites, to explore the metabolic pathways of JNJ-53718678, and to determine the chemical
      structure of predominant metabolites in healthy adult male participants after a single oral
      dose of 500 milligram (mg) 14C-JNJ-53718678.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Mass Balance of JNJ-53718678 in Healthy Adult Male Participants.
time frame: Up to Day 10
description: Total mass balance calculated by D(dose) urine, total (percent [%]) + D feces, total (%) + D duodenal, total (%) where D urine, total is the total percentage of the dose excreted into urine, calculated as 100 * (Ae total [total amount excreted into urine, calculated by adding the amounts of the individual intervals together] /Dose); D feces,total is the total percentage of the dose excreted into feces, calculated as 100 * (Ae total [total amount excreted into feces, calculated by adding the amounts of the individual stools together]/Dose) and D duodenal, total is defined as total percentage of the dose collected in all duodenal samples collectively, calculated as % of dose.
measure: Metabolic profiles of JNJ-53718678 in plasma, duodenal fluid, urine, and feces samples with radio high-performance liquid chromatography analysis
time frame: Up to Day 6
description: Metabolite profiling will be performed with radio high-performance liquid chromatography.
measure: Number of Participants With Adverse Events as a Measure of Safety and Tolerability
time frame: Throughout the study duration (up to 24 days)
description: Safety and Tolerability
arm group label: JNJ-53718678
arm group type: Experimental
intervention type: Drug
intervention name: JNJ-53718678
description: Participants will receive a single 500 milligram (mg) dose of 14C-JNJ-53718678 as an oral liquid solution containing 14C-labeled and unlabeled JNJ-53718678 corresponding to a radioactivity dose.
arm group label: JNJ-53718678
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: Netherlands
responsible party type: Sponsor