<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/NCT04500808</url>
  </required_header>
  <id_info>
    <org_study_id>CR108788</org_study_id>
    <secondary_id>67896062PAH1005</secondary_id>
    <nct_id>NCT04500808</nct_id>
  </id_info>
  <brief_title>A Study of Macitentan, in Healthy Japanese Male Participants</brief_title>
  <official_title>A Double-blind, Randomized, Placebo-controlled, Multiple-dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Macitentan and an Open-label, Randomized, Crossover, Single-dose Study to Evaluate the Effect of Food on Macitentan Pharmacokinetics, in Healthy Japanese Adult Male Participants</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Janssen Pharmaceutical K.K.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Janssen Pharmaceutical K.K.</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 main purpose of this study is to evaluate the safety and tolerability after multiple-dose&#xD;
      administrations of macitentan with titration regimen starting from Dose 1 once daily (qd) up&#xD;
      to Dose 2 qd in Japanese healthy adult male participants (Part 1) and to evaluate the effect&#xD;
      of food on pharmacokinetics of macitentan and its active metabolite (ACT-132577) in Japanese&#xD;
      healthy adult male participants with macitentan Dose 3 tablet (Part 2).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 21, 2020</start_date>
  <completion_date type="Actual">December 14, 2020</completion_date>
  <primary_completion_date type="Actual">December 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>Parallel Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Part 1: Number of Participants with Adverse Events (AEs)</measure>
    <time_frame>Up to Day 29</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 intervention. 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>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 1: Number of Participants with Adverse Event of Special Interests (AESIs)</measure>
    <time_frame>Up to Day 29</time_frame>
    <description>An AE is any untoward medical occurrence in a clinical study participant administered a medicinal product. An AE does not necessarily have a causal relationship with the intervention. 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 product, whether or not related to that medicinal product. The following are the AEs of special interest in this study: Hypotension: symptomatic hypotension or potentially clinically meaningful decrease in blood pressure, Edema/fluid retention: clinically relevant signs and symptoms of edema and/or fluid retention, Hemoglobin decrease/anemia: events of hemoglobin decrease from baseline of greater than (&gt;) 20 gram per liter (g/L), Liver events: liver aminotransferase abnormalities.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 1: Number of Participants with Serious Adverse Events (SAEs)</measure>
    <time_frame>Up to Day 29</time_frame>
    <description>A SAE is any AE that results in: death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect and is a suspected transmission of any infectious agent via a medicinal product, is medically important.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 1: Number of Participants with Clinical Laboratory Abnormalities</measure>
    <time_frame>Up to Day 29</time_frame>
    <description>Number of participants with clinical laboratory abnormalities (serum chemistry, hematology, blood coagulation) will be reported</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 1: Number of Participants with Abnormalities in ECG Variables</measure>
    <time_frame>Up to Day 29</time_frame>
    <description>Number of Participants with abnormalities in ECG variables such as: PR, QRS, QT, RR, and QT corrected Fridericia's formulae (QTcF) will be reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 1: Change from Baseline in Weight</measure>
    <time_frame>Baseline, up to Day 29</time_frame>
    <description>Change from baseline in body weight in kilograms as a part of physical examination will be reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 1: Change from Baseline in Height</measure>
    <time_frame>Baseline, up to Day 29</time_frame>
    <description>Change from baseline in height in centimeters as a part of physical examination will be reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 2: Plasma Concentration of Macitentan and its Active Metabolite (ACT-132577)</measure>
    <time_frame>Predose, 3, 5, 7, 8, 9, 10, 12, 16, 24, 48, 72, 120, 168, and 240 hours post dose</time_frame>
    <description>Plasma concentration of macitentan and its active metabolite (ACT-132577) will be reported.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Part 1: Plasma Concentration of Macitentan and its Active Metabolite (ACT-132577)</measure>
    <time_frame>Day 5 and Day 13 (predose,1, 3, 5, 7, 8, 9, 10, 12, and 16 hours postdose)</time_frame>
    <description>Plasma concentration of macitentan and its active metabolite (ACT-132577) will be reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part 1: Plasma Endothelin-1 (ET-1) Concentrations</measure>
    <time_frame>Up to Day 29</time_frame>
    <description>Plasma ET-1 concentrations for macitentan and ACT-132577 will be reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part 2: Number of Participants with Adverse Events (AEs)</measure>
    <time_frame>Up to Day 12</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 intervention. 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>Part 2: Number of Participants with Adverse Event of Special Interests (AESIs)</measure>
    <time_frame>Up to Day 12</time_frame>
    <description>An AE is any untoward medical occurrence in a clinical study participant administered a medicinal product. An AE does not necessarily have a causal relationship with the intervention. 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 product, whether or not related to that medicinal product. The following are the AEs of special interest in this study: Hypotension: symptomatic hypotension or potentially clinically meaningful decrease in blood pressure, Edema/fluid retention: clinically relevant signs and symptoms of edema and/or fluid retention, Hemoglobin decrease/anemia: events of hemoglobin decrease from baseline of greater than (&gt;) 20 gram per liter (g/L), Liver events: liver aminotransferase abnormalities.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part 2: Number of Participants with Serious Adverse Events (SAEs)</measure>
    <time_frame>Up to Day 12</time_frame>
    <description>A SAE is any AE that results in: death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect and is a suspected transmission of any infectious agent via a medicinal product, is medically important.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part 2: Number of Participants with Clinical Laboratory Abnormalities</measure>
    <time_frame>Up to Day 12</time_frame>
    <description>Number of participants with clinical laboratory abnormalities (serum chemistry, hematology, blood coagulation, and urine samples) will be reported</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part 2: Number of Participants with Abnormalities in ECG Variables</measure>
    <time_frame>Up to Day 12</time_frame>
    <description>Number of Participants with abnormalities in ECG variables such as: PR, QRS, QT, RR, and QT corrected Fridericia's formulae (QTcF) will be reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part 2: Change from Baseline in Weight</measure>
    <time_frame>Baseline, Up to Day 12</time_frame>
    <description>Change from baseline in body weight in kilograms as a part of physical examination will be reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part 2: Change from Baseline in Height</measure>
    <time_frame>Baseline, Up to Day 12</time_frame>
    <description>Change from baseline in height in centimeters as a part of physical examination will be reported.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Part 1: Double Blind Phase</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive macitentan or matching placebo from Day 1 up to Day 13 under fed conditions and will be up-titrated starting with 2 once daily (QD) dosing of Dose 1 from Days 1 to 2 followed by 3 qd doses of Dose 2 of macitentan from Days 3 to 5, followed by qd doses of Dose 3 macitentan from Days 6 to 13.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part 2: Open Label Phase: Treatment Sequence AB</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive Dose 3 of macitentan under fasted conditions (Treatment A) in period 1 followed by Dose 3 of macitentan under fed condition (Treatment B) in period 2 on Day 1 with a washout phase of at least 14 days between the two treatment periods.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part 2: Open Label Phase: Treatment Sequence BA</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 on Day 1 with a washout phase of at least 14 days between the two treatment periods.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Macitentan Dose 1</intervention_name>
    <description>Participants will receive Dose 1 of macitentan tablet in Part 1.</description>
    <arm_group_label>Part 1: Double Blind Phase</arm_group_label>
    <other_name>JNJ-67896062</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Macitentan Dose 2</intervention_name>
    <description>Participants will receive Dose 2 of macitentan tablet in Part 1.</description>
    <arm_group_label>Part 1: Double Blind Phase</arm_group_label>
    <other_name>JNJ-67896062</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Macitentan Dose 3</intervention_name>
    <description>Participants will receive Dose 2 of macitentan tablet in Part 1 and 2.</description>
    <arm_group_label>Part 1: Double Blind Phase</arm_group_label>
    <arm_group_label>Part 2: Open Label Phase: Treatment Sequence AB</arm_group_label>
    <arm_group_label>Part 2: Open Label Phase: Treatment Sequence BA</arm_group_label>
    <other_name>JNJ-67896062</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Participants will receive matching placebo from Day 1 up to Day 13.</description>
    <arm_group_label>Part 1: Double Blind Phase</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Be healthy on the basis of clinical laboratory tests performed at screening. If the&#xD;
             results of the serum chemistry panel, hematology, or urinalysis 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. This&#xD;
             determination must be recorded in the participant's source documents and initialed by&#xD;
             the investigator&#xD;
&#xD;
          -  Blood pressure (after the participant is supine for 5 minutes) between 90 and 140&#xD;
             millimeter of mercury (mmHg) systolic, inclusive, and no higher than 90 mmHg diastolic&#xD;
&#xD;
          -  A participant must wear a condom when engaging in any activity that allows for passage&#xD;
             of ejaculate to another person. Male participants should also be advised of the&#xD;
             benefit for a female partner to use a highly effective method of contraception as&#xD;
             condom may break or leak. Recommended highly effective methods of contraception in&#xD;
             this study for female partners of male participants to use in addition to the male&#xD;
             participant wearing a condom during include: oral hormonal contraception, intrauterine&#xD;
             device, intrauterine hormone-releasing system and bilateral tubal occlusion&#xD;
&#xD;
          -  A participant must agree not to donate sperm for the purpose of reproduction during&#xD;
             the study and for a minimum 90 Days after receiving the last dose of study&#xD;
             intervention&#xD;
&#xD;
          -  Nonsmoker or smoker habitually smokes no more than 10 cigarettes or equivalent of&#xD;
             e-cigarettes, or 2 cigars, or 2 pipes of tobacco per day for at least 6 months before&#xD;
             first study drug administration&#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, hepatic or renal insufficiency (creatinine clearance below&#xD;
             80 (milliliter per minute) mL/min calculated using Cockcroft-Gault equation), thyroid&#xD;
             disease, neurologic or psychiatric disease, infection, or any other illness that the&#xD;
             investigator considers should exclude the participant or that could interfere with the&#xD;
             interpretation of the study results&#xD;
&#xD;
          -  Clinically significant abnormal values for hematology, clinical chemistry, or&#xD;
             urinalysis at screening or at admission to the study site as deemed appropriate by the&#xD;
             investigator&#xD;
&#xD;
          -  History of malignancy within 5 years before screening (exceptions are squamous and&#xD;
             basal cell carcinomas of the skin or malignancy, which is considered cured with&#xD;
             minimal risk of recurrence)&#xD;
&#xD;
          -  Known allergies, hypersensitivity, or intolerance to macitentan or its excipients&#xD;
&#xD;
          -  Known allergy to heparin or history of heparin-induced thrombocytopenia&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Janssen Pharmaceutical K.K., Japan Clinical Trial</last_name>
    <role>Study Director</role>
    <affiliation>Janssen Pharmaceutical K.K.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Sumida Hospital</name>
      <address>
        <city>Tokyo</city>
        <zip>130-0004</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>July 17, 2020</study_first_submitted>
  <study_first_submitted_qc>August 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 5, 2020</study_first_posted>
  <last_update_submitted>January 12, 2021</last_update_submitted>
  <last_update_submitted_qc>January 12, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 14, 2021</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>Macitentan</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/NCT04500808
org study id: CR108788
secondary id: 67896062PAH1005
nct id: NCT04500808
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The main purpose of this study is to evaluate the safety and tolerability after multiple-dose
      administrations of macitentan with titration regimen starting from Dose 1 once daily (qd) up
      to Dose 2 qd in Japanese healthy adult male participants (Part 1) and to evaluate the effect
      of food on pharmacokinetics of macitentan and its active metabolite (ACT-132577) in Japanese
      healthy adult male participants with macitentan Dose 3 tablet (Part 2).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Triple (Participant, Care Provider, Investigator)
measure: Part 1: Number of Participants with Adverse Events (AEs)
time frame: Up to Day 29
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 intervention. 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: Part 1: Number of Participants with Adverse Event of Special Interests (AESIs)
time frame: Up to Day 29
description: An AE is any untoward medical occurrence in a clinical study participant administered a medicinal product. An AE does not necessarily have a causal relationship with the intervention. 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 product, whether or not related to that medicinal product. The following are the AEs of special interest in this study: Hypotension: symptomatic hypotension or potentially clinically meaningful decrease in blood pressure, Edema/fluid retention: clinically relevant signs and symptoms of edema and/or fluid retention, Hemoglobin decrease/anemia: events of hemoglobin decrease from baseline of greater than (>) 20 gram per liter (g/L), Liver events: liver aminotransferase abnormalities.
measure: Part 1: Number of Participants with Serious Adverse Events (SAEs)
time frame: Up to Day 29
description: A SAE is any AE that results in: death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect and is a suspected transmission of any infectious agent via a medicinal product, is medically important.
measure: Part 1: Number of Participants with Clinical Laboratory Abnormalities
time frame: Up to Day 29
description: Number of participants with clinical laboratory abnormalities (serum chemistry, hematology, blood coagulation) will be reported
measure: Part 1: Number of Participants with Abnormalities in ECG Variables
time frame: Up to Day 29
description: Number of Participants with abnormalities in ECG variables such as: PR, QRS, QT, RR, and QT corrected Fridericia's formulae (QTcF) will be reported.
measure: Part 1: Change from Baseline in Weight
time frame: Baseline, up to Day 29
description: Change from baseline in body weight in kilograms as a part of physical examination will be reported.
measure: Part 1: Change from Baseline in Height
time frame: Baseline, up to Day 29
description: Change from baseline in height in centimeters as a part of physical examination will be reported.
measure: Part 2: Plasma Concentration of Macitentan and its Active Metabolite (ACT-132577)
time frame: Predose, 3, 5, 7, 8, 9, 10, 12, 16, 24, 48, 72, 120, 168, and 240 hours post dose
description: Plasma concentration of macitentan and its active metabolite (ACT-132577) will be reported.
measure: Part 1: Plasma Concentration of Macitentan and its Active Metabolite (ACT-132577)
time frame: Day 5 and Day 13 (predose,1, 3, 5, 7, 8, 9, 10, 12, and 16 hours postdose)
description: Plasma concentration of macitentan and its active metabolite (ACT-132577) will be reported.
measure: Part 1: Plasma Endothelin-1 (ET-1) Concentrations
time frame: Up to Day 29
description: Plasma ET-1 concentrations for macitentan and ACT-132577 will be reported.
measure: Part 2: Number of Participants with Adverse Events (AEs)
time frame: Up to Day 12
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 intervention. 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: Part 2: Number of Participants with Adverse Event of Special Interests (AESIs)
time frame: Up to Day 12
description: An AE is any untoward medical occurrence in a clinical study participant administered a medicinal product. An AE does not necessarily have a causal relationship with the intervention. 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 product, whether or not related to that medicinal product. The following are the AEs of special interest in this study: Hypotension: symptomatic hypotension or potentially clinically meaningful decrease in blood pressure, Edema/fluid retention: clinically relevant signs and symptoms of edema and/or fluid retention, Hemoglobin decrease/anemia: events of hemoglobin decrease from baseline of greater than (>) 20 gram per liter (g/L), Liver events: liver aminotransferase abnormalities.
measure: Part 2: Number of Participants with Serious Adverse Events (SAEs)
time frame: Up to Day 12
description: A SAE is any AE that results in: death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect and is a suspected transmission of any infectious agent via a medicinal product, is medically important.
measure: Part 2: Number of Participants with Clinical Laboratory Abnormalities
time frame: Up to Day 12
description: Number of participants with clinical laboratory abnormalities (serum chemistry, hematology, blood coagulation, and urine samples) will be reported
measure: Part 2: Number of Participants with Abnormalities in ECG Variables
time frame: Up to Day 12
description: Number of Participants with abnormalities in ECG variables such as: PR, QRS, QT, RR, and QT corrected Fridericia's formulae (QTcF) will be reported.
measure: Part 2: Change from Baseline in Weight
time frame: Baseline, Up to Day 12
description: Change from baseline in body weight in kilograms as a part of physical examination will be reported.
measure: Part 2: Change from Baseline in Height
time frame: Baseline, Up to Day 12
description: Change from baseline in height in centimeters as a part of physical examination will be reported.
arm group label: Part 1: Double Blind Phase
arm group type: Experimental
description: Participants will receive macitentan or matching placebo from Day 1 up to Day 13 under fed conditions and will be up-titrated starting with 2 once daily (QD) dosing of Dose 1 from Days 1 to 2 followed by 3 qd doses of Dose 2 of macitentan from Days 3 to 5, followed by qd doses of Dose 3 macitentan from Days 6 to 13.
arm group label: Part 2: Open Label Phase: Treatment Sequence AB
arm group type: Experimental
description: Participants will receive Dose 3 of macitentan under fasted conditions (Treatment A) in period 1 followed by Dose 3 of macitentan under fed condition (Treatment B) in period 2 on Day 1 with a washout phase of at least 14 days between the two treatment periods.
arm group label: Part 2: Open Label Phase: Treatment Sequence BA
arm group type: Experimental
description: Participants will receive Treatment B in period 1 followed by Treatment A in period 2 on Day 1 with a washout phase of at least 14 days between the two treatment periods.
intervention type: Drug
intervention name: Macitentan Dose 1
description: Participants will receive Dose 1 of macitentan tablet in Part 1.
arm group label: Part 1: Double Blind Phase
other name: JNJ-67896062
intervention type: Drug
intervention name: Macitentan Dose 2
description: Participants will receive Dose 2 of macitentan tablet in Part 1.
arm group label: Part 1: Double Blind Phase
other name: JNJ-67896062
intervention type: Drug
intervention name: Macitentan Dose 3
description: Participants will receive Dose 2 of macitentan tablet in Part 1 and 2.
arm group label: Part 1: Double Blind Phase
arm group label: Part 2: Open Label Phase: Treatment Sequence AB
arm group label: Part 2: Open Label Phase: Treatment Sequence BA
other name: JNJ-67896062
intervention type: Drug
intervention name: Placebo
description: Participants will receive matching placebo from Day 1 up to Day 13.
arm group label: Part 1: Double Blind Phase
criteria: 
gender: Male
minimum age: 20 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Janssen Pharmaceutical K.K., Japan Clinical Trial
role: Study Director
affiliation: Janssen Pharmaceutical K.K.
facility: 
country: Japan
responsible party type: Sponsor
mesh term: Macitentan
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