A Study of Macitentan in Healthy Chinese Adult Male Participants

July 18, 2023 updated by: Actelion

A Double-blind, Randomized, Placebo-controlled, Single-dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Macitentan 75 mg in Healthy Chinese Adult Male Participants

The purpose of this study is to assess what macitentan and its active metabolite (aprocitentan) does to the body after single dose administration of macitentan in Chinese healthy adult male participants.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
12

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
      • Beijing, China, 100191
        • Recruiting
        • Peking University Third Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Chinese Male
  • Be health medically stable on the basis of physical examination, medical history, vital signs, 12-lead electrocardiograms (ECG) performed at screening. If there are any abnormalities, they must be considered not clinically relevant and this determination must be recorded in the participant's source documents and initialed by the investigator
  • Be healthy on the basis of clinical laboratory tests performed at screening. If the results of the serum chemistry panel, hematology, or urinalysis are outside the normal reference ranges, the participant may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant. This determination must be recorded in the participant's source documents and initialed by the investigator
  • Body mass index (weight /height^2) between 18.0 and 27.9 kilograms per meter square (kg/m^2) (inclusive), and body weight not less than 50.0 kg
  • Systolic blood pressure (BP) was between 100 and 140 millimeter of mercury (mmHg) and for diastolic BP - between 60 and 90 mmHg (after the participant is supine for 5 minutes and including boundary values)
  • A 12-lead ECG consistent with normal cardiac conduction and function
  • A participant must agree not to donate sperm for the purpose of reproduction during the study and for a minimum 90 days after receiving the last dose of study intervention
  • Must sign an ICF indicating that he understands the purpose of, and procedures required for the study and is willing to participate in the study

Exclusion Criteria:

  • History of or current clinically significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease, hematologic disease, coagulation disorders (including any abnormal bleeding or blood dyscrasias), lipid abnormalities, significant pulmonary disease, including bronchospastic respiratory disease, diabetes mellitus, hepatic or renal insufficiency (creatinine clearance below 80 milliliters per minute (mL/min) calculated using Cockcroft-Gault equation), thyroid disease, neurologic or psychiatric disease, infection, or any other illness that the investigator considers should exclude the participant or that could interfere with the interpretation of the study results
  • Clinically significant abnormal physical examination, vital signs, or 12-lead ECG at screening or at admission to the study site as deemed appropriate by the investigator
  • One or more of the following laboratory abnormalities at screening, defined as Grade 1 or more by the World Health Organisation (WHO )Toxicity Grading Scale for Determining the Severity of Adverse Events, February 2003: aspartate aminotransferase (AST) or alanine transaminase (ALT) greater than or equal to (>=)1.25x upper limit of normal (ULN); Total bilirubin >=1.25x ULN; Hemoglobin less than or equal to (<=)11 grams per deciliter (g/dL)
  • History of malignancy within 5 years before screening (exceptions are squamous and basal cell carcinomas of the skin or malignancy, which is considered cured with minimal risk of recurrence)
  • Known allergies, hypersensitivity, or intolerance to macitentan or its excipients
  • Use of any prescription or nonprescription medication (including vitamins and herbal supplements), except for acetaminophen within 14 days before the first dose of the study intervention is scheduled until completion of the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Macitentan 75 milligrams (mg)
Healthy participants will receive a single-dose of macitentan 75 mg tablet on Day 1 under fed condition.
Drug: Macitentan
Macitentan tablet will be administered orally.
Other Names:
  • JNJ-67896062
Experimental: Placebo
Healthy participants will receive matching placebo tablet on Day 1 under fed condition.
Drug: Placebo
Placebo will be administered orally.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Maximum Observed Plasma Concentration (Cmax) of Macitentan and Aprocitentan
Time Frame: Pre dose up to 336 hours post dose on Day 1
Cmax is the maximum observed plasma concentration of macitentan and aprocitentan.
Pre dose up to 336 hours post dose on Day 1
Time to Maximum Observed Plasma Concentration (Tmax) of Macitentan and Aprocitentan
Time Frame: Pre dose up to 336 hours post dose on Day 1
Tmax is the time to reach maximum observed plasma concentration of macitentan and aprocitentan.
Pre dose up to 336 hours post dose on Day 1
Area Under the Plasma Concentration Time Curve from Time Zero to Time of the Last Quantifiable Concentration (AUC [0-Last]) of Macitentan and Aprocitentan
Time Frame: Pre dose up to 336 hours post dose on Day 1
AUC (0-Last) is the area under the plasma concentration time curve from time 0 to time of the last measurable concentration of macitentan and aprocitentan.
Pre dose up to 336 hours post dose on Day 1
Area Under the Plasma Concentration Time Curve from Time Zero to Infinite time (AUC [0-Infinity]) of Macitentan and Aprocitentan
Time Frame: Pre dose up to 336 hours post dose on Day 1
AUC (0-Infinity) is the area under the plasma concentration time curve from time 0 to infinite time of macitentan and aprocitentan.
Pre dose up to 336 hours post dose on Day 1
Apparent Elimination Half-Life (t1/2) of Macitentan and Aprocitentan
Time Frame: Pre dose up to 336 hours post dose on Day 1
t1/2 is the apparent elimination half-life associated with the terminal slope of the semilogarithmic drug concentration-time curve of macitentan and aprocitentan.
Pre dose up to 336 hours post dose on Day 1
Total Systemic Clearance (CL/F) of Macitentan and Aprocitentan
Time Frame: Pre dose up to 336 hours post dose on Day 1
CL/F is the total systemic clearance following single-dose extravascular administration of macitentan and aprocitentan.
Pre dose up to 336 hours post dose on Day 1
Apparent Volume of Distribution (Vz/F) of Macitentan and Aprocitentan
Time Frame: Pre dose up to 336 hours post dose on Day 1
Vz/F is the apparent volume of distribution based on terminal phase of macitentan and aprocitentan.
Pre dose up to 336 hours post dose on Day 1
Number of Participants with Adverse Events (AEs)
Time Frame: Up to 9 weeks
An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have causal relationship with the intervention.
Up to 9 weeks
Number of Participants with Adverse Events of Special Interest (AESI)
Time Frame: Up to 9 weeks
Number of participants with AESIs will be reported. AESIs includes hypotension, anemia, edema, and liver events.
Up to 9 weeks
Number of Participants with Serious Adverse Events (SAEs)
Time Frame: Up to 9 weeks
Number of participants with SAEs will be reported. A SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect, is suspected transmission of any infectious agent via a medicinal product, is medically important to prevent one of the outcomes listed above.
Up to 9 weeks
Number of Participants with Clinical Laboratory Tests Abnormalities
Time Frame: Up to 9 weeks
Number of participants with clinical laboratory tests (including serum chemistry, hematology, and urinalysis) abnormalities will be reported.
Up to 9 weeks
Number of Participants with Vital Signs Abnormalities
Time Frame: Up to 9 weeks
Number of participants with vital signs (blood pressure, pulse rate, respiratory rate, and temperature [ear or axillary]) abnormalities will be reported.
Up to 9 weeks
Number of Participants with 12-lead Electrocardiogram (ECG) Abnormalities
Time Frame: Up to 9 weeks
Number of participants with 12-lead ECG abnormalities will be reported.
Up to 9 weeks
Number of Participants with Physical Examinations Abnormalities
Time Frame: Up to 9 weeks
Number of participants with physical examinations abnormalities will be reported.
Up to 9 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Actelion

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Actelion Clinical Trial, Actelion

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 5, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 29, 2023

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 29, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 18, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 18, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 25, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 25, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 18, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CR109324
  • 67896062PAH1009 (Other Identifier: Actelion)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan 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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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