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Search / Trial NCT05959941

A Study of Macitentan in Healthy Chinese Adult Male Participants

Launched by ACTELION · Jul 18, 2023

Trial Information

Current as of August 19, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is looking at a medication called macitentan to see how it affects the body after a single dose is given to healthy adult men from China. The study aims to understand how the body interacts with this drug and its active form, known as aprocitentan. It is currently recruiting participants who are healthy, between the ages of 18 and 45, and meet specific health criteria.

To be eligible, participants need to be medically stable, meaning they should not have significant health issues or abnormal test results that could affect the study. They also need to have a body weight of at least 50 kg and a body mass index (BMI) within a certain range. Participants can expect to undergo a thorough health screening, including physical exams and lab tests, before joining the study. It’s important to note that participants will need to agree not to donate sperm during the study and for 90 days afterward. This study provides a chance to contribute to medical research while ensuring participants’ health and safety are prioritized.

Gender

Male

Eligibility criteria

  • 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

About Actelion

Actelion, a biopharmaceutical company, specializes in the development and commercialization of innovative therapies for pulmonary arterial hypertension and other serious conditions. Established in 1997 and now a part of Johnson & Johnson, Actelion is committed to advancing medical science through rigorous clinical trials and research initiatives. With a focus on improving patient outcomes, the company leverages cutting-edge science and technology to deliver breakthrough treatments that address unmet medical needs, demonstrating a strong dedication to enhancing the quality of life for patients worldwide.

Locations

Beijing, Beijing, China

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Pre dose up to 336 hours post dose on Day 1