A Study of Macitentan in Healthy Chinese Adult Male Participants

Actelion Pharmaceuticals

Status and phase

Enrolling

Phase 1

Conditions

Healthy

Treatments

Drug: Placebo

Drug: Macitentan

Study type

Interventional

Funder types

Industry

Identifiers

NCT05959941

CR109324

67896062PAH1009 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

12 estimated patients

Sex

Male

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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