Clinical Study to Investigate the Effect of Macitentan on the Concentrations of Rosuvastatin in the Blood of Healthy Male Subjects

Principal Inclusion Criteria: * Signed informed consent in the local language prior to any study-mandated procedure. * Healthy male subjects aged between 18 and 55 years (inclusive) at screening. * No clinically significant findings on the physical examination at screening. * Body mass index of 18.0 to 30.0 kg/m2 (inclusive) at screening. * Systolic blood pressure 100-140 mmHg, diastolic blood pressure 60-90 mmHg, and pulse rate 50-90 beats per minute (inclusive), measured on the dominant arm, after 5 min in the supine position at screening. * 12-lead electrocardiogram (ECG) without clinically relevant abnormalities, measured after 5 min in the supine position at screening. * Hematology and clinical chemistry test results not deviating from the normal range to a clinically relevant extent at screening. * Negative results from urine drug screen and alcohol breath test at screening and Day -1. * Ability to communicate well with the investigator, in the local language, and to understand and comply with the requirements of the study. Principal Exclusion Criteria: * Known allergic reactions or hypersensitivity to macitentan, rosuvastatin, any drug of the same classes, or any of their excipients. * Any contraindication for rosuvastatin treatment. * History or clinical evidence of myopathy. * Subjects of Asian race. * Known hypersensitivity or allergy to natural rubber latex. * Values of hepatic aminotransferase (alanine aminotransferase and aspartate aminotransferase) outside of the normal range at screening. * Hemoglobin or hematocrit outside of the normal range at screening. * History or clinical evidence of any disease and/or existence of any surgical or medical condition, which might interfere with the absorption, distribution, metabolism or excretion of the study treatment(s) (appendectomy and herniotomy allowed, cholecystectomy not allowed). * Previous history of fainting, collapse, syncope, orthostatic hypotension, or vasovagal reactions. * Veins unsuitable for intravenous puncture on either arm (e.g., veins that are difficult to locate, access or puncture, veins with a tendency to rupture during or after puncture). * Previous exposure to macitentan. * Previous exposure to rosuvastatin. * Treatment with another investigational drug within 3 months prior to screening or participation in more than 3 investigational drug studies within 1 year prior to screening. * History or clinical evidence of alcoholism or drug abuse within the 3-year period prior to screening. * Excessive caffeine consumption, defined as ≥ 800 mg per day at screening. * Nicotine intake (e.g., smoking, nicotine patch, nicotine chewing gum or electronic cigarettes) within 3 months prior to screening and inability to refrain from nicotine intake from screening until End-Of-Study (EOS). * Previous treatment with any prescribed medications (including vaccines) or over-the-counter (OTC) medications (including herbal medicines such as St John's Wort, homeopathic preparations, vitamins, and minerals) within 3 weeks prior to first study treatment administration. * Loss of 250 mL or more of blood within 3 months prior to screening. * Positive results from the hepatitis serology, except for vaccinated subjects or subjects with past but resolved hepatitis, at screening. * Positive results from the HIV serology at screening. * Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol. * Legal incapacity or limited legal capacity at screening.