A Dose-Ranging Study to Evaluate the Effects of Oral Macitentan 10 mg versus 75 mg on Endothelin-1 Clearance, Endothelial Function, and Hemodynamics in Healthy Participants

The primary objective of this clinical study is to compare the impact of multiple-dose oral administration of **Macitentan**, at doses of 10 mg versus 75 mg, on **Endothelin-1** clearance, endothelial function, and hemodynamics in healthy participants. This investigation is clinically relevant as it aims to elucidate the dose-dependent effects of Macitentan, a medication used in the management of **Pulmonary Arterial Hypertension**. Understanding these effects is crucial for optimizing therapeutic strategies and improving patient outcomes in this condition.

The clinical trial focuses on **Pulmonary Arterial Hypertension** and includes a study population comprising both male and female participants. The age range of the participants is categorized under code "3," which typically represents adults. The trial population includes a vulnerable population, indicating that special considerations are in place for their protection. The sponsor has not provided information regarding the total number of participants. The selection criteria for the trial population, as well as any specific lifestyle considerations such as diet, physical activity, or habits, have not been disclosed. Key inclusion or exclusion criteria are also not specified by the sponsor.

The clinical trial is designed to evaluate the effects of multiple-dose oral administration of **macitentan** at doses of 10 mg and 75 mg on endothelin-1 clearance, endothelial function, and hemodynamics in healthy participants. This study is a Phase 2, randomized, double-blind, controlled trial, which aims to provide insights into the pharmacodynamics and safety profile of the drug. The trial is expected to commence on February 10, 2025, and conclude by September 26, 2025, with the total duration of participant involvement being approximately seven months.

Participants will undergo a series of study visits, beginning with an inclusion (screening) visit to assess eligibility based on predefined criteria. This initial visit will involve a comprehensive evaluation, including medical history, physical examination, and laboratory tests. Following successful screening, participants will be randomized to receive either 10 mg or 75 mg of macitentan. Subsequent follow-up visits will be scheduled at regular intervals to monitor drug efficacy and safety, assess hemodynamic parameters, and evaluate endothelial function. These visits will include clinical assessments, blood sampling, and other relevant diagnostic procedures.

The end-of-study visit will mark the conclusion of the participant's involvement in the trial. During this visit, final assessments will be conducted to ensure participant safety and to gather data for the study's endpoints. Participants may be withdrawn from the study prematurely if they experience adverse events that compromise their safety, fail to comply with study procedures, or withdraw consent. The trial's design and procedures are structured to ensure rigorous data collection while maintaining participant safety and adherence to ethical standards.

In this clinical trial, the experimental medication and non-experimental treatments have not been specified in the provided data. Therefore, a detailed description of the **experimental medication**, including its name, pharmaceutical form, dosage, route, and frequency of administration, cannot be provided. Similarly, information regarding any non-experimental treatments, such as standard-of-care therapy, placebo, or comparator treatment, is not available.

Due to the absence of specific details, additional relevant information about drug administration, dosing schedules, and participant compliance monitoring cannot be included. The description of the treatments used in this clinical trial remains incomplete based on the current data.

The clinical trial is in Phase 2 and is scheduled to begin recruitment on February 10, 2025, with an estimated end date of September 26, 2025. Efficacy will be assessed using specific parameters or endpoints, although these are not detailed in the provided data. The methods and schedule for measuring, collecting, and analyzing these efficacy parameters are not specified. The trial's primary and secondary endpoints, as well as any tools or instruments involved in efficacy assessments, are not mentioned in the available information. The trial is categorized under trial category 1, with a trial category ID of 68331.