Evaluation of Macitentan Dosing on Endothelin-1 Clearance, Endothelial Function, and Hemodynamics in Pulmonary Arterial Hypertension

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 involves participants diagnosed with **Pulmonary Arterial Hypertension**. The study population includes both male and female subjects, with an age range categorized under code "3", which typically represents adults. The trial population was selected to include a vulnerable population, although specific details regarding the total number of participants have not been provided by the sponsor. Participants' general health status, lifestyle considerations such as diet, physical activity, or habits, and specific inclusion or exclusion criteria are not detailed in the available data.

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 3, randomized, double-blind, controlled trial, which aims to provide robust data on the pharmacological impact of Macitentan. The trial is expected to commence recruitment on April 3, 2024, and is projected to conclude by March 11, 2025, indicating an overall duration of approximately 11 months.

Participants will undergo a series of study visits, beginning with an inclusion visit, also known as the screening visit, to assess eligibility based on predefined criteria. Following successful screening, participants will be randomized to receive either the 10 mg or 75 mg dose of Macitentan. Throughout the trial, participants will attend regular follow-up visits to monitor safety, efficacy, and any adverse events. These visits will include assessments of endothelial function and hemodynamic parameters. The end-of-study visit will mark the completion of the trial for each participant, where final evaluations will be conducted to gather comprehensive data on the study endpoints.

The expected length of participant involvement in the trial is contingent upon the study's schedule and the participant's adherence to the protocol. Conditions that may lead to early termination from the study include the occurrence of significant adverse events, non-compliance with study procedures, or withdrawal of consent by the participant. The trial's design ensures that data collected will contribute to understanding the therapeutic potential of Macitentan in managing conditions related to **Pulmonary Arterial Hypertension**. The study's methodology and structured visit schedule are integral to achieving the trial's objectives while maintaining participant safety and data integrity.

The clinical trial documentation does not provide specific details regarding the experimental medication, including its name, pharmaceutical form, dosage, route, and frequency of administration. As such, no detailed description of the experimental treatment can be provided based on the available data.

Similarly, there is no information available about any non-experimental treatments used in the study, such as standard-of-care therapy, placebo, or comparator treatment. Consequently, no description of these treatments can be included.

Additional relevant information about drug administration, dosing schedules, and participant compliance monitoring is also not provided in the source data. Therefore, no further details can be offered regarding these aspects of the clinical trial.

The clinical trial is designed to assess efficacy in a Phase 3 study. The trial is scheduled to begin recruitment on April 3, 2024, with an estimated end date of March 11, 2025. Efficacy will be evaluated using specific parameters or endpoints, although these are not detailed in the provided data. The trial will follow a structured schedule for measuring and collecting data, adhering to the rigorous standards expected in a Phase 3 trial. The methods for analyzing these efficacy parameters will be consistent with clinical trial protocols, ensuring that the results are scientifically valid and reliable. The trial's design and execution will focus on obtaining clear and objective data to determine the efficacy of the intervention under investigation.