Evaluation of Bosentan's Effect on Nerandomilast Pharmacokinetics in Healthy Male Volunteers

The primary objective of this study is to evaluate the pharmacokinetic interaction between **bosentan** and **nerandomilast** in healthy male volunteers. Understanding this interaction is clinically relevant as it may inform dosing strategies and safety considerations when these drugs are co-administered. The study is conducted in a population of healthy individuals to isolate the effects of the drug interaction without the confounding variables introduced by disease states.

The clinical trial involves a study population of **healthy volunteers**. The participants are exclusively male, with an age range corresponding to category code 3, which typically includes adults. The trial does not involve a vulnerable population. The sponsor has not provided information regarding the total number of participants. Selection criteria and lifestyle considerations such as diet, physical activity, or habits have not been specified. The trial population was selected based on the absence of any significant health conditions, as indicated by the focus on healthy volunteers.

The clinical trial is designed as a **randomized**, **double-blind**, and controlled study, focusing on the interaction between bosentan and nerandomilast in healthy male volunteers. The trial is categorized under Phase 3, indicating advanced testing of the drug's efficacy and safety. The estimated recruitment start date is August 5, 2025, with an anticipated end date of September 29, 2025, suggesting a concise trial duration. Participants will be involved in the study for a period that aligns with the trial's overall timeline, with specific involvement duration determined by the study protocol.

The sequence of study visits begins with an inclusion visit, also known as the screening visit, where potential participants are assessed for eligibility based on predefined criteria. This visit ensures that only suitable candidates are enrolled in the trial. Following successful screening, participants will undergo a series of follow-up visits, which are structured to monitor the effects of the drug interaction and gather necessary data. These visits are crucial for evaluating the primary and secondary endpoints of the study. The trial concludes with an end-of-study visit, where final assessments are conducted to ensure participant safety and to collect comprehensive data for analysis.

Participant involvement is expected to last throughout the trial duration, with specific timelines for each visit outlined in the study protocol. Conditions that may lead to early termination from the study include adverse reactions, non-compliance with study procedures, or withdrawal of consent by the participant. The trial is conducted under strict ethical guidelines, ensuring the safety and well-being of all participants while maintaining the integrity of the research data.

No specific information regarding the experimental medication, including its name, pharmaceutical form, dosage, route, and frequency of administration, is provided in the available data. Consequently, a detailed description of the experimental treatment cannot be formulated based on the current dataset.

Similarly, there is no information available about any non-experimental treatments, such as standard-of-care therapy, placebo, or comparator treatment, used in the study. Therefore, a description of these elements is not possible with the given data.

Additional relevant information about drug administration, dosing schedules, and participant compliance monitoring is also absent from the provided data. As such, no further details can be included in this description.

The clinical trial is designed to assess the efficacy of the investigational treatment in a Phase 3 study. The trial is scheduled to commence recruitment on August 5, 2025, with an estimated completion date of September 29, 2025. The efficacy of the treatment will be evaluated using specific parameters or endpoints, although these are not detailed in the provided data. The trial will follow a structured methodology to measure, collect, and analyze these efficacy parameters at predetermined timepoints throughout the study duration. The trial's design and execution will adhere to rigorous scientific standards to ensure the reliability and validity of the efficacy assessments.