Pharmacokinetic Interaction Study of Vicadrostat and Empagliflozin in Healthy Male Volunteers

The primary objective of this study is to evaluate the pharmacokinetic interaction between **vicadrostat** and **empagliflozin** when administered separately and in combination in healthy male volunteers. Understanding the interaction between these two compounds is clinically relevant as it may inform dosing strategies and safety profiles for potential therapeutic use. No secondary objectives are specified for this study.

The clinical trial involves **healthy volunteers** as the study population. The trial is exclusively composed of male participants, with an age range categorized under code "3," which typically corresponds to a specific adult age group. The sponsor has not provided the total number of participants involved in the study. The selection process for the trial population is not detailed, and there is no information regarding specific lifestyle considerations such as diet, physical activity, or habits. The trial does not include a vulnerable population, and no significant inclusion or exclusion criteria have been disclosed by the sponsor.

The clinical trial is designed as a **randomized**, **double-blind**, and **controlled** study, focusing on healthy male volunteers. The primary aim is to compare the pharmacokinetics of vicadrostat and empagliflozin when administered separately and in combination. The trial is categorized under Phase 3, indicating advanced stages of clinical research. The estimated duration of the trial spans from July 2, 2025, to August 9, 2025, with participant involvement expected to last throughout this period unless early termination criteria are met.

Participants will undergo a sequence of study visits, beginning with an inclusion visit, also known as the screening visit. This initial visit is crucial for assessing eligibility based on predefined inclusion and exclusion criteria. Following successful screening, participants will be randomized into different study arms. Subsequent follow-up visits will be scheduled to monitor the participants' health status, adherence to the study protocol, and any adverse events. These visits are essential for collecting data on the primary and secondary endpoints of the trial. The end-of-study visit will mark the conclusion of the participant's involvement, where final assessments will be conducted to ensure participant safety and gather comprehensive data for analysis.

Participant involvement is expected to last for the entire duration of the trial, approximately five weeks, unless specific conditions necessitate early withdrawal. Such conditions may include significant adverse reactions, non-compliance with the study protocol, or withdrawal of consent by the participant. The trial's design and procedures are structured to ensure the integrity of the data collected while prioritizing participant safety and adherence to ethical standards.

The clinical trial involves the administration of an **experimental medication**. However, specific details regarding the name, pharmaceutical form, dosage, route, and frequency of administration of the experimental medication are not provided in the available data. The trial documentation does not specify whether the medication is a **paediatric formulation** or if it is classified as an **orphan drug**. Additionally, there is no information on the maximum daily dose, total dose, or treatment period for the experimental medication.

In addition to the experimental medication, the trial may include the use of **non-experimental treatments** such as standard-of-care therapy, placebo, or comparator treatments. However, the data does not provide explicit details about these treatments, including their names, dosages, or administration routes. The trial documentation does not specify any additional relevant information about drug administration, dosing schedules, or participant compliance monitoring.

No specific details regarding the assessment of efficacy in the clinical trial are provided in the source data. Information on parameters or endpoints, methods, schedule for measuring, collecting, and analyzing efficacy parameters, as well as tools or instruments involved in efficacy assessments, is not available. The trial is identified as a Phase 3 study, with an estimated recruitment start date of July 2, 2025, and an estimated end date of August 9, 2025.