Evaluation of BI 3000202 on Pharmacokinetics of Rosuvastatin and Digoxin in Healthy Volunteers

The primary objective of this study is to evaluate the pharmacokinetic interaction of **BI 3000202** with **rosuvastatin** and **digoxin** in healthy volunteers. This is clinically relevant as it helps to understand how BI 3000202 may influence the absorption, distribution, metabolism, and excretion of these commonly used medications, which is crucial for ensuring safe and effective use in potential future therapeutic applications.

The clinical trial involves **healthy volunteers** as the study population, with both male and female participants included. The age range for participants is categorized as 3, which typically corresponds to adults. The trial does not focus on a vulnerable population. The sponsor has not provided information regarding the total number of participants. Participants were selected based on their general health status, ensuring they are free from any significant medical conditions. No specific lifestyle considerations such as diet or physical activity are highlighted in the available data. The sponsor has not disclosed detailed inclusion or exclusion criteria for this trial.

The clinical trial is designed as a **randomized**, **double-blind**, and **controlled** study, focusing on healthy volunteers to evaluate the pharmacokinetic interactions of BI 3000202 with **rosuvastatin** and **digoxin**. The trial is categorized under Phase 3 and is expected to commence recruitment on November 4, 2025, with an estimated completion date of December 22, 2025. The study will involve a series of visits, beginning with an inclusion visit, where participants will undergo screening to confirm eligibility based on predefined criteria. This visit will ensure that only healthy individuals are enrolled, as the trial is a healthy volunteer trial.

Following the inclusion visit, participants will attend multiple follow-up visits, which are structured to monitor the uptake and interaction of the investigational product with the other medications. These visits will include assessments such as blood sampling, vital signs monitoring, and other relevant clinical evaluations to ensure participant safety and gather necessary data. The end-of-study visit will conclude the trial, where final assessments will be conducted to evaluate the primary and secondary endpoints of the study.

The expected duration of participant involvement is approximately two months, from the initial screening to the end-of-study visit. Participants may be subject to early termination from the study if they experience adverse events, fail to comply with study procedures, or withdraw consent. The trial is conducted under strict adherence to ethical guidelines and regulatory requirements to ensure the safety and well-being of all participants.

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 cannot be provided.

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 in Phase 3 and is scheduled to begin recruitment on November 4, 2025, with an estimated end date of December 22, 2025. The efficacy of the intervention will be assessed through a structured evaluation process. However, specific parameters or endpoints used to evaluate efficacy, such as symptom improvement scores, biomarker levels, or disease remission rates, are not detailed in the available data. Similarly, the methods and schedule for measuring, collecting, and analyzing these efficacy parameters, including any tools or instruments involved, are not specified. The trial is categorized under trial category 1, with a trial category ID of 85088. Further details regarding the primary and secondary endpoints, as well as the main objective of the trial, are not provided in the source material.