Pharmacokinetic Evaluation of Three BI 764198 Formulations in Healthy Volunteers: Impact of Food on Drug Absorption

The primary objective of this study is to evaluate the **pharmacokinetics** of three different formulations of BI 764198 in healthy volunteers. This involves assessing how the drug is absorbed, distributed, metabolized, and excreted by the body. Understanding the pharmacokinetics is crucial for determining the optimal formulation that ensures maximum efficacy and safety of the drug. Additionally, the study aims to investigate the influence of food on the uptake of these formulations, which is important for providing guidance on how the medication should be administered in relation to meals.

The clinical trial involves **healthy volunteers** as the study population, encompassing both male and female participants. The age range for participants is categorized as adults, although specific age limits are not provided. The trial does not focus on a vulnerable population, indicating that participants are generally in good health. The sponsor has not disclosed the total number of participants involved in the study. Selection criteria for the trial population, including any lifestyle considerations such as diet or physical activity, have not been specified. The sponsor has not provided detailed information regarding key inclusion or exclusion criteria for this trial.

The clinical trial is designed as a **randomized**, **double-blind**, and controlled study, focusing on the pharmacokinetics of three different formulations of BI 764198 in healthy volunteers. The trial is categorized under Phase 3 and aims to assess how these formulations are absorbed in the body, with a particular interest in the influence of food on this process. The estimated recruitment start date is May 20, 2025, with the trial expected to conclude by June 28, 2025. Participants will be involved in the study for a duration that aligns with the trial's timeline, from recruitment to the end-of-study visit.

The sequence of study visits begins with an inclusion visit, where potential participants undergo screening to ensure they meet the eligibility criteria. This visit is crucial for confirming the health status of volunteers and their suitability for the trial. Following successful inclusion, participants will attend a series of follow-up visits. These visits are structured to monitor the participants' health, collect data on the drug's absorption, and assess any potential side effects. The end-of-study visit marks the conclusion of the participant's involvement, where final assessments are conducted to gather comprehensive data on the study's outcomes.

Participants are expected to adhere to the study protocol throughout their involvement. However, certain conditions may lead to early termination from the study. These conditions include the occurrence of adverse events that compromise participant safety, non-compliance with study procedures, or withdrawal of consent by the participant. The trial is conducted under strict ethical guidelines to ensure the safety and well-being of all participants, with continuous monitoring and evaluation throughout the study duration.

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. Information regarding the administration, dosing schedules, and participant compliance monitoring for these non-experimental treatments is also not available.

Due to the lack of specific information in the source data, further details about the **active substances**, their origin, and the **product authorization status** are not included. The trial documentation does not mention any additional relevant information about drug administration or participant compliance monitoring.

The efficacy assessment in this clinical trial will be conducted in accordance with the trial's phase 3 protocol. The trial is scheduled to commence recruitment on May 20, 2025, with an estimated end date of June 28, 2025. The evaluation of efficacy will be based on predefined primary and secondary endpoints, although specific endpoints are not detailed in the provided data. The trial will utilize scientifically validated methods and instruments to measure these endpoints, ensuring the reliability and accuracy of the collected data. The analysis of efficacy parameters will be performed at designated timepoints throughout the trial duration, adhering to the rigorous standards expected in phase 3 clinical trials. The results will contribute to the understanding of the treatment's effectiveness in the specified medical condition.