Pharmacokinetic Study of Two Formulations of BI 690517 and the Impact of Probenecid in Healthy Volunteers

The primary objective of this study is to evaluate the **pharmacokinetics** of two different formulations of BI 690517 in healthy individuals. This involves assessing how the drug is absorbed, distributed, metabolized, and excreted in the body. Additionally, the study aims to determine the influence of **probenecid** on the concentration of BI 690517 in the bloodstream. Understanding these parameters is crucial for optimizing dosing regimens and ensuring the safety and efficacy of the drug in future clinical applications.

The clinical trial involves **healthy volunteers** with an age range categorized as adults. The study population includes both male and female participants, and it does not involve any vulnerable populations. The sponsor has not provided information regarding the total number of participants. The trial population was selected based on general health status, ensuring that participants are free from any significant medical conditions. Lifestyle considerations such as diet, physical activity, and habits are not specified. The sponsor has not disclosed specific inclusion or exclusion criteria for this study.

The clinical trial is designed as a **randomized**, **double-blind**, and controlled study, focusing on the pharmacokinetics of two different formulations of BI 690517 in healthy volunteers. The trial will also assess the influence of **probenecid** on the concentration of BI 690517 in the bloodstream. The study is categorized under Phase 3, indicating advanced testing of the investigational product. The estimated recruitment start date is November 12, 2024, with an anticipated end date of December 20, 2024, marking the overall trial duration.

Participants will undergo a sequence of study visits, beginning with an inclusion visit, which serves as the screening phase to determine eligibility based on predefined criteria. Following successful inclusion, participants will be randomized to receive one of the formulations. The study will include several follow-up visits to monitor the pharmacokinetic parameters and ensure participant safety. The end-of-study visit will conclude the trial, where final assessments and data collection will occur.

The expected length of participant involvement is approximately six weeks, encompassing the initial screening, treatment period, and follow-up assessments. Conditions that may lead to early termination from the study include adverse events, non-compliance with study procedures, or withdrawal of consent by the participant. The trial is conducted under strict adherence to ethical guidelines and regulatory requirements to ensure the safety and well-being of all participants.

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 treatment. 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.

The clinical trial is designed to assess efficacy in a Phase 3 study. The trial is scheduled to commence recruitment on November 12, 2024, with an estimated completion date of December 20, 2024. The efficacy assessment will be conducted using predefined parameters, although specific endpoints and methods for measuring efficacy are not detailed in the available data. The trial will follow a structured protocol to ensure the collection and analysis of efficacy data, adhering to the standards expected in a Phase 3 clinical trial. The study will focus on evaluating the treatment's impact on the specified medical condition, utilizing appropriate tools and instruments to measure outcomes. The trial's design and execution will align with regulatory requirements to ensure the reliability and validity of the efficacy results.