Pharmacokinetics of BI 456906 in Subjects with Varying Degrees of Renal Impairment and Healthy Controls

The primary objective of this study is to evaluate the pharmacokinetics of **BI 456906** in individuals with varying degrees of **renal impairment** (mild, moderate, and severe) compared to healthy individuals. Understanding how the drug is absorbed, distributed, metabolized, and excreted in these populations is crucial for optimizing dosing regimens and ensuring safety and efficacy in patients with compromised kidney function.

The clinical trial involves a study population comprising both **male** and **female** participants, including individuals with **renal impairment** (mild, moderate, and severe) as well as healthy subjects. The age range of participants spans from 18 to 64 years. The trial includes a vulnerable population, although specific details regarding the selection process or lifestyle considerations such as diet or physical activity are not provided. The sponsor has not disclosed the total number of participants involved in the study. Key inclusion or exclusion criteria are not specified in the available data.

The clinical trial is designed to evaluate the pharmacokinetics of **BI 456906** in individuals with varying degrees of **renal impairment** as well as in healthy participants. This study is a Phase 3, randomized, double-blind, controlled trial. The estimated recruitment start date is May 30, 2024, with an anticipated end date of November 25, 2024. The trial will involve a series of study visits, beginning with an inclusion visit where participants will be screened for eligibility based on specific criteria. This initial visit will assess the health status of the participants and confirm their renal function classification.

Following the inclusion visit, participants will undergo a series of follow-up visits. These visits are structured to monitor the uptake of the investigational product in the bloodstream and to ensure participant safety. The frequency and number of follow-up visits will be determined by the study protocol, which aims to gather comprehensive data on the pharmacokinetics of the drug. The end-of-study visit will conclude the trial for each participant, during which final assessments will be conducted to evaluate the overall impact of the drug and to ensure the well-being of the participants.

The expected length of participant involvement will vary depending on individual response and adherence to the study protocol. Participants may be subject to early termination from the study if they experience adverse effects, fail to comply with study procedures, or withdraw consent. The trial is conducted under strict ethical guidelines to ensure the safety and rights of all participants are upheld throughout the study duration.

In this clinical trial, the experimental medication and non-experimental treatments have not been specified in the provided data. Therefore, a detailed description of the **experimental medication**, including its name, pharmaceutical form, dosage, route, and frequency of administration, cannot be provided. Similarly, information regarding any non-experimental treatments, such as standard-of-care therapy, placebo, or comparator treatment, is not available.

Due to the lack of specific data, additional relevant information about drug administration, dosing schedules, and participant compliance monitoring cannot be detailed. The absence of this information precludes the provision of a comprehensive description of the treatments used in this clinical trial.

The clinical trial is designed to assess efficacy in a Phase 3 study. The trial is scheduled to commence recruitment on May 30, 2024, with an estimated completion date of November 25, 2024. Efficacy will be evaluated using specific parameters or endpoints, although these are not detailed in the provided data. The methods and schedule for measuring, collecting, and analyzing these efficacy parameters are not specified. The trial will adhere to rigorous standards typical of Phase 3 studies, ensuring that the data collected is robust and reliable. The trial's design and execution will follow established clinical protocols to ensure the validity and reliability of the efficacy assessments.