Evaluation of Pharmacokinetics, Safety, and Tolerability of BIA 28-6156 in Patients with Parkinson's Disease and Renal Impairment

The primary objective of this Phase I, open-label study is to evaluate the **pharmacokinetics**, safety, and tolerability of BIA 28-6156 in participants with varying degrees of **renal impairment**. This is clinically relevant as it aims to understand how renal function affects the drug's absorption, distribution, metabolism, and excretion, which is crucial for optimizing dosing regimens in patients with **Parkinson's disease** who may have compromised renal function. No secondary objectives are provided for this study.

The clinical trial involves participants diagnosed with **Parkinson's disease**. The study population includes both male and female subjects, with an age range spanning from 18 to 64 years. The trial does not focus on a vulnerable population. The sponsor has not provided information regarding the total number of participants. Selection criteria and lifestyle considerations such as diet, physical activity, or habits have not been specified. The trial population was selected to include adults within the specified age range, without any additional key inclusion or exclusion criteria being highlighted by the sponsor.

The clinical trial is a **Phase I, open-label study** designed to evaluate the pharmacokinetics, safety, and tolerability of BIA 28-6156 in participants with varying degrees of renal impairment. The study focuses on individuals diagnosed with **Parkinson's disease**. The trial is set to commence on August 26, 2025, with an estimated completion date of July 29, 2026. The trial is categorized under Phase 3, indicating its advanced stage in the clinical research process.

Participants will undergo a series of study visits, beginning with an inclusion (screening) visit to assess eligibility based on predefined criteria. This initial visit will involve a comprehensive evaluation to ensure participants meet the necessary conditions for trial inclusion. Following the screening, participants will attend scheduled follow-up visits, which are designed to monitor the drug's effects, assess safety parameters, and collect pharmacokinetic data. These visits will occur at regular intervals throughout the trial duration. The end-of-study visit will mark the conclusion of the participant's involvement, where final assessments will be conducted to gather conclusive data on the drug's impact.

The expected length of participant involvement will span the entire trial duration, from the initial screening to the end-of-study visit. However, certain conditions may necessitate early termination from the study, such as adverse reactions, non-compliance with study protocols, or withdrawal of consent by the participant. The trial's design and procedures are structured to ensure the collection of robust and reliable data, contributing to the understanding of BIA 28-6156's pharmacokinetics and safety profile in the context of Parkinson's disease and renal impairment.

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 is not possible with the given data.

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 designed to assess efficacy in a Phase 3 study. The trial is scheduled to commence recruitment on August 26, 2025, with an estimated completion date of July 29, 2026. The efficacy assessment will be conducted through a series of predefined parameters, although specific endpoints are not detailed in the available data. The trial will follow a structured timeline to ensure systematic data collection and analysis. The methodology for measuring efficacy will adhere to standard clinical trial protocols, utilizing validated tools and instruments where applicable. The trial's design aims to provide robust and reliable data to evaluate the treatment's effectiveness within the specified timeframe.