Investigation of Pharmacokinetic Interactions Between BIA 28-6156, Clarithromycin, Midazolam, and Dabigatran Etexilate in Healthy Subjects

The primary objective of this study is to evaluate the **drug-drug interaction** between BIA 28-6156 and three other medications: **clarithromycin**, **midazolam**, and **dabigatran etexilate** in healthy participants. Understanding these interactions is clinically relevant as it helps to ensure the safety and efficacy of BIA 28-6156 when co-administered with these commonly used drugs. The study focuses on healthy volunteers to establish a baseline understanding of these interactions without the confounding effects of underlying health conditions.

The clinical trial involves **healthy volunteers** as the study population, encompassing both male and female participants. The age range of the participants falls between 18 to 64 years, indicating a focus on adult individuals. The trial does not include a vulnerable population, ensuring that the participants are generally in good health. The sponsor has not provided information regarding the total number of participants involved in the study. Selection criteria and lifestyle considerations such as diet, physical activity, or habits have not been specified. The absence of specific inclusion or exclusion criteria suggests a broad approach to participant selection within the defined age and health parameters.

The clinical trial is designed to evaluate the **drug-drug interaction** between BIA 28-6156 and other medications, including clarithromycin, midazolam, and dabigatran etexilate, in healthy participants. This study is a Phase 3 trial, which is randomized, double-blind, and controlled to ensure the reliability and validity of the results. The trial is expected to commence recruitment on April 1, 2025, and is estimated to conclude by July 31, 2025, making the overall duration approximately four months.

Participants will undergo a series of study visits, beginning with an inclusion visit, also known as the screening visit, where eligibility criteria will be assessed. This visit is crucial for ensuring that only suitable candidates are enrolled in the study. Following the screening, participants will attend multiple follow-up visits, which are scheduled to monitor the effects of the drug interactions and ensure participant safety. These visits will include assessments such as physical examinations, laboratory tests, and other relevant evaluations. The end-of-study visit will mark the conclusion of the participant's involvement, where final assessments will be conducted to gather comprehensive data on the study's outcomes.

The expected length of participant involvement is aligned with the trial's duration, approximately four months, unless early termination is warranted. Conditions that may lead to early termination include adverse events, non-compliance with study protocols, or withdrawal of consent by the participant. The study is conducted under strict ethical guidelines to ensure the safety and well-being of all participants throughout the trial period.

The clinical trial involves the administration of an **experimental medication**. However, specific details regarding the name, pharmaceutical form, dosage, route, and frequency of administration 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.

The clinical trial is designed to assess the efficacy of the investigational treatment in a Phase 3 study. The trial is scheduled to commence recruitment on April 1, 2025, with an estimated completion date of July 31, 2025. The efficacy of the treatment will be evaluated using specific parameters or endpoints, although these have not been detailed in the provided data. The trial will follow a structured methodology to ensure the accurate collection and analysis of efficacy data, adhering to the standards expected in a Phase 3 clinical trial. The trial's design and execution will be aligned with regulatory requirements to ensure the reliability and validity of the efficacy assessments.