Evaluation of Safety, Tolerability, and Pharmacokinetics of Tideglusib in Patients with Hepatic Impairment Compared to Healthy Controls

The primary objective of this study is to assess the **safety**, **tolerability**, and **pharmacokinetics** of tideglusib in subjects with **hepatic impairment** compared to healthy subjects. Evaluating these parameters is clinically relevant as it helps determine the appropriate dosing and potential risks of tideglusib in patients with liver dysfunction, ensuring safe and effective treatment options for this population.

The clinical trial involves a study population comprising both **healthy subjects** and individuals with **hepatic impairment**. The age range of participants is categorized as adults, and the trial includes both male and female subjects. The selection process for the trial population has not been disclosed by the sponsor, and the total number of participants is not provided. The study does not focus on a vulnerable population, and no specific lifestyle considerations such as diet, physical activity, or habits have been highlighted. Key inclusion or exclusion criteria have not been specified in the available data.

The clinical trial is designed to evaluate the **safety**, tolerability, and pharmacokinetics of tideglusib in subjects with **hepatic impairment** compared to healthy subjects. This study is a Phase 3, randomized, double-blind, controlled trial. The estimated recruitment start date is March 31, 2025, with an anticipated end date of January 5, 2026. The trial will involve a series of study visits, beginning with an inclusion (screening) visit to assess eligibility based on predefined criteria. Participants will be randomly assigned to receive either the investigational product or a control, with neither the participants nor the investigators aware of the group assignments to maintain blinding.

Throughout the trial, participants will attend scheduled follow-up visits to monitor their health status, assess the drug's effects, and ensure adherence to the study protocol. These visits will include various assessments such as laboratory tests, physical examinations, and questionnaires to gather data on the drug's pharmacokinetics and any adverse events. The end-of-study visit will occur after the final dose, where comprehensive evaluations will be conducted to conclude the participant's involvement in the trial.

The expected length of participant involvement will vary depending on the individual's response to the treatment and adherence to the study protocol. Conditions that may lead to early termination from the study include significant adverse reactions, non-compliance with study procedures, or withdrawal of consent by the participant. The trial aims to provide valuable insights into the drug's profile in the target population, contributing to the understanding of its potential therapeutic benefits and risks.

No specific information regarding the experimental medication, including its name, pharmaceutical form, dosage, route, and frequency of administration, is available from the provided data. Consequently, a detailed description of the experimental treatment cannot be provided.

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 treatments cannot be included.

Additional relevant information about drug administration, dosing schedules, and participant compliance monitoring is not provided in the data. As such, these details cannot be elaborated upon in this context.

The clinical trial is designed to assess efficacy in a Phase 3 study. The trial is scheduled to begin recruitment on March 31, 2025, with an estimated end date of January 5, 2026. The efficacy assessment will be conducted using predefined primary and secondary endpoints, 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 efficacy parameters will be measured at various timepoints throughout the study, utilizing validated tools and instruments appropriate for the condition under investigation. The analysis will be conducted in accordance with standard clinical trial protocols to ensure the reliability and validity of the results.