Pharmacokinetic Evaluation of Stiripentol in Patients with Renal Impairment Versus Healthy Controls: An Open-Label Phase I Study

The primary objective of this open-label, Phase I study is to assess and compare the **pharmacokinetic** parameters of stiripentol following multiple oral administrations of 1000 mg in patients with renal impairment and in matching controls with normal renal function. This evaluation is clinically relevant as it aims to understand how renal impairment affects the absorption, distribution, metabolism, and excretion of stiripentol, which is crucial for optimizing dosing regimens and ensuring safety and efficacy in this patient population.

The clinical trial involves **patients with renal impairment** and includes both male and female participants. The study population encompasses individuals from two age categories, specifically adults and older adults. The trial does not focus on a vulnerable population. The sponsor has not provided information regarding the total number of participants. The selection criteria for the trial population, as well as any relevant lifestyle considerations such as diet, physical activity, or habits, have not been disclosed. Key inclusion or exclusion criteria are also not specified in the available data.

The clinical trial is designed as an **open-label**, Phase I study to evaluate and compare the pharmacokinetic parameters following multiple oral administrations of stiripentol 1000 mg in patients with **renal impairment** and matched controls with normal renal function. The trial is scheduled to commence recruitment on July 24, 2023, and is expected to conclude by December 31, 2024. The study will involve a series of visits, beginning with an inclusion visit where participants will be screened for eligibility based on specific criteria related to renal function. This initial visit will ensure that only suitable candidates are enrolled in the trial.

Participants will undergo multiple follow-up visits throughout the study duration to monitor the pharmacokinetic response to the medication and assess any potential adverse effects. These visits are crucial for collecting data on the drug's behavior in the body, particularly in individuals with compromised renal function. The end-of-study visit will mark the conclusion of the participant's involvement, where final assessments will be conducted to gather comprehensive data for analysis.

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 the occurrence of significant adverse events or non-compliance with study protocols. The trial's design and procedures are structured to ensure the collection of robust and reliable data, contributing to a better understanding of stiripentol's pharmacokinetics in the context of renal impairment.

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 absence of specific details, additional relevant information about drug administration, dosing schedules, and participant compliance monitoring cannot be included. The data does not contain any information about the **disease** being studied, the trial's main objective, or any other pertinent details that would typically be included in a clinical trial description.

The clinical trial is a Phase 3 study with an estimated recruitment start date of July 24, 2023, and an estimated end date of December 31, 2024. Efficacy will be assessed through the evaluation of primary and secondary endpoints, although specific endpoints are not detailed in the provided data. The trial will likely involve systematic collection and analysis of efficacy parameters at predetermined timepoints throughout the study duration. The methods and tools for measuring these parameters are not specified in the available information. The trial is categorized under trial category 1, with a trial category ID of 52999.