Evaluation of the Pharmacokinetic Interaction of Gemfibrozil, Itraconazole, and Phenytoin on IPN60250 Plasma Levels in Healthy Adults

The primary objective of this study is to evaluate the effect of **gemfibrozil**, **itraconazole**, and **phenytoin** on the blood levels of **IPN60250** in healthy adult participants. Understanding these interactions is clinically relevant as it may inform dosing adjustments and safety considerations when these medications are co-administered. The study does not specify any secondary objectives.

The sponsor does not provide information regarding the total number of participants in the clinical trial. The study population includes both **female** and **male** subjects, with an age range category code of 3, which typically corresponds to adults. The trial does not specifically target a vulnerable population. The selection criteria for the trial population, as well as any relevant lifestyle considerations such as diet, physical activity, or habits, are not disclosed. Additionally, the sponsor has not provided details on the general health status of the participants or any key inclusion or exclusion criteria. The medical condition under investigation is not applicable, indicating that the trial may not be focused on a specific disease or health condition.

The clinical trial is designed to evaluate the pharmacokinetic interactions of **gemfibrozil**, **itraconazole**, and **phenytoin** on the blood levels of IPN60250 in healthy adult participants. This study is a Phase 3 trial, employing a randomized, double-blind, and controlled design to ensure the reliability and validity of the results. The trial is expected to commence recruitment on September 30, 2024, and is projected to conclude by December 12, 2024, marking the overall trial duration.

Participants will undergo a sequence of study visits, beginning with an inclusion visit, also known as the screening visit, to assess eligibility based on predefined criteria. Following successful screening, participants will be randomized into different study arms. Throughout the trial, there will be scheduled follow-up visits to monitor the participants' health status and collect necessary data. The end-of-study visit will be conducted to perform final assessments and gather comprehensive data for analysis.

The expected length of participant involvement will span the entire duration of the trial, from the initial screening to the end-of-study visit. However, certain conditions may lead to early termination from the study, such as adverse reactions, non-compliance with study protocols, or withdrawal of consent by the participant. The study is conducted under strict ethical guidelines, ensuring the safety and well-being of all participants throughout the trial process.

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. Consequently, additional relevant information about drug administration, dosing schedules, and participant compliance monitoring is also not included. The absence of these details precludes a comprehensive description of the treatments used in this clinical trial.

The clinical trial is designed to assess efficacy through a structured evaluation process. The trial is categorized as a Phase 3 study, indicating it is in the advanced stages of clinical research. The estimated recruitment start date is September 30, 2024, with an anticipated end date of December 12, 2024. Although specific efficacy parameters such as primary or secondary endpoints are not detailed, Phase 3 trials typically focus on confirming the effectiveness of a treatment, monitoring side effects, and collecting information that will allow the treatment to be used safely. The trial will likely involve systematic data collection and analysis to evaluate the treatment's impact on the disease condition. The methods and schedule for measuring efficacy will be aligned with standard clinical trial practices, ensuring rigorous assessment of the treatment's benefits.