Pharmacokinetic Interaction Study of Naronapride with Food, Itraconazole, and Rifampicin in Healthy Subjects

The primary objective of this study is to evaluate the effect of **food**, **itraconazole**, and **rifampicin** on the single-dose pharmacokinetics of **naronapride**. Understanding these interactions is clinically relevant as they can influence the absorption, distribution, metabolism, and excretion of naronapride, potentially affecting its therapeutic efficacy and safety profile. No secondary objectives are specified for this study.

The clinical trial involves a **study population** that includes both male and female participants, with an **age range** category code of 3, indicating a specific age group. The trial population is noted to include a **vulnerable population**, although specific details regarding the nature of this vulnerability are not provided. The sponsor has not disclosed the total number of participants involved in the study. Participants were selected without any specific **medical condition** being a requirement, as indicated by the absence of a medical condition criterion. The sponsor has not provided information on lifestyle considerations such as diet, physical activity, or habits, nor have they specified any key inclusion or exclusion criteria for the trial.

The clinical trial is designed to evaluate the effect of food, **itraconazole**, and **rifampicin** on the single-dose pharmacokinetics of **naronapride**. This study is a Phase 3 trial, which is categorized as a randomized, double-blind, controlled trial. The estimated recruitment start date is October 30, 2025, with an anticipated end date of February 3, 2026. The trial does not involve any specific medical condition, as indicated by the absence of a targeted disease.

Participants will undergo a series of study visits, beginning with an inclusion (screening) visit to assess eligibility based on predefined criteria. Following successful screening, participants will be randomized to receive the investigational product or a control. The trial will include multiple follow-up visits to monitor the pharmacokinetic parameters and ensure participant safety. The end-of-study visit will conclude the trial, where final assessments will be conducted to gather comprehensive data on the investigational product's effects.

The expected length of participant involvement will span the duration of the trial, from the initial screening to the end-of-study visit. Conditions that may lead to early termination from the study include adverse events, non-compliance with study procedures, or withdrawal of consent by the participant. The trial is structured to ensure rigorous data collection and analysis, adhering to ethical standards and regulatory requirements.

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 within the context of a Phase 3 study. The trial is scheduled to commence recruitment on October 30, 2025, with an estimated completion date of February 3, 2026. The efficacy assessment will be conducted using predefined parameters, although specific endpoints and methods for measuring efficacy are not detailed in the available data. The trial will adhere to rigorous standards typical of Phase 3 studies, ensuring that efficacy is evaluated with precision and scientific rigor. The absence of specific endpoints or measurement tools in the provided data suggests that these details will be outlined in the full trial protocol, which will guide the collection and analysis of efficacy data throughout the study duration.