Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Naronapride in Idiopathic or Diabetic Gastroparesis: A Phase 1 Randomized, Single-Blind Study

The primary objective of this study is to evaluate the **pharmacokinetics**, **pharmacodynamics**, safety, and tolerability of multiple-dose administration of three different doses of naronapride in patients with moderate idiopathic or diabetic **gastroparesis** compared to healthy subjects. This is clinically relevant as it aims to determine the optimal dosing regimen of naronapride, which could potentially improve gastric motility and alleviate symptoms in patients suffering from gastroparesis, a condition characterized by delayed gastric emptying without an obvious mechanical obstruction.

The clinical trial involves participants diagnosed with **idiopathic or diabetic gastroparesis**. The study population includes both male and female subjects, with an age range spanning from adolescents to adults. The trial population was selected to include a vulnerable population, although specific selection criteria have not been disclosed. The sponsor has not provided information regarding the total number of participants. Participants' general health status, lifestyle considerations such as diet, physical activity, or habits, have not been detailed in the available data.

The clinical trial is a **phase 1** multi-centre, randomized, single-blind, steady-state study designed to evaluate the pharmacokinetics, pharmacodynamics, safety, and tolerability of multiple-dose administration of three different doses of naronapride in patients with moderate **idiopathic or diabetic gastroparesis** compared to healthy subjects. The trial is expected to commence recruitment on May 1, 2025, and conclude by November 30, 2026. The study employs a randomized and controlled design to ensure the reliability and validity of the results, with participants being randomly assigned to different dosing groups or a control group. The single-blind nature of the trial means that participants are unaware of the specific treatment they receive, reducing bias in self-reported outcomes.

Participants will undergo a series of study visits, beginning with an inclusion (screening) visit to assess eligibility based on predefined criteria. This initial visit will involve a comprehensive evaluation to confirm the diagnosis of gastroparesis and ensure the absence of exclusion criteria. Following successful screening, participants will be enrolled in the study and attend multiple follow-up visits to monitor the effects of the treatment. These visits will include assessments of pharmacokinetic and pharmacodynamic parameters, as well as safety evaluations. The end-of-study visit will mark the conclusion of the participant's involvement, during which final assessments will be conducted to gather data on the long-term effects of the treatment.

The expected length of participant involvement in the trial is approximately 18 months, from the initial screening to the end-of-study visit. Conditions that may lead to early termination from the study include adverse events that compromise participant safety, non-compliance with study procedures, or withdrawal of consent. The trial is structured to ensure the collection of comprehensive data while prioritizing participant safety and adherence to ethical standards.

The clinical trial documentation does not provide specific details regarding the **experimental medication** used in the study. Information such as the name, pharmaceutical form, dosage, route, and frequency of administration is not available. Additionally, there is no data on whether the medication is a **paediatric formulation** or if it is classified as an **orphan drug**. The maximum daily dose, total dose, and treatment period are also unspecified.

Details about any **non-experimental treatments** used in the study, such as standard-of-care therapy, placebo, or comparator treatment, are not provided. There is no information on additional relevant aspects of drug administration, dosing schedules, or participant compliance monitoring. The absence of this data limits the ability to describe the treatments comprehensively.

The clinical trial is designed to assess efficacy in a Phase 3 study. The trial is scheduled to commence recruitment on May 1, 2025, with an estimated completion date of November 30, 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 follow a structured timeline to ensure systematic data collection and analysis. The focus will be on evaluating the treatment's impact on the specified medical condition, with results contributing to the understanding of the treatment's effectiveness in a controlled setting.