Evaluation of the Impact of a High-Fat Meal on the Pharmacokinetics of the Selective MET Kinase Inhibitor DO-2 in Healthy Volunteers

The primary objective of this study is to evaluate the effect of a **high-fat meal** on the pharmacokinetics of the selective **MET kinase inhibitor** DO-2 in subjects who are in good health. Understanding the impact of dietary intake on the pharmacokinetics of DO-2 is clinically relevant as it may influence dosing recommendations and optimize therapeutic efficacy in future clinical applications.

The clinical trial involves **healthy volunteers** as the study population, encompassing both male and female participants. The age range of the participants is categorized as adults, although specific age details are not provided. The trial does not include a vulnerable population. The sponsor has not disclosed the total number of participants involved in the study. Participants were selected based on their general health status as healthy individuals, without any specific lifestyle considerations such as diet or physical activity being highlighted. The sponsor has not provided detailed information regarding the key inclusion or exclusion criteria for this trial.

The clinical trial is designed to evaluate the effect of a high-fat meal on the pharmacokinetics of the selective **MET kinase inhibitor** DO-2 in healthy volunteers. This study is a Phase 3 trial, which is randomized, double-blind, and controlled to ensure the reliability and validity of the results. The trial is expected to commence recruitment on November 25, 2024, and conclude by January 25, 2025, with an overall duration of approximately two months.

Participants will undergo a series of study visits, beginning with an inclusion visit, also known as the screening visit, to assess eligibility based on predefined criteria. This visit will involve a comprehensive evaluation to confirm the health status of the volunteers. 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' response to the intervention and to collect pharmacokinetic data. These visits are crucial for assessing the impact of the high-fat meal on the drug's absorption and metabolism.

The end-of-study visit will mark the conclusion of the participant's involvement in the trial. During this visit, final assessments will be conducted to ensure the safety and well-being of the participants. The expected length of participant involvement is approximately two months, aligning with the overall trial duration. Conditions that may lead to early termination from the study include adverse events, non-compliance with study protocols, or withdrawal of consent by the participant. The trial is structured to maintain the highest ethical standards and ensure the safety of all participants throughout the study period.

The clinical trial documentation does not provide specific details regarding the experimental medication, including its name, pharmaceutical form, dosage, route, or frequency of administration. As such, no detailed description of the experimental treatment can be provided based on the available data.

Similarly, there is no information available about any non-experimental treatments used in the study, such as standard-of-care therapy, placebo, or comparator treatment. Consequently, no description of these treatments can be included.

Additional relevant information about drug administration, dosing schedules, and participant compliance monitoring is also not provided in the source data. Therefore, no further details can be offered regarding these aspects of the clinical trial.

The clinical trial is designed to assess efficacy in a Phase 3 study. The trial is scheduled to begin recruitment on November 25, 2024, with an estimated end date of January 25, 2025. The efficacy assessment will be conducted using predefined primary and secondary endpoints, although specific endpoints are not detailed in the provided 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 trial, utilizing appropriate tools and instruments to ensure accuracy and reliability of the data collected. The analysis will be conducted in accordance with standard clinical trial protocols to evaluate the treatment's impact on the specified medical condition.