Evaluation of Fisetin Pharmacokinetics, Safety, and Efficacy in Multimorbidity and Healthy Subjects: A Phase I/IIa Clinical Trial

The primary objective of this study is to evaluate the **pharmacokinetics**, safety, and efficacy of fisetin in individuals with **multimorbidity** and healthy participants. Understanding the pharmacokinetics of fisetin is clinically relevant as it provides insights into the absorption, distribution, metabolism, and excretion of the compound, which are crucial for determining appropriate dosing regimens. Assessing safety is essential to ensure that fisetin does not produce adverse effects, while evaluating efficacy will determine its potential therapeutic benefits. No secondary objectives are specified for this study.

The clinical trial involves a study population comprising both **male** and **female** participants, with an age range that includes young adults and middle-aged individuals. The trial encompasses individuals with **multimorbidity** as well as those who are **healthy**. The sponsor has not provided information regarding the total number of participants. The selection process for the trial population is not specified, and there are no details on lifestyle considerations such as diet, physical activity, or habits. The trial does not focus on a vulnerable population. Key inclusion or exclusion criteria have not been disclosed by the sponsor.

The clinical trial is designed to evaluate the **pharmacokinetics**, safety, and efficacy of fisetin in individuals with **multimorbidity** and healthy participants. This study is structured as a phase I and pilot phase IIa trial, with an estimated recruitment start date of June 1, 2024, and an anticipated completion by December 31, 2026. The trial will employ a randomized, double-blind, controlled design to ensure the reliability and validity of the results. Participants will be randomly assigned to either the treatment group receiving fisetin or a control group, with neither the participants nor the investigators aware of the group assignments to minimize bias.

The sequence of study visits will begin with an inclusion visit, where potential participants will undergo a screening process to determine eligibility based on predefined criteria. Following successful inclusion, participants will attend a series of follow-up visits at specified intervals to monitor their response to the treatment and assess any adverse effects. These visits will include comprehensive evaluations, such as physical examinations, laboratory tests, and questionnaires, to gather data on the primary and secondary endpoints of the study. The end-of-study visit will mark the conclusion of the participant's involvement, where final assessments will be conducted to evaluate the overall outcomes of the trial.

The expected length of participant involvement will vary depending on the specific phase of the trial they are enrolled in, with the entire study spanning approximately two and a half years. Conditions that may lead to early termination from the study include the occurrence of significant adverse events, non-compliance with study protocols, or withdrawal of consent by the participant. The trial's design and procedures are meticulously planned to ensure the collection of high-quality data while prioritizing the safety and well-being of all participants involved.

The clinical trial involves the administration of an **experimental medication**. However, specific details regarding the name, pharmaceutical form, dosage, route, and frequency of administration of the experimental medication are not provided in the available data. The trial documentation does not specify whether the medication is a **paediatric formulation** or if it is classified as an **orphan drug**. Additionally, there is no information on the maximum daily dose, total dose, or treatment period for the experimental medication.

In addition to the experimental medication, the trial may include the use of **non-experimental treatments** such as standard-of-care therapy, placebo, or comparator treatments. However, the data does not provide explicit details about these treatments. Information regarding the administration, dosing schedules, and participant compliance monitoring for these non-experimental treatments is also not available.

The clinical trial is scheduled to commence recruitment on June 1, 2024, with an estimated completion date of December 31, 2026. The trial is categorized under phase 9, indicating an advanced stage of clinical research. Efficacy assessments will be conducted throughout the trial period, although specific parameters or endpoints for evaluating efficacy are not detailed in the provided data. The trial will adhere to a structured timeline to ensure systematic data collection and analysis. The absence of explicit endpoints or measurement tools in the source material suggests that these details will be defined in the comprehensive trial protocol, which will guide the evaluation of treatment efficacy. The trial's design will likely incorporate standard methodologies for assessing clinical outcomes, consistent with the phase and category of the study.