Evaluation of [11C]Savolitinib Brain Penetration in Healthy Volunteers

The primary objective of this clinical trial is to evaluate the extent to which **[11C]savolitinib** penetrates the brain in healthy volunteers. Understanding the brain penetration of this compound is clinically relevant as it may provide insights into its potential therapeutic applications and safety profile in neurological conditions. No secondary objectives are specified for this study.

The clinical trial involves **healthy volunteers** as the study population, encompassing both male and female participants. The age range of the participants includes individuals from the categories of young adults and adults. The sponsor has not provided the total number of participants involved in the trial. The selection of the trial population does not include any vulnerable groups. There are no specific lifestyle considerations such as diet, physical activity, or habits mentioned for the participants. The sponsor has not disclosed detailed information regarding the key inclusion or exclusion criteria for this study.

The clinical trial is designed to evaluate the extent to which **[11C]savolitinib** penetrates the brain in healthy participants. This study is a Phase 3 trial, employing a **randomized**, **double-blind**, and **controlled** methodology to ensure the reliability and validity of the results. The trial is expected to commence recruitment on March 27, 2024, and conclude by June 28, 2024, with the overall duration spanning approximately three 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. Following successful screening, participants will be randomized into different study arms. The trial will include several follow-up visits, during which various assessments and measurements will be conducted to monitor the pharmacokinetics of the investigational compound and its distribution within the brain. The end-of-study visit will mark the completion of the trial for each participant, where final evaluations will be performed to gather comprehensive data on the study's primary and secondary endpoints.

The expected length of participant involvement is contingent upon the trial's schedule, with each participant anticipated to be involved for the entire duration of the study. However, certain conditions may necessitate early termination from the study, such as adverse events, non-compliance with study protocols, or withdrawal of consent by the participant. The trial is conducted under strict adherence to ethical guidelines and regulatory requirements to ensure the safety and well-being of all participants.

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 this study, there is no mention of any **non-experimental treatments** such as standard-of-care therapy, placebo, or comparator treatment being used. The data does not provide details on any additional relevant information about drug administration, dosing schedules, or participant compliance monitoring. The absence of these details suggests that the trial documentation may be incomplete or that such information is not applicable to this particular study.

The clinical trial is designed to assess efficacy in a Phase 3 study. The trial is scheduled to begin recruitment on March 27, 2024, with an estimated end date of June 28, 2024. The efficacy assessment will be conducted through a series of pre-defined parameters, 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 methods for measuring and analyzing efficacy will adhere to standard clinical trial protocols, ensuring the reliability and validity of the results. The trial's design and execution will be aligned with regulatory requirements and scientific standards to accurately evaluate the treatment's efficacy.