Pharmacokinetic Study of [14C]DLX313 (Minzasolmin) in Healthy Male Subjects with Parkinson’s Disease

The primary objective of this study is to evaluate the **absorption**, distribution, metabolism, and excretion (ADME) and pharmacokinetics of DLX313 (minzasolmin) following a single oral dose of [14C]DLX313 in healthy male participants. Understanding the ADME profile and pharmacokinetics of DLX313 is clinically relevant as it provides critical insights into the drug's behavior in the body, which is essential for determining appropriate dosing regimens and ensuring safety and efficacy in future therapeutic applications, particularly for conditions such as **Parkinson’s Disease**.

The clinical trial focuses on **Parkinson’s Disease** and involves a study population exclusively composed of male participants. The age range of the participants falls within the category code "3," which typically corresponds to adults, although specific age details are not provided. The trial does not include a vulnerable population, and the selection criteria for participants have not been disclosed. The sponsor has not provided information regarding the total number of participants. No specific lifestyle considerations, such as diet or physical activity, have been mentioned in the available data.

The clinical trial is designed as a **Phase I**, open-label, non-randomized study to evaluate the absorption, distribution, metabolism, and excretion, as well as the pharmacokinetics of DLX313 (minzasolmin) following a single oral dose of [14C]DLX313 in healthy male participants. The study focuses on understanding the pharmacokinetic profile of the investigational drug in the context of **Parkinson's Disease**. The trial is expected to commence recruitment on July 17, 2024, and is estimated to conclude by August 15, 2024.

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 ensure participants meet the study's inclusion requirements and do not fall under any exclusion criteria. Following the screening, eligible participants will receive a single oral dose of the investigational product. Subsequent follow-up visits will be scheduled to monitor the participants' health status and collect necessary pharmacokinetic data. These visits are crucial for assessing the drug's absorption, distribution, metabolism, and excretion parameters.

The end-of-study visit will mark the conclusion of the participant's involvement in the trial. This visit will include a final assessment to ensure the safety and well-being of the participants post-dosing. The expected length of participant involvement is determined by the time required to complete the dosing and follow-up assessments, which is anticipated to be within the trial's overall duration. Participants may be subject to early termination from the study if they experience adverse events that compromise their safety or if they withdraw consent at any point during the trial.

The clinical trial involves the administration of an **experimental medication**. However, specific details regarding the name, pharmaceutical form, dosage, route, and frequency of administration 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 treatment. 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 designed to assess efficacy in a Phase 3 study. The trial is scheduled to begin recruitment on July 17, 2024, with an estimated end date of August 15, 2024. 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 protocol to ensure the collection and analysis of efficacy data is consistent and reliable. The study will adhere to the standards expected in a Phase 3 trial, focusing on the evaluation of treatment effects in a larger patient population. The trial's design and execution will be aligned with regulatory requirements to ensure the validity and reliability of the efficacy outcomes.