Mass Balance Study of [14C]-TEV-56286 Absorption, Metabolism, and Excretion in Healthy Male Subjects Following Multiple Doses of Nonlabeled TEV-56286.

The primary objective of this clinical trial is to investigate the **absorption**, **metabolism**, and **excretion** of a single oral administration of [14C]-TEV-56286 following multiple oral administrations of nonlabeled TEV-56286 in healthy male participants. This study is clinically relevant as it aims to understand the pharmacokinetic profile of TEV-56286, which is crucial for determining its safety and efficacy in future therapeutic applications.

The clinical trial involves a study population consisting of **healthy participants** who are exclusively male. The age range of the participants spans from young adults to middle-aged individuals. The trial does not include any vulnerable populations. The sponsor has not provided information regarding the total number of participants involved in the study. Participants were selected based on their general health status, ensuring they are free from any significant medical conditions. There are no specific lifestyle considerations such as diet or physical activity mentioned for this trial. The sponsor has not disclosed any key inclusion or exclusion criteria for the study.

The clinical trial is designed as a **Phase 1 open-label mass balance study** to evaluate the absorption, metabolism, and excretion of a single oral administration of [14C]-TEV-56286 following multiple oral administrations of nonlabeled TEV-56286 in healthy male participants. The trial is scheduled to commence on October 1, 2024, with an estimated completion date of November 28, 2024. The study involves a sequence of visits, beginning with an inclusion visit where participants are screened for eligibility based on specific criteria. This is followed by multiple study visits where the investigational product is administered, and various pharmacokinetic parameters are assessed. The trial concludes with an end-of-study visit to evaluate the overall outcomes and ensure participant safety.

Participants are expected to be involved in the study for the entire duration, from the initial screening to the final visit, unless specific conditions necessitate early termination. Such conditions may include adverse reactions to the investigational product or non-compliance with study protocols. The trial's methodology does not include randomization or blinding, as it is an open-label study, allowing for direct observation of the investigational product's effects. The study aims to gather comprehensive data on the pharmacokinetics of TEV-56286, contributing valuable insights into its metabolic profile in healthy individuals.

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 both experimental and non-experimental treatments is not available in the provided data.

The clinical trial is designed to assess efficacy in a Phase 3 study. The trial is scheduled to commence recruitment on October 1, 2024, with an estimated completion date of November 28, 2024. The efficacy assessment will be conducted through a series of pre-defined 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 trial's design and execution will adhere to the standards expected in a Phase 3 clinical trial, focusing on the rigorous evaluation of the investigational product's efficacy.