Investigation of LEO 158968 on Pharmacokinetics, Safety, and Tolerability in Patients with Gout Flares

The primary objective of this study is to evaluate the **effect**, safety, tolerability, and pharmacokinetics of a single dose of LEO 158968 in subjects experiencing **gout flares**. This investigation is clinically relevant as it aims to assess a new compound that may potentially be used in the treatment of several autoinflammatory diseases, providing insights into its therapeutic potential and safety profile.

The clinical trial involves a total of **6 participants** who are exclusively male, as indicated by the selection criteria. The study population is composed of individuals within the **age range** of 18 to 64 years, which corresponds to the age categories 3 and 4. Participants are selected based on their experience with **gout flares**, a condition characterized by sudden and severe pain in the joints. The trial population includes a vulnerable group, although specific details regarding their general health status or lifestyle considerations such as diet, physical activity, or habits are not provided. The sponsor has not disclosed the main objective of the trial or the principal inclusion criteria.

The clinical trial is designed to evaluate the effect, safety, tolerability, and pharmacokinetics of a single dose of **LEO 158968** in subjects experiencing **gout flares**. 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 August 20, 2024, and is projected to conclude by February 28, 2025. Participants will be involved in the study for a duration that aligns with the trial's timeline, with specific visit schedules outlined to monitor their progress and response to the treatment.

The sequence of study visits includes an initial inclusion (screening) visit, where eligibility criteria are assessed to ensure participants meet the necessary conditions for trial entry. Following successful screening, participants will undergo a baseline visit, where initial measurements and assessments are conducted. Subsequent follow-up visits will be scheduled at predetermined intervals to monitor the participants' health status, treatment effects, and any adverse events. These visits are crucial for collecting data on the pharmacokinetics and safety profile of the investigational compound. The end-of-study visit marks the conclusion of the participant's involvement, where final assessments are conducted to gather comprehensive data on the trial outcomes.

Participants are expected to remain in the study for its entire duration unless specific conditions necessitate early termination. Such conditions may include the occurrence of significant adverse events, withdrawal of consent, or any other medical or ethical reasons deemed appropriate by the study investigators. The trial's design and procedures are structured to ensure the safety and well-being of participants while providing valuable insights into the potential therapeutic benefits of LEO 158968 for treating gout flares.

The clinical trial documentation does not provide specific details regarding the **experimental medication** used in the study. Information such as the name, pharmaceutical form, dosage, route, and frequency of administration is not available. Additionally, there is no data on whether the medication is a **paediatric formulation** or if it is classified as an **orphan drug**. The maximum daily dose, total dose, and treatment period are also unspecified.

Details about any **non-experimental treatments** used in the study, such as standard-of-care therapy, placebo, or comparator treatment, are not provided. There is no information on additional relevant aspects of drug administration, dosing schedules, or participant compliance monitoring. The absence of these details limits the ability to describe the treatment regimen comprehensively.

The clinical trial is designed to assess efficacy in a Phase 3 study. The trial is scheduled to commence recruitment on August 20, 2024, with an estimated completion date of February 28, 2025. Efficacy will be evaluated using specific parameters or endpoints, although these are not detailed in the provided data. The methods and schedule for measuring, collecting, and analyzing these efficacy parameters are not specified. The trial will adhere to rigorous standards typical of Phase 3 studies, ensuring that the data collected is robust and reliable for assessing the efficacy of the intervention under investigation.