Evaluation of the Impact of a High-Calorie, High-Fat Meal on the Bioavailability of 40 mg Extended-Release Deucrictibant in Hereditary Angioedema Patients

The primary objective of this study is to evaluate the **bioavailability** of a 40 mg extended-release (XR) deucrictibant oral formulation when administered as a single dose in healthy subjects, specifically assessing the influence of a high-calorie, high-fat meal. Understanding the impact of dietary intake on the bioavailability of deucrictibant is clinically relevant for optimizing dosing regimens in the management of **hereditary angioedema (HAE)**, a condition characterized by recurrent episodes of severe swelling. No secondary objectives are provided for this study.

The clinical trial focuses on participants diagnosed with **hereditary angioedema (HAE)**. The study population includes both male and female subjects, encompassing age ranges from adolescents to adults. The trial involves a vulnerable population, although specific details regarding the total number of participants have not been provided by the sponsor. Participants were selected based on criteria that ensure a representative sample of individuals affected by the condition. Lifestyle considerations such as diet, physical activity, or habits have not been specified. The trial aims to gather data from a diverse group to enhance the understanding of HAE across different demographics.

The clinical trial is designed as a **randomized**, open-label, two-period, cross-over study to evaluate the influence of a high-calorie, high-fat meal on the bioavailability of a 40 mg extended-release deucrictibant oral formulation. The study will involve healthy subjects and aims to provide insights into the pharmacokinetic profile of the drug under different dietary conditions. The trial is expected to commence on December 30, 2024, and conclude by February 19, 2025, with the total duration of the trial spanning approximately two months.

Participants will undergo a sequence of study visits, beginning with an inclusion visit, also known as the screening visit, where eligibility criteria will be assessed. This visit will ensure that only suitable candidates are enrolled in the study. Following the screening, participants will be randomized into two groups to receive the study drug under fed and fasted conditions in a cross-over manner. Each treatment period will be separated by a washout phase to eliminate any carryover effects. Follow-up visits will be scheduled to monitor the participants' health and collect necessary data on the drug's bioavailability. The end-of-study visit will mark the conclusion of the participant's involvement, where final assessments will be conducted to ensure the safety and well-being of the subjects.

The expected length of participant involvement is approximately two months, aligning with the overall trial duration. Conditions that may lead to early termination from the study include adverse events, non-compliance with study procedures, or withdrawal of consent by the participant. The study is focused on understanding the impact of dietary intake on the pharmacokinetics of the drug, which is relevant for the management of **hereditary angioedema**. The trial will adhere to rigorous scientific and ethical standards to ensure the validity and reliability of the results.

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 clinical trial, there is no mention of any **non-experimental treatments** such as standard-of-care therapy, placebo, or comparator treatment being used alongside the experimental medication. The data does not provide details on any additional relevant information about drug administration, dosing schedules, or participant compliance monitoring. Consequently, the trial documentation lacks comprehensive information on the treatment protocols and participant management strategies.

The clinical trial is designed to assess efficacy in a Phase 3 study. The trial is scheduled to commence recruitment on December 30, 2024, with an estimated completion date of February 19, 2025. The efficacy assessment will be conducted using predefined primary and secondary endpoints, although specific endpoints are not detailed in the provided data. The trial will follow a structured methodology to ensure the accurate collection and analysis of efficacy data. The schedule for measuring and collecting efficacy parameters will be aligned with the trial's timeline, ensuring that data is gathered at appropriate intervals to evaluate the treatment's impact effectively. The analysis will be conducted using scientifically validated methods to ensure the reliability and validity of the results. The trial's design and execution will adhere to rigorous standards to provide meaningful insights into the treatment's efficacy.