Bioavailability Assessment of Deucrictibant Formulations in Hereditary Angioedema: A Phase I, Open-Label, Randomized, Cross-Over Study in Healthy Subjects

The primary objective of this study is to assess the **bioavailability** of different formulations of deucrictibant when administered as a single dose under fasting conditions in healthy subjects. This evaluation is crucial for determining the optimal formulation for therapeutic use, particularly in the context of treating **hereditary angioedema (HAE)**. Understanding the bioavailability of deucrictibant formulations can inform dosing strategies and improve clinical outcomes for patients with HAE.

The clinical trial involves participants diagnosed with **hereditary angioedema (HAE)**. The study population includes both male and female subjects, with an age range categorized as adults. The trial does not specifically target a vulnerable population. The sponsor has not provided information regarding the total number of participants or specific lifestyle considerations such as diet, physical activity, or habits. The selection criteria for the trial population, including any key inclusion or exclusion criteria, have not been disclosed by the sponsor.

The clinical trial is a **Phase I**, open-label, randomized, two-period, cross-over study designed to assess the bioavailability of different formulations of deucrictibant administered as a single dose under fasting conditions. The study targets healthy subjects and aims to provide insights into the pharmacokinetic profile of the drug. The trial is expected to commence recruitment on June 27, 2024, and conclude by August 9, 2024. The study focuses on **hereditary angioedema (HAE)**, a rare genetic condition characterized by recurrent episodes of severe swelling.

Participants will undergo a series of study visits, beginning with an inclusion visit where eligibility is confirmed through screening procedures. This visit will involve a comprehensive assessment to ensure participants meet the study's inclusion criteria and do not fall under any exclusion criteria. Following the inclusion visit, participants will be randomized into different treatment sequences, receiving the investigational product in a cross-over manner. Each treatment period will be separated by a washout phase to prevent carryover effects.

Throughout the trial, follow-up visits will be scheduled to monitor participants' health status, adherence to the study protocol, and any adverse events. These visits are crucial for collecting data on the drug's bioavailability and ensuring participant safety. The end-of-study visit will mark the conclusion of the participant's involvement, where final assessments will be conducted, and any remaining study-related procedures will be completed.

The expected length of participant involvement is determined by the duration of the treatment periods and the washout phase, with the entire participation spanning several weeks. Conditions that may lead to early termination from the study include non-compliance with the study protocol, withdrawal of consent, or the occurrence of significant adverse events that compromise participant safety. The trial's design and procedures are structured to ensure rigorous data collection while prioritizing the well-being of the 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 commence recruitment on June 27, 2024, with an estimated end date of August 9, 2024. The efficacy assessment will be conducted in accordance with the trial's protocol, which is structured to ensure rigorous evaluation of the treatment's impact. Although specific endpoints and methods for measuring efficacy are not detailed, Phase 3 trials typically involve comprehensive data collection and analysis to determine the treatment's effectiveness. The trial will adhere to established clinical guidelines to ensure the reliability and validity of the efficacy outcomes.