Investigation of Rabeprazole's Impact on Deucrictiban Pharmacokinetics in Hereditary Angioedema Patients

The primary objective of this study is to evaluate the effect of multiple doses of the gastric acid-reducing agent **rabeprazole** on the single-dose pharmacokinetics of a 40 mg **deucrictiban** extended-release (XR) tablet in healthy subjects. Understanding this interaction is clinically relevant as it may influence the absorption and efficacy of deucrictiban, which is pertinent for patients with **hereditary angioedema**. The study aims to provide insights into potential adjustments needed in therapeutic regimens when these medications are co-administered.

The clinical trial involves participants diagnosed with **hereditary angioedema**. The study population includes both male and female subjects, with an age range of 18 to 65 years. The trial population was selected to include a vulnerable population, although specific selection criteria are not provided. The sponsor has not disclosed the total number of participants. Participants' general health status, lifestyle considerations such as diet, physical activity, or habits, and key inclusion or exclusion criteria are not specified in the available data.

The clinical trial is designed as an **open-label**, fixed-sequence drug interaction study aimed at evaluating the effect of multiple doses of the gastric acid-reducing agent rabeprazole on the single-dose pharmacokinetics of a 40 mg deucrictiban extended-release (XR) tablet. The study targets healthy subjects and is focused on understanding the pharmacokinetic interactions in the context of **hereditary angioedema**. The trial is categorized under Phase 3, indicating a focus on efficacy and monitoring of adverse reactions in a larger participant group.

The trial is expected to commence recruitment on August 1, 2024, with an estimated completion date of April 1, 2025. Participants will be involved in the study for a duration that aligns with the trial's timeline, subject to their adherence to the study protocol. The sequence of study visits includes an initial inclusion (screening) visit to assess eligibility based on predefined criteria. This is followed by a series of follow-up visits where participants will receive the investigational product and undergo necessary assessments to monitor drug interactions and pharmacokinetic parameters. The end-of-study visit will conclude the participant's involvement, during which final evaluations will be conducted to gather comprehensive data on the study's endpoints.

Participants may be subject to early termination from the study if they experience adverse events that compromise their safety, fail to comply with the study protocol, or withdraw consent. The study's design ensures that all procedures are conducted in accordance with ethical standards and regulatory requirements, providing a structured framework for data collection and analysis.

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 has orphan drug status. 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 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 August 1, 2024, with an estimated completion date of April 1, 2025. The efficacy assessment will be conducted through a series of planned evaluations, although specific parameters or endpoints for efficacy evaluation are not detailed in the available data. The trial will follow a structured timeline to ensure systematic data collection and analysis. The methods and tools for measuring efficacy, as well as the specific timepoints for these assessments, are not specified in the provided information. The trial's focus on efficacy is aligned with its categorization as a Phase 3 study, which typically involves a larger participant population to confirm effectiveness and monitor adverse reactions. The absence of detailed endpoints or measurement tools in the source material suggests that these elements will be defined in the full trial protocol.