Phase I Study on Deucrictibant's Effect on Pharmacokinetics of Digoxin and Rosuvastatin in Hereditary Angioedema Patients

The primary objective of this study is to evaluate the effect of a 40 mg **deucrictibant** tablet, administered once daily, on the pharmacokinetics of the P-glycoprotein (P-gp) substrate **digoxin** and the Breast Cancer Resistance Protein (BCRP) substrate **rosuvastatin** in healthy subjects. This investigation is clinically relevant as it aims to understand potential drug-drug interactions that could impact the efficacy and safety of medications commonly used in the management of various conditions, including **hereditary angioedema**. Understanding these interactions is crucial for optimizing therapeutic strategies and ensuring patient safety.

The clinical trial involves participants diagnosed with **hereditary angioedema**, a rare genetic condition. The study population includes both male and female subjects, with an age range of 18 to 65 years. The trial specifically targets a vulnerable population, although the total number of participants has not been disclosed by the sponsor. Participants were selected based on specific criteria, although these criteria have not been detailed. The study does not specify any particular lifestyle considerations such as diet or physical activity. The sponsor has not provided information regarding the total number of participants involved in the trial.

The clinical trial is designed as a **Phase I**, open-label, fixed sequence drug interaction study. The primary aim is to investigate the effect of a 40 mg deucrictibant tablet administered once daily on the pharmacokinetics of the **P-gp substrate digoxin** and the **BCRP substrate rosuvastatin**, administered as a drug cocktail. The study targets healthy subjects and is expected to provide insights into the drug interaction profile of deucrictibant. The trial is scheduled to commence recruitment on August 23, 2024, with an estimated completion date of September 18, 2024.

Participants will undergo a series of study visits, beginning with an inclusion (screening) visit to assess eligibility based on predefined criteria. Following successful screening, participants will proceed to the baseline visit, where initial measurements and assessments will be conducted. Subsequent visits will involve the administration of the study drug and the drug cocktail, with pharmacokinetic sampling and safety assessments conducted at specified intervals. The end-of-study visit will mark the conclusion of the participant's involvement, during which final evaluations will be performed to ensure participant safety and collect any remaining data.

The expected duration of participant involvement is contingent upon the study schedule, with the possibility of early termination if adverse events or protocol deviations occur. Participants may also be withdrawn if they fail to comply with study procedures or if the investigator deems it necessary for safety reasons. The study is conducted in accordance with ethical guidelines and regulatory requirements, ensuring the integrity and scientific validity of the trial outcomes.

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 these non-experimental treatments is also not available.

Due to the lack of specific information in the provided data, further details about the **experimental medication** and any **non-experimental treatments** used in the study cannot be elaborated upon. The trial documentation should be consulted for comprehensive information regarding the treatments involved in this clinical trial.

The clinical trial is designed to assess efficacy in a Phase 3 study. The trial is scheduled to commence recruitment on August 23, 2024, with an estimated completion date of September 18, 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.