Pharmacokinetic Interaction Study of Itraconazole, Quinidine, and Rifampicin on Single-Dose ZED1227 in Healthy Subjects

The primary objective of this study is to evaluate the effect of **Itraconazole**, **Quinidine**, and **Rifampicin** on the single-dose pharmacokinetics of **ZED1227**. Understanding these interactions is clinically relevant as it may inform dosing adjustments and safety considerations when these drugs are co-administered, potentially impacting therapeutic efficacy and patient safety.

The clinical trial involves a study population that includes both **male** and **female** participants. The age range of the participants is categorized as **3**, which typically corresponds to a specific age group, though the exact ages are not specified. The trial includes a vulnerable population, indicating that special considerations are taken into account for these participants. The sponsor has not provided information regarding the total number of participants involved in the study. There are no specific medical conditions being targeted, as the trial is not associated with any particular disease. The selection process for the trial population and any relevant lifestyle considerations, such as diet or physical activity, have not been disclosed. Key inclusion or exclusion criteria are also not specified by the sponsor.

The clinical trial is designed to evaluate the effect of **itraconazole**, **quinidine**, and **rifampicin** on the single-dose pharmacokinetics of ZED1227. This study is a Phase 3 trial, which is categorized as a controlled, randomized, and double-blind study. The trial is expected to commence recruitment on March 7, 2025, and is estimated to conclude by April 16, 2025. The trial does not target any specific medical condition, as indicated by the absence of a medical condition requirement for participation.

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 be randomized to receive either the investigational product or a control. The sequence of study visits will include baseline assessments, dosing visits, and follow-up visits to monitor pharmacokinetic parameters and ensure participant safety. The end-of-study visit will mark the completion of the trial for each participant, during which final assessments will be conducted.

The expected duration of participant involvement in the trial is approximately six weeks, from the initial screening to the end-of-study visit. Participants may be subject to early termination from the study if they experience adverse events that compromise their safety, fail to comply with study procedures, or withdraw consent. The trial is conducted under strict adherence to ethical guidelines and regulatory requirements to ensure the integrity of the data and the safety of the participants.

The clinical trial documentation does not provide specific details regarding the experimental medication, including its name, pharmaceutical form, dosage, route, or frequency of administration. As such, no detailed description of the experimental treatment can be provided based on the available data.

Similarly, there is no information available about any non-experimental treatments used in the study, such as standard-of-care therapy, placebo, or comparator treatment. Consequently, no description of these elements can be included in the trial documentation.

Additional relevant information about drug administration, dosing schedules, and participant compliance monitoring is also not provided in the source data. Therefore, no further details can be elaborated upon in this context.

The clinical trial is designed to assess efficacy in a Phase 3 study. The trial is scheduled to commence recruitment on March 7, 2025, with an estimated end date of April 16, 2025. The efficacy assessment will be conducted using predefined primary and secondary endpoints, although specific endpoints are not detailed in the available data. The trial will follow a structured methodology to ensure the accurate measurement and analysis of efficacy parameters. The trial's design and execution will adhere to rigorous standards to ensure the reliability and validity of the efficacy outcomes.