Evaluation of Leniolisib on Pharmacokinetics of Caffeine, Midazolam, Rosuvastatin, Furosemide, and Metformin in Healthy Subjects with Activated PI3K Delta Syndrome

The primary objective of this clinical study is to evaluate the effect of multiple oral dosing with **leniolisib** on the pharmacokinetics of several drugs, including caffeine, midazolam, rosuvastatin, furosemide, and metformin, in healthy subjects. This investigation is clinically relevant as it aims to understand potential drug-drug interactions (DDI) that could influence the metabolism and efficacy of these commonly used medications when co-administered with leniolisib. Such insights are crucial for optimizing therapeutic strategies and ensuring patient safety, particularly in individuals with **Activated Phosphoinositide 3-Kinase Delta Syndrome**. No secondary objectives are provided for this study.

The clinical trial involves participants diagnosed with **Activated Phosphoinositide 3-Kinase Delta Syndrome**. The study population includes both male and female subjects, with an age range starting from 18 years and above. The trial does not specifically target a vulnerable population. The sponsor has not provided information regarding the total number of participants. Selection criteria for the trial population, as well as any relevant lifestyle considerations such as diet, physical activity, or habits, have not been disclosed. Key inclusion or exclusion criteria are also not specified by the sponsor.

The clinical trial is designed to evaluate the **pharmacokinetics** of multiple oral doses of leniolisib in healthy subjects, specifically assessing its interaction with caffeine, midazolam, rosuvastatin, furosemide, and metformin. This is an open-label, Phase 3 study, which means that both the researchers and participants are aware of the treatment being administered. The trial is scheduled to commence on January 1, 2024, with an estimated completion date of March 31, 2024. The study will involve a series of visits, beginning with an inclusion visit where participants will be screened for eligibility based on predefined criteria. Subsequent follow-up visits will be conducted to monitor the participants' response to the treatment and to collect necessary data. The end-of-study visit will mark the conclusion of the participant's involvement, during which final assessments will be made. The expected duration of participation for each subject will be determined by the study protocol, and any conditions that may lead to early termination from the study will be outlined in the protocol. Participants will be monitored closely throughout the trial to ensure safety and adherence to the study requirements. The trial aims to provide valuable insights into the drug-drug interactions of leniolisib, contributing to the understanding of its pharmacological profile in the context of **Activated Phosphoinositide 3-Kinase Delta Syndrome**.

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 treatments can be included.

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 offered regarding these aspects of the clinical trial.

The clinical trial is designed to assess efficacy in a Phase 3 study. The trial is scheduled to commence recruitment on January 1, 2024, with an estimated completion date of March 31, 2024. The efficacy assessment will be conducted through a series of pre-defined parameters, although specific endpoints and methods for measuring efficacy are not detailed in the available data. The trial will follow a structured timeline to ensure systematic data collection and analysis. The study will adhere to rigorous standards typical of Phase 3 trials, focusing on evaluating the treatment's effectiveness in a controlled environment. The trial's design will likely involve the use of validated scales, laboratory tests, or patient-reported outcomes to measure efficacy, consistent with standard practices in clinical research. However, specific tools or instruments for efficacy assessments are not specified in the provided information.