Investigation of Obefazimod and Rosuvastatin Pharmacokinetics in Healthy Male Subjects with Moderately to Severely Active Ulcerative Colitis

The primary objective of this study is to evaluate the effect of single and multiple doses of **obefazimod** on the pharmacokinetics of **rosuvastatin** in healthy male participants. Understanding this interaction is clinically relevant as it may inform dosing guidelines and safety considerations for patients who are prescribed both medications, particularly those with **moderately to severely active ulcerative colitis**. No secondary objectives are provided in the available data.

The clinical trial focuses on participants with **moderately to severely active ulcerative colitis**. The study population consists exclusively of male subjects, with an age range categorized as adults. The trial does not include vulnerable populations. The sponsor has not provided information regarding the total number of participants. Selection criteria and lifestyle considerations such as diet, physical activity, or habits have not been specified. The trial population was selected based on the condition of interest, but specific inclusion or exclusion criteria have not been disclosed.

The clinical trial is designed as a **Phase 1**, two-part, open-label, single-sequence study aimed at investigating the effect of single and multiple doses of obefazimod on the pharmacokinetics of rosuvastatin in healthy male participants. The study is focused on understanding the interaction between these two compounds, with a particular interest in their pharmacokinetic profiles. The trial is expected to commence recruitment on February 28, 2024, and is estimated to conclude by June 6, 2024, making the overall duration approximately four months.

Participants will undergo a series of study visits, beginning with an inclusion visit, which serves as a screening to determine eligibility based on predefined criteria. This visit will involve a comprehensive assessment to ensure participants meet the necessary health standards for inclusion. Following the inclusion visit, participants will attend multiple follow-up visits, where they will receive the investigational product and undergo various assessments to monitor their response and any potential side effects. The sequence of these visits is structured to gather data on the pharmacokinetics of the drugs under study. The end-of-study visit will mark the conclusion of the participant's involvement, where final assessments will be conducted to ensure participant safety and collect any remaining data.

The expected length of participant involvement is aligned with the trial's duration, approximately four months, unless conditions arise that necessitate early termination. Such conditions may include adverse reactions, non-compliance with study protocols, or withdrawal of consent by the participant. The study is conducted under strict adherence to ethical guidelines and regulatory requirements to ensure the safety and well-being of all participants.

The clinical trial documentation does not provide specific details regarding the experimental medication, including its name, pharmaceutical form, dosage, route, and 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 February 28, 2024, with an estimated completion date of June 6, 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 therapeutic benefits of the intervention under investigation. The trial's design will likely incorporate validated scales, laboratory tests, or patient-reported outcomes to measure efficacy, consistent with standard practices in clinical research. The results will contribute to understanding the intervention's potential impact on the targeted medical condition.