Pharmacokinetics of IMU-838 Alone and with Gemfibrozil or Rifampicin in Healthy Subjects: A Phase 1 Study on Multiple Sclerosis

The primary objective of this study is to evaluate the **pharmacokinetics** of IMU-838 when administered alone and in combination with multiple doses of **gemfibrozil**, a known CYP2C8 inhibitor, or **rifampicin**, a CYP2C8 inducer, in healthy subjects. Understanding the pharmacokinetic profile of IMU-838 in these contexts is clinically relevant as it may inform dosing strategies and potential drug-drug interactions in the treatment of **multiple sclerosis**. No secondary objectives are provided in the available data.

The clinical trial involves participants diagnosed with **multiple sclerosis**. The study population includes both male and female subjects, with an age range category code of 3, indicating a specific age group, though the exact ages are not specified. The trial includes a vulnerable population, suggesting that special considerations are taken into account for these participants. The sponsor has not provided information regarding the total number of participants or specific lifestyle considerations such as diet, physical activity, or habits. Additionally, key inclusion or exclusion criteria have not been disclosed by the sponsor.

The clinical trial is designed as a **Phase 3**, single-center, open-label, fixed-sequence, 2-part adaptive study. It aims to assess the pharmacokinetics of IMU-838 when administered alone and in combination with multiple doses of gemfibrozil, a **CYP2C8** inhibitor, or rifampicin, a **CYP2C8** inducer, in healthy subjects. The trial is expected to commence recruitment on August 15, 2025, and conclude by January 2, 2026. The study will involve a sequence of visits, starting with an inclusion visit to screen participants for eligibility based on predefined criteria. This will be followed by a series of follow-up visits to monitor the pharmacokinetic parameters and any potential adverse effects. The end-of-study visit will serve to collect final data and ensure participant safety post-treatment.

Participants will be involved in the study for a duration that aligns with the trial's timeline, from the initial screening to the end-of-study visit. The study will include regular assessments to ensure compliance and monitor the effects of the investigational product. Conditions that may lead to early termination from the study include non-compliance with the study protocol, adverse events that compromise participant safety, or withdrawal of consent. The trial's design and procedures are structured to maintain scientific rigor and ensure the collection of reliable data to evaluate the pharmacokinetic profile of the investigational product in the context of **multiple sclerosis** treatment.

No specific information regarding the experimental medication, including its name, pharmaceutical form, dosage, route, and frequency of administration, is provided in the available data. Consequently, a detailed description of the experimental treatment cannot be formulated based on the current dataset.

Similarly, there is no information available about any non-experimental treatments, such as standard-of-care therapy, placebo, or comparator treatment, used in the study. Therefore, a description of these elements is not possible with the given data.

Additional relevant information about drug administration, dosing schedules, and participant compliance monitoring is also absent from the provided data. As such, no further details can be included in this description.

The clinical trial is designed to assess efficacy in a Phase 3 study. The trial is scheduled to commence recruitment on August 15, 2025, with an estimated completion date of January 2, 2026. The efficacy assessment will be conducted using predefined 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 focus will be on evaluating the treatment's impact over the course of the study, adhering to rigorous clinical standards. The trial's design and execution will align with the regulatory requirements for Phase 3 studies, ensuring that the efficacy data collected is robust and reliable.