Effect of Curcumin on the Pharmacokinetics of IMU 838 and Rosuvastatin in Subjects with Multiple Sclerosis

The primary objective of this study is to evaluate the effect of curcumin on the absorption and elimination of IMU 838, an investigational compound for the treatment of multiple sclerosis. This assessment is clinically relevant for understanding potential drug-nutrient interactions that may influence the pharmacokinetics of the novel therapeutic agent. Additionally, the study aims to determine the effect of IMU 838 on the absorption and elimination of rosuvastatin. 6

The sponsor did not provide information regarding the total number of participants. The study population consists of healthy volunteers within the age range of 18 to 44 years. Both males and females are included in the cohort, which contains vulnerable populations. Participants are characterized by the absence of multiple sclerosis.

This Phase 3 clinical trial utilizes a randomized, double-blind, controlled design to investigate the pharmacological interactions between curcumin and IMU 838, a novel compound under investigation for the treatment of multiple sclerosis. The study further evaluates the effect of IMU 838 on the pharmacokinetics of rosuvastatin, specifically regarding its absorption and elimination. The research methodology involves a sequence of scheduled study visits, beginning with a screening visit to assess eligibility. Subsequent follow-up visits are conducted to monitor the metabolic effects of the administered substances. The protocol concludes with an end-of-study visit. The total duration of participant involvement and specific conditions for early termination are determined by the clinical oversight protocols.

The assessment of efficacy in this Phase 3 clinical trial for multiple sclerosis is not specified in the provided documentation.