A Phase 1 Study to Evaluate the Pharmacokinetics and Drug-Drug Interaction Potential of IMU-838 and Oral Contraceptives in Women with Multiple Sclerosis

The primary objective of this phase 1 study is to evaluate the drug-drug interaction between IMU-838 and oral contraceptives. Determining the impact of co-administration on the pharmacokinetics of these agents is clinically significant for managing patients with multiple sclerosis who utilize hormonal therapies. No secondary objectives were identified.

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 30 years. The cohort is composed of female individuals identified as a vulnerable population. No data was provided concerning lifestyle considerations or specific inclusion and exclusion criteria.

This Phase 1, drug-drug interaction trial is designed to evaluate the effects of IMU-838 when administered alongside oral contraceptives in women. The study follows a specific research methodology to determine the pharmacokinetic impact of co-administration. The sequence of procedures begins with a screening visit to assess eligibility. Subsequent study visits are conducted to monitor the interaction and collect necessary data, concluding with an end-of-study visit. The total duration of participant involvement is determined by the specific study protocol. Early termination from the study may occur based on predefined safety criteria or protocol deviations.

The assessment of efficacy in this phase 3 clinical trial for multiple sclerosis will be conducted according to the specified study protocol. Specific parameters, measurement methods, and scheduled timepoints for evaluating clinical outcomes are not defined in the provided documentation.