Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

A Phase 1, Single-Center, Open-Label, Fixed-Sequence, 2-Part Study to Assess the Pharmacokinetics of IMU-838 Administered Alone and in Combination with Multiple Doses of Gemfibrozil as CYP2C8 Inhibitor, or Rifampicin as CYP2C8 Inducer, in Healthy Subjects

This early-stage study, called a Phase 1 trial, is investigating a new drug called IMU-838. We want to understand exactly how this drug is absorbed, processed, and removed from the body when given alone. We're also checking how it behaves when taken with two other common medicines, gemfibrozil and rifampicin. These medicines can sometimes change how other drugs work in the body. By doing this, we learn if other medications might affect IMU-838. This information is crucial for future studies, especially for people with conditions like multiple sclerosis, to make sure the drug is used safely and effectively. Healthy adult volunteers are taking part in this study.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Immunic AG

Enrolment target

Start

10 Jul 2025

Multiple sclerosis

What is this study about?

This research is an early step in developing a new medicine called IMU-838, which might one day help people with conditions like multiple sclerosis. In this first phase of testing, we're not yet giving the drug to people with the illness. Instead, we're focusing on understanding how the drug works inside the body of healthy volunteers.

Specifically, we want to see how IMU-838 is taken in, changed by the body, and eventually leaves the body. This process is called pharmacokinetics. We will give volunteers IMU-838 on its own, and then in combination with two other commonly used medicines, gemfibrozil and rifampicin. These other medicines are known to interact with certain enzymes in the body that process drugs.

By carefully observing these interactions, we can learn if taking IMU-838 with other drugs changes how it behaves. This information is really important because it helps scientists work out the right doses and understand any potential effects when patients are taking multiple medications. This research lays the groundwork for making sure future treatments are as safe and effective as possible.

Key takeaways

This is an early-stage study (Phase 1) of a new potential drug called IMU-838.
It aims to understand how the drug works in the body, alone and with other medicines.
Healthy adult volunteers, aged 18 and older, are needed.
The findings will help make future treatments safer and more effective for conditions like multiple sclerosis.
Participation involves stays at a research clinic and close medical monitoring.

Who may be eligible?

To join this study, you need to be a healthy adult aged 18 or older. Both men and women can take part. Being 'healthy' means you don't have any significant medical conditions that could affect the study results or put your health at risk.

Medical staff will carefully check your health to make sure you're a good fit for the study. This might involve looking at your medical history, having some blood tests, and a physical check-up. The main goal is to ensure your safety and that the study can gather clear and accurate information.

Quick self-check

Are you 18 years old or older?
Do you consider yourself generally healthy?
Are you able to commit to several stays at a research clinic?
Are you willing to have regular blood tests and medical check-ups?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part, you will be staying at a research clinic for several periods. You will receive the study drug, IMU-838, either on its own or with one of the other medicines (gemfibrozil or rifampicin). You'll have regular blood and urine tests during your stay to see how the drug is moving through your body. Nurses and doctors will carefully monitor your health and any effects you experience. There will also be follow-up visits after you leave the clinic to ensure you are well. The total duration of your participation in the study, including all stays and follow-up, will be explained in detail.

Potential risks and benefits

Participating in research can offer the satisfaction of contributing to medical science and helping develop future treatments for conditions like multiple sclerosis. However, like all medicines, IMU-838 may have side effects, which could be mild or more serious, even in healthy individuals. The study team will explain all known or potential risks to you. You are free to ask questions at any time, and you have the right to withdraw from the study at any point without giving a reason, and it will not affect your medical care.

Locations (1)

—
Netherlands

Common questions

What does 'Phase 1' mean?

Phase 1 studies are the first time a drug is tested in humans, usually healthy volunteers, to check its safety and how it works in the body.

What is 'pharmacokinetics'?

It's a scientific term that describes how your body handles a drug: how it's absorbed, distributed, changed, and eventually removed.

Why use healthy people instead of patients?

Testing in healthy volunteers first helps us understand the drug's basic behaviour without other illnesses complicating the results, ensuring it's safe enough for patients later.

What are gemfibrozil and rifampicin?

These are existing medicines that can affect how some other drugs are processed in the body. We're using them to see if they change how IMU-838 works.

Will I get paid for taking part?

Compensation for your time and expenses is often provided for participating in clinical trials. The study team will give you full details about this.