Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

Safety Study to Compare the Gastrointestinal Tolerability of Oral Tegomil Fumarate and Dimethyl Fumarate (Tecfidera®) in Healthy Volunteers.

This study is investigating a new medicine called Tegomil Fumarate. We want to see how well it's tolerated by the stomach and gut compared to an existing medicine called Tecfidera®. Both of these medicines are being developed to treat conditions like Multiple Sclerosis (MS). This is a very early-stage study, meaning it's one of the first times this new medicine is being given to people. Importantly, it's being tested in healthy volunteers, not people who have MS or any other illness. The main goal is to check its safety and how the body handles it, especially how it affects digestion, before it can be tested in patients who might benefit from it.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Neuraxpharm Pharmaceuticals S.L.

Enrolment target

210

Start

15 Mar 2024

Multiple Sclerosis

What is this study about?

This study is about understanding a new medicine called Tegomil Fumarate. We're comparing it with a medicine that's already used, called Tecfidera®. Both of these types of medicines are important for treating conditions like Multiple Sclerosis (MS), which affects the brain and spinal cord.

The main aim of this study is to see how well Tegomil Fumarate is tolerated by the body, especially your stomach and gut. Sometimes, medicines can cause side effects like stomach upset, and researchers want to find out if this new medicine might cause fewer of these issues compared to the existing one. By doing this early research, they hope to make future treatments more comfortable for patients.

This is a very early-stage study, often called a 'Phase I' study. This means it's one of the first times the new medicine is being given to people. Crucially, it's being tested in healthy adult volunteers. This allows researchers to carefully check the safety of the medicine and how it behaves in the body without the complications of an existing illness. The information gained from this study is vital to help decide if the new medicine is safe enough to be tested in people who actually have conditions like MS in later studies.

Key takeaways

This study is testing a new medicine (Tegomil Fumarate) against an existing one (Tecfidera®).
The main goal is to see which medicine is easier on the stomach and gut.
It's an early-stage safety study in healthy adult volunteers.
Results will help decide if the new medicine can be tested in people with MS later.
Participants must be 18 or older and healthy.
Participation involves clinic visits and taking study medication.

Who may be eligible?

To be part of this study, you need to be an adult, aged 18 or older. There is no upper age limit, so older adults can also take part.

This study is open to both men and women. Because this is an early safety study, participants must be healthy. This means you shouldn't have any major ongoing health problems or be taking lots of other medications that might interfere with the study medicine.

Quick self-check

Are you 18 years old or older?
Are you generally healthy with no major ongoing medical conditions?
Are you taking very few or no regular medications?
Are you able to attend several clinic visits as required?
Are you happy to take one of the study medicines?
Are you comfortable contributing to medical research for future patients?

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 would need to visit the study clinic several times. During these visits, the study team would check your health, likely with blood tests, urine tests, and by asking you questions about how you're feeling. You would be given either Tegomil Fumarate or Tecfidera® as part of the study.

Researchers would carefully monitor you after you take the medicine to see how your body reacts and to check for any side effects, particularly those affecting your stomach and gut. The exact number of visits, how long each visit lasts, and the total duration of the study would be explained in full by the study team. They will also let you know if you need to stay overnight at the clinic for any period.

Potential risks and benefits

Taking part in any study has potential benefits and risks. For healthy volunteers, a direct medical benefit is unlikely as you are not being treated for an illness. However, you would be contributing to medical science, which could help future patients with conditions like MS. Potential risks might include side effects from the medication, such as stomach upset or other reactions, and the inconvenience of study visits. All potential risks will be fully explained before you agree to participate. You always have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (1)

—
Portugal

Common questions

What is Multiple Sclerosis (MS)?

MS is a condition that affects your brain and spinal cord, which can lead to various symptoms like problems with movement, balance, and vision.

Why is this study in healthy volunteers and not people with MS?

Early studies like this are done in healthy people first to make sure the new medicine is safe and to understand how the body handles it, before giving it to people who are already unwell.

Will I know which medicine I'm getting?

In many studies like this, participants don't know whether they are receiving the new medicine or the comparison medicine. This helps ensure the results are fair.

Who is paying for this study?

The study is sponsored by a pharmaceutical company, which is common for new medicine development.

What happens after this study finishes?

If this study shows good results for safety and how the body handles the medicine, the new medicine might then be tested in people with MS in later stages of research.