RecruitingPHASE1INTERVENTIONAL

Study to Evaluate Pharmacokinetics, Relative Bioavailability, Palatability of Obefazimod Minitablet Formulation

Researchers are testing a new, smaller tablet version of a medicine called Obefazimod. The aim is to see if this new mini-tablet works in the body in the same way as the current capsule form. They also want to find out how easily people can take the mini-tablet, especially when mixed with soft foods like applesauce or yogurt. This study is for healthy adults aged 18 to 55. It's an early-stage study to gather important information about this new tablet before it might be used for children or others who find capsules difficult to swallow. Your involvement would help ensure new medicines are easy and safe to take.

At a glance

Status

Recruiting

Phase

PHASE1

Sponsor

Abivax S.A.

Enrolment target

Start

03 Mar 2026

Estimated completion

01 Oct 2026

Healthy

What is this study about?

This study is about a medicine called Obefazimod. Currently, it's available in a capsule form for adults. However, capsules can sometimes be hard for children or even some adults to swallow. That's why the makers of this medicine are developing a new version: a very small tablet, often called a 'minitablet'. This study is a first step to see how this new minitablet works.

The main goal is to find out if the Obefazimod minitablet delivers the medicine into the body in the same way as the existing adult capsule. They want to make sure the amount of medicine the body gets is similar, whether you take the capsule or the new minitablet. They'll also look at how quickly the medicine gets into the bloodstream and how easily people find taking the minitablet, especially when it's mixed with soft foods like applesauce, yogurt, or chocolate pudding.

This is an early stage, 'Phase 1' study. It involves healthy adult volunteers to carefully check the new minitablet's performance. The information gathered here is crucial for potentially developing this new minitablet for a wider range of patients, especially children, in the future. By participating, you would be helping to make medicines easier to take for many people.

Key takeaways

This study tests a new, smaller tablet form of Obefazimod medicine.
It aims to see if the minitablet works like the current adult capsule.
Healthy UK adults aged 18-55 are needed.
It involves taking the medicine and having blood tests.
Some minitablets will be taken with soft foods to check ease of use.
Your participation could help make medicine easier for children to take.

Who may be eligible?

This study is looking for healthy adults between 18 and 55 years old. You should have a body weight of at least 50 kg (around 7 stone 12 pounds) and a healthy Body Mass Index (BMI) between 18.0 and 32.0. Both men and women can join, but women must not be pregnant or breastfeeding and must agree to use effective contraception if needed.

There are certain reasons why you might not be able to join. For example, if you have or have had any significant health problems with your heart, kidneys, liver, stomach, or lungs, or any serious allergies. You also can't take part if you've had certain infections recently, such as shingles in the last two months, or if you've had your gallbladder removed or have gallstones.

Additionally, if you've taken part in another medical study using a new medicine within the last three months, you wouldn't be able to join this one. For the part of the study looking at mixing the tablets with food, you need to be able to eat applesauce, chocolate pudding, or yogurt and not have problems with taste or smell.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you between 18 and 55 years old?
Are you generally healthy with no major ongoing medical conditions?
Do you weigh at least 50 kg (around 7 stone 12 pounds)?
Have you avoided other medical research studies involving new medicines within the last 3 months?
If you are a woman, are you not pregnant or breastfeeding and willing to use contraception?
Can you eat applesauce, yogurt, or chocolate pudding without allergies or taste/smell problems?

Answer every question to see your result.

What does participation involve?

If you join this study, it's divided into two main parts. In both parts, you'll be given a single dose of either the Obefazimod capsule or the new minitablet. You will stay at the clinic for a period after taking the medicine so that the study team can take blood samples at specific times to measure how the medicine is absorbed and cleared from your body. You'll also have regular health checks, including physical exams, blood pressure, heart rate, and temperature.

In the second part of the study, you'll take the minitablet mixed with a soft food like applesauce, yogurt, or chocolate pudding, or just with water, to see how that affects the medicine's absorption. You would also have similar blood tests and health checks. You will have a screening visit before the study starts to make sure you are suitable, and then follow-up visits after the medicine has been given. The total duration of your participation, including screening and follow-up, will be explained in detail by the study team, but typically involves a stay at the clinic for a few days for each part you participate in, followed by outpatient visits.

Potential risks and benefits

Taking part in this study could help researchers develop new, easier-to-take forms of medicine, potentially benefiting children and others who struggle with swallowing capsules. The main risks involve potential side effects from the study medicine, though it's given in a single dose to healthy people. There are also discomforts from repeated blood draws and the time commitment. As with any study, you have the right to withdraw at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Quotient Sciences
Verified postcode
Nottingham, United Kingdom· Recruiting

Common questions

What is Obefazimod?

Obefazimod is a medicine that is currently available in a capsule form. This study is testing a new, smaller tablet version of it.

Why are you testing a new tablet form?

Capsules can be hard for some people, especially children, to swallow. The new minitablet is being developed to make it easier to take medicine.

Will I get the actual medicine or a dummy pill?

In this study, you will receive either the Obefazimod capsule or the new Obefazimod minitablet. There are no dummy pills (placebos) in this study.

Do I need to stay at a hospital?

You will need to stay at a clinical research centre for a period after taking the medicine so the team can monitor you and take blood samples.

Can I eat normally during the study?

You will have specific instructions about food and drink, and for part of the study, you'll take the minitablet with soft foods like applesauce or yogurt.

How to find out more

Josianne Nitcheu

josianne.nitcheu@abivax.com 33781759766 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.