Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

AN OPEN-LABEL, RANDOMIZED STUDY TO EVALUATE THE RELATIVE BIOAVAILABILITY OF A NEW TABLET FORMULATION OF MINZASOLMIN AND THE POTENTIAL EFFECT OF FOOD ON THE PHARMACOKINETICS OF MINZASOLMIN IN HEALTHY PARTICIPANTS

This research is testing a new tablet form of a medicine named Minzasolmin. We're trying to understand how much of the medicine the body takes in and how quickly it reaches the bloodstream. We'll compare this new tablet to an older version (granules in capsules) to see if it's absorbed similarly. We also want to find out if eating food makes a difference to how the body absorbs Minzasolmin tablets. This is a very early stage study, carried out in healthy volunteers, to make sure the new tablet form works as expected before it's tested in people with illnesses.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

UCB Biopharma

Enrolment target

Start

03 Sep 2024

Healthy Participants

What is this study about?

This study is focused on a medicine called Minzasolmin. Researchers are developing a new tablet version of Minzasolmin and need to understand how it behaves in the body. They want to compare it to an existing form (granules in capsules). When you take a medicine, your body absorbs it, and it travels through your bloodstream. The study aims to measure how much of the medicine gets into the bloodstream and how quickly it gets there. This helps scientists understand if the new tablet works in a similar way to the older form.

A key part of this research is also to see if eating food affects how your body absorbs the new Minzasolmin tablet. Sometimes, taking medicine with food can change how well it works, making it absorb faster or slower, or more or less effectively. Finding out this information is really important for doctors and patients to know the best way to take the medicine in the future.

This is a 'Phase I' study, which means it's an early stage of clinical research, typically done with healthy volunteers. The main goal at this stage is to gather basic information about how the drug is handled by the body and to check for any early safety concerns. It's an important step in the long process of developing new medicines.

Key takeaways

Tests a new Minzasolmin tablet in healthy adults.
Compares it to an existing Minzasolmin form.
Checks if food changes how the tablet is absorbed.
Involves taking the medicine and frequent blood tests.
Helps understand how the drug behaves in the body for future use.

Who may be eligible?

To join this study, people must be healthy. This means you shouldn't have any major ongoing health conditions or be taking medicines that could interfere with the study.

Participants need to be adults, aged 18 or older. There is no upper age limit, as long as you meet the other health criteria.

Both men and women are welcome to take part in this research. The study needs a variety of healthy individuals to get a good understanding of how the medicine works.

Quick self-check

Are you 18 years old or older?
Are you generally in good health?
Do you have no serious ongoing medical conditions?
Are you able to attend appointments and give blood samples?

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

What does participation involve?

If you take part in this study, you would likely receive a dose of Minzasolmin, sometimes as the new tablet, and sometimes as the older granules in capsules. You would receive these doses at different times, sometimes after fasting (not eating for a certain period) and sometimes after a meal.

Throughout the study, you would have regular blood tests. These blood tests are crucial because they help the researchers measure the amount of Minzasolmin in your blood over time. This shows how your body is absorbing and processing the medicine.

There might be several visits to the study clinic, and some of these could involve staying overnight or for several hours after taking the medicine to allow for all the necessary blood samples. The total length of your involvement, including all visits and follow-up, would be fully explained to you before you agree to take part.

Potential risks and benefits

Taking part in any study has potential benefits and risks. You might not directly benefit from this study, but your participation helps researchers learn vital information that could lead to better medicines for others in the future. Potential risks include discomfort from blood draws, and possible side effects from the study medicine, although Minzasolmin is expected to be generally well-tolerated in healthy individuals at this early stage. All known potential side effects will be fully explained. You are always free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

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Germany

Common questions

What is Minzasolmin?

Minzasolmin is a specific medicine that researchers are developing or testing in this study.

Why is it important to know if food affects the medicine?

Knowing if food affects the medicine helps doctors advise patients on the best way to take it – for example, whether to take it with or without a meal.

Will I get paid for taking part?

Reimbursement for time, travel, and inconvenience is typical in healthy volunteer studies, but the specifics would be discussed with you.

How many times will I have to give blood?

You will have several blood samples taken over a period after each dose to track the medicine's levels in your body. The exact number will be explained by the study team.

What is a 'Phase I' study?

Phase I is the first step in testing a new medicine in humans, usually healthy volunteers, to understand how it's absorbed and to check for early safety concerns.