Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

A Mass Balance Study of [14C]-IPN60250 in Healthy Adult Participants

This early-stage study, called a 'mass balance study,' is looking at a new medicine known as IPN60250. It involves healthy adult men and aims to understand how the body handles this medicine. Researchers want to see how it's absorbed, distributed, changed, and eventually leaves the body. This information is crucial for developing the medicine further, especially for conditions like primary sclerosing cholangitis (PSC), a chronic liver disease. By understanding these basic processes, scientists can make sure the medicine is used safely and effectively in the future, even though this particular study isn't directly testing it for PSC treatment.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Ipsen Pharma

Enrolment target

Start

29 Jan 2025

Primary sclerosing cholangitis (PSC)

What is this study about?

This study is a very early step in checking out a new medicine called IPN60250. It’s called a 'mass balance study,' which means scientists are trying to track everything that happens to the medicine once it's in the body. They want to see how much of it gets absorbed, where it goes, if the body changes it into other substances, and how it eventually leaves the body, for example, through urine or stool.

To do this, a special type of the medicine, marked with a tiny amount of a harmless tracing substance (like a 'GPS tracker' for the medicine), will be used. This allows researchers to follow its journey. It’s important to understand these processes because it helps scientists work out the right dose and how often a medicine should be taken, making it safer and more effective for people who might need it in the future.

While this study involves healthy men, the medicine IPN60250 is being developed for people with a condition called primary sclerosing cholangitis, or PSC. PSC is a long-term liver disease that affects the bile ducts. Learning how the body handles IPN60250 in healthy people first is a vital step before it can be tested in patients with PSC.

Key takeaways

This study tests a new medicine (IPN60250) in healthy men.
It aims to understand how the body processes the medicine.
The findings will help develop treatments for primary sclerosing cholangitis (PSC).
Participation involves taking the medicine and providing samples.
You will receive close medical supervision throughout the study.
It's an early-stage study; the medicine is not a proven treatment yet.

Who may be eligible?

This study is looking for healthy adult men to take part. To be considered, you must be 18 years old or older, with no upper age limit specified, as long as you are generally healthy.

Only men are being recruited for this particular study. This is common in early-stage studies to understand how a medicine works without the added complexities that might come from differences between men and women at this initial stage of research.

Being 'healthy' means you shouldn't have any major ongoing medical conditions, especially not the condition the medicine is eventually meant to treat (primary sclerosing cholangitis). You'll have a health check-up to make sure you're suitable.

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 a man?
Are you 18 years old or older?
Are you generally healthy with no major ongoing medical conditions?
Are you able to commit to several clinic visits and possibly overnight stays?

Answer every question to see your result.

What does participation involve?

If you join this study, you would receive the new medicine, IPN60250, likely as a single dose. Researchers would then closely monitor your body's response over several days or weeks, depending on how quickly the medicine is processed. This involves providing samples such as blood, urine, and possibly stool at regular intervals to track the medicine's journey.

Expect several visits to the study clinic, and you might need to stay overnight for a few days during certain parts of the study. You will have regular check-ups to make sure you are well. The total duration of your involvement, from your first visit to your last follow-up, will be clearly explained to you but is typically a few weeks for this type of study.

Potential risks and benefits

Potential benefits of participating include contributing valuable information that could help develop a new medicine for serious liver conditions, and you will receive careful medical monitoring. As with any medicine, there's always a chance of side effects, which could be mild (like a headache) or, rarely, more serious. All known risks will be thoroughly explained before you decide to take part. Remember, you have the right to withdraw from the study at any time without giving a reason, and it will not affect your medical care.

Locations (1)

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

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Unverified
Netherlands

Common questions

What is primary sclerosing cholangitis (PSC)?

PSC is a long-term disease that harms the bile ducts in your liver, which can lead to serious liver problems over time. This study is for a medicine that might help treat it in the future.

Why is this study only for healthy men?

In these very early studies, researchers often test new medicines in a specific group (like healthy men) to understand how the body handles it without other health conditions or factors that might complicate the results.

Will I feel any pain during the study?

You might experience some discomfort from blood draws, similar to standard blood tests. All procedures will be explained, and your comfort will be a priority.

What does a 'mass balance study' mean?

It means the researchers are carefully tracking everything the body does with the medicine – how it enters, moves around, changes, and eventually leaves your body. It's like accounting for every bit of the medicine.

Will the medicine help me directly?

No, this study is not designed to treat any condition in you. It's about gathering important information on how the medicine works in the body for future patients.