Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

Phase 1 Study to Determine the Effect of CYP Induction Following Administration of Nirogacestat in Healthy Men Participants

This is an early-stage study, called a Phase 1 trial, and it's looking at a new medicine named Nirogacestat. It involves healthy men, not people who have desmoid tumours. The main goal is to understand how the body processes this medicine. Researchers want to see if it changes the way certain important liver enzymes work. These enzymes help break down medicines in the body. By learning how Nirogacestat interacts with these enzymes, scientists can better understand how it might work and if it could be a useful treatment for desmoid tumours in the future. This basic information is crucial for planning later studies with people who actually have the condition.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Springworks Therapeutics Inc.

Enrolment target

Start

22 Oct 2025

Desmoid tumor

What is this study about?

This study is a very early step in testing a new medicine called Nirogacestat. It's a Phase 1 study, which means the main focus is on safety and how the medicine behaves in the body, rather than whether it treats a specific illness. In this case, researchers are giving Nirogacestat to healthy men to see how it affects certain important processes in their liver.

Think of your liver as a chemical factory; it has special workers (enzymes) that break down medicines and other substances. This study wants to find out if Nirogacestat makes these workers more active. If it does, it could mean that other medicines you take at the same time might be broken down faster, or slower, which doctors need to know.

While this study involves healthy men, the medicine, Nirogacestat, is being developed for a condition called desmoid tumour. Desmoid tumours are rare growths that are not cancer but can cause problems. By understanding how the body handles Nirogacestat in healthy people, scientists can then plan much larger studies with patients who have desmoid tumours, to see if the medicine can help them effectively and safely.

Key takeaways

An early study (Phase 1) focused on Nirogacestat medicine.
Only healthy male volunteers, aged 18 and over.
Aims to understand how the medicine is processed by the body.
Not an immediate treatment for desmoid tumours.
Participation involves taking medicine and regular health checks.
Contributes to future research for a rare condition.

Who may be eligible?

This study is specifically looking for healthy male volunteers. You would need to be at least 18 years old to take part, and there's no upper age limit mentioned.

Since this is an early study for a medicine meant to eventually help people with desmoid tumours, you would not be eligible if you actually have a desmoid tumour or other serious health conditions. The study needs participants who are generally healthy to properly understand how the medicine works in a typical body without other health issues impacting the results.

More detailed health checks would be done by the study team to make sure you're a good fit, so if you're interested, they would ask about your full medical history.

Quick self-check

Are you a man?
Are you 18 years old or older?
Are you generally healthy, without serious medical conditions?
Are you willing to take a new experimental medicine?
Are you able to attend several clinic visits for checks?

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 receive the study medicine, Nirogacestat. This is a Phase 1 study, so it would involve several visits to a clinic over a period of time. During these visits, the study team would closely monitor your health. This might include regular blood tests, urine tests, and checks of your vital signs like blood pressure and heart rate.

The specific schedule isn't detailed, but typically in these types of studies, you might stay at the clinic for a few days at a time, or come in for appointments over several weeks. All medication would be provided by the study. You would have your health carefully assessed throughout, and follow-up checks would happen even after you stop taking the medicine to ensure you are well. The total duration of your involvement could range from a few weeks to a couple of months.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. For this study, a potential benefit is contributing to medical science and helping researchers learn more about a new medicine that could one day help people with desmoid tumours. However, as an early-stage study, there's no direct health benefit to you as a healthy volunteer. Potential risks could include side effects from the study medicine, which would be explained in detail by the study team. You always have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

—
Netherlands

Common questions

What is a Phase 1 study?

It's the first stage of testing a new medicine in people. The main goals are to check if it's safe and how the body handles it.

Will this medicine treat my desmoid tumour?

No, this specific study is for healthy men, not for treating desmoid tumours yet. It's to gather basic information for future studies.

What are 'liver enzymes'?

These are special proteins in your liver that help break down medicines and other substances in your body.

Will I get paid to participate?

The information provided doesn't say. Often, studies provide some payment for your time and travel, but you should ask the study team directly.

What if I feel unwell during the study?

The study team will closely monitor you. You should immediately report any new or worsening symptoms to them.