Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

A study to learn how the study medicine called [14C]PF-07054894 is processed by the body.

This study is looking into a new medicine, called [14C]PF-07054894, which is being developed for people with inflammatory bowel disease. This is an early-stage study, meaning it's one of the first times it's being given to people. The main goal is to understand how your body processes this medicine. This includes seeing how well it's absorbed, what happens to it once it's inside your body, and how quickly it's removed. Knowing these details helps researchers understand how the medicine works and if it might be a good option for future treatments. We're looking for men aged 18 and over to take part.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Pfizer Inc.

Enrolment target

Start

15 May 2025

Inflammatory bowel disease.

What is this study about?

This research study is about a new medicine called [14C]PF-07054894, which is hoped to help people with inflammatory bowel disease. This disease causes long-lasting swelling and irritation in your digestive system.

The main purpose of this study is to understand what happens to this new medicine inside the human body. Think of it like watching a journey: we want to see how the medicine enters your body, how it changes while it's there, and finally, how it leaves. This information is really important because it helps scientists work out the right dose and how often someone might need to take the medicine in the future.

This is an early stage of testing, often called a 'Phase I' study. This means it's one of the first times this specific medicine is being given to people to see how it behaves. The insights gained from this study will help decide if it's safe and worth exploring further for people with inflammatory bowel disease.

Key takeaways

This study is testing a new medicine for inflammatory bowel disease.
It aims to understand how your body handles the medicine.
It's an early-stage study, focusing on how medicines work.
Only men aged 18 and over can take part.
Participation involves clinic visits and monitoring.
You can stop participating at any time.

Who may be eligible?

To join this study, we are looking for healthy adult men aged 18 years or older. There isn't an upper age limit, as long as you meet the other health requirements.

Because this study focuses on understanding how the body handles the medicine, we need participants who are generally healthy. There will be checks to make sure you are suitable for the study before you can take part.

This study is only for men. Other studies may be open to women, but for this specific research, only men are being included.

Quick self-check

Are you male?
Are you 18 years old or older?
Do you consider yourself generally healthy?
Are you able to attend study clinic visits?

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

What does participation involve?

If you join this study, you will be given the study medicine, [14C]PF-07054894. You will have several appointments at the study clinic where doctors and nurses will monitor your health closely. This will involve regular blood tests and possibly urine samples to see how the medicine is moving through and leaving your body. You might need to stay at the clinic for certain periods to allow for this close monitoring. The total time you'd be involved in the study, including all visits and follow-ups, would be explained to you in detail before you decide to take part.

Potential risks and benefits

Taking part in a study like this could help us learn more about potential new treatments for inflammatory bowel disease, which might ultimately benefit many people in the future. As with any medicine, there's always a chance of side effects, although this study is designed to be as safe as possible and you'll be closely watched by medical staff. You will be told about all known or possible risks before you agree to participate. You are completely free to change your mind and leave the study at any time, for any reason, without it affecting your medical care.

Locations (1)

—
Netherlands

Common questions

What is Inflammatory Bowel Disease (IBD)?

IBD is a condition that causes long-lasting swelling and irritation in your digestive system. It includes conditions like Crohn's disease and ulcerative colitis.

What does '[14C]' mean in the medicine's name?

The '[14C]' part means the medicine has a very tiny, safe marker (a type of carbon) in it. This helps researchers track how the medicine moves through your body using special scans, without harming you.

Is this medicine a cure for IBD?

This is an early study, so we don't know if this medicine will be a cure. The goal is to understand how it works in the body, which is the first step in developing new treatments.

Will I get paid for taking part?

It's common for studies to offer reimbursements for your time and travel. This will be fully explained to you before you agree to join.

What if I feel unwell during the study?

You will be closely monitored by doctors and nurses. If you feel unwell at any point, you should tell the study team immediately, and they will provide care and assistance.