Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

A Study to Learn About the Study Medicine Called PF-07054894 in People of Japanese Origin

This research study is about a new medicine, code-named PF-07054894, which is being investigated for people living with inflammatory bowel disease (IBD). IBD is a condition that causes long-lasting inflammation in the digestive system. This particular study is designed for individuals of Japanese origin and is an early-stage human pharmacology (Phase 1) trial. This means scientists are just beginning to learn how the medicine behaves in the human body, such as how it's absorbed, distributed, processed, and removed. The main goal is to understand its safety and how it works at a basic level, rather than to see if it cures the disease. It's a crucial step in developing new treatments.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Pfizer Inc.

Enrolment target

Start

15 Mar 2024

Inflammatory bowel disease

What is this study about?

This study is exploring a new medicine known as PF-07054894, which scientists hope could one day help people with inflammatory bowel disease (IBD). IBD is a group of conditions, like Crohn's disease or ulcerative colitis, where the body's immune system mistakenly attacks the digestive system, causing pain, diarrhoea, and other uncomfortable symptoms.

The study is specifically looking for participants of Japanese origin. This is a common practice in medicine to understand how new drugs might affect different ethnic groups. Our bodies can process medicines slightly differently depending on our genetic background, so it's important to gather this information early on.

This is an early-stage study, often called a 'Phase 1' trial. In this phase, researchers are mainly focused on understanding how the new medicine works in the human body. They want to find out how much of the medicine gets into the bloodstream, how long it stays there, and how the body breaks it down and gets rid of it. This helps them determine safe doses and predict potential side effects before moving on to larger studies that test if the medicine actually treats the disease itself.

Key takeaways

This study is testing a new medicine (PF-07054894) for inflammatory bowel disease.
It's an early-stage study focused on understanding how the medicine works in the body.
Only adults of Japanese origin can take part.
Participation involves taking the study medicine and regular clinic visits.
You'll get close medical monitoring by the research team.

Who may be eligible?

To be considered for this study, you must be an adult, aged 18 or older. There is no upper age limit, meaning older adults are also welcome to inquire.

Crucially, this study is specifically looking for people of Japanese origin. This is a key requirement for participation.

Both men and women can take part in this research study, as long as they meet the other criteria. The research team will need to check your medical history and other details to make sure this study is the right fit for you.

Quick self-check

Are you 18 years old or older?
Do you identify as being of Japanese origin?
Do you have inflammatory bowel disease?
Are you able to attend regular clinic appointments as required by the study?

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, PF-07054894. Throughout your involvement, you would have several visits to the clinic or hospital. These visits would involve various assessments, such as blood tests, physical examinations, and possibly other tests to see how your body is responding to the medicine and how it's being processed. The medical team will closely monitor your health. You'll be asked to follow specific instructions regarding the medication and any other lifestyle factors. The total duration of your participation in the study, including follow-up, will be explained in detail by the research team if you decide to inquire.

Potential risks and benefits

Potential benefits of taking part might include contributing to medical research for inflammatory bowel disease, which could help future patients. You would also receive close medical attention and monitoring. However, as with any new medicine, there are potential risks, including side effects from the study drug, which may or may not be known yet. The research team will explain all known and potential risks to you before you agree to participate. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

—
Belgium

Common questions

What is inflammatory bowel disease (IBD)?

IBD is a condition where your digestive system becomes inflamed for a long time. It includes diseases like Crohn's disease and ulcerative colitis, causing symptoms like tummy pain and frequent bowel movements.

Why is this study only for people of Japanese origin?

Because different ethnic groups can process medicines differently. Researchers need to understand how this specific medicine works in people of Japanese descent to ensure it's safe and effective for them.

What does 'Phase 1' study mean?

It's an early step in testing a new medicine. The main goals are to find out if the medicine is safe, what the right dose might be, and how it behaves in the human body, rather than checking if it cures the disease.

Will I get better if I join this study?

The main goal of this early study is not to treat your disease, but to learn about the new medicine. While some people might feel better, it's not guaranteed, and the focus is on research.

How long will I have to be in the study?

The research team will tell you the exact time commitment, including clinic visits and follow-up, during your initial discussions if you consider joining.