Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

A Study to Learn How a Tablet Compared with an IV Infusion of the Study Medicine Called Vepdegestrant is Taken up into the Blood in Healthy Adults.

This clinical trial is designed to understand how a new medicine, called vepdegestrant, works in the body. Specifically, researchers want to see how well it's absorbed into the bloodstream. There are two ways the medicine is being given: as a tablet you swallow, and as an injection directly into your vein (like a drip). The study is for healthy adults, meaning people who do not have any major health problems. It's a very early-stage trial, focusing on how the medicine moves through and is used by the body. This kind of research is important for future studies that might look at how well this medicine treats certain types of breast cancer, such as ER+/HER2- breast cancer.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Pfizer Inc.

Enrolment target

Start

10 Mar 2025

ER+/HER2- breast cancer

What is this study about?

This study is an important first step in understanding a new medicine called vepdegestrant. Think of it like learning how a new car works before you can drive it on the road. In this case, the researchers want to see how the body handles vepdegestrant – how much of it gets into the blood and how quickly.

They are comparing two different ways of giving the medicine: a tablet you swallow by mouth, and an IV infusion, which is when the medicine is given slowly into a vein in your arm. This comparison helps them work out the best way for people to take this medicine in the future.

Even though this medicine is being developed for a type of breast cancer (ER+/HER2- breast cancer), this particular study is not testing if it treats cancer. Instead, it's focusing on healthy adults to get a clear picture of how the medicine behaves in the body without the complications of a disease. This information is vital for doctors and scientists to decide how to best use vepdegestrant in later, larger studies that will look at its effects on cancer.

Key takeaways

This study is about how a new medicine, vepdegestrant, is absorbed by the body.
It compares a tablet form with an injection into a vein.
Only healthy adults, aged 18 and over, can participate.
It is a very early-stage study, not a cancer treatment trial.
Participating helps advance medical knowledge for future treatments.
You can stop participating at any time.

Who may be eligible?

To be part of this study, you need to be a healthy adult. This means you generally don't have any major medical conditions that could affect how your body handles the medicine being studied.

You must be at least 18 years old, and there's no upper age limit, meaning older adults can also take part if they meet the other health requirements.

Both men and women are welcome to participate, as the study needs to understand how the medicine works in different people.

Quick self-check

Are you 18 years old or older?
Do you consider yourself generally healthy?
Do you not have any major ongoing health problems?
Are you comfortable with potentially receiving a tablet or an IV injection?
Are you able to attend study visits as required?

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

What does participation involve?

This study will likely involve several visits to a clinic over a period of time. During these visits, you might have blood samples taken to check the levels of the study medicine in your body. You would receive either the tablet or the IV infusion of vepdegestrant, as decided by the study doctors.

There may also be other assessments, like check-ups or questionnaires, to make sure you're feeling well and to monitor any effects of the medicine. The total duration of your participation, including any follow-up, would be explained in detail by the study team.

Potential risks and benefits

A potential benefit of participating is helping medical science learn more about new medicines, which could lead to better treatments for future patients. However, there is no direct personal health benefit expected from this study, as it's not testing treatment for a disease. Potential risks could include side effects from the medicine, discomfort from blood draws or the IV, or allergic reactions. All known risks will be fully explained before you agree to take part. Remember, you can choose to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

—
Netherlands

Common questions

What is vepdegestrant?

Vepdegestrant is a new medicine that aims to treat a specific type of breast cancer, but this study isn't testing if it treats cancer.

Why are healthy people needed for this study?

Healthy volunteers help researchers understand how a new medicine works in the body without other illnesses affecting the results.

Will I receive treatment for breast cancer in this study?

No, this study is not designed to treat breast cancer. It's about how the medicine gets into the body.

What does 'ER+/HER2-' mean?

These are specific characteristics of breast cancer that help doctors choose the best treatment. This study is related to medicines for this type.

Will I have to pay to be in the study?

No, you will not have to pay to participate in the study. All study-related care and medication are free.