Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

A Study to Learn how Various Tablets of the Study Medicine Called Vepdegestrant are Taken up into the Blood in Healthy Adults

This study is testing a new medicine called vepdegestrant, which is designed to help people with a specific type of breast cancer (ER+/HER2- breast cancer). The main goal is to understand how different forms or doses of this medicine are absorbed into the body and get into the bloodstream. This helps doctors figure out the most effective and safest way to give the medicine in the future. This particular study is in a very early stage, involving healthy adult volunteers rather than patients with breast cancer. It's a crucial step in developing new treatments, allowing researchers to gather important information about how the drug behaves in the body before it's given to patients who are sick. By doing this, they can ensure it's handled safely and effectively.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Pfizer Inc.

Enrolment target

Start

08 Oct 2024

ER+/HER2- Breast Cancer

What is this study about?

This research study is about a new medicine called vepdegestrant. It's being developed to treat a specific kind of breast cancer known as ER+/HER2- breast cancer. This type of cancer is quite common, and finding new and better ways to treat it is very important. The main purpose of this study is to see how different forms of the vepdegestrant medicine are soaked up by the body and reach the bloodstream. Think of it like trying different ways to get water into a sponge – some ways might work better or faster than others. By understanding this, scientists can work out the best way to give the medicine to people so it can do its job properly.

This study is a very early step in testing a new medicine, often called a 'Phase 1' study. What makes this study different is that it's being done with healthy adult volunteers, not people who have breast cancer. This is a common and important step when developing new medicines. It allows researchers to carefully watch how the medicine behaves in the body of healthy people without the extra complications of a person being unwell. This helps them understand things like how quickly the medicine gets into the blood, how long it stays there, and whether it causes any noticeable effects.

The information gathered from this study is really important for the future of this medicine. It helps scientists decide the best dose and the best way to give vepdegestrant to patients later on. It's a foundational step to make sure that when the medicine eventually reaches people with breast cancer, it has the best chance of working effectively and safely. Everyone involved in this study is helping to advance our understanding of new treatments for breast cancer.

Key takeaways

Tests a new breast cancer medicine called vepdegestrant.
Aims to understand how the medicine is absorbed into the blood.
Involves healthy adult volunteers, not cancer patients.
It's a very early, important step in drug development.
Helps scientists find the best way to give the medicine for future use.

Who may be eligible?

To join this study, you need to be an adult, 18 years old or older. There is no upper age limit, meaning older adults can also take part.

This study is for both men and women. Because this is a very early study looking at how the medicine works in the body, it's designed for healthy people. This means you shouldn't have any major health problems. The aim is to understand the medicine's basic actions without other illnesses making it complicated.

Doctors and researchers will check your health carefully to make sure this study is safe for you. They will explain exactly what health checks are needed and confirm if you meet all the requirements.

Quick self-check

Are you 18 years old or older?
Are you generally in good health?
Are you able to attend several clinic visits?
Are you comfortable with regular blood tests?
Are you interested in helping medical research?

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 in this study, you'll be given the study medicine, vepdegestrant, in different forms or doses. You would have several visits to a clinic over a period of time. During these visits, doctors and nurses will take blood samples regularly to measure how much of the medicine is in your blood. You might also have other checks, like measuring your heartbeat or blood pressure, to see how your body is reacting to the medicine.

There will be appointments to make sure you are well throughout the study. The total time you'd spend involved in the study would depend on the specific schedule, but these types of studies usually involve several weeks, including follow-up appointments after you've finished taking the medicine. All the details about how many visits, what tests, and how long it lasts will be clearly explained if you are thinking of joining.

Potential risks and benefits

Because this is an early study in healthy people, the main benefit is contributing to medical science and helping develop new treatments for breast cancer, though there's no direct health benefit to you as a participant. Potential risks could include side effects from the study medicine, even though healthy people are involved. These could range from mild, like headaches or feeling tired, to more serious, although serious side effects are carefully monitored and rare in these types of studies. You will be closely watched by medical staff throughout. Before you agree to take part, all known risks will be clearly explained to you, and you are always free to leave the study at any time, for any reason, without it affecting your medical care.

Locations (1)

—
Belgium

Common questions

Why are healthy people in a breast cancer study?

This early study uses healthy volunteers to carefully observe how the new medicine works in the body without other health problems complicating the results. It's a vital first step to understand the drug's basic actions and safety before it's given to patients.

What is ER+/HER2- breast cancer?

This is a common type of breast cancer where the cancer cells grow because of hormones (ER+) and don't have too much of a specific protein called HER2 (HER2-). New treatments are always needed for this type of cancer.

Will I get paid for taking part?

Information about payment or reimbursement for travel and time is usually provided by the study team. You should ask them directly about this.

How long will I be in the study?

The exact duration varies, but these types of studies often involve several visits over a few weeks, including follow-up. The study team will give you a clear schedule before you decide to join.

What happens after the study is over?

After your last visit, your participation ends. The information collected from you and other volunteers will be used to understand the medicine better and help decide if it can move to the next stages of testing in patients.