Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

ADME: A Study to Understand What the Body does to the Study Compound Called PF-07220060 When Taken by Healthy Adults.

This study is investigating a new medication, known by its code name PF-07220060. The main goal is to understand what happens to this medicine once it's inside a healthy adult's body. Researchers want to see how it's absorbed, where it goes, how it's changed, and how it leaves the body. This information is really important because it helps scientists work out the best way to give the medicine and what dose might be safe and effective. While this particular study is done in healthy volunteers, the medicine is being developed as a potential treatment for advanced breast cancer. Understanding how healthy bodies process it is a crucial first step in its development.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Pfizer Inc.

Enrolment target

Start

14 Dec 2023

metastatic/advanced breast cancer

What is this study about?

This research study is about a new medicine called PF-07220060. When a new medicine is being developed, scientists need to understand a lot about it before it can be given to patients who are unwell. This study focuses on what's called 'ADME,' which stands for absorption, distribution, metabolism, and excretion.

In simple terms, researchers want to see what happens to the medicine when a healthy person takes it. They'll look at how much of it gets into the body, where it travels to, how the body changes it, and finally, how the body gets rid of it. This information is like a map for the medicine; it shows its journey through the body.

Even though this study is for healthy volunteers, the medicine itself is being developed to potentially treat advanced breast cancer. By understanding how the body processes the drug in healthy people, scientists can make informed decisions about its safety and how it might work in people with cancer. This is a very early but essential step in developing new treatments.

Key takeaways

This study is testing a new medicine called PF-07220060.
It aims to understand how a healthy body processes this medicine.
The medicine is being developed for people with advanced breast cancer.
Only adult male volunteers, aged 18 or older, are eligible for this study.
Taking part involves multiple visits, health checks, and taking the study medicine.
Your participation helps to advance medical science for future treatments.

Who may be eligible?

To be considered for this study, you need to be an adult, at least 18 years old. The study is specifically looking for male volunteers at this stage. You must also be generally healthy.

Being healthy means you don't have any major ongoing health problems. The research team will do medical checks to make sure you're suitable and healthy enough to take part. This is for your safety.

There will be other specific things the research team will look for in your medical history to make sure you fit all the requirements for this study.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

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

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would be given the study medicine, PF-07220060. The exact way you'd take it (e.g., as a pill) and the dose would be clearly explained. You would need to visit the study clinic or hospital a number of times for assessments. These assessments might include blood tests, urine tests, and general health checks to see how your body is reacting to the medicine and how it's processing it. The detailed schedule of visits and tests would be provided by the study team. They'll also tell you about any follow-up appointments after you've stopped taking the medicine. The total length of your participation, including all visits and follow-ups, would be explained before you agree to join.

Potential risks and benefits

Taking part in any study has potential pros and cons. A potential benefit of this study is helping advance medical knowledge, which could lead to new treatments for others in the future. You would also receive close medical attention and monitoring. Potential risks could include side effects from the study medicine, which would be fully explained by the study team. There might also be a small risk from procedures like blood tests. You have the right to leave the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Netherlands

Common questions

What does 'ADME' mean?

ADME stands for absorption, distribution, metabolism, and excretion. It’s about how your body takes in the medicine, where it goes, how your body changes it, and how it gets rid of it.

Why are healthy people needed for a cancer medicine study?

Studying healthy people first helps researchers understand how the medicine works in a 'normal' body without other health issues affecting the results. This is a vital early step in developing new drugs.

Will I get the medicine for breast cancer?

No, this specific study is for healthy volunteers and is about understanding how the new medicine works, not treating breast cancer. The medicine is for research purposes only.

What is 'Phase I'?

Phase I is an early stage of clinical research where a new medicine is tested in a small group of people, often healthy volunteers, to check its safety and how it is processed by the body.

Can I leave the study at any time?

Yes, you are free to withdraw from the study at any point, for any reason, without affecting your regular medical care.