Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

A Study to Learn How Different Amounts of the Study Medicine Called PF-07293893 are Tolerated and Act in the Body of Healthy Adults.

This early-stage medical study, called a Phase I trial, is exploring a new medicine named PF-07293893. It's designed for healthy adults and is focused on two main things: finding out how much of the medicine the body can handle without causing problems (tolerability), and understanding how the medicine works inside the body (pharmacology). Scientists are hopeful this medicine could one day help people with a specific type of heart failure. By studying healthy volunteers first, they can get important information about the medicine's safety and effects before testing it in patients. This foundational research is crucial for developing new treatments.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Pfizer Inc.

Enrolment target

Start

13 Dec 2023

heart failure with preserved ejection fraction

What is this study about?

This study is an early step in testing a new medicine called PF-07293893. Imagine researchers are trying to build a new car; this study is like testing the engine in a controlled environment before putting it into a full car and driving it on the road. In this case, the 'engine' is the new medicine, and researchers want to see how it works inside the human body.

The main goal is to understand how different amounts of this medicine are tolerated, meaning how well people's bodies handle it and if there are any side effects. They also want to learn how the medicine behaves once it's in the body – for example, how quickly it's absorbed, how it's broken down, and how it leaves the body. This helps scientists figure out the best and safest way to use it in the future.

While this study is being done in healthy adults, the medicine is being developed to potentially treat a condition called 'heart failure with preserved ejection fraction.' This is a type of heart failure where the heart can still pump blood, but it's stiff and doesn't fill with enough blood between beats. By gathering information from healthy volunteers, researchers can then decide if it's safe to test this medicine in people who actually have this heart condition.

Key takeaways

It's an early-stage study (Phase I) of a new medicine called PF-07293893.
The study aims to understand how the body handles the medicine and if it's safe.
Only healthy adult volunteers aged 18 and over can participate.
The medicine is being developed for a type of heart failure.
Participation helps advance medicine for future patients but may not directly benefit you.
You have the right to leave the study at any time.

Who may be eligible?

To join this study, you must be a healthy adult aged 18 or older. There is no upper age limit, meaning people of any adult age can take part as long as they are healthy. Both men and women are welcome to participate.

Being 'healthy' for a medical study usually means you don't have any significant ongoing medical conditions, are not taking certain medications, and meet specific health criteria determined by the study doctors. These criteria ensure that the medicine's effects can be studied clearly without being confused by other health issues.

Before you can join, a medical team will do a thorough health check-up to make sure it's safe for you to take part and that you meet all the necessary health requirements.

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.

I am 18 years old or older.
I consider myself to be in good overall health.
I am not currently dealing with any significant long-term health problems.
I am willing to undergo medical check-ups and follow study instructions.
I understand this study is for healthy volunteers, not intended to treat an illness.

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive the new medicine, PF-07293893. Since this is an early-stage study, you might stay at a clinic for a period, where nurses and doctors can closely monitor your health after you take the medicine. You would also have several visits to the clinic for various assessments.

These assessments typically include regular blood tests to see how the medicine is moving through your body, urine tests, heart checks (like ECGs), and physical examinations. The total length of the study for each participant can vary, but it would involve initial screening, receiving the medicine, and then follow-up checks. You would be given a detailed schedule explaining all visits and procedures.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. For this early-stage study, the main benefit is contributing to medical science and helping to develop new treatments that might eventually help people with heart failure. While you personally might not directly benefit from the medicine, your participation is invaluable for future patients. Potential risks include side effects from the new medicine, which are not yet fully known, as well as discomfort from medical procedures like blood tests. All potential risks will be thoroughly explained to you, and you will be carefully monitored throughout the study. Remember, you have the right to withdraw from 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
Belgium

Common questions

What is 'heart failure with preserved ejection fraction'?

It's a type of heart failure where your heart muscle is stiff. It can still pump blood, but it doesn't relax properly to fill with enough blood between beats. This can lead to symptoms like breathlessness and tiredness.

Why is this study only in healthy adults?

This is an early 'Phase I' study. It's often done in healthy volunteers first to safely learn how a new medicine is handled by the body and what dose might be safe before testing it in patients who might already have health problems.

Will I get better if I join this study?

This study is not designed to treat a disease, as it's for healthy adults. Your participation is about helping researchers learn about the medicine's safety and how it works, which could help future patients.

What is 'human pharmacology'?

It's the study of how a medicine interacts with the human body. This includes understanding how the body absorbs, distributes, changes, and gets rid of the medicine, and what effects it has.

Will I know if I'm getting the actual medicine or a dummy pill?

In this specific type of Phase 1 study, all participants usually receive the active medicine to test its effects. The study team will explain exactly what you will receive.