Ongoing, recruitingHuman Pharmacology (Phase I)- First administration to humansInterventional

A clinical study of MK-7228 in healthy men (MK-7228-001)

This research study, called MK-7228-001, is exploring a new investigational medicine named MK-7228. The main goal is to understand how this medicine behaves in the human body for the very first time, and to check its safety. This is a Phase I study, which means it's the initial step where a new medicine is given to people. In this particular study, only healthy male volunteers are invited to take part. The long-term aim of developing medicines like MK-7228 is to help people with serious health problems, such as atherosclerosis, which affects the arteries and can lead to heart disease. By studying this medicine now, scientists hope to learn important information for future treatments.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- First administration to humans

Sponsor

Merck Sharp & Dohme LLC

Enrolment target

Start

11 Mar 2025

Atherosclerosis

What is this study about?

This study is about a new medicine called MK-7228. It's a very early-stage research project, which means it's the first time this specific medicine is being given to people. Researchers want to carefully observe what happens when healthy volunteers take this medicine. Specifically, they'll be looking at how the medicine moves through the body, how long it stays there, and how the body copes with it. This helps them understand if it's safe enough to continue studying for wider use.

The main health condition that this type of medicine might eventually help with is called atherosclerosis. This is a serious condition where your arteries, which are blood vessels carrying blood from your heart, get clogged up with fatty substances. Over time, this can make the arteries narrow and hard, leading to problems like heart attacks or strokes.

By doing these early studies, scientists gather vital information. This information helps them decide if a new medicine has the potential to become a useful treatment for conditions like atherosclerosis in the future. It’s a significant step in the long process of developing new medicines that could improve people's health.

Key takeaways

This study is testing a new medicine called MK-7228 for the first time in people.
It's a very early-stage study focusing on safety and how the medicine works in the body.
Only healthy men aged 18 and over can take part.
The medicine is being developed with the aim of helping conditions like atherosclerosis.
Participants will have regular health checks and monitoring.

Who may be eligible?

To be considered for this study, you must be a man. You also need to be at least 18 years old. There is no upper age limit mentioned, meaning older men could also be eligible, as long as they meet all other health requirements.

This study is looking for healthy men. This means you should not have any significant ongoing health problems or conditions that might affect how the medicine works or put your health at risk during the study. The medical team will check your health very carefully to make sure it's safe for you to take part.

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 male?
Are you 18 years old or older?
Do you consider yourself generally healthy?
Do you have no significant ongoing medical conditions?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would likely have several visits to a clinic. During these visits, doctors and nurses would do various health checks. This could include things like blood tests, checking your blood pressure and heart rate, and asking detailed questions about your health. You would also be given the study medicine, MK-7228. It's possible you might need to stay at the clinic for certain periods, especially after taking the medicine, so they can closely monitor you. The doctors and nurses will explain exactly what will happen and how long each visit or stay might be. They will also tell you about any follow-up appointments after you've finished taking the medicine to make sure you are well. The total length of your involvement in the study would be fully explained before you agree to take part.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. A potential benefit could be contributing to important scientific knowledge that might help develop new treatments for conditions like atherosclerosis in the future. However, because this is an entirely new medicine being given to humans for the first time, there might be unknown risks or side effects. The study team will carefully monitor you for any problems. You will be given full details of any known potential risks before you decide to take part. Remember, you can choose 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.

—
Unverified
Belgium

Common questions

What is atherosclerosis?

Atherosclerosis is a condition where fatty deposits build up inside your arteries, making them narrow and hard. This can reduce blood flow and lead to serious heart problems.

Why is this medicine only being given to healthy men?

Early studies like this often start with healthy volunteers to see how the new medicine works in the body and if it's safe, without other health conditions making things more complicated. It's common to initially study medicines in one gender or a specific group.

What does 'Phase I' mean?

Phase I is the very first step in testing a new medicine in people. It's mainly about checking safety and how the medicine acts in the body, rather than whether it treats a disease.

Will taking part help my heart health?

This study is for healthy volunteers and is focused on researching the medicine, not on treating your own health conditions. The benefit is more about contributing to future medical knowledge.

What kind of tests will I have?

You can expect various health checks, including physical exams, blood tests, and monitoring of your vital signs like blood pressure and heart rate, to make sure you are safe.