Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

A clinical study of MK-2828 in healthy people (MK-2828-002)

This research study is about a new drug, MK-2828, and is for healthy adult men. The main purpose of this initial study is to find out if MK-2828 is safe and how it behaves in the human body. This is the very first stage of testing a new medicine in people, often called 'Phase 1'. It’s an important step to understand if the drug could be helpful for conditions like atherosclerosis, which is when fats and other substances build up in your arteries, making them narrow and hard. By studying healthy individuals first, researchers can learn a lot about the drug before it’s tested in people who are already unwell.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Merck Sharp & Dohme LLC

Enrolment target

Start

20 Dec 2024

Atherosclerosis

What is this study about?

This study is about a new medicine called MK-2828. Researchers want to understand if it's safe to use and how it works inside the body. This is an early stage of testing, often called a 'Phase 1' study. In this kind of study, new medicines are usually given to healthy people first to make sure there are no unexpected problems before they are given to people who are unwell.

The overall aim of developing MK-2828 is to find a new way to treat or prevent atherosclerosis. Atherosclerosis is a common condition where your arteries (the blood vessels that carry blood from your heart to the rest of your body) become narrowed and hardened due to a build-up of fatty materials, cholesterol, and other substances. This can lead to serious health problems like heart attacks and strokes.

By carefully studying how MK-2828 affects healthy men, the researchers can gather important information. This information will help them decide if it's safe and promising enough to continue with further studies. If successful, this medicine could one day offer a new treatment option for people affected by atherosclerosis.

Key takeaways

This study is testing a new medicine called MK-2828.
It's a very early 'Phase 1' study focused on safety and how the drug works.
Only healthy men aged 18 and over can participate.
The ultimate goal is to find new ways to treat atherosclerosis.
Your involvement could help advance medical research for future patients.

Who may be eligible?

This study is specifically looking for healthy volunteers. To be considered, you must be a man aged 18 years or older – there's no upper age limit, so older men can also take part.

Because this is a very early study of a new medicine, healthy volunteers are chosen to help researchers understand the drug's basic effects without other health conditions making it complicated.

You won't be able to join if you have certain health conditions or are taking particular medications, as these could affect how the new drug works or might make it unsafe for you. The study team will review your health in detail to ensure it's safe for you to participate.

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 a man?
Are you 18 years old or older?
Do you consider yourself generally healthy?
Are you able to commit to regular clinic visits?

Answer every question to see your result.

What does participation involve?

Taking part in this study would involve several visits to a clinic over a period of time, which the study team will explain in full detail. During these visits, you would receive the study medicine, MK-2828. You would also have regular check-ups, which might include blood tests, urine tests, heart checks (like an ECG), and physical examinations to see how your body is reacting to the medicine and to monitor your overall health. You would also be asked about any side effects you might experience. It's important to attend all scheduled visits and follow all instructions from the study team. You'll be told the exact duration of your participation and how many visits are needed before you decide to join.

Potential risks and benefits

While there's no direct personal health benefit for participants in this early stage study, your contribution is very valuable as it helps medical science learn about new potential treatments for atherosclerosis, which could help many people in the future. As with any new medicine, there's always a risk of side effects, which could be mild or more serious. The research team will monitor you closely and explain all known potential risks before you decide to take part. 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 atherosclerosis?

Atherosclerosis is when fats and other substances build up in your arteries, making them stiff and narrow. This can affect your heart and other parts of your body.

What is a 'Phase 1' study?

A Phase 1 study is the first time a new medicine is tested in people. It's mainly to check if it's safe and how it works in the body.

Who can take part in this study?

Only healthy men, aged 18 and over, are being sought for this particular study.

Will I get 'cured' of anything by joining?

No, this study is for healthy volunteers to test the safety of a new drug, not to treat an existing condition.

How long will I need to be involved?

The study team will give you a clear total duration of your participation, including the number of visits, before you decide to join.