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

A clinical study of MK-2828 in healthy people (MK-2828-001)

This research study, called MK-2828-001, is exploring a new medicine named MK-2828. Scientists want to understand how it affects healthy people, and if it's safe to use. This is the very first time this medicine will be given to humans, which is a crucial step in developing new treatments. The study is specifically looking for healthy male volunteers who are 18 years old or older. The main goal is to see how the new medicine behaves in the body and if there are any side effects. While the medicine is being developed for a condition called atherosclerosis (hardening of the arteries), this particular study is focused on its basic effects in healthy individuals, not on treating the condition itself.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- First administration to humans

Sponsor

Merck Sharp & Dohme LLC

Enrolment target

Start

19 Jul 2024

Atherosclerosis

What is this study about?

Imagine your blood vessels are like pipes that carry blood around your body. Sometimes, these pipes can get narrowed or hardened, a condition called atherosclerosis. This can cause serious health problems. Scientists are always trying to find new ways to prevent or treat this. This study is testing a brand new medicine, called MK-2828, which could one day help with this condition.

This particular study is a very early step in testing the new medicine. It's often called a 'Phase I' study, which means it's the very first time the medicine will be given to people. The main goal here isn't to treat atherosclerosis, but to simply see what the medicine does in a healthy human body. Researchers want to understand if it's safe, how much of it stays in the body, and how the body handles it.

If this initial study shows that MK-2828 is safe and works as expected in healthy volunteers, it might then be tested in people who have atherosclerosis in future studies. This careful step-by-step process helps make sure that any new medicine is thoroughly checked before it can be used more widely.

Key takeaways

This study is testing a brand new medicine, MK-2828, for the first time in people.
It's looking for healthy men aged 18 and over.
The main goal is to check the medicine's safety and how it behaves in the body.
Participation involves clinic visits, taking the medicine, and health monitoring.
You won't be treated for atherosclerosis in this particular study.
You can withdraw from the study at any time.

Who may be eligible?

This study is looking for volunteers who are healthy. You don't need to have any specific health conditions to take part. The main things are that you must be male and at least 18 years old. There is no upper age limit, so men of all adult ages can be considered.

It's important to remember that 'healthy' means you shouldn't have any major ongoing medical problems that could make taking a new medicine risky. The research team will carefully check your health to make sure it's safe for you to join. They will ask about your medical history and do some tests.

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?
Are you able to attend appointments at the study clinic?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be given the new medicine, MK-2828. This will happen over a set period. You will need to attend several appointments at the clinic. During these visits, the research team will monitor your health closely. This will involve things like blood tests, checking your blood pressure and heart rate, and asking you about how you are feeling and if you have any side effects.

You will likely be in the study for a specific number of weeks or months, as outlined by the research team. They will explain exactly how many visits you will need, how long each visit might take, and any follow-up appointments after you've stopped taking the medicine. All of these steps are designed to make sure the medicine is safe and to understand how it works in the body.

Potential risks and benefits

Potential immediate benefits for you include free health checks and medical supervision throughout the study, and you might be compensated for your time and travel. More broadly, participating could help advance medical science, potentially leading to new treatments for atherosclerosis in the future. However, as with any new medicine, there are potential risks, such as unexpected side effects or reactions. The research team will explain all known risks and carefully monitor you for any problems. 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 a condition where fatty deposits build up inside your arteries (blood vessels), making them narrow and hard. This can lead to serious heart problems.

Why are you only looking for healthy men?

Because this is the very first time the medicine is being given to people, researchers often start with healthy volunteers to see how the medicine acts in a body without other health issues, and to check for its basic safety and effects.

Will I get better if I join this study?

This study is not designed to treat a disease. It's about testing a new medicine's safety and how it works in healthy people. We don't expect you to 'get better' from a condition by joining this specific study.

What will happen during the study visits?

You'll have medical check-ups, blood tests, and vital sign measurements (like blood pressure), and the research team will ask about any feelings or side effects you might have.

Will I be paid for taking part?

Many early-stage clinical trials offer payment for your time and to cover travel expenses. This will be fully explained by the research team if you are eligible and interested.