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

A clinical study of MK-3214 in healthy people (MK-3214-001)

This research is looking at a new medicine called MK-3214. It's designed to help people who have high cholesterol, a condition that can increase the risk of heart problems. This is an early study, known as a Phase I trial. This means it's one of the first times this medicine is being given to people. The main goal is to find out if it's safe and how the body handles it. For this particular study, we are looking for healthy men to take part. By understanding how MK-3214 works safely in healthy volunteers, researchers can decide if it should be tested further in people actually living with high cholesterol.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- First administration to humans

Sponsor

Merck Sharp & Dohme LLC

Enrolment target

Start

15 Oct 2024

Hypercholesterolaemia

What is this study about?

You might have heard of cholesterol – it's a fatty substance in your blood. While your body needs some cholesterol, having too much, especially a type called 'bad' cholesterol, can be unhealthy. High cholesterol doesn't usually have symptoms, but it can make you more likely to develop serious heart conditions like heart attacks and strokes over time. Medications are often used to help lower cholesterol levels.

This study, called MK-3214-001, is about a new potential medicine named MK-3214. Researchers want to understand if this new medicine could be a safe and effective way to help people manage their cholesterol in the future. Because it’s a very early study, the main aim is to check its safety and how it behaves in the human body. This is a crucial step before it can be tested in people who actually have high cholesterol.

By taking part, you would be helping medical science learn more about this new medicine. The information gathered from healthy volunteers in this type of study is really important. It helps researchers decide if the medicine is promising enough to continue with further, larger studies, ultimately aiming to find new ways to improve health for people living with high cholesterol.

Key takeaways

This study is testing a new medicine (MK-3214) for high cholesterol.
It's an early-stage (Phase I) study, focusing on safety and how the medicine works in the body.
Only healthy adult men (18 years and older) can take part.
Participation involves clinic visits, health checks, and taking the study medicine.
You'll be closely monitored for any side effects.
Your involvement helps advance medical research for future treatments.

Who may be eligible?

This study is specifically looking for volunteers who are healthy adult men. You need to be at least 18 years old – there's no upper age limit, as long as you're in good health.

Being 'healthy' means that you don't have any significant ongoing medical conditions that might affect how the new medicine works or make taking part unsafe for you. The study team will carry out checks to make sure you fit all the health requirements.

It's important to remember that this study is only open to men. Women won't be able to take part in this particular 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 an adult aged 18 or older?
Are you male?
Are you generally healthy and don't have any major ongoing medical conditions?
Are you able to attend appointments at the study clinic as required?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll first have some health checks to make sure you're suitable. If you are, you would be given the new medicine, MK-3214, or possibly a placebo (a dummy medicine with no active ingredient) – you wouldn't know which one you received, nor would the doctors, to keep the results fair. You would need to attend several appointments at the study clinic, which might include overnight stays. During these visits, the study team would check your health, take blood samples, and ask you questions about how you're feeling. They will closely monitor you to see how the medicine affects your body and to check for any side effects. The total length of your involvement in the study, from your first screening visit to your final check-up, would be fully explained by the study team.

Potential risks and benefits

Taking part in any study has potential benefits and risks. A potential benefit of this study is contributing to medical knowledge that could help future patients with high cholesterol. You would also receive expert medical care and monitoring throughout the study. However, there are potential risks, as with any new medicine. You might experience side effects, which could be mild or, in rare cases, more serious. All known potential risks will be thoroughly explained to you before you decide to join. Remember, taking part is completely voluntary, and you are free to withdraw from the study at any time, for any reason, without it affecting your usual 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 'high cholesterol'?

High cholesterol means having too much of a fatty substance in your blood. If it builds up, it can cause serious heart problems over time. Medicines can help manage it.

Why are you only looking for healthy men for this study?

This is a very early study, and researchers often start by testing new medicines in a specific group of healthy volunteers to understand how it works and its safety, before moving to a wider group.

What does Phase I mean?

Phase I means it's one of the first times this new medicine is being given to people. The main goal is to check its safety and how the body handles it, rather than fully testing how well it treats a condition.

Will I definitely get the new medicine?

In studies like this, some participants might receive the new medicine and others might receive a placebo (a dummy treatment). This helps researchers accurately compare effects.

Will I get paid to take part?

Study participation usually involves compensation for your time and travel expenses. The exact details would be discussed with you by the study team.