Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

MK-4318 CIDF Target Engagement Study

This is an early study, called a Phase I trial, for a new medicine named MK-4318. The main goal is to understand how this new medicine affects the body at a very basic level, particularly how it interacts with specific targets involved in pain. This study is for healthy adult men only. By carefully observing these effects, researchers can learn if MK-4318 works in the way they expect it to. This information is crucial for deciding if the medicine should be tested further in larger studies with people who actually have pain. It's a key step in developing potential new treatments to help people manage pain.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Merck Sharp & Dohme LLC

Enrolment target

Start

09 Apr 2024

Pain

What is this study about?

This research is an early step in developing a new medicine, called MK-4318, which is being explored as a potential treatment for pain. Think of it like taking a brand-new car for a first test drive – you're checking how it handles and if all the parts are working correctly. In this study, instead of a car, researchers are carefully checking how the new medicine behaves inside the body.

Specifically, this study falls under what's called 'Human Pharmacology Phase I'. This means a small group of people are given the medicine for the first time to understand how it works and if it's safe enough to move to bigger studies. They'll be looking to see if the medicine reaches the right places in the body and if it has the desired chemical effects.

The information gathered from this study is really important. It helps researchers decide if this new medicine has the potential to help people with pain and if it should be studied further. If it looks promising, it would then move on to later phases of research, where it would be tested in people who actually have pain.

Key takeaways

This is an early study (Phase I) of a new pain medicine, MK-4318.
It's checking how the medicine works in the body.
Only healthy adult men aged 18 and over can join.
Participation involves taking the medicine and regular health checks.
Your health and safety will be carefully monitored.
You can leave the study at any time.

Who may be eligible?

To join this study, you must be an adult aged 18 years or older. There is no upper age limit, meaning older adults can also take part if they meet all other requirements.

It's very important that only men can participate in this particular study. This is often because early studies want to understand how a medicine affects one sex before looking at differences between men and women.

Because this is an early-stage study, participants will also need to be generally healthy. This means you shouldn't have any major ongoing health problems that could affect how the medicine works or put you at extra risk.

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 18 years old or older?
Are you a man?
Are you generally healthy?
Are you able to attend regular clinic visits?

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, MK-4318. The study involves regular visits to the clinic, where doctors and nurses will carefully monitor your health. They will take blood samples, measure your vital signs (like blood pressure and heart rate), and ask you about how you are feeling. The total duration of your participation in the study, including follow-up appointments, will be clearly explained to you before you agree to join.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. You might feel good about helping to advance medical science and potentially discover new ways to treat pain. However, there's always a chance you could experience side effects from the medicine, some of which might be unknown at this early stage. The study team will explain all known risks and monitor you closely for any changes. Remember, you have the right 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 a Phase I study?

A Phase I study is the first time a new medicine is given to people. It's mainly to check how safe it is and how it acts in the body, often in healthy volunteers.

Why can only men take part?

Early studies sometimes focus on one sex first to get a clear picture of how the medicine works without other biological differences affecting the results. Later studies might include women.

Will this medicine cure my pain?

This study is an early step and is not designed to cure pain. It's about seeing if the medicine works as expected in the body, which could one day lead to an understanding if it might help with pain.

Do I get paid for taking part?

Payment for participation varies between studies. This would be clearly explained by the research team if you are considering joining.

What if I feel unwell during the study?

The study team will monitor you closely. If you feel unwell, you should tell them immediately. They are there to look after your health throughout the study.