AuthorisedHuman Pharmacology (Phase I)- OtherInterventional

A clinical study of MK-5661 in healthy people (MK-5661-007)

This research study, called MK-5661-007, is looking at a new potential medicine named MK-5661. This medicine is being developed to treat pain. In this study, doctors want to learn more about how MK-5661 works in the human body and if it causes any side effects. This is a very early stage of testing, often called 'Phase I'. It involves healthy adult volunteers, not people who are ill. By carefully studying this new medicine, researchers hope to gather important information that could help develop better treatments for pain in the future. The study is open to anyone aged 18 and over.

At a glance

Status

Authorised

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Merck Sharp & Dohme LLC

Enrolment target

Start

23 May 2025

Pain

What is this study about?

Imagine you have a new key, but you don't know what lock it fits or how it works. This study is a bit like that, but with a new medicine called MK-5661. Researchers want to understand exactly what happens when the human body takes this medicine. They'll be looking at things like how the medicine is absorbed, what it does inside the body, and how the body gets rid of it. This helps them figure out the right amount to give and how often.

This kind of study is really important and is often one of the very first steps in developing a new medicine. It helps scientists learn if the medicine is safe enough to be tested in people who actually have the condition it's meant to treat. Think of it as laying the groundwork for future treatments. Because it's an early-stage study, it's being done with healthy volunteers, not people already experiencing pain.

The overall goal is to find better ways to manage and treat pain. Pain can affect many aspects of life, and new, effective treatments are always needed. By taking part in this study, healthy volunteers contribute valuable information that could lead to new pain relief options for many people in the future.

Key takeaways

This study is testing a new medicine (MK-5661) for pain.
It's an early-stage safety and dosage study in healthy adults.
Participation involves taking the medicine and regular health checks.
The goal is to gather information for future pain treatments.
You must be 18 or older to join, and both men and women are welcome.
You can stop participating at any time.

Who may be eligible?

To join this study, you need to be a healthy adult. This means you should generally be in good health and not have any ongoing serious medical conditions that might affect how your body reacts to the new medicine.

You must be at least 18 years old. There's no upper age limit specified, so as long as you meet the other health requirements, your age won't stop you from taking part.

Both men and women are welcome to participate in this study. The researchers want to make sure they get information from a wide range of healthy individuals.

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 generally healthy and don't have any major ongoing health problems?
Are you willing to visit the clinic for health checks and tests?
Are you comfortable potentially taking a new, untested medicine?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be given the new medicine, MK-5661, and your health will be carefully checked. This will probably involve several visits to a clinic or hospital over a period of time. During these visits, you might have blood samples taken, your vital signs (like blood pressure and heart rate) checked, and you'll be asked about how you're feeling and any side effects you might experience. The full duration of your participation, including all visits and follow-up checks, would be explained to you in detail before you agree to join.

Potential risks and benefits

While there's no direct personal benefit for healthy volunteers in this study, the information gained could help develop new pain treatments for others. As with any medicine, there's a chance of experiencing side effects, which could be mild or, less commonly, more serious. All known risks would be fully explained to you before you agree to participate. 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 MK-5661?

MK-5661 is a new medicine being developed to potentially treat pain. This study is one of the first times it's being tested in people.

Why are they using healthy people instead of people with pain?

In early-stage studies like this, healthy volunteers are used to find out how the body reacts to the new medicine and if it's safe, without the complications of existing illnesses.

Will I get paid to participate?

Information about payment or compensation for your time and travel would be fully explained in the detailed study information if you inquire about joining.

How long will the study last if I join?

The exact length of your involvement, including hospital visits and follow-ups, would be clearly explained to you before you agree to take part.

What happens if I change my mind after joining?

You are free to leave the study at any point, for any reason, and it won't affect your future medical care or relationship with your doctor.