Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

A clinical study of MK-6916 in healthy people (MK-6916-006)

This study is an early investigation into a new medicine, known for now as MK-6916. Researchers want to understand how it affects healthy people, and if it's safe. This kind of study is a first step to see if the medicine could eventually be used to help people who experience pain, both short-term (acute) and long-term (chronic). It's called a 'Phase I' study, which means it’s designed to learn about the medicine's basic effects in the body, rather than testing if it treats a specific condition. Participants must be at least 18 years old.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Merck Sharp & Dohme LLC

Enrolment target

Start

28 May 2025

Acute and chronic Pain

What is this study about?

This study is about a new medicine called MK-6916. Researchers want to find out how this new medicine works in the human body and if it's safe. Instead of testing it on people who are unwell, this early study is being done with healthy volunteers. This is a common and important first step when developing any new medicine.

The main goal is to understand things like how the medicine is absorbed, what it does inside the body, and how the body gets rid of it. Researchers will also be looking very closely for any side effects or problems it might cause. Information from this study will help them decide if it's safe enough to move on to other studies in the future, possibly involving people who live with pain.

While this study doesn't aim to treat pain directly, medicines like MK-6916 are being explored because they might offer new ways to help people who suffer from different types of pain. By learning more about this medicine now, scientists hope to eventually develop better treatments for pain in the future.

Key takeaways

This is an early study of a new medicine called MK-6916.
It's for healthy adults, aged 18 years or older.
The main aim is to check its safety and how it works in the body.
It could help develop future treatments for pain.
Your participation would help advance medical science.
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 generally feel well and don't have any major ongoing health problems.

Anyone aged 18 years or older can be considered. There isn't an upper age limit mentioned in this initial information, but other health checks will be done later to make sure it's safe for you to take part.

Both men and women are welcome to participate in this study. The medical team leading the study will need to check your full medical history and do some tests to make sure that the study is a safe and suitable option for you.

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?
Do you consider yourself generally healthy?
Do you not have any major ongoing health conditions?
Are you able to attend appointments as required by the study team?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive the study medicine, MK-6916. As this is an early stage study, it's likely you would have regular visits to the clinic, possibly daily or every few days, for a period of time. These visits would include check-ups, blood tests, and perhaps other assessments to see how your body is reacting to the medicine.

The study would involve careful monitoring by the medical team. The total duration of your involvement could range from several days to a few weeks, including follow-up appointments after you've stopped taking the medicine. All these details would be explained thoroughly before you agree to join.

Potential risks and benefits

Taking part in any study has potential benefits and risks. A potential benefit is contributing to medical knowledge that could lead to new pain treatments. You will be closely monitored by medical professionals. Potential risks include experiencing side effects from the new medicine, which are not yet fully known. You would be given a detailed explanation of all known potential risks before deciding to join. Remember, taking part is 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.

—
Unverified
Belgium

Common questions

What is MK-6916?

MK-6916 is the name of a new medicine being tested in this early study. It doesn't have a common name yet.

What is a 'Phase I' study?

It's the very first time a new medicine is tested in people, usually healthy volunteers. The main goal is to check its safety and how it works in the body, not yet to treat a disease.

Will this medicine help my pain?

This study is not designed to treat pain. It's an early safety study in healthy people to see if it might be useful for pain in the future.

Do I need to be ill to join?

No, this study is looking for healthy volunteers, not people with specific health problems.

How long would I be involved?

The exact length isn't stated, but Phase I studies often involve several visits over a few weeks, including follow-up.