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

A Single-Ascending-Dose Study of MK6916 in Healthy Participants

This study is looking for healthy men aged 18 and over to test a new medicine called MK6916, which might one day help people with acute (sudden) or chronic (long-lasting) pain. This is a very early-stage study, known as Phase I, meaning it's the first time this medicine is being given to people. Researchers will give participants a single, small dose of the medicine and carefully watch how their bodies react. The main goal is to see if the medicine is safe and what happens to it inside the body, not to treat any pain directly. It's an important step in developing new treatments for pain.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- First administration to humans

Sponsor

Merck Sharp & Dohme LLC

Enrolment target

Start

25 Apr 2024

Acute and chronic Pain

What is this study about?

This study is a bit like the first test drive of a brand new car. Researchers are giving a new medicine, called MK6916, to people for the very first time. They want to see how the car (the medicine) performs on a simple test track (healthy volunteers) before even thinking about putting it on the main road (patients with pain).

The main purpose of this study is to check if MK6916 is safe and how the body handles it. They will start with a very small dose and only increase it carefully in different groups of participants. By doing this, they can make sure that giving this new medicine to people is as safe as possible. This type of study, often called a 'Phase I' or 'Human Pharmacology' study, is crucial for developing any new medicine.

While this specific study isn't designed to treat pain, the information gathered from it is vital. The hope is that if MK6916 proves to be safe and manageable in healthy individuals, it could eventually be developed into a new treatment option for people suffering from various types of pain, whether it's pain that comes on suddenly or pain that lasts a long time.

Key takeaways

It's about a new medicine called MK6916 for pain.
It's the very first time it's being tested in people.
Only healthy men, aged 18 and over, can take part.
The main aim is to check the medicine's safety and how the body reacts to it.
You won't get treatment for pain, but you'd help future pain relief.

Who may be eligible?

To join this study, you need to be a healthy man, aged 18 years or older. This means you shouldn't have any major ongoing health problems.

Because this is the very first time the medicine is being tested in humans, the researchers want to start with a very specific and healthy group to make sure they can clearly see how the medicine acts without other health conditions complicating the results. If you have any serious medical conditions or take regular medications, you might not be able to take part.

They are only looking for men at this stage. Scientists often start drug testing in one sex first, and if it proves safe, they might include women in future stages of testing.

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 a man?
Are you at least 18 years old?
Do you consider yourself generally healthy?
Do you not have any ongoing serious medical conditions?

Answer every question to see your result.

What does participation involve?

If you join this study, you'll be given a single dose of the study medicine, MK6916. The dose will be very small to begin with. You would likely need to stay at a special clinic for a period of time, perhaps overnight or for a few days, so the doctors and nurses can closely monitor you. They will check your health regularly using things like blood tests, urine tests, heart traces (ECGs), and by asking how you feel.

There might be several follow-up appointments after you receive the medicine, possibly over a few weeks, to make sure you're doing well and to check for any delayed effects. The total duration of your involvement, including all visits and follow-ups, would be explained to you in detail before you agree to take part.

Potential risks and benefits

Taking part in any medical study carries some potential risks, as this is a new medicine whose effects on humans are not yet fully understood. You might experience side effects, which could be mild, like a headache, or more serious. However, the study will be carefully monitored, starting with very low doses, to ensure your safety. On the benefit side, you wouldn't directly benefit from treatment for pain in this particular study, but you would be contributing essential information that could help develop new pain medications for others in the future. Remember, you can choose to leave 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 'Phase I' of a clinical trial?

Phase I is the first time a new medicine is tested in people, usually healthy volunteers. The main goal is to find out if it's safe and how the body handles it.

Will this medicine treat my pain?

No, this study is not designed to treat pain. It's for healthy volunteers to test the safety of a new medicine for potential future use in pain relief.

Why are only men included in this study?

Sometimes, in the very early stages of testing a new medicine, researchers choose to include only one sex to simplify the initial safety assessment. If it's safe, women might be included later.

How long would I need to be involved?

The exact time will be explained, but it could involve a stay at a clinic for a short period after receiving the medicine, plus several follow-up visits over a few weeks or months.

Will I get paid for taking part?

Many early-stage trials offer payment for your time and inconvenience. This would be clearly explained by the research team.