Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

A clinical study of MK-6916 in healthy people (MK-6916-002)

This is a research study called MK-6916-002, and its main goal is to understand how a new medicine, MK-6916, affects the human body. Researchers are looking for healthy adults, aged 18 and over, to take part. This type of study is one of the very first steps in testing a new medicine in people. By studying healthy volunteers, doctors can learn important information about how the drug is absorbed, how long it stays in the body, and if it has any side effects, before it's given to people who are unwell. The information gathered from this study will help decide if MK-6916 could potentially be developed further to treat conditions like acute and chronic pain in the future.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Merck Sharp & Dohme LLC

Enrolment target

Start

06 Dec 2024

Acute and Chronic Pain

What is this study about?

This study, known as MK-6916-002, is an early-stage clinical trial looking into a new medicine called MK-6916. It's designed to understand how this medicine acts within healthy people. Think of it like taking a brand-new car for a test drive – but instead of a car, it's a medicine, and instead of a test track, it's the human body.

The main purpose of this study is to gather initial information about the new medicine. This includes checking how the body reacts to MK-6916, how much of it gets into the blood, and how long it stays there. They also want to identify any early side effects. This crucial information helps researchers decide if the medicine is safe enough and works in a way that makes it suitable for further studies in people who might benefit from it.

While this study is being conducted in healthy individuals, the ultimate aim for medicines like MK-6916 is often to help people with specific health problems. In this case, MK-6916 is being explored for its potential to help manage different types of pain, both sudden (acute) and long-lasting (chronic). By understanding its basic properties in healthy people first, doctors can then evaluate its potential to treat pain more effectively and safely in the future.

Key takeaways

This is an early-stage study (Phase I) testing a new medicine called MK-6916.
It's looking for healthy volunteers, aged 18 and over.
The main goal is to understand how the medicine behaves in the body and check its safety.
The information gained could help develop new treatments for pain in the future.
Participation involves regular clinic visits and health checks.

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 serious ongoing medical conditions.

Participants must be at least 18 years old. There isn't an upper age limit mentioned, so older adults can also be considered as long as they are healthy.

Both men and women are welcome to take part in this 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 18 years old or older?
Are you generally in good health?
Do you not have any serious ongoing medical conditions?
Are you able to commit to regular clinic visits?

Answer every question to see your result.

What does participation involve?

The detailed steps for taking part in this study haven't been provided here, but generally, in early-stage studies like this, you would likely have: visits to a clinic for medical check-ups, blood tests, and to receive the study medicine, which might be given in different ways (e.g., as a tablet or injection). The medicine would be provided by the study team. You might be asked to stay at the clinic for a short period after receiving the medicine for observation. There would also be follow-up appointments to monitor your health and any effects of the medicine. The total duration of your involvement could range from a few weeks to a couple of months, depending on the number of doses and follow-up needed.

Potential risks and benefits

Taking part in any study has potential benefits and risks. You won't personally benefit from solving your pain, as this study is for healthy individuals, but you'll be helping doctors learn important information that could lead to new treatments for others in the future. Potential risks could include side effects from the experimental medicine, which will be explained in detail by the study team. 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-6916?

MK-6916 is a new medicine being tested for the first time in people to see how it works in the body and if it's safe.

Why are healthy people needed for this study?

By studying healthy people, doctors can learn about the medicine's basic effects without other illnesses making it harder to understand the results.

Will I get paid for taking part?

This information isn't provided here, but many early-stage studies offer payment for your time and travel. This would be explained if you enquire.

Will this medicine help my pain?

No, this study is for healthy people and not designed to treat existing pain, though the medicine is being explored for future use in pain conditions.

How long will the study last for me?

The exact duration isn't given here, but early-stage studies often involve multiple visits over a few weeks or months.