Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

A clinical study of MK-6916 and placebo in healthy people (MK-6916-003)

This is an early-stage research study, sometimes called a Phase I study. Doctors are looking at a new medicine, or 'drug,' called MK-6916. The main goal is to find out how this new medicine works in the body and if it's safe for people to take. They will also compare it to a dummy medicine, called a placebo, which contains no active ingredients. This study includes healthy men and is a first step in developing new ways to help people who experience pain. It's important to understand how new medicines work at this early stage before they can be tested in people who are actually unwell.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Merck Sharp & Dohme LLC

Enrolment target

Start

03 Dec 2024

Acute and chronic Pain

What is this study about?

This study is about a new medicine called MK-6916. It's a very early look at the medicine, often called a 'Phase I' study. The main purpose of this kind of study is to see how the medicine acts inside the body. For example, researchers want to know how much medicine gets into the bloodstream, how long it stays there, and how the body gets rid of it. They also want to make sure it's safe and doesn't cause unexpected problems in healthy people.

This study is a first step in developing new ways to treat different types of pain, both short-term (like a sprain) and long-term (like back pain that doesn't go away). By understanding how MK-6916 works and if it's safe in healthy volunteers, researchers can decide if it's promising enough to test in people who actually have pain.

Taking part in studies like this is really important because it helps scientists learn more about new medicines. This knowledge can then lead to better treatments for many conditions in the future. It's a key part of how new medications become available to patients.

Key takeaways

This is an early study of a new medicine for pain called MK-6916.
The main goal is to check safety and how the medicine works in the body.
Only healthy men aged 18 and over can take part.
Participants will receive either the new medicine or a dummy pill (placebo).
Taking part helps advance medical knowledge for future pain treatments.

Who may be eligible?

This study is looking for healthy men to take part. To be considered, you must be an adult aged 18 years or older. There is no upper age limit for this particular study, meaning older adults are also welcome to inquire.

It's important that you are generally healthy. This means you shouldn't have any serious ongoing medical conditions that might affect how the medicine works or put your health at risk during the 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 a man?
Are you 18 years old or older?
Are you generally healthy?
Do you understand that this is a research study about a new medicine?

Answer every question to see your result.

What does participation involve?

If you take part in this study, you will likely have several visits to a clinic. These visits will involve various tests to check your health, such as blood tests, urine tests, and possibly scans to see how the medicine is affecting your body. You will be given either the new medicine, MK-6916, or a placebo, which looks the same but has no active ingredients. You won't know which one you're receiving.

During your time in the study, you'll be carefully monitored by doctors and nurses. They will keep an eye on your health and check for any side effects. After taking the medicine, there will be follow-up appointments to make sure you remain well. The total time you'd be involved in the study would depend on its design, but early-stage studies often involve short stays in a clinic or regular visits over a few weeks.

Potential risks and benefits

Taking part in a study like this might have some potential benefits, such as contributing to scientific knowledge that could help others with pain conditions in the future. You will also receive thorough medical check-ups. However, there are also potential risks; for example, the new medicine might cause side effects that we don't fully know about yet. You will be given a complete explanation of all known or expected risks before you agree to participate. Remember, you can decide to stop taking part in 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 MK-6916?

MK-6916 is a new medicine being tested. Researchers want to understand how it works in the body and if it's safe.

What is a placebo?

A placebo is a 'dummy' medicine that looks like the real thing but contains no active drug. It helps researchers see if the new medicine works better than no treatment at all.

Why are only men included in this study?

Sometimes, in early studies, researchers might focus on one group (like men) to simplify the first look at a new medicine and understand its effects more clearly. Later studies might include women.

Will I know if I'm getting the medicine or the placebo?

No, this study is 'blinded,' meaning neither you nor the study staff will know whether you are receiving MK-6916 or the placebo. This helps make the study results more reliable.

What does 'Phase I' mean?

Phase I is the earliest stage of human testing for a new medicine. It focuses on safety and how the medicine acts in the body, usually in healthy volunteers, before it's given to patients with a condition.