Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

MK-7091 Formulations Study in Healthy Adult Participants

This research study is called the "MK-7091 Formulations Study." It's an early-stage study, meaning it's one of the first times this new medicine is being given to people. Researchers are testing different ways that MK-7091 can be prepared and given, to see how the body absorbs and uses it. They are looking for healthy adult volunteers, aged 18 and over, to take part. This medicine is being developed to potentially help people with high cholesterol in the future, but this particular study focuses on understanding the medicine itself in healthy individuals, not yet treating a specific condition.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Merck Sharp & Dohme LLC

Enrolment target

Start

04 Jun 2024

Hypercholesterolemia

What is this study about?

Imagine you have a new ingredient for a cake, but you need to figure out the best way to mix it and bake it so it tastes good and works well. This study is a bit like that, but for a new medicine called MK-7091.

Researchers are testing different 'formulations' of MK-7091. This means they are looking at various ways the medicine can be made and given – maybe different strengths, or different types of pills or liquids. They want to see how these different versions perform in the body. For example, how quickly is it absorbed? How long does it stay in the system? And how does the body process it?

This is a very early step in developing a new medicine. While MK-7091 is being looked at for conditions like high cholesterol in the future, this specific study isn't about treating high cholesterol yet. Instead, it's about gathering important information on the medicine itself from healthy volunteers. This helps scientists choose the best way to give the medicine in future studies that will look at treating specific health problems.

Key takeaways

This is an early study testing a new medicine called MK-7091.
It's primarily for healthy adults, aged 18 and over.
The goal is to see how different forms of the medicine work in the body.
It aims to gather information for future studies, not to treat a condition.
You would attend regular clinic visits for monitoring if you participate.

Who may be eligible?

To join this study, you need to be an adult, 18 years old or older. There is no upper age limit, so people of many ages can take part, as long as they are adults. Both men and women are welcome to participate in this research.

Because this study is about understanding how a new medicine works in a healthy body, it's important that you are generally well. They won't be looking for people who already have serious health problems or are taking lots of other medications that might affect how the study medicine works.

The research team will carry out checks to make sure the study is safe for you and that you meet all the specific health requirements. These checks will be explained to you fully before you make any decisions.

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?
Are you willing to attend regular clinic visits?
Are you able to follow specific study instructions?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be given the study medicine, MK-7091, in one of its different forms. You'll have regular visits to the clinic, where doctors and nurses will monitor your health. This will involve physical examinations, taking blood and urine samples, and possibly other tests to see how your body is reacting to the medicine and how it's being processed.

The study will involve several visits over a period of time, and you'll need to follow specific instructions, such as avoiding certain foods or activities, or taking the medicine at particular times. The research team will explain the exact schedule of visits, what happens at each visit, and how long the entire study will last for you, including any follow-up appointments after you stop taking the medicine.

Potential risks and benefits

Taking part in any research study has potential benefits and potential risks. A potential benefit of this study is that you would be contributing to medical science, helping to develop new medicines that might one day help people with high cholesterol. You may also receive careful health monitoring during the study. Potential risks could include side effects from the study medicine, discomfort from blood tests, or inconvenience from clinic visits. All known potential risks will be thoroughly explained to you, and you will have the right 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.

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Unverified
Belgium

Common questions

What is MK-7091?

MK-7091 is a new medicine being developed that might help people with high cholesterol in the future.

Am I being treated for high cholesterol in this study?

No, this specific study is about understanding how different versions of the medicine work in healthy volunteers, not about treating a condition like high cholesterol.

Who can take part?

Healthy men and women aged 18 and over can take part. You must meet other specific health requirements that will be checked by the study team.

What will I have to do if I join?

You'll take the study medicine and attend several clinic visits for health checks, blood tests, and monitoring.

Will I get paid for taking part?

Study participation often includes remuneration for time and travel; this will be fully explained by the research team.