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

MK-4646 Single Ascending Dose Study and DDI in Healthy Participants

This research study is about a new drug, MK-4646, which could help people with HIV. It's a very early stage study, meaning it's the first time this medicine is being given to people. The main goals are to find out if the drug is safe, how different doses affect the body, and if it interacts with other medicines. This information is important for potentially developing new treatments for HIV in the future. For this first study, only healthy adult men are invited to take part. This helps researchers understand the drug's basic effects before testing it in people who have HIV. It's a key first step in bringing new medicines to those who need them.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- First administration to humans

Sponsor

Merck Sharp & Dohme LLC

Enrolment target

Start

17 Jun 2024

HIV infection

What is this study about?

This study is the very first time a new medicine, called MK-4646, is being given to people. It's a crucial step in developing new treatments, especially for conditions like HIV. Right now, the researchers aren't testing to see if it cures or treats HIV directly in this study. Instead, they want to understand the basic science of the drug.

Think of it like testing a brand-new ingredient in a recipe. Before you can make the whole meal, you need to know if the ingredient itself is safe to eat, how much of it is too much, and if it goes well with other common ingredients. That's what this study aims to do for MK-4646 – check its safety, find the right dose, and see how it interacts with other medicines in the body.

This kind of early research is vital because it helps scientists decide if a new medicine is promising enough to continue with further, larger studies. The information gathered here will pave the way for bigger ongoing studies that will eventually include people living with HIV, hopefully leading to new and better treatment options for them in the future. It's all about making sure new medicines are safe and effective.

Key takeaways

Tests a new medicine, MK-4646, for HIV.
First time given to humans (Phase I study).
Aims to check safety, dosing, and drug interactions.
Participants must be healthy adult men.
Information helps develop future HIV treatments.
Contribution to medical research.

Who may be eligible?

To be able to join this study, there are a few important things you need to know.

Firstly, you must be an adult, aged 18 years old or older. There is no upper age limit, as long as you meet the other requirements. Secondly, this particular study is only open to men. This is common in early-stage trials as it helps researchers focus on how the drug works in a more controlled group before expanding to others.

As this is a very early study to check basic safety, it's also important that you are generally healthy. This means you should not have any serious health conditions. The research team will do medical checks to make sure you are suitable and that taking part would be safe 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?
Are you a man?
Are you generally healthy?
Are you able to attend all study visits?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, it would involve several visits to a healthcare facility for assessments. These assessments might include physical exams, blood tests, and other checks to see how the new medicine, MK-4646, is affecting your body. You will be given the study medication, likely in different doses, to help researchers understand how much is needed and how your body processes it. There will also be follow-up appointments to monitor your health and any potential changes after you've taken the medicine. The total duration of your participation, including all visits and follow-ups, would be explained to you in detail by the study team.

Potential risks and benefits

Participating in a study like this could offer an opportunity to contribute to medical science and help develop future treatments for HIV. However, as with any new medicine, there are potential risks, including side effects that are not yet fully understood. The study team will closely monitor your health and explain all known risks. 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 HIV?

HIV (Human Immunodeficiency Virus) is a virus that attacks the body's immune system. If left untreated, it can lead to AIDS.

Will I get the actual medicine for HIV?

This study is for a new medicine called MK-4646, which is being investigated for HIV. However, it's a very early safety study in healthy people, not a treatment study for people with HIV at this stage.

How long does the study last?

The study team will tell you the exact length of your participation, including all visits and follow-up checks.

Will I be paid for taking part?

Information about potential compensation for your time and travel will be provided by the study team if it is offered.

What does 'Phase I' mean?

Phase I means it's the very first time the medicine is being tested in people. It mainly checks for safety and how the drug behaves in the body.