AuthorisedHuman Pharmacology (Phase I)- OtherInterventional

Mass Balance and Absolute Oral Bioavailability of [14C]VH4524184

This is an early-stage study, sometimes called a Phase 1 study, for a new medicine named VH4524184. It's designed for adults with HIV. The main goal is to understand exactly how this new medicine travels through the body, how much of it gets into your system, and how your body breaks it down and gets rid of it. Researchers use a special, very small amount of a 'labelled' version of the medicine to track its journey. This helps them learn important details about the medicine's behaviour. This information is crucial for developing new and potentially better treatments for HIV in the future, ensuring they are both safe and effective.

At a glance

Status

Authorised

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Viiv Healthcare UK Limited

Enrolment target

Start

18 May 2026

human immunodeficiency virus (HIV)

What is this study about?

This study is about a new medicine called VH4524184, which is being developed to help people living with HIV. When scientists create a new medicine, they need to thoroughly understand how it works inside the human body. This particular study is an early step in that process. It's called a 'mass balance and absolute oral bioavailability' study.

In simple terms, 'mass balance' means the researchers want to track the complete journey of the medicine from the moment it enters your body until it leaves. They'll look at how much of the medicine is absorbed, what parts of your body it goes to, how it changes, and how your body eventually gets rid of it, whether through urine or other ways. 'Absolute oral bioavailability' means they want to find out exactly how much of the medicine you swallow actually makes it into your bloodstream in its active form.

To do this, a tiny, harmless amount of the medicine is specially marked (that's what '[14C]' refers to, a special label that can be tracked). This allows the scientists to follow its path very accurately. The results from this study are really important because they help researchers understand if the medicine is absorbed well, how long it stays in the body, and how it's handled. This information is vital for deciding the right dose and how to best use the medicine in future studies, with the ultimate goal of offering better and safer treatments for HIV.

Key takeaways

This is an early-stage study for a new HIV medicine (VH4524184).
It aims to understand how the medicine moves through and leaves the body.
Participation involves taking the medicine and providing samples (blood, urine).
It's open to adults aged 18 and over who have HIV.
This study helps develop potentially better future HIV treatments.

Who may be eligible?

To join this study, you need to be an adult, aged 18 or older. There is no upper age limit, so people of all adult ages can be considered. The study is open to both men and women.

Because this is an early study, participants will likely need to be in generally good health, apart from having HIV. This is important so that any effects seen can be clearly linked to the new medicine and not other health conditions.

The research team will need to check your medical history and do some health assessments to make sure it's safe for you to take part. This ensures the study is suitable 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?
Do you have HIV?
Are you generally in good health (apart from HIV)?
Are you able to stay at a study clinic for a period if needed?
Are you willing to provide blood and urine samples regularly?

Answer every question to see your result.

What does participation involve?

Taking part in this study would involve a few steps. You would first have a screening visit where doctors check your health to see if you can join. If you qualify, you'd be given the study medicine, probably in a pill or liquid form. Because this study tracks how the medicine moves through your body, you would likely need to stay at a special research clinic for a period, perhaps a few days or even longer, depending on how quickly the medicine leaves your system.

During your stay, the medical team would collect samples of your blood, urine, and possibly stools regularly. This is to measure the levels of the medicine and its by-products in your body. You might also have regular health checks like blood pressure, heart rate, and possibly scans.

After you leave the clinic, there might be a follow-up visit or two to ensure your health is good and to collect any final information. The full length of your involvement, from the first screening to the last follow-up, will be clearly explained before you agree to join.

Potential risks and benefits

Taking part in any medical study has both potential benefits and risks. A potential benefit of joining this study is contributing to the development of new HIV treatments that could help many people in the future. You'd also receive close medical attention during the study period. However, there's always a risk of side effects from taking a new medicine, which could range from mild discomfort to more serious reactions, though serious reactions are rare in these early-stage studies. The research team will carefully explain all known or expected risks. Remember, you 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
Netherlands

Common questions

What is HIV?

HIV stands for Human Immunodeficiency Virus. It's a virus that attacks the body's immune system, which helps fight off infections.

Why is this study important for HIV?

This study helps scientists understand a new medicine called VH4524184. Knowing how it works in the body is a vital early step to see if it could become a safe and effective treatment for HIV in the future.

Will I get 'cured' by taking part?

No, this is an early-stage study focused on understanding the medicine, not curing HIV. While your health will be closely monitored, the primary goal is not personal treatment.

Do I have to pay to join the study?

No, you do not have to pay to join. Study-related medical care and the medicine will be provided free of charge.

What does '[14C]' mean?

It means the medicine has been very slightly and safely marked with a special, traceable carbon atom. This allows doctors to follow its path through your body without harming you.