Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

Mass balance study of [14C]-VAD044

This research is a 'mass balance study' looking at a new drug called VAD044. It's an early-stage study, meaning it's one of the first times it's being tested in people. The main goal is to understand exactly how the body handles VAD044. This includes how it's absorbed, how it changes once inside the body, and how the body eventually gets rid of it. Participants will be healthy men, and it helps researchers learn vital information about the drug before it can be tested in patients with conditions like vascular malformations. This understanding is key for developing new and safer treatments in the future.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Vaderis Therapeutics AG

Enrolment target

Start

23 Dec 2024

Vascular malformation

What is this study about?

This study is called a 'mass balance study' and it's a very important early step in testing a new medicine, VAD044. Imagine taking a drink of water – your body absorbs it, uses some of it, and then you get rid of what's left. This study is doing something similar for VAD044. Researchers want to track the drug's journey inside the body.

They'll give a special, slightly radioactive version of VAD044 (which is safe) to healthy volunteers. This special version allows them to follow the drug's path precisely. They will collect samples like blood, urine, and faeces over a period of time to see exactly how much of the drug goes in, where it goes, what it turns into, and how much comes out. This helps them create a complete picture, a 'balance sheet', of the drug's journey through the body.

Understanding how a drug is processed by the body is crucial. It helps researchers work out the right dose, how often it should be taken, and how safe it might be. This information is a vital building block for future studies that will look into whether VAD044 can effectively treat conditions like vascular malformations.

Key takeaways

This is an early study of a new drug, VAD044, in healthy people.
It aims to understand how the body absorbs, processes, and removes the drug.
Only men aged 18 and over can take part.
Participation helps future research for conditions like vascular malformations.
You will have regular health checks and provide samples (blood, urine, faeces).

Who may be eligible?

This study is specifically looking for healthy male volunteers. You'll need to be at least 18 years old to take part, and there's no upper age limit mentioned.

Because this is an early-stage study designed to understand how the drug works in a typical human body, they are looking for people who are generally well. This means that if you have any serious or long-term health conditions, you might not be able to join. However, the full details of what would make you eligible or not will be discussed with the study team.

If you are a woman, you will not be able to take part in this particular study. This is common in early drug development, sometimes to avoid potential risks to women of childbearing age or to simply focus on one sex at a time to keep the study design clear.

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 male?
Are you 18 years old or older?
Are you generally healthy?
Are you able to commit to several clinic visits?

Answer every question to see your result.

What does participation involve?

Taking part in this study would involve several visits to the clinic over a period of time. You would receive a single dose of the study drug, VAD044, which has been specially marked so researchers can track its movement in your body.

Throughout the study, you would provide various samples, likely including blood, urine, and faeces, at specific times. This helps the researchers understand how your body handles the drug over time. There will also be regular check-ups to monitor your health and ensure you are feeling well. The total duration of your participation would be explained in detail by the study team.

Potential risks and benefits

The main benefit of taking part in this study is contributing to medical research that could, in the long term, lead to new treatments for conditions like vascular malformations. You might also receive free health checks during your participation. As with any drug, there are potential risks, such as side effects from VAD044, though early-stage studies often start with very low doses. The study team will explain all known or potential risks in detail, and you will 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
Netherlands

Common questions

What is a 'mass balance study'?

It's a study that tracks exactly how a drug enters the body, how it changes, and how it leaves the body, like creating a full 'balance sheet' for the drug.

Why is this study only for men?

Sometimes early studies focus on one sex, often to simplify the research or address potential risks differently at this stage of drug development.

What is a 'vascular malformation'?

It's a type of birthmark or abnormal connection of blood vessels that can cause health problems.

Will I get paid to participate?

The study information doesn't mention payment, but it's common for clinical trials to compensate participants for their time and expenses. You should ask the study team about this.

Will I be given the actual medicine for vascular malformations?

No, this study is to understand how the drug works in healthy people, not to treat a condition. It’s an early step before it could potentially be used for patients.