AuthorisedHuman Pharmacology (Phase I)- OtherInterventional

A PHASE 1, OPEN-LABEL STUDY TO ASSESS THE ABSORPTION, DISTRIBUTION, METABOLISM, AND EXCRETION, INCLUDING THE MASS BALANCE, OF A SINGLE ORAL DOSE OF [14C]-VAFIDEMSTAT IN HEALTHY MALE PARTICIPANTS

This is an early and very important study (called Phase 1) looking at a new medicine named Vafidemstat. It involves healthy men and is 'open-label,' meaning both participants and researchers know what treatment is being given. The main goal is to understand how the body handles a single dose of Vafidemstat. This includes how it's absorbed into the bloodstream, where it goes in the body, how the body changes it, and eventually how it's removed. Knowing this 'ADME' (Absorption, Distribution, Metabolism, Excretion) information, including something called 'mass balance,' is crucial for developing any new medicine safely and effectively. It helps scientists predict how the drug might work in future studies with patients.

At a glance

Status

Authorised

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Oryzon Genomics S.A.

Enrolment target

Start

30 Apr 2026

Healthy volunteers

What is this study about?

Imagine you take a new medicine – how does your body deal with it? This study aims to answer exactly that for a new drug called Vafidemstat. It's an early-stage study, often called a Phase 1 study, which is one of the first times a new medicine is given to people. Instead of looking at whether the drug treats a specific illness, these studies focus on foundational information about the medicine itself.

The main purpose here is to see how your body takes in Vafidemstat after you swallow a single dose, where it travels to inside your body, how your body breaks it down, and finally, how it leaves your body. This detailed understanding of the medicine's journey is super important for doctors and scientists to work out how much medicine might be needed and how often, as well as to spot any potential problems early on. They also look at something called 'mass balance,' which means they want to make sure they can account for almost all the medicine that was given, even if it's changed form.

Because this is an early and very detailed study about how the drug moves through the body, it involves healthy male volunteers. This helps researchers get a clear picture of the drug's basic actions without other health conditions complicating the results. The insights gained from studies like this are vital for deciding if a new medicine is safe and promising enough to be tested in larger studies with people who have specific health conditions.

Key takeaways

This is an early-stage study of a new medicine called Vafidemstat.
It aims to understand how the body takes in, uses, and gets rid of the medicine.
Only healthy men aged 18 and over can participate.
Participants will receive a single dose of the medicine.
It helps scientists learn if the drug is safe and how it works in the body.
Participation helps future medical research but doesn't offer direct health benefits.

Who may be eligible?

This study is looking for healthy male volunteers. To be considered, you need to be at least 18 years old. There isn't an upper age limit mentioned, but generally, the study team will assess your overall health to make sure you're suitable.

Being 'healthy' for a study like this means you don't have any major ongoing health conditions and aren't taking regular medications that could interfere with the study drug. The study team will conduct thorough checks, including medical history and examinations, to confirm you meet all the health requirements.

Since this study specifically looks at how the body handles the medicine in men, women are not eligible to take part.

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 in good health?
Are you willing to stay at a study clinic for monitoring?
Are you able to attend several follow-up appointments?
Are you not currently taking other regular medications that could interfere with the study?

Answer every question to see your result.

What does participation involve?

If you join this study, you would receive a single dose of the study medicine, Vafidemstat, by mouth. This is an 'open-label' study, which means you and the study team will both know that you are receiving the active drug.

Before and after taking the medicine, you will have several assessments. These will include blood tests and urine samples to track how the medicine moves through and leaves your body. You might also have other check-ups like heart rhythm recordings (ECGs) and general health checks. You can expect to spend a significant amount of time at the clinic, especially around when you take the medicine and for some time afterwards, for all the necessary measurements. This could involve an overnight stay or several clinic visits over a period. The total duration of your participation, including follow-up checks, will be carefully explained by the study team.

Potential risks and benefits

Participating in a study like this might not directly benefit your health, as you are a healthy volunteer. However, you would be helping medical science learn important information about a potential new medicine, which could eventually help others in the future. As with any medicine, there's always a chance of side effects, which could range from mild discomfort to more serious reactions. The study team will carefully monitor you for any changes and explain all known risks. You are free 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 'Phase 1' of a clinical trial?

Phase 1 is the earliest stage of human testing for a new medicine. It focuses on the safety of the drug and how the body handles it, rather than treating an illness.

What does 'open-label' mean?

Open-label means that both you, as a participant, and the study doctors will know that you are receiving the actual study medicine, not a placebo.

What does 'ADME' stand for?

ADME stands for Absorption, Distribution, Metabolism, and Excretion. It describes how the body takes in, spreads, uses, and gets rid of a medicine.

Will I get paid for taking part?

It's common for healthy volunteer studies to offer compensation for your time and travel, but this would be confirmed and explained by the study team.

Why are only men included in this study?

Sometimes, early studies focus on one sex to understand basic drug behaviour without potential hormonal differences complicating the results. This specific study focuses on male participants.