Mass Balance Study of [14C] ABBV-932 in Healthy Male Volunteers
This early-stage clinical trial is looking at a new medicine called ABBV-932 in healthy male volunteers. It is known as a 'mass balance' study. The main goal is to find out what happens to the medicine once it enters the human body. To trace the medicine, scientists attach a tiny, safe marker (carbon-14) to it. This acts like a mild tracking tag, allowing researchers to measure how much of the drug gets into the bloodstream and how it leaves the body through urine and stools. Volunteers will stay in a specialised research clinic for close monitoring. While healthy participants will not receive any personal medical benefit from the drug, the information collected is vital. It helps scientists understand how to dose the medicine safely before it is tested in people who have medical conditions.
At a glance
What is this study about?
When scientists create a new medicine, an essential early step is to see exactly what the human body does to it. This Phase 1 trial tests an experimental medicine named ABBV-932 in healthy male volunteers. It is called a 'mass balance' study because researchers aim to account for all of the medicine—from the moment it is swallowed to the time it completely leaves the body.
To follow the path of the drug, scientists add a tiny, safe amount of a marker called carbon-14. This marker acts like a gentle tracking device. By collecting and testing samples of blood, urine, and stools over several days, the research team can see how quickly the medicine enters the blood, how organs like the liver break it down, and how it is cleared away.
Taking part in this study does not treat an illness, and healthy volunteers do not gain direct health benefits. However, this type of research is a foundation of modern medicine. Without it, doctors would not know how long a drug stays active in the body or what dose to give patients in future trials.
Key takeaways
- The study tests how the body processes and clears a new medicine called ABBV-932.
- Open to healthy adult men aged 18 and older.
- Uses a tiny, safe tracking marker to follow the medicine through the body.
- Involves an overnight stay at a specialist research clinic to collect samples.
- Taking part is voluntary, and you can withdraw at any time.
Who may be eligible?
This trial is specifically looking for adult men who are in good general health. To take part, volunteers must be at least 18 years of age and meet standard health criteria, such as having a healthy weight, normal blood pressure, and no significant long-term illnesses.
Women are not eligible to take part in this particular study. People with serious heart, liver, or kidney problems, or those who take certain regular prescription medicines, will not be able to join. This is to protect participant safety and ensure the results are clear.
Before anyone is accepted, the study team will carry out health checks. These include checking medical history, performing physical examinations, testing blood and urine, and checking the heart with an ECG (a simple heart trace test).
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.
- I am a man aged 18 or older.
- I consider myself to be in good general health.
- I do not have any serious heart, liver, or kidney conditions.
- I am not currently taking regular prescription medications.
- I am willing and able to stay at a research clinic for several days.
What does participation involve?
Taking part usually involves staying as an inpatient at a specialist clinical research clinic for several days or weeks. During this stay, you will receive a single dose of the study medicine containing the tracking marker. The clinic staff will look after you, provide your meals, and carry out regular health checks such as blood pressure readings and heart traces. Because the goal is to see how the medicine leaves the body, staff will collect all of your urine and stool samples during your stay until almost all of the medicine has cleared. After you leave the clinic, you may need to return for one final follow-up visit so the doctors can check that you are feeling well.
Potential risks and benefits
Locations (1)
- —UnverifiedNetherlands
Common questions
What is a 'mass balance' study?
It is a study designed to track 100% of a medicine as it moves through the body, showing how it is absorbed, broken down, and finally removed in urine and stools.
Is the radioactive marker dangerous?
The amount of radiation used is very small and carefully calculated to be safe. It is comparable to everyday background radiation or a standard medical scan.
Do I have to stay overnight in the clinic?
Yes. Most mass balance studies require you to stay at the clinic for several days so the staff can collect all necessary samples and monitor your health.
Are volunteers paid for their time?
Phase 1 trials with healthy volunteers usually provide payment to compensate you for your time, travel, and the inconvenience of staying at the clinic.
Can I leave the study if I feel uncomfortable?
Yes. Joining a clinical trial is entirely voluntary. You can choose to stop and leave the clinic at any time, for any reason.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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