A Phase I, open-label, non-randomized study to assess the absorption, distribution, metabolism and excretion (ADME) and pharmacokinetics of LTP001 following a single oral dose of [14C]LTP001 in healthy male participants
This clinical trial is an early-stage Phase 1 study testing an experimental medicine known as LTP001. Doctors want to understand exactly what happens to the drug once it enters the human body. This includes measuring how well it is absorbed into the bloodstream, where it travels, how the liver breaks it down, and how it is cleared out. Healthy male volunteers aged 18 and over will take a single oral dose of LTP001. The medicine contains a very small, harmless amount of a tracking substance called carbon-14. This works like a tracer, allowing scientists to follow the drug's journey through regular blood, urine, and stool samples. Because this is an early safety trial in healthy volunteers, participants will not receive any direct medical benefit. However, the study provides crucial safety information needed before the medicine can be tested in patients who have specific medical conditions.
At a glance
What is this study about?
When scientists create a new medicine, they must carefully map out its journey through the human body. This Phase 1 study focuses on an experimental medicine named LTP001. The main goal is to carry out what scientists call an 'ADME' study. This stands for Absorption, Distribution, Metabolism, and Excretion. In simple terms, researchers want to see how the body takes the drug in, where it goes, how it changes, and how it leaves.
To track the drug accurately, researchers add a tiny, safe tag called carbon-14 to a single tablet or liquid dose. This tag emits a very weak signal that laboratory equipment can detect. By measuring this signal in blood, urine, and stool samples over several days, scientists can build a complete picture of how the body handles the medicine.
Studies like this are an essential step in modern drug development. They ensure that a medicine behaves predictably and does not build up to harmful levels in the body. The findings will help doctors choose the right doses and schedules for future trials involving patients with real illnesses.
Key takeaways
- This is an early Phase 1 study testing how a single dose of LTP001 behaves in the human body.
- The trial is open only to healthy men aged 18 and older.
- The medicine contains a tiny, safe tracking marker that allows scientists to follow its path.
- Participants will need to stay in a specialist research clinic for regular monitoring and sample collection.
- There is no direct health benefit, but volunteers usually receive payment for their time and travel.
Who may be eligible?
This study is designed specifically for healthy men aged 18 and older. Because the purpose is to understand how the drug behaves in an ordinary, healthy body, volunteers must not have any serious long-term illnesses or take regular prescription medicines that could interfere with the results.
Women cannot take part in this specific trial. In very early studies that use tracking tags, researchers often limit participation to men to avoid any potential risks to female reproductive health or unborn children while the medicine is still new.
Before being accepted onto the study, volunteers will have a thorough medical check-up. This will include blood tests, heart checks (ECGs), blood pressure readings, and a review of your medical history to ensure it is completely safe for you 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.
- I am a man aged 18 or older.
- I consider myself to be in good overall health.
- I do not have any major ongoing medical conditions.
- I am not taking regular prescription medications.
- I am willing to stay overnight at a clinical research unit.
- I am comfortable providing blood, urine, and stool samples.
What does participation involve?
Taking part usually involves an initial screening visit followed by a short stay at a specialist clinical research unit. During your stay, you will swallow a single dose of LTP001 with a glass of water. Over the following days, the medical team will look after you and regularly collect blood, urine, and stool samples. They will also monitor your heart rate, blood pressure, and overall wellbeing. Once testing is complete and the drug has left your system, you will be able to go home. You will attend a final follow-up visit a week or two later to confirm that you are fit and well.
Potential risks and benefits
Locations (1)
- —UnverifiedNetherlands
Common questions
What does an ADME study mean?
ADME stands for Absorption, Distribution, Metabolism, and Excretion. It is a study that tracks how a medicine enters your body, travels through your tissues, gets broken down, and leaves through your waste.
Is the radioactive tracer safe?
Yes. The study uses an extremely small and carefully controlled amount of carbon-14. The radiation dose is very low and comparable to everyday background radiation or an ordinary hospital X-ray.
Will I be paid for taking part?
Phase 1 studies with healthy volunteers usually provide financial payment to compensate you for your time, travel, and the inconvenience of staying in the clinic.
Do I have to stay overnight in a clinic?
Yes. Because scientists need to collect regular samples over several days to track the medicine, participants usually need to stay in a dedicated research unit for part of the study.
Can I leave the study early if I change my mind?
Yes. Taking part is entirely voluntary. You have the right to withdraw from the trial at any time, for any reason, and your normal medical care will not be affected.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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