A Phase 1 Open-Label Mass Balance clinical trial to Investigate the Absorption, Metabolism, and Excretion of Single Oral Administration of [14C]-TEV-56286 Following Multiple Oral Administrations of Nonlabeled TEV-56286 to Healthy Male Participants.
This research study is about a new drug, TEV-56286. Researchers are trying to discover how this medicine moves through the body of healthy male volunteers. This involves giving participants the medicine a few times, then giving a special dose that can be traced. Scientists will then check blood, urine, and faeces to see how the body absorbs, breaks down, and gets rid of the drug. This type of study is called a 'mass balance' trial and is an early step in testing new medicines. It helps us understand how the drug behaves in people, which is really important for developing new treatments safely and effectively.
At a glance
What is this study about?
This study is an early stage of testing a new medicine called TEV-56286. Think of it like taking a brand-new car for its first detailed test drive. Before a new medicine can be given to patients who need it, scientists must first understand exactly what happens to it inside the human body. This particular study is designed to answer fundamental questions about how the body handles TEV-56286.
Specifically, researchers want to track the medicine's journey from start to finish. This includes finding out how much of the medicine your body absorbs after you take it by mouth, how your body then processes or changes it (this is called metabolism), and finally, how your body gets rid of it (this is called excretion). This complete picture helps scientists understand if the medicine is being used efficiently by the body and if there are any unexpected effects. It's a crucial step to make sure the medicine is safe and works as intended down the line.
To do this, you would first take the medicine regularly for a short period. Then, you would receive a single, special dose of TEV-56286 which has a tiny, safe tracker (a 'carbon-14' label) added to it. This tracker allows the researchers to follow the medicine's path through your body very precisely. By understanding these steps, we can work towards developing new and better treatments for various conditions in the future.
Key takeaways
- New medicine called TEV-56286 is being tested for the first time in people.
- The study looks at how your body handles the medicine: absorbs it, uses it, and gets rid of it.
- Only healthy men aged 18 and older can take part.
- Participants will stay at a clinic and provide samples (blood, urine, stool).
- This research helps scientists understand new medicines better.
- Participation is voluntary, and you can withdraw at any time.
Who may be eligible?
This study is looking for healthy men to take part. To be considered, you must be 18 years old or older. There is no upper age limit for participants in this study, as long as you are healthy.
Being 'healthy' means that you don't have any serious ongoing medical conditions or illnesses that might affect the study results or put your health at risk during the trial. The research team will do medical checks to make sure you are suitable.
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?
- Are you a man?
- Do you generally consider yourself to be in good health?
- Do you have any serious ongoing medical conditions?
- Are you able to stay at a clinic for the duration of the study?
What does participation involve?
If you decide to take part, you would first have a screening visit to check your health and make sure you're suitable for the study. If you qualify, you would then stay at a clinic for a period. During this time, you would take the study medicine (TEV-56286) multiple times. After taking the last dose of the regular medicine, you'd be given a special dose that helps researchers track it.
Throughout your stay and possibly for a short period afterwards, the research team would collect blood samples, urine samples, and stool samples. These samples help them see how your body takes in, uses, and gets rid of the medicine. There will be careful monitoring by doctors and nurses. The total duration including follow-up visits would be explained in detail if you are interested.
Potential risks and benefits
Locations (1)
- —UnverifiedNetherlands
Common questions
What is TEV-56286?
TEV-56286 is a new investigational medicine that is being studied for the first time in humans.
Why is this study only for healthy men?
Early studies like this often start with healthy volunteers to understand how the medicine works in typical, healthy bodies before testing it in patients with specific conditions. Sometimes, studies start with men because certain medications might act differently in men and women, or to avoid any potential risks to women of childbearing age during very early testing.
What does 'mass balance' mean?
It means the study aims to account for all of the medicine you take – where it goes in your body, how it changes, and how it eventually leaves your body. It's like balancing an equation.
Will I be paid for taking part?
It is common for healthy volunteer studies to offer payment for your time and inconvenience. The exact details would be explained by the study team.
How long will I need to be in the clinic?
The study involves a stay at a clinic. The exact length of your stay and any follow-up visits would be fully explained by the research team.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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