A multicentric, open-label, non-randomized study to evaluate the pharmacokinetic, safety and tolerability of ITF2357 given as an oral single 50 mg dose in participants with chronic hepatic impairment relative to matched participants with normal hepatic function.
This study is testing a new medication called ITF2357. The main goal is to understand how your body processes this medicine, especially when someone has liver problems, compared to someone with a healthy liver. We also want to check how safe it is and if there are any side effects. Participants will take one 50mg pill of ITF2357. This is an early-stage study, which means it's one of the first times this medicine is being tested in humans. It will help us learn important information about how the medicine works in the body before it can be studied in more people for specific health conditions.
At a glance
What is this study about?
This study is about a new medicine called ITF2357. When a new medicine is developed, scientists need to understand how the body deals with it. This includes how much of the medicine gets into your blood, how long it stays there, and how your body gets rid of it. This process is called 'pharmacokinetics.' It's really important because it helps doctors know the right dose to give people.
In this particular study, we're especially interested in how ITF2357 works in people who have liver problems, compared to those with healthy livers. Your liver is very important for breaking down medicines, so if it's not working properly, medicines might stay in your body longer or at higher levels. This study will look at people with mild or moderate liver problems and compare them to people with healthy livers to see if the medicine behaves differently.
We also want to make sure the medicine is safe and well-tolerated. This means checking for any side effects or problems people might experience. This is an early stage of testing for this medicine, often called 'Phase I'. The information we gather will help us decide if it's safe to continue testing ITF2357 and if the dosage needs to be adjusted for people with liver conditions in future studies.
Key takeaways
- This study is testing a new medicine called ITF2357.
- It aims to understand how the body handles the medicine, especially for people with liver problems.
- We also want to check for safety and side effects.
- Participants will take a single 50mg pill.
- This is an early-stage study, gathering basic information about the medicine.
- You can be aged 18 or over, with a healthy liver or mild to moderate liver problems.
Who may be eligible?
This study is looking for adults aged 18 or older. We need both men and women to take part.
To join, you'll either need to be a healthy adult with a normally functioning liver, or an adult who has been diagnosed with either mild or moderate liver problems. These liver problems aren't about something like a temporary infection, but rather a long-term (chronic) condition.
If you have severe liver problems, you wouldn't be able to join this particular study. There will also be other health checks to make sure the study is safe for you.
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?
- Do you have a healthy liver, OR have you been diagnosed with mild or moderate long-term liver problems?
- Are you able to attend several clinic visits for health checks and monitoring?
- Are you able to take a single pill by mouth?
What does participation involve?
If you decide to take part, you will visit the study clinic multiple times. During these visits, the study team will carry out health checks, which might include blood tests, urine tests, and a physical examination. You will be given a single 50mg pill of the study medicine, ITF2357, to take by mouth.
After you take the medicine, you will need to stay at the clinic for a period of time. This is so the team can monitor you closely for any side effects and take several blood samples at specific times. These blood samples help us understand how the medicine is moving through your body. There will also be follow-up appointments to ensure you are well. The total duration of your involvement in the study will be explained in detail by the study team, including how many visits and how long each visit will be.
Potential risks and benefits
Locations (2)
- —UnverifiedBulgaria
- —UnverifiedFrance
Common questions
What kind of medicine is ITF2357?
ITF2357 is a new medicine currently being tested to understand how it works in the body and if it's safe.
What does 'chronic hepatic impairment' mean?
This means you have a long-term (chronic) problem with your liver that affects how well it works.
Will I get better if I join this study?
This study is not designed to treat a specific illness, but to understand the new medicine. You may not personally feel better from taking part.
How often will I need to go to the clinic?
You will need to attend several visits, including one where you take the medicine and stay for monitoring, and some follow-up visits. The exact schedule will be explained to you.
What is a 'single 50mg dose'?
It means you will take just one 50 milligram pill of the study medicine by mouth.
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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