A clinical trial to learn how an investigational drug (norucholic acid) is absorbed, distributed, broken down, and removed from the body when given to people with kidney problems
This study is testing a new medicine called norucholic acid. It's designed for people who have certain liver conditions, specifically nonalcoholic fatty liver disease (NAFLD) or primary sclerosing cholangitis (PSC). The main goal is to understand exactly what happens to this medicine inside your body. We want to see how it's absorbed after you take it, where it goes, how your body breaks it down, and finally, how it leaves your system. This type of study helps doctors understand how a new medicine works, which is an important step before it can be used more widely. It's an early-stage study, meaning we're focused on safety and how the medicine behaves in the body.
At a glance
What is this study about?
This study is about a new medicine called norucholic acid. When doctors are developing a new medicine, they need to carefully understand how it works in the body. This particular study is focused on people who have certain liver problems, like nonalcoholic fatty liver disease (NAFLD) or primary sclerosing cholangitis (PSC).
The main thing we want to learn is what happens to norucholic acid once you take it. This includes several steps: how well your body absorbs the medicine, how it spreads throughout your system, how your body breaks it down, and finally, how it's removed. Knowing these details is really important because it helps scientists figure out the right dose to give and how often it should be taken to be most effective and safe.
This is an early-stage study, sometimes called a Phase I study. This means it's one of the first times this medicine is being tested in humans to see how it acts in the body, rather than focusing on whether it can cure a disease yet. The information we gather will help guide future research and development of this potential new treatment.
Key takeaways
- This study is testing a new medicine called norucholic acid.
- It's for adults with Nonalcoholic Fatty Liver Disease (NAFLD) or Primary Sclerosing Cholangitis (PSC).
- The main goal is to understand how your body handles the medicine.
- It's an early-stage study to gather important information for future research.
- Participation involves taking the medicine and having health checks.
- You can stop participating at any time.
Who may be eligible?
To join this study, you need to be an adult, 18 years old or older. The study is open to both men and women.
Because we're looking at how the medicine works in people with specific health issues, you would need to have a diagnosis of either nonalcoholic fatty liver disease (NAFLD) or primary sclerosing cholangitis (PSC). These are liver conditions that the study is interested in.
There might be other specific health requirements or conditions that would mean you couldn't take part, even if you meet these general rules. These will be discussed in detail by the study team.
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 diagnosis of Nonalcoholic Fatty Liver Disease (NAFLD)?
- Do you have a diagnosis of Primary Sclerosing Cholangitis (PSC)?
- Are you comfortable with taking a new, experimental medicine?
- Are you able to attend several study appointments?
What does participation involve?
If you decide to take part, you would receive the investigational medicine, norucholic acid. The study team would carefully monitor you to see how your body reacts to the medicine. This will involve several visits to the clinic, where you might have blood tests, urine tests, and other health checks to see how the medicine is moving through and being processed by your body. The team will also check for any side effects.
The number of visits, how long each visit lasts, and the total duration of your involvement in the study would be explained in detail by the study team. It's important to understand that new medicines are often given for a set period, with follow-up appointments after you stop taking it.
Potential risks and benefits
Locations (1)
- —UnverifiedHungary
Common questions
What is NAFLD?
NAFLD stands for Nonalcoholic Fatty Liver Disease, which is a condition where too much fat builds up in the liver, not caused by alcohol.
What is PSC?
PSC stands for Primary Sclerosing Cholangitis, a chronic liver disease that slowly damages the bile ducts, which carry digestive liquid from your liver to your small intestine.
Will this medicine cure my condition?
This early-stage study is mainly to understand how the medicine works in your body, not to see if it cures your condition. That would be studied in later research.
What does 'investigational drug' mean?
It means the medicine, norucholic acid, is still being studied and is not yet approved for general use by the public.
Will I have to stay in the hospital?
The study team will explain the exact schedule, including if any overnight stays are needed, or if all visits are outpatient clinic appointments.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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