Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

A study to characterize the pharmacokinetic profile of norucholic acid (NCA) in patients with primary sclerosing cholangitis (PSC)

This research is an early-stage study, sometimes called a Phase I trial, looking into a new medicine called norucholic acid (NCA). We want to understand how this medicine is absorbed, used, and removed by the body in people who have a liver condition called primary sclerosing cholangitis (PSC). This information helps scientists figure out the best way to give the medicine and how much to give. It's a key first step in developing new treatments, but it's not designed to test if the medicine works to treat PSC yet. It's about safety and how the body handles the medicine.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Dr. Falk Pharma GmbH

Enrolment target

Start

01 Dec 2023

Primary Sclerosing Cholangitis (PSC)

What is this study about?

This study is about a new medicine called norucholic acid (NCA) and how it behaves inside the body of people who have primary sclerosing cholangitis (PSC). PSC is a condition where the bile ducts in the liver become inflamed and scarred, which can lead to serious liver problems. Before a new medicine can be tested to see if it helps treat a condition, researchers need to understand how the body handles it.

This type of study is often one of the first steps when bringing a new medicine from the lab to patients. It helps doctors understand things like how much of the medicine the body takes in, how long it stays in the body, and how the body gets rid of it. This information is really important for deciding on the right dose and how often the medicine should be given in future, larger studies.

The main goal here is not to see if NCA cures PSC, but to gather important information about how it interacts with the human body. This foundational knowledge is crucial for the safe and effective development of new treatments for PSC in the future.

Key takeaways

This is an early-stage study for a new medicine for PSC patients.
It aims to understand how norucholic acid (NCA) moves through the body.
The study includes adults aged 18 and over, both men and women.
It is not testing if the medicine cures PSC, but gathering crucial information for future studies.
Participation involves taking the medicine and having regular check-ups and blood tests.
You can withdraw from the study at any time.

Who may be eligible?

This study is open to both men and women. To take part, you need to be at least 18 years old. There is no upper age limit for joining this study, so older adults are also welcome if they meet other health requirements.

Because this is a very early study looking at how a new medicine moves through the body, researchers will have specific health checks to make sure it's safe for you to take part. These checks would include reviewing your medical history and current health.

You would need to have a diagnosis of Primary Sclerosing Cholangitis (PSC) to be considered for this study. The medical team would discuss all the specific details with you to see if the study is a good fit for your situation.

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 Primary Sclerosing Cholangitis (PSC)?
Are you able to attend regular clinic appointments?
Are you willing to take a new, unapproved medicine?
Are you comfortable with having blood samples taken periodically?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would be given the new medicine, norucholic acid (NCA). The study would involve several visits to a clinic or hospital. During these visits, the research team would likely take blood samples at different times to measure how much of the medicine is in your body and how long it stays there. They might also check your vital signs like blood pressure and heart rate, and ask about any side effects you might be feeling.

The total length of time you would be involved in the study would be explained to you in detail. This type of study usually involves a period of taking the medicine and then follow-up appointments to make sure everything is okay. All your appointments and assessments would be carefully planned and communicated.

Potential risks and benefits

Like any medical study, there could be some potential benefits and some potential risks to taking part. A potential benefit is that you would receive a new investigational medicine that might, in the future, help with PSC, though this study isn't designed to show treatment effects. You would also be closely monitored by medical professionals, and your participation helps advance medical science, potentially leading to new treatments for others. However, there's always a risk of side effects from any new medicine, and some procedures like blood tests can cause minor discomfort or bruising. You are always free to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (4)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Germany
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Unverified
Austria
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Unverified
Finland
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Unverified
Norway

Common questions

What is Primary Sclerosing Cholangitis (PSC)?

PSC is a long-term liver disease that damages the small tubes (bile ducts) inside your liver, which can lead to scarring and affect how your liver works.

What does 'Human Pharmacology (Phase I)' mean?

It means this is a very early study in people, focusing on understanding how a new medicine behaves in the body and checking for its safety, rather than if it cures a disease.

Will this medicine cure my PSC?

This particular study is not designed to see if the medicine treats or cures PSC. Its main purpose is to understand how the medicine works in the body and its safety at an early stage.

Will I have to pay to be in the study?

No, you should not have to pay to participate in a clinical trial. Any study-related care and medicines would typically be provided at no cost to you.

What is 'norucholic acid (NCA)'?

NCA is the name of the new medicine being studied. At this stage, it's an 'investigational' medicine, meaning it's still being researched and is not yet available as a standard treatment.