CompletedPhase IInterventional

Pharmacokinetic study to the open-label Phase of NUC-5/primary sclerosing cholangitis study

This is an early research study, known as Phase I, which means it's one of the first times this new medicine, NUC-5, is being tested in people. The study is specifically for a liver condition called primary sclerosing cholangitis. The main goal of this particular part of the study is to understand how the body handles the medicine – how it's absorbed, distributed, processed, and removed. This helps researchers work out the best way to give the medicine. At the moment, full details about who can join and what exactly happens in the study aren't available to the public. They will be shared later, within 30 months after the study has finished.

At a glance

Status

Completed

Phase

Phase I

Sponsor

Dr Falk Pharma (Germany)

Enrolment target

Start

16 Sep 2024

Estimated completion

31 Dec 2024

The Health Research Authority (HRA) has approved deferral of publication of the full details of the trial. The full details will be added to the study record within 30 months after the trial has ended.

What is this study about?

This study is an early step in developing a new medicine, NUC-5, for a health condition known as primary sclerosing cholangitis (PSC). PSC is a chronic disease that slowly damages the bile ducts in the liver and can eventually lead to serious liver problems. Finding new treatments for conditions like PSC is very important.

Because this is an early study, called a Phase I trial, the main focus is on carefully understanding how NUC-5 behaves in the human body. This includes looking at how much of the medicine gets into the bloodstream, how long it stays there, and how the body breaks it down and gets rid of it. This information is vital for future studies to make sure the medicine is given safely and effectively.

While the detailed information about who can take part and exactly what the study involves isn't public yet, it's reassuring to know these studies are carefully planned and monitored. All the full details will be made available to everyone within 30 months after the study has finished, ensuring transparency once the research has been completed.

Key takeaways

This is an early-stage (Phase I) study for a new medicine, NUC-5.
It's for people with primary sclerosing cholangitis (PSC), a liver condition.
The main goal is to understand how the body processes the new medicine.
Full details about the study won't be public until later.
Only adults aged 18 and over can take part.

Who may be eligible?

At present, the full information about who can and cannot take part in this study isn't available to the public. This detailed guidance, including specific health requirements and conditions, will be shared later once the study is further along or completed.

What we do know is that participants must be at least 18 years old. Both men and women can potentially join the study. More precise details, such as other health conditions or medicines that might affect participation, will be provided at a later date.

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 primary sclerosing cholangitis (PSC)?
Are you able to commit to potential clinic visits and tests?
Are you interested in participating in early-stage medical research?

Answer every question to see your result.

What does participation involve?

Because the full study details are not yet public, we can't tell you exactly what taking part would involve. Generally, in early-stage studies like this, participants might have several visits to a clinic for health checks, to receive the study medicine, and to have blood samples taken. This helps researchers understand how the body reacts to the new medicine.

You would likely be given the new medicine, NUC-5, over a period. There would be follow-up appointments to monitor your health and how you respond to the treatment. The total duration of participation varies greatly in different studies, and we don't have that information yet for this specific trial. All these details will be made clear and explained fully to potential participants once they become available.

Potential risks and benefits

Taking part in any medical study carries potential benefits and possible risks. Potential benefits might include access to a new medicine not yet widely available, and helping advance medical science for others with primary sclerosing cholangitis. Risks could include side effects from the new medicine, or the need for frequent clinic visits and medical tests. You would always have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (2)

Queen Elizabeth Hospital Birmingham
Approximate
Birmingham, United Kingdom
Royal Free Hospital
Approximate
London, United Kingdom

Common questions

What is primary sclerosing cholangitis (PSC)?

PSC is a long-term liver disease that causes damage to the bile ducts, which carry digestive fluid from your liver. It can lead to serious liver problems over time.

What is a 'Phase I' study?

Phase I is the earliest stage of human testing for a new medicine. It mainly focuses on safety and how the body handles the medicine, rather than whether it cures a disease.

Why are the full details not available yet?

Sometimes, study details are kept private temporarily to protect the integrity of the research or for commercial reasons. They will be published later.

When will the full study details be available?

The full details will be shared within 30 months after the study has officially finished.

Can children take part in this study?

No, this study is only open to adults aged 18 years and older.

How to find out more

GKM Gesellschaft fuer Therapieforschung mbH

nuc-11@gkm-therapieforschung.de +49 (0)892091200 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.