Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

A Study to Assess the Pharmacokinetics of Rifaximin Soluble Solid Dispersion (SSD) Formulation in Adult Subjects with Impaired Hepatic Function

This research is a 'Phase I' study, which means it’s one of the first times this new version of the medicine, Rifaximin Soluble Solid Dispersion (SSD), is being tested in people. Specifically, doctors want to see how the body handles this medicine in adults who have liver problems. They will be observing how the medicine is absorbed, how it travels through the body, and how it is eventually removed. This helps them work out the best and safest ways to use the new medicine in people with liver conditions. It’s an important step in making sure new medications are appropriate for everyone, including those with other health issues.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Salix Pharmaceuticals Inc.

Enrolment target

Start

13 Oct 2023

Hepatic impairment.

What is this study about?

This study is about a medicine called Rifaximin, but it's a new version of it, described as a 'Soluble Solid Dispersion' or SSD. Think of it like a new way to package or prepare the medicine so it might work better. The main goal of this research is to understand how this new version of Rifaximin behaves inside the body of adults who have impaired hepatic function – that's a medical way of saying their liver isn't working as well as it should. The liver plays a really important role in processing medicines.

When you take a medicine, your body absorbs it, uses it, and then your liver often helps to break it down and remove it from your system. If your liver isn't working properly, it might process medicines differently. This study aims to find out if this new Rifaximin SSD is handled in the same way, or if it acts differently in people with liver problems compared to people with healthy livers. This kind of information is vital for doctors to know so they can give the correct and safest dose of medicine to everyone.

This is a 'Phase I' study, which means it's an early stage of human testing. These studies are mostly about safety and understanding how the body handles the drug, rather than purely checking if it cures a disease. By doing this research, scientists can gather important information to make sure that future treatments for liver-related conditions are as effective and safe as possible for all patients.

Key takeaways

This study is testing a new form of Rifaximin in adults with liver problems.
It's an early-stage study focused on how the body handles the medicine, not a cure.
Participants must be 18 or older and have a diagnosed liver problem.
Taking part will involve clinic visits, blood tests, and close monitoring.
You can stop participating at any time.
The information learned helps doctors prescribe medicines more safely in the future.

Who may be eligible?

To join this study, participants must be adults, aged 18 or older. It doesn't matter if you are male or female, as both men and women can take part. The main specific requirement for this study is that you have some level of 'hepatic impairment'. This means that your liver isn't working as well as it should, and a doctor would have diagnosed you with this condition.

More detailed information about exactly what kind of liver impairment is needed would be discussed by the research team. They will carry out tests to confirm if your liver condition meets the study's requirements. This often involves blood tests and reviewing your medical history.

It's important to remember that even if you meet these general criteria, there might be other reasons why you can't join the study. These could include other health conditions you have, medicines you're currently taking, or certain test results. The study team will explain everything thoroughly to make sure taking part is safe for you.

Quick self-check

Are you 18 years old or older?
Do you have a personal diagnosis of a liver condition or problem?
Are you able to attend appointments at a study clinic?
Are you willing to have blood tests and other health checks?
Are you comfortable potentially taking a new form of medicine?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in this study, you would first have a screening visit. During this visit, a doctor and nurse would check your general health, review your medical history, and carry out some tests, such as blood tests, to make sure the study is right and safe for you. If you qualify and agree to join, you would be given the study medicine, Rifaximin SSD, usually on a specific schedule. You would be closely monitored by the study team.

This monitoring would involve several visits to the clinic, where you might have regular blood samples taken, blood pressure checks, and other assessments to see how your body is reacting to the medicine and how it's being processed. The number and length of these visits, as well as the total time you would be involved in the study, would be explained to you in detail by the research team. You would also have follow-up appointments after you stop taking the medicine to ensure everything is well.

Potential risks and benefits

Taking part in a study like this might offer a chance to receive a new form of medicine and contribute to valuable medical research that could help others in the future. However, there are potential risks, just like with any medicine. You might experience side effects from the study drug, which could be mild or, less commonly, more serious. The research team will explain all known side effects and monitor you closely for any changes in your health. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

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Hungary

Common questions

What is Rifaximin SSD?

It's a new version of an existing medicine called Rifaximin. SSD stands for Soluble Solid Dispersion, which is a modern way to prepare the medicine.

Why is this study only for people with liver problems?

The liver processes medicines, and if it's not working well, medicines can act differently. This study wants to understand how this new Rifaximin acts specifically in people with liver conditions to ensure it's safe and effective for them.

Will I get better if I join this study?

This early-stage study primarily aims to understand how the medicine works in the body and its safety, not to treat your condition. We can't promise you will get better from taking part.

Is this a new medicine that will cure my liver problem?

Rifaximin is already used for some conditions. This is a new formulation (version) of it. This study is not designed to find a cure, but to understand the new formulation's behaviour in the body.

What kind of tests will I have?

You can expect to have blood tests, physical exams, and possibly other checks to see how your body handles the medicine and how you are feeling during the study.