Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

A Multiple Dose Pharmacokinetic Study of AMX0035 in Participants with Impaired Hepatic Function and in Healthy Participants

Researchers are investigating a new medication called AMX0035. The main goal of this study is to understand how the body absorbs, breaks down, and gets rid of this medication. They are looking at two groups of people: those with liver problems and healthy volunteers. By comparing these groups, scientists can learn if liver function affects how the medication works and if different doses might be needed. This is an early-stage study, meaning it's focused on understanding the drug's basic behaviour in the body rather than treating a specific illness. This information is crucial for developing safe and effective treatments in the future.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Amylyx Pharmaceuticals EMEA B.V., Amylyx Pharmaceuticals Inc.

Enrolment target

Start

23 Aug 2023

Volunteers with Hepatic Impairment Healthy volunteers

What is this study about?

Imagine your body as a chemical factory. When you take a medication, this factory processes it. This study is like taking a close look at how the body's 'factory' handles a new drug called AMX0035. Researchers want to understand exactly how the body absorbs the drug, how it breaks it down, and how it gets rid of it. This process is called pharmacokinetics.

They are particularly interested in how AMX0035 is handled in people who have liver problems, compared to people with healthy livers. The liver plays a big role in processing medications, so knowing how it affects AMX0035 is very important. This information helps scientists figure out if the drug might build up to unsafe levels in people with liver issues, or if it might not work as well.

This is a very early stage of research, sometimes called a Phase I study. At this point, the focus isn't on treating a specific disease. Instead, it's about gathering fundamental information on how the drug behaves in the human body. This foundational knowledge is essential for all future steps in developing AMX0035 as a potential treatment, ensuring it can be used safely and effectively.

Key takeaways

Researchers are studying a new drug called AMX0035.
The study aims to understand how the body processes the medication.
It includes both people with liver problems and healthy volunteers.
This is an early-stage study to gather basic information about the drug.
Participation involves taking the medication and regular health checks.
Findings will help guide future development of AMX0035.

Who may be eligible?

This study is open to both men and women who are at least 18 years old. There's no upper age limit listed, so older adults might be able to take part too.

They are specifically looking for two main groups of people: those who have some kind of liver problem (impaired hepatic function) and those who are generally healthy. This allows the researchers to compare how the medicine works in people with and without liver conditions.

Beyond age and liver health, there will be other specific health checks and criteria that will determine if you can join. These will be explained in detail by the study team, for example, to ensure you don't have other health conditions or are on medications that might interfere with the study.

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 diagnosed liver condition or are you generally healthy?
Are you able to commit to several clinic visits and follow study instructions?
Do you understand that this is an early-stage study of a new medication?

Answer every question to see your result.

What does participation involve?

Taking part in this study would involve several visits to a clinic. You would receive doses of the medication AMX0035. During your visits, the research team would regularly take blood and urine samples to check how your body is handling the medication. They would also monitor your general health closely through various tests and observations. The exact number of visits, the length of each visit, and the total time you would be involved in the study would be fully explained by the study team before you decide to take part.

Potential risks and benefits

Potential benefits of participating are primarily contributing to medical knowledge that could help develop future treatments, especially for people with liver conditions. You will also receive careful medical monitoring. As this is a new medication, there might be unknown side effects or risks, including discomfort from blood draws or potential reactions to the study drug. All known risks will be thoroughly explained. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

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

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Unverified
Bulgaria

Common questions

What does 'hepatic function' mean?

It refers to how well your liver is working. Your liver is a vital organ that helps clean your blood and process medicines.

Why are they studying healthy people too?

Comparing healthy people with those who have liver problems helps researchers understand how liver function affects the medication's journey through the body.

Is AMX0035 currently used as a treatment?

No, this is an early-stage study for a new medication. It's not yet approved for general use as a treatment.

Will I know if I'm getting the actual drug or a dummy pill?

In this type of study, everyone usually receives the active drug (AMX0035), but the specific details will be fully explained by the research team.

How long does a study like this typically last?

The duration can vary, but generally, early-stage studies might involve several weeks or a few months of active participation, including follow-up visits.