Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

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

This research study is investigating a new medicine called AMX0035. The main goal is to understand how the body handles this medicine, specifically how it's absorbed, distributed, processed, and removed. Researchers are interested in seeing whether having kidney problems affects these processes differently compared to healthy individuals. By studying both groups, they hope to learn the best way to use this new medicine in people with varying kidney health. It's a very early-stage study, designed to get basic information about the medicine's behaviour within the human body.

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 Renal Impairment Healthy volunteers

What is this study about?

This study is a special type of research that looks at how a new medicine, called AMX0035, works once it's inside the body. Think of it like watching a journey – from the moment you take the pill, where it goes, what it does, and how your body eventually gets rid of it. This process is called 'pharmacokinetics', and it’s important for understanding how a new drug might be used safely and effectively.

The researchers want to compare how AMX0035 behaves in people who have kidney problems versus those who have healthy kidneys. The kidneys play a big role in cleaning the blood and removing medicines from the body. If your kidneys aren't working as well as they should, it might mean a medicine stays in your body for longer or at higher levels, which could affect how it works or if you experience side effects. By understanding these differences, doctors can figure out if they need to adjust the dose of AMX0035 for people with kidney issues.

This is a very early stage of testing, often called a 'Phase I' study. It's not about treating a specific illness yet, but rather about gathering fundamental information about the medicine itself. The results from this type of study help decide if further research is safe and worthwhile, paving the way for potential future treatments.

Key takeaways

This study is examining a new medicine called AMX0035.
It aims to understand how the body processes the medicine.
Both people with kidney problems and healthy volunteers are needed.
It's an early-stage study to gather basic information about the medicine.
Results will help determine safe and effective dosing in the future.

Who may be eligible?

This study is looking for two main groups of people to take part. The first group includes adults aged 18 and older who have some level of kidney problems. The researchers will be looking closely at how well your kidneys are working to determine if you fit into this group.

The second group they need are healthy adults, also aged 18 and over, who do not have any significant health conditions. This group helps the researchers compare how the new medicine works in a healthy body versus one with kidney issues.

No matter which group you might consider joining, you would need to meet other specific health requirements set by the study doctors to make sure it's safe for you to participate.

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 kidney problems, or are you generally healthy?
Are you able to attend regular clinic visits?
Are you willing to have blood and urine tests?
Do you understand that this is an early-stage study, not a treatment?

Answer every question to see your result.

What does participation involve?

Taking part in this study would involve several visits to the clinic over a period of time. You would receive the study medicine, AMX0035, likely in multiple doses. Doctors and nurses would regularly check your health, which might include blood tests, urine tests, and other physical examinations. These tests help them understand how your body is handling the medicine. The total length of your participation, including follow-up appointments after you've finished taking the medicine, would be specifically explained by the study team.

Potential risks and benefits

Potential benefits of participating include contributing to medical knowledge that could help future patients, and you would receive careful medical attention during the study. However, there is no guarantee that taking part will directly benefit your health. Potential risks might include side effects from the study medicine, discomfort from blood tests or other procedures, or unforeseen reactions. You are free 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 is AMX0035?

AMX0035 is a new medicine being studied to understand how it works in the human body.

What does 'pharmacokinetic study' mean?

It means the study is looking at how your body absorbs, uses, and gets rid of the medicine.

Why are they studying people with kidney problems?

To see if kidney function changes how the medicine behaves in the body, which helps determine the right dose for everyone.

Will this medicine help my kidney problem?

This early-stage study isn't designed to treat diseases. It's about gathering basic information on the medicine itself.

Is the study suitable for people under 18?

No, participants must be at least 18 years old to join this study.

How to find out more

Official trial record

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