Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

A PHASE 1, OPENLABEL, SINGLECENTER STUDY TO EVALUATE DRUGDRUG INTERACTIONS WITH GEMFIBROZIL, ITRACONAZOLE, AND CARBAMAZEPINE AND THE FOOD-EFFECT ON ORAL LERIGLITAZONE IN MALE HEALTHY SUBJECTS

This study focuses on a new medicine called leriglitazone, which is being developed to treat a serious condition called Adrenoleukodystrophy. Researchers are testing it in healthy men to understand how it acts in the body. Specifically, they want to see if taking leriglitazone with other widely used medications, like those for cholesterol or epilepsy, changes how it's absorbed or used by the body. They are also investigating if eating a meal affects how leriglitazone works. This kind of early research is important for ensuring the new medicine is safe and effective when it eventually goes to patients. It helps doctors know how to prescribe it correctly, avoiding unwanted interactions.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Minoryx Therapeutics S.L.

Enrolment target

Start

04 Aug 2025

Adrenoleukodystrophy

What is this study about?

This study is an early-stage research project designed to understand how a new medicine, called leriglitazone, works in healthy men. This medicine is being developed to treat a serious condition known as Adrenoleukodystrophy, which affects the brain and nervous system.

The main goal is to see how leriglitazone behaves in the body, especially when taken with other common medicines or food. For example, researchers want to know if medicines often used for cholesterol problems (like gemfibrozil), fungal infections (like itraconazole), or epilepsy (like carbamazepine) change how much leriglitazone gets into the bloodstream. They also want to understand if eating a high-fat meal makes a difference.

This type of study is crucial because it helps doctors and scientists understand potential drug interactions. If other medicines or food change how leriglitazone is absorbed or processed, it could affect how well it works or if it causes side effects. By learning this early on, doctors can make sure that when leriglitazone is eventually used by patients, it is prescribed safely and effectively.

Key takeaways

This study is researching a new medicine, leriglitazone, for Adrenoleukodystrophy.
It's a very early-stage study involving healthy adult men.
The main goals are to see how other common medicines and food affect leriglitazone in the body.
Participants will have blood tests and health checks.
Your involvement helps scientists understand how to use this new medicine safely and effectively.
You can withdraw from the study at any time.

Who may be eligible?

This study is looking for healthy adult men to take part. To be eligible, you must be at least 18 years old.

Since this is a very early study to understand how a new drug interacts with others, women are not included at this stage. Also, participants need to be generally healthy and not currently taking many other medications that might interfere with the results.

More detailed health checks will be done by the study team 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 an adult man, aged 18 years or older?
Are you generally healthy?
Are you able to attend several study visits?
Are you comfortable with regular blood tests and medical checks?

Answer every question to see your result.

What does participation involve?

If you take part in this study, you will visit the study clinic multiple times. You will be given leriglitazone and, at different times, you might also take other medicines like those for cholesterol, fungal infections, or epilepsy. In one part of the study, you'll take leriglitazone after eating a high-fat meal.

During your visits, blood samples will be taken regularly to measure how much leriglitazone is in your body and how it's processed. You'll also have checks like electrocardiograms (ECGs) to monitor your heart, have your blood pressure and other vital signs recorded, and undergo general safety blood tests. Each part of the study involves taking medicines and staying for observation, with follow-up checks. The total duration of your involvement will depend on which parts of the study you participate in, but it will involve several visits over a period.

Potential risks and benefits

Participating in research studies always carries some potential risks, mainly from the medicines being tested and the procedures like blood draws. You might experience side effects from leriglitazone or the other study drugs, or discomfort from multiple blood tests. However, the study team will monitor you closely for any issues and will explain all known risks. As this is an early-stage study in healthy volunteers, there are no direct health benefits to you, but your participation is vital for helping develop new medicines for serious conditions like Adrenoleukodystrophy. 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
Poland

Common questions

What is Adrenoleukodystrophy?

Adrenoleukodystrophy (ALD) is a serious inherited condition that affects the brain and nervous system, leading to worsening symptoms over time.

What does a 'Phase I' study mean?

Phase I studies are the very first tests of a new medicine in humans, usually in healthy volunteers. They focus on safety and how the drug acts in the body, rather than treating a disease.

Why are only men included in this study?

Early studies like this often start with a clearer, more predictable group (like men only) to simplify understanding how a new medicine acts in the body, before including broader groups.

Will I receive treatment for Adrenoleukodystrophy?

No, this study is for healthy volunteers and will not provide treatment for Adrenoleukodystrophy. It's designed to understand the drug's basic behaviour.

What are 'drug-drug interactions'?

This refers to what happens when you take two or more medicines at the same time, and one affects how the other works in your body. It can change how effective they are or cause unexpected side effects.