Study of drug interactions between leriglitazone, gemfibrozil, itraconazole, and carbamazepine and food effects in healthy male volunteers for adrenoleukodystrophy treatment

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What is this study about?

This clinical trial aims to study the effects of various medications when taken together with leriglitazone, an investigational drug, in healthy male subjects. The study will also examine how food affects the way leriglitazone works in the body. The trial involves testing interactions between leriglitazone and three different medicines: gemfibrozil (a medication used to lower blood fats), itraconazole (an antifungal medication), and carbamazepine (a medication used to treat epilepsy and nerve pain).

The study consists of four parts. In the first three parts, participants will receive leriglitazone along with one of the three mentioned medications to see how they interact. In the fourth part, researchers will study how taking leriglitazone with a high-fat meal affects the way the body processes the medication. The medication will be given as an oral suspension, which means it is a liquid form that can be swallowed.

Throughout the study, researchers will monitor participants’ health through various tests, including blood samples to measure medication levels in the body, heart recordings (electrocardiograms), vital signs, and laboratory tests. They will also look at specific genes that might affect how the body processes these medications. The study is designed to understand how these different factors might change the way leriglitazone works in the body.

1 Study initiation

The study is divided into four parts (A, B, C, and D), focusing on how leriglitazone interacts with other medications and food

You will need to avoid alcohol, caffeine, and foods containing methylxanthine (such as coffee, tea, cola, chocolate, energy drinks) for 3 days before entering the clinical research center and during your stay

2 Part A – Interaction with gemfibrozil

You will receive leriglitazone orally (by mouth) as a single dose

You will also receive gemfibrozil tablets (600 mg) orally

Blood samples will be collected to measure how these medications interact in your body

3 Part B – Interaction with itraconazole

You will receive leriglitazone orally as a single dose

You will also receive itraconazole capsules (100 mg) orally

Blood samples will be collected to measure how these medications interact in your body

4 Part C – Interaction with carbamazepine

You will receive leriglitazone orally as a single dose

You will also receive carbamazepine tablets (200-300 mg) orally

Blood samples will be collected to measure how these medications interact in your body

5 Part D – Food effect study

You will receive leriglitazone orally as a single dose

The medication will be taken with a high-fat breakfast to study how food affects the medication absorption

Blood samples will be collected to measure how food affects the medication in your body

6 Safety monitoring

Throughout the study, you will undergo regular safety checks including:

Heart monitoring (electrocardiograms)

Vital signs measurements

Laboratory safety tests

Monitoring for any side effects

Who Can Join the Study?

Must be a healthy male between 18 and 50 years old
Body Mass Index (BMI) must be between 18 and 30 kg/m² (BMI is a measure that uses your height and weight to determine if your weight is healthy)
Must be able and willing to provide informed consent (agreement to participate after understanding study details)
Male participants with female partners who can become pregnant must either:
- Avoid sexual intercourse, or
- Use a condom and ensure their partner uses highly effective birth control (with less than 1% failure rate) for at least 90 days after the last study treatment
Must not donate sperm for at least 12 weeks after the last study treatment
Must have no significant medical conditions based on:
- Medical history review
- Physical examination
- Laboratory test results
Must be willing to avoid:
- Alcohol
- Caffeine
- Foods and drinks containing methylxanthine (such as coffee, tea, cola, chocolate, energy drinks) for 3 days before and during the study center stay

Who Cannot Join the Study?

History of any significant medical conditions, including but not limited to heart, liver, kidney, nervous system, or mental health disorders
Current use of medications that could interact with the study drug (except those specified in the study)
Female participants (study is limited to male participants only)
Age below 18 or above 55 years
Body Mass Index (BMI) outside the range of 18.5-30 kg/m² (BMI is a measure of body fat based on height and weight)
Abnormal blood pressure readings or irregular heart rhythm
History of drug or alcohol abuse within the past 2 years
Participation in other clinical trials within the past 30 days
Known allergies to any medications similar to the study drug
Smoking or use of nicotine products within 3 months before the study
Significant abnormal findings in laboratory tests, including blood and urine tests
Unable to follow study procedures or provide informed consent
History of severe allergic reactions to any medications
Regular consumption of more than 2 alcoholic drinks per day
Use of herbal supplements or vitamins within 7 days before the study

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Mtz Clinical Research Powered By Pratia	Warsaw	Poland

Trial status

Country	Status	Recruitment Start
Poland	Not recruiting	01.07.2025

Trial locations

Investigated drugs:

Leriglitazone is an investigational medication being studied for its interaction with other drugs and food effects. It is given orally.

Gemfibrozil is a medication commonly used to lower high triglyceride and cholesterol levels in the blood. It belongs to a group of drugs called fibrates.

Itraconazole is an antifungal medication used to treat various fungal infections. It works by stopping the growth of fungi that cause infections.

Carbamazepine is an anticonvulsant and mood-stabilizing medication primarily used to treat epilepsy and neuropathic pain. It is also sometimes prescribed for bipolar disorder.

Investigated diseases:

Adrenoleukodystrophy

Adrenoleukodystrophy – A rare genetic condition that causes damage to the protective covering (myelin sheath) of nerve cells in the brain and spinal cord. The disease primarily affects males and is characterized by the buildup of very long-chain fatty acids in the body. It typically begins in childhood with symptoms that can include behavioral changes, vision problems, difficulty with walking and coordination. The condition progresses to affect hearing, speech, and muscle movement. The disease can occur in several forms, with varying ages of onset and patterns of progression.

Trial ID:

2025-521508-23-00

Protocol code:

MT-1-02

Trial Phase:

Human Pharmacology (Phase I) – Other

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Study of drug interactions between leriglitazone, gemfibrozil, itraconazole, and carbamazepine and food effects in healthy male volunteers for adrenoleukodystrophy treatment

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?