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A plain-language summary of the goals, design and what participants do
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.
The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.
12 criteria
15 criteria
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is an investigational medication being studied for its interaction with other drugs and food effects. It is given orally.
is a medication commonly used to lower high triglyceride and cholesterol levels in the blood. It belongs to a group of drugs called fibrates.
is an antifungal medication used to treat various fungal infections. It works by stopping the growth of fungi that cause infections.
is an anticonvulsant and mood-stabilizing medication primarily used to treat epilepsy and neuropathic pain. It is also sometimes prescribed for bipolar disorder.
An oral medication currently being investigated in clinical trials for the treatment of Adrenoleukodystrophy, a rare genetic disorder affecting the nervous system. This drug belongs to the class of PPAR (peroxisome proliferator-activated receptor) agonists and is being studied for its interaction with other medications such as gemfibrozil, itraconazole, and carbamazepine. The medication is taken by mouth and its absorption characteristics with food are being evaluated in clinical trials.
A lipid-lowering medication taken orally that belongs to the fibrate class of drugs, commonly used to reduce triglycerides and increase good cholesterol levels in the blood. It works by activating certain proteins that break down fats in the body and is often studied in drug interaction trials due to its effects on various metabolic pathways.
An oral antifungal medication used to treat various types of fungal infections, belonging to the azole class of antifungal drugs. It works by preventing the formation of fungal cell membranes and is frequently used in drug interaction studies because it can affect how other medications are processed by the body.
An oral anticonvulsant medication primarily used to treat epilepsy and neuropathic pain, which works by decreasing abnormal electrical activity in the brain. It belongs to the dibenzazepine family of drugs and is often included in drug interaction studies as it can affect the metabolism of other medications in the body.
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