Study of drug interactions between leriglitazone, gemfibrozil, itraconazole, and carbamazepine and food effects in healthy male volunteers for adrenoleukodystrophy treatment
- Participants:Adults · Healthy volunteers
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Gemfibrozil is a lipid-regulating agent, a medicine that changes the levels of fats (lipids) in the blood. Its full chemical name is 5-(2,5-dimethylphenoxy)2,2-dimethylpentanoic acid, and it is a chemically synthesised substance.[2] Gemfibrozil is an authorised medicine: in Spain it is available as Gemfibrozilo STADA 600 mg film-coated tablets, supplied by Laboratorio STADA, S.L.[1] It is classified under the ATC code C10AB04.[1]
Gemfibrozil decreases serum triglycerides and very low density lipoprotein (VLDL) cholesterol, and increases high density lipoprotein (HDL) cholesterol.[2] It may also produce modest decreases in total and low density lipoprotein (LDL) cholesterol.[2] In the registered trial, gemfibrozil was not being tested for its own lipid-lowering effect but was used as an auxiliary medicine to see how it changes the way the body processes another medicine, leriglitazone.[1]
Gemfibrozil is given by mouth as a film-coated tablet.[1] Each tablet contains 600 mg of gemfibrozil.[2] In the registered trial, the product used was Gemfibrozilo STADA 600 mg film-coated tablets for oral use.[1]
One completed Phase 1 trial, registered as 2025-521508-23-00, enrolled 73 male healthy subjects.[1] The trial was open-label and single-centre. Its purpose was to evaluate drug-drug interactions: how gemfibrozil, itraconazole and carbamazepine each affect the single-dose pharmacokinetics (how the body absorbs, distributes and removes a medicine) of oral leriglitazone.[1] Gemfibrozil was used in Part A of the study as a precipitant, meaning a medicine that may change how another medicine behaves in the body.[1] The primary endpoints were the maximum concentration of leriglitazone in the blood (Cmax) and the total exposure over time (AUC).[1] The trial also measured the effect of a high-fat breakfast on leriglitazone.[1]
The sources provided do not include a list of side effects for gemfibrozil, so this section is not included.
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