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

Adrenoleukodystrophy

To determine the DDI effect on the single-dose PK of oral leriglitazone as substrate when coadministered with gemfibrozil (Part A), itraconazole (Part B), or carbamazepine (Part C) as precipitants. Primary endpoint: Leriglitazone – Cmax, AUC(0-last), AUC(0-inf)., To determine the effect of food (highfat breakfast) on the single-dose PK of oral leriglitazone (Part D). Primary endpoint: Leriglitazone – Cmax, AUC(0-last), AUC(0-inf)

To determine the DDI effect on the single-dose PK of oral leriglitazone as substrate when coadministered with gemfibrozil (Part A), itraconazole (Part B), or carbamazepine (Part C) as precipitants. Secondary endpoints: a) Leriglitazone – tmax, λz, t1/2, CL/F, and Vz/F. b) M3 – Cmax, tmax, AUC(0-inf), λz, and t1/2. c) Metabolite/parent (MR) ratios [ie, MRCmax, MRAUC(0last), and MRAUC(0inf)]., To determine the effect of food (highfat breakfast) on the single-dose PK of oral leriglitazone (Part D). Secondary endpoint: a)Leriglitazone – tmax, λz, t1/2, CL/F, and Vz/F. b) M3 – Cmax, tmax, AUC(0-inf), λz, and t1/2. c) Metabolite/parent (MR) ratios [ie, MRCmax, MRAUC(0last), and MRAUC(0inf)]., Reported AEs, and changes in electrocardiograms (PR, QRS, QT, and QTcF), vital signs, and clinical safety laboratory tests., Parts A, B, and C: To explore the potential impact of CYP2C8 and CYP3A4 gene polymorphisms on the PK of leriglitazone. Endpoint: Serum gene expression levels of CYP2C8 and CYP3A4 polymorphism versus PK., Part B: To explore the potential impact of CYP3A5 gene polymorphism on the PK of leriglitazone when given concomitantly with CYP3A4 inhibitors (eg, itraconazole). Endpoint: Serum gene expression levels of CYP3A5 polymorphism versus PK.

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