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Clinical Trial 19324
Interventions:EPZ-6438 (Tazemetostat); Fluconazole; Repaglinide; Tazemetostat; omeprazole (Prilosec)
Study Type: Treatment
Phase of Study: Phase I
- Julio Chavez
An Open-Label, Multicenter, Two-Part, Phase 1 Study to Characterize the Effects of a Moderate CYP3A Inhibitor on the Pharmacokinetics of Tazemetostat (EPZ-6438) (Part A), the Effects of Tazemetostat on the Pharmacokinetics of CYP2C8 and CYP2C19 Substrates, and the Effect of Increased Gastric pH on the Pharmacokinetics of Tazemetostat (Part B) in Subjects with B-cell Lymphomas or Advanced Solid Tumors
This study is being done to determine what happens to tazemetostat (either higher or lower amounts of tazemetostat in the participant¿s bloodstream) in their body when it is taken with a drug called fluconazole (commonly prescribed for fungal infections). This study also intends to find out how safe it is to take tazemetostat and what effects, good and/or bad, it has on participants and their cancer.
Primary Objectives Part A: To determine the effect of CYP3A inhibition by fluconazole on the pharmacokinetics (PK) of tazemetostat. Part B: To investigate the potential of tazemetostat to inhibit or induce CYP2C8 using repaglinide as a probe substrate. To investigate the potential of tazemetostat to inhibit or induce CYP2C19 using omeprazole as a probe substrate. To investigate the effect of increased gastric pH by omeprazole on the PK of tazemetostat. Secondary Objectives Part A: To investigate the safety profile of tazemetostat 400 mg twice daily (BID) after co-administration with fluconazole. To determine the PK of tazemetostat and its metabolites after administration alone and with fluconazole. To determine the systemic exposure of fluconazole after administration of 400 mg once daily for 4 days. Part B: To investigate the safety profile of tazemetostat, repaglinide, and omeprazole after co-administration. To determine the PK of repaglinide and its metabolites after administration with omeprazole and administration with omeprazole and tazemetostat. To determine the PK of omeprazole and its metabolites after administration with repaglinide and administration with repaglinide and tazemetostat. To determine the PK of tazemetostat and its metabolites after repeated dose of tazemetostat alone and with fluconazole. Parts A and B: To assess antitumor activity of tazemetostat in subjects with diffuse large B-cell lymphoma (DLBCL), primary mediastinal B-cell lymphoma (PMBCL), mantle cell lymphoma (MCL), marginal zone lymphoma (MZL), follicular lymphoma (FL), or advanced solid tumors. Exploratory Objectives: To investigate the effects of variations in genes encoding for CYP enzymes and transporters on the potential drug-drug interaction profile of tazemetostat. To explore the effect of tazemetostat on overall survival (OS).