Open-Label, Multicenter, Two-Part, Phase 1 Study to Characterize Effects of a Moderate CYP3A Inhibitor on PK of Tazemetostat, Effects of Tazemetostat on PK of CYP2C8 and CYP2C19 Substrates, and Effect of Increased Gastric pH on PK of Tazemetostat in B-cell Lymphoma or Advanced Solid Tumor Patients

Phase 1 Completed 32 enrolled Epizyme, Inc.

NaSingle-groupOpen-labelTreatment

Summary

This is a Phase 1, open-label, two-part, safety, PK, and activity study designed to characterize the DDI potential of tazemetostat. Tazemetostat will be taken orally BID continuously in 28-day cycles in both study parts.

Timeline

Start: 2017-03-27
Primary completion: 2019-10-31
Completion: 2019-11-29

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Omeprazole	Other / unclassified	20 mg	Oral
Subject	Repaglinide	Small molecule	0.25 mg	Oral
Subject	Tazemetostat	Small molecule	800 mg	Oral
Background	Fluconazole	Small molecule	200 mg	Oral
Background	Fluconazole	Small molecule	400 mg	Oral

Open-Label, Multicenter, Two-Part, Phase 1 Study to Characterize Effects of a Moderate CYP3A Inhibitor on PK of Tazemetostat, Effects of Tazemetostat on PK of CYP2C8 and CYP2C19 Substrates, and Effect of Increased Gastric pH on PK of Tazemetostat in B-cell Lymphoma or Advanced Solid Tumor Patients

Summary

Timeline

Drugs

Indications