drugset / Trial / NCT03010982

Open-Label, Multi-Center, Two-Part, Ph1 Study to Characterize the PKs of an Intravenous Micro-Dose of [14C]-Tazemetostat (EPZ 6438) and the ADME of an Oral [14C]-Labeled Dose of Tazemetostat in Subjects With B-Cell Lymphomas or Adv Solid Tumors

NCT03010982

Phase 1 Completed 3 enrolled Epizyme, Inc.
NaSingle-groupOpen-labelTreatment

Summary

This is a Phase 1, open-label, two-part study designed to characterize the PK of an IV dose of approximately 12 µg tazemetostat that contains approximately 500 nCi of \[14C\] tazemetostat and the ADME of an oral dose of 800 mg tazemetostat that contains approximately 400 µCi of \[14C\]-labeled tazemetostat in three subjects with B-cell lymphomas or advanced solid tumors.

Timeline

Start
2018-06-20
Primary completion
2019-01-08
Completion
2019-01-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Tazemetostat Small molecule 12 ug Oral
Subject Tazemetostat Small molecule 800 mg Oral