drugset / Trial / NCT04537715

Effects of Itraconazole and Rifampin on the Blood Tazemetostat Levels

NCT04537715

Phase 1 Completed 42 enrolled Epizyme, Inc.
Non-randomizedCrossoverOpen-labelTreatment

Summary

The participants of this study will have advanced malignancies (also known as advanced cancer). The main aim of this trial will be to study the blood levels (known as pharmacokinetics) of the tazemtostat (the study drug) when administered in combination with another drug. Part 1 of the study will evaluate the interaction between the drugs tazemetostat and itraconazole. Part 2 of the study will evaluate the interaction between the drugs tazemetostat and rifampin For both Parts 1 and 2, safety and the level that effects of the study drug can be tolerated (known as tolerability) will be assessed throughout.

Timeline

Start
2020-04-23
Primary completion
2023-04-03
Completion
2023-04-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Itraconazole Small molecule 200 mg Oral
Subject Rifampin Small molecule 600 mg Oral
Subject Tazemetostat Small molecule 400 mg Oral
Subject Tazemetostat Small molecule 800 mg Oral