drugset / Trial / NCT01844583

Safety, Tolerability and Pharmacokinetic (PK) of Concomitant Esomeprazole and Rifampin, and QT Study on Single and Multiple-doses of Alisertib

NCT01844583

Phase 1 Completed 55 enrolled Millennium Pharmaceuticals, Inc.
RandomizedSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to assess the drug-drug interaction (DDI) of either esomeprazole or rifampin on the single-dose PK of alisertib, and to complete an intensive QT study of single and multiple-dose alisertib.

Timeline

Start
2013-06-25
Primary completion
2014-08-04
Completion
2016-09-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Alisertib Small molecule 50 mg Oral
Subject Esomeprazole Small molecule 40 mg Oral
Subject Rifampin Small molecule 600 mg Oral

Indications