drugset / Trial / NCT01714947

Mass Balance, Pharmacokinetics and Metabolism Study of Alisertib

NCT01714947

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

Summary

The purpose of this study is to assess the mass balance (i.e. cumulative excretion of total radioactivity \[TRA\] in urine and feces) of alisertib and pharmacokinetic (PK) of alisertib in plasma and urine, and of TRA in plasma and whole blood.

Timeline

Start
2013-01-24
Primary completion
2013-04-04
Completion
2013-06-14

Drugs

EvaluationDrugModalityDoseRoute
Subject Alisertib Small molecule 35 mg Oral
Subject Alisertib Small molecule 50 mg Oral

Indications