drugset / Trial / NCT04128787

A Study to Compare the Relative Bioavailability of Two AG-881 Formulations and Evaluate the Effect of Food and Omeprazole on the Pharmacokinetics of AG-881

NCT04128787

Phase 1 Completed 36 enrolled Agios Pharmaceuticals, Inc.
RandomizedCrossoverOpen-labelTreatment

Summary

The purpose of this study is to compare the single-dose pharmacokinetics (PK) of two formulations (Formulation 1 and Formulation 2) of AG-881 and to examine the effect of food and multiple-dose omeprazole on the single-dose PK of AG-881 Formulation 2 in healthy adult participants. This study will also assess the safety and tolerability of single-dose AG-881 (Formulation 1 and 2) alone and of AG-881 Formulation 2 when administered with and without food and when coadministered with omeprazole in healthy adult subjects.

Timeline

Start
2019-09-30
Primary completion
2019-12-18
Completion
2019-12-18

Drugs

EvaluationDrugModalityDoseRoute
Subject Omeprazole Other / unclassified 40 mg Oral
Subject Vorasidenib Small molecule 50 mg Oral

Indications

No indication recorded.