A Study to Evaluate AG-881 in Healthy Japanese and Non-Asian Participants

Phase 1 Completed 32 enrolled Agios Pharmaceuticals, Inc.

SequentialOpen-labelTreatment

Summary

The purpose of this study is to compare the pharmacokinetics (PK) and safety of AG-881 in healthy Japanese and Non-Asian participants after single oral doses of 10 mg and 50 mg of AG-881.

Timeline

Start: 2019-10-02
Primary completion: 2019-12-11
Completion: 2019-12-18

Publications

Limsakun T, Man A, Nguyen D, Hossain M. A Phase 1, Open-Label, Single Ascending (Two Levels) Dose Study to Evaluate the Pharmacokinetics of Vorasidenib in Healthy Japanese and Non-Asian Participants. J Clin Pharmacol. 2026 May;66(5):e70196. doi: 10.1002/jcph.70196.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Vorasidenib	Small molecule	10 mg	Oral
Subject	Vorasidenib	Small molecule	50 mg	Oral

Indications

No indication recorded.