Japanese Bridging Study of Ivosidenib (AG-120) in Healthy Subjects

Summary

The purpose of this Phase I, single-dose, open-label trial is to evaluate the pharmacokinetics and safety of ivosidenib (AG-120) in healthy, adult male Japanese and Caucasian subjects. The study plans to evaluate 3 cohorts of a single oral dose of ivosidenib (AG-120) in Japanese and Caucasian subjects. Pharmacokinetic sampling will take place serially through-out the duration of subject participation.

Timeline

Start

2017-03-31

Primary completion

2017-05-09

Completion

2017-09-06

Drugs

Indications

No indication recorded.