NCT03071770

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

A Phase 1, Single-Dose, Open-Label Trial to Evaluate the Pharmacokinetics and Safety of AG-120 in Healthy Male Japanese Subjects Relative to Healthy Male Caucasian Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Agios Pharmaceuticals, Inc. · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	ivosidenib (AG-120)	A single-dose of ivosidenib (AG-120) administered in healthy Japanese and Caucasian subjects

Timeline

• Start date: 2017-03-31
• Primary completion: 2017-05-09
• Completion: 2017-09-06
• First posted: 2017-03-07
• Last updated: 2018-01-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study