A Study of AG-120 (Ivosidenib) in Subjects With Mild or Moderate Hepatic Impairment or Normal Hepatic Function

Phase 1 Completed 33 enrolled Agios Pharmaceuticals, Inc.

Non-randomizedParallel-groupOpen-labelTreatment

Summary

Study AG120-C-012 is a Phase 1, open-label, single-dose study designed to evaluate the PK, safety, and tolerability of a single 500 mg AG-120 (Ivosidenib) dose in subjects with mild or moderate hepatic impairment (HI) compared to subjects with normal hepatic function. The study will be conducted at 2 US centers.

Timeline

Start: 2017-09-26
Primary completion: 2018-03-31
Completion: 2018-03-31

Publications

Fan B, Dai D, Cohen M, Xu H, Yin F, Nagaraja R, Mobilia M, Almon C, Basile FG, Yang H. Effect of Mild and Moderate Hepatic Impairment on the Pharmacokinetics, Safety, and Tolerability of a Single Dose of Oral Ivosidenib in Otherwise Healthy Participants. Clin Pharmacol Drug Dev. 2021 Jan;10(1):99-109. doi: 10.1002/cpdd.821. Epub 2020 Jul 9.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ivosidenib	Small molecule	500 mg	Oral

Indications

No indication recorded.