NCT03282513

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

A Phase 1, Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of AG-120 (Ivosidenib) in Subjects With Mild or Moderate Hepatic Impairment or Normal Hepatic Function

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Agios Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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.

Conditions

• Hepatic Impairment

Interventions

Type	Name	Description
DRUG	AG-120 (Ivosidenib)	Single 500 mg dose of AG-120 (Ivosidenib).

Timeline

• Start date: 2017-09-26
• Primary completion: 2018-03-31
• Completion: 2018-03-31
• First posted: 2017-09-14
• Last updated: 2018-04-27

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study