NCT01563562

Single-Dose, Open-Label Pharmacokinetic Study of Bardoxolone Methyl in Subjects With Mild, Moderate, and Severe Hepatic Impairment and Normal Hepatic Function

A Single-Dose, Open-Label Pharmacokinetic Study of Bardoxolone Methyl in Subjects With Mild, Moderate, and Severe Hepatic Impairment and Normal Hepatic Function

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Biogen · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to assess the pharmacokinetic profile of bardoxolone methyl following a single oral dose of 20 mg bardoxolone methyl in subjects with mild, moderate, and severe hepatic impairment, as compared to healthy volunteers.

Conditions

• Hepatic Impairment
• Healthy

Interventions

Type	Name	Description
DRUG	Bardoxolone Methyl	Oral, Single dose

Timeline

• Start date: 2012-04-30
• Primary completion: 2012-11-30
• Completion: 2012-11-30
• First posted: 2012-03-27
• Last updated: 2025-05-29

Locations

2 sites across 1 country: United States