drugset / Trial / NCT01563562

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

NCT01563562 ↗

Phase 1 Completed 34 enrolled Biogen
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2012-04-30
Primary completion
2012-11-30
Completion
2012-11-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Bardoxolone methyl Small molecule 20 mg Oral

Indications

No indication recorded.