NCT01503866

A Phase I Study to Investigate the Absorption, Metabolism and Excretion in Healthy Male Subjects

A Phase 1 Study to Investigate the Absorption, Metabolism, and Excretion of [14C]-Bardoxolone Methyl Following a Single Oral Dose Administration in Healthy Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Biogen · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to determine the absorption and excretion kinetics of bardoxolone methyl and to determine and characterize metabolites present in plasma, urine and feces in men following a single oral does or 20 mg of \[14C\]-bardoxolone methyl.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	bardoxolone methyl	oral, single dose

Timeline

• Start date: 2011-12-01
• Primary completion: 2011-12-31
• Completion: 2011-12-31
• First posted: 2012-01-04
• Last updated: 2025-05-29

Locations

1 site across 1 country: United States