NCT01598363

An Open-Label Study of the Effect of Bardoxolone Methyl on the Single Dose Pharmacokinetics of Digoxin and Rosuvastatin in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Biogen · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the potential effect of bardoxolone methyl on the pharmacokinetics of digoxin and rosuvastatin and to assess the safety of the concomitant administration of bardoxolone methyl with digoxin or rosuvastatin.

Detailed description

Subjects in Cohort 1 will receive a single dose of digoxin (0.5 mg) on Study Day 1, an initial dose of bardoxolone methyl (60 mg) and a single dose of digoxin (0.5 mg) on Study Day 10, and once daily doses of bardoxolone methyl (20 mg) on Study Days 11 through 14. Subjects in Cohort 2 will receive a single dose of rosuvastatin (20 mg) on Study Day 1, an initial dose of bardoxolone methyl (60 mg) and a single dose of rosuvastatin (20 mg) on Study Day 10, and once daily doses of bardoxolone methyl (20 mg) on Study Days 11 through 14. All doses will be given in the morning under fasting conditions. Bardoxolone methyl and the probe substrates (digoxin, rosuvastatin) will be dosed at the same time. Confinement will begin on Study Day -1 (Study Day before the first dosing day) and end after the collection of the 216 hour blood samples and scheduled study procedures on Study Day 19.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	Digoxin	Oral, Day 1 and Day 10
DRUG	Rosuvastatin	Oral, Day 1 and Day 10

Timeline

• Start date: 2012-06-30
• Primary completion: 2012-07-31
• Completion: 2012-07-31
• First posted: 2012-05-15
• Last updated: 2025-05-29

Locations

1 site across 1 country: United States