Effect of Itraconazole on the Pharmacokinetics of Bardoxolone Methyl in Healthy Adults

PHASE1CompletedINTERVENTIONAL
Enrollment

16

Participants

Timeline

Start Date

October 16, 2017

Primary Completion Date

November 13, 2017

Study Completion Date

November 13, 2017

Conditions
Healthy Volunteers
Interventions
DRUG

Bardoxolone methyl capsules 10 mg

One 10 mg capsule of bardoxolone methyl administered on Study Day 1 (Period 1) of the trial and one 10 mg capsule of bardoxolone methyl administered on Study Day 18 (Period 2) of the trial

DRUG

Itraconazole capsules 100 mg

Two 100 mg capsules of itraconazole administered once daily during Study Days 15 - 27 (Period 2) of the trial

Trial Locations (1)

45227

Medpace Clinical Pharmacology Unit, Cincinnati

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Biogen

INDUSTRY