Effect of Itraconazole on the Pharmacokinetics of Bardoxolone Methyl in Healthy Adults
Status:
Completed
Trial end date:
2017-11-13
Target enrollment:
Participant gender:
Summary
This trial will study the impact of a strong CYP3A4 inhibitor (itraconazole) on the
pharmacokinetics of bardoxolone methyl (RTA 402) in healthy adult subjects.
This is an open-label, fixed-sequence crossover pharmacokinetic (PK) study in healthy
volunteers.
Subjects will complete a screening visit within 28 days of Study Day 1. Subjects must qualify
for the study based on inclusion/exclusion criteria. For Period 1, all qualified subjects
shall receive a single oral dose of bardoxolone methyl (10 mg) on Day 1. For Period 2,
following a washout of 14 days, itraconazole (SPORANOX®) capsules (100 mg) will be
administered as a 200-mg single daily dose on Study Days 15 through 27, with bardoxolone
methyl (10 mg) administered on Day 18 (1 hour after itraconazole administration).
Bardoxolone methyl doses will be administered under fasted conditions. Itraconazole will be
administered under fed conditions on Study Days 15-17, and Study Days 19-27.
On study Day 18, itraconazole will be administered under fasted conditions. Subjects will be
confined beginning on Study Day -1 through the last blood sample collection on Study Day 9
during Period 1, and from Study Day 14 through the last PK blood draw on Study Day 28 during
Period 2.