Clinical Trial: An Open-label DDI Study of Omaveloxolone in Healthy Subjects
Study Status: NOT_YET_RECRUITING
Recruit Status: NOT_YET_RECRUITING
Condition: Healthy Adult Subjects
Study Type: INTERVENTIONAL
Official Title: A Single Sequence, 2-Period, Open-label Crossover Study in Healthy Subjects to Determine the Effect of a Moderate CYP3A4 Inducer on the Pharmacokinetics of Omaveloxolone
Brief Summary:
This is an open-label, single-sequence, 2-period crossover study in healthy subjects.In this study, 20 subjects will be enrolled to allow at least 16 evaluable subjects.Subjects will receive a single oral dose of 150 mg omaveloxolone (3 × 50 mg capsules) on Day 1 (Period 1) and on Day 29 (Period 2), and 600 mg efavirenz once a day from Days 15 through 42 (Period 2).
Read more