clinical trial · NCT05909644
An Open-label DDI Study of Omaveloxolone in Healthy Subjects
Biogen·phase1·completed·n = 20
Healthy Adult SubjectsOmaveloxoloneEfavirenz
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).
started
Jul 5, 2023
primary completion
Aug 30, 2023
completion
Aug 30, 2023
last updated
May 30, 2025
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
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol