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An Open-label DDI Study of Omaveloxolone in Healthy Subjects

Healthy Adult Subjects Clinical Trial

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

Clinical Trial 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).

Clinical Trial Description

Study Sponsor, originally Reata Pharmaceuticals, Inc., is now Reata Pharmaceuticals, Inc., a wholly owned subsidiary of Biogen. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05909644
Study type Interventional
Source Biogen
Contact
Status Completed
Phase Phase 1
Start date July 5, 2023
Completion date August 30, 2023
View Details
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