NCT03664453

A Pharmacokinetic Study of Omaveloxolone in Healthy Volunteers

A Phase 1, Open-Label, Food Effect, And Dose Proportionality Study With Omaveloxolone In Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Biogen · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This study will determine the effect of food on the pharmacokinetics of omaveloxolone (150 mg) in healthy adult subjects and will assess the safety, tolerability, and dose proportionality of 50 mg, 100 mg, and 150 mg omaveloxolone in healthy adult subjects. The study will be conducted in two parts, conducted simultaneously. Part 1 will assess the food effect, while Part 2 will assess dose proportionality.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	omaveloxolone	Omaveloxolone 50 mg capsules

Timeline

• Start date: 2018-10-29
• Primary completion: 2018-11-20
• Completion: 2018-11-20
• First posted: 2018-09-10
• Last updated: 2025-05-30

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study