NCT03902002

A Pharmacokinetic Study of Omaveloxolone in Subjects With Hepatic Impairment and Normal Hepatic Function

A Single Dose, Open Label Pharmacokinetic Study of Omaveloxolone in Subjects With Mild, Moderate, or Severe Hepatic Impairment, or With Normal Hepatic Function

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Biogen · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

This study will examine the pharmacokinetics (PK) of omaveloxolone following a single oral dose of omaveloxolone in subjects with mild, moderate, or severe hepatic impairment compared to healthy subjects with normal hepatic function.

Conditions

• Hepatic Impairment

Interventions

Type	Name	Description
DRUG	Omaveloxolone 50 mg capsules	Capsules containing 50 mg of omaveloxolone

Timeline

• Start date: 2019-07-19
• Primary completion: 2020-01-27
• Completion: 2020-01-27
• First posted: 2019-04-03
• Last updated: 2025-05-30

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study