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

ClinicalTrials.gov ID: NCT03902002

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Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID: NCT03902002
Recruitment status: Completed
Study type: Interventional
Phase: Phase 1
Lead sponsor: Biogen; Industry
Enrollment: 48 participants

Conditions and interventions

Conditions

Hepatic Impairment

Interventions

Omaveloxolone 50 mg capsules Drug

Drug

Eligibility (public fields only)

Age range: 18 Years to 70 Years
Sex: All
Healthy volunteers: Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Jul 19, 2019 (Actual)
Primary completion: Jan 27, 2020 (Actual)
Completion: Jan 27, 2020 (Actual)
Last update posted: May 30, 2025

2019 – 2020

United States locations

U.S. sites: 3
U.S. states: 2
U.S. cities: 3

Facility	City	State	ZIP	Site status
Orange County Research Center	Tustin	California	92780	—
Clinical Pharmacology of Miami, LLC	Miami	Florida	33014	—
Orlando Clinical Research Center	Orlando	Florida	32809	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT03902002, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted May 30, 2025 · Synced Nov 13, 2026