A Pharmacokinetic Study of Omaveloxolone in Subjects With Hepatic Impairment and Normal Hepatic Function
Public ClinicalTrials.gov record NCT03902002. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
- Enrollment
- 48 participants
Conditions and interventions
Conditions
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 18, 2019
- Primary completion
- Jan 26, 2020
- Completion
- Jan 26, 2020
- Last update posted
- May 29, 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 29, 2025 · Synced Sep 29, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03902002 live on ClinicalTrials.gov.