A Human AME Study for Omaveloxolone
Public ClinicalTrials.gov record NCT03931590. 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
Phase 1 Study to Investigate the Absorption, Metabolism, and Excretion of [14C] Omaveloxolone Following Single Oral Dose Administration in Healthy Male Subjects
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This study will assess the pharmacokinetics (PK), mass balance, metabolite profiles, and rates and routes of elimination of \[14C\] omaveloxolone and derived metabolites following administration as a single 150 mg (containing approximately 90 µCi) dose to healthy male subjects.
Study identification
- NCT ID
- NCT03931590
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 8 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 55 Years
- Sex
- Male
- 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
- Apr 10, 2019
- Primary completion
- May 30, 2019
- Completion
- May 30, 2019
- Last update posted
- May 29, 2025
2019
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Covance Clinical Research Unit (CRU) Inc. | Madison | Wisconsin | 53704 | — |
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 NCT03931590, 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 4, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03931590 live on ClinicalTrials.gov.