NCT03931590

A Human AME Study for Omaveloxolone

Phase 1 Study to Investigate the Absorption, Metabolism, and Excretion of [14C] Omaveloxolone Following Single Oral Dose Administration in Healthy Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Biogen · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Healthy Male Subjects

Interventions

Type	Name	Description
DRUG	[14C]-Omaveloxolone	\[14C\]-Omaveloxolone 50 mg capsules

Timeline

• Start date: 2019-04-11
• Primary completion: 2019-05-31
• Completion: 2019-05-31
• First posted: 2019-04-30
• Last updated: 2025-05-30

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study