A Study to Learn How the Body Processes BIIB141 (Omaveloxolone) When Taken as a Capsule or as a Tablet Dissolved in Liquid, and to Learn About Its Safety in Healthy Adults Ages 18 to 55
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Phase
Phase 1
Status
Completed
Study type
Interventional
Design
Randomized · None · Treatment
Enrollment
70actual
Sites
1
Country
United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2025-12-12 | actual | When the study began enrolling |
| Primary completion | 2026-05-01 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2026-05-01 | actual | The whole study's end, after follow-up |
| First posted | 2025-12-22 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-05-14 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Healthy Volunteer
Intervention
- Drug: Omaveloxolone — also filed as BIIB141, SKYCLARYS
Primary outcomes
what the primary-completion date above is the date OFMaximum Observed Plasma Concentration (Cmax) of Omaveloxolone
measured Pre-dose and at multiple timepoints post-dose up to Day 29
Area Under the Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of Omaveloxolone
measured Pre-dose and at multiple timepoints post-dose up to Day 29
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