A Study to Find Out How BIIB141 (Omaveloxolone) Moves From the Blood Into the Breastmilk of Healthy Women Who Are Breastfeeding or Pumping Milk
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Phase
Phase 1
Status
Completed
Study type
Interventional
Design
Na · None · Treatment
Enrollment
12actual
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 | 2024-10-18 | actual | When the study began enrolling |
| Primary completion | 2025-03-11 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2025-04-08 | actual | The whole study's end, after follow-up |
| First posted | 2024-09-25 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2025-04-22 | 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 Concentration (Cmax) of Omaveloxolone in Breast Milk
measured Predose and at multiple timepoints postdose (up to Day 15)
Time to Achieve Cmax (Tmax) of Omaveloxolone in Breast Milk
measured Predose and at multiple timepoints postdose (up to Day 15)
Average Concentration Based on Area Under the Concentration-Time Curve (AUC [Cav]) of Omaveloxolone in Breast Milk
measured Predose and at multiple timepoints postdose (up to Day 15)
Area Under the Concentration Time Curve From Time Zero to the Time of Last Measurable Concentration (AUC0-tlast) of Omaveloxolone in Breast Milk
measured Predose and at multiple timepoints postdose (up to Day 15)
Time of the Last Measurable Concentration (Tlast) of Omaveloxolone in Breast milk
measured Predose and at multiple timepoints postdose (up to Day 15)
AUC Time Curve From Time Zero to Infinity (AUCinf) of Omaveloxolone in Breast Milk
measured Predose and at multiple timepoints postdose (up to Day 15)
Milk-to-Plasma Ratio (M/P) of Omaveloxolone
measured Predose and at multiple timepoints postdose (up to Day 15)
Cumulative Amount of Omaveloxolone Excreted in Breast Milk (Ae) Over 24 Hours (Ae0-24) Postdose
measured At multiple timepoints postdose (up to 24 hours)
Cumulative Amount of Omaveloxolone Excreted in Breast Milk (Ae) Over 96 Hours (Ae0-96) Postdose
measured At multiple timepoints postdose (up to 96 hours)
Fraction of Omaveloxolone Excreted in Breast Milk (Fe) Over 24 Hours (Fe0-24)
measured At multiple timepoints postdose (up to 24 hours)
Fraction of Omaveloxolone Excreted in Breast Milk (Fe) Over 96 Hours (Fe0-96)
measured At multiple timepoints postdose (up to 96 hours)
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