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In this study, researchers will learn how BIIB141, also known as omaveloxolone or SKYCLARYS®, moves through the body. This is a drug available for doctors to prescribe for patients with Friedrich's Ataxia. But, this drug has not yet been tested in women who have recently given birth and are breastfeeding or pumping milk for their babies. So, researchers do not know how much of the drug could be passed on to babies through the breastmilk of mothers who may take BIIB141.
The main objective of this study is to learn how a single dose of BIIB141 is processed in both the breastmilk and in the blood of healthy women who are breastfeeding.
The main question researchers want to answer in this study is:
Researchers will also learn more about:
This study will be done as follows:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Omaveloxolone | Experimental | Participants will receive a single oral dose of omaveloxolone on Day 1. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Omaveloxolone | Drug | Administered as specified in the treatment arm. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Concentration (Cmax) of Omaveloxolone in Breast Milk | Predose and at multiple timepoints postdose (up to Day 15) | |
| Time to Achieve Cmax (Tmax) of Omaveloxolone in Breast Milk | 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 | 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 | Predose and at multiple timepoints postdose (up to Day 15) | |
| Time of the Last Measurable Concentration (Tlast) of Omaveloxolone in Breast milk | Predose and at multiple timepoints postdose (up to Day 15) | |
| AUC Time Curve From Time Zero to Infinity (AUCinf) of Omaveloxolone in Breast Milk | Predose and at multiple timepoints postdose (up to Day 15) | |
| Milk-to-Plasma Ratio (M/P) of Omaveloxolone | 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 | At multiple timepoints postdose (up to 24 hours) | |
| Cumulative Amount of Omaveloxolone Excreted in Breast Milk (Ae) Over 96 Hours (Ae0-96) Postdose |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax of Omaveloxolone in Plasma | Predose and at multiple timepoints postdose (up to Day 15) | |
| Tmax of Omaveloxolone in Plasma | Predose and at multiple timepoints postdose (up to Day 15) | |
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Key Inclusion Criteria:
Key Exclusion Criteria:
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Biogen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fortrea Madison WI, CRU | Madison | Wisconsin | 53704 | United States |
In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/
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| ID | Term |
|---|---|
| C000589490 | omaveloxolone |
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| At multiple timepoints postdose (up to 96 hours) |
| Fraction of Omaveloxolone Excreted in Breast Milk (Fe) Over 24 Hours (Fe0-24) | At multiple timepoints postdose (up to 24 hours) |
| Fraction of Omaveloxolone Excreted in Breast Milk (Fe) Over 96 Hours (Fe0-96) | At multiple timepoints postdose (up to 96 hours) |
| AUC[Cav] of Omaveloxolone in Plasma |
| Predose and at multiple timepoints postdose (up to Day 15) |
| AUC0-tlast of Omaveloxolone in Plasma | Predose and at multiple timepoints postdose (up to Day 15) |
| AUCinf of Omaveloxolone in Plasma | Predose and at multiple timepoints postdose (up to Day 15) |
| Terminal Elimination Rate Constant (λz) of Omaveloxolone in Plasma | Predose and at multiple timepoints postdose (up to Day 15) |
| Apparent Plasma Terminal Elimination Half-Life (t1/2) of Omaveloxolone | Predose and at multiple timepoints postdose (up to Day 15) |
| Apparent Plasma Clearance After Extravascular Administration (CL/F) of Omaveloxolone | Predose and at multiple timepoints postdose (up to Day 15) |
| Apparent Volume of Distribution During the Terminal Elimination Phase After Extravascular Administration (Vz/F) of Omaveloxolone | Predose and at multiple timepoints postdose (up to Day 15) |
| Percent of Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUC%extrap) of Omaveloxolone | Predose and at multiple timepoints postdose (up to Day 15) |
| Plasma Unbound Fraction (fu,p) of Omaveloxolone | Predose and at multiple timepoints postdose (up to Day 15) |
| Cmax of Unbound Plasma Fraction (Cmax,u) of Omaveloxolone | Predose and at multiple timepoints postdose (up to Day 15) |
| Cav of Unbound Plasma Fraction (AUCinf,u) of Omaveloxolone | Predose and at multiple timepoints postdose (up to Day 15) |
| AUC0-tlast of Unbound Plasma Fraction (AUC0-last,u) of Omaveloxolone in Plasma | Predose and at multiple timepoints postdose (up to Day 15) |
| AUCinf of Unbound Plasma Fraction (AUCinf,u) of Omaveloxolone | Predose and at multiple timepoints postdose (up to Day 15) |
| Estimated Daily Infant Dosage (DID) of Omaveloxolone | Predose and at multiple timepoints postdose (up to Day 15) |
| Relative Infant Dose (RID) of Omaveloxolone | Predose and at multiple timepoints postdose (up to Day 15) |
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | From Day 1 up to end of study follow-up (up to 45 days) |