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Healthy VolunteerPhase 1NCT06612879

A Study to Find Out How BIIB141 (Omaveloxolone) Moves From the Blood Into the Breastmilk of Healthy Women Who Are Breastfeeding or Pumping Milk

A Phase 1 study testing Omaveloxolone in people with Healthy Volunteer, run by Biogen at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 45 years, women onlyHealthy volunteers can take part
Conditions the study is for
Healthy Volunteer
What is being tested?
Omaveloxolone
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteUnited States
Study dates
18 Oct 2024to 8 Apr 2025
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Lactating female 18 to 45 years of age.
  • Has given birth to an infant of at least 37 weeks' gestation.
  • Is at least 6 weeks postpartum by Day 1.
  • Body mass index at screening between 18.0 and and < 35.0 kilograms per meter square (kg/m^2), inclusive.
  • Is willing to discontinue breastfeeding their infant from check-in (Day -1) through 19 days after dosing.
  • Has never taken omaveloxolone.

Who cannot join

  • History of any clinically significant cardiovascular, endocrine, gastrointestinal, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, dermatologic, neurologic, psychiatric, or renal disease, or other major disease, as determined by the Investigator.
  • Clinically significant (as determined by the Investigator) 12-lead electrocardiogram (ECG) abnormalities.
  • History of, or positive test result at Screening for, human immunodeficiency virus.
  • Chronic, recurrent, or serious infection (e.g., pneumonia, septicemia), as determined by the Investigator, within 90 days prior to Screening or between Screening and Day -1.
  • Presence or history of hypotension or hypertension.
  • NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Fortrea Madison WI, CRU

    Madison, Wisconsin, 53704

Other trials in United States

About this study

Official title: An Open-Label, Single Dose Study to Assess the Breast Milk and Plasma Pharmacokinetics of Omaveloxolone (BIIB141) in Healthy Lactating Women

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.

Read more

The main question researchers want to answer in this study is:

  • How does BIIB141 move from the blood into the breastmilk?

Researchers will also learn more about:

  • How BIIB141 moves through the blood
  • What dose of BIIB141 a baby may get from the mother's breastmilk
  • Any medical problems the participants have during the study

This study will be done as follows:

  • Participants will be screened to check if they can join the study. The screening period will be up to 28 days, after which participants will check into their study research center.
  • Participants will take a single dose of BIIB141 as a tablet by mouth on Day 1.
  • Participants will remain at their study research center for 6 days. During this time, the participants will be provided with an electric breast pump. This is so that the researchers can collect breastmilk samples before and after the participants take BIIB141. The researchers will also collect blood samples.
  • After leaving the study research center, the participants will return every 2 days for the next 10 days for more tests and checkups.
  • Finally, there will be a follow-up with a "lactation consultant" up to 30 days after each participant's last study visit. This is someone who can help participants with breastfeeding or pumping.
  • Each participant will be in the study for up to 2.5 months.
Being tested
Omaveloxolone

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OmaveloxoloneDrug

    Also called BIIB141, SKYCLARYS

    Administered as specified in the treatment arm.

Study groups in NCT06612879
Study groupRoleWhat they receive
OmaveloxoloneExperimentalParticipants will receive a single oral dose of omaveloxolone on Day 1.
Receives: Drug: Omaveloxolone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximum Observed Concentration (Cmax) of Omaveloxolone in Breast Milk

    Measured: Predose and at multiple timepoints postdose (up to Day 15)

  2. Time to Achieve Cmax (Tmax) of Omaveloxolone in Breast Milk

    Measured: Predose and at multiple timepoints postdose (up to Day 15)

  3. 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)

  4. 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)

  5. Time of the Last Measurable Concentration (Tlast) of Omaveloxolone in Breast milk

    Measured: Predose and at multiple timepoints postdose (up to Day 15)

  6. 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)

  7. Milk-to-Plasma Ratio (M/P) of Omaveloxolone

    Measured: Predose and at multiple timepoints postdose (up to Day 15)

  8. Cumulative Amount of Omaveloxolone Excreted in Breast Milk (Ae) Over 24 Hours (Ae0-24) Postdose

    Measured: At multiple timepoints postdose (up to 24 hours)

  9. Cumulative Amount of Omaveloxolone Excreted in Breast Milk (Ae) Over 96 Hours (Ae0-96) Postdose

    Measured: At multiple timepoints postdose (up to 96 hours)

  10. Fraction of Omaveloxolone Excreted in Breast Milk (Fe) Over 24 Hours (Fe0-24)

    Measured: At multiple timepoints postdose (up to 24 hours)

  11. Fraction of Omaveloxolone Excreted in Breast Milk (Fe) Over 96 Hours (Fe0-96)

    Measured: At multiple timepoints postdose (up to 96 hours)

Secondary outcomes (18)

  1. Cmax of Omaveloxolone in Plasma

    Measured: Predose and at multiple timepoints postdose (up to Day 15)

  2. Tmax of Omaveloxolone in Plasma

    Measured: Predose and at multiple timepoints postdose (up to Day 15)

  3. AUC[Cav] of Omaveloxolone in Plasma

    Measured: Predose and at multiple timepoints postdose (up to Day 15)

  4. AUC0-tlast of Omaveloxolone in Plasma

    Measured: Predose and at multiple timepoints postdose (up to Day 15)

  5. AUCinf of Omaveloxolone in Plasma

    Measured: Predose and at multiple timepoints postdose (up to Day 15)

  6. Terminal Elimination Rate Constant (λz) of Omaveloxolone in Plasma

    Measured: Predose and at multiple timepoints postdose (up to Day 15)

  7. Apparent Plasma Terminal Elimination Half-Life (t1/2) of Omaveloxolone

    Measured: Predose and at multiple timepoints postdose (up to Day 15)

  8. Apparent Plasma Clearance After Extravascular Administration (CL/F) of Omaveloxolone

    Measured: Predose and at multiple timepoints postdose (up to Day 15)

  9. Apparent Volume of Distribution During the Terminal Elimination Phase After Extravascular Administration (Vz/F) of Omaveloxolone

    Measured: Predose and at multiple timepoints postdose (up to Day 15)

  10. Percent of Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUC%extrap) of Omaveloxolone

    Measured: Predose and at multiple timepoints postdose (up to Day 15)

  11. Plasma Unbound Fraction (fu,p) of Omaveloxolone

    Measured: Predose and at multiple timepoints postdose (up to Day 15)

  12. Cmax of Unbound Plasma Fraction (Cmax,u) of Omaveloxolone

    Measured: Predose and at multiple timepoints postdose (up to Day 15)

  13. Cav of Unbound Plasma Fraction (AUCinf,u) of Omaveloxolone

    Measured: Predose and at multiple timepoints postdose (up to Day 15)

  14. AUC0-tlast of Unbound Plasma Fraction (AUC0-last,u) of Omaveloxolone in Plasma

    Measured: Predose and at multiple timepoints postdose (up to Day 15)

  15. AUCinf of Unbound Plasma Fraction (AUCinf,u) of Omaveloxolone

    Measured: Predose and at multiple timepoints postdose (up to Day 15)

  16. Estimated Daily Infant Dosage (DID) of Omaveloxolone

    Measured: Predose and at multiple timepoints postdose (up to Day 15)

  17. Relative Infant Dose (RID) of Omaveloxolone

    Measured: Predose and at multiple timepoints postdose (up to Day 15)

  18. Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Measured: From Day 1 up to end of study follow-up (up to 45 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Sep 2024
  2. Study start18 Oct 2024
  3. Primary completion11 Mar 2025
  4. Study completion8 Apr 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06612879
Sponsor's protocol ID
296HV101
Status last verified
Apr 2025
First submitted
23 Sep 2024
Last updated
22 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Omaveloxolone in people with Healthy Volunteer, run by Biogen at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum Observed Concentration (Cmax) of Omaveloxolone in Breast Milk (time frame: Predose and at multiple timepoints postdose (up to Day 15)). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06612879.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2025.

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