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NCT06612879 · ClinicalTrials.gov registry record · Phase 1
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, sponsored by Biogen.
- Completed
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
NCT06612879: Completed Phase 1 study, sponsored by Biogen.
NCT06612879 is a Phase 1 study that has completed, run by Biogen. The registered enrollment target is 12 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06612879, a Phase 1 study, has completed, sponsored by Biogen.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
Study 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. 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: * 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.
Interventions
- DRUG Omaveloxolone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2024-10-18 |
| Est. Completion | 2025-04-08 |
| Phase | Phase 1 |
What the finished NCT06612879 record still lists
NCT06612879 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower).
The record links to 0 conditions, and to 1 intervention - of which Omaveloxolone is the first listed.
NCT06612879 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06612879 about?
NCT06612879 is a clinical study titled "A Study to Find Out How BIIB141 (Omaveloxolone) Moves From the Blood Into the Breastmilk of Healthy Women Who Are Breastfeeding or Pumping Milk". 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 breastfe...
What is the current status of trial NCT06612879?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2024-10-18. Estimated completion is 2025-04-08.
What interventions are being tested in trial NCT06612879?
The interventions under investigation include: Omaveloxolone (DRUG).
Who is sponsoring clinical trial NCT06612879?
This trial is sponsored by Biogen, which has 334 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06612879's enrollment target sits among peer trials
12 1852nd of 2000 higher than 90 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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