Search / Trial NCT06612879

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

Launched by REATA, A WHOLLY OWNED SUBSIDIARY OF BIOGEN · Sep 23, 2024

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Trial Information

Current as of December 21, 2024

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying how a medication called BIIB141 (also known as omaveloxolone or SKYCLARYS®) moves from the blood into the breastmilk of healthy women who are breastfeeding or pumping. This drug is currently prescribed for patients with a condition called Friedrich's Ataxia, but researchers want to understand its effects in new mothers because it hasn’t been tested in this group yet. The main goal is to see how much of the drug can be found in breastmilk after a mother takes a single dose, which will help ensure the safety of breastfeeding infants.

To participate in this study, women must be between 18 and 45 years old, at least six weeks postpartum, and willing to stop breastfeeding for about 19 days. They should also have a body mass index within a specific range and must not have taken this medication before. Participants will take the drug as a tablet and then stay in a research center for six days, where their blood and breastmilk will be tested. After that, they'll have follow-up visits for about ten days. Throughout the study, a lactation consultant will be available to help with any breastfeeding questions. This study will last up to 2.5 months for each participant.

Gender

FEMALE

Eligibility criteria

  • Key Inclusion Criteria:
  • • 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.
  • Key Exclusion Criteria:
  • • 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 Officials

Medical Director

Study Director

Biogen

About Reata, A Wholly Owned Subsidiary Of Biogen

Reata, a wholly owned subsidiary of Biogen, is a biopharmaceutical company dedicated to the development of innovative therapies for serious neurological and rare diseases. Leveraging cutting-edge science and advanced research methodologies, Reata focuses on addressing significant unmet medical needs through its robust pipeline of drug candidates. With a commitment to improving patient outcomes, the company integrates expertise in clinical development, regulatory affairs, and commercial strategy, positioning itself at the forefront of transforming the landscape of neurological medicine.

Locations

Madison, Wisconsin, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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