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

Trial Information

Current as of October 08, 2024

Not yet recruiting

Keywords

Description

No description provided

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.

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.

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People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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