Status:
COMPLETED
A Study to Find Out How BIIB141 (Omaveloxolone) Moves From the Blood Into the Breastmilk of Healthy Women Who Are Breastfeeding or Pumping Milk
Lead Sponsor:
Biogen
Conditions:
Healthy Volunteer
Eligibility:
FEMALE
18-45 years
Phase:
PHASE1
Brief 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 At...
Eligibility Criteria
Inclusion
- Key
- 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
- 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.
Key Trial Info
Start Date :
October 18 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 8 2025
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT06612879
Start Date
October 18 2024
End Date
April 8 2025
Last Update
April 22 2025
Active Locations (1)
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1
Fortrea Madison WI, CRU
Madison, Wisconsin, United States, 53704