Status:
COMPLETED
A Study to Learn if Taking BIIB141 (Omaveloxolone) Affects How Omeprazole is Processed in the Body and About BIIB141's Safety in Healthy Adults Aged 18 to 55
Lead Sponsor:
Biogen
Conditions:
Healthy Volunteer
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
In this study, researchers will learn more about BIIB141, also known as omaveloxolone or SKYCLARYS®. This drug has been approved, or made available for doctors to prescribe, for people with Friedrich'...
Detailed Description
The primary objective of this study is to assess the effect of omaveloxolone on the pharmacokinetics (PK) of omeprazole in healthy adult participants. The secondary objective of this study is to asse...
Eligibility Criteria
Inclusion
- Key
- All female participants of childbearing potential must have negative results for pregnancy tests as follows:
- At screening, based on a serum sample obtained within 28 days prior to initial study drug administration; and
- Prior to dosing, based on a serum sample obtained on Study Day -1.
- Body mass index (BMI) at screening between 18 and 32 kilograms per square meter (kg/m\^2), inclusive.
- Key
Exclusion
- History of any clinically significant cardiac, endocrine, gastrointestinal, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, 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 (HIV).
- History of hepatitis C infection or positive test result at Screening for hepatitis C virus antibody (HCV Ab).
- Current hepatitis B infection \[defined as positive for hepatitis B surface antigen (HBsAg) and/or total anti-HBc\]. Participants with immunity to hepatitis B from previous natural infection (defined as negative HBsAg, positive anti-HBc, and positive anti-HBs) or vaccination (defined as negative HBsAg, negative anti-HBc, and positive anti-HBs) are eligible to participate in the study.
- Chronic, recurrent, or serious infection (e.g., pneumonia, septicemia, and herpes simplex virus), as determined by the Investigator, within 90 days prior to Screening or between Screening and Day -1.
- Symptoms of bacterial, fungal, or viral infection (including upper respiratory tract infection) within 14 days prior to Screening or between Screening and Day -1. Participants with local fungal infection (e.g., candidiasis, tinea) are eligible to be rescreened after successful treatment of the infection.
- Prior exposure to omaveloxolone.
- NOTE: Other protocol-defined inclusion/exclusion criteria may apply.
Key Trial Info
Start Date :
September 2 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 16 2025
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT07149415
Start Date
September 2 2025
End Date
October 16 2025
Last Update
October 23 2025
Active Locations (1)
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1
Austin Clinical Research Unit
Austin, Texas, United States, 78744