A Study to Learn How the Body Processes BIIB141 (Omaveloxolone) When Taken as a Capsule or as a Tablet Dissolved in Liquid, and to Learn About Its Safety in Healthy Adults Ages 18 to 55
NCT ID: NCT07297199
Last Updated: 2026-01-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
70 participants
INTERVENTIONAL
2025-12-12
2026-04-17
Brief Summary
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The main question researchers want to answer in this study is :
• How does the body process BIIB141 when taken as a tablet dissolved in liquid compared to capsules?
Researchers will also learn more about:
* How many participants have adverse events during the study. An adverse event is a health problem that may or may not be caused by the study drug.
* If there are any changes in the participants' overall health 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 stay at the study research center for about 30 days.
* This is an "open label" study. In this kind of study, the participants, study doctor, and site staff know which study drug the participant is taking. In this study, all participants will take BIIB141.
* This study also has a "crossover" design. This means that all of the participants will take BIIB141, once as a tablet that dissolves in liquid and once as a capsule. But the order in which the participants take them will be different. There will be a break of about 14 days between the 2 doses.
* Throughout the study, researchers will take participants' blood and urine samples. Researchers will also do other tests to check the participants' overall health and will ask participants how they are feeling.
* Each participant will be in the study for up to 57 days.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Treatment Sequence AB
Participants will receive treatment A (omaveloxolone capsule orally) on Day 1 followed by treatment B (omaveloxolone TOS) on Day 15.
Omaveloxolone
Administered orally
Treatment Sequence BA
Participants will receive treatment B (omaveloxolone TOS) on Day 1 followed by treatment A (omaveloxolone capsule orally) on Day 15.
Omaveloxolone
Administered orally
Interventions
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Omaveloxolone
Administered orally
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
1. At screening, based on a serum sample obtained within 28 days prior to initial study drug administration; and
2. 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 meter square (kg/m\^2), inclusive.
* Participants must be in good health.
Exclusion Criteria
* Clinically significant, as determined by the Investigator, 12-lead electrocardiogram (ECG) abnormalities.
* History of, or positive test result 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 \[defined as positive for hepatitis B surface antigen (HBsAg) and/or total hepatitis B core antibody (anti-HBc)\]. 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), as determined by the Investigator, within 90 days prior to Screening or between Screening and Day -1.
* Prior exposure to the study treatment.
* Any clinically significant abnormal laboratory test value as determined by the Investigator, as Screening or Day-1.
18 Years
55 Years
ALL
Yes
Sponsors
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Biogen
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Biogen
Locations
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Trialmed formerly PPD, Austin Clinical Research Unit
Austin, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Role: primary
Other Identifiers
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296HV102
Identifier Type: -
Identifier Source: org_study_id