Omaveloxolone for Healthy Subjects
What You Need to Know Before You Apply
What is the purpose of this trial?
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's Ataxia (FA) who are at least 16 years old. Currently, BIIB141 is taken by mouth as capsules or capsule contents sprinkled over applesauce. But, there may be some people who have trouble swallowing capsules. In this study, the main goal was to learn if BIIB141 is processed similarly in the body of healthy adults when taken as tablets that dissolve in liquid compared to the currently available capsules.
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.
Who Is on the Research Team?
Medical Director
Principal Investigator
Biogen
Are You a Good Fit for This Trial?
This trial is for healthy adults aged 18 to 55 with a BMI between 18 and 32 kg/m^2. Participants must be in good health as determined by serum samples taken during screening and before dosing.Inclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- Omaveloxolone
Trial Overview
Researchers are testing how the body processes BIIB141 (Omaveloxolone) when taken as a tablet dissolved in liquid versus capsules. This open-label, crossover study requires participants to stay at the research center for about 30 days, taking both forms of the drug with a break in between.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Participants will receive treatment B (omaveloxolone TOS) on Day 1 followed by treatment A (omaveloxolone capsule orally) on Day 15.
Participants will receive treatment A (omaveloxolone capsule orally) on Day 1 followed by treatment B (omaveloxolone TOS) on Day 15.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Biogen
Lead Sponsor
Daniel Quirk
Biogen
Chief Medical Officer
MD
Christopher A. Viehbacher
Biogen
Chief Executive Officer since 2022
Graduated from Queen's University, Kingston, Ontario, Canada
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