Omaveloxolone for Healthy Subjects
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to compare how the body processes the drug omaveloxolone when taken as a tablet dissolved in liquid versus a capsule. Although omaveloxolone typically treats Friedrich's Ataxia, this study examines its behavior in healthy adults. Participants will take both forms of the drug, with a break in between, to compare results. Individuals in good health who meet specific criteria may qualify for this study. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, allowing participants to contribute to early-stage drug development.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, since participants must be in good health and free from significant diseases, it's possible that some medications might need to be paused. Please consult with the study team for specific guidance.
Is there any evidence suggesting that this treatment is likely to be safe for humans?
Previous studies have shown omaveloxolone, also known as BIIB141 or SKYCLARYS®, to be safe. It is currently approved for individuals aged 16 and older with Friedreich's Ataxia. Research indicates that most side effects linked to omaveloxolone are mild or moderate, meaning they are usually not serious.
For the capsule form, studies have not identified any major safety issues, suggesting it is generally well-tolerated when used as directed. The new tablet form, which dissolves in liquid, is being tested to determine if it functions similarly in the body as the capsules. Although specific safety data for the tablet form is not yet available, its similarity to the capsule suggests it might also be safe.
This study is in its early phase and focuses on safety and how the body processes the drug. Such studies are essential to ensure treatments are safe before they are widely used.12345Why are researchers excited about this trial?
Omaveloxolone is unique because it targets oxidative stress and inflammation, offering a fresh approach compared to standard treatments. Most current options focus on managing symptoms without directly addressing these underlying issues. Omaveloxolone's mechanism potentially provides a more comprehensive treatment by enhancing cellular defense pathways. Researchers are excited about its promise to not only manage but possibly modify the progression of conditions associated with oxidative stress.
What evidence suggests that this trial's treatments could be effective for processing BIIB141 in healthy subjects?
This trial will study omaveloxolone in healthy subjects. Research has shown that omaveloxolone, also known as Skyclarys, effectively treats Friedrich's Ataxia (FA) by slowing the worsening of neurological function in patients aged 16 and older. Studies have found improvements in neurological function using the modified Friedreich Ataxia Rating Scale (mFARS). This treatment activates a protein called Nrf2, which protects cells from damage. Long-term evidence supports its ability to slow disease progression over four years, making it a promising option for managing FA.678910
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
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive omaveloxolone as a tablet dissolved in liquid and as a capsule in a crossover design with a 14-day break between doses
Follow-up
Participants are monitored for safety and effectiveness after treatment
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
Citations
NCT07297199 | A Study to Learn How the Body Processes ...
The primary objective of the study is to assess the bioequivalence (BE) of omaveloxolone tablets for oral suspension (TOS) compared to capsules ...
Omaveloxolone for Healthy Subjects · Info for Participants
At a dose of 160 mg/day, omaveloxolone significantly improved neurological function as measured by the modified Friedreich Ataxia Rating Scale (mFARS), ...
3.
friedreichsataxianews.com
friedreichsataxianews.com/news/four-years-skyclarys-slows-friedreichs-ataxia-progression/4 years of Skyclarys slows Friedreich's ataxia progression
Four years of daily treatment with Skyclarys (omaveloxolone) continues to slow the progression of Friedreich's ataxia (FA) compared to what ...
Safety and efficacy of omaveloxolone v/s placebo for the ...
Omaveloxolone (Omav) is an Nrf2 activator and has been reported to have antioxidative potential in various disease conditions.
Latest clinical trial results support the long-term efficacy of ...
Latest clinical trial results support the long-term efficacy of two pharmacological treatments in slowing progression of Friedreich's ataxia ...
Safety Data Sheet
Safety, health and environmental regulations/legislation specific for the substance or mixture. No further relevant information available. · ...
MATERIAL SAFETY DATA SHEET Omaveloxolone (RTA408)
Fire hazard: No data available. Reactivity: The product is non-reactive under normal conditions of use, storage and transport. 5.3. Special ...
216718Orig1s000 CLINICAL PHARMACOLOGY REVIEW(S)
For patients with severe hepatic impairment,. Omav should be avoided due to clinical team's concerns about the limited safety data in these ...
Safety, pharmacokinetics, and pharmacodynamics of oral ...
Omaveloxolone (RTA 408) is a semisynthetic triterpenoid developed through lead optimization to suppress interferon-γ-mediated nitric oxide ...
10.
medchemexpress.com
medchemexpress.com/RTA-408.html?srsltid=AfmBOoorthhJeMMLUrZTHufx7Zmg4aDOCV3Id4sjV52SzCACSqBzrhV9Omaveloxolone (RTA 408) | Nrf2 Activator
Omaveloxolone (RTA 408) is an antioxidant inflammation modulator (AIM), which activates Nrf2 and suppresses nitric oxide (NO).
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