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NCT07297199 · ClinicalTrials.gov registry record · Phase 1
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
A Phase 1 study of Healthy Volunteer, sponsored by Biogen.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 70
- Enrollment target
- 1
- Study location
NCT07297199: Recruiting Phase 1 study of Healthy Volunteer, sponsored by Biogen.
NCT07297199 is a Phase 1 study of Healthy Volunteer that is actively recruiting participants, run by Biogen. The registered enrollment target is 70 participants, below the 201-participant average among 112 other Healthy Volunteer trials with a reported enrollment target (65% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07297199, a Phase 1 study of Healthy Volunteer, is actively recruiting participants, sponsored by Biogen.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 70 participants
- Enrollment target
- 1
- Study location
Study 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'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 heal
Conditions Studied
Interventions
- DRUG Omaveloxolone
Study Locations (1)
Texas
- Trialmed formerly PPD, Austin Clinical Research Unit - Austin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 70 participants |
| Start Date | 2025-12-12 |
| Est. Completion | 2026-04-17 |
| Phase | Phase 1 |
What NCT07297199 shows while recruiting
NCT07297199 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 70 participants, a relatively small participant target, below the 201-participant average among 112 other Healthy Volunteer trials with a reported enrollment target (65% lower).
The record links to 1 condition, with Healthy Volunteer appearing as the primary indexed condition, and to 1 intervention - of which Omaveloxolone is the first listed.
NCT07297199 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT07297199 about?
NCT07297199 is a clinical study titled "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". 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 cap...
What is the current status of trial NCT07297199?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 70 participants. The study started on 2025-12-12. Estimated completion is 2026-04-17.
What conditions does trial NCT07297199 study?
This clinical trial studies the following conditions: Healthy Volunteer.
What interventions are being tested in trial NCT07297199?
The interventions under investigation include: Omaveloxolone (DRUG).
Who is sponsoring clinical trial NCT07297199?
This trial is sponsored by Biogen, which has 334 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07297199 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT07297199's enrollment target sits among peer trials
70 52nd of 112 higher than 61 of 112 other Healthy Volunteer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy Volunteer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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