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NCT07019064 · ClinicalTrials.gov registry record · Phase 1
A Study to Learn How BIIB141 (Omaveloxolone) is Processed in the Body When Taken as Capsules Compared to Sprinkled on Yogurt in Healthy Adults Aged 18 to 55
A Phase 1 study, sponsored by Biogen.
- Completed
- Registry status
- Phase 1
- Development phase
- 52
- Enrollment target
NCT07019064 is a Phase 1 study that has completed, run by Biogen. The registered enrollment target is 52 participants.
The verdict
NCT07019064, a Phase 1 study, has completed, sponsored by Biogen.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 52 participants
- Enrollment target
Study Summary
In this study, researchers will learn more about how BIIB141, also known as omaveloxolone or SKYCLARYS®, is processed in the body when taken in different ways. 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, people with FA can take it either as whole capsules or opening the capsules and sprinkling its contents over applesauce. The main goal of this study is to learn if BIIB141 is processed any differently when taken sprinkled over low-fat, non-Greek yogurt compared to whole capsules. This will help researchers learn if yogurt could be another option for people to take BIIB141 with. The main questions researchers want to answer in this study are : • How does the body process BIIB141 when taken as whole capsules compared to being sprinkled over yogurt? Researchers will also learn more about : * How many participants have adverse reactions during the study. An adverse reaction is a health problem that may 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 a "crossover" study. In this kind of study, all participants receive the same 2 or more study drugs (or ways of taking the drug), but the order in which they receive them depends on the group they are randomly assigned to. * In Group 1, participants will take a single dose of BIIB141 as a capsule, followed by a break of 14 days. Then, the participants will take a single dose of BIIB141 sprinkled over yogurt. * In Group 2, participants will take a single dose of BIIB141 sprinkled over yogurt, followed by a break of 14 days. Then, the participants will tak
Interventions
- DRUG Omaveloxolone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 52 participants |
| Start Date | 2025-06-11 |
| Est. Completion | 2025-08-19 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07019064
The ClinicalTrials.gov registry entry for NCT07019064 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 52 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Biogen, which has 334 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Omaveloxolone is the first listed.
NCT07019064 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT07019064 about?
NCT07019064 is a clinical study titled "A Study to Learn How BIIB141 (Omaveloxolone) is Processed in the Body When Taken as Capsules Compared to Sprinkled on Yogurt in Healthy Adults Aged 18 to 55". In this study, researchers will learn more about how BIIB141, also known as omaveloxolone or SKYCLARYS®, is processed in the body when taken in different ways. 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 o...
What is the current status of trial NCT07019064?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 52 participants. The study started on 2025-06-11. Estimated completion is 2025-08-19.
What interventions are being tested in trial NCT07019064?
The interventions under investigation include: Omaveloxolone (DRUG).
Who is sponsoring clinical trial NCT07019064?
This trial is sponsored by Biogen, which has 334 total clinical trials registered on ClinicalTrials.gov.
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