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NCT07149415 · ClinicalTrials.gov registry record · Phase 1
A Study to Learn if Taking BIIB141 (Omaveloxolone) Affects How Omeprazole is Processed in the Body and About BIIB141's Safety in Healthy Adults Aged 18 to 55
A Phase 1 study, sponsored by Biogen.
- Completed
- Registry status
- Phase 1
- Development phase
- 22
- Enrollment target
NCT07149415: Completed Phase 1 study, sponsored by Biogen.
NCT07149415 is a Phase 1 study that has completed, run by Biogen. The registered enrollment target is 22 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (63% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07149415, a Phase 1 study, has completed, sponsored by Biogen.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 22 participants
- Enrollment target
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. This is called a "drug-drug interaction" study. In this kind of study, researchers are looking at what happens when 2 or more medicines affect each other in the body. This could change how 1 or both of the drugs work, either making them stronger, weaker, or causing health problems. The main goal of this study is to learn if taking BIIB141 affects how omeprazole is processed in the body. Omeprazole is a commonly used medicine to help lower the amount of acid the stomach makes. The main question researchers want to answer in this study is : • How does the body process omeprazole when taken with BIIB141? 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. * 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 17 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 took BIIB141 and omprezole. * Participants will take omeprazole on Day 1 and Day 16. They will also take BIIB141 once a day from Day 2 through Day 16. * Throughout the study, researchers will take participants' blood and urine samples. Researchers wi
Interventions
- DRUG Omeprazole
- DRUG Omaveloxolone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2025-09-02 |
| Est. Completion | 2025-10-16 |
| Phase | Phase 1 |
What the finished NCT07149415 record still lists
NCT07149415 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (63% lower).
The record links to 0 conditions, and to 2 interventions - of which Omeprazole is the first listed.
NCT07149415 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07149415 about?
NCT07149415 is a clinical study titled "A Study to Learn if Taking BIIB141 (Omaveloxolone) Affects How Omeprazole is Processed in the Body and About BIIB141's Safety in Healthy Adults Aged 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. This is called a "drug-drug interaction" study. In this...
What is the current status of trial NCT07149415?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 22 participants. The study started on 2025-09-02. Estimated completion is 2025-10-16.
What interventions are being tested in trial NCT07149415?
The interventions under investigation include: Omeprazole (DRUG), Omaveloxolone (DRUG).
Who is sponsoring clinical trial NCT07149415?
This trial is sponsored by Biogen, which has 334 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07149415's enrollment target sits among peer trials
22 1601st of 2000 higher than 386 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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