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
Public ClinicalTrials.gov record NCT07149415. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 1, Open-Label, Single-Sequence, 2-Period, Drug-Drug Interaction Study in Healthy Participants Evaluating the Effect of Omaveloxolone on the Pharmacokinetics of CYP2C19 Substrate, Omeprazole
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 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 45 days.
Study identification
- NCT ID
- NCT07149415
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 22 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 55 Years
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 1, 2025
- Primary completion
- Oct 15, 2025
- Completion
- Oct 15, 2025
- Last update posted
- Oct 22, 2025
2025
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Austin Clinical Research Unit | Austin | Texas | 78744 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07149415, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 22, 2025 · Synced Sep 7, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT07149415 live on ClinicalTrials.gov.