Healthy VolunteerPhase 1NCT07149415
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 testing Omaveloxolone and Omeprazole in people with Healthy Volunteer, run by Biogen at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- Omaveloxolone and Omeprazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Sep 2025to 16 Oct 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- All female participants of childbearing potential must have negative results for pregnancy tests as follows:
- At screening, based on a serum sample obtained within 28 days prior to initial study drug administration; and
- Prior to dosing, based on a serum sample obtained on Study Day -1.
- Body mass index (BMI) at screening between 18 and 32 kilograms per square meter (kg/m^2), inclusive.
Who cannot join
- History of any clinically significant cardiac, endocrine, gastrointestinal, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, or renal disease, or other major disease, as determined by the Investigator.
- Clinically significant, as determined by the Investigator, 12-lead electrocardiogram (ECG) abnormalities.
- History of, or positive test result at Screening for, human immunodeficiency virus (HIV).
- History of hepatitis C infection or positive test result at Screening for hepatitis C virus antibody (HCV Ab).
- Current hepatitis B infection [defined as positive for hepatitis B surface antigen (HBsAg) and/or total anti-HBc]. Participants with immunity to hepatitis B from previous natural infection (defined as negative HBsAg, positive anti-HBc, and positive anti-HBs) or vaccination (defined as negative HBsAg, negative anti-HBc, and positive anti-HBs) are eligible to participate in the study.
- Chronic, recurrent, or serious infection (e.g., pneumonia, septicemia, and herpes simplex virus), as determined by the Investigator, within 90 days prior to Screening or between Screening and Day -1.
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- Symptoms of bacterial, fungal, or viral infection (including upper respiratory tract infection) within 14 days prior to Screening or between Screening and Day -1. Participants with local fungal infection (e.g., candidiasis, tinea) are eligible to be rescreened after successful treatment of the infection.
- Prior exposure to omaveloxolone.
- NOTE: Other protocol-defined inclusion/exclusion criteria may apply.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read more
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.
Read the detailed description
The primary objective of this study is to assess the effect of omaveloxolone on the pharmacokinetics (PK) of omeprazole in healthy adult participants.
The secondary objective of this study is to assess the effect of omaveloxolone on the PK of omeprazole and to assess the safety and tolerability of a single dose administered alone and when administered concurrently with omeprazole to healthy adult participants.
- Conditions
- Healthy Volunteer
- Being tested
- Omaveloxolone, Omeprazole
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OmaveloxoloneDrug
Also called BIIB141, RTA-408
Oral capsules
OmeprazoleDrug
Oral tablet
| Study group | Role | What they receive |
|---|---|---|
| Period 1: Omeprazole | Experimental | Participants will receive a single oral dose of omeprazole on Day 1. Receives: Drug: Omeprazole |
| Period 2: Omaveloxolone + Omeprazole | Experimental | Participants will receive omaveloxolone from Days 2 to 15, followed by both omaveloxolone and omeprazole on Day 16. Receives: Drug: Omaveloxolone; Drug: Omeprazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Plasma Concentration-Time Curve From Time Zero to Last Measurable Concentration (AUC0-t) of Omeprazole
Measured: Pre-dose and at multiple timepoints post-dose on Days 1, 2, 16 and 17
Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of Omeprazole
Measured: Pre-dose and at multiple timepoints post-dose on Days 1, 2, 16 and 17
Secondary outcomes (5)
Maximum Observed Plasma Concentration (Cmax) of Omeprazole
Measured: Pre-dose and at multiple timepoints post-dose on Days 1, 2, 16 and 17
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Measured: From Day 1 up to end of the study (Up to Day 17)
Number of Participants With Clinically Significant Change From Baseline in Laboratory Abnormalities
Measured: From Day 1 up to end of the study (Up to Day 17)
Number of Participants With Change From Baseline in Clinically Relevant Abnormalities in Vital Sign Parameters
Measured: From Day 1 up to end of the study (Up to Day 17)
Number of Participants With Change From Baseline in Clinically Relevant Abnormalities in Electrocardiogram (ECG) Parameters
Measured: From Day 1 up to end of the study (Up to Day 17)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2025
- Study start2 Sep 2025
- Primary completion16 Oct 2025
- Study completion16 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteerStudies of the same condition, open and under way.
- More trials run by BiogenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biogen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Biogen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07149415
- Sponsor's protocol ID
- 296HV104
- Status last verified
- Oct 2025
- First submitted
- 28 Aug 2025
- Last updated
- 23 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07149415
- Acronym / sponsor ID
- 296HV104
- Conditions
- Healthy Volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Study start
- 2 Sep 2025 (actual)
- Primary completion
- 16 Oct 2025 (actual)
- Study completion
- 16 Oct 2025 (actual)
- First posted
- 2 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The primary objective of this study is to assess the effect of omaveloxolone on the pharmacokinetics (PK) of omeprazole in healthy adult participants.
The secondary objective of this study is to assess the effect of omaveloxolone on the PK of omeprazole and to assess the safety and tolerability of a single dose administered alone and when administered concurrently with omeprazole to healthy adult participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Period 1: Omeprazole | Experimental | Drug: OmeprazoleParticipants will receive a single oral dose of omeprazole on Day 1. |
| Period 2: Omaveloxolone + Omeprazole | Experimental | Drug: Omaveloxolone, Drug: OmeprazoleParticipants will receive omaveloxolone from Days 2 to 15, followed by both omaveloxolone and omeprazole on Day 16. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- All female participants of childbearing potential must have negative results for pregnancy tests as follows:
- Body mass index (BMI) at screening between 18 and 32 kilograms per square meter (kg/m^2), inclusive.
Key exclusion criteria (9 listed)
- History of any clinically significant cardiac, endocrine, gastrointestinal, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, or renal disease, or other major disease, as determined by the Investigator.
- Clinically significant, as determined by the Investigator, 12-lead electrocardiogram (ECG) abnormalities.
- History of, or positive test result at Screening for, human immunodeficiency virus (HIV).
- History of hepatitis C infection or positive test result at Screening for hepatitis C virus antibody (HCV Ab).
- Current hepatitis B infection [defined as positive for hepatitis B surface antigen (HBsAg) and/or total anti-HBc]. Participants with immunity to hepatitis B from previous natural infection (defined as negative HBsAg, positive anti-HBc, and positive anti-HBs) or vaccination (defined as negative HBsAg, negative anti-HBc, and positive anti-HBs) are eligible to participate in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OmaveloxoloneAlso: BIIB141, RTA-408Oral capsules | Drug | Period 2: Omaveloxolone + Omeprazole |
| OmeprazoleOral tablet | Drug | Period 1: Omeprazole, Period 2: Omaveloxolone + Omeprazole |
Primary outcome
Area Under the Plasma Concentration-Time Curve From Time Zero to Last Measurable Concentration (AUC0-t) of Omeprazole
Time frame: Pre-dose and at multiple timepoints post-dose on Days 1, 2, 16 and 17
Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of Omeprazole
Time frame: Pre-dose and at multiple timepoints post-dose on Days 1, 2, 16 and 17
5 secondary outcomes
Maximum Observed Plasma Concentration (Cmax) of Omeprazole
Time frame: Pre-dose and at multiple timepoints post-dose on Days 1, 2, 16 and 17
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: From Day 1 up to end of the study (Up to Day 17)
Number of Participants With Clinically Significant Change From Baseline in Laboratory Abnormalities
Time frame: From Day 1 up to end of the study (Up to Day 17)
Number of Participants With Change From Baseline in Clinically Relevant Abnormalities in Vital Sign Parameters
Time frame: From Day 1 up to end of the study (Up to Day 17)
Number of Participants With Change From Baseline in Clinically Relevant Abnormalities in Electrocardiogram (ECG) Parameters
Time frame: From Day 1 up to end of the study (Up to Day 17)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2025.
- Individual participant dataSharing planned: Yes. In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Biogen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Omaveloxolone and Omeprazole in people with Healthy Volunteer, run by Biogen at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area Under the Plasma Concentration-Time Curve From Time Zero to Last Measurable Concentration (AUC0-t) of Omeprazole (time frame: Pre-dose and at multiple timepoints post-dose on Days 1, 2, 16 and 17). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2025.