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Healthy VolunteerPhase 1NCT07019064

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 testing Omaveloxolone in people with Healthy Volunteer, run by Biogen at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. 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
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
52 participants
Where
1 siteUnited States
Study dates
11 Jun 2025to 19 Aug 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

  • Body Mass Index (BMI) at screening between 18 and 32 kilograms per meter square (kg/m^2), inclusive
  • Must be in good health as determined by the Investigator, based on medical history and Screening evaluations

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
  • History of, or ongoing, malignant disease (with exceptions for completely excised basal cell carcinomas and squamous cell carcinomas cured at least 1 year prior to Day -1)
  • Systolic blood pressure > 150 millimeters of mercury (mmHg) or < 90 mmHg after sitting for 5 minutes
  • Clinically significant, as determined by the Investigator, 12-lead electrocardiogram (ECG) abnormalities
  • Corrected QT interval > 450 milliseconds (ms) for males and > 460 ms for females
  • Positive diagnostic tuberculosis test result within 30 days of Enrollment
Show all 16Show fewer
  • History of, or positive test result for human immunodeficiency virus (HIV)
  • History of hepatitis C infection or positive test result for hepatitis C virus antibody (HCV Ab)
  • Current hepatitis B infection
  • Any value for alanine aminotransferase, aspartate aminotransferase, bilirubin, or serum creatinine above the upper limit of normal
  • Platelets below the lower limit of normal
  • Any clinically significant value out of normal range for total white blood cells
  • Prior exposure to the study treatment
  • Use of prescription medication (excluding oral contraceptives and hormone replacement therapy), over-the-counter oral medication that alters hepatic or renal clearance, or nutraceuticals within 28 days prior to Day -1
  • Use of other over-the-counter oral medication, vitamins, dietary supplements, or antacids within 14 days prior to Day -1
  • NOTE: Other protocol-defined Inclusion/Exclusion criteria may apply

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Trialmed formerly PPD, Austin Clinic

    Austin, Texas, 78744

Other trials in United States

About this study

Official title: A Phase 1, Randomized, Open-label, Single-dose, Crossover, Relative Bioavailability Study of Omaveloxolone Intact Capsules Versus Capsule Contents Sprinkled Over Low-fat, Non-Greek Yogurt in Healthy Adult Subjects

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 :

Read more
  • 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 take a single dose of BIIB141 as a capsule.
  • Each participant will be in the study for up to 57 days.
Read the detailed description

The primary objective of the study is to assess the relative bioavailability of omaveloxolone capsules when administered as either intact capsules or capsule contents sprinkled over low-fat, non-Greek yogurt in healthy adult participants. The secondary objective of the study is to evaluate the safety and tolerability of a single dose of omaveloxolone administered as either an intact capsule or sprinkled over low-fat, non-Greek yogurt in healthy adult participants.

Being tested
Omaveloxolone

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OmaveloxoloneDrug

    Also called BIIB141

    Administered as specified in the treatment arm.

Study groups in NCT07019064
Study groupRoleWhat they receive
Treatment Sequence ABExperimentalParticipants will receive treatment A (omaveloxolone capsule orally on Day 1) followed by treatment B (omaveloxolone capsule content sprinkled over low-fat, non-Greek yogurt on Day 15).
Receives: Drug: Omaveloxolone
Treatment Sequence BAExperimentalParticipants will receive treatment B (omaveloxolone capsule content sprinkled over low-fat, non-Greek yogurt on Day 1) followed by treatment A (omaveloxolone capsule orally on Day 15).
Receives: Drug: Omaveloxolone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximum Observed Plasma Concentration (Cmax) of Omaveloxolone

    Measured: Pre-dose and at multiple time points post dose up to Day 29

  2. Area Under the Concentration-Time Curve From Time Zero to Time of the Last Measurable Concentration (AUC0-t) of Omaveloxolone

    Measured: Pre-dose and at multiple time points post dose up to Day 29

  3. Area Under the Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of Omaveloxolone

    Measured: Pre-dose and at multiple time points post dose up to Day 29

Secondary outcomes (2)

  1. Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Measured: From Day 1 up to end of study (up to 29 days)

  2. Number of Participants with Abnormalities in Clinical Laboratory Assessments, Vital Signs, and Electrocardiogram (ECGs)

    Measured: From Day 1 up to end of study (up to 29 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jun 2025
  2. Study start11 Jun 2025
  3. Primary completion19 Aug 2025
  4. Study completion19 Aug 2025

Resources

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
Randomised
Intervention model
Crossover
Model description
This 2-way crossover study will be conducted in 2 Periods with a washout period of 14 days.
Masking
None (open label)
Enrolment
52 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07019064
Sponsor's protocol ID
296HV103
Status last verified
Sep 2025
First submitted
5 Jun 2025
Last updated
22 Sep 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/

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Omaveloxolone 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 2 inclusion and 16 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 22 Sep 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?

Maximum Observed Plasma Concentration (Cmax) of Omaveloxolone (time frame: Pre-dose and at multiple time points post dose up to Day 29). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07019064.

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 22 Sep 2025.

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