Healthy volunteers help uncover drug interactions for FA treatment

NCT ID NCT07149415

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This completed Phase 1 study in 22 healthy volunteers looked at whether omaveloxolone (a drug for Friedreich's ataxia) changes how the body processes omeprazole (a common stomach acid reducer). Participants took omeprazole alone and then together with omaveloxolone over 17 days. Researchers measured drug levels in the blood and monitored safety to understand any interactions.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Omaveloxolone (also known as BIIB141 or SKYCLARYS) and omeprazole
What this could lead to
If successful, this study could help doctors understand how to safely prescribe omaveloxolone with other common drugs like omeprazole.
What could go wrong
This is a small, early-phase study in healthy people, not patients. It only looks at drug interactions, not whether the drug works for any disease.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

22 people

The number who actually took part.

Started

Sep 2025

Finished

Oct 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 55 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key Inclusion Criteria: * All female participants of childbearing potential must have negative results for pregnancy tests as follows: 1. At screening, based on a serum sample obtained within 28 days prior to initial study drug administration; and 2. 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. Key Exclusion Criteria: * 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. * 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.

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Austin Clinical Research Unit

    Austin, Texas, 78744, United States

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