Healthy volunteers help uncover drug interactions for FA treatment
NCT ID NCT07149415
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 Hide 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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