New dissolvable tablet could make taking medication easier
NCT ID NCT07297199
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tested whether a tablet that dissolves in liquid works the same as the capsule form of the drug omaveloxolone (SKYCLARYS). The drug is already approved for Friedreich's ataxia, but some people have trouble swallowing capsules. Seventy healthy adults took both forms in random order, with a two-week break in between. Researchers measured how the drug moved through the body and checked for side effects.
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)
- What this could lead to
- If successful, this study could show that the tablet form works as well as the capsule, offering an easier way for people who have trouble swallowing capsules to take this medication.
- What could go wrong
- This is an early-phase study in healthy volunteers, not patients. It only checks how the drug is processed, not whether it works for any disease. Results may not apply to people with medical conditions.
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
-
70 people
The number who actually took part.
- Started
-
Dec 2025
- Finished
-
May 2026
- 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 meter square (kg/m\^2), inclusive. * Participants must be in good health. 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 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 \[defined as positive for hepatitis B surface antigen (HBsAg) and/or total hepatitis B core antibody (anti-HBc)\]. 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), as determined by the Investigator, within 90 days prior to Screening or between Screening and Day -1. * Prior exposure to the study treatment. * Any clinically significant abnormal laboratory test value as determined by the Investigator, as Screening or Day-1. 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
-
Trialmed formerly PPD, Austin Clinical Research Unit
Austin, Texas, 78744, United States
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