Yogurt or capsule? study tests new way to take FA drug
NCT ID NCT07019064
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This study looked at how the body processes the drug omaveloxolone (SKYCLARYS®) when taken as a whole capsule versus when the capsule contents are sprinkled over low-fat yogurt. 52 healthy adults took the drug both ways to see if the body absorbs it differently. The goal is to offer people with Friedreich's Ataxia another easy option for taking their medication.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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52 people
The number who actually took part.
- Started
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Jun 2025
- Finished
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Aug 2025
- Lead sponsor
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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
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18 to 55 years
- Sex
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Anyone
- Healthy volunteers
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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: * 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 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 * 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 * 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
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Genom att skicka in godkänner du våra Användarvillkor
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Trialmed formerly PPD, Austin Clinic
Austin, Texas, 78744, United States
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