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Yogurt or capsule? study tests new way to take FA drug

NCT ID NCT07019064

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 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.

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

52 people

The number who actually took part.

Started

Jun 2025

Finished

Aug 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: * 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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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 Clinic

    Austin, Texas, 78744, United States

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