Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

New dissolvable tablet could make taking medication easier

NCT ID NCT07297199

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

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.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Healthy volunteer are added.

Vår säkerhetsrekommendation!

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

  • Trialmed formerly PPD, Austin Clinical Research Unit

    Austin, Texas, 78744, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.