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Omaveloxolone

A Study to Learn How BIIB141 (Omaveloxolone) is Processed in the Body When Taken as Capsules Compared to Sprinkled on Yogurt in Healthy Adults Aged 18 to 55

Ensayo de BIOGEN INC. en Voluntarios sanos.

Fase

Fase 1

Estado

Completado

Participantes

52

previstos

Centros

1

Fin del objetivo primario

ago 2025

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, abierto. Comenzó en jun 2025.

Qué mide

Maximum Observed Plasma Concentration (Cmax) of Omaveloxolone (Pre-dose and at multiple time points post dose up to Day 29) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroIn this study, researchers will learn more about how BIIB141, also known as omaveloxolone or SKYCLARYS®, is processed in the body when taken in different ways. This drug has been approved, or made available for doctors to prescribe, for people with Friedrich's Ataxia (FA) who are at least 16 years old. Currently, people with FA can take it either as whole capsules or opening the capsules and sprinkling its contents over applesauce. The main goal of this study is to learn if BIIB141 is processed any differently when taken sprinkled over low-fat, non-Greek yogurt compared to whole capsules. This will help researchers learn if yogurt could be another option for people to take BIIB141 with. The main questions researchers want to answer in this study are : • How does the body process BIIB141 when taken as whole capsules compared to being sprinkled over yogurt? Researchers will also learn more about : * How many participants have adverse reactions during the study. An adverse reaction is a health problem that may be caused by the study drug. * If there are any changes in the participants' overall health during the study This study will be done as follows: * Participants will be screened to check if they can join the study. The screening period will be up to 28 days, after which participants will check into their study research center. * Participants will stay at the study research center for about 30 days. * This is a "crossover" study. In this kind of study, all participants receive the same 2 or more study drugs (or ways of taking the drug), but the order in which they receive them depends on the group they are randomly assigned to. * In Group 1, participants will take a single dose of BIIB141 as a capsule, followed by a break of 14 days. Then, the participants will take a single dose of BIIB141 sprinkled over yogurt. * In Group 2, participants will take a single dose of BIIB141 sprinkled over yogurt, followed by a break of 14 days. Then, the participants will take a single dose of BIIB141 as a capsule. * Each participant will be in the study for up to 57 days.

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Ficha completa en ClinicalTrials.gov (NCT07019064), actualizada en sep 2025.