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A Study to Learn if Taking BIIB141 (Omaveloxolone) Affects How Omeprazole is Processed in the Body and About BIIB141's Safety in Healthy Adults Aged 18 to 55

NCT07149415 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2025-10-23

No results posted yet for this study

Summary

In this study, researchers will learn more about BIIB141, also known as omaveloxolone or SKYCLARYS®. 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. This is called a "drug-drug interaction" study. In this kind of study, researchers are looking at what happens when 2 or more medicines affect each other in the body. This could change how 1 or both of the drugs work, either making them stronger, weaker, or causing health problems.

The main goal of this study is to learn if taking BIIB141 affects how omeprazole is processed in the body. Omeprazole is a commonly used medicine to help lower the amount of acid the stomach makes.

The main question researchers want to answer in this study is :

• How does the body process omeprazole when taken with BIIB141?

Researchers will also learn more about :

* How many participants have adverse events during the study. An adverse event is a health problem that may or may not be caused by the study drug.
* 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 17 days.
* This is an "open label" study. In this kind of study, the participants, study doctor, and site staff know which study drug the participant is taking. In this study, all participants took BIIB141 and omprezole.
* Participants will take omeprazole on Day 1 and Day 16. They will also take BIIB141 once a day from Day 2 through Day 16.
* Throughout the study, researchers will take participants' blood and urine samples. Researchers will also do other tests to check the participants' overall health and will ask participants how they are feeling.
* Each participant will be in the study for up to 45 days.

Conditions

  • Healthy Volunteer

Interventions

DRUG

Omaveloxolone

Oral capsules

DRUG

Omeprazole

Oral tablet

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Biogen

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-09-02
Primary Completion
2025-10-16
Completion
2025-10-16
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07149415 on ClinicalTrials.gov