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.
The primary objective of this study is to assess the effect of omaveloxolone on the pharmacokinetics (PK) of omeprazole in healthy adult participants. The secondary objective of this study is to assess the effect of omaveloxolone on the PK of omeprazole and to assess the safety and tolerability of a single dose administered alone and when administered concurrently with omeprazole to healthy adult participants.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
22
Oral capsules
Oral tablet
Austin Clinical Research Unit
Austin, Texas, United States
Area Under the Plasma Concentration-Time Curve From Time Zero to Last Measurable Concentration (AUC0-t) of Omeprazole
Time frame: Pre-dose and at multiple timepoints post-dose on Days 1, 2, 16 and 17
Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of Omeprazole
Time frame: Pre-dose and at multiple timepoints post-dose on Days 1, 2, 16 and 17
Maximum Observed Plasma Concentration (Cmax) of Omeprazole
Time frame: Pre-dose and at multiple timepoints post-dose on Days 1, 2, 16 and 17
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: From Day 1 up to end of the study (Up to Day 17)
Number of Participants With Clinically Significant Change From Baseline in Laboratory Abnormalities
Time frame: From Day 1 up to end of the study (Up to Day 17)
Number of Participants With Change From Baseline in Clinically Relevant Abnormalities in Vital Sign Parameters
Time frame: From Day 1 up to end of the study (Up to Day 17)
Number of Participants With Change From Baseline in Clinically Relevant Abnormalities in Electrocardiogram (ECG) Parameters
Time frame: From Day 1 up to end of the study (Up to Day 17)
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