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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 :
This study will be done as follows:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Period 1: Omeprazole | Experimental | Participants will receive a single oral dose of omeprazole on Day 1. |
|
| Period 2: Omaveloxolone + Omeprazole | Experimental | Participants will receive omaveloxolone from Days 2 to 15, followed by both omaveloxolone and omeprazole on Day 16. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Omaveloxolone | Drug | Oral capsules |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Plasma Concentration-Time Curve From Time Zero to Last Measurable Concentration (AUC0-t) of Omeprazole | 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 | Pre-dose and at multiple timepoints post-dose on Days 1, 2, 16 and 17 |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) of Omeprazole | 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) | From Day 1 up to end of the study (Up to Day 17) |
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Key Inclusion Criteria:
All female participants of childbearing potential must have negative results for pregnancy tests as follows:
Body mass index (BMI) at screening between 18 and 32 kilograms per square meter (kg/m^2), inclusive.
Key Exclusion Criteria:
NOTE: Other protocol-defined inclusion/exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Biogen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Austin Clinical Research Unit | Austin | Texas | 78744 | United States |
In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/
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| Omeprazole | Drug | Oral tablet |
|
| Number of Participants With Clinically Significant Change From Baseline in Laboratory Abnormalities | 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 | 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 | From Day 1 up to end of the study (Up to Day 17) |
| ID | Term |
|---|---|
| C000589490 | omaveloxolone |
| D009853 | Omeprazole |
| ID | Term |
|---|---|
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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