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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. Currently, BIIB141 is taken by mouth as capsules or capsule contents sprinkled over applesauce. But, there may be some people who have trouble swallowing capsules. In this study, the main goal was to learn if BIIB141 is processed similarly in the body of healthy adults when taken as tablets that dissolve in liquid compared to the currently available capsules.
The main question researchers want to answer in this study is :
• How does the body process BIIB141 when taken as a tablet dissolved in liquid compared to capsules?
Researchers will also learn more about:
This study will be done as follows:
The primary objective of the study is to assess the bioequivalence (BE) of omaveloxolone tablets for oral suspension (TOS) compared to capsules in healthy adult participants. The secondary objective of the study is to assess the safety and tolerability of a single dose of omaveloxolone when administered as TOS or capsule in healthy adult participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Sequence AB | Experimental | Participants will receive treatment A (omaveloxolone capsule orally) on Day 1 followed by treatment B (omaveloxolone TOS) on Day 15. |
|
| Treatment Sequence BA | Experimental | Participants will receive treatment B (omaveloxolone TOS) on Day 1 followed by treatment A (omaveloxolone capsule orally) on Day 15. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Omaveloxolone | Drug | Administered orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) of Omaveloxolone | Pre-dose and at multiple timepoints post-dose up to Day 29 | |
| Area Under the Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of Omaveloxolone | Pre-dose and at multiple timepoints post-dose up to Day 29 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | From Day 1 up to end of study (up to Day 29) | |
| Number of Participants With Clinically Significant Change From Baseline in Laboratory Abnormalities | From Day 1 up to end of study (up to Day 29) |
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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 meter square (kg/m^2), inclusive.
Participants must be in good health.
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 |
|---|---|---|---|---|---|---|
| Trialmed formerly PPD, 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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This 2-way crossover study will be conducted in 2 periods.
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| Number of Participants With Change From Baseline in Clinically Relevant Vital Sign Abnormalities | From Day 1 up to end of study (up to Day 29) |
| Number of Participants With Change From Baseline in Clinically Relevant Electrocardiogram (ECG) Abnormalities | From Day 1 up to end of study (up to Day 29) |
| ID | Term |
|---|---|
| C000589490 | omaveloxolone |
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