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In 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 :
This study will be done as follows:
The primary objective of the study is to assess the relative bioavailability of omaveloxolone capsules when administered as either intact capsules or capsule contents sprinkled over low-fat, non-Greek yogurt in healthy adult participants. The secondary objective of the study is to evaluate the safety and tolerability of a single dose of omaveloxolone administered as either an intact capsule or sprinkled over low-fat, non-Greek yogurt 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 capsule content sprinkled over low-fat, non-Greek yogurt on Day 15). |
|
| Treatment Sequence BA | Experimental | Participants will receive treatment B (omaveloxolone capsule content sprinkled over low-fat, non-Greek yogurt on Day 1) followed by treatment A (omaveloxolone capsule orally on Day 15). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Omaveloxolone | Drug | Administered as specified in the treatment arm. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) of Omaveloxolone | Pre-dose and at multiple time points post dose up to Day 29 | |
| Area Under the Concentration-Time Curve From Time Zero to Time of the Last Measurable Concentration (AUC0-t) of Omaveloxolone | Pre-dose and at multiple time points 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 time points 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 29 days) | |
| Number of Participants with Abnormalities in Clinical Laboratory Assessments, Vital Signs, and Electrocardiogram (ECGs) |
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Key Inclusion Criteria:
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 Clinic | 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 with a washout period of 14 days.
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| From Day 1 up to end of study (up to 29 days) |
| ID | Term |
|---|---|
| C000589490 | omaveloxolone |
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