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| Name | Class |
|---|---|
| Celerion | INDUSTRY |
| Q2 Solutions | INDUSTRY |
| Altasciences Company Inc. | INDUSTRY |
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This is an open-label, single-sequence, 2-period crossover study in healthy subjects.
In this study, 20 subjects will be enrolled to allow at least 16 evaluable subjects.
Subjects will receive a single oral dose of 150 mg omaveloxolone (3 × 50 mg capsules) on Day 1 (Period 1) and on Day 29 (Period 2), and 600 mg efavirenz once a day from Days 15 through 42 (Period 2).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Omaveloxolone only (Period 1), Then Omaveloxolone and efavirenz (Period 2) | Experimental | Period 1 (Day 1 - 15): Omaveloxolone Capsules, 150 mg, administered orally in a single dose on Day 1 Period 2 (Day 15 - 43): Efavirenz Tablet, 600 mg, administered orally once daily from Day 15 - Day 42 and Omaveloxolone Capsules, 150 mg, administered orally in a single dose on Day 29 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Omaveloxolone | Drug | Omaveloxolone Capsules, 150 mg, administered orally |
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| Measure | Description | Time Frame |
|---|---|---|
| Maximum concentration (Cmax) of omaveloxolone | Blood samples to assess omaveloxolone PK will be collected predose and at the specified time points over a 336-hour period following each omaveloxolone dose for the duration of the study. | 43 days |
| Area under the plasma concentration-time curve from 0 to tlast (AUC0-tlas) of omaveloxolone | Blood samples to assess omaveloxolone PK will be collected predose and at the specified time points over a 336-hour period following each omaveloxolone dose for the duration of the study. | 43 days |
| Area under the plasma concentration-time curve from 0 extrapolated to infinity (AUC0-∞) of omaveloxolone | Blood samples to assess omaveloxolone PK will be collected predose and at the specified time points over a 336-hour period following each omaveloxolone dose for the duration of the study. | 43 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michelle Valentine, DO | Celerion | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Celerion, Inc. | Tempe | Arizona | 85283 | United States |
In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/
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| ID | Term |
|---|---|
| C000589490 | omaveloxolone |
| C098320 | efavirenz |
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| Efavirenz | Drug | Efavirenz Tablet, 600 mg, administered orally once daily |
|