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This study will assess the pharmacokinetics (PK), mass balance, metabolite profiles, and rates and routes of elimination of [14C] omaveloxolone and derived metabolites following administration as a single 150 mg (containing approximately 90 µCi) dose to healthy male subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy Male Subjects | Experimental | Single oral dose of 150 mg of [14C] omaveloxolone containing approximately 90 μCi as a capsule after an overnight fast of at least 10 hours. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [14C]-Omaveloxolone | Drug | [14C]-Omaveloxolone 50 mg capsules |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum concentration (Cmax) of omaveloxolone | Pharmacokinetics will be assessed by blood sampling for omaveloxolone to determine maximum observed concentration (Cmax). | 22 days |
| Area under the omaveloxolone concentration-time curve (AUC) | Pharmacokinetics will be assessed by blood sampling for omaveloxolone to determine area under the curve (AUC). | 22 days |
| Maximum concentration of total radioactivity in blood and plasma | Mass balance and metabolite profiles will be assessed by blood sampling for omaveloxolone to determine maximum concentration of total radioactivity | 22 days |
| Area under the concentration-time curve total radioactivity in blood and plasma | Mass balance and metabolite profiles will be assessed by blood sampling for total radioactivity to determine area under the concentration-time curve. | 22 days |
| Amount of radioactivity excreted in urine (Aeu) | Rates and routes of elimination will be assessed by urine sampling for radioactivity. | 22 days |
| Amount of radioactivity excreted in feces (Aef) | Rates and routes of elimination will be assessed by sampling of feces for radioactivity. | 22 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nicholas Siebers, MD | Covance CRU Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Covance Clinical Research Unit (CRU) Inc. | Madison | Wisconsin | 53704 | United States |
In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/
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