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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
8
\[14C\]-Omaveloxolone 50 mg capsules
Covance Clinical Research Unit (CRU) Inc.
Madison, Wisconsin, United States
Maximum concentration (Cmax) of omaveloxolone
Pharmacokinetics will be assessed by blood sampling for omaveloxolone to determine maximum observed concentration (Cmax).
Time frame: 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).
Time frame: 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
Time frame: 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.
Time frame: 22 days
Amount of radioactivity excreted in urine (Aeu)
Rates and routes of elimination will be assessed by urine sampling for radioactivity.
Time frame: 22 days
Amount of radioactivity excreted in feces (Aef)
Rates and routes of elimination will be assessed by sampling of feces for radioactivity.
Time frame: 22 days
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