The purpose of this study is to determine the absorption and excretion kinetics of bardoxolone methyl and to determine and characterize metabolites present in plasma, urine and feces in men following a single oral does or 20 mg of \[14C\]-bardoxolone methyl.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
6
oral, single dose
Covance Clinical Research Unit
Madison, Wisconsin, United States
area under curve
Time frame: 0, 0.5, 1, 2, 3, 4, 6, 9, 12, 18, 24, 36, 48, 72, 96, and 120 hours after dose administration
radioactivity in plasma
Time frame: 0, 0.5, 1, 2, 3, 4, 6, 9, 12, 18, 24, 36, 48, 72, 96, and 120 hours after dose administration
metabolites of ]14C]-bardoxolone methyl
Time frame: 0, 0.5, 1, 2, 3, 4, 6, 9, 12, 18, 24, 36, 48, 72, 96, and 120 hours after dose administration
Plasma concentrations of cold bardoxolone methyl
Time frame: 0, 0.5, 1, 2, 3, 4, 6, 9, 12, 18, 24, 36, 48, 72, 96, and 120 hours after dose administration
radioactivity in urine
Time frame: 0 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 48, 48 to 72, 72 to 96, 96 to 120,120 to 144, 144 to 168, 168 to 192, 192 to 216, 216 to 240, 240 to 264, 264 to 288, and 288 to 312 hours after dose administration
radioactivity in feces
Time frame: 0 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 48, 48 to 72, 72 to 96, 96 to 120,120 to 144, 144 to 168, 168 to 192, 192 to 216, 216 to 240, 240 to 264, 264 to 288, and 288 to 312 hours after dose administration
radioactivity in whole blood
Time frame: 0, 0.5, 1, 2, 3, 4, 6, 9, 12, 18, 24, 36, 48, 72, 96, and 120 hours after dose administration
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