To assess the plasma pharmacokinetics, the routes extent of elimination, and the metabolites of TS-142 after single oral dose of \[14C\] TS-142 in Japanese healthy male subjects. To assess the safety of single oral dose of \[14C\] TS-142 in Japanese healthy male subjects.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
6
Subjects received single dose of 7.5 mg of TS-142 containing 20 kBq \[14C\]TS-142 as an oral solution
Taisho Pharmaceutical Co., Ltd selected site
Tokyo, Japan
Radioactivity concentration in whole blood and plasma
Time frame: Up to 168 hours after dosing
Calculation of cumulative urinary and fecal recovery of total radioactivity, and calculation of mass balance as a sum of the percentages of total radioactivity recovered in urine and faeces
Time frame: Up to 168 hours after dosing
Concentration of unchanged form and its major metabolites in plasma
Time frame: Up to 168 hours after dosing
Percentage of TS-142 and metabolites to total radioactivity in plasma
Time frame: Up to 168 hours after dosing
Percentage of TS-142 and metabolites to total radioactivity in urine and faeces
Time frame: Up to 168 hours after dosing
Metabolite profiling and structural identification of metabolites in plasma, urine and faeces
Time frame: Up to 168 hours after dosing
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