Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| [14C] TS-142 | Experimental | Participants will receive oral [14C] TS-142 under fasted conditions |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [14C] TS-142 | Drug | Subjects received single dose of 7.5 mg of TS-142 containing 20 kBq [14C]TS-142 as an oral solution |
|
| Measure | Description | Time Frame |
|---|---|---|
| Radioactivity concentration in whole blood and plasma | 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 | Up to 168 hours after dosing | |
| Concentration of unchanged form and its major metabolites in plasma | Up to 168 hours after dosing | |
| Percentage of TS-142 and metabolites to total radioactivity in plasma | Up to 168 hours after dosing | |
| Percentage of TS-142 and metabolites to total radioactivity in urine and faeces | Up to 168 hours after dosing | |
| Metabolite profiling and structural identification of metabolites in plasma, urine and faeces | Up to 168 hours after dosing |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Taisho Direcoter | Taisho Pharmaceutical Co., Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Taisho Pharmaceutical Co., Ltd selected site | Tokyo | Japan |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| C000723815 | TS-142 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided