Healthy Male Subjects
Conditions
Brief summary
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.
Interventions
DRUG[14C] TS-142
Subjects received single dose of 7.5 mg of TS-142 containing 20 kBq \[14C\]TS-142 as an oral solution
Sponsors
Taisho Pharmaceutical Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
20 Years to 39 Years
Healthy volunteers
Yes
Inclusion criteria
* Japanese males aged \>=20 and \<40 years at the signing of informed consent * Subjects whose body mass index (BMI) \>=18.5 and \<25.0 kg/m2 at screening * Subjects who have no abnormal findings in the physical examination, vital signs, and standard 12-lead ECG in the screening test and the test on the day of admission and the test obtained prior to administration of the investigational drug, and whose clinical test results are within the standard values of the clinical trial site in the screening test and the test on the day of admission. However, if who showed abnormal findings but not clinically significant, they can be enrolled in clinical trials based on comprehensive consideration of medical viewpoints by the principal investigator(s) or subinvestigator(s). * Subjects who understand, and have willingness and ability to read and sign, the informed consent form
Exclusion criteria
* Subjects who have received a substance labeled with a radioisotope within the last 12 months prior to dosing of the investigational drug * Subjects who have been exposed to a large amount of radiation for therapeutic or diagnostic reasons (CT scan, stomach X-ray, PET scan etc.) within the last 12 months prior to dosing of the investigational drug * Occupationally exposed worker in the last 12 months prior to dosing of the investigational drug * Subjects who have had 3 days or less that one or more spontaneous defecations (defecation that occurs without laxatives, enemas, disimpaction) within 7 days before consent is obtained and during the 7 days until on the day of admission. Those who have diarrhea during the 7 days until on the day of admission * History of any disease or surgery which have impact on investigational drug absorption such as gastrectomy, gastroenterostomy or bowel resection * Other protocol defined
Design outcomes
Primary
| Measure | 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 |
Countries
Japan
Outcome results
None listed