Status:
COMPLETED
A Mass Balance Study of TS-172 in Healthy Adult Subjects
Lead Sponsor:
Taisho Pharmaceutical Co., Ltd.
Conditions:
Healthy Male Subjects
Eligibility:
MALE
20-39 years
Phase:
PHASE1
Brief Summary
To assess the plasma pharmacokinetics, the routes extent of elimination, and the metabolites of TS-172 after single oral dose of \[14C\] TS-172 in Japanese healthy male subjects. To assess the safety...
Eligibility Criteria
Inclusion
- 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 or values outside the reference ranges 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
- Subjects who have been administered substances labelled with radioisotopes or exposed to high levels of radiation (e.g. CT scan, gastric X-ray, PET scan) within one year prior to dosing of the investigational drug.
- Occupationally exposed worker within one year prior to dosing of the investigational drug (e.g. workers who handle nuclear power or radioactive substances)
- 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 or 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 gastrointestinal ulcer, gastrectomy, gastroenterostomy or bowel resection
Key Trial Info
Start Date :
September 26 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 28 2024
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT06596356
Start Date
September 26 2024
End Date
October 28 2024
Last Update
February 28 2025
Active Locations (1)
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1
Taisho Pharmaceutical Co., Ltd selected site
Tokyo, Japan