A Mass Balance Study of TS-172 in Healthy Adult Subjects

Taisho Pharmaceutical

Status and phase

Completed

Phase 1

Conditions

Healthy Male Subjects

Treatments

Drug: [14C] TS-172

Study type

Interventional

Funder types

Industry

Identifiers

NCT06596356

TS172-02-02

Details and patient eligibility

About

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 of single oral dose of [14C] TS-172 in Japanese healthy male subjects.

Enrollment

6 patients

Sex

Male

Ages

20 to 39 years old

Volunteers

Accepts Healthy Volunteers

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 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 criteria

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