Mass Balance Study of TS-142 in Healthy Adult Subjects.

Taisho Pharmaceutical

Status and phase

Completed

Phase 1

Conditions

Healthy Male Subjects

Treatments

Drug: [14C] TS-142

Study type

Interventional

Funder types

Industry

Identifiers

NCT04814771

TS142-206

Details and patient eligibility

About

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.

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 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 exclusion criteria could apply