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

NCT ID: NCT06596356

Last Updated: 2025-02-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-26
• Study Completion Date: 2024-10-28

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

Conditions

Healthy Male Subjects

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

[14C] TS-172

Participants will receive oral \[14C\] TS-172 under fasted conditions

Group Type: EXPERIMENTAL

[14C] TS-172

Intervention Type: DRUG

Subjects will receive single dose of about 30 mg of TS-172 containing 1 MBq \[14C\]TS-172 as an oral solution

Interventions

[14C] TS-172

Subjects will receive single dose of about 30 mg of TS-172 containing 1 MBq \[14C\]TS-172 as an oral solution

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 39 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Taisho Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Taisho Director

Role: STUDY_DIRECTOR

Taisho Pharmaceutical Co., Ltd.

Locations

Taisho Pharmaceutical Co., Ltd selected site

Tokyo, , Japan

Countries

Japan

Other Identifiers

TS172-02-02

Identifier Type: -

Identifier Source: org_study_id