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

NCT ID: NCT04814771

Last Updated: 2025-02-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-19
• Study Completion Date: 2021-05-19

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.

Conditions

Healthy Male Subjects

Study Design

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

Study Groups

[14C] TS-142

Participants will receive oral \[14C\] TS-142 under fasted conditions

Group Type: EXPERIMENTAL

[14C] TS-142

Intervention Type: DRUG

Subjects received single dose of 7.5 mg of TS-142 containing 20 kBq \[14C\]TS-142 as an oral solution

Interventions

[14C] TS-142

Subjects received single dose of 7.5 mg of TS-142 containing 20 kBq \[14C\]TS-142 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 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

• 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 Direcoter

Role: STUDY_DIRECTOR

Taisho Pharmaceutical Co., Ltd.

Locations

Taisho Pharmaceutical Co., Ltd selected site

Tokyo, , Japan

Countries

Japan

Other Identifiers

TS142-206

Identifier Type: -

Identifier Source: org_study_id