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

NCT04814771 | Completed Phase 1

• 1 other identifier: TS142-206
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (6)

• Radioactivity concentration in whole blood and plasma

  Up to 168 hours after dosing

• Calculation of cumulative urinary and fecal recovery of total radioactivity, and calculation of mass balance as a sum of the percentages of total radioactivity recovered in urine and faeces

  Up to 168 hours after dosing

• Concentration of unchanged form and its major metabolites in plasma

  Up to 168 hours after dosing

• Percentage of TS-142 and metabolites to total radioactivity in plasma

  Up to 168 hours after dosing

• Percentage of TS-142 and metabolites to total radioactivity in urine and faeces

  Up to 168 hours after dosing

• Metabolite profiling and structural identification of metabolites in plasma, urine and faeces

  Up to 168 hours after dosing

Study Arms (1)

[14C] TS-142

EXPERIMENTAL

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

Drug: [14C] TS-142

Interventions

[14C] TS-142 DRUG

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

[14C] TS-142

Eligibility Criteria

• Age: 20 Years - 39 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Taisho Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Taisho Pharmaceutical Co., Ltd selected site

Tokyo, Japan

Location

MeSH Terms

Interventions

TS-142

Study Officials

• Taisho Direcoter

  Taisho Pharmaceutical Co., Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2021
• First Posted: March 24, 2021
• Study Start: April 19, 2021
• Primary Completion: May 19, 2021
• Study Completion: May 19, 2021
• Last Updated: February 28, 2025

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)