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

Phase 1

Completed

• Conditions: Healthy Male Subjects
• Interventions: Drug: [14C] TS-172

• Registration Number: NCT06596356
• Lead Sponsor: Taisho Pharmaceutical Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-09-02
• Study First Submitted QC: 2024-09-10
• Study First Posted: 2024-09-19
• Study Start: 2024-09-26
• Primary Completion: 2024-10-28
• Study Completion: 2024-10-28
• Status Verified: 2024-11
• Last Update Submitted: 2025-02-26
• Last Update Posted: 2025-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 6

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Radioactivity concentration in whole blood and plasma	Up to 240 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 240 hours after dosing
Concentration of unchanged form and its major metabolites in plasma	Up to 240 hours after dosing
Percentage of unchanged form and metabolites to total radioactivity in plasma	Up to 240 hours after dosing
Percentage of unchanged form and metabolites to total radioactivity in urine and faeces	Up to 240 hours after dosing

Trial Locations

Locations (1)

Taisho Pharmaceutical Co., Ltd selected site; 🇯🇵 Tokyo, Japan