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

A Phase 1 Mass Balance Study of TS-172 in Healthy Adult Subjects

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.

Study Overview

• Status: Completed
• Conditions: Healthy Male Subjects
• Intervention / Treatment: Drug: [14C] TS-172

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Phase 1

Contacts and Locations

Study Locations

• Japan
  • Tokyo, Japan
    • Taisho Pharmaceutical Co., Ltd selected site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: [14C] TS-172; Participants will receive oral [14C] TS-172 under fasted conditions	Drug: [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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Taisho Pharmaceutical Co., Ltd.
• Investigators: Study Director: Taisho Director, Taisho Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): September 26, 2024
• Primary Completion (Actual): October 28, 2024
• Study Completion (Actual): October 28, 2024

Study Registration Dates

• First Submitted: September 2, 2024
• First Submitted That Met QC Criteria: September 10, 2024
• First Posted (Actual): September 19, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 26, 2025
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: TS172-02-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No