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

NCT06596356 | Completed Phase 1

• 1 other identifier: TS172-02-02
• 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-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

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (1)

[14C] TS-172

EXPERIMENTAL

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

Drug: [14C] TS-172

Interventions

[14C] TS-172 DRUG

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

[14C] TS-172

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 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Taisho Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Taisho Pharmaceutical Co., Ltd selected site

Tokyo, Japan

Location

Study Officials

• Taisho Director

  Taisho Pharmaceutical Co., Ltd.

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: September 2, 2024
• First Posted: September 19, 2024
• Study Start: September 26, 2024
• Primary Completion: October 28, 2024
• Study Completion: October 28, 2024
• Last Updated: February 28, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)