Skip to main content
OpenTrials
Completed

NCT Number: NCT06596356

A 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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

20 year–39 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Taisho Pharmaceutical Co., Ltd selected site

Tokyo, Japan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

[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

Primary outcomes

  1. Radioactivity concentration in whole blood and plasma

    Time frame: Up to 240 hours after dosing

  2. 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

    Time frame: Up to 240 hours after dosing

  3. Concentration of unchanged form and its major metabolites in plasma

    Time frame: Up to 240 hours after dosing

  4. Percentage of unchanged form and metabolites to total radioactivity in plasma

    Time frame: Up to 240 hours after dosing

  5. Percentage of unchanged form and metabolites to total radioactivity in urine and faeces

    Time frame: Up to 240 hours after dosing

Sponsors and collaborators

Lead sponsor

Taisho Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Sep 19, 2024
Registry last updated
Feb 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.