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Completed

NCT Number: NCT04814771

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

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.

Completed

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Key information

Conditions

Healthy Male Subjects

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 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 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
  • Other protocol defined exclusion criteria could apply

Treatment and study plan

[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

Primary outcomes

  1. Radioactivity concentration in whole blood and plasma

    Time frame: Up to 168 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 168 hours after dosing

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

    Time frame: Up to 168 hours after dosing

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

    Time frame: Up to 168 hours after dosing

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

    Time frame: Up to 168 hours after dosing

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

    Time frame: Up to 168 hours after dosing

Sponsors and collaborators

Lead sponsor

Taisho Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

Mass Balance Recovery, Pharmacokinetics, Metabolite Identification and Profiling of 14C-labeled TS-142 in Healthy Adult Subjects.

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Mar 24, 2021
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.

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