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

Healthy Male Subjects Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04814771
• Other study ID #: TS142-206
• Status: Completed
• Phase: Phase 1
• Start date: April 19, 2021
• Est. completion date: May 19, 2021

Study information

• Verified date: June 2021
• Source: Taisho Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: May 19, 2021
• Est. primary completion date: May 19, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 39 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Male Subjects

Intervention

Drug:
• [14C] TS-142
Subjects received single dose of 7.5 mg of TS-142 containing 20 kBq [14C]TS-142 as an oral solution

Locations

Country	Name	City	State
Japan	Taisho Pharmaceutical Co., Ltd selected site	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Taisho Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Radioactivity concentration in whole blood and plasma		Up to 168 hours after dosing
Primary	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 168 hours after dosing
Primary	Concentration of unchanged form and its major metabolites in plasma		Up to 168 hours after dosing
Primary	Percentage of TS-142 and metabolites to total radioactivity in plasma		Up to 168 hours after dosing
Primary	Percentage of TS-142 and metabolites to total radioactivity in urine and faeces		Up to 168 hours after dosing
Primary	Metabolite profiling and structural identification of metabolites in plasma, urine and faeces		Up to 168 hours after dosing