Clinical trial NCT04814771: Mass Balance Study of TS-142 in Healthy Adult Subjects.
Official title: Mass Balance Recovery, Pharmacokinetics, Metabolite Identification and Profiling of 14C-labeled TS-142 in Healthy Adult Subjects.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Male Subjects
Lead sponsor: Taisho Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2021-03-24
Enrollment: 6
Sex: MALE
Minimum age (years): 20
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Radioactivity concentration in whole blood and plasma
timeFrame: Up to 168 hours after dosing
measure: 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
timeFrame: Up to 168 hours after dosing
measure: Concentration of unchanged form and its major metabolites in plasma
timeFrame: Up to 168 hours after dosing
measure: Percentage of TS-142 and metabolites to total radioactivity in plasma
timeFrame: Up to 168 hours after dosing
measure: Percentage of TS-142 and metabolites to total radioactivity in urine and faeces
timeFrame: Up to 168 hours after dosing
measure: Metabolite profiling and structural identification of metabolites in plasma, urine and faeces
timeFrame: Up to 168 hours after dosing
Secondary outcomes:
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Taisho Pharmaceutical Co., Ltd selected site
Study officials:
affiliation: Taisho Pharmaceutical Co., Ltd.
name: Taisho Direcoter
role: STUDY_DIRECTOR
References: