Clinical trial NCT06596356: A Mass Balance Study of TS-172 in Healthy Adult Subjects
Official title: A Phase 1 Mass Balance Study of TS-172 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: 2024-09-19
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: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* Japanese males aged \&gt;=20 and \&lt;40 years at the signing of informed consent
* Subjects whose body mass index (BMI) \&gt;=18.5 and \&lt;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

Primary outcomes:
measure: Radioactivity concentration in whole blood and plasma
timeFrame: Up to 240 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 240 hours after dosing
measure: Concentration of unchanged form and its major metabolites in plasma
timeFrame: Up to 240 hours after dosing
measure: Percentage of unchanged form and metabolites to total radioactivity in plasma
timeFrame: Up to 240 hours after dosing
measure: Percentage of unchanged form and metabolites to total radioactivity in urine and faeces
timeFrame: Up to 240 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 Director
role: STUDY_DIRECTOR
References: