A mass balance study of TS-172 in healthy adult subjects

JRCT ID: jRCT2031240318

Registered date:04/09/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Hyperphosphatemia
• Date of first enrollment: 26/09/2024
• Target sample size: 6
• Study type: Interventional
• Intervention(s): Subjects received single dose of about 30 mg of TS-172 containing 1 MBq [14C]TS-172 as an oral solution

Outcome(s)

Primary Outcome

- Radioactivity concentration in whole blood and plasma
- 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
- Concentration of unchanged form and its major metabolites in plasma
- Percentage of unchanged form and metabolites to total radioactivity in plasma
- Percentage of unchanged form and metabolites to total radioactivity in urine and faeces
- Metabolite profiling and structural identification of metabolites in plasma, urine and faeces

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 39age old
• Gender: Male

Include 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

Exclude 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

Related Information

• Primary Sponsor: Mita Seiji