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Mass balance study of TS-142 in healthy adult subjects.

Mass balance study of TS-142 in healthy adult subjects.

6

Age(years):Mean+-SD 32.2+-3.8, Body Weight(kg):Mean+-SD 66.58+-6.52, BMI:Mean+-SD 22.28+-1.17

A total of 6 subjects completed the study.

Adverse events were reported in all of 6 subjects who received the investigational drug.

[14C]TS-142 was rapidly absorbed and excreted,and the mean cumulative excretion rates of radioactivity in urine and feces were favorable. Radioactive unchanged compound was not detected in either urine or feces. The major component of radioactivity in plasma was parent compound. No metabolites were found with portion greater than 10% for total radioactivity.

[14C]TS-142 was rapidly absorbed and excreted,and the mean cumulative excretion rates of radioactivity in urine and feces were favorable. Radioactive unchanged compound was not detected in either urine or feces. The major component of radioactivity in plasma was parent compound. No metabolites were found with portion greater than 10% for total radioactivity. Single dose of [14C]TS-142 was found to be safe and well tolerated.

No

https://jrct.mhlw.go.jp/latest-detail/jRCT2031210027

Mita Seiji

Taisho Pharmaceutical Co., LTD.

3-24,1, Takada, Toshima-Ku, Tokyo

shu_chiken@taisho.co.jp

Development Management Development Headquarters

Taisho Pharmaceutical Co., LTD.

3-24,1, Takada, Toshima-Ku, Tokyo

+81-3-3985-1118

shu_chiken@taisho.co.jp

Complete

April. 14, 2021

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

- 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

- 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

Male

Insomnia

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

- 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 TS-142 and metabolites to total radioactivity in plasma
- Percentage of TS-142 and metabolites to total radioactivity in urine and faeces
- Metabolite profiling and structural identification of metabolites in plasma, urine and faeces

+81-42-625-5216

Mar. 15, 2021

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