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

Phase 1

• Conditions: Insomnia

• Registration Number: JPRN-jRCT2031210027
• Lead Sponsor: Mita Seiji

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-04-09
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Male
• Target Recruitment: 6

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified