A phase I study of TS-172 in healthy adult subjects (Single and Multiple doses)
Completed
- Conditions
- Healthy adult subjects
- Registration Number
- jRCT2071210043
- Lead Sponsor
- Taisho Pharmaceutical Co., LTD.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Male
- Target Recruitment
- 41
Inclusion Criteria
- Japanese healthy males aged 20 years or older but less than 40 years at the time of informed consent
- Those with a BMI of 18.5 or more and less than 25.0 at screening test
- Those who are able to receive the explanation before participating in the study, understand the content of the study, and provide written informed consent by the subjects themselves.
Exclusion Criteria
- Subjects who have any disease and are not considered healthy subjects based on the medical judgment of the principal investigator or sub-investigator.
- Those who correspond to any of the following about bowel movements;
- Repeated diarrhea (Bristol Stool Form Score [BSFS] score of 6 or higher) on a daily basis
- Repeated constipation (no defecation for 2 days or more in a week) on a daily basis
- Those who correspond to any of the following about bowel movements in the 7 days before administration;
- Diarrhea on 2 or more days in 7 days
- 2 or more days without a bowel movement in 7 days
- Those who have a history of gastrointestinal ulceration
- Those who correspond to any of the following about infection;
- Positive for SARS-CoV-2 in the nucleic acid amplification test performed at the time of admission
- Suspected of having COVID-19
Study & Design
- Study Type
- Interventional
- Study Design
- parallel assignment
- Primary Outcome Measures
Name Time Method - Safety, pharmacokinetics, and pharmacodynamics
- Secondary Outcome Measures
Name Time Method