Mass Balance Study of NS-229 in Healthy Adult Males (Phase I) (NS229-P1-03)
Not yet recruiting
- Conditions
- Healthy volunteer
- Registration Number
- jRCT2071240076
- Lead Sponsor
- Nippon Shinyaku Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Male
- Target Recruitment
- 8
Inclusion Criteria
- Provided written informed consent
- Japanese male subjects
- Body mass index (BMI) >=18.5 and <25.0 kg/m2 at the time of screening tests and hospitalization
Exclusion Criteria
- Subjects with active systemic infections (including tuberculosis, pneumonia, pneumocystis pneumonia, sepsis, opportunistic infections)
- Medically problematic values of activated partial thromboplastin time (APTT) or prothrombin timeinternational normalized ratio (PT-INR) at screening
- Subjects with a history of blood disease
Study & Design
- Study Type
- Interventional
- Study Design
- single assignment
- Primary Outcome Measures
Name Time Method - Pharmacokinetics and safety of NS-229
- Secondary Outcome Measures
Name Time Method