A phase 1, randomized, placebo-controlled, double-blind, multiple oral dose study of DS-8500a in Japanese healthy male subjects
Phase 1
- Conditions
- Healthy volunteers
- Registration Number
- JPRN-jRCT2080223495
- Lead Sponsor
- DAIICHI SANKYO CO., LTD.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- Male
- Target Recruitment
- 36
Inclusion Criteria
1)Japanese male
2)Persons >= 20 years and =< 45 years of age at the time of informed consent
3)Persons with a body mass index (BMI; calculated by body weight [kg]/height [m]2) of >= 18.5 kg/m2 and < 25.0 kg/m2 at the screening examination
Exclusion Criteria
1)Persons with hypersensitivity or idiosyncratic reactions to a drug, (such as penicillin allergy)
2)Persons with drug or alcohol dependence
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method