A Phase 1 Study of CS-3150 Evaluation of Safety, Pharmacokinetics, and Pharmacodynamics after Multiple Oral Administration in Japanese Healthy Adult Male Subjects
Phase 1
Completed
- Conditions
- Healthy volunteers
- Registration Number
- JPRN-jRCT2080223421
- Lead Sponsor
- DAIICHI SANKYO Co.,Ltd.
- Brief Summary
Esaxerenone was well tolerated in multiple oral administration of the drug at doses of 10 mg to 100 mg once daily for 10 days in Japanese healthy male subjects.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- Male
- Target Recruitment
- 40
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 safety<br>Safety, pharmacokinetics and Pharmacodynamics
- Secondary Outcome Measures
Name Time Method