CS-3150 midazolam DDI study
Phase 1
Completed
- Conditions
- Healthy volunteers
- Registration Number
- JPRN-jRCT2080222780
- Lead Sponsor
- DAIICHISANKYO Co.,Ltd.
- Brief Summary
Esaxerenone increased midazolam Cmax and AUC by approximately 1.2 fold compared to administration of midazolam alone. It was considered that there were no safety concerns when midazolam was administered concomitantly with esaxerenone.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- Male
- Target Recruitment
- 28
Inclusion Criteria
1. Male Japanese
2. Between the age of 20 and 45
3. Between the BMI of 18.5 and 24.9
4. Sitting blood pressure : systolic blood pressure < 140 mmHg, and diastolic blood pressure < 90 mmHg
5. Pulse rate <=99 bpm
Exclusion Criteria
1. Presence or history of hypersensitivity or idiosyncratic reaction (penicillin allergy etc.) to a drug including midazolam.
2. Presence or history of drug or alcohol dependence. etc.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method pharmacokinetics<br>The PK parameters of midazolam
- Secondary Outcome Measures
Name Time Method safety<br>pharmacokinetics<br>1. Other PK parameters of free form and metabolites of midazolam<br>2. The PK parameters of CS-3150<br>3. Safety