Clinical Pharmacology study for AS-3201 in renal impairment subjects
Phase 1
- Conditions
- renal impairment subjects
- Registration Number
- JPRN-jRCT2080222701
- Lead Sponsor
- Sumitomo Dainippon Pharmaceuticals Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 24
Inclusion Criteria
-Subjects who provided written voluntary consent to participate in the study
-eGFR < 60 mL/min/1.73 m2 (renal impairment subjects)
-45.0 kg =< body weight =< 80.0 kg and 18.5 kg/m2 =< BMI <30.0 kg/m2
Exclusion Criteria
-Subjects who have a serious complication
-Subjects who received an AS-3201
Etc
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pharmacokinetics<br>Cmax, AUC, etc.
- Secondary Outcome Measures
Name Time Method Safety<br>Clinical laboratory test, vital sign, 12-lead ECG, etc.