Clinical Pharmacology study for AS-3201 in hepatic impairment subjects
Phase 1
- Conditions
- hepatic impairment subjects
- Registration Number
- JPRN-jRCT2080222664
- Lead Sponsor
- Sumitomo Dainippon Pharma Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 18
Inclusion Criteria
- Subjects who provided written voluntary consent to participate in the study
- Child-Pugh class A or B (hepatic impairment subjects)
- 45.0 kg < body weight < 80.0 kg and 18.5 < BMI <30.0 kg/m2
Etc.
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.