Clinical Pharmacology Study of CS-3150 A single-dose study to assess the pharmacokinetics and safety of CS-3150 in Japanese subjects with varying degrees of hepatic functio
- Conditions
- Subjects with hepatic impairment
- Registration Number
- JPRN-jRCT2080223284
- Lead Sponsor
- DAIICHI SANKYO Co.,Ltd.
- Brief Summary
Comparing the PK with the normal hepatic function group, Cmax was similar in the mild hepatic impairment group, but AUC was slightly 0.8-fold lower. In the moderate hepatic impairment group, Cmax was slightly 0.8-fold lower, while AUC was slightly 1.1-fold greater. The current findings indicate that mild or moderate hepatic impairment has no effect on esaxerenone PK. A single 2.5-mg dose of esaxerenone can be safely administered to patients with mild or moderate hepatic dysfunction.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 18
1)Japanese male and female subjects, >= 20 years of age inclusive and with weight >= 45 kg for males and >= 40 kg for females and BMI < 30.0 kg/m2, inclusive, at screening.
2)AST/ALT or Estimated Child-Pugh Grade at screening within the categories shown below
Normal hepatic function: AST/ALT < 2 x ULN at screening
Mild hepatic impairment: Child-Pugh Grade A, score 5 - 6
Moderate hepatic impairment: Child-Pugh Grade B, score 7 - 9
1)Presence or history of drug allergies or idiosyncratic drug response (such as to penicillin)
2)History of drug or alcohol abuse
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method safety<br>pharmacokinetics<br>Pharmacokinetics and safety
- Secondary Outcome Measures
Name Time Method