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 function

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080223284

Enrollment

Registered

2016-08-04

Start date

2016-09-28

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Subjects with hepatic impairment

Interventions

investigational material(s) Generic name etc : CS-3150 INN of investigational material : esaxerenone Therapeutic category code : 214 Antihypertensives Dosage and Administration for Investigational mat

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 1)Presence or history of drug allergies or idiosyncratic drug response (such as to penicillin) 2)History of drug or alcohol abuse

Design outcomes

Primary

Measure	Time frame
safety pharmacokinetics Pharmacokinetics and safety	—

Countries

Japan

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026