Clinical Pharmacology study for AS-3201 in hepatic impairment subjects

Status

Unknown

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080222664

Enrollment

Registered

2014-11-21

Start date

2014-11-21

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

hepatic impairment subjects

Interventions

investigational material(s) Generic name etc : AS-3201 (ranirestat) INN of investigational material : ranirestat Therapeutic category code : 129 Other agents affecting peripheral nervous system Dosage

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria: - Subjects who have a serious complication - Subjects who received an AS-3201 Etc.

Design outcomes

Primary

Measure	Time frame
Pharmacokinetics Cmax, AUC, etc.	—

Secondary

Measure	Time frame
Safety Clinical laboratory test, vital sign, 12-lead ECG, etc.	—

Outcome results

None listed

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