Pharmacokinetic study of SK-1405 in subjects with or without hepatic impairment

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080223781

Enrollment

Registered

2018-01-19

Start date

2018-01-22

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

Interventions

investigational material(s) Generic name etc : SK-1405 INN of investigational material : - Therapeutic category code : 119 Other agents affecting central nervous system Dosage and Administration for I

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Capable of giving written consent to participate in the study from oneself - BMI: equal to or more than 18.5, and less than 30.0 (exclusive); at the screening - (Only in subjects with hepatic impairment) Diagnosed to have cirrhosis etc.

Exclusion criteria

Exclusion criteria: - Use of contraindicated drug - History of surgery on digestive disease - Mental disease - Severe heart disease - Severe allergy - Complication or hisoty of drug dependence - Habit of excessive drinking of alcohol etc.

Design outcomes

Primary

Measure	Time frame
other - Pharmacokinetics - Drug concentrations - Pharmacokinetic parameters	—

Secondary

Measure	Time frame
safety - Safety	—

Countries

Japan

Outcome results

None listed

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