Clinical pharmacology study of Tofogliflozin in patients with hepatic impairment

Clinical pharmacology study of Tofogliflozin (CSG452) in patients with hepatic impairment

Status

Unknown

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080221650

Enrollment

Registered

2011-11-11

Start date

2011-11-11

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

Type 2 diabetes

Interventions

investigational material(s) Generic name etc : Tofogliflozin INN of investigational material : Tofogliflozin Therapeutic category code : 396 Antidiabetic agents Dosage and Administration for Investiga

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients with hepatic impairment -Is suspected of having hepatic cirrhosis based on the results of ultrasonography or a CT scan -Has moderate hepatic impairment (Class B) according to the Child-Pugh Classification Subjects with normal hepatic function -Is a healthy subject

Exclusion criteria

Exclusion criteria: -Has moderate or severe renal impairment -Has or is suspected of having diabetes -Has been administered any of the medicines, foods and drinks that can affect the pharmacokinetics of Tofogliflozin within two weeks before administration Etc.

Design outcomes

Primary

Measure	Time frame
Pharmacokinetics, Safety	—

Outcome results

None listed

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