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Clinical pharmacology study of FYX-051 for subjects with renal insufficiency

Clinical pharmacology study of FYX-051 for subjects with renal insufficiency

Status
Unknown
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2080221510
Enrollment
Unknown
Registered
2011-07-11
Start date
2011-07-11
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

Subjects with renal insufficiency

Interventions

investigational material(s) Generic name etc : FYX-051 INN of investigational material : topiroxostat Therapeutic category code : 394 Agents for treatment of gout Dosage and Administration for Investi

Sponsors

Fuji Yakuhin Co., Ltd.
Lead Sponsor
SANWA KAGAKU KENKYUSHO Co., Ltd.
Collaborator

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: Subjects belonging to the following criteria of inulin clearance (Cin) Normal group (Cin: 90mL/min/1.73m^2 or more), Slightly-decreased group (Cin: 60mL/min/1.73m^2 or more, 90mL/min/1.73m^2 under), Moderately-decreased group (Cin: 30mL/min/1.73m^2 or more, 60mL/min/1.73m^2 under),

Exclusion criteria

Exclusion criteria: Subject with disease of gut, heart and liver Subject with surgical history of apparatus digestorius (gut, liver, gallbladder, bile duct, pancreas and so on) and kidney Subject with AST(GOT) or ALT(GPT) of 100IU/L or more

Design outcomes

Primary

MeasureTime frame
Pharmacokinetics Concentration of drug in the plasma—

Secondary

MeasureTime frame
Pharmacodynamics Concentration of uric acid in the plasma and urine—

Outcome results

None listed

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