NIPH Clinical Trials Search

Basic Information

Recruitment status
Health condition(s) or Problem(s) studied	Subjects with renal insufficiency
Date of first enrollment	11/07/2011
Target sample size
Countries of recruitment
Study type	Interventional
Intervention(s)	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 Investigational material : 80mg

Outcome(s)

Primary Outcome	Pharmacokinetics Concentration of drug in the plasma
Secondary Outcome	Pharmacodynamics Concentration of uric acid in the plasma and urine

Key inclusion & exclusion criteria

Age minimum	>= 20age old
Age maximum	<= 64age old
Gender	Male
Include 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),
Exclude 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