NIPH Clinical Trials Search

Basic Information

Recruitment status
Health condition(s) or Problem(s) studied	Subjects with hepatic or renal impairment
Date of first enrollment	18/01/2016
Target sample size	48
Countries of recruitment
Study type	Interventional
Intervention(s)	investigational material(s) Generic name etc : DS-8500a INN of investigational material : Therapeutic category code : 396 Antidiabetic agents Dosage and Administration for Investigational material : Oral

Outcome(s)

Primary Outcome	Pharmacokinetics and safety
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum	>= 20age old
Age maximum	Not applicable
Gender	Both
Include criteria	[Subjects must meet ALL of the following criteria for inclusion in the study] 1)Japanese male and female subjects, >= 20 years of age inclusive and with weight >= 45 kg for males and >= 40 kg for females and BMI < 30.0 kg/m2, inclusive, at screening. [In addition, subjects with normal and impaired hepatic functions must fulfill the following criteria] 2)AST/ALT or Estimated Child-Pugh Grade at screening within the categories shown below Normal hepatic function: AST/ALT < 2 &#61620; ULN at screening Mild hepatic impairment: Child-Pugh Grade A, score 5 - 6 Moderate hepatic impairment: Child-Pugh Grade B, score 7 - 9 [In addition, subjects with normal and renal impaired functions must fulfill the following criteria] 3)Estimated eGFR(mL/min/1.73 m2) * within the categories shown below Normal renal function: eGFR > 90 Mild renal impairment: 60 =< eGFR < 90 Moderate renal impairment: 30 =< eGFR < 60 Severe renal impairment: 15 =< eGFR < 30 End-stage renal disease: eGFR < 15 or patients undergoing hemodialysis * : calculated using the eGFRcreat Formula
Exclude criteria	[Subjects who meet any of the following criteria will be excluded from the study] 1)Presence or history of drug allergies or idiosyncratic drug response (such as to penicillin) 2)History of drug or alcohol abuse