An open-label, single-dose study to evaluate the pharmacokinetics and safety of DS-8500a in Japanese subjects with varying degrees of hepatic or renal function

DAIICHI SANKYO CO., LTD.0 个研究点目标入组 48 人开始时间: 2016年1月18日最近更新: 2023年10月17日

适应症

试验速览

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•[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  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

•[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

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