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 functio
- Conditions
- Subjects with hepatic or renal impairment
- Registration Number
- JPRN-jRCT2080223081
- Lead Sponsor
- DAIICHI SANKYO CO., LTD.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 48
[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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pharmacokinetics and safety
- Secondary Outcome Measures
Name Time Method