DS-5565 Clinical Pharmacology Study in Japanese Subjects with varying degrees of renal functio
- Conditions
- Japanese Subjects with varying degrees of renal function
- Registration Number
- JPRN-jRCT2080222129
- Lead Sponsor
- DAIICHISANKYO Co.,Ltd.
- Brief Summary
The AUClast increased with severity of renal impairment. It was notably greater for the subjects with ESRD than that for normal renal function. The CL/F and CLR decreased with severity of renal impairment. A single 5-mg oral dose of DS-5565 was considered to be well tolerated in subjects with normal renal function, mild renal impairment, moderate renal impairment, or severe renal impairment. In subjects with ESRD, it was also considered to be tolerated, but with a relatively high incidence of TEAEs.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 30
Japanese with renal function impairment (Estimated CLcr [mL/min/1.73 m2] by Cockcroft-Gault Formula within the categories as follows; Normal renal function [CLcr > 80], Mild renal impairment [50 =< CLcr =< 80], Moderate renal impairment [30 =< CLcr =< 50], Severe renal impairment [CLcr < 30], End-stage renal disease [patients undergoing hemodialysis regardless of CLcr])
-between the age of 20 or more
-between the BMI of 18.5 and 30.0
-A history of serious diseases caused by disorders of the central nervous system, circulatory system, respiratory system, blood/hematopoietic system, gastrointestinal system, hepatic and renal function, thyroid function, pituitary gland function, adrenal function, etc., and the judgment of the investigator or subinvestigator that participation in the clinical study could pose a risk to the subject's safety
-Presence or history of drug allergies or idiosyncratic drug response (such as to penicillin)
-History of drug or alcohol abuse
-Inappropriateness for inclusion into the study as judged by the investigator or subinvestigator (for example, subjects who may have difficulty in visiting the study center or ensuring compliance)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method