JPRN-jRCT2080222129已完成1 期
DS-5565 Clinical Pharmacology Study An Open-Label, Single-Dose Study to Assess the Pharmacokinetics and Safety of DS-5565 in Japanese Subjects with varying degrees of renal function
DAIICHISANKYO Co.,Ltd.0 个研究点目标入组 30 人开始时间: 2013年6月28日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •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
排除标准
- •-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)
研究者
相似试验
已完成
1 期
STUDY OF PF-06882961 IN PARTICIPANTS WITH TYPE 2 DIABETES MELLITUS WITH VARYING DEGREES OF RENAL IMPAIRMENT AND PARTICIPANTS WITHOUT RENAL IMPAIRMENTRenal ImpairmentHealthyDiabetes Mellitus, Type 2NCT04616027Pfizer42
Enrolling By Invitation
不适用
The Effect of Education Based on Orem's Self-Care Deficit Theory and Tele-Monitoring on Rational Drug Use in Haemodialysis PatientsHaemodialysisNCT06689228Akdeniz University70
已完成
1 期
Pharmacokinetic Study of Aztreonam-Avibactam in Severe Renal ImpairmentRenal InsufficiencyNCT04486625Pfizer11
已完成
1 期
Pharmacokinetics and Safety Study of Cabazitaxel in Cancer Patients With Renal ImpairmentNeoplasm MalignantNCT01527929Sanofi25
已完成
1 期
A Phase l Study to Evaluate the Pharmacokinetics and Safety Pasireotide in Subjects With Varying Degrees of Renal Impairment Compared to Healthy VolunteersRenal ImpairmentNCT01578928Novartis Pharmaceuticals50