NIPH Clinical Trials Search

DS-5565 Clinical Pharmacology Study in Japanese Subjects with varying degrees of renal function

Basic Information

Recruitment status	completed
Health condition(s) or Problem(s) studied	Japanese Subjects with varying degrees of renal function
Date of first enrollment	24/07/2013
Target sample size	30
Countries of recruitment	Japan
Study type	Interventional
Intervention(s)	investigational material(s) Generic name etc : DS-5565 INN of investigational material : mirogabalin Therapeutic category code : 119 Other agents affecting central nervous system Dosage and Administration for Investigational material : A oral single dose (one 5-mg tablet) control material(s) Generic name etc : - INN of investigational material : - Therapeutic category code : Dosage and Administration for Investigational material : -

Outcome(s)

Primary Outcome	pharmacokinetics Pharmacokinetic and Safety To evaluate pharmacokinetic endpoints according to the free form of DS-5565 in plasma. To evaluate safety endpoints according to the adverse events, vital signs, 12-lead ECGs and laboratory values.
Secondary Outcome	-

Key inclusion & exclusion criteria

Age minimum	>= 20age old
Age maximum	Not applicable
Gender	Both
Include criteria	-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
Exclude criteria	-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)