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

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

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080222129

Enrollment

Registered

2013-06-28

Start date

2013-07-24

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Japanese Subjects with varying degrees of renal function

Interventions

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 Administra

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion 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

Exclusion criteria

Exclusion 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)

Design outcomes

Primary

Measure	Time frame
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.	—

Countries

Japan

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026