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 function

Status

Unknown

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080223081

Enrollment

Registered

2016-01-18

Start date

2016-01-18

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

Subjects with hepatic or renal impairment

Interventions

investigational material(s) Generic name etc : DS-8500a INN of investigational material : Therapeutic category code : 396 Antidiabetic agents Dosage and Administration for Investigational material :

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: [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 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

Exclusion criteria

Exclusion criteria: [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

Design outcomes

Primary

Measure	Time frame
Pharmacokinetics and safety	—

Outcome results

None listed

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