DS-8500a Food Effect Study

An Open-Label, 3-Way Crossover Study to Evaluate the Effect of Food on the Pharmacokinetics of DS-8500a in Japanese Healthy Subjects

Status

Unknown

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080223244

Enrollment

Registered

2016-06-16

Start date

2016-06-16

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

Healthy Volunteers

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: -Japanese -Between the age of 20 and 45 -Between the BMI of 18.5 and 25.0 -HbA1c < 6.5%

Exclusion criteria

Exclusion criteria: -Hypersensitivity or idiosyncratic reactions to a drug (such as penicillin allergy) -People with drug or alcohol dependence. etc

Design outcomes

Primary

Measure	Time frame
-Plasma concentrations and derived PK parameters for DS-8500a and a metabolite of DS-8500a.	—

Secondary

Measure	Time frame
-Safety.	—

Outcome results

None listed

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