A phase 1, randomized, placebo-controlled, double-blind, multiple oral dose study of DS-8500a in Japanese healthy male subjects

Status

Unknown

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080223495

Enrollment

Registered

2017-03-30

Start date

2017-03-30

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

Male

Inclusion criteria

Inclusion criteria: 1)Japanese male 2)Persons >= 20 years and == 18.5 kg/m2 and < 25.0 kg/m2 at the screening examination

Exclusion criteria

Exclusion criteria: 1)Persons with hypersensitivity or idiosyncratic reactions to a drug, (such as penicillin allergy) 2)Persons with drug or alcohol dependence

Design outcomes

Primary

Measure	Time frame
Safety and Pharmacokinetics	—

Outcome results

None listed

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