DS-8500a midazolam DDI study

An open-label, non-randomized, single-sequence study to evaluate the effects of DS-8500a on the pharmacokinetics of midazolam in Japanese healthy subjects

Status

Unknown

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080222622

Enrollment

Registered

2014-10-07

Start date

2014-10-07

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: 1) Japanese 2) Between the age of 20 and 45 3) Between the BMI of 18.5 and 25.0 4) HbA1c < 6.5% 5) Between the fasting blood glucose level of 70 mg/dL and 109 mg/dL

Exclusion criteria

Exclusion criteria: 1) Presence or history of severe adverse reaction to any drug including midazolam or sensitivity. 2) Presence or history of drug or alcohol abuse. etc.

Design outcomes

Primary

Measure	Time frame
The PK parameters of midazolam	—

Secondary

Measure	Time frame
1) Other PK parameters of free form and metabolites of midazolam 2) The PK parameters of DS-8500a 3) Safety	—

Outcome results

None listed

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