DS-8500a atorvastatin DDI study

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

Status

Unknown

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080222826

Enrollment

Registered

2015-04-23

Start date

2015-04-23

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 40 3. Between the BMI of 18.5 and 25.0 4. HbA1c < 6.5% 5. Fasting blood glucose level within the reference range of a site

Exclusion criteria

Exclusion criteria: 1. Presence or history of hypersensitivity or idiosyncratic reaction (penicillin allergy etc,) to a drug including atorvastatin. 2. Presence or history of drug or alcohol dependence. etc.

Design outcomes

Primary

Measure	Time frame
The PK parameters of atorvastatin	—

Secondary

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

Outcome results

None listed

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