Clinical Pharmacology Study of NS-229 in Healthy male subjects (Phase I Study) (Drug-Drug Interaction Study with Prednisolone)

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2051210094

Enrollment

Registered

2021-09-30

Start date

2021-10-13

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

inflammatory diseases

Interventions

Day 1:Prednisolone will be orally administered. Day 3-8:NS-229 will be orally administered once a day Day 9:NS-229 and Prednisolone will be orally administered at the same time

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: 1) Provided written informed consent 2) Japanese male subjects 3) Body mass index (BMI) >=18.5 and <25.0 kg/m2 at the time of screening tests and hospitalization

Exclusion criteria

Exclusion criteria: 1) Subjects with active systemic infections 2) Subjects who may have latent tuberculosis, including subjects who have already been infected with tuberculosis 3) Subjects who are contraindicated for predonisolone

Design outcomes

Primary

Measure	Time frame
PK parameters of Prednisolone (AUC0-t and Cmax)	—

Contacts

Public ContactClinical Operations

Nippon Shinyaku Co., Ltd.

zz_mail_clinical-trials@po.nippon-shinyaku.co.jp+81-120-40-8930

Outcome results

None listed

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