Clinical Pharmacology Study of NS-229 in Healthy male subjects (Phase I Study) (Drug-Drug Interaction Study with triazolam, itraconazole and rifampicin)

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2071250080

Enrollment

Registered

2025-09-30

Start date

2025-10-15

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 volunteer

Interventions

Step 1 Day 1, 15: Triazolam will be orally administered in single dose. Day 2-Day 15: NS-229 will be orally administered in multiple doses. Step 2 Day 1, 8: NS-229 will be orally administered in sing

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 a history of surgery which may have an impact on drug absorption 2) Subjects with a history of allergy or hypersensitivity to drugs or foods 3) Subjects who collected 200 mL or more of whole blood or component blood within 2 weeks before administration of the study drug 4) Subjects who have received other investigational products within 16 weeks (112 days) prior to the first investigational product administration

Design outcomes

Primary

Measure	Time frame
PK parameters (AUC0-t and Cmax) of NS-229 and combination drugs (triazolam, itraconazole and rifampicin).	—

Contacts

Public ContactOperations Clinical

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