Drug-drug interaction study of NS-580 in Healthy male subjects (Phase I Study)

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2071220031

Enrollment

Registered

2022-07-26

Start date

2022-08-18

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

Subjects receives single or multiple oral doses of NS-580 and combination drugs (itraconazole, caffeine, triazolam, and rosuvastatin).

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 with a history of drug and food allergies and hypersensitivity 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 are contraindicated for itraconazole, caffeine, triazolam, and rosuvastatin

Design outcomes

Primary

Measure	Time frame
PK parameters (AUC0-t and Cmax) of NS-580 and combination drugs (itraconazole, caffeine, triazolam, and rosuvastatin).	—

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