A Phase I Clinical Study of NS-245 in Healthy Subjects

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2071250086

Enrollment

157

Registered

2025-10-17

Start date

2025-11-11

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

1) Part A: Single administration Subjects receive single oral dose of NS-245 or placebo. 2) Part B:Food effect Subjects receive single oral dose of NS-245 under fasting and non-fasting condition. 3)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Provided written informed consent 2) Japanese male subjects 3) White male subjects 4) Japanese female subjects of non-childbearing potential

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
Pharmacokinetic, Safety, Tolerability	—

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