臨床研究等提出・公開システム

Date of registration	Jan. 24, 2025
Last modified on	Oct. 06, 2025
Trial ID	jRCT2031240632

Scientific Title	Clinical Pharmacology Study of NS-025 in Healthy male subjects (Phase I Study) (Drug-Drug Interaction Study with triazolam) (NS025-P1-02)
Public Title	Clinical Pharmacology Study of NS-025 in Healthy male subjects (Phase I Study) (Drug-Drug Interaction Study with triazolam) (NS025-P1-02)

Contact for Scientific Queries	Name	Higashioka Masaya
	Affiliation	Nippon Shinyaku Co., Ltd.
	Address	14, Nishinosho-Monguchi-cho, Kisshoin, Minami-ku, Kyoto
	Telephone	+81-120-40-8930
	E-mail	zz_mail_clinical-trials@po.nippon-shinyaku.co.jp
Contact for Public Queries	Name	Clinical Development Operations
	Affiliation	Nippon Shinyaku Co., Ltd.
	Address	14, Nishinosho-Monguchi-cho, Kisshoin, Minami-ku, Kyoto
	Telephone	+81-120-40-8930
	E-mail	zz_mail_clinical-trials@po.nippon-shinyaku.co.jp

Recruitment status	Complete

Anticipated date of first enrollment		Mar. 01, 2025
Actual date of first enrollment		Mar. 06, 2025
Target sample size		25
Study Type		Interventional
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	uncontrolled control
	assignment	single assignment
	purpose	other
Key inclusion & exclusion 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	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
	Age Minimum	20age old over
	Age Maximum	45age old not
	Gender	Male
Health Condition(s) or Problem(s) Studied		Healthy volunteer
Intervention(s)		Day 1: Triazolam will be orally administered in single dose. Day 2-22: NS-025 will be orally administered in multiple doses. Day 2, 8, 22: NS-025 and Triazolam will be orally administered in single dose at the same time.
Primary Outcome(s)		Plasma concentrations of NS-025 Plasma concentrations and PK parameters of Triazolam

Primary Sponsor	Nippon Shinyaku Co., Ltd.

Name of Certified Review Board	Review Board of Human Rights and Ethics for Clinical Studies Institutional Review Board
Address	2-2-1, Kyobashi, Chuo-ku, Tokyo
Telephone	+81-3-6665-0572
E-Mail	soudan@hurecs.org
Approval Status	Approval
Date of approval	Feb. 14, 2025

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
3	Oct. 06, 2025	(this page)	Changes
2	April. 16, 2025	Detail	Changes
1	Jan. 24, 2025	Detail

List of change history