臨床研究等提出・公開システム

Date of registration	July. 08, 2023
Last modified on	Mar. 25, 2025
Trial ID	jRCT2071230038

Scientific Title	A Phase I Clinical Study of NS-863 in Healthy Subjects
Public Title	A Phase I Clinical Study of NS-863 in Healthy Subjects

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		Aug. 08, 2023
Actual date of first enrollment		Aug. 08, 2023
Target sample size		158
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	double blind
	control	placebo control
	assignment	parallel assignment
	purpose	basic science
Key inclusion & exclusion 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	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	65age old not
	Gender	Both
Health Condition(s) or Problem(s) Studied		Healthy volunteer
Intervention(s)		1)Part A: Single administration Subjects receive single oral dose of NS-863 or placebo. 2)Part B:Food effect Subjects receive single oral dose of NS-863 under fasting and non-fasting condition. 3)Part C: Multiple administrations Subjects receive multiple oral doses of NS-863 or placebo.
Primary Outcome(s)		Pharmacokinetic, Safety, Tolerability

Primary Sponsor	Nippon Shinyaku Co., Ltd.

Name of Certified Review Board	Hakata Clinic Institutional Review Board
Address	6-18, Tenyamachi, Hakata-ku, Fukuoka 812-0025, Japan, Fukuoka
Telephone	+81-92-283-7701
Approval Status	Approval
Date of approval	July. 13, 2023

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
3	Mar. 25, 2025	(this page)	Changes
2	Sept. 24, 2023	Detail	Changes
1	July. 08, 2023	Detail

List of change history