臨床研究等提出・公開システム

Date of registration	Jan. 17, 2025
Last modified on	Oct. 06, 2025
Trial ID	jRCT2071240098

Scientific Title	Clinical Pharmacology Study of NS-863 in Healthy female subjects (Phase I Study) (Drug-Drug Interaction Study with triazolam and combined oral contraceptive) (NS863-P1-02)
Public Title	Clinical Pharmacology Study of NS-863 in Healthy female subjects (Phase I Study) (Drug-Drug Interaction Study with triazolam and combined oral contraceptive) (NS863-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		Feb. 01, 2025
Actual date of first enrollment		Feb. 07, 2025
Target sample size		30
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 female subjects 3) Body mass index (BMI) >=17.6 and <25.0 kg/m2 at the time of screening tests and hospitalization
	Exclusion Criteria	1) Subjects who are pregnant, may become pregnant, or wish to become pregnant during the trial period 2) Subjects who are breastfeeding 3) Subjects who have not confirmed a regular menstrual cycle at the time of screening test 4) Subjects who are irregular bleeding
	Age Minimum	20age old over
	Age Maximum	40age old not
	Gender	Female
Health Condition(s) or Problem(s) Studied		Healthy volunteer
Intervention(s)		Day 1 of first period: Triazolam will be orally administered in single dose. Second period: COC will be orally administered in multiple doses. Day1-16 of Third period: COC will be orally administered in multiple doses. Day1, 5 and 23 of Third period: Triazolam will be orally administered in single dose. Day3-23 of Third period: NS-863 will be orally administered in multiple doses.
Primary Outcome(s)		Plasma concentrations and PK parameters of triazolam Plasma concentrations and PK parameters of combined oral contraceptive Plasma concentrations and PK parameters of NS-863

Primary Sponsor	Nippon Shinyaku Co., Ltd.

Secondary Sponsor

Secondary Sponsor

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
E-Mail	miyako-koga@lta-med.com
Approval Status	Approval
Date of approval	Jan. 16, 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	Feb. 28, 2025	Detail	Changes
1	Jan. 17, 2025	Detail

List of change history