臨床研究等提出・公開システム

A Phase I Clinical Study of NS-025 in Healthy Subjects

A Phase I Clinical Study of NS-025 in Healthy Subjects

Higashioka Masaya

Nippon Shinyaku Co., Ltd.

14, Nishinosho-Monguchi-cho, Kisshoin, Minami-ku, Kyoto

zz_mail_clinical-trials@po.nippon-shinyaku.co.jp

Clinical Development Operations

Nippon Shinyaku Co., Ltd.

14, Nishinosho-Monguchi-cho, Kisshoin, Minami-ku, Kyoto

+81-120-40-8930

zz_mail_clinical-trials@po.nippon-shinyaku.co.jp

Complete

Dec. 27, 2022

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

basic science

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

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

Both

Healthy volunteer

1)Part A: Single administration
Subjects receive single oral dose of NS-025 or placebo.
2)Part B: Food effect
Subjects receive single oral dose of NS-025 under fasting and non-fasting condition.
3)Part C: Multiple administrations
Subjects receive multiple oral doses of NS-025 or placebo once daily for 21 days.

Pharmacokinetic, Safety, Tolerability

+81-3-6665-0572

Dec. 05, 2022

No

none