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

JRCT ID: jRCT2071230038

Registered date:08/07/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Healthy volunteer
• Date of first enrollment: 08/08/2023
• Target sample size: 158
• Study type: Interventional

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.

Outcome(s)

• Primary Outcome: Pharmacokinetic, Safety, Tolerability

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 65age old
• Gender: Both

Include criteria

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

Exclude 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

Related Information

• Primary Sponsor: Higashioka Masaya