A Phase I Clinical Study of NS-161 in Healthy Female Subjects

JRCT ID: jRCT2071220066

Registered date:02/11/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Healthy volunteer
• Date of first enrollment: 11/11/2022
• Target sample size: 130
• Study type: Interventional

Intervention(s)

1)Part A: Single administration
Subjects receive single oral dose of NS-161 or placebo.
2)Part B:Food effect
Subjects receive single oral dose of NS-161 under fasting and non-fasting condition.
3)Part C: Multiple administrations
Subjects receive multiple oral doses of NS-161 or placebo once daily for 7 days.

Outcome(s)

• Primary Outcome: Pharmacokinetic, Safety, Tolerability

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 45age old
• Gender: Female

Include criteria

1) Provided written informed consent
2) Japanese female subjects
3) White female subjects
4) Body mass index (BMI) >=17.6 and <25.0 kg/m2 (Japanese) and >=17.6 and <30.0 kg/m2 (White) at the time of screening tests and hospitalization

Exclude criteria

1) Sublects 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

Related Information

• Primary Sponsor: Higashioka Masaya