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

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2071220066

Enrollment

130

Registered

2022-11-02

Start date

2022-11-11

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy volunteer

Interventions

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

Eligibility

Sex/Gender

Female

Inclusion criteria

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

Exclusion criteria

Exclusion 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

Design outcomes

Primary

Measure	Time frame
Pharmacokinetic, Safety, Tolerability	—

Contacts

Public ContactOperations Clinical

Nippon Shinyaku Co., Ltd.

zz_mail_clinical-trials@po.nippon-shinyaku.co.jp+81-120-40-8930

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026