Clinical Pharmacology Study of NS-863 in Healthy female subjects (Phase I Study) (Drug-Drug Interaction Study with triazolam and combined oral contraceptive)

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

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2071240098

Enrollment

Registered

2025-01-17

Start date

2025-02-07

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

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

Eligibility

Sex/Gender

Female

Inclusion 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

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

Design outcomes

Primary

Measure	Time frame
Plasma concentrations and PK parameters of triazolam Plasma concentrations and PK parameters of combined oral contraceptive Plasma concentrations and PK parameters of NS-863	—

Contacts

Public ContactClinical Development Operations

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