Clinical Pharmacology Study of NS-580 in Healthy female subjects (Phase I Study)

JRCT ID: jRCT2071220011

Registered date:27/05/2022

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: endometriosis
• Date of first enrollment: 10/06/2022
• Target sample size: 64
• Study type: Interventional
• Intervention(s): Each subject receives a single oral dose of NS-580.

Outcome(s)

• Primary Outcome: PK parameters of NS-580 (AUC0-t and Cmax)

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) Body mass index (BMI) >=17.6 and <25.0 kg/m2 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