Clinical Pharmacology Study of NS-229 in Healthy female subjects (Phase I Study) (Drug-Drug Interaction Study with combined oral contraceptive)

JRCT ID: jRCT2071240058

Registered date:17/09/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Healthy volunteer
• Date of first enrollment: 11/10/2024
• Target sample size: 25
• Study type: Interventional

Intervention(s)

Day 1:Combined oral contraceptive will be orally administered in single dose.
Day 6-23:NS-229 will be orally administered in multiple doses.
Day 19:NS-229 and combined oral contraceptive will be orally administered in single dose at the same time.

Outcome(s)

Primary Outcome

Plasma concentrations and PK parameters of combined oral contraceptive
Plasma concentrations and PK parameters of NS-229

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 40age old
• Gender: Female

Include criteria

1) Provided written informed consent
2) Japanese female subjects
3) Body mass index (BMI) >=18.5 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