Drug-drug interaction study of NS-580 in Healthy male subjects (Phase I Study)

JRCT ID: jRCT2071220031

Registered date:26/07/2022

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Healthy volunteer
• Date of first enrollment: 18/08/2022
• Target sample size: 60
• Study type: Interventional
• Intervention(s): Subjects receives single or multiple oral doses of NS-580 and combination drugs (itraconazole, caffeine, triazolam, and rosuvastatin).

Outcome(s)

• Primary Outcome: PK parameters (AUC0-t and Cmax) of NS-580 and combination drugs (itraconazole, caffeine, triazolam, and rosuvastatin).

Key inclusion & exclusion criteria

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

Include criteria

1) Provided written informed consent
2) Japanese male subjects
3) Body mass index (BMI) >=18.5 and <25.0 kg/m2 at the time of screening tests and hospitalization

Exclude criteria

1) Subjects with active systemic infections
2) Subjects with a history of drug and food allergies and hypersensitivity
3) Subjects who collected 200 mL or more of whole blood or component blood within 2 weeks before administration of the study drug
4) Subjects who are contraindicated for itraconazole, caffeine, triazolam, and rosuvastatin

Related Information

• Primary Sponsor: Higashioka Masaya