Clinical Pharmacology Study of NS-229 in Healthy male subjects (Phase I Study) (Drug-Drug Interaction Study with Prednisolone)

JRCT ID: jRCT2051210094

Registered date:30/09/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: inflammatory diseases
• Date of first enrollment: 13/10/2021
• Target sample size: 20
• Study type: Interventional

Intervention(s)

Day 1:Prednisolone will be orally administered.
Day 3-8:NS-229 will be orally administered once a day
Day 9:NS-229 and Prednisolone will be orally administered at the same time

Outcome(s)

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

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 who may have latent tuberculosis, including subjects who have already been infected with tuberculosis
3) Subjects who are contraindicated for predonisolone

Related Information

• Primary Sponsor: Higashioka Masaya