Mass Balance Study of NS-229 in Healthy Adult Males (Phase I)

JRCT ID: jRCT2071240076

Registered date:18/11/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Healthy volunteer
• Date of first enrollment: 19/12/2024
• Target sample size: 8
• Study type: Interventional
• Intervention(s): [14C]NS-229 will be orally administered in single dose.

Outcome(s)

• Primary Outcome: Pharmacokinetics and safety of NS-229

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 40age 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 (including tuberculosis, pneumonia, pneumocystis pneumonia, sepsis, opportunistic infections)
2) Medically problematic values of activated partial thromboplastin time (APTT) or prothrombin timeinternational
normalized ratio (PT-INR) at screening
3) Subjects with a history of blood disease

Related Information

• Primary Sponsor: Higashioka Masaya