NIPH Clinical Trials Search

Pharmacokinetic study of NS-863 in subjects with renal impairment (Phase I Study)

Basic Information

Recruitment status	Pending
Health condition(s) or Problem(s) studied	Healthy volunteer and subjects with renal impairement
Date of first enrollment	22/05/2026
Target sample size	14
Countries of recruitment
Study type	Interventional
Intervention(s)	Day 1: NS-863 will be orally administered in single dose.

Outcome(s)

Primary Outcome	1) Plasma concentration and PK parameters of NS-863 2) Plasma unbound fraction of NS-863 3) Urinary excretion rate and renal clearance of NS-863
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	< 65age old
Gender	Both
Include criteria	1) Provided written informed consent 2) Japanese subjects 3) eGFR(mL/min) at the time of screening and admission meets the following criteria Healthy volunteer: 90 or higher Moderate renal impairment: >=30 and < 60
Exclude criteria	1) Subjects with a history of surgery which may have an impact on drug absorption 2) Subjects with a history of allergy or hypersensitivity to drugs or foods 3) Subjects who collected 200 mL of whole blood or component blood within 2 weeks before administration of the study drug 4) Subjects who have received other investigational products within 16 weeks (112 days) prior to the first investigational product administration