Healthy volunteer and subjects with renal impairement
Conditions
Interventions
Day 1: NS-863 will be orally administered in single dose.
Sponsors
Higashioka Masaya
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion 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
Exclusion criteria
Exclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Contacts
Public ContactOperations Clinical
Nippon Shinyaku Co., Ltd.
Outcome results
None listed