A Study of Absorption, Metabolism, Excretion of [14C]-NS-580 in Healthy Male Subjects
- Registration Number
- NCT06670898
- Lead Sponsor
- Nippon Shinyaku Co., Ltd.
- Brief Summary
The purpose of this study was to determine the absorption, metabolism, and excretion of radioactivity and to characterize and determine, where possible, the metabolites present in plasma, urine, and faeces in healthy male subjects following a single oral administration of \[14C\]-NS-580.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 8
- Males of any race, between 35 and 60 years of age, inclusive.
- Body mass index between 18.0 and 32.0 kg/m2, inclusive.
- History of a minimum of 1 bowel movement per day.
- Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, haematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the investigator (or designee).
- History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the investigator (or designee).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Administration of [14C] NS-580 [14C] NS-580 -
- Primary Outcome Measures
Name Time Method t1/2 of [14C] NS-580 in plasma and whole blood for Total Radioactivity Pre-dose up to 56 days post-dose t1/2 of \[14C\] NS-580 in plasma and whole blood
Renal clearance (CLR) of NS-580 Pre-dose up to 28 days post-dose CLR of NS-580 in plasma
Percentage of dose administered urine recovered (feu) of NS-580 Pre-dose up to 56 days post-dose feu of NS-580
Total radioactivity recovery Pre-dose up to 56 days post-dose Total radioactivity recovery in urine and faeces
Area under the concentration-time curve, from time 0 infinity (AUC0-inf) of NS-580 in plasma Pre-dose up to 28 days post-dose AUC0-inf of NS-580 in plasma
AUC0-inf of [14C] NS-580 in plasma and whole blood for Total Radioactivity Pre-dose up to 56 days post-dose AUC0-inf of \[14C\] NS-580 in plasma and whole blood
Area under the concentration-time curve from time 0 to the time of the last quantifiable concentration (AUC0-tlast) Pre-dose up to 28 days post-dose AUC0-tlast of NS-580 in plasma
AUC0-tlast of [14C] NS-580 in plasma and whole blood for Total Radioactivity Pre-dose up to 56 days post-dose AUC0-tlast of \[14C\] NS-580 in plasma and whole blood
Maximum observed concentration (Cmax) of NS-580 Pre-dose up to 28 days post-dose Cmax of NS-580 in plasma
Cmax of [14C] NS-580 in plasma and whole blood for Total Radioactivity Pre-dose up to 56 days post-dose Cmax of \[14C\] NS-580 in plasma and whole blood
Time of the maximum observed concentration (Tmax) of NS-580 Pre-dose up to 28 days post-dose Tmax of NS-580 in plasma
Tmax of [14C] NS-580 in plasma and whole blood for Total Radioactivity Pre-dose up to 56 days post-dose Tmax of \[14C\] NS-580 in plasma and whole blood
Apparent terminal elimination half-life (t1/2) of NS-580 Pre-dose up to 28 days post-dose t1/2 of NS-580 in plasma
Amount of dose administered urine recovered (Aeu) of NS-580 Pre-dose up to 56 days post-dose Aeu of NS-580
- Secondary Outcome Measures
Name Time Method Incidence and severity of AEs Pre-dose up to 56 days post-dose Proportions of NS-580 major metabolites Pre-dose up to 56 days post-dose
Trial Locations
- Locations (1)
Fortrea Clinical Research Unit Ltd
🇬🇧Leeds, United Kingdom
Fortrea Clinical Research Unit Ltd🇬🇧Leeds, United Kingdom