A Phase 1, Open-label Study of the Absorption, Metabolism, Excretion of [14C]-NS-580 Following a Single Oral Dose in Healthy Male Subjects
Overview
- Phase
- Phase 1
- Intervention
- [14C] NS-580
- Conditions
- Healthy
- Sponsor
- Nippon Shinyaku Co., Ltd.
- Enrollment
- 8
- Locations
- 1
- Primary Endpoint
- Area under the concentration-time curve, from time 0 infinity (AUC0-inf) of NS-580 in plasma
- Status
- Completed
- Last Updated
- last year
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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).
Arms & Interventions
Administration of [14C] NS-580
Intervention: [14C] NS-580
Outcomes
Primary Outcomes
Area under the concentration-time curve, from time 0 infinity (AUC0-inf) of NS-580 in plasma
Time Frame: 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
Time Frame: 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)
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: Pre-dose up to 28 days post-dose
t1/2 of NS-580 in plasma
t1/2 of [14C] NS-580 in plasma and whole blood for Total Radioactivity
Time Frame: 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
Time Frame: Pre-dose up to 28 days post-dose
CLR of NS-580 in plasma
Amount of dose administered urine recovered (Aeu) of NS-580
Time Frame: Pre-dose up to 56 days post-dose
Aeu of NS-580
Percentage of dose administered urine recovered (feu) of NS-580
Time Frame: Pre-dose up to 56 days post-dose
feu of NS-580
Total radioactivity recovery
Time Frame: Pre-dose up to 56 days post-dose
Total radioactivity recovery in urine and faeces
Secondary Outcomes
- Proportions of NS-580 major metabolites(Pre-dose up to 56 days post-dose)
- Incidence and severity of AEs(Pre-dose up to 56 days post-dose)