Healthy
Conditions
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.
Interventions
DRUG[14C] NS-580
Oral suspension
Sponsors
Nippon Shinyaku Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
35 Years to 60 Years
Healthy volunteers
Yes
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total radioactivity recovery | Pre-dose up to 56 days post-dose | Total radioactivity recovery in urine and faeces |
| Amount of dose administered urine recovered (Aeu) of NS-580 | Pre-dose up to 56 days post-dose | Aeu of NS-580 |
| Percentage of dose administered urine recovered (feu) of NS-580 | Pre-dose up to 56 days post-dose | feu of NS-580 |
| 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 |
| 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 |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
United Kingdom
Outcome results
None listed