Fortrea Clinical Research Unit Ltd
Leeds, LS11 9EH, United Kingdom
Completed
NCT Number: NCT06670898
A Study of Absorption, Metabolism, Excretion of [14C]-NS-580 in Healthy Male Subjects
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.
Completed
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Conditions
Age range
35 year–60 year
Sex eligibility
Male
Study type
Interventional
Phase
Phase 1
Primary location
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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).
Treatment and study plan
[14C] NS-580
DrugOral suspension
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
Time frame: Pre-dose up to 56 days post-dose
-
Incidence and severity of AEs
Time frame: Pre-dose up to 56 days post-dose
Sponsors and collaborators
Lead sponsor
Nippon Shinyaku Co., Ltd.
Industry
Registry information
Official study title
A Phase 1, Open-label Study of the Absorption, Metabolism, Excretion of [14C]-NS-580 Following a Single Oral Dose in Healthy Male Subjects
Important dates
- Study start
- 2023
- Primary completion
- 2024
- Study completion
- 2024
- First posted
- Nov 1, 2024
- Registry last updated
- Nov 1, 2024
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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