Clinical trial NCT06670898: A Study of Absorption, Metabolism, Excretion of [14C]-NS-580 in Healthy Male Subjects
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Nippon Shinyaku Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-11-01
Enrollment: 8
Sex: MALE
Minimum age (years): 35
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.


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).

Primary outcomes:
measure: Area under the concentration-time curve, from time 0 infinity (AUC0-inf) of NS-580 in plasma
timeFrame: Pre-dose up to 28 days post-dose
measure: AUC0-inf of [14C] NS-580 in plasma and whole blood for Total Radioactivity
timeFrame: Pre-dose up to 56 days post-dose
measure: Area under the concentration-time curve from time 0 to the time of the last quantifiable concentration (AUC0-tlast)
timeFrame: Pre-dose up to 28 days post-dose
measure: AUC0-tlast of [14C] NS-580 in plasma and whole blood for Total Radioactivity
timeFrame: Pre-dose up to 56 days post-dose
measure: Maximum observed concentration (Cmax) of NS-580
timeFrame: Pre-dose up to 28 days post-dose
measure: Cmax of [14C] NS-580 in plasma and whole blood for Total Radioactivity
timeFrame: Pre-dose up to 56 days post-dose
measure: Time of the maximum observed concentration (Tmax) of NS-580
timeFrame: Pre-dose up to 28 days post-dose
measure: Tmax of [14C] NS-580 in plasma and whole blood for Total Radioactivity
timeFrame: Pre-dose up to 56 days post-dose
measure: Apparent terminal elimination half-life (t1/2) of NS-580
timeFrame: Pre-dose up to 28 days post-dose
measure: t1/2 of [14C] NS-580 in plasma and whole blood for Total Radioactivity
timeFrame: Pre-dose up to 56 days post-dose
measure: Renal clearance (CLR) of NS-580
timeFrame: Pre-dose up to 28 days post-dose
measure: Amount of dose administered urine recovered (Aeu) of NS-580
timeFrame: Pre-dose up to 56 days post-dose
measure: Percentage of dose administered urine recovered (feu) of NS-580
timeFrame: Pre-dose up to 56 days post-dose
measure: Total radioactivity recovery
timeFrame: Pre-dose up to 56 days post-dose
Secondary outcomes:
measure: Proportions of NS-580 major metabolites
timeFrame: Pre-dose up to 56 days post-dose
measure: Incidence and severity of AEs
timeFrame: Pre-dose up to 56 days post-dose
Other outcomes:
Locations:
city: Leeds
country: United Kingdom
facility: Fortrea Clinical Research Unit Ltd
Study officials:
References: