A Study of Absorption, Metabolism, Excretion of [14C]-NS-580 in Healthy Male Subjects

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: [14C] NS-580

• 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

Study Timeline

• Study Start: 2023-11-08
• Primary Completion: 2024-01-18
• Study Completion: 2024-01-18
• Status Verified: 2024-10
• Study First Submitted: 2024-10-22
• Study First Submitted QC: 2024-10-31
• Last Update Submitted: 2024-10-31
• Study First Posted: 2024-11-01
• Last Update Posted: 2024-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 8

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.

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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).

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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
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
Total radioactivity recovery	Pre-dose up to 56 days post-dose	Total radioactivity recovery in urine and faeces
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
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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Fortrea Clinical Research Unit Ltd; 🇬🇧 Leeds, United Kingdom