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

A Phase 1, Open-label Study of the Absorption, Metabolism, Excretion of [14C]-NS-580 Following a Single Oral Dose 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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: [14C] NS-580

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • Leeds, United Kingdom, LS11 9EH
    • Fortrea Clinical Research Unit Ltd

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Administration of [14C] NS-580	Drug: [14C] NS-580; Oral suspension

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area under the concentration-time curve, from time 0 infinity (AUC0-inf) of NS-580 in plasma	AUC0-inf of NS-580 in plasma	Pre-dose up to 28 days post-dose
AUC0-inf of [14C] NS-580 in plasma and whole blood for Total Radioactivity	AUC0-inf of [14C] NS-580 in plasma and whole blood	Pre-dose up to 56 days post-dose
Area under the concentration-time curve from time 0 to the time of the last quantifiable concentration (AUC0-tlast)	AUC0-tlast of NS-580 in plasma	Pre-dose up to 28 days post-dose
AUC0-tlast of [14C] NS-580 in plasma and whole blood for Total Radioactivity	AUC0-tlast of [14C] NS-580 in plasma and whole blood	Pre-dose up to 56 days post-dose
Maximum observed concentration (Cmax) of NS-580	Cmax of NS-580 in plasma	Pre-dose up to 28 days post-dose
Cmax of [14C] NS-580 in plasma and whole blood for Total Radioactivity	Cmax of [14C] NS-580 in plasma and whole blood	Pre-dose up to 56 days post-dose
Time of the maximum observed concentration (Tmax) of NS-580	Tmax of NS-580 in plasma	Pre-dose up to 28 days post-dose
Tmax of [14C] NS-580 in plasma and whole blood for Total Radioactivity	Tmax of [14C] NS-580 in plasma and whole blood	Pre-dose up to 56 days post-dose
Apparent terminal elimination half-life (t1/2) of NS-580	t1/2 of NS-580 in plasma	Pre-dose up to 28 days post-dose
t1/2 of [14C] NS-580 in plasma and whole blood for Total Radioactivity	t1/2 of [14C] NS-580 in plasma and whole blood	Pre-dose up to 56 days post-dose
Renal clearance (CLR) of NS-580	CLR of NS-580 in plasma	Pre-dose up to 28 days post-dose
Amount of dose administered urine recovered (Aeu) of NS-580	Aeu of NS-580	Pre-dose up to 56 days post-dose
Percentage of dose administered urine recovered (feu) of NS-580	feu of NS-580	Pre-dose up to 56 days post-dose
Total radioactivity recovery	Total radioactivity recovery in urine and faeces	Pre-dose up to 56 days post-dose

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Nippon Shinyaku Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): November 8, 2023
• Primary Completion (Actual): January 18, 2024
• Study Completion (Actual): January 18, 2024

Study Registration Dates

• First Submitted: October 22, 2024
• First Submitted That Met QC Criteria: October 31, 2024
• First Posted (Estimated): November 1, 2024

Study Record Updates

• Last Update Posted (Estimated): November 1, 2024
• Last Update Submitted That Met QC Criteria: October 31, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: NS580-P1-06

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No