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

NCT06670898 | Completed Phase 1

• 1 other identifier: NS580-P1-06
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (14)

• 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 Outcomes (2)

• 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

Study Arms (1)

Administration of [14C] NS-580

EXPERIMENTAL

Drug: [14C] NS-580

Interventions

[14C] NS-580 DRUG

Oral suspension

Administration of [14C] NS-580

Eligibility Criteria

• Age: 35 Years - 60 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Nippon Shinyaku Co., Ltd.: lead

Study Sites (1)

Fortrea Clinical Research Unit Ltd

Leeds, LS11 9EH, United Kingdom

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2024
• First Posted: November 1, 2024
• Study Start: November 8, 2023
• Primary Completion: January 18, 2024
• Study Completion: January 18, 2024
• Last Updated: November 1, 2024

Record last verified: 2024-10

Locations

GB (1)