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

October 31, 2024 updated by: Nippon Shinyaku Co., Ltd.

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
8

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Administration of [14C] NS-580
Drug: [14C] NS-580
Oral suspension

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Pre-dose up to 28 days post-dose
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
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)
Time Frame: Pre-dose up to 28 days post-dose
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
Time Frame: Pre-dose up to 56 days post-dose
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
Time Frame: Pre-dose up to 28 days post-dose
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
Time Frame: Pre-dose up to 56 days post-dose
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
Time Frame: Pre-dose up to 28 days post-dose
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
Time Frame: Pre-dose up to 56 days post-dose
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
Time Frame: Pre-dose up to 28 days post-dose
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
Time Frame: Pre-dose up to 56 days post-dose
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
Time Frame: Pre-dose up to 28 days post-dose
CLR of NS-580 in plasma
Pre-dose up to 28 days post-dose
Amount of dose administered urine recovered (Aeu) of NS-580
Time Frame: Pre-dose up to 56 days post-dose
Aeu of NS-580
Pre-dose up to 56 days post-dose
Percentage of dose administered urine recovered (feu) of NS-580
Time Frame: Pre-dose up to 56 days post-dose
feu of NS-580
Pre-dose up to 56 days post-dose
Total radioactivity recovery
Time Frame: Pre-dose up to 56 days post-dose
Total radioactivity recovery in urine and faeces
Pre-dose up to 56 days post-dose

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Proportions of NS-580 major metabolites
Time Frame: Pre-dose up to 56 days post-dose
Pre-dose up to 56 days post-dose
Incidence and severity of AEs
Time Frame: Pre-dose up to 56 days post-dose
Pre-dose up to 56 days post-dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Nippon Shinyaku Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 8, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 18, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 18, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 22, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 31, 2024

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 1, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 1, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 31, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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