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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-08

Study Completion Date

2024-01-18

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Administration of [14C] NS-580

Group Type EXPERIMENTAL

[14C] NS-580

Intervention Type DRUG

Oral suspension

Interventions

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[14C] NS-580

Oral suspension

Intervention Type DRUG

Eligibility Criteria

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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).

Minimum Eligible Age

35 Years

Maximum Eligible Age

60 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes