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OpenTrials
Completed

NCT Number: NCT07036458

To Evaluate the Mass Balance Recovery, Metabolite Profile and Metabolite Identification in Healthy Male Subjects

To Evaluate the Mass Balance Recovery, Metabolite Profile and Metabolite Identification in Healthy Male Subjects

Completed

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Key information

Conditions

Healthy Male Adults

Age range

30 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Quotient Science

Nottingham, United Kingdom

About this study

The following blood, urine and faecal samples will be collected, and assessments performed, at specified time points

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy volunteers

Exclusion criteria

  • Subjects does not meet the Inclusion Criteria

Treatment and study plan

14C Epaminurad Oral Solution

Drug

Subjects will receive a single administration of 14C Epaminurad Oral Solution

Primary outcomes

  1. Mass balance recovery of total radioactivity in all excreta (urine and faeces)

    Time frame: Baseline to Day 8

    Collection of plasma, urine and faeces samples during time frame point

  2. Metabolite profling and structural identification

    Time frame: Baseline to Day 8

    Collection of plasma, urine and faeces samples during time frame point

Sponsors and collaborators

Lead sponsor

JW Pharmaceutical

Industry

Registry information

Official study title

An Open-label, Single-dose, Single-period Study Designed to Assess the Mass Balance Recovery, Metabolite Profile and Metabolite Identification of 14C Epaminurad in Healthy Male Subjects

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jun 25, 2025
Registry last updated
Apr 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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