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

NCT07036458 — Phase 1, Completed, 8 participants, JW Pharmaceutical

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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

Registry	NCT07036458
Status	Completed
Phase	Phase 1
Study type	Interventional; na, single group, masking: none, other
Enrollment	8 (Actual)
Sponsor	JW Pharmaceutical (Industry)
Conditions	Healthy Male Adults
Interventions	14C Epaminurad Oral Solution (Drug)
Dates	start 2025-08-22, primary completion 2025-09-05, completion 2025-09-05, first posted 2025-06-25, last updated 2026-04-23
Locations	1 site in United Kingdom

-Summary

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

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+Detailed description

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

+Arms and interventions

Arm	Type	Interventions	Description
Subjects will receive a single administration of 14C Epaminurad Oral Solution	Other	Drug: 14C Epaminurad Oral Solution

14C Epaminurad Oral Solution (Drug): Subjects will receive a single administration of 14C Epaminurad Oral Solution

+Outcome measures

Primary outcomes

Mass balance recovery of total radioactivity in all excreta (urine and faeces) [Baseline to Day 8]: Collection of plasma, urine and faeces samples during time frame point
Metabolite profling and structural identification [Baseline to Day 8]: Collection of plasma, urine and faeces samples during time frame point

+Eligibility

Sex: Male, ages: 30 Years to 65 Years, accepts healthy volunteers

Inclusion Criteria:

1\. Healthy volunteers

Exclusion Criteria:

1\. Subjects does not meet the Inclusion Criteria

+Locations (1)

Facility	City	Country	Status
Quotient Science	Nottingham	United Kingdom

+Investigators

McKenzie Litza, Principal Investigator, Principal investigator, Quotient Sciences