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

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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07036458
Enrollment
8
Registered
2025-06-25
Start date
2025-08-22
Completion date
2025-09-05
Last updated
2026-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Male Adults

Brief summary

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

Detailed description

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

Interventions

DRUG14C Epaminurad Oral Solution

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

Sponsors

JW Pharmaceutical
Lead SponsorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
30 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

1\. Healthy volunteers

Exclusion criteria

1\. Subjects does not meet the Inclusion Criteria

Design outcomes

Primary

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

Countries

United Kingdom

Contacts

PRINCIPAL_INVESTIGATORMcKenzie Litza, Principal Investigator

Quotient Sciences

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 24, 2026