Phase 1 ADME study of [14C]Epaminurad (QSC301741)
Research type
Research Study
Full 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
IRAS ID
1010507
Contact name
Inyoung Park
Contact email
Sponsor organisation
JW Pharmaceutical Corporation
Clinicaltrials.gov Identifier
Research summary
The Sponsor is developing the test medicine, Epaminurad, as a potential treatment for gout. Gout is caused by an abnormally high levels of uric acid in the blood. The high levels of uric acid in the blood can cause crystals to form in the joints and other body tissues and cause problems such as red, hot and painful swollen joints (arthritis) typically affecting the big toe, hard lumps in the skin (gouty tophi), kidney stones and damage to the kidneys.
In this study, we’ll give healthy volunteers a single dose of test medicine to find out how the body breaks down and gets rid of the test medicine. The test medicine will be ‘radiolabelled’ - it will contain a small amount of radioactivity (Carbon-14) - so that we can track it in the body. We also want to get more information on the safety and tolerability of the test medicine and any side effects.
This study will take place at 1 site in Nottingham.
We plan to enrol 8 healthy men aged 30-65 years.
Volunteers will receive a single dose of radiolabelled test medicine, as an oral solution. They’ll stay in the clinic for up to 10 nights, attend 2 outpatient visits, and take up to 6 weeks to finish the study.
We’ll collect blood and urine samples to do safety tests. Over a period of up to 11 days, we’ll take many blood samples and volunteers will collect all their urine and faeces so that we can measure the amount of test medicine and its breakdown products.
REC name
HSC REC B
REC reference
25/NI/0051
Date of REC Opinion
1 Jul 2025
REC opinion
Further Information Favourable Opinion