NCT07036458

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Aug 2025

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 16, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 25, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

August 22, 2025

Completed
14 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 5, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 5, 2025

Completed
Last Updated

April 23, 2026

Status Verified

July 1, 2025

Enrollment Period

14 days

First QC Date

June 16, 2025

Last Update Submit

April 22, 2026

Conditions

Healthy Male Adults

Outcome Measures

Primary Outcomes (2)

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

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

    Baseline to Day 8

  • Metabolite profling and structural identification

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

    Baseline to Day 8

Study Arms (1)

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

OTHER
Drug: 14C Epaminurad Oral Solution

Interventions

14C Epaminurad Oral SolutionDRUG

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

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

Eligibility Criteria

Age30 Years - 65 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \. Healthy volunteers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Quotient Science

Nottingham, United Kingdom

Location

Study Officials

  • McKenzie Litza, Principal Investigator

    Quotient Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 16, 2025

First Posted

June 25, 2025

Study Start

August 22, 2025

Primary Completion

September 5, 2025

Study Completion

September 5, 2025

Last Updated

April 23, 2026

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)