NCT06665425

Brief Summary

A Phase 1 Study to evaluate the safety, PK/PD, drug-drug interaction(DDI) of Epaminurad and C2406 in Healthy Volunteers

Trial Health

87
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for phase_1 healthy-volunteers

Timeline
Completed

Started Mar 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

October 28, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 30, 2024

Completed
5 months until next milestone

Study Start

First participant enrolled

March 24, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 2, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 4, 2025

Completed
Last Updated

April 20, 2026

Status Verified

April 1, 2026

Enrollment Period

1 month

First QC Date

October 28, 2024

Last Update Submit

April 17, 2026

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (2)

  • Area under the plasma concentration versus time curve (AUC)

    To evaluate the AUC of Epaminurad and C2406

    7 days

  • Peak plasma concentrations (Cmax)

    To evaluate the Cmax of Epaminurad and C2406

    7 days

Study Arms (1)

Arm 1

EXPERIMENTAL

Epaminurad 9mg, C2406 0.6mg

Drug: Epaminurad 9 mgDrug: C2406

Interventions

Epaminurad 9 mgDRUG

Period 1: Epaminurad / Period 2: C2406 -\> Epaminurad + C2406

Arm 1
C2406DRUG

Period 1: Epaminurad / Period 2: C2406 -\> Epaminurad + C2406

Arm 1

Eligibility Criteria

Age19 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age: 19\~50
  • Weight: between 50.0 kg\~90.0 kg, Body Mass Index(BMI): 18.0 kg/m\^2 or heavier and below 30.0 kg/m\^2

You may not qualify if:

  • Medical history- chronic liver disease, acute gout attack, uric acid stone, diabetes, hypertension, hyperlipidemia or lipid abnormality
  • Clinical examination
  • eGFR (CKD-EPI) \< 90mL/min/1.73m\^2
  • Serum uric acid \< 3 mg/dL or \> 7 mg/dL
  • AST (SGOT), ALT (SGPT) \> upper limit of normal ranges X 1.5
  • Total bilirubin, γ-GTP \> upper limit of normal ranges X 1.5
  • CK \> upper limit of normal ranges X 2
  • Positive serologic results

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital Clinical Trials Center

Seoul, Seoul, 110-744, South Korea

Location

Study Officials

  • Kyung-sang Yu, MD

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

October 28, 2024

First Posted

October 30, 2024

Study Start

March 24, 2025

Primary Completion

May 2, 2025

Study Completion

September 4, 2025

Last Updated

April 20, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)