PK,PD and DDI of Epaminurad and Naproxen in Healthy Volunteers

A Phase 1 Study to Evaluate the Safety and PK/PD Drug-drug Interaction Between Epaminurad and Naproxen or to Assess the Safety and Multiple-Dose PK/PD Characteristics of Epaminurad in Healthy Volunteers

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Epaminurad; Drug: Epaminurad placebo; Drug: Epaminurad, Naproxen

Detailed Description

Part 1: to evaluate the safety, PK/PD, drug-drug interaction(DDI) of Epaminurad and Naproxen in Healthy Koreans/ Part 2: to evaluate the safety, PK/PD of Epaminurad in Healthy Caucasians

• Study Type: Interventional
• Enrollment (Actual): 57
• Phase: Phase 1

Contacts and Locations

Study Locations

• South Korea
  • Seoul, South Korea
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Age: 19~50
2. 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
3. Part 1: Korean/ Part 2: Caucasian

Exclusion Criteria:

1. Medical history- chronic liver disease, acute gout attack, uric acid stone, diabetes, hypertension, hyperlipidemia or lipid abnormality
2. 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 Cystatin C > 1.26mg/L (man), > 1.19 mg/L (woman)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part 1; Epaminurad 6 mg, Epaminurad 9 mg, Naproxen 500 mg	Drug: Epaminurad, Naproxen; Period 1: Epaminurad 6mg -> Epaminurad 9mg -> Epaminurad 9mg +Naproxen Period 2: Naproxen; Other Names: URC102, Naxen
Experimental: Part 2(Test group); Epaminurad 6 mg, Epaminurad 9 mg	Drug: Epaminurad; Epaminurad; Other Names: URC102
Placebo Comparator: Part 2(Control group); Epaminurad 6 mg placebo, Epaminurad 9 mg placebo	Drug: Epaminurad placebo; Epaminurad placebo; Other Names: URC102 placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area under the plasma concentration versus time curve (AUC)	To evaluate the AUC of Naproxen	5 days
Area under the plasma concentration versus time curve (AUC)	To evaluate the AUC of Epaminurad	7 days
Peak plasma concentrations (Cmax)	To evaluate the Cmax of Epaminurad	7 days
Peak plasma concentrations (Cmax)	To evaluate the Cmax of Naproxen	5 days

Collaborators and Investigators

• Sponsor: JW Pharmaceutical
• Investigators: Principal Investigator: Kyung-sang Yu, MD, Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 3, 2024
• Primary Completion (Actual): December 30, 2025
• Study Completion (Actual): December 30, 2025

Study Registration Dates

• First Submitted: May 24, 2024
• First Submitted That Met QC Criteria: May 24, 2024
• First Posted (Actual): May 30, 2024

Study Record Updates

• Last Update Posted (Actual): April 16, 2026
• Last Update Submitted That Met QC Criteria: April 13, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Organic Chemicals; Hydrocarbons; Hydrocarbons, Cyclic; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Polycyclic Compounds; Naphthaleneacetic Acids; Naproxen; URC102
• Other Study ID Numbers: JW23103

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No