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Completed

NCT Number: NCT06435442

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

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

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Key information

Conditions

Healthy

Age range

19 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Seoul National University Hospital

Seoul, South Korea

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • Part 1: Korean/ Part 2: Caucasian

Exclusion criteria

  • 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 Cystatin C > 1.26mg/L (man), > 1.19 mg/L (woman)

Treatment and study plan

Epaminurad, Naproxen

Drug

Period 1: Epaminurad 6mg -> Epaminurad 9mg -> Epaminurad 9mg +Naproxen Period 2: Naproxen

Other names: URC102, Naxen

Epaminurad

Drug

Epaminurad

Other names: URC102

Epaminurad placebo

Drug

Epaminurad placebo

Other names: URC102 placebo

Primary outcomes

  1. Area under the plasma concentration versus time curve (AUC)

    Time frame: 5 days

    To evaluate the AUC of Naproxen

  2. Area under the plasma concentration versus time curve (AUC)

    Time frame: 7 days

    To evaluate the AUC of Epaminurad

  3. Peak plasma concentrations (Cmax)

    Time frame: 7 days

    To evaluate the Cmax of Epaminurad

  4. Peak plasma concentrations (Cmax)

    Time frame: 5 days

    To evaluate the Cmax of Naproxen

Sponsors and collaborators

Lead sponsor

JW Pharmaceutical

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
May 30, 2024
Registry last updated
Apr 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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