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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06435442

Enrollment

Registered

2024-05-30

Start date

2024-06-03

Completion date

2025-12-30

Last updated

2026-04-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Brief summary

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

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

Interventions

DRUGEpaminurad, Naproxen

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

DRUGEpaminurad

Epaminurad

DRUGEpaminurad placebo

Epaminurad placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Masking description

PART 1: None (Open Label)/ PART 2: Double (Participant, Investigator)

Intervention model description

PART 1: A open-label, multiple-dose, single group/ PART 2: A placebo-controlled, randomized, double-blind, multiple-dose, parallel group

Eligibility

Sex/Gender

ALL

Age

19 Years to 50 Years

Healthy volunteers

Yes

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)

Design outcomes

Primary

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

Countries

South Korea

Contacts

PRINCIPAL_INVESTIGATORKyung-sang Yu, MD

Seoul National University Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 17, 2026