CompletedPhase 1

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

South Korea57 participantsStarted 2024-06-03

Plain-language summary

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

Age range19 Years – 50 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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

✕. 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)

Area under the plasma concentration versus time curve (AUC)

Timeframe: 5 days

Area under the plasma concentration versus time curve (AUC)

Timeframe: 7 days

Peak plasma concentrations (Cmax)

Timeframe: 7 days

Peak plasma concentrations (Cmax)

Timeframe: 5 days

NCT IDNCT06435442

SponsorJW Pharmaceutical

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-12-30