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

JW Pharmaceutical

Status and phase: Not yet enrolling; Phase 1

Conditions: Healthy

Treatments: Drug: Epaminurad, Naproxen; Drug: Epaminurad placebo; Drug: Epaminurad

Study type: Interventional

Funder types: Industry

Identifiers

NCT06435442

JW23103

Details and patient eligibility

About

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

Full 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

Enrollment: 28 estimated patients

Sex: All

Ages: 19 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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28 participants in 3 patient groups, including a placebo group

Part 1

Experimental group

Description:

Epaminurad 9 mg, Naproxen 500 mg

Treatment:

Drug: Epaminurad, Naproxen

Part 2(Test group)

Experimental group

Description:

Epaminurad 9 mg

Treatment:

Drug: Epaminurad

Part 2(Control group)

Placebo Comparator group

Description:

Epaminurad 9 mg placebo

Treatment:

Drug: Epaminurad placebo