PK,PD and DDI of Epaminurad and C2406 in Healthy Volunteers

JW Pharmaceutical

Status and phase: Not yet enrolling; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: Epaminurad 9 mg; Drug: C2406

Study type: Interventional

Funder types: Industry

Identifiers

NCT06665425

JW24103

Details and patient eligibility

About

A Phase 1 Study to evaluate the safety, PK/PD, drug-drug interaction(DDI) of Epaminurad and C2406 in Healthy Volunteers

Enrollment: 18 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

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: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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18 participants in 1 patient group

Arm 1

Experimental group

Description:

Epaminurad 9mg, C2406 0.6mg

Treatment:

Drug: C2406

Drug: Epaminurad 9 mg