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

Phase 1

Not yet recruiting

• Conditions: Healthy Volunteers
• Interventions: Drug: Epaminurad 9 mg; Drug: C2406

• Registration Number: NCT06665425
• Lead Sponsor: JW Pharmaceutical

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-10
• Study First Submitted: 2024-10-28
• Study First Submitted QC: 2024-10-28
• Last Update Submitted: 2024-10-28
• Study First Posted: 2024-10-30
• Last Update Posted: 2024-10-30
• Study Start: 2024-11
• Primary Completion: 2025-02
• Study Completion: 2025-02

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 18

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm 1	Epaminurad 9 mg	Epaminurad 9mg, C2406 0.6mg
Arm 1	C2406	Epaminurad 9mg, C2406 0.6mg

Primary Outcome Measures

Name	Time	Method
Area under the plasma concentration versus time curve (AUC)	7 days	To evaluate the AUC of Epaminurad and C2406
Peak plasma concentrations (Cmax)	7 days	To evaluate the Cmax of Epaminurad and C2406