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

NCT06435442 | Completed Phase 1

• 1 other identifier: JW23103
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (4)

• Area under the plasma concentration versus time curve (AUC)

  To evaluate the AUC of Naproxen

  5 days

• Area under the plasma concentration versus time curve (AUC)

  To evaluate the AUC of Epaminurad

  7 days

• Peak plasma concentrations (Cmax)

  To evaluate the Cmax of Epaminurad

  7 days

• Peak plasma concentrations (Cmax)

  To evaluate the Cmax of Naproxen

  5 days

Study Arms (3)

Part 1

EXPERIMENTAL

Epaminurad 6 mg, Epaminurad 9 mg, Naproxen 500 mg

Drug: Epaminurad, Naproxen

Part 2(Test group)

EXPERIMENTAL

Epaminurad 6 mg, Epaminurad 9 mg

Drug: Epaminurad

Part 2(Control group)

PLACEBO COMPARATOR

Epaminurad 6 mg placebo, Epaminurad 9 mg placebo

Drug: Epaminurad placebo

Interventions

Epaminurad, Naproxen DRUG

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

Also known as: URC102, Naxen

Part 1

Epaminurad DRUG

Epaminurad

Also known as: URC102

Part 2(Test group)

Epaminurad placebo DRUG

Epaminurad placebo

Also known as: URC102 placebo

Part 2(Control group)

Eligibility Criteria

• Age: 19 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• JW Pharmaceutical: lead

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

MeSH Terms

Interventions

Naproxen; URC102

Intervention Hierarchy (Ancestors)

Naphthaleneacetic Acids; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Officials

• Kyung-sang Yu, MD

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: PART 1: None (Open Label)/ PART 2: Double (Participant, Investigator)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: May 24, 2024
• First Posted: May 30, 2024
• Study Start: June 3, 2024
• Primary Completion: December 30, 2025
• Study Completion: December 30, 2025
• Last Updated: April 16, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)