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NCT06435442 Clinical Trial

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

Healthy Clinical Trial

Official title:
A Phase 1 Study to Evaluate the Safety and PK/PD Drug-drug Interaction Between Epaminurad and Naproxen or to Assess the Safety and Multiple-Dose PK/PD Characteristics of Epaminurad in Healthy Volunteers

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06435442
Other study ID # JW23103
Secondary ID
Status Not yet recruiting
Phase Phase 1
First received
Last updated
Start date May 2024
Est. completion date August 2024

Study information
Verified date May 2024
Source JW Pharmaceutical
Contact JW Pharmaceutical
Phone +82-2-840-6852
Email jy.park@jwhealthcare.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 28
Est. completion date August 2024
Est. primary completion date August 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 19 Years to 50 Years
Eligibility 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, ?-GTP > upper limit of normal ranges X 1.5, CK > upper limit of normal ranges X 2, Positive serologic results

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Epaminurad, Naproxen
Period 1: Epaminurad/ Period 2: Naproxen -> Epaminurad+Naproxen
• Epaminurad
Epaminurad
• Epaminurad placebo
Epaminurad placebo

Locations
Country Name City State
Korea, Republic of Seoul National University Hospital Seoul

Sponsors (1)
Lead Sponsor Collaborator
JW Pharmaceutical

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Area under the plasma concentration versus time curve (AUC) To evaluate the AUC of Epaminurad and Naproxen 7 days
Primary Peak plasma concentrations (Cmax) To evaluate the Cmax of Epaminurad and Naproxen 7 days
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