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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

PHASE1

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-03

Study Completion Date

2026-01-31

Brief Summary

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

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Detailed Description

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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

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

PART 1: None (Open Label)/ PART 2: Double (Participant, Investigator)

Study Groups

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Part 1

Epaminurad 6 mg, Epaminurad 9 mg, Naproxen 500 mg

Group Type EXPERIMENTAL

Epaminurad, Naproxen

Intervention Type DRUG

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

Part 2(Test group)

Epaminurad 6 mg, Epaminurad 9 mg

Group Type EXPERIMENTAL

Epaminurad

Intervention Type DRUG

Epaminurad

Part 2(Control group)

Epaminurad 6 mg placebo, Epaminurad 9 mg placebo

Group Type PLACEBO_COMPARATOR

Epaminurad placebo

Intervention Type DRUG

Epaminurad placebo

Interventions

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Epaminurad, Naproxen

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

Intervention Type DRUG

Epaminurad

Intervention Type DRUG

Epaminurad placebo

Intervention Type DRUG

Other Intervention Names

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URC102, Naxen URC102 URC102 placebo

Eligibility Criteria

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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 Cystatin C \> 1.26mg/L (man), \> 1.19 mg/L (woman)

Minimum Eligible Age

19 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes