## Protocol Section
### Identification Module
**NCT ID:** NCT06435442

**Brief Title:** PK,PD and DDI of Epaminurad and Naproxen in Healthy Volunteers

**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

#### Organization Study ID Info
**ID:** JW23103
#### Organization
**Class:** INDUSTRY
**Full Name:** JW Pharmaceutical
### Status Module
#### Completion Date
**Date:** 2024-08

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-24

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2024-08

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-24
**Study First Submit QC Date:** 2024-05-24
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** JW Pharmaceutical

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

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

**Detailed 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

### Conditions Module

**Conditions:**

- Healthy

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

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

##### Masking Info

**Masking:** DOUBLE

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

**Who Masked:**

- PARTICIPANT

- INVESTIGATOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 28

**Type:** ESTIMATED

**Phases:**

- PHASE1

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Epaminurad 9 mg, Naproxen 500 mg

**Intervention Names:**

- Drug: Epaminurad, Naproxen

**Label:** Part 1

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Epaminurad 9 mg

**Intervention Names:**

- Drug: Epaminurad

**Label:** Part 2(Test group)

**Type:** EXPERIMENTAL

#### Arm Group 3

**Description:** Epaminurad 9 mg placebo

**Intervention Names:**

- Drug: Epaminurad placebo

**Label:** Part 2(Control group)

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Part 1

**Description:** Period 1: Epaminurad/ Period 2: Naproxen -\> Epaminurad+Naproxen

**Name:** Epaminurad, Naproxen

**Other Names:**

- URC102, Naxen

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Part 2(Test group)

**Description:** Epaminurad

**Name:** Epaminurad

**Other Names:**

- URC102

**Type:** DRUG

#### Intervention 3

**Arm Group Labels:**

- Part 2(Control group)

**Description:** Epaminurad placebo

**Name:** Epaminurad placebo

**Other Names:**

- URC102 placebo

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** To evaluate the AUC of Epaminurad and Naproxen

**Measure:** Area under the plasma concentration versus time curve (AUC)

**Time Frame:** 7 days

**Description:** To evaluate the Cmax of Epaminurad and Naproxen

**Measure:** Peak plasma concentrations (Cmax)

**Time Frame:** 7 days

### Eligibility Module

**Eligibility Criteria:** 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

**Healthy Volunteers:** True

**Maximum Age:** 50 Years

**Minimum Age:** 19 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** jy.park@jwhealthcare.com

**Name:** JW Pharmaceutical

**Phone:** +82-2-840-6852

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Seoul

**Contacts:**

***Contact 1:***

- **Name:** Kyung-sang Yu

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** Korea, Republic of

**Facility:** Seoul National University Hospital

#### Overall Officials

**Official 1:**

**Affiliation:** Seoul National University Hospital

**Name:** Kyung-sang Yu, MD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Intervention Browse Module - Ancestors

- ID: D000000894

- Term: Anti-Inflammatory Agents, Non-Steroidal

- ID: D000018712

- Term: Analgesics, Non-Narcotic

- ID: D000000700

- Term: Analgesics

- ID: D000018689

- Term: Sensory System Agents

- ID: D000018373

- Term: Peripheral Nervous System Agents

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000000893

- Term: Anti-Inflammatory Agents

- ID: D000018501

- Term: Antirheumatic Agents

- ID: D000006074

- Term: Gout Suppressants

- ID: D000016861

- Term: Cyclooxygenase Inhibitors

- ID: D000004791

- Term: Enzyme Inhibitors

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

### Intervention Browse Module - Browse Branches

- Abbrev: Infl

- Name: Anti-Inflammatory Agents

- Abbrev: ARhu

- Name: Antirheumatic Agents

- Abbrev: Analg

- Name: Analgesics

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M12239

- Name: Naproxen

- Relevance: HIGH

- As Found: ACT

- ID: M4217

- Name: Anti-Inflammatory Agents

- Relevance: LOW

- As Found: Unknown

- ID: M4218

- Name: Anti-Inflammatory Agents, Non-Steroidal

- Relevance: LOW

- As Found: Unknown

- ID: M4032

- Name: Analgesics

- Relevance: LOW

- As Found: Unknown

- ID: M20786

- Name: Analgesics, Non-Narcotic

- Relevance: LOW

- As Found: Unknown

- ID: M20604

- Name: Antirheumatic Agents

- Relevance: LOW

- As Found: Unknown

- ID: M19209

- Name: Cyclooxygenase Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M7951

- Name: Enzyme Inhibitors

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000009288

- Term: Naproxen

### Misc Info Module

- Version Holder: 2024-05-31
