PK,PD and DDI of Epaminurad and C2406 in Healthy Volunteers | NCT06665425

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

NCT06665425

Sponsor

JW Pharmaceutical

Status

Completed

Last Update Posted

Apr 20, 2026Actual

Enrollment

18Actual

Phase

Phase 1

Conditions

Healthy Volunteers

Interventions

Epaminurad 9 mg
C2406

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 24, 2025Actual

Primary Completion Date

May 2, 2025Actual

Completion Date

Sep 4, 2025Actual

First Submitted Date

Oct 28, 2024

First Submission Date that Met QC Criteria

Oct 28, 2024

First Posted Date

Oct 30, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 17, 2026

Last Update Posted Date

Apr 20, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

18Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Arm 1	Experimental	Epaminurad 9mg, C2406 0.6mg	Drug: Epaminurad 9 mg Drug: C2406

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Epaminurad 9 mg	Drug	Period 1: Epaminurad / Period 2: C2406 -> Epaminurad + C2406	Arm 1

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kyung-sang Yu, MD	Seoul National University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul National University Hospital Clinical Trials Center		Seoul	Seoul	110-744	South Korea

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided