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

An Open-label, Crossover, Phase 1 Clinical Trial to Evaluate the Pharmacokinetic/Pharmacodynamic Drug-drug Interactions and Safety/Tolerability of Epaminurad and C2406 When Co-administered in Healthy Adults

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06665425

Enrollment

Registered

2024-10-30

Start date

2025-03-24

Completion date

2025-09-07

Last updated

2025-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteers

Brief summary

A Phase 1 Study to evaluate the safety, PK/PD, drug-drug interaction(DDI) of Epaminurad and C2406 in Healthy Volunteers

Interventions

DRUGEpaminurad 9 mg

Period 1: Epaminurad / Period 2: C2406 -\> Epaminurad + C2406

DRUGC2406

Period 1: Epaminurad / Period 2: C2406 -\> Epaminurad + C2406

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

19 Years to 50 Years

Healthy volunteers

Yes

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

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

Design outcomes

Primary

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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026