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
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 57
- Locations
- 1
- Primary Endpoint
- Area under the plasma concentration versus time curve (AUC)
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Masking Description
PART 1: None (Open Label)/ PART 2: Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 19 Years to 50 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
- •Part 1: Korean/ Part 2: Caucasian
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 Cystatin C > 1.26mg/L (man), > 1.19 mg/L (woman)
Arms & Interventions
Part 2(Test group)
Epaminurad 6 mg, Epaminurad 9 mg
Intervention: Epaminurad (Drug)
Part 2(Control group)
Epaminurad 6 mg placebo, Epaminurad 9 mg placebo
Intervention: Epaminurad placebo (Drug)
Part 1
Epaminurad 6 mg, Epaminurad 9 mg, Naproxen 500 mg
Intervention: Epaminurad, Naproxen (Drug)
Outcomes
Primary Outcomes
Area under the plasma concentration versus time curve (AUC)
Time Frame: 5 days
To evaluate the AUC of Naproxen
Peak plasma concentrations (Cmax)
Time Frame: 7 days
To evaluate the Cmax of Epaminurad
Area under the plasma concentration versus time curve (AUC)
Time Frame: 7 days
To evaluate the AUC of Epaminurad
Peak plasma concentrations (Cmax)
Time Frame: 5 days
To evaluate the Cmax of Naproxen
Secondary Outcomes
No secondary outcomes reported