Phase 2a Study of AR882 Alone and in Combination With Febuxostat or Allopurinol in Gout Patients

Arthrosi Therapeutics30 enrolled

Overview

The study is designed to evaluate the PK/PD, safety and tolerability of AR882 alone or in combination with febuxostat or allopurinol when administered to gout patients.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Gout Patients

Interventions

Group 1: AR882 Alone and in Combination with Febuxostat (FBX)DRUG

AR882 + Febuxostat, AR882 alone, Febuxostat alone

Group 2: AR882 Alone and in Combination with Allopurinol (ALLO)DRUG

AR882 + Allopurinol, AR882 alone, Allopurinol alone

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Key Inclusion Criteria: * History of gout * sUA \> 7 mg/dL * Estimated Glomerular Filtration Rate (eGFR) ≥ 60 mL/min/1.73m2 Key Exclusion Criteria: * Malignancy within 5 years, except for successfully treated basal or squamous cell carcinoma of the skin * History of cardiac abnormalities * Active peptic ulcer disease or active liver disease * History of kidney stones * Allergy or intolerance to colchicine, febuxostat, and allopurinol

Locations (1)

Christchurch Clinical Studies Trust, Ltd (CCST)

Christchurch, New Zealand

Outcomes

Primary Outcomes

PD profile of AR882 administered alone or in combination with febuxostat

Profile from serum uric acid concentration over time

Time frame: 22 Days

PD profile of AR882 administered alone or in combination with allopurinol

Profile from serum uric acid concentration over time.

Time frame: 22 Days

Serum uric acid (sUA) response rate

sUA response rate to achieve sUA \<6, \<5, \<4, and \<3 mg/dL

Time frame: 22 Days

Secondary Outcomes

Area under the curve (AUC) for plasma AR882

Profile from plasma in terms of AUC for AR882

Time frame: 22 Days

Time to maximum plasma concentration (Tmax) for AR882

Profile from plasma in terms of Tmax for AR882

Time frame: 22 Days

Maximum plasma concentration (Cmax) for AR882

Profile from plasma in terms of Cmax for AR882

Time frame: 22 Days

Apparent terminal half-life (t1/2) for AR882

Profile from plasma in terms of t1/2 for AR882

Time frame: 22 Days

Amount excreted (Ae) into urine for AR882

Profile from urine in terms of Ae for AR882

Time frame: 22 Days

Renal clearance (CLr) for AR882

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.