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

Phase 2

Completed

• Conditions: Gout Patients

• Registration Number: NCT04155918
• Lead Sponsor: Arthrosi Therapeutics

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-10-25
• Study First Submitted QC: 2019-11-05
• Study First Posted: 2019-11-07
• Study Start: 2020-02-03
• Primary Completion: 2020-09-03
• Study Completion: 2020-09-03
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-18
• Last Update Posted: 2020-11-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Serum uric acid (sUA) response rate	22 Days	sUA response rate to achieve sUA \<6, \<5, \<4, and \<3 mg/dL
PD profile of AR882 administered alone or in combination with febuxostat	22 Days	Profile from serum uric acid concentration over time
PD profile of AR882 administered alone or in combination with allopurinol	22 Days	Profile from serum uric acid concentration over time.

Secondary Outcome Measures

Name	Time	Method
AUC for plasma for febuxostat	22 Days	Profile from plasma in terms of AUC for febuxostat
Cmax for allopurinol/oxypurinol	22 Days	Profile from plasma in terms of Cmax for allopurinol/oxypurinol
Maximum plasma concentration (Cmax) for AR882	22 Days	Profile from plasma in terms of Cmax for AR882
Amount excreted (Ae) into urine for AR882	22 Days	Profile from urine in terms of Ae for AR882
t1/2 for for colchicine	22 Days	Profile from plasma in terms of t1/2 for colchicine
Area under the curve (AUC) for plasma AR882	22 Days	Profile from plasma in terms of AUC for AR882
Time to maximum plasma concentration (Tmax) for AR882	22 Days	Profile from plasma in terms of Tmax for AR882
Renal clearance (CLr) for AR882	22 Days	Profile from urine in terms of CLr for AR882
Tmax for febuxostat	22 Days	Profile from plasma in terms of Tmax for febuxostat
AUC for plasma allopurinol/oxypurinol	22 Days	Profile from plasma in terms of AUC for allopurinol/oxypurinol
Apparent terminal half-life (t1/2) for AR882	22 Days	Profile from plasma in terms of t1/2 for AR882
Incidence of Adverse Events, changes in laboratory, electrocardiogram, and vital signs	28 Days
Cmax for febuxostat	22 Days	Profile from plasma in terms of Cmax for febuxostat
t1/2 for febuxostat	22 Days	Profile from plasma in terms of t1/2 for febuxostat
Tmax for allopurinol/oxypurinol	22 Days	Profile from plasma in terms of Tmax for allopurinol/oxypurinol
Tmax for colchicine	22 Days	Profile from plasma in terms of Tmax for colchicine
Cmax for colchicine	22 Days	Profile from plasma in terms of Cmax for colchicine
t1/2 for for allopurinol/oxypurinol	22 Days	Profile from plasma in terms of t1/2 for allopurinol/oxypurinol
Ae in urine for allopurinol/oxypurinol	22 Days	Profile from urine in terms of Ae for allopurinol/oxypurinol
CLr for allopurinol/oxypurinol	22 Days	Profile from urine in terms of CLr for allopurinol/oxypurinol
AUC for plasma for colchicine	22 Days	Profile from plasma in terms of AUC for colchicine

Trial Locations

Locations (1)

Christchurch Clinical Studies Trust, Ltd (CCST); 🇳🇿 Christchurch, New Zealand