A Phase 2 interventional study of Group 1: AR882 Alone and in Combination with Febuxostat (FBX) and Group 2: AR882 Alone and in Combination with Allopurinol (ALLO) in Gout Patients, sponsored by Arthrosi Therapeutics. Completed at 1 site in New Zealand. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2020-11-19.
Sponsored by Arthrosi Therapeutics · Phase 2, Interventional, and Treatment
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.
232 studies on the registry are indexed under Gout; 45 are open to participants now.
This study's enrollment of 30 is below the median of 121 across 202 interventional studies indexed under Gout.
Browse Gout studies →Arthrosi Therapeutics is the lead sponsor of 10 studies on the registry; none are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key Exclusion Criteria:
Drug: Group 1: AR882 Alone and in Combination with Febuxostat (FBX)
Drug: Group 2: AR882 Alone and in Combination with Allopurinol (ALLO)
AR882 + Febuxostat, AR882 alone, Febuxostat alone
Also known as: Febuxostat (Adenuric®, Uloric®)
AR882 + Allopurinol, AR882 alone, Allopurinol alone
Also known as: Allopurinol (Allosig®, Progout®, Zyloprim®)
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
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
Profile from urine in terms of CLr for AR882
Time frame: 22 Days
AUC for plasma for febuxostat
Profile from plasma in terms of AUC for febuxostat
Time frame: 22 Days
Tmax for febuxostat
Profile from plasma in terms of Tmax for febuxostat
Time frame: 22 Days
Cmax for febuxostat
Profile from plasma in terms of Cmax for febuxostat
Time frame: 22 Days
t1/2 for febuxostat
Profile from plasma in terms of t1/2 for febuxostat
Time frame: 22 Days
AUC for plasma allopurinol/oxypurinol
Profile from plasma in terms of AUC for allopurinol/oxypurinol
Time frame: 22 Days
Tmax for allopurinol/oxypurinol
Profile from plasma in terms of Tmax for allopurinol/oxypurinol
Time frame: 22 Days
Cmax for allopurinol/oxypurinol
Profile from plasma in terms of Cmax for allopurinol/oxypurinol
Time frame: 22 Days
t1/2 for for allopurinol/oxypurinol
Profile from plasma in terms of t1/2 for allopurinol/oxypurinol
Time frame: 22 Days
Ae in urine for allopurinol/oxypurinol
Profile from urine in terms of Ae for allopurinol/oxypurinol
Time frame: 22 Days
CLr for allopurinol/oxypurinol
Profile from urine in terms of CLr for allopurinol/oxypurinol
Time frame: 22 Days
AUC for plasma for colchicine
Profile from plasma in terms of AUC for colchicine
Time frame: 22 Days
Tmax for colchicine
Profile from plasma in terms of Tmax for colchicine
Time frame: 22 Days
Cmax for colchicine
Profile from plasma in terms of Cmax for colchicine
Time frame: 22 Days
t1/2 for for colchicine
Profile from plasma in terms of t1/2 for colchicine
Time frame: 22 Days
Incidence of Adverse Events, changes in laboratory, electrocardiogram, and vital signs
Time frame: 28 Days
This study is completed, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.
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Arthrosi Therapeutics