Clinical trial NCT04155918: Phase 2a Study of AR882 Alone and in Combination With Febuxostat or Allopurinol in Gout Patients
Official title: A Phase 2a, Open-Label Study to Evaluate the Safety and Efficacy of AR882 Administered Alone or in Combination With Febuxostat or Allopurinol in Gout Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Gout Patients
Keywords: Hyperuricemia
Gout
URAT1
Lead sponsor: Arthrosi Therapeutics
Sponsor class: INDUSTRY
First posted: 2019-11-07
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: PD profile of AR882 administered alone or in combination with febuxostat
timeFrame: 22 Days
measure: PD profile of AR882 administered alone or in combination with allopurinol
timeFrame: 22 Days
measure: Serum uric acid (sUA) response rate
timeFrame: 22 Days
Secondary outcomes:
measure: Area under the curve (AUC) for plasma AR882
timeFrame: 22 Days
measure: Time to maximum plasma concentration (Tmax) for AR882
timeFrame: 22 Days
measure: Maximum plasma concentration (Cmax) for AR882
timeFrame: 22 Days
measure: Apparent terminal half-life (t1/2) for AR882
timeFrame: 22 Days
measure: Amount excreted (Ae) into urine for AR882
timeFrame: 22 Days
measure: Renal clearance (CLr) for AR882
timeFrame: 22 Days
measure: AUC for plasma for febuxostat
timeFrame: 22 Days
measure: Tmax for febuxostat
timeFrame: 22 Days
measure: Cmax for febuxostat
timeFrame: 22 Days
measure: t1/2 for febuxostat
timeFrame: 22 Days
measure: AUC for plasma allopurinol/oxypurinol
timeFrame: 22 Days
measure: Tmax for allopurinol/oxypurinol
timeFrame: 22 Days
measure: Cmax for allopurinol/oxypurinol
timeFrame: 22 Days
measure: t1/2 for for allopurinol/oxypurinol
timeFrame: 22 Days
measure: Ae in urine for allopurinol/oxypurinol
timeFrame: 22 Days
measure: CLr for allopurinol/oxypurinol
timeFrame: 22 Days
measure: AUC for plasma for colchicine
timeFrame: 22 Days
measure: Tmax for colchicine
timeFrame: 22 Days
measure: Cmax for colchicine
timeFrame: 22 Days
measure: t1/2 for for colchicine
timeFrame: 22 Days
measure: Incidence of Adverse Events, changes in laboratory, electrocardiogram, and vital signs
timeFrame: 28 Days
Other outcomes:
Locations:
city: Christchurch
country: New Zealand
facility: Christchurch Clinical Studies Trust, Ltd (CCST)
Study officials:
affiliation: Christchurch Clinical Studies Trust Ltd
name: Christopher Wynne, MBChB, Grad Dip Pharm Med
role: PRINCIPAL_INVESTIGATOR
References: