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

Gout Patients Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04155918
• Other study ID #: AR882-201
• Status: Completed
• Phase: Phase 2
• Start date: February 3, 2020
• Est. completion date: September 3, 2020

Study information

• Verified date: November 2020
• Source: Arthrosi Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 3, 2020
• Est. primary completion date: September 3, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Gout
• Gout Patients

Intervention

Drug:
• Group 1: AR882 Alone and in Combination with Febuxostat (FBX)
AR882 + Febuxostat, AR882 alone, Febuxostat alone
• Group 2: AR882 Alone and in Combination with Allopurinol (ALLO)
AR882 + Allopurinol, AR882 alone, Allopurinol alone

Locations

Country	Name	City	State
New Zealand	Christchurch Clinical Studies Trust, Ltd (CCST)	Christchurch

Sponsors (1)

Lead Sponsor	Collaborator
Arthrosi Therapeutics

Country where clinical trial is conducted

New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PD profile of AR882 administered alone or in combination with febuxostat	Profile from serum uric acid concentration over time	22 Days
Primary	PD profile of AR882 administered alone or in combination with allopurinol	Profile from serum uric acid concentration over time.	22 Days
Primary	Serum uric acid (sUA) response rate	sUA response rate to achieve sUA <6, <5, <4, and <3 mg/dL	22 Days
Secondary	Area under the curve (AUC) for plasma AR882	Profile from plasma in terms of AUC for AR882	22 Days
Secondary	Time to maximum plasma concentration (Tmax) for AR882	Profile from plasma in terms of Tmax for AR882	22 Days
Secondary	Maximum plasma concentration (Cmax) for AR882	Profile from plasma in terms of Cmax for AR882	22 Days
Secondary	Apparent terminal half-life (t1/2) for AR882	Profile from plasma in terms of t1/2 for AR882	22 Days
Secondary	Amount excreted (Ae) into urine for AR882	Profile from urine in terms of Ae for AR882	22 Days
Secondary	Renal clearance (CLr) for AR882	Profile from urine in terms of CLr for AR882	22 Days
Secondary	AUC for plasma for febuxostat	Profile from plasma in terms of AUC for febuxostat	22 Days
Secondary	Tmax for febuxostat	Profile from plasma in terms of Tmax for febuxostat	22 Days
Secondary	Cmax for febuxostat	Profile from plasma in terms of Cmax for febuxostat	22 Days
Secondary	t1/2 for febuxostat	Profile from plasma in terms of t1/2 for febuxostat	22 Days
Secondary	AUC for plasma allopurinol/oxypurinol	Profile from plasma in terms of AUC for allopurinol/oxypurinol	22 Days
Secondary	Tmax for allopurinol/oxypurinol	Profile from plasma in terms of Tmax for allopurinol/oxypurinol	22 Days
Secondary	Cmax for allopurinol/oxypurinol	Profile from plasma in terms of Cmax for allopurinol/oxypurinol	22 Days
Secondary	t1/2 for for allopurinol/oxypurinol	Profile from plasma in terms of t1/2 for allopurinol/oxypurinol	22 Days
Secondary	Ae in urine for allopurinol/oxypurinol	Profile from urine in terms of Ae for allopurinol/oxypurinol	22 Days
Secondary	CLr for allopurinol/oxypurinol	Profile from urine in terms of CLr for allopurinol/oxypurinol	22 Days
Secondary	AUC for plasma for colchicine	Profile from plasma in terms of AUC for colchicine	22 Days
Secondary	Tmax for colchicine	Profile from plasma in terms of Tmax for colchicine	22 Days
Secondary	Cmax for colchicine	Profile from plasma in terms of Cmax for colchicine	22 Days
Secondary	t1/2 for for colchicine	Profile from plasma in terms of t1/2 for colchicine	22 Days
Secondary	Incidence of Adverse Events, changes in laboratory, electrocardiogram, and vital signs		28 Days