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

Primary Purpose

Gout Patients

Status
Completed
Phase
Phase 2
Locations
New Zealand
Study Type
Interventional
Intervention
Group 1: AR882 Alone and in Combination with Febuxostat (FBX)
Group 2: AR882 Alone and in Combination with Allopurinol (ALLO)
Sponsored by
Arthrosi Therapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gout Patients focused on measuring Hyperuricemia, Gout, URAT1

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Christchurch Clinical Studies Trust, Ltd (CCST)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

AR882/FBX

AR882/ALLO

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
October 25, 2019
Last Updated
November 18, 2020
Sponsor
Arthrosi Therapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT04155918
Brief Title
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

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
February 3, 2020 (Actual)
Primary Completion Date
September 3, 2020 (Actual)
Study Completion Date
September 3, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Arthrosi Therapeutics

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gout Patients
Keywords
Hyperuricemia, Gout, URAT1

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AR882/FBX
Arm Type
Experimental
Arm Title
AR882/ALLO
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Group 1: AR882 Alone and in Combination with Febuxostat (FBX)
Other Intervention Name(s)
Febuxostat (Adenuric®, Uloric®)
Intervention Description
AR882 + Febuxostat, AR882 alone, Febuxostat alone
Intervention Type
Drug
Intervention Name(s)
Group 2: AR882 Alone and in Combination with Allopurinol (ALLO)
Other Intervention Name(s)
Allopurinol (Allosig®, Progout®, Zyloprim®)
Intervention Description
AR882 + Allopurinol, AR882 alone, Allopurinol alone
Primary Outcome Measure Information:
Title
PD profile of AR882 administered alone or in combination with febuxostat
Description
Profile from serum uric acid concentration over time
Time Frame
22 Days
Title
PD profile of AR882 administered alone or in combination with allopurinol
Description
Profile from serum uric acid concentration over time.
Time Frame
22 Days
Title
Serum uric acid (sUA) response rate
Description
sUA response rate to achieve sUA <6, <5, <4, and <3 mg/dL
Time Frame
22 Days
Secondary Outcome Measure Information:
Title
Area under the curve (AUC) for plasma AR882
Description
Profile from plasma in terms of AUC for AR882
Time Frame
22 Days
Title
Time to maximum plasma concentration (Tmax) for AR882
Description
Profile from plasma in terms of Tmax for AR882
Time Frame
22 Days
Title
Maximum plasma concentration (Cmax) for AR882
Description
Profile from plasma in terms of Cmax for AR882
Time Frame
22 Days
Title
Apparent terminal half-life (t1/2) for AR882
Description
Profile from plasma in terms of t1/2 for AR882
Time Frame
22 Days
Title
Amount excreted (Ae) into urine for AR882
Description
Profile from urine in terms of Ae for AR882
Time Frame
22 Days
Title
Renal clearance (CLr) for AR882
Description
Profile from urine in terms of CLr for AR882
Time Frame
22 Days
Title
AUC for plasma for febuxostat
Description
Profile from plasma in terms of AUC for febuxostat
Time Frame
22 Days
Title
Tmax for febuxostat
Description
Profile from plasma in terms of Tmax for febuxostat
Time Frame
22 Days
Title
Cmax for febuxostat
Description
Profile from plasma in terms of Cmax for febuxostat
Time Frame
22 Days
Title
t1/2 for febuxostat
Description
Profile from plasma in terms of t1/2 for febuxostat
Time Frame
22 Days
Title
AUC for plasma allopurinol/oxypurinol
Description
Profile from plasma in terms of AUC for allopurinol/oxypurinol
Time Frame
22 Days
Title
Tmax for allopurinol/oxypurinol
Description
Profile from plasma in terms of Tmax for allopurinol/oxypurinol
Time Frame
22 Days
Title
Cmax for allopurinol/oxypurinol
Description
Profile from plasma in terms of Cmax for allopurinol/oxypurinol
Time Frame
22 Days
Title
t1/2 for for allopurinol/oxypurinol
Description
Profile from plasma in terms of t1/2 for allopurinol/oxypurinol
Time Frame
22 Days
Title
Ae in urine for allopurinol/oxypurinol
Description
Profile from urine in terms of Ae for allopurinol/oxypurinol
Time Frame
22 Days
Title
CLr for allopurinol/oxypurinol
Description
Profile from urine in terms of CLr for allopurinol/oxypurinol
Time Frame
22 Days
Title
AUC for plasma for colchicine
Description
Profile from plasma in terms of AUC for colchicine
Time Frame
22 Days
Title
Tmax for colchicine
Description
Profile from plasma in terms of Tmax for colchicine
Time Frame
22 Days
Title
Cmax for colchicine
Description
Profile from plasma in terms of Cmax for colchicine
Time Frame
22 Days
Title
t1/2 for for colchicine
Description
Profile from plasma in terms of t1/2 for colchicine
Time Frame
22 Days
Title
Incidence of Adverse Events, changes in laboratory, electrocardiogram, and vital signs
Time Frame
28 Days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher Wynne, MBChB, Grad Dip Pharm Med
Organizational Affiliation
Christchurch Clinical Studies Trust Ltd
Official's Role
Principal Investigator
Facility Information:
Facility Name
Christchurch Clinical Studies Trust, Ltd (CCST)
City
Christchurch
Country
New Zealand

12. IPD Sharing Statement

Learn more about this trial

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

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