Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04155918
Recruitment Status : Completed
First Posted : November 7, 2019
Last Update Posted : November 19, 2020
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Gout Patients Drug: Group 1: AR882 Alone and in Combination with Febuxostat (FBX) Drug: Group 2: AR882 Alone and in Combination with Allopurinol (ALLO) Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : February 3, 2020
Actual Primary Completion Date : September 3, 2020
Actual Study Completion Date : September 3, 2020

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Gout
MedlinePlus related topics: Gout

Arm Intervention/treatment
Experimental: AR882/FBX Drug: Group 1: AR882 Alone and in Combination with Febuxostat (FBX)
AR882 + Febuxostat, AR882 alone, Febuxostat alone
Other Name: Febuxostat (Adenuric®, Uloric®)

Experimental: AR882/ALLO Drug: Group 2: AR882 Alone and in Combination with Allopurinol (ALLO)
AR882 + Allopurinol, AR882 alone, Allopurinol alone
Other Name: Allopurinol (Allosig®, Progout®, Zyloprim®)




Primary Outcome Measures :
  1. PD profile of AR882 administered alone or in combination with febuxostat [ Time Frame: 22 Days ]
    Profile from serum uric acid concentration over time

  2. PD profile of AR882 administered alone or in combination with allopurinol [ Time Frame: 22 Days ]
    Profile from serum uric acid concentration over time.

  3. Serum uric acid (sUA) response rate [ Time Frame: 22 Days ]
    sUA response rate to achieve sUA <6, <5, <4, and <3 mg/dL


Secondary Outcome Measures :
  1. Area under the curve (AUC) for plasma AR882 [ Time Frame: 22 Days ]
    Profile from plasma in terms of AUC for AR882

  2. Time to maximum plasma concentration (Tmax) for AR882 [ Time Frame: 22 Days ]
    Profile from plasma in terms of Tmax for AR882

  3. Maximum plasma concentration (Cmax) for AR882 [ Time Frame: 22 Days ]
    Profile from plasma in terms of Cmax for AR882

  4. Apparent terminal half-life (t1/2) for AR882 [ Time Frame: 22 Days ]
    Profile from plasma in terms of t1/2 for AR882

  5. Amount excreted (Ae) into urine for AR882 [ Time Frame: 22 Days ]
    Profile from urine in terms of Ae for AR882

  6. Renal clearance (CLr) for AR882 [ Time Frame: 22 Days ]
    Profile from urine in terms of CLr for AR882

  7. AUC for plasma for febuxostat [ Time Frame: 22 Days ]
    Profile from plasma in terms of AUC for febuxostat

  8. Tmax for febuxostat [ Time Frame: 22 Days ]
    Profile from plasma in terms of Tmax for febuxostat

  9. Cmax for febuxostat [ Time Frame: 22 Days ]
    Profile from plasma in terms of Cmax for febuxostat

  10. t1/2 for febuxostat [ Time Frame: 22 Days ]
    Profile from plasma in terms of t1/2 for febuxostat

  11. AUC for plasma allopurinol/oxypurinol [ Time Frame: 22 Days ]
    Profile from plasma in terms of AUC for allopurinol/oxypurinol

  12. Tmax for allopurinol/oxypurinol [ Time Frame: 22 Days ]
    Profile from plasma in terms of Tmax for allopurinol/oxypurinol

  13. Cmax for allopurinol/oxypurinol [ Time Frame: 22 Days ]
    Profile from plasma in terms of Cmax for allopurinol/oxypurinol

  14. t1/2 for for allopurinol/oxypurinol [ Time Frame: 22 Days ]
    Profile from plasma in terms of t1/2 for allopurinol/oxypurinol

  15. Ae in urine for allopurinol/oxypurinol [ Time Frame: 22 Days ]
    Profile from urine in terms of Ae for allopurinol/oxypurinol

  16. CLr for allopurinol/oxypurinol [ Time Frame: 22 Days ]
    Profile from urine in terms of CLr for allopurinol/oxypurinol

  17. AUC for plasma for colchicine [ Time Frame: 22 Days ]
    Profile from plasma in terms of AUC for colchicine

  18. Tmax for colchicine [ Time Frame: 22 Days ]
    Profile from plasma in terms of Tmax for colchicine

  19. Cmax for colchicine [ Time Frame: 22 Days ]
    Profile from plasma in terms of Cmax for colchicine

  20. t1/2 for for colchicine [ Time Frame: 22 Days ]
    Profile from plasma in terms of t1/2 for colchicine

  21. Incidence of Adverse Events, changes in laboratory, electrocardiogram, and vital signs [ Time Frame: 28 Days ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04155918


Locations
Layout table for location information
New Zealand
Christchurch Clinical Studies Trust, Ltd (CCST)
Christchurch, New Zealand
Sponsors and Collaborators
Arthrosi Therapeutics
Investigators
Layout table for investigator information
Principal Investigator: Christopher Wynne, MBChB, Grad Dip Pharm Med Christchurch Clinical Studies Trust Ltd
Layout table for additonal information
Responsible Party: Arthrosi Therapeutics
ClinicalTrials.gov Identifier: NCT04155918    
Other Study ID Numbers: AR882-201
First Posted: November 7, 2019    Key Record Dates
Last Update Posted: November 19, 2020
Last Verified: November 2020

Layout table for additional information
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
Keywords provided by Arthrosi Therapeutics:
Hyperuricemia
Gout
URAT1
Additional relevant MeSH terms:
Layout table for MeSH terms
Gout
Arthritis
Joint Diseases
Musculoskeletal Diseases
Crystal Arthropathies
Rheumatic Diseases
Purine-Pyrimidine Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Metabolic Diseases
Allopurinol
Febuxostat
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Gout Suppressants
Antirheumatic Agents
Free Radical Scavengers
Antioxidants
Protective Agents
Physiological Effects of Drugs