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

NCT04155918 | Completed Phase 2 FDA Drug

• 1 other identifier: AR882-201
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Gout Patients

Keywords

Hyperuricemia; Gout; URAT1

Outcome Measures

Primary Outcomes (3)

• PD profile of AR882 administered alone or in combination with febuxostat

  Profile from serum uric acid concentration over time

  22 Days

• PD profile of AR882 administered alone or in combination with allopurinol

  Profile from serum uric acid concentration over time.

  22 Days

• Serum uric acid (sUA) response rate

  sUA response rate to achieve sUA \<6, \<5, \<4, and \<3 mg/dL

  22 Days

Secondary Outcomes (21)

• Area under the curve (AUC) for plasma AR882

  22 Days

• Time to maximum plasma concentration (Tmax) for AR882

  22 Days

• Maximum plasma concentration (Cmax) for AR882

  22 Days

• Apparent terminal half-life (t1/2) for AR882

  22 Days

• Amount excreted (Ae) into urine for AR882

  22 Days

Study Arms (2)

AR882/FBX

EXPERIMENTAL

Drug: Group 1: AR882 Alone and in Combination with Febuxostat (FBX)

AR882/ALLO

EXPERIMENTAL

Drug: Group 2: AR882 Alone and in Combination with Allopurinol (ALLO)

Interventions

Group 1: AR882 Alone and in Combination with Febuxostat (FBX) DRUG

AR882 + Febuxostat, AR882 alone, Febuxostat alone

Also known as: Febuxostat (Adenuric®, Uloric®)

AR882/FBX

Group 2: AR882 Alone and in Combination with Allopurinol (ALLO) DRUG

AR882 + Allopurinol, AR882 alone, Allopurinol alone

Also known as: Allopurinol (Allosig®, Progout®, Zyloprim®)

AR882/ALLO

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• History of gout
• sUA \> 7 mg/dL
• Estimated Glomerular Filtration Rate (eGFR) ≥ 60 mL/min/1.73m2

You may not qualify if:

• 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

Sponsors & Collaborators

• Arthrosi Therapeutics: lead

Study Sites (1)

Christchurch Clinical Studies Trust, Ltd (CCST)

Christchurch, New Zealand

Location

MeSH Terms

Conditions

Hyperuricemia; Gout

Interventions

Febuxostat; Allopurinol

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Arthritis; Joint Diseases; Musculoskeletal Diseases; Crystal Arthropathies; Rheumatic Diseases; Purine-Pyrimidine Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Christopher Wynne, MBChB, Grad Dip Pharm Med

  Christchurch Clinical Studies Trust Ltd

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2019
• First Posted: November 7, 2019
• Study Start: February 3, 2020
• Primary Completion: September 3, 2020
• Study Completion: September 3, 2020
• Last Updated: November 19, 2020

Record last verified: 2020-11

Locations

NZ (1)