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

NCT ID: NCT04155918

Last Updated: 2020-11-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-03

Study Completion Date

2020-09-03

Brief Summary

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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.

Detailed Description

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Conditions

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Gout Patients

Keywords

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Hyperuricemia Gout URAT1

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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AR882/FBX

Group Type EXPERIMENTAL

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

Intervention Type DRUG

AR882 + Febuxostat, AR882 alone, Febuxostat alone

AR882/ALLO

Group Type EXPERIMENTAL

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

Intervention Type DRUG

AR882 + Allopurinol, AR882 alone, Allopurinol alone

Interventions

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

AR882 + Febuxostat, AR882 alone, Febuxostat alone

Intervention Type DRUG

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

AR882 + Allopurinol, AR882 alone, Allopurinol alone

Intervention Type DRUG

Other Intervention Names

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Febuxostat (Adenuric®, Uloric®) Allopurinol (Allosig®, Progout®, Zyloprim®)

Eligibility Criteria

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Inclusion Criteria

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

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Arthrosi Therapeutics

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Christopher Wynne, MBChB, Grad Dip Pharm Med

Role: PRINCIPAL_INVESTIGATOR

Christchurch Clinical Studies Trust Ltd

Locations

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Christchurch Clinical Studies Trust, Ltd (CCST)

Christchurch, , New Zealand

Site Status

Countries

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New Zealand

Other Identifiers

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AR882-201

Identifier Type: -

Identifier Source: org_study_id