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The Study is Designed to Evaluate Single Ascending Doses of AR882 in Healthy Adult Males

NCT ID: NCT04347005

Last Updated: 2020-11-16

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

PHASE1

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-22

Study Completion Date

2019-07-31

Brief Summary

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A randomized, double-blind, placebo-controlled, single ascending dose study of AR882 in healthy adult males.

Detailed Description

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Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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AR882 (Dose A)

Group Type EXPERIMENTAL

Cohort 1: AR882

Intervention Type DRUG

Single dose of AR882 or matching placebo

AR882 (Dose B)

Group Type EXPERIMENTAL

Cohort 2: AR882

Intervention Type DRUG

Single dose of AR882 or matching placebo

Cohort 6: AR882 Food Effect

Intervention Type DRUG

Single dose of AR882 or matching placebo in a fed state

Cohort 8: AR882 in combination with allopurinol

Intervention Type DRUG

Single dose of allopurinol alone and a single dose of AR882 in combination with a single dose of allopurinol

Cohort 9: AR882 in combination with febuxostat

Intervention Type DRUG

Single dose of febuxostat alone and a single dose of AR882 in combination with a single dose of febuxostat

AR882 (Dose C)

Group Type EXPERIMENTAL

Cohort 3: AR882

Intervention Type DRUG

Single dose of AR882 or matching placebo

AR882 (Dose D)

Group Type EXPERIMENTAL

Cohort 4: AR882

Intervention Type DRUG

Single dose of AR882 or matching placebo

AR882 (Dose E)

Group Type EXPERIMENTAL

Cohort 5: AR882

Intervention Type DRUG

Single dose of AR882 or matching placebo

AR882 (Dose B) Solid Oral Formulation

Group Type EXPERIMENTAL

Cohort 7: AR882 Solid Oral Formulation

Intervention Type DRUG

Single dose of AR882 or matching placebo

Placebo

Group Type PLACEBO_COMPARATOR

Cohort 1: AR882

Intervention Type DRUG

Single dose of AR882 or matching placebo

Cohort 2: AR882

Intervention Type DRUG

Single dose of AR882 or matching placebo

Cohort 3: AR882

Intervention Type DRUG

Single dose of AR882 or matching placebo

Cohort 4: AR882

Intervention Type DRUG

Single dose of AR882 or matching placebo

Cohort 5: AR882

Intervention Type DRUG

Single dose of AR882 or matching placebo

Cohort 6: AR882 Food Effect

Intervention Type DRUG

Single dose of AR882 or matching placebo in a fed state

Cohort 7: AR882 Solid Oral Formulation

Intervention Type DRUG

Single dose of AR882 or matching placebo

Allopurinol

Group Type ACTIVE_COMPARATOR

Cohort 8: AR882 in combination with allopurinol

Intervention Type DRUG

Single dose of allopurinol alone and a single dose of AR882 in combination with a single dose of allopurinol

Febuxostat

Group Type ACTIVE_COMPARATOR

Cohort 9: AR882 in combination with febuxostat

Intervention Type DRUG

Single dose of febuxostat alone and a single dose of AR882 in combination with a single dose of febuxostat

Interventions

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Cohort 1: AR882

Single dose of AR882 or matching placebo

Intervention Type DRUG

Cohort 2: AR882

Single dose of AR882 or matching placebo

Intervention Type DRUG

Cohort 3: AR882

Single dose of AR882 or matching placebo

Intervention Type DRUG

Cohort 4: AR882

Single dose of AR882 or matching placebo

Intervention Type DRUG

Cohort 5: AR882

Single dose of AR882 or matching placebo

Intervention Type DRUG

Cohort 6: AR882 Food Effect

Single dose of AR882 or matching placebo in a fed state

Intervention Type DRUG

Cohort 7: AR882 Solid Oral Formulation

Single dose of AR882 or matching placebo

Intervention Type DRUG

Cohort 8: AR882 in combination with allopurinol

Single dose of allopurinol alone and a single dose of AR882 in combination with a single dose of allopurinol

Intervention Type DRUG

Cohort 9: AR882 in combination with febuxostat

Single dose of febuxostat alone and a single dose of AR882 in combination with a single dose of febuxostat

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Serum uric acid level ≥ 4.5 mg/dL (268 µmol/L)
* Body weight no less than 50 kg and body mass index (BMI) within the range of ≥18 and ≤33 kg/m2
* Must be free of any clinically significant disease that requires a physician's care and/or would interfere with study evaluations or procedures

Exclusion Criteria

* Malignancy within 5 years, except for successfully treated basal or squamous cell carcinoma of the skin
* History of cardiac abnormalities
* History and/or presence of drug addiction or excessive use of alcohol
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Arthrosi Therapeutics

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Nucleus Network Pty, Ltd.

Melbourne, Victoria, Australia

Site Status

Countries

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Australia

Other Identifiers

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AR882-101

Identifier Type: -

Identifier Source: org_study_id