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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT04347005




Registration number
NCT04347005
Ethics application status
Date submitted
10/03/2020
Date registered
15/04/2020
Date last updated
16/11/2020

Titles & IDs
Public title
The Study is Designed to Evaluate Single Ascending Doses of AR882 in Healthy Adult Males
Scientific title
A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single Rising Dose Study of AR882, a Potent Uricosuric Agent, in Healthy Adult Male Volunteers
Secondary ID [1] 0 0
AR882-101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy Volunteers 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Cohort 1: AR882
Treatment: Drugs - Cohort 2: AR882
Treatment: Drugs - Cohort 3: AR882
Treatment: Drugs - Cohort 4: AR882
Treatment: Drugs - Cohort 5: AR882
Treatment: Drugs - Cohort 6: AR882 Food Effect
Treatment: Drugs - Cohort 7: AR882 Solid Oral Formulation
Treatment: Drugs - Cohort 8: AR882 in combination with allopurinol
Treatment: Drugs - Cohort 9: AR882 in combination with febuxostat

Experimental: AR882 (Dose A) -

Experimental: AR882 (Dose B) -

Experimental: AR882 (Dose C) -

Experimental: AR882 (Dose D) -

Experimental: AR882 (Dose E) -

Experimental: AR882 (Dose B) Solid Oral Formulation -

Placebo Comparator: Placebo -

Active Comparator: Allopurinol -

Active Comparator: Febuxostat -


Treatment: Drugs: Cohort 1: AR882
Single dose of AR882 or matching placebo

Treatment: Drugs: Cohort 2: AR882
Single dose of AR882 or matching placebo

Treatment: Drugs: Cohort 3: AR882
Single dose of AR882 or matching placebo

Treatment: Drugs: Cohort 4: AR882
Single dose of AR882 or matching placebo

Treatment: Drugs: Cohort 5: AR882
Single dose of AR882 or matching placebo

Treatment: Drugs: Cohort 6: AR882 Food Effect
Single dose of AR882 or matching placebo in a fed state

Treatment: Drugs: Cohort 7: AR882 Solid Oral Formulation
Single dose of AR882 or matching placebo

Treatment: Drugs: 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

Treatment: Drugs: 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 code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
To evaluate the safety profile of AR882 based on incidence of abnormal laboratory findings - Analysis of abnormal safety laboratory findings
Timepoint [1] 0 0
8 Days
Primary outcome [2] 0 0
Safety Analyses - ECG Heart Rate
Timepoint [2] 0 0
8 Days
Primary outcome [3] 0 0
Safety Analyses - ECG PR-Interval
Timepoint [3] 0 0
8 Days
Primary outcome [4] 0 0
Safety Analyses - ECG RR-Interval
Timepoint [4] 0 0
8 Days
Primary outcome [5] 0 0
Safety Analyses - ECG QRS-Interval
Timepoint [5] 0 0
8 Days
Primary outcome [6] 0 0
Safety Analyses - ECG QT-Interval
Timepoint [6] 0 0
8 Days
Primary outcome [7] 0 0
Safety Analyses - ECG QTc-Interval
Timepoint [7] 0 0
8 Days
Primary outcome [8] 0 0
Safety Analyses - Vital Sign - Systolic Blood Pressure
Timepoint [8] 0 0
8 Days
Primary outcome [9] 0 0
Safety Analyses - Vital Sign - Diastolic Blood Pressure
Timepoint [9] 0 0
8 Days
Primary outcome [10] 0 0
Safety Analyses - Vital Sign - Pulse Rate
Timepoint [10] 0 0
8 Days
Primary outcome [11] 0 0
Safety Analyses - Vital Sign - Body Temperature
Timepoint [11] 0 0
8 Days
Primary outcome [12] 0 0
Safety Analyses - Vital Sign - Respiratory Rate
Timepoint [12] 0 0
8 Days
Primary outcome [13] 0 0
Area under the curve (AUC) for plasma AR882 - Profile from plasma in terms of AUC for AR882
Timepoint [13] 0 0
6 Days
Primary outcome [14] 0 0
Time to maximum plasma concentration (Tmax) for AR882 - Profile from plasma in terms of Tmax for AR882
Timepoint [14] 0 0
6 Days
Primary outcome [15] 0 0
Maximum plasma concentration (Cmax) for AR882 - Profile from plasma in terms of Cmax for AR882
Timepoint [15] 0 0
6 Days
Primary outcome [16] 0 0
Apparent terminal half-life (t1/2) for AR882 - Profile from plasma in terms of t1/2 for AR882
Timepoint [16] 0 0
6 Days
Primary outcome [17] 0 0
Amount excreted (Ae) into urine for AR882 - Profile from urine in terms of Ae for AR882
Timepoint [17] 0 0
6 Days
Primary outcome [18] 0 0
Fractional Excretion (FEUA) for AR882 - Profile from urine in terms of FEUA for AR882
Timepoint [18] 0 0
6 Days
Secondary outcome [1] 0 0
PD profile of a single dose of AR882 - Profile from serum uric acid concentrations over time
Timepoint [1] 0 0
6 Days
Secondary outcome [2] 0 0
PD profile of a single dose of AR882 in combination with allopurinol - Profile from serum uric acid concentrations over time
Timepoint [2] 0 0
6 Days
Secondary outcome [3] 0 0
PD profile of a single dose of AR882 in combination with febuxostat - Profile from serum uric acid concentrations over time
Timepoint [3] 0 0
6 Days

Eligibility
Key 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
Minimum age
18 Years
Maximum age
55 Years
Gender
Males
Can healthy volunteers participate?
Yes
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Nucleus Network Pty, Ltd. - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Arthrosi Therapeutics
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
A randomized, double-blind, placebo-controlled, single ascending dose study of AR882 in
healthy adult males.
Trial website
https://clinicaltrials.gov/show/NCT04347005
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications