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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT04347005
Ethics application status
Date submitted
10/03/2020
Date registered
15/04/2020

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
Timepoint [1] 0 0
8 Days
Primary outcome [2] 0 0
Safety Analyses
Timepoint [2] 0 0
8 Days
Primary outcome [3] 0 0
Safety Analyses
Timepoint [3] 0 0
8 Days
Primary outcome [4] 0 0
Safety Analyses
Timepoint [4] 0 0
8 Days
Primary outcome [5] 0 0
Safety Analyses
Timepoint [5] 0 0
8 Days
Primary outcome [6] 0 0
Safety Analyses
Timepoint [6] 0 0
8 Days
Primary outcome [7] 0 0
Safety Analyses
Timepoint [7] 0 0
8 Days
Primary outcome [8] 0 0
Safety Analyses
Timepoint [8] 0 0
8 Days
Primary outcome [9] 0 0
Safety Analyses
Timepoint [9] 0 0
8 Days
Primary outcome [10] 0 0
Safety Analyses
Timepoint [10] 0 0
8 Days
Primary outcome [11] 0 0
Safety Analyses
Timepoint [11] 0 0
8 Days
Primary outcome [12] 0 0
Safety Analyses
Timepoint [12] 0 0
8 Days
Primary outcome [13] 0 0
Area under the curve (AUC) for plasma AR882
Timepoint [13] 0 0
6 Days
Primary outcome [14] 0 0
Time to maximum plasma concentration (Tmax) for AR882
Timepoint [14] 0 0
6 Days
Primary outcome [15] 0 0
Maximum plasma concentration (Cmax) for AR882
Timepoint [15] 0 0
6 Days
Primary outcome [16] 0 0
Apparent terminal half-life (t1/2) for AR882
Timepoint [16] 0 0
6 Days
Primary outcome [17] 0 0
Amount excreted (Ae) into urine for AR882
Timepoint [17] 0 0
6 Days
Primary outcome [18] 0 0
Fractional Excretion (FEUA) for AR882
Timepoint [18] 0 0
6 Days
Secondary outcome [1] 0 0
PD profile of a single dose of AR882
Timepoint [1] 0 0
6 Days
Secondary outcome [2] 0 0
PD profile of a single dose of AR882 in combination with allopurinol
Timepoint [2] 0 0
6 Days
Secondary outcome [3] 0 0
PD profile of a single dose of AR882 in combination with febuxostat
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
Sex
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
22/01/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
31/07/2019
Sample size
Target
Accrual to date
Final
64
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
Trial website
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04347005