Trial Review

Did you know?

The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04314986




Registration number
NCT04314986
Ethics application status
Date submitted
10/03/2020
Date registered
19/03/2020
Date last updated
16/11/2020

Titles & IDs
Public title
Multiple Ascending Dose Study of AR882 in Healthy Adult Male Volunteers
Scientific title
A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study of AR882, a Potent Uricosuric Agent, in Healthy Adult Male Volunteers
Secondary ID [1] 0 0
AR882-102
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 or placebo
Treatment: Drugs - Cohort 2: AR882 or placebo
Treatment: Drugs - Cohort 3: AR882 or placebo
Treatment: Drugs - Cohort 4: AR882 or placebo

Experimental: AR882 (Dose A) -

Experimental: AR882 (Dose B) -

Experimental: AR882 (Dose C) -

Experimental: AR882 (Dose D) -

Placebo comparator: Placebo -


Treatment: Drugs: Cohort 1: AR882 or placebo
AR882 or matching placebo administered once daily for 10 days

Treatment: Drugs: Cohort 2: AR882 or placebo
AR882 or matching placebo administered once daily for 10 days.

Treatment: Drugs: Cohort 3: AR882 or placebo
AR882 or matching placebo administered once daily for 10 days

Treatment: Drugs: Cohort 4: AR882 or placebo
AR882 or matching placebo administered once daily for 10 days
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 adverse events
Timepoint [1] 0 0
22 Days
Primary outcome [2] 0 0
To evaluate the safety profile of AR882 based on incidence of abnormal laboratory findings
Timepoint [2] 0 0
22 Days
Primary outcome [3] 0 0
To evaluate the safety profile of AR882 based on incidence of abnormal electrocardiogram findings
Timepoint [3] 0 0
22 Days
Primary outcome [4] 0 0
To evaluate the safety profile of AR882 based on incidence of abnormal vital signs findings
Timepoint [4] 0 0
22 Days
Primary outcome [5] 0 0
Area under the curve (AUC) for plasma AR882
Timepoint [5] 0 0
15 Days
Primary outcome [6] 0 0
Time to maximum plasma concentration (Tmax) for AR882
Timepoint [6] 0 0
15 Days
Primary outcome [7] 0 0
Maximum plasma concentration (Cmax) for AR882
Timepoint [7] 0 0
15 Days
Primary outcome [8] 0 0
Apparent terminal half-life (t1/2) for AR882
Timepoint [8] 0 0
15 Days
Primary outcome [9] 0 0
Amount excreted (Ae) into urine for AR882
Timepoint [9] 0 0
15 Days
Primary outcome [10] 0 0
Fractional Excretion (FEUA) for AR882
Timepoint [10] 0 0
15 Days
Secondary outcome [1] 0 0
PD profile following multiple doses of AR882
Timepoint [1] 0 0
15 Days

Eligibility
Key inclusion criteria
* Screening serum uric acid level = 4.5 mg/dL (268 µmol/L) and < 9 mg/dL (535 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
Other
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
28/06/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
18/09/2019
Sample size
Target
Accrual to date
Final
30
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 study to assess multiple ascending doses of AR882 in healthy adult males.
Trial website
https://clinicaltrials.gov/study/NCT04314986
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

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04314986