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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