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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/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 - Incidence of adverse events following multiple doses of AR882
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 - Incidence of abnormal laboratory findings following multiple doses of AR882
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 - Incidence of abnormal electrocardiogram findings following multiple doses of AR882
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 - Incidence of abnormal vital signs findings following multiple doses of AR882
Timepoint [4] 0 0
22 Days
Primary outcome [5] 0 0
Area under the curve (AUC) for plasma AR882 - Profile from plasma in terms of AUC following multiple doses of AR882
Timepoint [5] 0 0
15 Days
Primary outcome [6] 0 0
Time to maximum plasma concentration (Tmax) for AR882 - Profile from plasma in terms of Tmax following multiple doses of AR882
Timepoint [6] 0 0
15 Days
Primary outcome [7] 0 0
Maximum plasma concentration (Cmax) for AR882 - Profile from plasma in terms of Cmax following multiple doses of AR882
Timepoint [7] 0 0
15 Days
Primary outcome [8] 0 0
Apparent terminal half-life (t1/2) for AR882 - Profile from plasma in terms of t1/2 following multiple doses of AR882
Timepoint [8] 0 0
15 Days
Primary outcome [9] 0 0
Amount excreted (Ae) into urine for AR882 - Profile from urine in terms of Ae following multiple doses of AR882
Timepoint [9] 0 0
15 Days
Primary outcome [10] 0 0
Fractional Excretion (FEUA) for AR882 - Profile from urine in terms of FEUA following multiple doses of AR882
Timepoint [10] 0 0
15 Days
Secondary outcome [1] 0 0
PD profile following multiple doses of AR882 - Profile from serum uric acid concentrations over time
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
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
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
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 study to assess multiple ascending doses of AR882 in healthy adult males.
Trial website
https://clinicaltrials.gov/show/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
Other publications