Register a trial

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

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/NCT04646889




Registration number
NCT04646889
Ethics application status
Date submitted
18/11/2020
Date registered
30/11/2020

Titles & IDs
Public title
Pharmacokinetic Study of AR882 in Subjects With Various Degrees of Renal Impairment
Scientific title
A Phase 1, Pharmacokinetic and Pharmacodynamic Study of AR882 in Adult Volunteers With Various Degrees of Renal Impairment
Secondary ID [1] 0 0
AR882-104
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Renal Impairment 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - AR882 Single Dose
Treatment: Drugs - AR882 Multiple Dose

Experimental: Renal Impairment - Subjects with various degrees of renal impairment

Experimental: Normal Renal Function - Subjects with normal renal function


Treatment: Drugs: AR882 Single Dose
A single dose of AR882

Treatment: Drugs: AR882 Multiple Dose
AR882 taken once daily for 14 days
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Area under the curve (AUC) for plasma following a single dose of AR882 in subjects with renal impairment and normal renal function
Timepoint [1] 0 0
6 days
Primary outcome [2] 0 0
Time to maximum plasma concentration (Tmax) following a single dose of AR882 in subjects with renal impairment and normal renal function
Timepoint [2] 0 0
6 days
Primary outcome [3] 0 0
Maximum plasma concentration (Cmax) following a single dose of AR882 in subjects with renal impairment and normal renal function
Timepoint [3] 0 0
6 days
Primary outcome [4] 0 0
Terminal half-life (t 1/2) following a single dose of AR882 in subjects with renal impairment and normal renal function
Timepoint [4] 0 0
6 days
Primary outcome [5] 0 0
Amount excreted (Ae) into urine following a single dose of AR882 in subjects with renal impairment and normal renal function
Timepoint [5] 0 0
6 days
Primary outcome [6] 0 0
Renal clearance (CLr) following a single dose of AR882 in subjects with renal impairment and normal renal function
Timepoint [6] 0 0
6 days
Primary outcome [7] 0 0
AUC for plasma following multiple doses of AR882 in subjects with renal impairment and normal renal function
Timepoint [7] 0 0
15 days
Primary outcome [8] 0 0
Tmax following multiple doses of AR882 in subjects with renal impairment and normal renal function
Timepoint [8] 0 0
15 days
Primary outcome [9] 0 0
Cmax following multiple doses of AR882 in subjects with renal impairment and normal renal function
Timepoint [9] 0 0
15 days
Primary outcome [10] 0 0
t 1/2 following multiple doses of AR882 in subjects with renal impairment and normal renal function
Timepoint [10] 0 0
15 days
Secondary outcome [1] 0 0
Incidence of Adverse Events, changes in laboratory, electrocardiogram, and vital signs following a single dose of AR882 in subjects with renal impairment and normal renal function
Timepoint [1] 0 0
14 days
Secondary outcome [2] 0 0
Incidence of Adverse Events, changes in laboratory, electrocardiogram, and vital signs following multiple doses of AR882 in subjects with renal impairment and normal renal function
Timepoint [2] 0 0
21 days

Eligibility
Key inclusion criteria
All Subjects:

* Males and non-pregnant, non-lactating females
* Body weight no less than 50 kg
* sUA greater than or equal to 4.0 mg/dL

Renal Impaired Subjects:

• History of chronic renal impairment (> 6 months)
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
All Subjects:

* Malignancy within 5 years, except for successfully treated basal or squamous cell carcinoma of the skin
* History of cardiac abnormalities
* Active peptic ulcer disease or active liver disease
* History of kidney stones

Renal Impaired Subjects:

• Requires dialysis

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Open (masking not used)
Who is / are masked / blinded?



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
14/01/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
27/06/2022
Sample size
Target
Accrual to date
Final
46
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Florida
Country [2] 0 0
United States of America
State/province [2] 0 0
Texas
Country [3] 0 0
New Zealand
State/province [3] 0 0
Auckland
Country [4] 0 0
New Zealand
State/province [4] 0 0
Christchurch

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Arthrosi Therapeutics
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Iqvia Pty Ltd
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Vijay Hingorani, MD, PhD, MBA
Address 0 0
Arthrosi Therapeutics
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/NCT04646889