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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04646889




Registration number
NCT04646889
Ethics application status
Date submitted
18/11/2020
Date registered
30/11/2020
Date last updated
5/08/2022

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
This is a 2-segment, multi-center, phase 1, open-label, study evaluating the pharmacokinetics
and pharmacodynamics of AR882 in subjects with various degrees of renal impairment.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04646889
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04646889