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AR882 Single Dose

Phase 1

Renal Impairment | Small molecule | Nephrology |IQVIA Holdings, Inc.|Last Updated: Aug 5, 2022

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment46

FDA Designations

No designations recorded

Clinical trial landscape

AR882 Single Dose · 1 trial · 1 indication

Phase 1 1
NCT04646889Pharmacokinetic Study of AR882 in Subjects With Various Degrees of Renal ImpairmentRenal Impairment
COMPLETED46 Analytics
PHASE1COMPLETED
Pharmacokinetic Study of AR882 in Subjects With Various Degrees of Renal Impairment
Renal Impairment
NCT0464688946
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Study Endpoints

Primary Endpoints

Area under the curve (AUC) for plasma following a single dose of AR882 in subjects with renal impairment and normal renal function
6 days
Time to maximum plasma concentration (Tmax) following a single dose of AR882 in subjects with renal impairment and normal renal function
6 days
Maximum plasma concentration (Cmax) following a single dose of AR882 in subjects with renal impairment and normal renal function
6 days
Terminal half-life (t 1/2) following a single dose of AR882 in subjects with renal impairment and normal renal function
6 days
Amount excreted (Ae) into urine following a single dose of AR882 in subjects with renal impairment and normal renal function
6 days
Renal clearance (CLr) following a single dose of AR882 in subjects with renal impairment and normal renal function
6 days
AUC for plasma following multiple doses of AR882 in subjects with renal impairment and normal renal function
15 days
Tmax following multiple doses of AR882 in subjects with renal impairment and normal renal function
15 days
Cmax following multiple doses of AR882 in subjects with renal impairment and normal renal function
15 days
t 1/2 following multiple doses of AR882 in subjects with renal impairment and normal renal function
15 days

Secondary Endpoints

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
14 days
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
21 days
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Renal ImpairmentEXPERIMENTALSubjects with various degrees of renal impairment
Normal Renal FunctionEXPERIMENTALSubjects with normal renal function

Interventions

NameTypeDescription
AR882 Single DoseDRUGA single dose of AR882
AR882 Multiple DoseDRUGAR882 taken once daily for 14 days
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Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersYes
Study Sites4

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) Exclusion Criteria: All Subjects: * Malignancy within 5 year...

Countries:United StatesNew Zealand
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Frequently asked questions about AR882 Single Dose

What is AR882 Single Dose used for?

AR882 Single Dose is an investigational small molecule being studied for use in renal impairment. It is currently in Phase 1 clinical development, with a completed pharmacokinetic study evaluating the drug in subjects with various degrees of renal impairment.

Who is developing AR882 Single Dose?

AR882 Single Dose is being developed by IQVIA Holdings, Inc., a company traded on the stock exchange under the ticker symbol IQV. The drug is in Phase 1 clinical development for renal impairment.

What phase is AR882 Single Dose in?

AR882 Single Dose is in Phase 1 clinical development. One Phase 1 study of the drug has been completed, and the drug is not yet approved for any use. It remains investigational.

What clinical trials is AR882 Single Dose in?

AR882 Single Dose has one completed clinical trial, identified as NCT04646889, titled "Pharmacokinetic Study of AR882 in Subjects With Various Degrees of Renal Impairment." The study enrolled 46 participants and was conducted in the United States and New Zealand.

Is AR882 Single Dose being studied in healthy volunteers?

Yes, AR882 Single Dose is being studied in healthy volunteers. The completed Phase 1 trial, NCT04646889, included healthy volunteers and enrolled 46 participants aged 18 years and older, of all sexes.