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AR882 Single Dose

Phase 1

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

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
CONTROLLED
Total Trials1
Total Enrollment46
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04646889Pharmacokinetic Study of AR882 in Subjects With Various Degrees of Renal ImpairmentPHASE1 COMPLETED 46 — — Jan 14, 2021Jun 27, 2022Aug 5, 20224 United States, New Zealand
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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 — 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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