Pharmacokinetic Study of AR882 in Subjects With Various Degrees of Renal Impairment

Study Overview
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Brief Summary
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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.

Official Title
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A Phase 1, Pharmacokinetic and Pharmacodynamic Study of AR882 in Adult Volunteers With Various Degrees of Renal Impairment

Conditions
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Renal Impairment

Intervention / Treatment
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* Drug: AR882 Single Dose
* Drug: AR882 Multiple Dose


Participation Criteria
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Eligibility Criteria
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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 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Renal Impairment<br>Subjects with various degrees of renal impairment | Drug: AR882 Single Dose<br>* A single dose of AR882<br>Drug: AR882 Multiple Dose<br>* AR882 taken once daily for 14 days<br>|
| Experimental: Normal Renal Function<br>Subjects with normal renal function | Drug: AR882 Single Dose<br>* A single dose of AR882<br>Drug: AR882 Multiple Dose<br>* AR882 taken once daily for 14 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |