Multiple Ascending Dose Study of AR882 in Healthy Adult Male Volunteers

Study Overview
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Brief Summary
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A study to assess multiple ascending doses of AR882 in healthy adult males.

Official Title
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A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study of AR882, a Potent Uricosuric Agent, in Healthy Adult Male Volunteers

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: Cohort 1: AR882 or placebo
* Drug: Cohort 2: AR882 or placebo
* Drug: Cohort 3: AR882 or placebo
* Drug: Cohort 4: AR882 or placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Screening serum uric acid level ≥ 4.5 mg/dL (268 µmol/L) and < 9 mg/dL (535 µmol/L) Body weight no less than 50 kg and body mass index (BMI) within the range of ≥18 and ≤33 kg/m2 Must be free of any clinically significant disease that requires a physician's care and/or would interfere with study evaluations or procedures Exclusion Criteria: Malignancy within 5 years, except for successfully treated basal or squamous cell carcinoma of the skin History of cardiac abnormalities History and/or presence of drug addiction or excessive use of alcohol

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Male

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: Randomized
Intervention Model: Sequential Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AR882 (Dose A)<br> | Drug: Cohort 1: AR882 or placebo<br>* AR882 or matching placebo administered once daily for 10 days<br>|
| Experimental: AR882 (Dose B)<br> | Drug: Cohort 2: AR882 or placebo<br>* AR882 or matching placebo administered once daily for 10 days.<br>|
| Experimental: AR882 (Dose C)<br> | Drug: Cohort 3: AR882 or placebo<br>* AR882 or matching placebo administered once daily for 10 days<br>|
| Experimental: AR882 (Dose D)<br> | Drug: Cohort 4: AR882 or placebo<br>* AR882 or matching placebo administered once daily for 10 days<br>|
| Placebo Comparator: Placebo<br> | Drug: Cohort 1: AR882 or placebo<br>* AR882 or matching placebo administered once daily for 10 days<br>Drug: Cohort 2: AR882 or placebo<br>* AR882 or matching placebo administered once daily for 10 days.<br>Drug: Cohort 3: AR882 or placebo<br>* AR882 or matching placebo administered once daily for 10 days<br>Drug: Cohort 4: AR882 or placebo<br>* AR882 or matching placebo administered once daily for 10 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the safety profile of AR882 based on incidence of adverse events | Incidence of adverse events following multiple doses of AR882 | 22 Days | 
| To evaluate the safety profile of AR882 based on incidence of abnormal laboratory findings | Incidence of abnormal laboratory findings following multiple doses of AR882 | 22 Days | 
| To evaluate the safety profile of AR882 based on incidence of abnormal electrocardiogram findings | Incidence of abnormal electrocardiogram findings following multiple doses of AR882 | 22 Days | 
| To evaluate the safety profile of AR882 based on incidence of abnormal vital signs findings | Incidence of abnormal vital signs findings following multiple doses of AR882 | 22 Days | 
| Area under the curve (AUC) for plasma AR882 | Profile from plasma in terms of AUC following multiple doses of AR882 | 15 Days | 
| Time to maximum plasma concentration (Tmax) for AR882 | Profile from plasma in terms of Tmax following multiple doses of AR882 | 15 Days | 
| Maximum plasma concentration (Cmax) for AR882 | Profile from plasma in terms of Cmax following multiple doses of AR882 | 15 Days | 
| Apparent terminal half-life (t1/2) for AR882 | Profile from plasma in terms of t1/2 following multiple doses of AR882 | 15 Days | 
| Amount excreted (Ae) into urine for AR882 | Profile from urine in terms of Ae following multiple doses of AR882 | 15 Days | 
| Fractional Excretion (FEUA) for AR882 | Profile from urine in terms of FEUA following multiple doses of AR882 | 15 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PD profile following multiple doses of AR882 | Profile from serum uric acid concentrations over time | 15 Days |