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A study to assess multiple ascending doses of AR882 in healthy adult males.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AR882 (Dose A) | Experimental |
| |
| AR882 (Dose B) | Experimental |
| |
| AR882 (Dose C) | Experimental |
| |
| AR882 (Dose D) | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cohort 1: AR882 or placebo | Drug | AR882 or matching placebo administered once daily for 10 days |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| PD profile following multiple doses of AR882 | Profile from serum uric acid concentrations over time | 15 Days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nucleus Network Pty, Ltd. | Melbourne | Victoria | 3004 | Australia |
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| Cohort 2: AR882 or placebo | Drug | AR882 or matching placebo administered once daily for 10 days. |
|
| Cohort 3: AR882 or placebo | Drug | AR882 or matching placebo administered once daily for 10 days |
|
| Cohort 4: AR882 or placebo | Drug | AR882 or matching placebo administered once daily for 10 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 |