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A randomized, double-blind, placebo-controlled, single ascending dose study 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 |
| |
| AR882 (Dose E) | Experimental |
| |
| AR882 (Dose B) Solid Oral Formulation | Experimental |
| |
| Placebo | Placebo Comparator |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cohort 1: AR882 | Drug | Single dose of AR882 or matching placebo |
| |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the safety profile of AR882 based on incidence of abnormal laboratory findings | Analysis of abnormal safety laboratory findings | 8 Days |
| Safety Analyses | ECG Heart Rate | 8 Days |
| Safety Analyses | ECG PR-Interval | 8 Days |
| Safety Analyses | ECG RR-Interval | 8 Days |
| Safety Analyses | ECG QRS-Interval | 8 Days |
| Safety Analyses | ECG QT-Interval | 8 Days |
| Safety Analyses | ECG QTc-Interval | 8 Days |
| Safety Analyses | Vital Sign - Systolic Blood Pressure | 8 Days |
| Safety Analyses | Vital Sign - Diastolic Blood Pressure | 8 Days |
| Measure | Description | Time Frame |
|---|---|---|
| PD profile of a single dose of AR882 | Profile from serum uric acid concentrations over time | 6 Days |
| PD profile of a single dose of AR882 in combination with allopurinol | Profile from serum uric acid concentrations over time |
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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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| Allopurinol | Active Comparator |
|
| Febuxostat | Active Comparator |
|
| Cohort 2: AR882 |
| Drug |
Single dose of AR882 or matching placebo |
|
| Cohort 3: AR882 | Drug | Single dose of AR882 or matching placebo |
|
| Cohort 4: AR882 | Drug | Single dose of AR882 or matching placebo |
|
| Cohort 5: AR882 | Drug | Single dose of AR882 or matching placebo |
|
| Cohort 6: AR882 Food Effect | Drug | Single dose of AR882 or matching placebo in a fed state |
|
| Cohort 7: AR882 Solid Oral Formulation | Drug | Single dose of AR882 or matching placebo |
|
| Cohort 8: AR882 in combination with allopurinol | Drug | Single dose of allopurinol alone and a single dose of AR882 in combination with a single dose of allopurinol |
|
| Cohort 9: AR882 in combination with febuxostat | Drug | Single dose of febuxostat alone and a single dose of AR882 in combination with a single dose of febuxostat |
|
| Safety Analyses |
Vital Sign - Pulse Rate |
| 8 Days |
| Safety Analyses | Vital Sign - Body Temperature | 8 Days |
| Safety Analyses | Vital Sign - Respiratory Rate | 8 Days |
| Area under the curve (AUC) for plasma AR882 | Profile from plasma in terms of AUC for AR882 | 6 Days |
| Time to maximum plasma concentration (Tmax) for AR882 | Profile from plasma in terms of Tmax for AR882 | 6 Days |
| Maximum plasma concentration (Cmax) for AR882 | Profile from plasma in terms of Cmax for AR882 | 6 Days |
| Apparent terminal half-life (t1/2) for AR882 | Profile from plasma in terms of t1/2 for AR882 | 6 Days |
| Amount excreted (Ae) into urine for AR882 | Profile from urine in terms of Ae for AR882 | 6 Days |
| Fractional Excretion (FEUA) for AR882 | Profile from urine in terms of FEUA for AR882 | 6 Days |
| 6 Days |
| PD profile of a single dose of AR882 in combination with febuxostat | Profile from serum uric acid concentrations over time | 6 Days |
| ID | Term |
|---|---|
| D000493 | Allopurinol |
| D000069465 | Febuxostat |
| ID | Term |
|---|---|
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
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