A study to assess multiple ascending doses of AR882 in healthy adult males.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
30
AR882 or matching placebo administered once daily for 10 days
AR882 or matching placebo administered once daily for 10 days.
AR882 or matching placebo administered once daily for 10 days
Nucleus Network Pty, Ltd.
Melbourne, Victoria, Australia
To evaluate the safety profile of AR882 based on incidence of adverse events
Incidence of adverse events following multiple doses of AR882
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 22 Days
Area under the curve (AUC) for plasma AR882
Profile from plasma in terms of AUC following multiple doses of AR882
Time frame: 15 Days
Time to maximum plasma concentration (Tmax) for AR882
Profile from plasma in terms of Tmax following multiple doses of AR882
Time frame: 15 Days
Maximum plasma concentration (Cmax) for AR882
Profile from plasma in terms of Cmax following multiple doses of AR882
Time frame: 15 Days
Apparent terminal half-life (t1/2) for AR882
Profile from plasma in terms of t1/2 following multiple doses of AR882
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AR882 or matching placebo administered once daily for 10 days
Time frame: 15 Days
Amount excreted (Ae) into urine for AR882
Profile from urine in terms of Ae following multiple doses of AR882
Time frame: 15 Days
Fractional Excretion (FEUA) for AR882
Profile from urine in terms of FEUA following multiple doses of AR882
Time frame: 15 Days
PD profile following multiple doses of AR882
Profile from serum uric acid concentrations over time
Time frame: 15 Days