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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
46
A single dose of AR882
AR882 taken once daily for 14 days
Arthrosi Investigative Site
Orlando, Florida, United States
Arthrosi Investigative Site
Dallas, Texas, United States
Arthrosi Investigative Site
Auckland, New Zealand
Arthrosi Investigative Site
Christchurch, New Zealand
Area under the curve (AUC) for plasma following a single dose of AR882 in subjects with renal impairment and normal renal function
Time frame: 6 days
Time to maximum plasma concentration (Tmax) following a single dose of AR882 in subjects with renal impairment and normal renal function
Time frame: 6 days
Maximum plasma concentration (Cmax) following a single dose of AR882 in subjects with renal impairment and normal renal function
Time frame: 6 days
Terminal half-life (t 1/2) following a single dose of AR882 in subjects with renal impairment and normal renal function
Time frame: 6 days
Amount excreted (Ae) into urine following a single dose of AR882 in subjects with renal impairment and normal renal function
Time frame: 6 days
Renal clearance (CLr) following a single dose of AR882 in subjects with renal impairment and normal renal function
Time frame: 6 days
AUC for plasma following multiple doses of AR882 in subjects with renal impairment and normal renal function
Time frame: 15 days
Tmax following multiple doses of AR882 in subjects with renal impairment and normal renal function
Time frame: 15 days
Cmax following multiple doses of AR882 in subjects with renal impairment and normal renal function
Time frame: 15 days
t 1/2 following multiple doses of AR882 in subjects with renal impairment and normal renal function
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Time frame: 15 days
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
Time frame: 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
Time frame: 21 days