This is a multi-center, open-label, PK and safety study of VNRX-5133 and VNRX-5022 when co-administered in male and female subjects with varying levels of renal impairment and healthy normal controls.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
33
intravenous infusion
Orlando Cliniical Research Associates
Orlando, Florida, United States
New Orleans Center for Clinical Research
Knoxville, Tennessee, United States
Peak Plasma Concentration (Cmax)
To assess the pharmacokinetics of VNRX-5133 and VNRX-5022 in combination by assessment of Cmax
Time frame: 72 hours
Area under the plasma concentration versus time curve (AUC)
To assess the pharmacokinetics of VNRX-5133 and VNRX-5022 in combination by assessment of AUC
Time frame: 72 hours
Safety and tolerability of VNRX-5133 and VNRX-5022 measured as number of subjects with adverse events.
Number of Subjects with AEs (Assessed via patient report, physical exam, ECGs, vital signs, laboratory investigations, and use of concomitant medications for the treatment of AEs)
Time frame: 8 Days
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