This is a Phase 1, open-label study to assess the PK, safety and tolerability of XNW4107, imipenem and cilastatin administered by 60-minute (60-min) IV infusion to adults with various degrees of renal insufficiency as compared to subjects with normal renal function.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
39
Drug: XNW4107 250mg IV over 60 minutes as a single dose Drug: Imipenem/Cilastatin 500mg/500mg IV over 60 minutes as a single dose
Drug: XNW4107 250mg IV over 60 minutes as a single dose Drug: Imipenem/Cilastatin 500mg/500mg IV over 60 minutes as a single dose
Drug: XNW4107 250mg IV over 60 minutes as a single dose Drug: Imipenem/Cilastatin 500mg/500mg IV over 60 minutes as a single dose
Division of Clinical Pharmacology (DCP), University of Miami
Miami, Florida, United States
Orlando Clinical Research Center (OCRC)
Orlando, Florida, United States
Total body clearance (CL) of XNW4107, imipenem and cilastatin in subjects with various of Renal function.
Time frame: From baseline to 48 hours post-dose
Apparent steady-state volume of distribution (Vss) of XNW4107, imipenem and cilastatin in subjects with various of Renal function.
Time frame: From baseline to 48 hours post-dose
Area under the curve from time zero to infinity (AUC0-∞)of XNW4107, imipenem and cilastatin in subjects with various of Renal function.
Time frame: From baseline to 48 hours post-dose
Maximum plasma concentration (Cmax) of XNW4107, imipenem and cilastatin in subjects with various of Renal function.
Time frame: From baseline to 48 hours post-dose
Time to the maximum plasma concentration (Tmax) of XNW4107, imipenem and cilastatin in subjects with various of Renal function.
Time frame: From baseline to 48 hours post-dose
The terminal elimination half-life (t1/2) of XNW4107, imipenem and cilastatin in subjects with various of Renal function.
Time frame: From baseline to 48 hours post-dose
Adverse event (include SAEs) will be assessed and categorized.
Safety and tolerability up to the last study visit as assessed by the percentage of treatment-emergent AEs \[including serious adverse events (SAEs)\] categorized by severity, relationship to study drug, system organ class (SOC), AE preferred term (PT), along with percentage of clinically significant changes from baseline in clinical laboratory values, physical examination, vital signs, and ECG parameters.
Time frame: From baseline up to 10 days post-dose
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Drug: XNW4107 100mg IV over 60 minutes as a single dose Drug: Imipenem/Cilastatin 200mg/200mg IV over 60 minutes as a single dose
Drug: XNW4107 100mg IV over 60 minutes as a single dose Drug: Imipenem/Cilastatin 200mg/200mg IV over 60 minutes as a single dose