To Investigate The Pharmacokinetics Of Intravenous WCK 5222 (FEP-ZID) In Patients With Renal Impairment

Study Overview
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Brief Summary
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This is a Phase 1, open label, single-dose, pharmacokinetic study to be conducted in male and female subjects with normal and impaired renal function. The study will be composed of five groups of patients with mild (6 patients), moderate (6 patients), severe (6 patients) renal impairment, end stage renal disease patients on hemodialysis (6 patients) and their respective matched controls in 1:1 ratio (24 healthy subjects with normal renal function). The severity of renal impairment will be assessed based on estimated creatinine clearance (CLCR) by the Cockcroft-Gault equation

Official Title
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A Phase 1, Open-label, Single-dose Study to Investigate the Pharmacokinetics of Intravenous WCK 5222 (FEP-ZID) in Patients With Renal Impairment

Conditions
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Renal Impairment

Intervention / Treatment
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* Drug: WCK 5222


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Body mass index (BMI) 18.0 and 40.0 (kg/m2) and body weight of at least 50 kg. Patients with renal impairment: Have a diagnosis of renal impairment that has been stable, without any change in overall disease status in the last 1 month Healthy Subjects: Have normal renal function with creatinine clearance more than 90 mL/min and no evidence of any disease or condition that may affect pharmacokinetics of FEP ZID. A resting blood pressure 90-145 (systolic) / 60-95 (diastolic) mmHg for healthy volunteers and 90-155 (systolic) / 50-100 (diastolic) mmHg for patients with renal impairment. Exclusion Criteria: History or presence of significant hematologic, pulmonary, cardiovascular, gastrointestinal, neurological, rheumatologic, hepatic, urologic, immunologic, infectious, skin and subcutaneous tissue, psychiatric or mood disorders (including any past suicide attempt), or uncontrolled metabolic or endocrine disorders (including diabetes, hypercholesterolemia, or dyslipidemia) that in the opinion of the Investigator would confound subject's participation and follow-up in the clinical trial. Evidence of hepatorenal syndrome or acute glomerulonephritis

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: WCK 5222 (Cefepime and zidebactam combination)<br>IV infusion over a period of 60 minutes | Drug: WCK 5222<br>* IV infusion over a period of 60 minutes<br>* Other names: Cefepime and zidebactam combination;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| maximum plasma concentrations (Cmax) |  | from 0 hours to day 3 | 
| area under the plasma concentration versus time curve |  | from 0 hours to day 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety assessment with number of abnormalities reported by physical examination, vital signs,ECG, clinical laboratory parameters, local tolerability at injection site and adverse events. |  | Day 1-3 and day 1 of follow up visit |