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

Wockhardt

Status and phase: Completed; Phase 1

Conditions: Renal Impairment

Treatments: Drug: WCK 5222

Study type: Interventional

Funder types: Industry

Identifiers

NCT02942810

W-5222-102

Details and patient eligibility

About

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

Enrollment: 48 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Body mass index (BMI) 18.0 and 40.0 (kg/m2) and body weight of at least 50 kg.

   Patients with renal impairment:

2. Have a diagnosis of renal impairment that has been stable, without any change in overall disease status in the last 1 month

   Healthy Subjects:

3. 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.

4. 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

1. 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.
2. Evidence of hepatorenal syndrome or acute glomerulonephritis

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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48 participants in 1 patient group

WCK 5222 (Cefepime and zidebactam combination)

Experimental group

Description:

IV infusion over a period of 60 minutes

Treatment:

Drug: WCK 5222