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

Phase 1

Completed

• Conditions: Renal Impairment
• Interventions: Drug: WCK 5222

• Registration Number: NCT02942810
• Lead Sponsor: Wockhardt

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-10-20
• Study First Submitted QC: 2016-10-21
• Study First Posted: 2016-10-24
• Study Start: 2016-10-25
• Primary Completion: 2017-04
• Study Completion: 2017-04
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-31
• Last Update Posted: 2018-08-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
WCK 5222 (Cefepime and zidebactam combination)	WCK 5222	IV infusion over a period of 60 minutes

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

University of Miami,Division of Clinical Pharmacology; 🇺🇸 Miami, Florida, United States