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

Primary Purpose

Renal Impairment

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
WCK 5222
Sponsored by
Wockhardt
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Renal Impairment

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • University of Miami,Division of Clinical Pharmacology

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

WCK 5222 (Cefepime and zidebactam combination)

Arm Description

IV infusion over a period of 60 minutes

Outcomes

Primary Outcome Measures

maximum plasma concentrations (Cmax)
area under the plasma concentration versus time curve

Secondary Outcome Measures

Safety assessment with number of abnormalities reported by physical examination, vital signs,ECG, clinical laboratory parameters, local tolerability at injection site and adverse events.

Full Information

First Posted
October 20, 2016
Last Updated
July 31, 2018
Sponsor
Wockhardt
Collaborators
Clinartis
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1. Study Identification

Unique Protocol Identification Number
NCT02942810
Brief Title
To Investigate The Pharmacokinetics Of Intravenous WCK 5222 (FEP-ZID) In Patients With Renal Impairment
Official Title
A Phase 1, Open-label, Single-dose Study to Investigate the Pharmacokinetics of Intravenous WCK 5222 (FEP-ZID) in Patients With Renal Impairment
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
October 25, 2016 (Actual)
Primary Completion Date
April 2017 (Actual)
Study Completion Date
April 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wockhardt
Collaborators
Clinartis

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Impairment

7. Study Design

Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
WCK 5222 (Cefepime and zidebactam combination)
Arm Type
Experimental
Arm Description
IV infusion over a period of 60 minutes
Intervention Type
Drug
Intervention Name(s)
WCK 5222
Other Intervention Name(s)
Cefepime and zidebactam combination
Intervention Description
IV infusion over a period of 60 minutes
Primary Outcome Measure Information:
Title
maximum plasma concentrations (Cmax)
Time Frame
from 0 hours to day 3
Title
area under the plasma concentration versus time curve
Time Frame
from 0 hours to day 3
Secondary Outcome Measure Information:
Title
Safety assessment with number of abnormalities reported by physical examination, vital signs,ECG, clinical laboratory parameters, local tolerability at injection site and adverse events.
Time Frame
Day 1-3 and day 1 of follow up visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
University of Miami,Division of Clinical Pharmacology
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
30397067
Citation
Preston RA, Mamikonyan G, DeGraff S, Chiou J, Kemper CJ, Xu A, Mastim M, Yeole R, Chavan R, Patel A, Friedland HD, Bhatia A. Single-Center Evaluation of the Pharmacokinetics of WCK 5222 (Cefepime-Zidebactam Combination) in Subjects with Renal Impairment. Antimicrob Agents Chemother. 2018 Dec 21;63(1):e01484-18. doi: 10.1128/AAC.01484-18. Print 2019 Jan.
Results Reference
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To Investigate The Pharmacokinetics Of Intravenous WCK 5222 (FEP-ZID) In Patients With Renal Impairment

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