NCT02942810

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Oct 2016

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 20, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 24, 2016

Completed
1 day until next milestone

Study Start

First participant enrolled

October 25, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
Last Updated

August 2, 2018

Status Verified

July 1, 2018

Enrollment Period

5 months

First QC Date

October 20, 2016

Last Update Submit

July 31, 2018

Conditions

Renal Impairment

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (1)

  • 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

Study Arms (1)

WCK 5222 (Cefepime and zidebactam combination)

EXPERIMENTAL

IV infusion over a period of 60 minutes

Drug: WCK 5222

Interventions

WCK 5222DRUG

IV infusion over a period of 60 minutes

Also known as: Cefepime and zidebactam combination
WCK 5222 (Cefepime and zidebactam combination)

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Miami,Division of Clinical Pharmacology

Miami, Florida, 33136, United States

Location

Related Publications (1)

  • 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.

    PMID: 30397067DERIVED

MeSH Terms

Conditions

Renal Insufficiency

Interventions

cefepime-zidebactamCefepime

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Cephalosporinsbeta-LactamsLactamsAmidesOrganic ChemicalsThiazinesSulfur CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 20, 2016

First Posted

October 24, 2016

Study Start

October 25, 2016

Primary Completion

April 1, 2017

Study Completion

April 1, 2017

Last Updated

August 2, 2018

Record last verified: 2018-07

Locations

US(1)