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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-25

Study Completion Date

2017-04-30

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

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Detailed Description

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Conditions

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Renal Impairment

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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WCK 5222 (Cefepime and zidebactam combination)

IV infusion over a period of 60 minutes

Group Type EXPERIMENTAL

WCK 5222

Intervention Type DRUG

IV infusion over a period of 60 minutes

Interventions

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WCK 5222

IV infusion over a period of 60 minutes

Intervention Type DRUG

Other Intervention Names

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Cefepime and zidebactam combination

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes