To Investigate The Pharmacokinetics Of Intravenous WCK 5222 (FEP-ZID) In Patients With Renal Impairment
Status: | Completed |
---|---|
Conditions: | Renal Impairment / Chronic Kidney Disease |
Therapuetic Areas: | Nephrology / Urology |
Healthy: | No |
Age Range: | 18 - 80 |
Updated: | 8/4/2018 |
Start Date: | October 25, 2016 |
End Date: | April 2017 |
A Phase 1, Open-label, Single-dose Study to Investigate the Pharmacokinetics of Intravenous WCK 5222 (FEP-ZID) in Patients With Renal Impairment
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
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
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
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