To Investigate The Pharmacokinetics Of Intravenous WCK 5222 (FEP-ZID) In Patients With Renal Impairment
Completed · Phase 1
Conditions studied: Renal Impairment
In brief
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
Key facts
- Study ID
- NCT02942810
- Run by
- Wockhardt
- People needed
- 48
- Starts
- 2016-10-25
- Expected to finish
- 2017-04-01
- Last updated by the study team
- 2018-08-02
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: accepted.
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
Where it is running
- University of Miami,Division of Clinical Pharmacology — Miami, Florida, United States
Full record on ClinicalTrials.gov
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