Renal Impairment
Conditions
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
Interventions
DRUGWCK 5222
IV infusion over a period of 60 minutes
Sponsors
Clinartis
Wockhardt
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Outcome results
None listed