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| Name | Class |
|---|---|
| Clinartis | INDUSTRY |
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| WCK 5222 (Cefepime and zidebactam combination) | Experimental | IV infusion over a period of 60 minutes |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| WCK 5222 | Drug | IV infusion over a period of 60 minutes |
|
| Measure | Description | 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 |
| Measure | Description | 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 |
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Inclusion Criteria:
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.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami,Division of Clinical Pharmacology | Miami | Florida | 33136 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30397067 | Derived | 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. |
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| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| C000624485 | cefepime-zidebactam |
| D000077723 | Cefepime |
| ID | Term |
|---|---|
| D002511 | Cephalosporins |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D009930 |
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| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| Organic Chemicals |
| D013843 | Thiazines |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |