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

Renal Impairment Clinical Trial

Official title:

A Phase 1, Open-label, Single-dose Study to Investigate the Pharmacokinetics of Intravenous WCK 5222 (FEP-ZID) in Patients With Renal Impairment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02942810
• Other study ID #: W-5222-102
• Status: Completed
• Phase: Phase 1
• Start date: October 25, 2016
• Est. completion date: April 2017

Study information

• Verified date: July 2018
• Source: Wockhardt
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: April 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Renal Impairment
• Renal Insufficiency

Intervention

Drug:
• WCK 5222
IV infusion over a period of 60 minutes

Locations

Country	Name	City	State
United States	University of Miami,Division of Clinical Pharmacology	Miami	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Wockhardt	Clinartis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	maximum plasma concentrations (Cmax)		from 0 hours to day 3
Primary	area under the plasma concentration versus time curve		from 0 hours to day 3
Secondary	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