A Single-dose Study to Investigate the Pharmacokinetics of Intravenous FEP-TAZ in Patients With Renal Impairment

Phase 1

Completed

• Conditions: Renal Impairment
• Interventions: Drug: Cefepime and Tazobactam combination

• Registration Number: NCT02709382
• Lead Sponsor: Wockhardt

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-02-26
• Study Start: 2016-03
• Study First Submitted QC: 2016-03-10
• Study First Posted: 2016-03-16
• Status Verified: 2016-08
• Primary Completion: 2016-08
• Study Completion: 2016-08
• Last Update Submitted: 2016-08-25
• Last Update Posted: 2016-08-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

-Patients with renal impairment: mild, moderate, severe and patients on hemodialysis) that has been stable OR

• Healthy Subjects:
• Have normal renal function
• No evidence of any disease or condition that may affect pharmacokinetics of FEP-TAZ.

Exclusion Criteria

• Evidence of hepatorenal or nephritic syndrome
• Any clinically significant abnormal findings on medical history, physical examination,or clinical laboratory tests (other than those associated with controlled diabetes,hypertension, hypercholesterolemia, dyslipidemia, or renal impairment or related or causative diseases)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
FEP-TAZ	Cefepime and Tazobactam combination	Cefepime and Tazobactam combination; IV infusion over a period of 90 minutes Healthy subjects, Mild and Moderate RI: 4 g (2 g FEP and 2 g TAZ) Severe RI and patients on HD: 2 g (1 g FEP and 1 g TAZ)

Primary Outcome Measures

Name	Time	Method
plasma concentrations (Cmax)	48 hrs
Tmax The elimination half-life (t1/2),	48 hrs

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Abnormal Laboratory Values	14 days
Number of Participants With Adverse Events	14 days

Trial Locations

Locations (1)

University of Miami,Division of Clinical Pharmacology; 🇺🇸 Miami, Florida, United States