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

Wockhardt

Status and phase: Completed; Phase 1

Conditions: Renal Impairment

Treatments: Drug: Cefepime and Tazobactam combination

Study type: Interventional

Funder types: Industry

Identifiers

NCT02709382

W-4282-104

Details and patient eligibility

About

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).

Enrollment: 48 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

48 participants in 1 patient group

FEP-TAZ

Experimental group

Description:

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)

Treatment:

Drug: Cefepime and Tazobactam combination