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

• Status: Completed
• Trial end date: 2016-08-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Wockhardt
• Collaborator: Clinartis
• Treatments: Cefepime; Tazobactam

Criteria

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)