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

Overview

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).

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Masking: None (Open Label)
  • Study Primary Completion Date: August 2016

Interventions

  • Drug: Cefepime and Tazobactam combination

Arms, Groups and Cohorts

  • Experimental: FEP-TAZ
    • 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)

Clinical Trial Outcome Measures

Primary Measures

  • plasma concentrations (Cmax)
    • Time Frame: 48 hrs
  • Tmax The elimination half-life (t1/2),
    • Time Frame: 48 hrs

Secondary Measures

  • Number of Participants With Abnormal Laboratory Values
    • Time Frame: 14 days
  • Number of Participants With Adverse Events
    • Time Frame: 14 days

Participating in This Clinical Trial

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)

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Wockhardt
  • Collaborator
    • Clinartis
  • Provider of Information About this Clinical Study
    • Sponsor

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