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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