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

Renal Impairment Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02709382
• Other study ID #: W-4282-104
• Status: Completed
• Phase: Phase 1
• First received: February 26, 2016
• Last updated: August 25, 2016
• Start date: March 2016
• Est. completion date: August 2016

Study information

• Verified date: August 2016
• Source: Wockhardt
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Renal Impairment
• Renal Insufficiency

Intervention

Drug:
• Cefepime and Tazobactam combination

Locations

Country	Name	City	State
United States	University of Miami,Division of Clinical Pharmacology	Miami	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Wockhardt	Clinartis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	plasma concentrations (Cmax)		48 hrs	No
Primary	Tmax The elimination half-life (t1/2),		48 hrs	No
Secondary	Number of Participants With Abnormal Laboratory Values		14 days	Yes
Secondary	Number of Participants With Adverse Events		14 days	Yes