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

Completed · Phase 1

Conditions studied: Renal Impairment

In brief

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).

Key facts

Study ID

NCT02709382

Run by

Wockhardt

People needed

48

Starts

2016-03-01

Expected to finish

2016-08-01

Last updated by the study team

2016-08-26

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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)

Where it is running

• University of Miami,Division of Clinical Pharmacology — Miami, Florida, United States

Full record on ClinicalTrials.gov

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