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Completed

NCT Number: NCT02709382

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

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).

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Key information

Conditions

Renal Impairment Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of Miami,Division of Clinical Pharmacology

Miami, Florida, 33136, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Cefepime and Tazobactam combination

Drug

Primary outcomes

  1. plasma concentrations (Cmax)

    Time frame: 48 hrs

  2. Tmax The elimination half-life (t1/2),

    Time frame: 48 hrs

Secondary outcomes

  1. Number of Participants With Abnormal Laboratory Values

    Time frame: 14 days

  2. Number of Participants With Adverse Events

    Time frame: 14 days

Sponsors and collaborators

Lead sponsor

Wockhardt

Industry

Collaborators

  • Clinartis

Registry information

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Mar 16, 2016
Registry last updated
Aug 26, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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