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A Study to Assess the Levels of CAZ-AVI and Metronidazole in the Blood When Given Together and Separately

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ClinicalTrials.gov Identifier: NCT01534247
Recruitment Status : Completed
First Posted : February 16, 2012
Last Update Posted : September 5, 2017
Sponsor:
Collaborator:
Forest Laboratories
Information provided by (Responsible Party):
Pfizer

Brief Summary:
The purpose of the study is to assess whether there is any pharmacokinetic interactions between CAZ-AVI and metronidazole.

Condition or disease Intervention/treatment Phase
Healthy Drug: CAZ-AVI Drug: metronidazole Drug: CAZ-AVI + metronidazole Phase 1

Detailed Description:
A Phase I, Open-Label, 3-way Crossover, Pharmacokinetic and Drug-Drug Interaction Study of ceftazidime avibactam (CAZ-AVI) and Metronidazole when Administered Alone and in Combination in Healthy Subjects

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: A Phase I, Open-Label, 3-way Crossover, Pharmacokinetic and Drug-Drug Interaction Study of Ceftazidime Avibactam (CAZ-AVI) and Metronidazole When Administered Alone and in Combination in Healthy Subjects
Study Start Date : February 2012
Actual Primary Completion Date : July 2012
Actual Study Completion Date : July 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: CAZAVI
CAZ-AVI (2000 mg ceftazidime/500 mg avibactam)
Drug: CAZ-AVI
Infusion
Active Comparator: Metronidazole
Metronidazole (500 mg)
Drug: metronidazole
Infusion
Active Comparator: CAZAVI+metronidazole
CAZ-AVI (2000mg ceftazidime/500 mg avibactam) + metronidazole (500 mg)
Drug: CAZ-AVI + metronidazole
Infusion



Primary Outcome Measures :
  1. Profile of pharmacokinetic of ceftazidime, avibactam and metronidazole when administering CAZ-AVI plus metronidazole in combination compared to administration of individual components [ Time Frame: CAZ-AVI: pre-dose, 0.5, 1, 1.5, 2, 2.25, 2.5, 2.75, 3, 4, 5, 7, 11, 23, 73, 73.5, 74, 74.5, 75, 75.25, 75.5, 75.75, 76, 77, 78, 80, 84 and 95 hours post-dose ]
  2. Profile of pharmacokinetic of ceftazidime, avibactam and metronidazole when administering CAZ-AVI plus metronidazole in combination compared to administration of individual components [ Time Frame: Metronidazole: pre-dose, 0.5, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 72, 72.5, 73, 73.25, 73.5, 74, 75, 76, 78, 80, 84 and 96 hours post-dose ]
  3. Profile of pharmacokinetic of ceftazidime, avibactam and metronidazole when administering CAZ-AVI plus metronidazole in combination compared to administration of individual components [ Time Frame: CAZ-AVI and metronidazole: pre-dose, 0.5, 1, 1.25, 1.5, 2.5, 3, 3.25, 3.5, 3.75, 4, 5, 6, 8, 12, 24, 72, 72.5, 73, 73.25, 73.5, 74, 74.5, 75, 75.25, 75.5, 75.75, 76, 77, 78, 80, 84 and 96 hours post-dose ]

Secondary Outcome Measures :
  1. To assess safety and tolerability of CAZ-AVI and metronidazole when administered as a 2- and 1-hour infusion, respectively, every 8 hours by assessment of adverse events, lab, vital signs, ECG, physical examination [ Time Frame: Screening up to 26 days after first dose ]


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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Provision of signed and dated, written informed consent prior to any study-specific procedures.
  • Healthy male and female subjects aged 18 to 50 years (inclusive) with suitable veins for cannulation or repeated venipuncture; female subjects must be post menopausal or surgically sterile.
  • Male subjects should be willing to use barrier contraception ie, condoms, from the first day of the investigational product administration until 3 months after the last administration of the investigational product.
  • Have a body mass index (BMI) between 19 and 30 kg/m2
  • Be able to understand and willing to comply with study procedures, restrictions, and requirements, as judged by the Investigator

Exclusion Criteria:

  • History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study
  • History or presence of gastrointestinal, hepatic or renal disease, or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs
  • Known history of serious allergy, hypersensitivity (eg, anaphylaxis), or any serious reaction to carbapenem or cephalosporin antibiotics or other beta-actam antibiotics or any other investigational product to be administered as part of the study
  • Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks prior to the first administration of investigational product Any clinically significant abnormalities in physical examination, ECG, clinical chemistry, haematology, or urinalysis results, as judged by the Investigator

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01534247


Locations
United States, Kansas
Research site
Overland Park, Kansas, United States
Sponsors and Collaborators
Pfizer
Forest Laboratories
Investigators
Study Chair: Mirjana Kujacic, MD AstraZenecaMolndal Sweden
Principal Investigator: David Mathews, MD QuintilesOverland Park, US
Study Director: Paul Newell Astrazeneca Alderly UK

Additional Information:
Publications:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01534247     History of Changes
Other Study ID Numbers: D4280C00012
First Posted: February 16, 2012    Key Record Dates
Last Update Posted: September 5, 2017
Last Verified: September 2017

Keywords provided by Pfizer:
Phase I
drug to drug
CAZ-AVI
Healthy volunteer
pharmacokinetics
open label
metronidazole
safety

Additional relevant MeSH terms:
Avibactam
Metronidazole
Ceftazidime
Anti-Infective Agents
Antiprotozoal Agents
Antiparasitic Agents
Anti-Bacterial Agents
beta-Lactamase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action