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

Last updated on November 11, 2019

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Study Location
Research site
Overland Park, Kansas, United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-50 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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

NCT01534247
Pfizer
Completed
A Study to Assess the Levels of CAZ-AVI and Metronidazole in the Blood When Given Together and Separately

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Descriptive Information
Brief Title  ICMJE A Study to Assess the Levels of CAZ-AVI and Metronidazole in the Blood When Given Together and Separately
Official Title  ICMJE 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
Brief SummaryThe purpose of the study is to assess whether there is any pharmacokinetic interactions between CAZ-AVI and metronidazole.
Detailed DescriptionA 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  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: CAZ-AVI
    Infusion
  • Drug: metronidazole
    Infusion
  • Drug: CAZ-AVI + metronidazole
    Infusion
Study Arms  ICMJE
  • Experimental: CAZAVI
    CAZ-AVI (2000 mg ceftazidime/500 mg avibactam)
    Intervention: Drug: CAZ-AVI
  • Active Comparator: Metronidazole
    Metronidazole (500 mg)
    Intervention: Drug: metronidazole
  • Active Comparator: CAZAVI+metronidazole
    CAZ-AVI (2000mg ceftazidime/500 mg avibactam) + metronidazole (500 mg)
    Intervention: Drug: CAZ-AVI + metronidazole
Publications *Das S, Li J, Armstrong J, Learoyd M, Edeki T. Randomized pharmacokinetic and drug-drug interaction studies of ceftazidime, avibactam, and metronidazole in healthy subjects. Pharmacol Res Perspect. 2015 Oct;3(5):e00172. doi: 10.1002/prp2.172. Epub 2015 Aug 25.


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 13, 2012)
28
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2012
Actual Primary Completion DateJuly 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01534247
Other Study ID Numbers  ICMJE D4280C00012
Has Data Monitoring CommitteeNot Provided
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Forest Laboratories
Investigators  ICMJE
Study Chair:Mirjana Kujacic, MDAstraZenecaMolndal Sweden
Principal Investigator:David Mathews, MDQuintilesOverland Park, US
Study Director:Paul NewellAstrazeneca Alderly UK
PRS AccountPfizer
Verification DateSeptember 2017

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

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Contact

[email protected]

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