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Study to Assess the Concentration of Avibactam and Ceftazidime in Epithelial Lining Fluid and Plasma

Last updated on November 12, 2019

FOR MORE INFORMATION
Study Location
Research Site
London, , United Kingdom
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 with veins suitable for cannulation or repeated
venepuncture; female subjects must be postmenopausal or surgically sterile. Female
subjects must have a negative pregnancy test at screening and on admission to the
unit, must not be lactating and must be of non-child-bearing potential

- Male subjects should be willing to use barrier contraception ie, condoms, from dosing
to 3 months after dosing with the IP

- Have a body mass index (BMI) between 19 and 30 kg/m2

- As judged by the Investigator, all the subjects must be able to understand and be
willing to comply with study procedures, restrictions and requirements

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

- History or presence of any clinically significant disease or disorder (including a
history of chronic respiratory disease eg, asthma, chronic obstructive pulmonary
disease [COPD], cystic fibrosis or interstitial lung disease) 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 allergy to lidocaine/lignocaine, midazolam, alfentanyl or other topical
anaesthetics/sedatives in similar classes to these agents

- Any clinically significant illness, medical/surgical procedure or trauma within 4
weeks of the first administration of IP

- Any clinically significant abnormalities in physical examination, lung function test,
ECG, clinical chemistry, haematology, coagulation screen, or urinalysis results as
judged by the Investigator

NCT01395420
Pfizer
Completed
Study to Assess the Concentration of Avibactam and Ceftazidime in Epithelial Lining Fluid and Plasma

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Descriptive Information
Brief Title  ICMJE Study to Assess the Concentration of Avibactam and Ceftazidime in Epithelial Lining Fluid and Plasma
Official Title  ICMJE A Phase I Open-Label, 2-Part, 3-Cohort, Single-Centre Study to Assess the Concentration of Avibactam and Ceftazidime in Epithelial Lining Fluid (ELF) and Plasma Using at Least Two Different Dosing Regimens in Healthy Volunteers
Brief SummaryThis is an open-label study divided in 2 parts and 3 cohorts to determine the concentration of Avibactam and Ceftazidime in the lining of the lungs and the blood.
Detailed DescriptionA Phase I Open-Label, 2-Part, 3-Cohort, Single-Centre Study to Assess the Concentration of Avibactam and Ceftazidime in Epithelial Lining Fluid and Plasma Using at Least Two Different Dosing Regimens in Healthy Volunteers
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: CAZ104
    IV Infusion
    Other Name: CAZ104 (2000mg Ceftazidime/500mg Avibactam)
  • Drug: CAZ104
    IV Infusion
    Other Name: CAZ104 (3000mg Ceftazidime/1000mg Avibactam)
Study Arms  ICMJE
  • Experimental: 1
    CAZ104 (2000mg Ceftazidime/500mg Avibactam)
    Intervention: Drug: CAZ104
  • Experimental: 2
    CAZ104 (3000mg Ceftazidime/1000mg Avibactam)
    Intervention: Drug: CAZ104
Publications *Nicolau DP, Siew L, Armstrong J, Li J, Edeki T, Learoyd M, Das S. Phase 1 study assessing the steady-state concentration of ceftazidime and avibactam in plasma and epithelial lining fluid following two dosing regimens. J Antimicrob Chemother. 2015 Oct;70(10):2862-9. doi: 10.1093/jac/dkv170. Epub 2015 Jul 1.


*   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: August 16, 2012)
45
Original Estimated Enrollment  ICMJE
 (submitted: July 14, 2011)
63
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 with veins suitable for cannulation or repeated venepuncture; female subjects must be postmenopausal or surgically sterile. Female subjects must have a negative pregnancy test at screening and on admission to the unit, must not be lactating and must be of non-child-bearing potential
  • Male subjects should be willing to use barrier contraception ie, condoms, from dosing to 3 months after dosing with the IP
  • Have a body mass index (BMI) between 19 and 30 kg/m2
  • As judged by the Investigator, all the subjects must be able to understand and be willing to comply with study procedures, restrictions and requirements

Exclusion Criteria:

  • History or presence of any clinically significant disease or disorder (including a history of chronic respiratory disease eg, asthma, chronic obstructive pulmonary disease [COPD], cystic fibrosis or interstitial lung disease) 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 allergy to lidocaine/lignocaine, midazolam, alfentanyl or other topical anaesthetics/sedatives in similar classes to these agents
  • Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first administration of IP
  • Any clinically significant abnormalities in physical examination, lung function test, ECG, clinical chemistry, haematology, coagulation screen, 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 Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01395420
Other Study ID Numbers  ICMJE D4280C00009
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Paul Newell, MDAstraZeneca
Principal Investigator:Leonard Siew, MBCHB, MRCP(UK)Quintiles Phase I unit London
Study Chair:Mirjana Kujacic, MDAstraZeneca
PRS AccountPfizer
Verification DateAugust 2017

ICMJE     Data element required by the

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

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