Study to Assess the Concentration of Avibactam and Ceftazidime in Epithelial Lining Fluid and Plasma
NCT01395420
ABOUT THIS STUDY
FOR MORE INFORMATION
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1-800-718-1021
Adult Trials: 18+ Years
- 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
- 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
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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 Summary | This 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 Description | A 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 |
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| Study Arms ICMJE |
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| 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 | 45 | |||||||||
| Original Estimated Enrollment ICMJE | 63 | |||||||||
| Actual Study Completion Date ICMJE | July 2012 | |||||||||
| Actual Primary Completion Date | July 2012 (Final data collection date for primary outcome measure) | |||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| 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 Committee | No | |||||||||
| U.S. FDA-regulated Product | Not Provided | |||||||||
| IPD Sharing Statement ICMJE | Not Provided | |||||||||
| Responsible Party | Pfizer | |||||||||
| Study Sponsor ICMJE | Pfizer | |||||||||
| Collaborators ICMJE | Not Provided | |||||||||
| Investigators ICMJE |
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| PRS Account | Pfizer | |||||||||
| Verification Date | August 2017 | |||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | ||||||||||