Status:
COMPLETED
A Study to Assess the Levels of Two Antibiotics in the Blood When Given Together and Separately
Lead Sponsor:
Pfizer
Conditions:
Healthy
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
Brief Summary
This is a randomised study divided into 2 parts. Part A investigates the effect of prolonged dosing (ten days) with Avibactam and Ceftazidime when given together and how this will effect how much Avib...
Detailed Description
A Phase I, 2-Part, Open-Label, Pharmacokinetic and Drug-Drug Interaction Study of CAZ104 (Avibactam and Ceftazidime in Healthy Subjects)
Eligibility Criteria
Inclusion
- Provision of signed and dated, written informed consent prior to any study specific procedures
- Healthy male and female subjects aged 18 to 50 years 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 admi
- Male subjects should be willing to use barrier contraception ie, condoms, from dosing to 3 months after dosing with the IP (investigational product).
- 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
- 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
- History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged by the Investigator or history of hypersensitivity to drugs with a similar chemical structure or class to avibactam, ceftazidime, and/or excipients
- Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first administration of IP Prolonged QTcF (\>450 ms) or shortened QTcF (\<350 ms) or a family history of long QT syndrome
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2012
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT01430910
Start Date
September 1 2011
End Date
October 1 2012
Last Update
September 1 2017
Active Locations (1)
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1
Research site
London, United Kingdom