A Study to Assess the Levels of CAZ-AVI and Metronidazole in the Blood When Given Together and Separately
NCT01534247
ABOUT THIS STUDY
FOR MORE INFORMATION
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Adult Trials: 18+ Years
- 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
- 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
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| Descriptive Information | ||||||||||
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| 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 Summary | The purpose of the study is to assess whether there is any pharmacokinetic interactions between CAZ-AVI and metronidazole. | |||||||||
| 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 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 |
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| Study Arms ICMJE |
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| 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 | 28 | |||||||||
| Original Estimated Enrollment ICMJE | Same as current | |||||||||
| 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 States | |||||||||
| Removed Location Countries | ||||||||||
| Administrative Information | ||||||||||
| NCT Number ICMJE | NCT01534247 | |||||||||
| Other Study ID Numbers ICMJE | D4280C00012 | |||||||||
| Has Data Monitoring Committee | Not Provided | |||||||||
| U.S. FDA-regulated Product | Not Provided | |||||||||
| IPD Sharing Statement ICMJE | Not Provided | |||||||||
| Responsible Party | Pfizer | |||||||||
| Study Sponsor ICMJE | Pfizer | |||||||||
| Collaborators ICMJE | Forest Laboratories | |||||||||
| Investigators ICMJE |
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| PRS Account | Pfizer | |||||||||
| Verification Date | September 2017 | |||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | ||||||||||