- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01534247
A Study to Assess the Levels of CAZ-AVI and Metronidazole in the Blood When Given Together and Separately
September 1, 2017 updated by: Pfizer
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
The purpose of the study is to assess whether there is any pharmacokinetic interactions between CAZ-AVI and metronidazole.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Actual)
28
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Kansas
-
Overland Park, Kansas, United States
- Research Site
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: CAZAVI
CAZ-AVI (2000 mg ceftazidime/500 mg avibactam)
|
Infusion
|
ACTIVE_COMPARATOR: Metronidazole
Metronidazole (500 mg)
|
Infusion
|
ACTIVE_COMPARATOR: CAZAVI+metronidazole
CAZ-AVI (2000mg ceftazidime/500 mg avibactam) + metronidazole (500 mg)
|
Infusion
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Profile of pharmacokinetic of ceftazidime, avibactam and metronidazole when administering CAZ-AVI plus metronidazole in combination compared to administration of individual components
Time Frame: CAZ-AVI: pre-dose, 0.5, 1, 1.5, 2, 2.25, 2.5, 2.75, 3, 4, 5, 7, 11, 23, 73, 73.5, 74, 74.5, 75, 75.25, 75.5, 75.75, 76, 77, 78, 80, 84 and 95 hours post-dose
|
CAZ-AVI: pre-dose, 0.5, 1, 1.5, 2, 2.25, 2.5, 2.75, 3, 4, 5, 7, 11, 23, 73, 73.5, 74, 74.5, 75, 75.25, 75.5, 75.75, 76, 77, 78, 80, 84 and 95 hours post-dose
|
Profile of pharmacokinetic of ceftazidime, avibactam and metronidazole when administering CAZ-AVI plus metronidazole in combination compared to administration of individual components
Time Frame: Metronidazole: pre-dose, 0.5, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 72, 72.5, 73, 73.25, 73.5, 74, 75, 76, 78, 80, 84 and 96 hours post-dose
|
Metronidazole: pre-dose, 0.5, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 72, 72.5, 73, 73.25, 73.5, 74, 75, 76, 78, 80, 84 and 96 hours post-dose
|
Profile of pharmacokinetic of ceftazidime, avibactam and metronidazole when administering CAZ-AVI plus metronidazole in combination compared to administration of individual components
Time Frame: CAZ-AVI and metronidazole: pre-dose, 0.5, 1, 1.25, 1.5, 2.5, 3, 3.25, 3.5, 3.75, 4, 5, 6, 8, 12, 24, 72, 72.5, 73, 73.25, 73.5, 74, 74.5, 75, 75.25, 75.5, 75.75, 76, 77, 78, 80, 84 and 96 hours post-dose
|
CAZ-AVI and metronidazole: pre-dose, 0.5, 1, 1.25, 1.5, 2.5, 3, 3.25, 3.5, 3.75, 4, 5, 6, 8, 12, 24, 72, 72.5, 73, 73.25, 73.5, 74, 74.5, 75, 75.25, 75.5, 75.75, 76, 77, 78, 80, 84 and 96 hours post-dose
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To assess safety and tolerability of CAZ-AVI and metronidazole when administered as a 2- and 1-hour infusion, respectively, every 8 hours by assessment of adverse events, lab, vital signs, ECG, physical examination
Time Frame: Screening up to 26 days after first dose
|
Screening up to 26 days after first dose
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Chair: Mirjana Kujacic, MD, AstraZenecaMolndal Sweden
- Principal Investigator: David Mathews, MD, QuintilesOverland Park, US
- Study Director: Paul Newell, Astrazeneca Alderly UK
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2012
Primary Completion (ACTUAL)
July 1, 2012
Study Completion (ACTUAL)
July 1, 2012
Study Registration Dates
First Submitted
February 9, 2012
First Submitted That Met QC Criteria
February 13, 2012
First Posted (ESTIMATE)
February 16, 2012
Study Record Updates
Last Update Posted (ACTUAL)
September 5, 2017
Last Update Submitted That Met QC Criteria
September 1, 2017
Last Verified
September 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- D4280C00012
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Healthy
-
Prevent Age Resort "Pervaya Liniya"RecruitingHealthy Aging | Healthy Diet | Healthy LifestyleRussian Federation
-
Maastricht University Medical CenterCompletedHealthy Volunteers | Healthy Subjects | Healthy AdultsNetherlands
-
Yale UniversityNot yet recruitingHealth-related Benefits of Introducing Table Olives Into the Diet of Young Adults: Olives For HealthHealthy Diet | Healthy Lifestyle | Healthy Nutrition | CholesterolUnited States
-
Hasselt UniversityRecruitingHealthy | Healthy AgingBelgium
-
Galera Therapeutics, Inc.Syneos HealthCompleted
-
Galera Therapeutics, Inc.Syneos HealthCompletedHealthy | Healthy VolunteersAustralia
-
University of PennsylvaniaActive, not recruitingHealthy | Healthy AgingUnited States
-
Chalmers University of TechnologyGöteborg UniversityCompletedHealthy | Nutrition, HealthySweden
-
University of ManitobaNot yet recruitingHealthy | Healthy Diet
Clinical Trials on CAZ-AVI
-
PfizerForest LaboratoriesCompletedSystemic InfectionsUnited States
-
PfizerCompleted
-
PfizerCompletedPharmacokinetics | Safety | Open Label | CAZ-AVI | CXL | Effect on Intestinal FloraSweden
-
PfizerForest LaboratoriesCompletedComplicated Intra-Abdominal InfectionUnited States, Croatia, Bulgaria, Peru, Russian Federation, Latvia, Ukraine, Mexico, Romania, South Africa, Argentina, Czechia, Hungary, Israel, Taiwan, India, Thailand, Spain, Netherlands, Malaysia
-
Qianfoshan HospitalRecruitingCarbapenem-Resistant Enterobacteriaceae InfectionChina
-
PfizerForest LaboratoriesCompletedComplicated Intra-abdominal Infection | Complicated Urinary Tract InfectionCroatia, Bulgaria, Korea, Republic of, Mexico, Peru, Russian Federation, Spain, Turkey, Poland, Romania, Ukraine, South Africa, Argentina, Israel, United States, Philippines, France, Czechia
-
Imperial College LondonSarepta Therapeutics, Inc.; Department of Health, United KingdomCompletedDuchenne Muscular DystrophyUnited Kingdom
-
Sarepta Therapeutics, Inc.United States Department of DefenseCompletedMarburg Hemorrhagic FeverUnited States
-
PfizerRecruitingHospital Acquired Pneumonia | Complicated Intra Abdominal Infections | Ventilator Acquired PneumoniaChina
-
Sarepta Therapeutics, Inc.TerminatedCardiovascular Disease | Coronary Artery BypassUkraine