A Study to Assess the Levels of CAZ-AVI and Metronidazole in the Blood When Given Together and Separately

This study has been completed.
Sponsor:
Collaborator:
Cerexa, Inc.
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01534247
First received: February 9, 2012
Last updated: July 9, 2012
Last verified: July 2012
  Purpose

The purpose of the study is to assess whether there is any pharmacokinetic interactions between CAZ-AVI and metronidazole.


Condition Intervention Phase
Healthy
Drug: CAZ-AVI
Drug: metronidazole
Drug: CAZ-AVI + metronidazole
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: 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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 28
Study Start Date: February 2012
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CAZAVI
CAZ-AVI (2000 mg ceftazidime/500 mg avibactam)
Drug: CAZ-AVI
Infusion
Active Comparator: Metronidazole
Metronidazole (500 mg)
Drug: metronidazole
Infusion
Active Comparator: CAZAVI+metronidazole
CAZ-AVI (2000mg ceftazidime/500 mg avibactam) + metronidazole (500 mg)
Drug: CAZ-AVI + metronidazole
Infusion

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

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01534247

Locations
United States, Kansas
Research site
Overland Park, Kansas, United States
Sponsors and Collaborators
AstraZeneca
Cerexa, Inc.
Investigators
Study Chair: Mirjana Kujacic, MD AstraZenecaMolndal Sweden
Principal Investigator: David Mathews, MD QuintilesOverland Park, US
Study Director: Paul Newell Astrazeneca Alderly UK
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01534247     History of Changes
Other Study ID Numbers: D4280C00012
Study First Received: February 9, 2012
Last Updated: July 9, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by AstraZeneca:
Phase I
drug to drug
CAZ-AVI
Healthy volunteer
pharmacokinetics
open label
metronidazole
safety

Additional relevant MeSH terms:
Ceftazidime
Metronidazole
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antiprotozoal Agents
Antiparasitic Agents
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on August 28, 2014