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

Information source: AstraZeneca
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy

Intervention: CAZ-AVI (Drug); metronidazole (Drug); CAZ-AVI + metronidazole (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
Mirjana Kujacic, MD, Study Chair, Affiliation: AstraZenecaMolndal Sweden
David Mathews, MD, Principal Investigator, Affiliation: QuintilesOverland Park, US
Paul Newell, Study Director, Affiliation: Astrazeneca Alderly UK

Summary

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

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Primary outcome:

Profile of pharmacokinetic of ceftazidime, avibactam and metronidazole when administering CAZ-AVI plus metronidazole in combination compared to administration of individual components

Profile of pharmacokinetic of ceftazidime, avibactam and metronidazole when administering CAZ-AVI plus metronidazole in combination compared to administration of individual components

Profile of pharmacokinetic of ceftazidime, avibactam and metronidazole when administering CAZ-AVI plus metronidazole in combination compared to administration of individual components

Secondary outcome: 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

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

Minimum age: 18 Years. Maximum age: 50 Years. Gender(s): Both.

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

Locations and Contacts

Research site, Overland Park, Kansas, United States
Additional Information

Starting date: February 2012
Last updated: July 9, 2012

Page last updated: August 23, 2015

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