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

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

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