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

Pfizer

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: metronidazole; Drug: CAZ-AVI; Drug: CAZ-AVI + metronidazole

Study type: Interventional

Funder types: Industry

Identifiers

NCT01534247

D4280C00012

Details and patient eligibility

About

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

Full 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

Enrollment: 28 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

28 participants in 3 patient groups

CAZAVI

Experimental group

Description:

CAZ-AVI (2000 mg ceftazidime/500 mg avibactam)

Treatment:

Drug: CAZ-AVI

Metronidazole

Active Comparator group

Description:

Metronidazole (500 mg)

Treatment:

Drug: metronidazole

CAZAVI+metronidazole

Active Comparator group

Description:

CAZ-AVI (2000mg ceftazidime/500 mg avibactam) + metronidazole (500 mg)

Treatment:

Drug: CAZ-AVI + metronidazole