A Study to Assess the Levels of Two Antibiotics in the Blood When Given Together and Separately

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2012-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This is a randomised study divided into 2 parts. Part A investigates the effect of prolonged dosing (ten days) with Avibactam and Ceftazidime when given together and how this will effect how much Avibactam and Ceftazidime enters the blood. Part B investigates how much Avibactam (NXL104) and Ceftazidime enter the blood when Avibactam and Ceftazidine are given separately or together intravenously.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Relationship Between Different Administration Regimens of Ceftazidime/Avibactam and Clinical Outcomes

NCT06528028

Anti-Infective Agent

RECRUITING PHASE4

Ceftazidime-Avibactam for the Treatment of Infections Due to Ceftazidime Resistant Pathogens

NCT01644643

Complicated Urinary Tract Infection Complicated Intra-abdominal Infection

COMPLETED PHASE3

Ceftazidime-Avibactam Compared With Doripenem Followed by Oral Therapy for Hospitalized Adults With Complicated UTIs (Urinary Tract Infections)

NCT01599806

Complicated Urinary Tract Infection (cUTI) Including Acute Pyelonephritis

COMPLETED PHASE3

EXTENDed Antibiotic Durations Compared to Standard Durations for Patients With Complicated Intra-abdominal Infection.

NCT05148702

Complicated Intra-abdominal Infection

RECRUITING PHASE3

Ceftazidime-Avibactam Use in Critically Ill Patients With Carbapenem-Resistant Enterobacteriaceae Infections

NCT05258851

Carbapenem-Resistant Enterobacteriaceae Infection

TERMINATED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

A Phase I, 2-Part, Open-Label, Pharmacokinetic and Drug-Drug Interaction Study of CAZ104 (Avibactam and Ceftazidime in Healthy Subjects)

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

CAZ104 (2000mg Ceftazidime/500mg Avibactam)

Group Type EXPERIMENTAL

CAZ104

Intervention Type DRUG

IV infusion

2

500mg Avibactam

Group Type ACTIVE_COMPARATOR

Avibactam

Intervention Type DRUG

IV infusion

3

2000mg Ceftazidime

Group Type ACTIVE_COMPARATOR

Ceftazidime

Intervention Type DRUG

IV infusion

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

CAZ104

IV infusion

Intervention Type DRUG

Avibactam

IV infusion

Intervention Type DRUG

Ceftazidime

IV infusion

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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 with veins suitable for cannulation or repeated venepuncture; female subjects must be postmenopausal or surgically sterile. Female subjects must have a negative pregnancy test at screening and on admi
* Male subjects should be willing to use barrier contraception ie, condoms, from dosing to 3 months after dosing with the IP (investigational product).
* Have a body mass index (BMI) between 19 and 30 kg/m2
* As judged by the Investigator, all the subjects must be able to understand and be willing to comply with study procedures, restrictions and requirements

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
* History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged by the Investigator or history of hypersensitivity to drugs with a similar chemical structure or class to avibactam, ceftazidime, and/or excipients
* Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first administration of IP Prolonged QTcF (\>450 ms) or shortened QTcF (\<350 ms) or a family history of long QT syndrome

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes