To Investigate the Safety and Tolerability of Aztreonam-Avibactam (ATM-AVI)

Pfizer

Status and phase: Completed; Phase 1

Conditions: Complicated Infection; Bacterial Infections

Treatments: Drug: Avibactam (AVI); Drug: combination of Aztreonam - Avibactam (ATM-AVI); Drug: Placebo; Drug: Aztreonam (ATM)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01689207

D4910C00001

Details and patient eligibility

About

This is a randomised, double-blind, 3-part study designed to investigate the safety and tolerability of ATM-AVI. The study aims to characterise the pharmacokinetics of ATM-AVI, when both drugs are administered alone (ATM or AVI) and in combination (ATM-AVI), following single administration, and following multiple administrations of ATM-AVI in healthy male and female (females of nonchildbearing potential) volunteers both young and elderly.

Full description

A Phase I, Randomised, Double-blind, 3-Part Study in Healthy Young and Elderly Subjects to Assess the Safety and Tolerability, and Investigate the Pharmacokinetics of Aztreonam and Avibactam given Alone and in Combination (ATM-AVI)

Enrollment: 222 patients

Sex: All

Ages: 18 to 130 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Provision of signed and dated, written informed consent prior to any study specific procedures
• Healthy young male and female volunteers aged 18 to 45 years (inclusive) and healthy elderly volunteers aged 65 or older (Part C) with suitable veins for cannulation or repeated venipuncture
• 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 PI

Exclusion criteria

• History of any clinically significant disease or disorder which, in the opinion of the PI, may either put the volunteer at risk because of participation in the study, or influence the results or the volunteer'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 severe allergy to betalactam and/or L-arginine
• History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity, as judged by the PI or history of hypersensitivity to drugs with a similar chemical structure or class to ATM or AVI
• Any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks prior to the first administration of IP

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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222 participants in 4 patient groups, including a placebo group

Drug: A

Experimental group

Description:

Avibactam (AVI)

Treatment:

Drug: Avibactam (AVI)

Drug: B

Experimental group

Description:

Aztreonam (ATM)

Treatment:

Drug: Aztreonam (ATM)

Drug: C

Experimental group

Description:

combination of Aztreonam-Avibactam (ATM-AVI)

Treatment:

Drug: combination of Aztreonam - Avibactam (ATM-AVI)

Drug: D

Placebo Comparator group

Description:

Matching Placebo

Treatment:

Drug: Placebo