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

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

222 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2014-12-31

Brief Summary

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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.

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Detailed Description

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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)

Conditions

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Complicated Infection Bacterial Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Drug: A

Avibactam (AVI)

Group Type EXPERIMENTAL

Avibactam (AVI)

Intervention Type DRUG

PART A: AVI IV infusion

Drug: B

Aztreonam (ATM)

Group Type EXPERIMENTAL

Aztreonam (ATM)

Intervention Type DRUG

PART A: ATM IV infusion

Drug: C

combination of Aztreonam-Avibactam (ATM-AVI)

Group Type EXPERIMENTAL

combination of Aztreonam - Avibactam (ATM-AVI)

Intervention Type DRUG

PART A: ATM-AVI IV infusion. PART B and C: ATM-AVI IV infusions.

Drug: D

Matching Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

PART A, PART B, PART C: matching placebo IV infusions

Interventions

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Avibactam (AVI)

PART A: AVI IV infusion

Intervention Type DRUG

Aztreonam (ATM)

PART A: ATM IV infusion

Intervention Type DRUG

combination of Aztreonam - Avibactam (ATM-AVI)

PART A: ATM-AVI IV infusion. PART B and C: ATM-AVI IV infusions.

Intervention Type DRUG

Placebo

PART A, PART B, PART C: matching placebo IV infusions

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

130 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes