NCT01689207

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

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)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 222 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years – 130 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed 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)

Conditions

• Complicated Infection
• Bacterial Infections

Interventions

Type	Name	Description
DRUG	Avibactam (AVI)	PART A: AVI IV infusion
DRUG	Aztreonam (ATM)	PART A: ATM IV infusion
DRUG	combination of Aztreonam - Avibactam (ATM-AVI)	PART A: ATM-AVI IV infusion. PART B and C: ATM-AVI IV infusions.
DRUG	Placebo	PART A, PART B, PART C: matching placebo IV infusions

Timeline

• Start date: 2012-09-01
• Primary completion: 2014-12-01
• Completion: 2014-12-01
• First posted: 2012-09-21
• Last updated: 2017-09-06
• Results posted: 2016-10-26

Locations

1 site across 1 country: United Kingdom