CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 222 enrolled
Drug / intervention
Avibactam (AVI) +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01689207
NCT01689207Phase 1Completed
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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)

Pfizer·interventional·Posted Sep 21, 2012·Updated Sep 6, 2017

In Brief

A Phase 1 clinical trial evaluating Avibactam (AVI), Aztreonam (ATM), and 2 other interventions for Complicated Infection and Bacterial Infections. Completed, enrolled 222 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsComplicated Infection, Bacterial Infections
CountriesUnited Kingdom
Collaborators--

Timeline

Phase 1CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedSep 21, 2012
Enrollment StartSep 1, 2012
Primary CompletionDec 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 13.8 years ago

Interventions

Avibactam (AVI)drug

PART A: AVI IV infusion

Aztreonam (ATM)drug

PART A: ATM IV infusion

combination of Aztreonam - Avibactam (ATM-AVI)drug

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

Placebodrug

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