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

NCT01689207 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 222

Last updated 2017-09-06

Study results available
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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.

Conditions

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Frans van den Berg, MD · Hammersmith Medicines Research Cumberland Avenue Park Royal London NW10 7EW, England Telephone: +44 020 8961 4130 Fax: +44 020 8961 8665

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
130 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-09-30
Primary Completion
2014-12-31
Completion
2014-12-31

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01689207 on ClinicalTrials.gov