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

Last updated on May 10, 2018

FOR MORE INFORMATION
Study Location
Research Site
London, , United Kingdom
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Complicated Infection, Bacterial Infections
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-130 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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

NCT01689207
Pfizer
Completed
To Investigate the Safety and Tolerability of Aztreonam-Avibactam (ATM-AVI)

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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)
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.
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)
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
  • Complicated Infection
  • Bacterial Infections
  • 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
  • Experimental: Drug: A
    Avibactam (AVI)
    Intervention: Drug: Avibactam (AVI)
  • Experimental: Drug: B
    Aztreonam (ATM)
    Intervention: Drug: Aztreonam (ATM)
  • Experimental: Drug: C
    combination of Aztreonam-Avibactam (ATM-AVI)
    Intervention: Drug: combination of Aztreonam - Avibactam (ATM-AVI)
  • Placebo Comparator: Drug: D
    Matching Placebo
    Intervention: Drug: Placebo
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
222
December 2014
December 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 130 Years   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
 
NCT01689207
D4910C00001
Not Provided
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Principal Investigator: 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
Pfizer
August 2017

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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