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

NCT01689207

Last updated date
Study Location
Research Site
London, , , United Kingdom
Contact
1-800-718-1021

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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

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Complicated Infection, Bacterial InfectionsTo Investigate the Safety and Tolerability of Aztreonam-Avibactam (ATM-AVI)
NCT01689207
  1. London,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE To Investigate the Safety and Tolerability of Aztreonam-Avibactam (ATM-AVI)
Official Title  ICMJE 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)
Brief 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)
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE
  • Complicated Infection
  • Bacterial Infections
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 6, 2016)
222
Original Estimated Enrollment  ICMJE
 (submitted: September 20, 2012)
71
Actual Study Completion Date  ICMJE December 2014
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 130 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01689207
Other Study ID Numbers  ICMJE D4910C00001
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator:Frans van den Berg, MDHammersmith Medicines Research Cumberland Avenue Park Royal London NW10 7EW, England Telephone: +44 020 8961 4130 Fax: +44 020 8961 8665
PRS Account Pfizer
Verification Date August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP