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

Information source: AstraZeneca
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Complicated Infection; Bacterial Infections

Intervention: Avibactam (AVI) (Drug); Aztreonam (ATM) (Drug); combination of Aztreonam - Avibactam (ATM-AVI) (Drug); Placebo (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
Frans van den Berg, MD, Principal Investigator, Affiliation: Hammersmith Medicines Research Cumberland Avenue Park Royal London NW10 7EW, England Telephone: +44 020 8961 4130 Fax: +44 020 8961 8665

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.

Clinical Details

Official title: 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 design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Primary outcome:

Part A: Safety profile in terms of adverse events, ECG, blood pressure, pulse, physical examination, body temperature, haematology, clinical chemistry, coagulation, urinalysis and Direct Coombs Test.

Part B: Safety profile in terms of adverse events, ECG, blood pressure, pulse, physical examination, body temperature, haematology, clinical chemistry, coagulation, urinalysis and Direct Coombs Test.

Part C: Safety profile in terms of adverse events, ECG, blood pressure, pulse, physical examination, body temperature, haematology, clinical chemistry, coagulation, urinalysis and Direct Coombs Test.

Secondary outcome:

Part A: PK- Plasma pharmacokinetic profile in terms of (see description) for ATM (alone) and AVI (alone) and ATM-AVI (combined) following single 1 hour IV infusions

Part A: PK- Plasma pharmacokinetic profile in terms of (see description) for ATM (alone) and AVI (alone) and ATM-AVI (combined) following single 1 hour IV infusions

Part B: PK- Plasma pharmacokinetic profile in terms of (see description) for ATM-AVI following a single IV infusion on Day 1 and multiple IV infusions on Days 2-11

Part B: PK- Plasma pharmacokinetic profile in terms of (see description) for ATM-AVI following a single IV infusion on Day 1 and multiple IV infusions on Days 2-11

Part C: PK- Plasma pharmacokinetic profile in terms of (see description) for ATM-AVI following multiple IV infusions Days 1-10

Part C: PK- Plasma pharmacokinetic profile in terms of (see description) for ATM-AVI following multiple IV infusions Days 1-10

Part A:To characterize the renal clearance of combination ATM-AVI using the following urine PK parameters (see description)

Part B: To characterize the renal clearance of combination ATM-AVI using the following urine PK parameters (see description)

Part C: To characterize the renal clearance of combination ATM-AVI using the following urine PK parameters:(see description)

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)

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

Research Site, London, United Kingdom
Additional Information

Starting date: September 2012
Last updated: January 27, 2015

Page last updated: August 20, 2015

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