Phase 1
Completed N=92
To Investigate the Safety and Tolerability of Aztreonam-Avibactam (ATM-AVI)
Complicated Infection · Bacterial Infections
Source: ClinicalTrials.gov NCT01689207 ↗
Enrolled (actual)
92
Serious AEs
0.9%
Results posted
Oct 2016
Primary outcomePrimary: Safety Profile - Number of Subjects With at Least 1 AE — 1; 2; 3; 4 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Safety Profile - Number of Subjects With at Least 1 AE |
1; 2; 3; 4; 2; 6 | — |
| SECONDARY PK- Plasma Pharmacokinetic Parameter AUC (ug*h/mL) for Aztreonam (ATM) and Avibactam (AVI) Alone and in Combination (ATM-AVI) in Parts A, B and C |
NA; 372; NA; NA; NA; NA | — |
| SECONDARY PK- Plasma Pharmacokinetic Parameter t1/2(h) for Aztreonam (ATM) and Avibactam (AVI) Alone and in Combination (ATM-AVI) in Parts A, B and C |
NA; 1.98; NA; NA; NA; NA | — |
| SECONDARY PK- Plasma Pharmacokinetic Parameter Tmax for Aztreonam (ATM) and Avibactam (AVI) Alone and in Combination (ATM-AVI) on Day 1 in Parts A, B and C |
NA; 0.98; NA; NA; NA; NA | — |
| SECONDARY PK- Plasma Pharmacokinetic Parameter Cmax for Aztreonam (ATM) and Avibactam (AVI) Alone and in Combination (ATM-AVI) in Parts A, B and C |
NA; 143; NA; NA; NA; NA | — |
| SECONDARY PK- Plasma Pharmacokinetic Parameters CL and CLr for Aztreonam (ATM) and Avibactam (AVI) Alone and in Combination (ATM-AVI) in Parts A, B and C |
NA; 5.37; NA; NA; NA; NA | — |
| SECONDARY PK- Plasma Pharmacokinetic Parameter Vss for Aztreonam (ATM) and Avibactam (AVI) Alone and in Combination (ATM-AVI) in Parts A, B and C |
NA; 13.4; NA; NA; NA; NA | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01689207). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.