A study of blood levels & side effects of avibactam and aztreonam; v1

• Research type

  Research Study

• Full 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) (12-018)

• IRAS ID

  112756

• Contact name

  Gary Peters

• Sponsor organisation

  AstraZeneca AB

• Eudract number

  2012-002641-37

• ISRCTN Number

  No number provided

• Clinicaltrials.gov Identifier

  No number provided

• Research summary

  Avibactam is an experimental new medicine for use in treating bacterial infections. In this study, We'll test avibactam alone and in combination with an antibiotic called aztreonam, which has been used worldwide for over 25 years to treat bacterial infections. There has been an increase in the number of infections that are resistant to treatment with antibiotics. Resistant bacteria break down the antibiotic, which stops the antibiotic working. Avibactam works by stopping bacteria from breaking down aztreonam. We need to test avibactam, alone and in combination with aztreonam, in healthy people before it??s tested in patients with infections. We'll test single and repeated doses of the study medicines, to find out their side effects and blood levels. The study will be in 3 parts: * in Part A, We'll give 12 healthy men and women, aged 18??45 years, single doses of the study medicines, alone and in combination, or dummy medicine; * in Part B, We'll give 24 healthy men and women, aged 18??45 years, repeated doses of the study medicines, in combination, or dummy medicine, over 11 days; and * in Part C, We'll give 23 healthy men and women, aged 18??45 years, and 12 healthy men and women, aged 65 years and older, repeated doses of the study medicines, in combination, or dummy medicine, over 10 days. Participants will take up to 7 weeks to finish the study. They??ll make 2 outpatient visits, and stay on the ward for up to 11 nights. A pharmaceutical company (Astra Zeneca) is funding the study. The study will take place at 1 centre in London. We'll recruit healthy participants by: advertising (newspaper, radio, and websites); by word of mouth; from volunteer databases; and via our websites.

• REC name

  London - Brent Research Ethics Committee

• REC reference

  12/LO/1265

• Date of REC Opinion

  3 Sep 2012

• REC opinion

  Favourable Opinion