To assess ceftaroline in various infusion volumes

• Research type

  Research Study

• Full title

  A Phase I, Single-center, 2-part, Randomized, 2-way Crossover Study to Assess the Local Tolerability and Safety (Multiple-dose) and to Assess the Pharmacokinetics, Safety, and Tolerability (single-dose) of Ceftaroline in Healthy Subjects when Ceftaroline Fosamil is Diluted in Various Infusion Volumes.

• IRAS ID

  91189

• Contact name

  Darren Wilbraham

• Sponsor organisation

  AstraZeneca R&D

• Eudract number

  2011-003999-36

• Research summary

  Ceftaroline fosamil is marketed in the US since October 2010 and is prescribed for treatment of complicated skin infections as well as chest infections. The application for approval in the European Union has been submitted in December 2010 and is currently under review. This study is being conducted to assess the tolerability of ceftaroline in lower infusion volumes which are more concentrated. This study will take place in 2 parts; Part A and Part B. The main purpose of Part A is to assess the tolerability of multiple doses of ceftaroline when it is given into the same vein in different infusion volumes. If treatments in Part A are not well tolerated, Part A may be repeated using different infusion volumes. The main purpose of Part B is to assess the pharmacokinetics (the way the drug enters and leaves the blood and tissues over time) following a single dose of ceftaroline when given in different infusion volumes.

• REC name

  East of England - Cambridgeshire and Hertfordshire Research Ethics Committee

• REC reference

  11/IE/0152

• Date of REC Opinion

  7 Feb 2012

• REC opinion

  Further Information Favourable Opinion