PK study of Ceftaroline in dialysis patients and healthy volunteers

• Research type

  Research Study

• Full title

  A Phase I Study to Assess the Pharmacokinetics of Ceftaroline After Intravenous Administration of a Single Dose of Ceftaroline Fosamil (200 mg) to Patients with End-stage Renal Disease Undergoing Haemodialysis when Compared to a Single Dose of Ceftaroline Fosamil (600 mg) to a Matched Control Population with Normal Renal Function

• IRAS ID

  106871

• Contact name

  Darren Wilbraham

• Sponsor organisation

  AstraZeneca R&D Mölndal

• Eudract number

  2012-001261-33

• Research summary

  This study is to evaluate an antibiotic called ceftaroline. Ceftaroline is licensed in the USA but is awaiting licensing in the European Union (EU). Ceftaroline is removed from the body mainly by the kidneys. The aim of this study is to look at how the kidneys remove the drug in healthy volunteers (with normal kidney function) and to compare this with patients who are on kidney dialysis (with reduced kidney function). This study will look at the levels of the ceftaroline in the blood after intravenous (into a vein in the forearm) dosing in these 2 groups of healthy volunteers/patients. In the patients on kidney dialysis, we will also study the effect of dialysis on the blood levels of the drug so the drug will be given on 2 occasions, once before dialysis and once after dailysis on two seperate occasions.

• REC name

  London - London Bridge Research Ethics Committee

• REC reference

  12/LO/0808

• Date of REC Opinion

  28 Jun 2012

• REC opinion

  Further Information Favourable Opinion