A Single-centre, Randomised, Double-blind, Placebo-controlled, Four Way Crossover Phase I Study to Investigate the Effect on QT/QTc Interval of Ceftazidime NXL104 or Ceftaroline Fosamil NXL104, Compared With Placebo, Using Moxifloxacin (Avelox®) as a Positive Control, in Healthy Male Volunteers

Phase 1 Completed 54 enrolled Pfizer

RandomizedCrossoverQuadruple-blindBasic science

Summary

This is a single dose study in healthy male volunteers to investigate the effect of high doses of ceftazidime NXL104 (CAZ104) or ceftaroline fosamil NXL104 (CXL104) on the QT interval

Timeline

Start: 2011-02
Primary completion: 2011-05
Completion: 2011-05

Publications

Das S, Armstrong J, Mathews D, Li J, Edeki T. Randomized, placebo-controlled study to assess the impact on QT/QTc interval of supratherapeutic doses of ceftazidime-avibactam or ceftaroline fosamil-avibactam. J Clin Pharmacol. 2014 Mar;54(3):331-40. doi: 10.1002/jcph.199. Epub 2013 Oct 22.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ceftaroline	Other / unclassified	1500 mg	Intravenous
Subject	Ceftazidime	Small molecule	3000 mg	Intravenous
Comparator	Moxifloxacin	Small molecule	400 mg	Oral
Subject	avibactam	Small molecule	2000 mg	Intravenous

Indications

No indication recorded.