Study identifier:D4280C00007
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
A single-centre, randomised, double-blind, placebo-controlled, four way crossover Phase I study to investigate the effect on QT/QTc interval of a single dose of intravenous ceftazidime NXL104 (3000/2000 mg) or ceftaroline fosamil NXL104 (1500/2000 mg), compared with placebo, using open-label moxifloxacin (Avelox®) as a positive control, in healthy male volunteers
Healthy male volunteers
Phase 1
Yes
NXL104, Ceftaroline, Placebo Infusion, Ceftazidime, Moxifloxacin
Male
54
Interventional
18 Years - 45 Years
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind
Primary Purpose: Basic Science
Verified 01 Jul 2014 by AstraZeneca Pharmaceuticals
AstraZeneca Pharmaceuticals
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No locations available
Arms | Assigned Interventions |
---|---|
Experimental: CXL104 2000 mg NXL104 + 1500 mg Ceftaroline (IV) | Drug: NXL104 IV Solution Drug: Ceftaroline IV Solution |
Experimental: CAZ104 Placebo Infusion (saline) + 2000 mg NXL104 + 3000 mg Ceftazidime (IV) | Drug: NXL104 IV Solution Drug: Placebo Infusion IV Saline Drug: Ceftazidime IV Solution |
Active Comparator: Moxifloxacin Moxifloxacin 400mg (1 tablet) | Drug: Moxifloxacin Tablet (1) |
Placebo Comparator: Placebo Placebo Infusion (saline) | Drug: Placebo Infusion IV Saline |