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

Study identifier:D4280C00007

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

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

Medical condition

Healthy male volunteers

Phase

Phase 1

Healthy volunteers

Yes

Study drug

NXL104, Ceftaroline, Placebo Infusion, Ceftazidime, Moxifloxacin

Sex

Male

Actual Enrollment

54

Study type

Interventional

Age

18 Years - 45 Years

Date

Study Start Date: 01 Feb 2011
Primary Completion Date: 01 May 2011
Study Completion Date: 01 May 2011

Study design

Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind
Primary Purpose: Basic Science

Verification:

Verified 01 Jul 2014 by AstraZeneca Pharmaceuticals

Sponsors

AstraZeneca Pharmaceuticals

Collaborators

-

Inclusion and exclusion criteria