A study to assess safety, tolerability and pharmacokinetics of ceftaroline in healthy subjects

Study identifier:D3720C00010

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A Phase I, Single Centre, Randomised, Double-blind, Placebo-controlled Parallel Group Study to Assess the Safety, Tolerability, and Pharmacokinetics of Ceftaroline after Different Intravenous Dose Regimens of Ceftaroline Fosamil to Healthy Subjects

Medical condition

Healthy Volunteers

Phase

Phase 1

Healthy volunteers

Yes

Study drug

600 mg Ceftaroline fosamil, Placebo

Sex

All

Actual Enrollment

41

Study type

Interventional

Age

18 Years - 55 Years

Date

Study Start Date: 01 Jul 2012
Primary Completion Date: 01 Nov 2012
Study Completion Date: 01 Nov 2012

Study design

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

Verification:

Verified 01 Jul 2015 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria