A 2-part study to assess local tolerability, safety and pharmacokinetics of ceftaroline in healthy subjects
Study identifier:D3720C00015
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A Phase I, Single-center, 2-part, Randomized, 2-way Crossover Study to Assess the Local Tolerability and Safety (Multiple-dose) and to Assess the Pharmacokinetics, Safety, and Tolerability (Single-dose) of Ceftaroline in Healthy Subjects when Ceftaroline Fosamil is Diluted in Various Infusion Volume
Medical condition
Healthy
Phase
Phase 1
Healthy volunteers
Yes
Study drug
600 mg ceftaroline fosamil in 50 ml infusion volume, Placebo in 50 ml infusion volume, 600 ceftaroline fosamil in 250 ml infusion volume, Placebo in 250 ml infusion volume, 600 mg ceftaroline in 100 ml infusion volume, Placebo in 100 ml infusion volume
Sex
All
Actual Enrollment
34
Study type
Interventional
Age
18 Years - 75 Years
Date
Study Start Date: 01 Apr 2012
Primary Completion Date: 01 Sept 2012
Study Completion Date: 01 Sept 2012
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
Sponsors
AstraZeneca
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: A 600 mg ceftaroline fosamil in 50 ml infusion volume | Drug: 600 mg ceftaroline fosamil in 50 ml infusion volume IV infusion |
| Placebo Comparator: B Placebo in 50 ml infusion volume | Drug: Placebo in 50 ml infusion volume IV infusion |
| Experimental: C 600 ceftaroline fosamil in 250 ml infusion volume | Drug: 600 ceftaroline fosamil in 250 ml infusion volume IV infusion |
| Placebo Comparator: D Placebo in 250 ml infusion volume | Drug: Placebo in 250 ml infusion volume IV infusion |
| Experimental: E 600 mg ceftaroline in 100 ml infusion volume | Drug: 600 mg ceftaroline in 100 ml infusion volume IV infusion |
| Placebo Comparator: F Placebo in 100 ml infusion volume | Drug: Placebo in 100 ml infusion volume IV infusion |
Contacts
Investigators
Principal Investigator
David Melnick
AstraZeneca PharmaceuticalsC2C-7161800 Concord PikePO. Box 15437Wilmington De 19850-5437
