MedTrace Logo

A 2-part Study to Assess Local Tolerability, Safety and Pharmacokinetics of Ceftaroline in Healthy Subjects

NCT01577589 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2017-09-05

No results posted yet for this study

Summary

The purpose of this study is to assess the safety, tolerability, and pharmacokinetics of Ceftaroline 600 mg when administered by varying infusion volumes.

Conditions

  • Healthy

Interventions

DRUG

600 mg ceftaroline fosamil in 50 ml infusion volume

IV infusion

DRUG

Placebo in 50 ml infusion volume

IV infusion

DRUG

600 ceftaroline fosamil in 250 ml infusion volume

IV infusion

DRUG

Placebo in 250 ml infusion volume

IV infusion

DRUG

600 mg ceftaroline in 100 ml infusion volume

IV infusion

DRUG

Placebo in 100 ml infusion volume

IV infusion

Sponsors & Collaborators

Principal Investigators

  • David Melnick, MD · AstraZeneca PharmaceuticalsC2C-7161800 Concord PikePO. Box 15437Wilmington De 19850-5437

  • Elizabeth Tranter, MBCHB MRCP · Hammersmith Medicines Research Cumberland Avenue London NW10 EW UK

  • Mirjana Kujacic, MD · AstraZeneca Research and DevelopmentSE-431 83 MölndalSweden

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-04-30
Primary Completion
2012-09-30
Completion
2012-09-30

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01577589 on ClinicalTrials.gov