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ceftaroline in infusion volume

Phase 1

Undisclosed | Small molecule | Other |Pfizer, Inc.|Trials Updated: Sep 5, 2017

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment34

FDA Designations

No designations recorded

ceftaroline in infusion volume clinical trials

ceftaroline in infusion volume · 1 trial · 1 indication

Phase 1 1
NCT01577589A 2-part Study to Assess Local Tolerability, Safety and Pharmacokinetics of Ceftaroline in Healthy SubjectsHealthy
COMPLETED34 Analytics
PHASE1COMPLETED
A 2-part Study to Assess Local Tolerability, Safety and Pharmacokinetics of Ceftaroline in Healthy Subjects
Healthy
NCT0157758934
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Study Endpoints

Primary Endpoints

24-hour pharmacokinetic profile in terms of (see description) for ceftaroline following single-dose administration of ceftaroline fosamil 600 mg diluted in various infusion volumes
Pre-dose, 20 min, 40 min, 60 min, 65 min, 75 min, 90 min, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 18 h, 24 h post-dose

Maximum plasma concentration (Cmax) Time to maximum concentration (tmax) Area under the concentration-time curve from zero to infinity (AUC) Area under the plasma concentration-time curve from zero to time of the last quantifiable concentrations \[AUC(0-t)\] Area under the plasma concentration-time curve from zero to 12 hours after the start of the infusion \[AUC(0-12)\]

24-hour pharmacokinetic profile in terms of (see description)for ceftaroline following single-dose administration of ceftaroline fosamil 600 mg diluted in various infusion volumes
Pre-dose, 20 min, 40 min, 60 min, 65 min, 75 min, 90 min, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 18 h, 24 h post-dose

Apparent terminal elimination rate constant (Lz) Half-life associated with the terminal slope (t½Lz),mean residence time (MRT) Total body clearance of drug from plasma (CL) Volume of distribution based on the terminal phase(Vz) Volume of distribution at steady state (Vss) Cmax ratios of ceftaroline/ceftaroline fosamil and ceftaroline M-1/ceftaroline (RM/D,Cmax) AUC ratios of ceftaroline/ceftaroline fosamil and ceftaroline M-1/ceftaroline (RM/D,AUC)

Local tolerability in terms of adverse events including local infusion site tolerability for ceftaroline following ceftaroline 600 mg diluted in various infusion volumes every 12 hours for 72 hours
From baseline to 14 days after first dose

Baseline is defined as - Screening up.

Secondary Endpoints

Safety profile in terms of vital signs, ECG, laboratory variables, physical examination for ceftaroline following ceftaroline 600 mg diluted in various infusion volumes every 12 hours for 72 hours
From baseline to 14 days after first dose
24-hour pharmacokinetic profile in terms of ( see description) for ceftaroline fosamil and ceftaroline M-1following single-dose administration of ceftaroline fosamil 600 mg diluted in various infusion volumes
Pre-dose, 20 min, 40 min, 60 min, 65 min, 75 min, 90 min, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 18 h, 24 h post-dose
Safety and tolerability profile in terms of adverse events, vital signs, ECG, laboratory variables, physical exam of ceftaroline following single-dose administration of ceftaroline fosamil 600 mg diluted in various infusion volumes
From baseline to 14 days after first dose)
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelCROSSOVER
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
AEXPERIMENTAL600 mg ceftaroline fosamil in 50 ml infusion volume
BPLACEBO_COMPARATORPlacebo in 50 ml infusion volume
CEXPERIMENTAL600 ceftaroline fosamil in 250 ml infusion volume
DPLACEBO_COMPARATORPlacebo in 250 ml infusion volume
EEXPERIMENTAL600 mg ceftaroline in 100 ml infusion volume
FPLACEBO_COMPARATORPlacebo in 100 ml infusion volume

Interventions

NameTypeDescription
600 mg ceftaroline fosamil in 50 ml infusion volumeDRUGIV infusion
Placebo in 50 ml infusion volumeDRUGIV infusion
600 ceftaroline fosamil in 250 ml infusion volumeDRUGIV infusion
Placebo in 250 ml infusion volumeDRUGIV infusion
600 mg ceftaroline in 100 ml infusion volumeDRUGIV infusion
Placebo in 100 ml infusion volumeDRUGIV infusion
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Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Provision of informed consent prior to any study specific requirements * Women of childbearing potential must have a negative pregnancy test, be non-lactating, and be using a highly effective form of birth control for 3 months prior to enrollment, during the study, and for 3 m...

Countries:United Kingdom
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Frequently asked questions about ceftaroline in infusion volume

What is ceftaroline in infusion volume?

Ceftaroline in infusion volume is a small molecule formulation of ceftaroline, given as 600 mg in a 100 ml infusion volume. It was studied by Pfizer in a Phase 1 trial in healthy adult volunteers in the United Kingdom. The specific therapeutic indication for this formulation is undisclosed.

Who makes ceftaroline in infusion volume?

Pfizer, Inc. (ticker PFE) is the developer of ceftaroline in infusion volume. The company sponsored the Phase 1 study of this formulation, which was conducted in healthy subjects in the United Kingdom.

What phase is ceftaroline in infusion volume in?

Ceftaroline in infusion volume is in Phase 1 development. One Phase 1 trial has been completed, and no trials are currently active. The study enrolled 34 healthy adult volunteers and was randomized, double blind, and placebo controlled.

What clinical trial is ceftaroline in infusion volume in?

Ceftaroline in infusion volume was studied in NCT01577589, titled A 2-part Study to Assess Local Tolerability, Safety and Pharmacokinetics of Ceftaroline in Healthy Subjects. The Phase 1 trial enrolled 34 healthy volunteers in the United Kingdom, was randomized, double blind, and placebo controlled, and has been completed.

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