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600 ceftaroline fosamil in infusion volume

Phase 1

Healthy | Small molecule | Other |Pfizer, Inc.|Last 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

Clinical trial landscape

600 ceftaroline fosamil 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 600 ceftaroline fosamil in infusion volume

What is 600 ceftaroline fosamil in infusion volume used for?

600 ceftaroline fosamil in infusion volume is an investigational small molecule being studied in healthy volunteers. It is being evaluated for local tolerability, safety, and pharmacokinetics in a Phase 1 clinical trial. The drug is not approved and remains in clinical development.

Who makes 600 ceftaroline fosamil in infusion volume?

Pfizer, Inc. (NYSE: PFE) is developing 600 ceftaroline fosamil in infusion volume. The company is conducting a Phase 1 clinical trial of the drug in healthy subjects.

What phase is 600 ceftaroline fosamil in infusion volume in?

600 ceftaroline fosamil in infusion volume is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The Phase 1 trial has been completed.

What clinical trials is 600 ceftaroline fosamil in infusion volume in?

600 ceftaroline fosamil in infusion volume is associated with one completed clinical trial, NCT01577589, titled "A 2-part Study to Assess Local Tolerability, Safety and Pharmacokinetics of Ceftaroline in Healthy Subjects." The trial enrolled 34 participants in the United Kingdom.

Is 600 ceftaroline fosamil in infusion volume the same as ceftaroline?

600 ceftaroline fosamil in infusion volume is a formulation of ceftaroline fosamil, as indicated by the trial title referencing ceftaroline. The drug is being studied for its local tolerability, safety, and pharmacokinetics in healthy subjects.