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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
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment34
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01577589A 2-part Study to Assess Local Tolerability, Safety and Pharmacokinetics of Ceftaroline in Healthy SubjectsPHASE1 COMPLETED 34 — — Apr 1, 2012Sep 1, 2012Sep 5, 20171 United Kingdom
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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 — 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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