- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01612507
A Study to Assess Safety, Tolerability and Pharmacokinetics of Ceftaroline in Healthy Subjects
August 31, 2017 updated by: Pfizer
A Phase I, Single Centre, Randomised, Double-blind, Placebo-controlled Parallel Group Study to Assess the Safety, Tolerability, and Pharmacokinetics of Ceftaroline After Different Intravenous Dose Regimens of Ceftaroline Fosamil to Healthy Subjects
The purpose of this study is to assess the safety, tolerability, and pharmacokinetics of different dose regimens of Ceftaroline
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
A Phase I, Single Centre, Randomised, Double-blind, Placebo-controlled Parallel Group Study to Assess the Safety, Tolerability, and Pharmacokinetics of Ceftaroline after Different Intravenous Dose Regimens of Ceftaroline Fosamil to Healthy Subjects
Study Type
Interventional
Enrollment (Actual)
41
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
London, United Kingdom
- Research Site
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Provision of signed and dated, written informed consent prior to any study specific procedures including the optional safety biomarker analysis
- Healthy male and female subjects aged 18 to 55 years (inclusive) with suitable veins for cannulation or repeated venipuncture
- Women of childbearing potential must have a negative pregnancy test, be non-lactating, and be using a highly effective form of birth control for 1 month prior to enrollment, during the study, and for 3 months after completion of all study-related proceed
- Have a body mass index (BMI) between 18 and 30 kg/m2 and weigh at least 50 kg and no more than 100 kg
Exclusion Criteria:
- Has received another new chemical entity (defined as a compound which has not been approved for marketing) or has participated in any other clinical study that included drug treatment within 3 months of the first administration of investigational drug
- History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study
- Any positive result on screening for serum hepatitis B surface antigen, hepatitis C antibody, and human immunodeficiency virus (HIV)
- History or presence of gastrointestinal, hepatic, or renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs
- Any clinically significant abnormalities in the physical examination, 12-lead ECG, or vital signs, as judged by the Investigator
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: A
600 mg Ceftaroline fosamil 1 h infusion
|
1 h infusion
2 h infusion
|
Experimental: B
Placebo 1 h infusion
|
1 h infusion
2 h infusion
|
Experimental: C
600 mg Ceftaroline fosamil 2 h infusion
|
1 h infusion
2 h infusion
|
Experimental: D
Placebo 2 h infusion
|
1 h infusion
2 h infusion
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Safety and tolerability in terms of adverse events, laboratory data, vital signs following single and multiple dose regimens of ceftaroline fosamil compared to placebo
Time Frame: Screening up to 19 days after first dose
|
Screening up to 19 days after first dose
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
24-hour plasma pharmacokinetic profile in terms of (see description) for ceftaroline following single dose administration of ceftaroline fosamil 600 mg (every 12 h) 1 h infusion
Time Frame: Day 1, 4 and 8: Pre-dose, 20 min, 40 min, 55 min, 65 min, 75 min, 90 min, 120 min, 3 h, 4 h, 6 h, 8 h, 12 h, 18 h 24 h Day 6:predose
|
Maximum plasma concentration (Cmax), time to maximum concentration (tmax), area under the plasma 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), apparent terminal rate constant (λz), terminal half life (t1/2λz,h).
|
Day 1, 4 and 8: Pre-dose, 20 min, 40 min, 55 min, 65 min, 75 min, 90 min, 120 min, 3 h, 4 h, 6 h, 8 h, 12 h, 18 h 24 h Day 6:predose
|
24-hour plasma pharmacokinetic profile in terms of (see description) for ceftaroline following multiple dose administration of ceftaroline fosamil 600 mg (every 12 h) 1 h infusion
Time Frame: Day 1, 4 and 8: Pre-dose, 20 min, 40 min, 55 min, 65 min, 75 min, 90 min, 120 min, 3 h, 4 h, 6 h, 8 h, 12 h, 18 h 24 h,Day 6:predose
|
Maximum plasma concentration at steady state during dosing interval (Css,max), time to maximum concentration at steady state during dosing interval (tss,max), minimum plasma concentration at steady state during dosing interval (Css,min), 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 the end of the dosing interval (AUCτ); average plasma concentration during the dosing interval (Css,av), fluctuation index (FI, %)
|
Day 1, 4 and 8: Pre-dose, 20 min, 40 min, 55 min, 65 min, 75 min, 90 min, 120 min, 3 h, 4 h, 6 h, 8 h, 12 h, 18 h 24 h,Day 6:predose
|
24-hour plasma pharmacokinetic profile in terms of (see description) for ceftaroline following single dose administration of ceftaroline fosamil 600 mg (every 8 h) 2 h infusion
Time Frame: Day 1, 4 and 8: Pre-dose, 30 min, 60 min, 90 min, 115 min, 125 min, 2 h 15 min, 2.5 h, 3 h, 4 h, 6 h, 8 h, 12 h, 18 h 24 h,Day 6:predose
|
Maximum plasma concentration (Cmax), time to maximum concentration (tmax), area under the plasma 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 8 hours after the start of the infusion [AUC(0-8), apparent terminal rate constant (λz), terminal half life (t1/2λz,h).
|
Day 1, 4 and 8: Pre-dose, 30 min, 60 min, 90 min, 115 min, 125 min, 2 h 15 min, 2.5 h, 3 h, 4 h, 6 h, 8 h, 12 h, 18 h 24 h,Day 6:predose
|
24 hour plasma pharmacokinetic profile in terms of (see description) for ceftaroline following multiple dose administration of ceftaroline fosamil 600 mg (every 8 h) 2 h infusion
Time Frame: Day 1,4 and 8: Pre-dose, 30 min, 60 min, 90 min, 115 min, 125 min, 2 h 15 min, 2.5 h, 3 h, 4 h, 6 h, 8 h, 12 h, 18 h 24 h,Day 6:predose
|
Maximum plasma concentration at steady state during dosing interval (Css,max), time to maximum concentration at steady state during dosing interval (tss,max), minimum plasma concentration at steady state during dosing interval (Css,min), 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 the end of the dosing interval (AUCτ); average plasma concentration during the dosing interval (Css,av), fluctuation index (FI, %)
|
Day 1,4 and 8: Pre-dose, 30 min, 60 min, 90 min, 115 min, 125 min, 2 h 15 min, 2.5 h, 3 h, 4 h, 6 h, 8 h, 12 h, 18 h 24 h,Day 6:predose
|
Urine pharmacokinetic parameters in terms of (see description) for ceftaroline following single dose administration of ceftaroline fosamil 600 mg (every 12 h) 1 h infusion
Time Frame: Day 1
|
Amount of analyte excreted in the urine (Ae) during each interval and cumulatively, fraction of dose excreted into urine (fe,%) during each interval and cumulatively, total fraction of dose excreted in urine for all analytes combined (fe,total¬,%), and renal clearance (CLR).
|
Day 1
|
Urine pharmacokinetic parameters in terms of (see description) for ceftaroline following multiple dose administration of ceftaroline fosamil 600 mg (every 12 h) 1 h infusion
Time Frame: Day 8
|
Amount of analyte excreted in the urine (Ae,ss, mg) during each interval and cumulatively up to the end of the dosing interval, fraction of dose excreted into urine (fe,ss,%) during each interval and cumulatively up to the end of the dosing interval, total fraction of dose excreted in urine for all analytes combined (fe,ss,total ,%), and renal clearance (CLR,ss, L/h).
|
Day 8
|
24-hour plasma pharmacokinetic profile in terms of (see description) for ceftaroline fosamil following single dose administration of ceftaroline fosamil 600 mg (every 12 h) 1 h infusion
Time Frame: Day 1, 4 and 8: Pre-dose, 20 min, 40 min, 55 min, 65 min, 75 min, 90 min, 120 min, 3 h, 4 h, 6 h, 8 h, 12 h, 18 h 24 h,Day 6:predose
|
Maximum plasma concentration (Cmax), time to maximum concentration (tmax), area under the plasma 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), apparent terminal rate constant (λz), terminal half life (t1/2λz,h).
|
Day 1, 4 and 8: Pre-dose, 20 min, 40 min, 55 min, 65 min, 75 min, 90 min, 120 min, 3 h, 4 h, 6 h, 8 h, 12 h, 18 h 24 h,Day 6:predose
|
24-hour plasma pharmacokinetic profile in terms of (see description) for ceftaroline fosamil following multiple dose administration of ceftaroline fosamil 600 mg (every 12 h) 1 h infusion
Time Frame: Day 1, 4 and 8: Pre-dose, 20 min, 40 min, 55 min, 65 min, 75 min, 90 min, 120 min, 3 h, 4 h, 6 h, 8 h, 12 h, 18 h 24 h,Day 6:predose
|
Maximum plasma concentration at steady state during dosing interval (Css,max), time to maximum concentration at steady state during dosing interval (tss,max), minimum plasma concentration at steady state during dosing interval (Css,min), 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 the end of the dosing interval (AUCτ); average plasma concentration during the dosing interval (Css,av), fluctuation index (FI, %)
|
Day 1, 4 and 8: Pre-dose, 20 min, 40 min, 55 min, 65 min, 75 min, 90 min, 120 min, 3 h, 4 h, 6 h, 8 h, 12 h, 18 h 24 h,Day 6:predose
|
24-hour plasma pharmacokinetic profile in terms of (see description) for ceftaroline fosamil following single dose administration of ceftaroline fosamil 600 mg (every 8 h) 2 h infusion
Time Frame: Day 1, 4 and 8: Pre-dose, 30 min, 60 min, 90 min, 115 min, 125 min, 2 h 15 min, 2.5 h, 3 h, 4 h, 6 h, 8 h, 12 h, 18 h 24 h,Day 6:predose
|
Maximum plasma concentration (Cmax), time to maximum concentration (tmax), area under the plasma 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 8 hours after the start of the infusion [AUC(0-8), apparent terminal rate constant (λz), terminal half life (t1/2λz,h).
|
Day 1, 4 and 8: Pre-dose, 30 min, 60 min, 90 min, 115 min, 125 min, 2 h 15 min, 2.5 h, 3 h, 4 h, 6 h, 8 h, 12 h, 18 h 24 h,Day 6:predose
|
24-hour plasma pharmacokinetic profile in terms of (see description) for ceftaroline fosamil following multiple dose administration of ceftaroline fosamil 600 mg (every 8 h) 2 h infusion
Time Frame: Day 1, 4 and 8: Pre-dose, 30 min, 60 min, 90 min, 115 min, 125 min, 2 h 15 min, 2.5 h, 3 h, 4 h, 6 h, 8 h, 12 h, 18 h 24 h,Day 6:predose
|
Maximum plasma concentration at steady state during dosing interval (Css,max), time to maximum concentration at steady state during dosing interval (tss,max), minimum plasma concentration at steady state during dosing interval (Css,min), 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 the end of the dosing interval (AUCτ); average plasma concentration during the dosing interval (Css,av), fluctuation index (FI, %)
|
Day 1, 4 and 8: Pre-dose, 30 min, 60 min, 90 min, 115 min, 125 min, 2 h 15 min, 2.5 h, 3 h, 4 h, 6 h, 8 h, 12 h, 18 h 24 h,Day 6:predose
|
24-hour plasma pharmacokinetic profile in terms of (see description) for ceftaroline M-1 following single dose administration of ceftaroline fosamil 600 mg (every 12 h) 1 h infusion
Time Frame: Day 1, 4 and 8: Pre-dose, 20 min, 40 min, 55 min, 65 min, 75 min, 90 min, 120 min, 3 h, 4 h, 6 h, 8 h, 12 h, 18 h 24 h,Day 6:predose
|
Maximum plasma concentration (Cmax), time to maximum concentration (tmax), area under the plasma 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), apparent terminal rate constant (λz), terminal half life (t1/2λz,h).
|
Day 1, 4 and 8: Pre-dose, 20 min, 40 min, 55 min, 65 min, 75 min, 90 min, 120 min, 3 h, 4 h, 6 h, 8 h, 12 h, 18 h 24 h,Day 6:predose
|
24-hour plasma pharmacokinetic profile in terms of (see description) for ceftaroline M-1 following multiple dose administration of ceftaroline fosamil 600 mg (every 12 h) 1 h infusion
Time Frame: Day 1, 4 and 8: Pre-dose, 20 min, 40 min, 55 min, 65 min, 75 min, 90 min, 120 min, 3 h, 4 h, 6 h, 8 h, 12 h, 18 h 24 h,Day 6:predose
|
Maximum plasma concentration at steady state during dosing interval (Css,max), time to maximum concentration at steady state during dosing interval (tss,max), minimum plasma concentration at steady state during dosing interval (Css,min), 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 the end of the dosing interval (AUCτ); average plasma concentration during the dosing interval (Css,av), fluctuation index (FI,%)
|
Day 1, 4 and 8: Pre-dose, 20 min, 40 min, 55 min, 65 min, 75 min, 90 min, 120 min, 3 h, 4 h, 6 h, 8 h, 12 h, 18 h 24 h,Day 6:predose
|
24-hour plasma pharmacokinetic profile in terms of (see description) for ceftaroline M-1 following single dose administration of ceftaroline fosamil 600 mg (every 8 h) 2 h infusion
Time Frame: Day 1, 4 and 8: Pre-dose, 30 min, 60 min, 90 min, 115 min, 125 min, 2 h 15 min, 2.5 h, 3 h, 4 h, 6 h, 8 h, 12 h, 18 h 24 h,Day 6:predose
|
Maximum plasma concentration (Cmax), time to maximum concentration (tmax), area under the plasma 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 8 hours after the start of the infusion [AUC(0-8), apparent terminal rate constant (λz), terminal half life (t1/2λz,h).
|
Day 1, 4 and 8: Pre-dose, 30 min, 60 min, 90 min, 115 min, 125 min, 2 h 15 min, 2.5 h, 3 h, 4 h, 6 h, 8 h, 12 h, 18 h 24 h,Day 6:predose
|
24-hour plasma pharmacokinetic profile in terms of (see description) for ceftaroline M-1 following multiple dose administration of ceftaroline fosamil 600 mg (every 8 h) 2 h infusion
Time Frame: Day 1, 4 and 8: Pre-dose, 30 min, 60 min, 90 min, 115 min, 125 min, 2 h 15 min, 2.5 h, 3 h, 4 h, 6 h, 8 h, 12 h, 18 h 24 h,Day 6:predose
|
Maximum plasma concentration at steady state during dosing interval (Css,max), time to maximum concentration at steady state during dosing interval (tss,max), minimum plasma concentration at steady state during dosing interval (Css,min), 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 the end of the dosing interval (AUCτ); average plasma concentration during the dosing interval (Css,av), fluctuation index (FI, %)
|
Day 1, 4 and 8: Pre-dose, 30 min, 60 min, 90 min, 115 min, 125 min, 2 h 15 min, 2.5 h, 3 h, 4 h, 6 h, 8 h, 12 h, 18 h 24 h,Day 6:predose
|
Urine pharmacokinetic parameters in terms of (see description) for ceftaroline fosamil following single dose administration of ceftaroline fosamil 600 mg (every 12 h) 1 h infusion
Time Frame: Day 1
|
Amount of analyte excreted in the urine (Ae) during each interval and cumulatively, fraction of dose excreted into urine (fe,%) during each interval and cumulatively, total fraction of dose excreted in urine for all analytes combined (fe,total¬,%), and renal clearance (CL R).
|
Day 1
|
Urine pharmacokinetic parameters in terms of (see description) for ceftaroline fosamil following multiple dose administration of ceftaroline fosamil 600 mg (every 12 h) 1 h infusion
Time Frame: Day 8
|
Amount of analyte excreted in the urine (Ae,ss, mg) during each interval and cumulatively up to the end of the dosing interval, fraction of dose excreted into urine (fe,ss,%) during each interval and cumulatively up to the end of the dosing interval, total fraction of dose excreted in urine for all analytes combined (fe,ss,total ,%), and renal clearance (CLR,ss, L/h).
|
Day 8
|
Urine pharmacokinetic parameters in terms of (see description) for ceftaroline fosamil following single dose administration of ceftaroline fosamil 600 mg (every 8 h) 2 h infusion
Time Frame: Day 1
|
Amount of analyte excreted in the urine (Ae) during each interval and cumulatively, fraction of dose excreted into urine (fe,%) during each interval and cumulatively, total fraction of dose excreted in urine for all analytes combined (fe,total¬,%), and renal clearance (CLR).
|
Day 1
|
Urine pharmacokinetic parameters in terms of (see description) for ceftaroline fosamil following multiple dose administration of ceftaroline fosamil 600 mg (every 8 h) 2 h infusion
Time Frame: Day 8
|
Amount of analyte excreted in the urine (Ae,ss, mg) during each interval and cumulatively up to the end of the dosing interval, fraction of dose excreted into urine (fe,ss,%) during each interval and cumulatively up to the end of the dosing interval, total fraction of dose excreted in urine for all analytes combined (fe,ss,total ,%), and renal clearance (CLR,ss, L/h).
|
Day 8
|
Urine pharmacokinetic parameters in terms of (see description) for ceftaroline M- 1 following single dose administration of ceftaroline fosamil 600 mg (every 12 h) 1 h infusion
Time Frame: Day 1
|
Amount of analyte excreted in the urine (Ae) during each interval and cumulatively, fraction of dose excreted into urine (fe,%) during each interval and cumulatively, total fraction of dose excreted in urine for all analytes combined (fe,total¬,%), and renal clearance (CLR).
|
Day 1
|
Urine pharmacokinetic parameters in terms of (see description) for ceftaroline M- 1 following multiple dose administration of ceftaroline fosamil 600 mg (every 12 h) 1 h infusion
Time Frame: Day 8
|
Amount of analyte excreted in the urine (Ae,ss, mg) during each interval and cumulatively up to the end of the dosing interval, fraction of dose excreted into urine (fe,ss,%) during each interval and cumulatively up to the end of the dosing interval, total fraction of dose excreted in urine for all analytes combined (fe,ss,total ,%), and renal clearance (CLR,ss, L/h).
|
Day 8
|
Urine pharmacokinetic parameters in terms of (see description) for ceftaroline M- 1 following single dose administration of ceftaroline fosamil 600 mg (every 8 h) 2 h infusion
Time Frame: Day 1
|
Amount of analyte excreted in the urine (Ae) during each interval and cumulatively, fraction of dose excreted into urine (fe,%) during each interval and cumulatively, total fraction of dose excreted in urine for all analytes combined (fe,total¬,%), and renal clearance (CLR).
|
Day 1
|
Urine pharmacokinetic parameters in terms of (see description) for ceftaroline M- 1 following multiple dose administration of ceftaroline fosamil 600 mg (every 8 h) 2 h infusion
Time Frame: Day 8
|
Amount of analyte excreted in the urine (Ae,ss, mg) during each interval and cumulatively up to the end of the dosing interval, fraction of dose excreted into urine (fe,ss,%) during each interval and cumulatively up to the end of the dosing interval, total fraction of dose excreted in urine for all analytes combined (fe,ss,total ,%), and renal clearance (CLR,ss, L/h).
|
Day 8
|
Urine pharmacokinetic parameters in terms of (see description) for ceftaroline following single dose administration of ceftaroline fosamil 600 mg (every 8 h) 2 h infusion
Time Frame: Day 1
|
Amount of analyte excreted in the urine (Ae) during each interval and cumulatively, fraction of dose excreted into urine (fe,%) during each interval and cumulatively, total fraction of dose excreted in urine for all analytes combined (fe,total¬,%), and renal clearance (CLR).
|
Day 1
|
Urine pharmacokinetic parameters in terms of (see description) for ceftaroline following multiple dose administration of ceftaroline fosamil 600 mg (every 8 h) 2 h infusion
Time Frame: Day 8
|
amount of analyte excreted in the urine (Ae,ss, mg) during each interval and cumulatively up to the end of the dosing interval, fraction of dose excreted into urine (fe,ss,%) during each interval and cumulatively up to the end of the dosing interval, total fraction of dose excreted in urine for all analytes combined (fe,ss,total ,%), and renal clearance (CLR,ss, L/h).
|
Day 8
|
24-hour plasma pharmacokinetic profile in terms of (see description) for ceftaroline following single dose administration of ceftaroline fosamil 600 mg (every 12 h) 1 h infusion
Time Frame: Day 1, 4 and 8: Pre-dose, 20 min, 40 min, 55 min, 65 min, 75 min, 90 min, 120 min, 3 h, 4 h, 6 h, 8 h, 12 h, 18 h 24 h Day 6:predose
|
Mean residence time (MRT), total body clearance of drug from plasma (CL for ceftaroline fosamil, apparent CL for ceftaroline), volume of distribution based on the terminal phase (Vz for ceftaroline fosamil, apparent Vz for ceftaroline), and volume of distribution at steady state (Vss for ceftaroline fosamil, apparent Vss for ceftaroline).
|
Day 1, 4 and 8: Pre-dose, 20 min, 40 min, 55 min, 65 min, 75 min, 90 min, 120 min, 3 h, 4 h, 6 h, 8 h, 12 h, 18 h 24 h Day 6:predose
|
24-hour plasma pharmacokinetic profile in terms of (see description) for ceftaroline following multiple dose administration of ceftaroline fosamil 600 mg (every 12 h) 1 h infusion
Time Frame: Day 1, 4 and 8: Pre-dose, 20 min, 40 min, 55 min, 65 min, 75 min, 90 min, 120 min, 3 h, 4 h, 6 h, 8 h, 12 h, 18 h 24 h,Day 6:predose
|
Apparent terminal rate constant (λz), terminal half-life (t½λz, h), accumulation ratio based on Cmax [Rac(Cmax)], accumulation ratio based on AUC [Rac(AUC)], and linearity factor.Mean residence time (MRT), plasma clearance at steady state (CLss for ceftaroline fosamil, apparent CLss for ceftaroline), volume of distribution based on the terminal phase (Vz for ceftaroline fosamil, apparent Vz for ceftaroline), and volume of distribution at steady state (Vss for ceftaroline fosamil, apparent Vss for ceftaroline).
|
Day 1, 4 and 8: Pre-dose, 20 min, 40 min, 55 min, 65 min, 75 min, 90 min, 120 min, 3 h, 4 h, 6 h, 8 h, 12 h, 18 h 24 h,Day 6:predose
|
24-hour plasma pharmacokinetic profile in terms of (see description) for ceftaroline following single dose administration of ceftaroline fosamil 600 mg (every 8 h) 2 h infusion
Time Frame: Day 1, 4 and 8: Pre-dose, 30 min, 60 min, 90 min, 115 min, 125 min, 2 h 15 min, 2.5 h, 3 h, 4 h, 6 h, 8 h, 12 h, 18 h 24 h,Day 6:predose
|
Mean residence time (MRT), total body clearance of drug from plasma (CL for ceftaroline fosamil, apparent CL for ceftaroline), volume of distribution based on the terminal phase (Vz for ceftaroline fosamil, apparent Vz for ceftaroline), and volume of distribution at steady state (Vss for ceftaroline fosamil, apparent Vss for ceftaroline).
|
Day 1, 4 and 8: Pre-dose, 30 min, 60 min, 90 min, 115 min, 125 min, 2 h 15 min, 2.5 h, 3 h, 4 h, 6 h, 8 h, 12 h, 18 h 24 h,Day 6:predose
|
24 hour plasma pharmacokinetic profile in terms of (see description) for ceftaroline following multiple dose administration of ceftaroline fosamil 600 mg (every 8 h) 2 h infusion
Time Frame: Day 1,4 and 8: Pre-dose, 30 min, 60 min, 90 min, 115 min, 125 min, 2 h 15 min, 2.5 h, 3 h, 4 h, 6 h, 8 h, 12 h, 18 h 24 h,Day 6:predose
|
Apparent terminal rate constant (λz), terminal half-life (t½λz, h), accumulation ratio based on Cmax [Rac(Cmax)], accumulation ratio based on AUC [Rac(AUC)], and linearity factor.
Mean residence time (MRT), plasma clearance at steady state (CLss for ceftaroline fosamil, apparent CLss for ceftaroline), volume of distribution based on the terminal phase (Vz for ceftaroline fosamil, apparent Vz for ceftaroline), and volume of distribution at steady state (Vss for ceftaroline fosamil, apparent Vss for ceftaroline).
|
Day 1,4 and 8: Pre-dose, 30 min, 60 min, 90 min, 115 min, 125 min, 2 h 15 min, 2.5 h, 3 h, 4 h, 6 h, 8 h, 12 h, 18 h 24 h,Day 6:predose
|
24-hour plasma pharmacokinetic profile in terms of (see description) for ceftaroline fosamil following single dose administration of ceftaroline fosamil 600 mg (every 12 h) 1 h infusion
Time Frame: Day 1, 4 and 8: Pre-dose, 20 min, 40 min, 55 min, 65 min, 75 min, 90 min, 120 min, 3 h, 4 h, 6 h, 8 h, 12 h, 18 h 24 h,Day 6:predose
|
Mean residence time (MRT), total body clearance of drug from plasma (CL for ceftaroline fosamil, apparent CL for ceftaroline), volume of distribution based on the terminal phase (Vz for ceftaroline fosamil, apparent Vz for ceftaroline), and volume of distribution at steady state (Vss for ceftaroline fosamil, apparent Vss for ceftaroline).
|
Day 1, 4 and 8: Pre-dose, 20 min, 40 min, 55 min, 65 min, 75 min, 90 min, 120 min, 3 h, 4 h, 6 h, 8 h, 12 h, 18 h 24 h,Day 6:predose
|
24-hour plasma pharmacokinetic profile in terms of (see description) for ceftaroline fosamil following multiple dose administration of ceftaroline fosamil 600 mg (every 12 h) 1 h infusion
Time Frame: Day 1, 4 and 8: Pre-dose, 20 min, 40 min, 55 min, 65 min, 75 min, 90 min, 120 min, 3 h, 4 h, 6 h, 8 h, 12 h, 18 h 24 h,Day 6:predose
|
Apparent terminal rate constant (λz), terminal half-life (t½λz, h), accumulation ratio based on Cmax [Rac(Cmax)], accumulation ratio based on AUC [Rac(AUC)], and linearity factor.Mean residence time (MRT), plasma clearance at steady state (CLss for ceftaroline fosamil, apparent CLss for ceftaroline), volume of distribution based on the terminal phase (Vz for ceftaroline fosamil, apparent Vz for ceftaroline), and volume of distribution at steady state (Vss for ceftaroline fosamil, apparent Vss for ceftaroline).
|
Day 1, 4 and 8: Pre-dose, 20 min, 40 min, 55 min, 65 min, 75 min, 90 min, 120 min, 3 h, 4 h, 6 h, 8 h, 12 h, 18 h 24 h,Day 6:predose
|
24-hour plasma pharmacokinetic profile in terms of (see description) for ceftaroline fosamil following single dose administration of ceftaroline fosamil 600 mg (every 8 h) 2 h infusion
Time Frame: Day 1, 4 and 8: Pre-dose, 30 min, 60 min, 90 min, 115 min, 125 min, 2 h 15 min, 2.5 h, 3 h, 4 h, 6 h, 8 h, 12 h, 18 h 24 h,Day 6:predose
|
Mean residence time (MRT), total body clearance of drug from plasma (CL for ceftaroline fosamil, apparent CL for ceftaroline), volume of distribution based on the terminal phase (Vz for ceftaroline fosamil, apparent Vz for ceftaroline), and volume of distribution at steady state (Vss for ceftaroline fosamil, apparent Vss for ceftaroline).
|
Day 1, 4 and 8: Pre-dose, 30 min, 60 min, 90 min, 115 min, 125 min, 2 h 15 min, 2.5 h, 3 h, 4 h, 6 h, 8 h, 12 h, 18 h 24 h,Day 6:predose
|
24-hour plasma pharmacokinetic profile in terms of (see description) for ceftaroline fosamil following multiple dose administration of ceftaroline fosamil 600 mg (every 8 h) 2 h infusion
Time Frame: Day 1, 4 and 8: Pre-dose, 30 min, 60 min, 90 min, 115 min, 125 min, 2 h 15 min, 2.5 h, 3 h, 4 h, 6 h, 8 h, 12 h, 18 h 24 h,Day 6:predose
|
Apparent terminal rate constant (λz), terminal half-life (t½λz, h), accumulation ratio based on Cmax [Rac(Cmax)], accumulation ratio based on AUC [Rac(AUC)], and linearity factor.
Mean residence time (MRT), plasma clearance at steady state (CLss for ceftaroline fosamil, apparent CLss for ceftaroline), volume of distribution based on the terminal phase (Vz for ceftaroline fosamil, apparent Vz for ceftaroline), and volume of distribution at steady state (Vss for ceftaroline fosamil, apparent Vss for ceftaroline).
|
Day 1, 4 and 8: Pre-dose, 30 min, 60 min, 90 min, 115 min, 125 min, 2 h 15 min, 2.5 h, 3 h, 4 h, 6 h, 8 h, 12 h, 18 h 24 h,Day 6:predose
|
24-hour plasma pharmacokinetic profile in terms of (see description) for ceftaroline M-1 following multiple dose administration of ceftaroline fosamil 600 mg (every 12 h) 1 h infusion
Time Frame: Day 1, 4 and 8: Pre-dose, 20 min, 40 min, 55 min, 65 min, 75 min, 90 min, 120 min, 3 h, 4 h, 6 h, 8 h, 12 h, 18 h 24 h,Day 6:predose
|
Apparent terminal rate constant (λz), terminal half-life (t½λz, h), accumulation ratio based on Cmax [Rac(Cmax)], accumulation ratio based on AUC [Rac(AUC)], and linearity factor.
|
Day 1, 4 and 8: Pre-dose, 20 min, 40 min, 55 min, 65 min, 75 min, 90 min, 120 min, 3 h, 4 h, 6 h, 8 h, 12 h, 18 h 24 h,Day 6:predose
|
24-hour plasma pharmacokinetic profile in terms of (see description) for ceftaroline M-1 following multiple dose administration of ceftaroline fosamil 600 mg (every 8 h) 2 h infusion
Time Frame: Day 1, 4 and 8: Pre-dose, 30 min, 60 min, 90 min, 115 min, 125 min, 2 h 15 min, 2.5 h, 3 h, 4 h, 6 h, 8 h, 12 h, 18 h 24 h,Day 6:predose
|
Apparent terminal rate constant (λz), terminal half-life (t½λz, h), accumulation ratio based on Cmax [Rac(Cmax)], accumulation ratio based on AUC [Rac(AUC)], and linearity factor.
|
Day 1, 4 and 8: Pre-dose, 30 min, 60 min, 90 min, 115 min, 125 min, 2 h 15 min, 2.5 h, 3 h, 4 h, 6 h, 8 h, 12 h, 18 h 24 h,Day 6:predose
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: David Melnick, MD, AstraZeneca PharmaceuticalsC2C-7161800 Concord PikePO. Box 15437Wilmington De 19850-5437
- Study Chair: Mirjana Kujacic, MD, AstraZeneca Research and DevelopmentSE-431 83 MolndalSweden
- Principal Investigator: Elizabeth Tranter, MBCHB MRCP, Hammersmith Medicines Cumberland Avenue London NW10 7EW UK
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Das S, Li J, Iaconis J, Zhou D, Stone GG, Yan JL, Melnick D. Ceftaroline fosamil doses and breakpoints for Staphylococcus aureus in complicated skin and soft tissue infections. J Antimicrob Chemother. 2019 Feb 1;74(2):425-431. doi: 10.1093/jac/dky439.
- Yang L, Sunzel M, Xu P, Edeki T, Wilson D, Li J, Li H. Evaluation of the pharmacokinetics and safety of single and multiple ceftaroline fosamil infusions in healthy Chinese and Western subjects. Int J Clin Pharmacol Ther. 2015 Aug;53(8):681-91. doi: 10.5414/CP202343.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2012
Primary Completion (Actual)
November 1, 2012
Study Completion (Actual)
November 1, 2012
Study Registration Dates
First Submitted
June 4, 2012
First Submitted That Met QC Criteria
June 4, 2012
First Posted (Estimate)
June 5, 2012
Study Record Updates
Last Update Posted (Actual)
September 5, 2017
Last Update Submitted That Met QC Criteria
August 31, 2017
Last Verified
August 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- D3720C00010
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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