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A Study to Assess Safety, Tolerability and Pharmacokinetics of Ceftaroline in Healthy Subjects

31 de agosto de 2017 atualizado por: 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

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Descrição detalhada

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

Tipo de estudo

Intervencional

Inscrição (Real)

41

Estágio

  • Fase 1

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos a 55 anos (Adulto)

Aceita Voluntários Saudáveis

Sim

Gêneros Elegíveis para o Estudo

Tudo

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Ciência básica
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Triplo

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: A
600 mg Ceftaroline fosamil 1 h infusion
Medicamento: 600 mg de ceftarolina fosamil
1h de infusão
Medicamento: 600 mg Ceftaroline fosamil
2 h infusion
Experimental: B
Placebo 1 h infusion
Medicamento: Placebo
1 h infusion
Medicamento: Placebo
2 h infusion
Experimental: C
600 mg Ceftaroline fosamil 2 h infusion
Medicamento: 600 mg de ceftarolina fosamil
1h de infusão
Medicamento: 600 mg Ceftaroline fosamil
2 h infusion
Experimental: D
Placebo 2 h infusion
Medicamento: Placebo
1 h infusion
Medicamento: Placebo
2 h infusion

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Prazo
Safety and tolerability in terms of adverse events, laboratory data, vital signs following single and multiple dose regimens of ceftaroline fosamil compared to placebo
Prazo: Screening up to 19 days after first dose
Screening up to 19 days after first dose

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Pfizer

Investigadores

  • Diretor de estudo: David Melnick, MD, AstraZeneca PharmaceuticalsC2C-7161800 Concord PikePO. Box 15437Wilmington De 19850-5437
  • Cadeira de estudo: Mirjana Kujacic, MD, AstraZeneca Research and DevelopmentSE-431 83 MolndalSweden
  • Investigador principal: Elizabeth Tranter, MBCHB MRCP, Hammersmith Medicines Cumberland Avenue London NW10 7EW UK

Publicações e links úteis

A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.

Publicações Gerais

Links úteis

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo

1 de julho de 2012

Conclusão Primária (Real)

1 de novembro de 2012

Conclusão do estudo (Real)

1 de novembro de 2012

Datas de inscrição no estudo

Enviado pela primeira vez

4 de junho de 2012

Enviado pela primeira vez que atendeu aos critérios de CQ

4 de junho de 2012

Primeira postagem (Estimativa)

5 de junho de 2012

Atualizações de registro de estudo

Última Atualização Postada (Real)

5 de setembro de 2017

Última atualização enviada que atendeu aos critérios de controle de qualidade

31 de agosto de 2017

Última verificação

1 de agosto de 2017

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • D3720C00010

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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