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Trial record 1 of 1 for:    NCT01458743
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Ceftaroline China Pharmacokinetics Study (CeftarolineChi)

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ClinicalTrials.gov Identifier: NCT01458743
Recruitment Status : Completed
First Posted : October 25, 2011
Last Update Posted : September 5, 2017
Sponsor:
Collaborator:
Forest Laboratories
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE September 30, 2011
First Posted Date  ICMJE October 25, 2011
Last Update Posted Date September 5, 2017
Study Start Date  ICMJE October 2011
Actual Primary Completion Date April 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 21, 2012)
  • Area under the concentration curve of Ceftaroline over the time (AUC). [ Time Frame: Group1: Samples taken on Day 8:Pre-dose, 20 min, 40 min, 55 min, 65 min, 75 min, 1.5 hr, 2 hr, 3 hr ,4 hr, 6hr , 8 hr, 12 hr, 18 hr, 24 hr, 36 hr and 48 hr after the start of infusion of the study drug. ]
  • Area under the concentration curve of Ceftaroline over the time (AUC). [ Time Frame: Group2: Day3 and Day 5 through 8: pre-dose; Day 4: Pre-dose, 60 min, 90 min, 115 min, 125 min, 2 hr15min, 2.5hr, 3 hr ,4hr, 6hr, 8 hr after the start of infusion of the study drug. ]
  • Area under the concentration curve of Ceftaroline over the time (AUC). [ Time Frame: Group 2: Day 9: Pre-dose, 60 min, 90 min, 115 min, 125 min, 2 hr15min, 2.5hr, 3 hr ,4 hr, 6hr, 8 hr,12hr,18hr,24hr after the start of infusion of the study drug. ]
  • Maximum plasma concentration (Cmax) of Ceftaroline. [ Time Frame: Group1: Samples taken on Day 8:Pre-dose, 20 min, 40 min, 55 min, 65 min, 75 min, 1.5 hr, 2 hr, 3 hr ,4 hr, 6hr , 8 hr, 12 hr, 18 hr, 24 hr, 36 hr and 48 hr after the start of infusion of the study drug. ]
  • Maximum plasma concentration (Cmax) of Ceftaroline. [ Time Frame: Group2:Days 2 through 7: Pre-dose Day 8: Pre-dose, 60 min,90 min,115 min,125 min,2 hr15min,2.5hr,3 hr,4 hr,6hr, 8 hr,12hr,18hr,24hr after the start of infusion of the study drug ]
  • Area under the concentration curve of Ceftaroline over the time (AUC) [ Time Frame: Group1: Samples taken on Day 1:Pre-dose, 20 min, 40 min, 55 min, 65 min, 75 min, 1.5 hr, 2 hr, 3 hr ,4 hr, 6hr , 8 hr, 12 hr, 18 hr, 24 hr, 36 hr and 48 hr after the start of infusion of the study drug. ]
  • Area under the concentration curve of Ceftaroline over the time (AUC) [ Time Frame: Group2: Samples taken on Day 1:Pre-dose, 60 min, 90 min, 115 min, 125 min, 2 hr15min, 2.5hr, 3 hr ,4 hr, 6hr , 8 hr, 12 hr, 18 hr, 24 hr after the start of infusion of the study drug. ]
  • Maximum plasma concentration (Cmax) of Ceftaroline [ Time Frame: Group1: Samples taken on Day 1:Pre-dose, 20 min, 40 min, 55 min, 65 min, 75 min, 1.5 hr, 2 hr, 3 hr ,4 hr, 6hr , 8 hr, 12 hr, 18 hr, 24 hr, 36 hr and 48 hr after the start of infusion of the study drug. ]
  • Maximum plasma concentration (Cmax) of Ceftaroline [ Time Frame: Group2: Samples taken on Day 1:Pre-dose, 60 min, 90 min, 115 min, 125 min, 2 hr15min, 2.5hr, 3 hr ,4 hr, 6hr , 8 hr, 12 hr, 18 hr, 24 hr after the start of infusion of the study drug. ]
Original Primary Outcome Measures  ICMJE
 (submitted: October 24, 2011)
  • Area under the concentration curve of Ceftaroline over the time (AUC). [ Time Frame: Samples taken on Day 1: pre-dose, 20 min, 40 min, 55 min, 65 min, 75 min, 1.5 hr, 2 hr, 3 hr ,4 hr, 6hr , 8 hr, 12 hr, 18 hr, 24 hr, 36 hr and 48 hr after the start of infusion of the study drug. ]
  • Maximum plasma concentration (Cmax) of Ceftaroline. [ Time Frame: Samples taken on Day 1: pre-dose, 20 min, 40 min, 55 min, 65 min, 75 min, 1.5 hr, 2 hr, 3 hr ,4 hr, 6hr , 8 hr, 12 hr, 18 hr, 24 hr, 36 hr and 48 hr after the start of infusion of the study drug. ]
  • Area under the concentration curve of Ceftaroline over the time (AUC). [ Time Frame: Samples taken on Day 8: pre-dose, 20 min, 40 min, 55 min, 65 min, 75 min, 1.5 hr, 2 hr, 3 hr ,4 hr, 6hr , 8 hr, 12 hr, 18 hr, 24 hr, 36 hr and 48 hr after the start of infusion of the study drug. ]
  • Maximum plasma concentration (Cmax) of Ceftaroline. [ Time Frame: Samples taken on Day 8: pre-dose, 20 min, 40 min, 55 min, 65 min, 75 min, 1.5 hr, 2 hr, 3 hr ,4 hr, 6hr , 8 hr, 12 hr, 18 hr, 24 hr, 36 hr and 48 hr after the start of infusion of the study drug. ]
Change History Complete list of historical versions of study NCT01458743 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 21, 2012)
  • Area under the concentration curve of Ceftaroline metabolite (Ceftaroline M-1) over the time (AUC). [ Time Frame: Group1: Samples taken on Day 1:Pre-dose, 20 min, 40 min, 55 min, 65 min, 75 min, 1.5 hr, 2 hr, 3 hr ,4 hr, 6hr , 8 hr, 12 hr, 18 hr, 24 hr, 36 hr and 48 hr after the start of infusion of the study drug. ]
  • Area under the concentration curve of Ceftaroline metabolite (Ceftaroline M-1) over the time (AUC). [ Time Frame: Group2: Samples taken on Day 1:Pre-dose, 60 min, 90 min, 115 min, 125 min, 2 hr15min, 2.5hr, 3 hr ,4 hr, 6hr , 8 hr, 12 hr, 18 hr, 24 hr after the start of infusion of the study drug. ]
  • Maximum plasma concentration (Cmax) of Ceftaroline metabolite (Ceftaroline M-1) [ Time Frame: Group1: Samples taken on Day 1:Pre-dose, 20 min, 40 min, 55 min, 65 min, 75 min, 1.5 hr, 2 hr, 3 hr ,4 hr, 6hr , 8 hr, 12 hr, 18 hr, 24 hr, 36 hr and 48 hr after the start of infusion of the study drug. ]
  • Maximum plasma concentration (Cmax) of Ceftaroline metabolite (Ceftaroline M-1) [ Time Frame: Group2: Samples taken on Day 1:Pre-dose, 60 min, 90 min, 115 min, 125 min, 2 hr15min, 2.5hr, 3 hr ,4 hr, 6hr , 8 hr, 12 hr, 18 hr, 24 hr after the start of infusion of the study drug. ]
  • Area under the concentration curve of Ceftaroline metabolite (Ceftaroline M-1) over the time (AUC). [ Time Frame: Group1: Samples taken on Day 8:Pre-dose, 20 min, 40 min, 55 min, 65 min, 75 min, 1.5 hr, 2 hr, 3 hr ,4 hr, 6hr , 8 hr, 12 hr, 18 hr, 24 hr, 36 hr and 48 hr after the start of infusion of the study drug. ]
  • Area under the concentration curve of Ceftaroline metabolite (Ceftaroline M-1) over the time (AUC). [ Time Frame: Group2:Days 2 through 7:Pre-dose Day8: Pre-dose,60 min,90 min,115 min,125 min, 2 hr 15min,2.5hr,3 hr,4 hr,6hr,8 hr,12hr,18hr,24hr after the start of infusion of the study drug. ]
  • Maximum plasma concentration (Cmax) of Ceftaroline metabolite (Ceftaroline M-1) [ Time Frame: Group1: Samples taken on Day 8:Pre-dose, 20 min, 40 min, 55 min, 65 min, 75 min, 1.5 hr, 2 hr, 3 hr ,4 hr, 6hr , 8 hr, 12 hr, 18 hr, 24 hr, 36 hr and 48 hr after the start of infusion of the study drug. ]
  • Number of patients with adverse events. [ Time Frame: From baseline to day 10 ]
  • Maximum plasma concentration (Cmax) of Ceftaroline metabolite (Ceftaroline M-1) [ Time Frame: Group2: Day3 and Day 5 through 8: pre-dose; Day 4: Pre-dose, 60 min, 90 min, 115 min, 125 min, 2 hr 15min, 2.5hr, 3 hr ,4hr, 6hr, 8 hr after the start of infusion of the study drug. ]
  • Maximum plasma concentration (Cmax) of Ceftaroline metabolite (Ceftaroline M-1) [ Time Frame: Group2: Day 9: Pre-dose, 60 min, 90 min, 115 min, 125 min, 2 hr15min, 2.5hr, 3 hr ,4 hr, 6hr, 8 hr, 12hr, 18hr, 24hr after the start of infusion of the study drug. ]
  • Area under the concentration curve of Ceftaroline fosamil over the time (AUC). [ Time Frame: Group1: Samples taken on Day 1:Pre-dose, 20 min, 40 min, 55 min, 65 min, 75 min, 1.5 hr, 2 hr, 3 hr ,4 hr, 6hr , 8 hr, 12 hr, 18 hr, 24 hr, 36 hr and 48 hr after the start of infusion of the study drug. ]
  • Area under the concentration curve of Ceftaroline fosamil over the time (AUC). [ Time Frame: Group2: Samples taken on Day 1:Pre-dose, 60 min, 90 min, 115 min, 125 min, 2 hr15min, 2.5hr, 3 hr ,4 hr, 6hr , 8 hr, 12 hr, 18 hr, 24 hr after the start of infusion of the study drug. ]
  • Maximum plasma concentration (Cmax) of Ceftaroline fosamil [ Time Frame: Group1: Samples taken on Day 1:Pre-dose, 20 min, 40 min, 55 min, 65 min, 75 min, 1.5 hr, 2 hr, 3 hr ,4 hr, 6hr , 8 hr, 12 hr, 18 hr, 24 hr, 36 hr and 48 hr after the start of infusion of the study drug. ]
  • Maximum plasma concentration (Cmax) of Ceftaroline fosamil [ Time Frame: Group2: Samples taken on Day 1:Pre-dose, 60 min, 90 min, 115 min, 125 min, 2 hr15min, 2.5hr, 3 hr ,4 hr, 6hr , 8 hr, 12 hr, 18 hr, 24 hr after the start of infusion of the study drug. ]
  • Area under the concentration curve of Ceftaroline fosamil over the time (AUC). [ Time Frame: Group1: Samples taken on Day 8:Pre-dose, 20 min, 40 min, 55 min, 65 min, 75 min, 1.5 hr, 2 hr, 3 hr ,4 hr, 6hr , 8 hr, 12 hr, 18 hr, 24 hr, 36 hr and 48 hr after the start of infusion of the study drug. ]
  • Area under the concentration curve of Ceftaroline fosamil over the time (AUC). [ Time Frame: Group2: Day3 and Day 5 through 8: pre-dose; Day 4: Pre-dose, 60 min, 90 min, 115 min, 125 min, 2 hr15min, 2.5hr, 3 hr ,4hr, 6hr, 8 hr after the start of infusion of the study drug. ]
  • Area under the concentration curve of Ceftaroline fosamil over the time (AUC). [ Time Frame: Group2: Day 9: Pre-dose, 60 min, 90 min, 115 min, 125 min, 2 hr15min, 2.5hr, 3 hr ,4 hr, 6hr, 8 hr,12hr,18hr,24hr after the start of infusion of the study drug. ]
  • Maximum plasma concentration (Cmax) of Ceftaroline fosamil [ Time Frame: Group1: Samples taken on Day 8:Pre-dose, 20 min, 40 min, 55 min, 65 min, 75 min, 1.5 hr, 2 hr, 3 hr ,4 hr, 6hr , 8 hr, 12 hr, 18 hr, 24 hr, 36 hr and 48 hr after the start of infusion of the study drug. ]
  • Maximum plasma concentration (Cmax) of Ceftaroline fosamil [ Time Frame: Group2: Day3 and Day 5 through 8: pre-dose; Day 4: Pre-dose, 60 min, 90 min, 115 min, 125 min, 2 hr 15min, 2.5hr, 3 hr ,4hr, 6hr, 8 hr after the start of infusion of the study drug. ]
  • Maximum plasma concentration (Cmax) of Ceftaroline fosamil [ Time Frame: Group2: Day 9: Pre-dose, 60 min, 90 min, 115 min, 125 min, 2 hr15min, 2.5hr, 3 hr ,4 hr, 6hr, 8 hr,12hr,18hr,24hr after the start of infusion of the study drug. ]
Original Secondary Outcome Measures  ICMJE
 (submitted: October 24, 2011)
  • Area under the concentration curve of Ceftaroline metabolite (Ceftaroline M-1) over the time (AUC). [ Time Frame: Samples taken on Day 1: pre-dose, 20 min, 40 min, 55 min, 65 min, 75 min, 1.5 hr, 2 hr, 3 hr ,4 hr, 6hr , 8 hr, 12 hr, 18 hr, 24 hr, 36 hr and 48 hr after the start of infusion of the study drug. ]
  • Maximum plasma concentration (Cmax) of Ceftaroline metabolite (Ceftaroline M-1). [ Time Frame: Samples taken on Day 1: pre-dose, 20 min, 40 min, 55 min, 65 min, 75 min, 1.5 hr, 2 hr, 3 hr ,4 hr, 6hr , 8 hr, 12 hr, 18 hr, 24 hr, 36 hr and 48 hr after the start of infusion of the study drug. ]
  • Area under the concentration curve of Ceftaroline metabolite (Ceftaroline M-1) over the time (AUC). [ Time Frame: Samples taken on Day 8: pre-dose, 20 min, 40 min, 55 min, 65 min, 75 min, 1.5 hr, 2 hr, 3 hr ,4 hr, 6hr , 8 hr, 12 hr, 18 hr, 24 hr, 36 hr and 48 hr after the start of infusion of the study drug. ]
  • Maximum plasma concentration (Cmax) of Ceftaroline metabolite (Ceftaroline M-1). [ Time Frame: Samples taken on Day 8: pre-dose, 20 min, 40 min, 55 min, 65 min, 75 min, 1.5 hr, 2 hr, 3 hr ,4 hr, 6hr , 8 hr, 12 hr, 18 hr, 24 hr, 36 hr and 48 hr after the start of infusion of the study drug. ]
  • Area under the concentration curve of Ceftaroline fosamil over the time (AUC). [ Time Frame: Samples taken on Day 1: pre-dose, 20 min, 40 min, 55 min, 65 min, 75 min, 1.5 hr, 2 hr, 3 hr ,4 hr, 6hr , 8 hr, 12 hr, 18 hr, 24 hr, 36 hr and 48 hr after the start of infusion of the study drug. ]
  • Maximum plasma concentration (Cmax) of Ceftaroline fosamil. [ Time Frame: Samples taken on Day 1: pre-dose, 20 min, 40 min, 55 min, 65 min, 75 min, 1.5 hr, 2 hr, 3 hr ,4 hr, 6hr , 8 hr, 12 hr, 18 hr, 24 hr, 36 hr and 48 hr after the start of infusion of the study drug. ]
  • Area under the concentration curve of Ceftaroline fosamil over the time (AUC). [ Time Frame: Samples taken on Day 8: pre-dose, 20 min, 40 min, 55 min, 65 min, 75 min, 1.5 hr, 2 hr, 3 hr ,4 hr, 6hr , 8 hr, 12 hr, 18 hr, 24 hr, 36 hr and 48 hr after the start of infusion of the study drug. ]
  • Maximum plasma concentration (Cmax) of Ceftaroline fosamil. [ Time Frame: Samples taken on Day 8: pre-dose, 20 min, 40 min, 55 min, 65 min, 75 min, 1.5 hr, 2 hr, 3 hr ,4 hr, 6hr , 8 hr, 12 hr, 18 hr, 24 hr, 36 hr and 48 hr after the start of infusion of the study drug. ]
  • Number of patients with adverse events. [ Time Frame: From baseline to day 10 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ceftaroline China Pharmacokinetics Study
Official Title  ICMJE A Phase I, Single Center, Open Label, Two Groups Study to Assess the Safety and Pharmacokinetics of Ceftaroline in Healthy Chinese Volunteers Following Single and Multiple Administration of 600 mg Ceftaroline Fosamil as 60-minute Intravenous Infusion Every 12 Hours and as 120-minute Intravenous Infusion Every 8 Hours
Brief Summary The purpose of this study is to evaluate the pharmacokinetics, safety and tolerability of ceftaroline in Chinese healthy subjects following single and multiple intravenous doses.
Detailed Description A Phase I, Single Center and Open Label Study to Assess the Safety and Pharmacokinetics of Ceftaroline in Healthy Chinese Volunteers Following Single and Multiple Administration of 600 mg Ceftaroline Fosamil as 60-minute Intravenous Infusion Every 12 hours and as 120-minute Intravenous Infusion Every 8 hours.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: Ceftaroline
    60-minute single intravenous dose of 600 mg of Ceftaroline on Days 1 and 8; 60-minute intravenous dose of 600 mg of Ceftaroline twice per day on Days 3-7.
  • Drug: Ceftaroline
    Single intravenous dose on Days 1 and 9. Intravenous three times per day on Days 2-8.
Study Arms  ICMJE
  • Experimental: Ceftaroline q12h
    Ceftaroline 600mg q12h
    Intervention: Drug: Ceftaroline
  • Experimental: Ceftaroline q8h
    ceftaroline 600mg q8h
    Intervention: Drug: Ceftaroline
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 14, 2011)
24
Original Estimated Enrollment  ICMJE
 (submitted: October 24, 2011)
12
Actual Study Completion Date  ICMJE April 2012
Actual Primary Completion Date April 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Provision of informed consent prior to any study specific procedures.
  • Are healthy male or female Chinese volunteers aged between 18 and 45 inclusive.
  • Have a Body Mass Index (BMI) between (and including) 19 and 24 kg/m2 and weigh at least 50 kg.
  • Be willing to communicate with the investigator and comply with all study procedures.

Exclusion Criteria:

  • Creatine clearance <80 mL/min as calculated by the Cockcroft Gault equation
  • History of any hypersensitivity or allergic reaction to any β-lactam antimicrobial.
  • Symptoms of any clinically significant illness within 2 weeks of screening.
  • Use of any other investigational compound or participation in another clinical trial within 2 months prior to Visit 2.
  • Blood donation with 3 months of screening.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01458743
Other Study ID Numbers  ICMJE D3720C00005
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Forest Laboratories
Investigators  ICMJE
Study Director: David Melnick AstraZeneca Pharmaceuticals-US
PRS Account Pfizer
Verification Date September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP