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Ceftaroline China Pharmacokinetics Study (CeftarolineChi)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01458743
First Posted: October 25, 2011
Last Update Posted: September 4, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Forest Laboratories
Information provided by (Responsible Party):
Pfizer
  Purpose
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.

Condition Intervention Phase
Healthy Drug: Ceftaroline Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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. ]

Secondary Outcome Measures:
  • 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. ]

Enrollment: 24
Study Start Date: October 2011
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ceftaroline q12h
Ceftaroline 600mg q12h
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.
Experimental: Ceftaroline q8h
ceftaroline 600mg q8h
Drug: Ceftaroline
Single intravenous dose on Days 1 and 9. Intravenous three times per day on Days 2-8.

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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01458743


Locations
China
Beijing, China
Sponsors and Collaborators
Pfizer
Forest Laboratories
Investigators
Study Director: David Melnick AstraZeneca Pharmaceuticals-US
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01458743     History of Changes
Other Study ID Numbers: D3720C00005
First Submitted: September 30, 2011
First Posted: October 25, 2011
Last Update Posted: September 4, 2017
Last Verified: September 2017

Keywords provided by Pfizer:
pharmacokinetics

Additional relevant MeSH terms:
Cephalosporins
Anti-Bacterial Agents
Anti-Infective Agents