Ceftaroline China Pharmacokinetics Study (CeftarolineChi)

This study has been completed.
Sponsor:
Collaborator:
Forest Laboratories
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01458743
First received: September 30, 2011
Last updated: July 31, 2012
Last verified: July 2012
  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
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: 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 AstraZeneca:

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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]

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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • Number of patients with adverse events. [ Time Frame: From baseline to day 10 ] [ Designated as safety issue: Yes ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01458743

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

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01458743     History of Changes
Other Study ID Numbers: D3720C00005
Study First Received: September 30, 2011
Last Updated: July 31, 2012
Health Authority: China: Food and Drug Administration

Keywords provided by AstraZeneca:
pharmacokinetics

ClinicalTrials.gov processed this record on August 20, 2014