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Completed

NCT Number: NCT01458743

Ceftaroline China Pharmacokinetics Study

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.

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Key information

Conditions

Healthy

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Beijing, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ceftaroline

Drug

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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

  6. 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.

  7. 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.

  8. 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.

  9. 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 outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. Number of patients with adverse events.

    Time frame: From baseline to day 10

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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.

  16. 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.

  17. 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.

  18. 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.

  19. 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.

  20. 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.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Collaborators

  • Forest Laboratories

Registry information

Official study 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

Acronym: CeftarolineChi

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Oct 25, 2011
Registry last updated
Sep 5, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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