Ceftaroline China Pharmacokinetics Study
- Registration Number
- NCT01458743
- Lead Sponsor
- Pfizer
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 24
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Ceftaroline q12h Ceftaroline Ceftaroline 600mg q12h Ceftaroline q8h Ceftaroline ceftaroline 600mg q8h
- Primary Outcome Measures
Name Time Method Area under the concentration curve of Ceftaroline over the time (AUC). 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. 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) 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 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
Name Time Method Area under the concentration curve of Ceftaroline metabolite (Ceftaroline M-1) over the time (AUC). 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) 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. Number of patients with adverse events. From baseline to day 10 Area under the concentration curve of Ceftaroline fosamil over the time (AUC). 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 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.