Healthy
Conditions
Keywords
pharmacokinetics
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.
Interventions
DRUGCeftaroline
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.
Sponsors
Forest Laboratories
Pfizer
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the concentration curve of Ceftaroline over the time (AUC). | 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. | 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) | 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 | 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. |
Secondary
| Measure | Time frame |
|---|---|
| Area under the concentration curve of Ceftaroline metabolite (Ceftaroline M-1) over the time (AUC). | 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 | 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) | 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. |
| Number of patients with adverse events. | From baseline to day 10 |
| Area under the concentration curve of Ceftaroline fosamil over the time (AUC). | 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. |
Countries
China
Outcome results
None listed