Ceftaroline China Pharmacokinetics Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Healthy

Intervention / Treatment
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* Drug: Ceftaroline
* Drug: Ceftaroline


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ceftaroline q12h<br>Ceftaroline 600mg q12h | Drug: Ceftaroline<br>* 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.<br>|
| Experimental: Ceftaroline q8h<br>ceftaroline 600mg q8h | Drug: Ceftaroline<br>* Single intravenous dose on Days 1 and 9. Intravenous three times per day on Days 2-8.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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. | 
| Area under the concentration curve of Ceftaroline over the time (AUC). |  | 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). |  | 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. |  | 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. |  | 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) |  | 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) |  | 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 |  | 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 |  | 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

| Outcome Measure | Measure Description | 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. | 
| Area under the concentration curve of Ceftaroline metabolite (Ceftaroline M-1) 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 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. | 
| Maximum plasma concentration (Cmax) of Ceftaroline metabolite (Ceftaroline M-1) |  | 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). |  | 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). |  | 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) |  | 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. |  | From baseline to day 10 | 
| Maximum plasma concentration (Cmax) of Ceftaroline metabolite (Ceftaroline M-1) |  | 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) |  | 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). |  | 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). |  | 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 |  | 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 |  | 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). |  | 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). |  | 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). |  | 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 |  | 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 |  | 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 |  | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pharmacokinetics