Ceftaroline China Pharmacokinetics Study

• Status: Completed
• Trial end date: 2012-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: AstraZeneca; Pfizer
• Collaborator: Forest Laboratories
• Treatments: Ceftaroline fosamil; Cephalosporins

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.