A 2-part Study to Assess Local Tolerability, Safety and Pharmacokinetics of Ceftaroline in Healthy Subjects

• Status: Completed
• Trial end date: 2012-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to assess the safety, tolerability, and pharmacokinetics of Ceftaroline 600 mg when administered by varying infusion volumes.

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

Details

• Lead Sponsor: AstraZeneca; Pfizer
• Treatments: Ceftaroline fosamil; Cephalosporins

Criteria

Inclusion Criteria:

• Provision of informed consent prior to any study specific requirements

• Women of childbearing potential must have a negative pregnancy test, be non-lactating, and be using a highly effective form of birth control for 3 months prior to enrollment, during the study, and for 3 months after completion of all study-related proceed

• Male volunteers must be willing to use barrier contraception from the first day of dosing until 3 months after the last dose of IP.

• Have a body mass index (BMI) between 18 and 30 kg/m2, and weigh at least 50 kg

• Healthy male and/or female volunteers between the ages of 18 to 75 years inclusive, with veins on the back of both hands and both forearms suitable for cannulation or repeated venipuncture.

Exclusion Criteria:

• Use of any other investigational compound or participation in another clinical trial within 1 month prior to first administration of IP in this study

• History of any clinically significant disease or disorder (e.g., neurological, haematological, psychiatric, gastrointestinal, hepatic, renal disease)

• Positive serology result on screening for serum hepatitis B surface antigen, hepatitis C antibody (HCV), or human immunodeficiency virus (HIV)

• History or presence of gastrointestinal, hepatic, or renal disease or any other condition known to interfere with the absorption, distribution, metabolism or excretion of drugs

• Any clinically significant abnormalities in the physical examination, lab, 12-lead ECG or vital signs as judged by the investigator