A Study to Assess Safety, Tolerability and Pharmacokinetics of Ceftaroline in Healthy Subjects

Pfizer

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: Placebo; Drug: 600 mg Ceftaroline fosamil

Study type: Interventional

Funder types: Industry

Identifiers

NCT01612507

D3720C00010

Details and patient eligibility

About

The purpose of this study is to assess the safety, tolerability, and pharmacokinetics of different dose regimens of Ceftaroline

Full description

A Phase I, Single Centre, Randomised, Double-blind, Placebo-controlled Parallel Group Study to Assess the Safety, Tolerability, and Pharmacokinetics of Ceftaroline after Different Intravenous Dose Regimens of Ceftaroline Fosamil to Healthy Subjects

Enrollment: 41 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Provision of signed and dated, written informed consent prior to any study specific procedures including the optional safety biomarker analysis
• Healthy male and female subjects aged 18 to 55 years (inclusive) with suitable veins for cannulation or repeated venipuncture
• Women of childbearing potential must have a negative pregnancy test, be non-lactating, and be using a highly effective form of birth control for 1 month prior to enrollment, during the study, and for 3 months after completion of all study-related proceed
• Have a body mass index (BMI) between 18 and 30 kg/m2 and weigh at least 50 kg and no more than 100 kg

Exclusion criteria

• Has received another new chemical entity (defined as a compound which has not been approved for marketing) or has participated in any other clinical study that included drug treatment within 3 months of the first administration of investigational drug
• History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study
• Any positive result on screening for serum hepatitis B surface antigen, hepatitis C antibody, and human immunodeficiency virus (HIV)
• History or presence of gastrointestinal, hepatic, or renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs
• Any clinically significant abnormalities in the physical examination, 12-lead ECG, or vital signs, as judged by the Investigator

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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41 participants in 4 patient groups

A

Experimental group

Description:

600 mg Ceftaroline fosamil 1 h infusion

Treatment:

Drug: 600 mg Ceftaroline fosamil

Drug: 600 mg Ceftaroline fosamil

B

Experimental group

Description:

Placebo 1 h infusion

Treatment:

Drug: Placebo

Drug: Placebo

C

Experimental group

Description:

600 mg Ceftaroline fosamil 2 h infusion

Treatment:

Drug: 600 mg Ceftaroline fosamil

Drug: 600 mg Ceftaroline fosamil

D

Experimental group

Description:

Placebo 2 h infusion

Treatment:

Drug: Placebo

Drug: Placebo