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

Pfizer

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Placebo in 100 ml infusion volume; Drug: 600 mg ceftaroline in 100 ml infusion volume; Drug: Placebo in 50 ml infusion volume; Drug: 600 ceftaroline fosamil in 250 ml infusion volume; Drug: Placebo in 250 ml infusion volume; Drug: 600 mg ceftaroline fosamil in 50 ml infusion volume

Study type: Interventional

Funder types: Industry

Identifiers

NCT01577589

D3720C00015

Details and patient eligibility

About

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

Full description

A Phase I, Single-center, 2-part, Randomized, 2-way Crossover Study to Assess the Local Tolerability and Safety (Multiple-dose) and to Assess the Pharmacokinetics, Safety, and Tolerability (Single-dose) of Ceftaroline in Healthy Subjects when Ceftaroline Fosamil is Diluted in Various Infusion Volume

Enrollment: 34 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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34 participants in 6 patient groups, including a placebo group

A

Experimental group

Description:

600 mg ceftaroline fosamil in 50 ml infusion volume

Treatment:

Drug: 600 mg ceftaroline fosamil in 50 ml infusion volume

B

Placebo Comparator group

Description:

Placebo in 50 ml infusion volume

Treatment:

Drug: Placebo in 50 ml infusion volume

C

Experimental group

Description:

600 ceftaroline fosamil in 250 ml infusion volume

Treatment:

Drug: 600 ceftaroline fosamil in 250 ml infusion volume

D

Placebo Comparator group

Description:

Placebo in 250 ml infusion volume

Treatment:

Drug: Placebo in 250 ml infusion volume

E

Experimental group

Description:

600 mg ceftaroline in 100 ml infusion volume

Treatment:

Drug: 600 mg ceftaroline in 100 ml infusion volume

F

Placebo Comparator group

Description:

Placebo in 100 ml infusion volume

Treatment:

Drug: Placebo in 100 ml infusion volume