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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-30

Study Completion Date

2012-09-30

Brief Summary

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

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Detailed Description

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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

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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A

600 mg ceftaroline fosamil in 50 ml infusion volume

Group Type EXPERIMENTAL

600 mg ceftaroline fosamil in 50 ml infusion volume

Intervention Type DRUG

IV infusion

B

Placebo in 50 ml infusion volume

Group Type PLACEBO_COMPARATOR

Placebo in 50 ml infusion volume

Intervention Type DRUG

IV infusion

C

600 ceftaroline fosamil in 250 ml infusion volume

Group Type EXPERIMENTAL

600 ceftaroline fosamil in 250 ml infusion volume

Intervention Type DRUG

IV infusion

D

Placebo in 250 ml infusion volume

Group Type PLACEBO_COMPARATOR

Placebo in 250 ml infusion volume

Intervention Type DRUG

IV infusion

E

600 mg ceftaroline in 100 ml infusion volume

Group Type EXPERIMENTAL

600 mg ceftaroline in 100 ml infusion volume

Intervention Type DRUG

IV infusion

F

Placebo in 100 ml infusion volume

Group Type PLACEBO_COMPARATOR

Placebo in 100 ml infusion volume

Intervention Type DRUG

IV infusion

Interventions

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600 mg ceftaroline fosamil in 50 ml infusion volume

IV infusion

Intervention Type DRUG

Placebo in 50 ml infusion volume

IV infusion

Intervention Type DRUG

600 ceftaroline fosamil in 250 ml infusion volume

IV infusion

Intervention Type DRUG

Placebo in 250 ml infusion volume

IV infusion

Intervention Type DRUG

600 mg ceftaroline in 100 ml infusion volume

IV infusion

Intervention Type DRUG

Placebo in 100 ml infusion volume

IV infusion

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes