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A Study Evaluating the Pharmacokinetics of Ceftobiprole When Taken by Obese Patients

NCT ID: NCT01026558

Last Updated: 2012-08-28

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

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-08-31

Study Completion Date

2007-11-30

Brief Summary

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The primary objective of this study is to compare the pharmacokinetics (how drugs are absorbed in the body, how they are distributed within the body and how they are removed from the body over time) of ceftobiprole in morbidly obese patients and non-obese patients. The secondary objectives are to assess the pharmacodynamics (the study of the action or effects a drug has on the body) and to assess safety and tolerability of ceftobiprole in order to support dosing recommendations in the morbidly obese population.

Detailed Description

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This is an open-label (all people involved know the identity of the intervention), parallel-group, Phase 1 study in morbidly obese and non-obese men and women. A total of 25 patients (12 morbidly obese and 13 non-obese) patients will be enrolled in the study. Morbidly obese and nonobese patients are matched individually 1:1 by age (±10 years), sex, and renal function (as defined by creatinine levels in the urine). There are 4 phases in the clinical study: the pretreatment (screening/baseline) phase of up to 21 days; the 2-day open-label treatment phase when each patients receives a single 2-hour intravenous (directly into the vein) infusion of ceftobiprole 500 mg followed by multiple (up to 15) blood and urine samples drawn over the 24 hours following study drug administration; and the follow-up phase of approximately 1 week after the last blood sample when each patient will be monitored by telephone for development of new adverse events and assessment of ongoing adverse events. Each patient receives a single 2-hour infusion (directly into the vein) of ceftobiprole 500 mg

Conditions

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Obesity Staphylococcal Skin Infections Streptococcal Infections

Keywords

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Obesity, Ceftobiprole Skin Infections Staphylococcal Skin Infections Bacterial Skin Infections Streptococcal Infection

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Ceftobiprole (not morbidly obese subjects)

Ceftobiprole 500 mg single-dose over 2 hours.

Group Type ACTIVE_COMPARATOR

Ceftobiprole

Intervention Type DRUG

Ceftobiprole, 500 mg as single iv infusion over 2 hours

Ceftobiprole (morbidly obese subjects)

Ceftobiprole 500 mg single-dose over 2 hours.

Group Type EXPERIMENTAL

Ceftobiprole

Intervention Type DRUG

Ceftobiprole, 500 mg as single iv infusion over 2 hours

Interventions

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Ceftobiprole

Ceftobiprole, 500 mg as single iv infusion over 2 hours

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Body mass index (BMI) =or \> 40 kg/m2 or normal BMI between 18-30
* Blood pressure 90-140 mm
* Non-smoker

Exclusion Criteria

* History of medically significant illness
* Uncontrolled hypertension
* Uncontrolled high blood cholesterol and triglycerides
Minimum Eligible Age

19 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

INDUSTRY

Sponsor Role collaborator

Basilea Pharmaceutica

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial

Role: STUDY_DIRECTOR

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Related Links

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http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_6051&studyid=770&filename=CR014185_CSR.pdf

Open-Label, Single Dose, Parallel Group Pharmacokinetic Study of Ceftobiprole in Morbidly Obese and Non-Obese Subjects

Other Identifiers

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CSI-1008

Identifier Type: OTHER

Identifier Source: secondary_id

CR014185

Identifier Type: -

Identifier Source: org_study_id