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

NCT ID: NCT01026558

Last Updated: 2012-08-28

Basic Information

• 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

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

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

Obesity; Staphylococcal Skin Infections; Streptococcal Infections

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

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

Ceftobiprole

Ceftobiprole, 500 mg as single iv infusion over 2 hours

Intervention Type: DRUG

Eligibility Criteria

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

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

INDUSTRY

Sponsor Role: collaborator

Basilea Pharmaceutica

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

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

Role: STUDY_DIRECTOR

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

Related Links

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

CSI-1008

Identifier Type: OTHER

Identifier Source: secondary_id

CR014185

Identifier Type: -

Identifier Source: org_study_id