A Study Evaluating the Pharmacokinetics of Ceftobiprole When Taken by Obese Patients
Primary Purpose
Obesity, Staphylococcal Skin Infections, Streptococcal Infections
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Ceftobiprole
Sponsored by
About this trial
This is an interventional basic science trial for Obesity focused on measuring Obesity, Ceftobiprole, Skin Infections, Staphylococcal Skin Infections, Bacterial Skin Infections, Streptococcal Infection
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Ceftobiprole (not morbidly obese subjects)
Ceftobiprole (morbidly obese subjects)
Arm Description
Ceftobiprole 500 mg single-dose over 2 hours.
Ceftobiprole 500 mg single-dose over 2 hours.
Outcomes
Primary Outcome Measures
The pharmacokinetics of ceftobiprole in morbidly obese patients and non-obese patients
Secondary Outcome Measures
To assess the pharmacodynamics of ceftobiprole in morbidly obese patients and non-obese patients.
To assess safety and tolerability of ceftobiprole in order to support dosing recommendations in the morbidly obese population.
Full Information
NCT ID
NCT01026558
First Posted
December 3, 2009
Last Updated
August 27, 2012
Sponsor
Basilea Pharmaceutica
Collaborators
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
1. Study Identification
Unique Protocol Identification Number
NCT01026558
Brief Title
A Study Evaluating the Pharmacokinetics of Ceftobiprole When Taken by Obese Patients
Official Title
Open-Label, Single Dose, Parallel Group Pharmacokinetic Study of Ceftobiprole in Morbidly Obese and Non-Obese Patients
Study Type
Interventional
2. Study Status
Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
August 2007 (undefined)
Primary Completion Date
November 2007 (Actual)
Study Completion Date
November 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Basilea Pharmaceutica
Collaborators
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Staphylococcal Skin Infections, Streptococcal Infections
Keywords
Obesity, Ceftobiprole, Skin Infections, Staphylococcal Skin Infections, Bacterial Skin Infections, Streptococcal Infection
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ceftobiprole (not morbidly obese subjects)
Arm Type
Active Comparator
Arm Description
Ceftobiprole 500 mg single-dose over 2 hours.
Arm Title
Ceftobiprole (morbidly obese subjects)
Arm Type
Experimental
Arm Description
Ceftobiprole 500 mg single-dose over 2 hours.
Intervention Type
Drug
Intervention Name(s)
Ceftobiprole
Intervention Description
Ceftobiprole, 500 mg as single iv infusion over 2 hours
Primary Outcome Measure Information:
Title
The pharmacokinetics of ceftobiprole in morbidly obese patients and non-obese patients
Time Frame
up to 30 days (up to 21 days screening plus 2 days open-label treatment phase plus 1-week follow-up).
Secondary Outcome Measure Information:
Title
To assess the pharmacodynamics of ceftobiprole in morbidly obese patients and non-obese patients.
Time Frame
Up to 30 days (up to 21 days screening plus 2 days open label treatment phase plus 1-week follow-up)
Title
To assess safety and tolerability of ceftobiprole in order to support dosing recommendations in the morbidly obese population.
Time Frame
Throughout the study from Day -1 through the post-study follow up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
Organizational Affiliation
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Official's Role
Study Director
12. IPD Sharing Statement
Links:
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_6051&studyid=770&filename=CR014185_CSR.pdf
Description
Open-Label, Single Dose, Parallel Group Pharmacokinetic Study of Ceftobiprole in Morbidly Obese and Non-Obese Subjects
Learn more about this trial
A Study Evaluating the Pharmacokinetics of Ceftobiprole When Taken by Obese Patients
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