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

Study Overview
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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

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

Conditions
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Obesity, Staphylococcal Skin Infections, Streptococcal Infections

Intervention / Treatment
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* Drug: Ceftobiprole


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ceftobiprole (not morbidly obese subjects)<br>Ceftobiprole 500 mg single-dose over 2 hours. | Drug: Ceftobiprole<br>* Ceftobiprole, 500 mg as single iv infusion over 2 hours<br>|
| Experimental: Ceftobiprole (morbidly obese subjects)<br>Ceftobiprole 500 mg single-dose over 2 hours. | Drug: Ceftobiprole<br>* Ceftobiprole, 500 mg as single iv infusion over 2 hours<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The pharmacokinetics of ceftobiprole in morbidly obese patients and non-obese patients |  | up to 30 days (up to 21 days screening plus 2 days open-label treatment phase plus 1-week follow-up). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the pharmacodynamics of ceftobiprole in morbidly obese patients and non-obese patients. |  | Up to 30 days (up to 21 days screening plus 2 days open label treatment phase plus 1-week follow-up) | 
| To assess safety and tolerability of ceftobiprole in order to support dosing recommendations in the morbidly obese population. |  | Throughout the study from Day -1 through the post-study follow up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obesity, Ceftobiprole, Skin Infections, Staphylococcal Skin Infections, Bacterial Skin Infections, Streptococcal Infection