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

This study has been completed.
Sponsor:
Collaborator:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Information provided by (Responsible Party):
Basilea Pharmaceutica
ClinicalTrials.gov Identifier:
NCT01026558
First received: December 3, 2009
Last updated: August 27, 2012
Last verified: August 2012
  Purpose

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.


Condition Intervention Phase
Obesity
Staphylococcal Skin Infections
Streptococcal Infections
Drug: Ceftobiprole
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Open-Label, Single Dose, Parallel Group Pharmacokinetic Study of Ceftobiprole in Morbidly Obese and Non-Obese Patients

Resource links provided by NLM:


Further study details as provided by Basilea Pharmaceutica:

Primary Outcome Measures:
  • 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). ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 25
Study Start Date: August 2007
Study Completion Date: November 2007
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Ceftobiprole (not morbidly obese subjects)
Ceftobiprole 500 mg single-dose over 2 hours.
Drug: Ceftobiprole
Ceftobiprole, 500 mg as single iv infusion over 2 hours
Experimental: Ceftobiprole (morbidly obese subjects)
Ceftobiprole 500 mg single-dose over 2 hours.
Drug: Ceftobiprole
Ceftobiprole, 500 mg as single iv infusion over 2 hours

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

  Eligibility

Ages Eligible for Study:   19 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01026558

Sponsors and Collaborators
Basilea Pharmaceutica
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Investigators
Study Director: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
  More Information

Additional Information:
No publications provided

Responsible Party: Basilea Pharmaceutica
ClinicalTrials.gov Identifier: NCT01026558     History of Changes
Other Study ID Numbers: CR014185, CSI-1008
Study First Received: December 3, 2009
Last Updated: August 27, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Basilea Pharmaceutica:
Obesity, Ceftobiprole
Skin Infections
Staphylococcal Skin Infections
Bacterial Skin Infections
Streptococcal Infection

Additional relevant MeSH terms:
Obesity
Skin Diseases, Infectious
Staphylococcal Skin Infections
Streptococcal Infections
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Infection
Skin Diseases
Staphylococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Skin Diseases, Bacterial
Cephalosporins
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014