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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
Basilea Pharmaceutica
About
Eligibility
Locations
Arms
Outcomes
Full info

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

19 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    December 3, 2009
    Last Updated
    August 27, 2012
    Sponsor
    Basilea Pharmaceutica
    Collaborators
    Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
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    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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