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Pharmacokinetic Study,Ceftobiprole,Healthy Volunteers,Healthy Patients With End Stage Renal Disease

Primary Purpose

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 Staphylococcal Skin Infections focused on measuring Renal Dialysis, Ceftobiprole, Skin and soft tissue Infections, Staphylococcal Skin Infections, Streptococcal Infection

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Healthy volunteer or be a hemodialysis patient in stable physical condition with a diagnosis of ESRD and requiring hemodialysis treatment 3 times per week

Exclusion Criteria:

  • History of repeated severe nausea
  • History of infection with hepatitis B, hepatitis C, or human immunodeficiency virus (HIV)
  • Recent febrile illness

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Ceftobiprole (end-stage renal disease subjects).

    Ceftobiprole (healthy subjects)

    Arm Description

    Ceftobiprole 250mg single dose over 2 hours.

    Ceftobiprole 250 mg single dose over 2 hours.

    Outcomes

    Primary Outcome Measures

    To characterize the pharmacokinetics of ceftobiprole and its open-ring metabolite in patients undergoing dialysis.

    Secondary Outcome Measures

    To assess the safety and tolerability of ceftobiprole in patients with ESRD undergoing dialysis and in a control group of healthy volunteers with normal renal function
    To compare the pharmacokinetics of ceftobiprole and its open-ring metabolite in patients with ESRD undergoing hemodialysis with a control group of healthy volunteers with normal renal function
    To determine the extent of the ceftobiprole dose removed by hemodialysis

    Full Information

    First Posted
    December 10, 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
    NCT01030731
    Brief Title
    Pharmacokinetic Study,Ceftobiprole,Healthy Volunteers,Healthy Patients With End Stage Renal Disease
    Official Title
    An Open-Label Pharmacokinetic Study of Ceftobiprole in Healthy Volunteers and Patients With End Stage Renal Disease Receiving Hemodialysis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2012
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2007 (undefined)
    Primary Completion Date
    August 2007 (Actual)
    Study Completion Date
    August 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 purpose of this study is to characterize 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 after a single 250-mg intravenous (IV) infusion (given directly into the vein) for 2 hours, before and after dialysis to patients with end-stage renal disease (ESRD) requiring hemodialysis or healthy volunteers.
    Detailed Description
    The purpose of this study is to characterize 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 after a single 250-mg intravenous (IV) infusion (given directly into the vein) for 2 hours, before and after dialysis to patients with end-stage renal disease (ESRD) requiring hemodialysis or healthy volunteers. This is a Phase 1, open label study (all patients involved know the identity of the drug). Healthy volunteers will be given a single 2-hour infusion of 250 mg ceftobiprole; patients with ESRD on hemodialysis will be given a 2-hour infusion of 250 mg ceftobiprole 3 hours either before dialysis or immediately after dialysis. Plasma and urine samples will be assayed for ceftobiprole. Samples will be collected over a 48 hour period of time. Safety evaluations will include monitoring of adverse events, clinical laboratory tests (hematology and serum chemistry in all patients/volunteers, and urinalysis in healthy volunteers subjects), pregnancy testing, vital signs, physical examination, and recording of concomitant medications. Healthy volunteers will be given a single 2-hour infusion of 250 mg ceftobiprole; patients with ESRD on hemodialysis will be given a 2-hour infusion of 250 mg ceftobiprole 3 hours either before dialysis or immediately after dialysis.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Staphylococcal Skin Infections, Streptococcal Infections
    Keywords
    Renal Dialysis, Ceftobiprole, Skin and soft tissue Infections, Staphylococcal Skin Infections, Streptococcal Infection

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Phase 1
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Enrollment
    12 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Ceftobiprole (end-stage renal disease subjects).
    Arm Type
    Experimental
    Arm Description
    Ceftobiprole 250mg single dose over 2 hours.
    Arm Title
    Ceftobiprole (healthy subjects)
    Arm Type
    Active Comparator
    Arm Description
    Ceftobiprole 250 mg single dose over 2 hours.
    Intervention Type
    Drug
    Intervention Name(s)
    Ceftobiprole
    Intervention Description
    Ceftobiprole 250mg single dose over 2 hours.
    Primary Outcome Measure Information:
    Title
    To characterize the pharmacokinetics of ceftobiprole and its open-ring metabolite in patients undergoing dialysis.
    Time Frame
    Days 1 through 3 of study period 1 for healthy volunteers with normal renal function and Days 1 through 5 of study period 1 (predialysis) and study period 2 (postdialysis) for patients with ESRD
    Secondary Outcome Measure Information:
    Title
    To assess the safety and tolerability of ceftobiprole in patients with ESRD undergoing dialysis and in a control group of healthy volunteers with normal renal function
    Time Frame
    31 days for healthy volunteers and 52 days for patients with ESRD, including the screening, treatment, end-of-study, and follow-up phase
    Title
    To compare the pharmacokinetics of ceftobiprole and its open-ring metabolite in patients with ESRD undergoing hemodialysis with a control group of healthy volunteers with normal renal function
    Time Frame
    Days 1 through 3 of study period 1 for healthy volunteers with normal renal function and Days 1 through 5 of study period 1 (predialysis) and study period 2 (postdialysis) for patients with ESRD
    Title
    To determine the extent of the ceftobiprole dose removed by hemodialysis
    Time Frame
    Days 1 through 3 of study period 1 for healthy volunteers with normal renal function and Days 1 through 5 of study period 1 (predialysis) and study period 2 (postdialysis) for patients with ESRD

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Healthy volunteer or be a hemodialysis patient in stable physical condition with a diagnosis of ESRD and requiring hemodialysis treatment 3 times per week Exclusion Criteria: History of repeated severe nausea History of infection with hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) Recent febrile illness
    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=746&filename=CR012448_CSR.pdf
    Description
    Pharmacokinetic Study of Ceftobiprole in Healthy Volunteers and Patients With End Stage Renal Disease Receiving Hemodialysis

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