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
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
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
NCT ID
NCT01030731
First Posted
December 10, 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
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
Learn more about this trial
Pharmacokinetic Study,Ceftobiprole,Healthy Volunteers,Healthy Patients With End Stage Renal Disease
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