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

Study Overview
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Brief Summary
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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
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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.

Official Title
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An Open-Label Pharmacokinetic Study of Ceftobiprole in Healthy Volunteers and Patients With End Stage Renal Disease Receiving Hemodialysis

Conditions
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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: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Male

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
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ceftobiprole (end-stage renal disease subjects).<br>Ceftobiprole 250mg single dose over 2 hours. | Drug: Ceftobiprole<br>* Ceftobiprole 250mg single dose over 2 hours.<br>|
| Active Comparator: Ceftobiprole (healthy subjects)<br>Ceftobiprole 250 mg single dose over 2 hours. | Drug: Ceftobiprole<br>* Ceftobiprole 250mg single dose over 2 hours.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To characterize the pharmacokinetics of ceftobiprole and its open-ring metabolite in patients undergoing dialysis. |  | 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 Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  | 31 days for healthy volunteers and 52 days for patients with ESRD, including the screening, treatment, end-of-study, and follow-up phase | 
| 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 |  | 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 | 
| To determine the extent of the ceftobiprole dose removed by hemodialysis |  | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Renal Dialysis, Ceftobiprole, Skin and soft tissue Infections, Staphylococcal Skin Infections, Streptococcal Infection