| Trial ID: | L1646 |
| Source ID: | NCT01030731
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| Associated Drug: |
Ceftobiprole
|
| Title: |
Pharmacokinetic Study,Ceftobiprole,Healthy Volunteers,Healthy Patients With End Stage Renal Disease
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| Acronym: |
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| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Staphylococcal Skin Infections|Streptococcal Infections
|
| Interventions: |
DRUG: Ceftobiprole
|
| Outcome Measures: |
Primary: 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: 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
|
| Sponsor/Collaborators: |
Sponsor: Basilea Pharmaceutica | Collaborators: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
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| Gender: |
MALE
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| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
12
|
| Study Type: |
INTERVENTIONAL
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| Study Designs: |
Allocation: |Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: BASIC_SCIENCE
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| Start Date: |
2007-05
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| Completion Date: |
2007-08
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| Results First Posted: |
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| Last Update Posted: |
2012-08-28
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| Locations: |
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| URL: |
https://clinicaltrials.gov/show/NCT01030731
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