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The purpose of this study is to evaluate the effect of renal function on the biological activity of telavancin using blood samples obtained from subjects with normal renal function, severe renal impairment, and end stage renal disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Normal renal function | Experimental | Subjects with normal renal function |
|
| Severe renal impairment | Experimental | Subjects with severe renal impairment |
|
| End stage renal disease | Experimental | Subjects with end stage renal disease |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| telavancin | Drug | Intravenous |
|
| Measure | Description | Time Frame |
|---|---|---|
| Concentration of telavancin as estimated by antibiotic potency bioassay | Days 1-4 | |
| Concentration of telavancin as determined by standard Liquid Chromatography Tandem Mass Spectrometer (LC/MS/MS) | Days 1-4 |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic variables through analysis of blood samples | Days 1-4 |
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Inclusion Criteria:
Weighs at least 45 kg and body mass index of 18 to 40 kg/m2, inclusive
An estimated creatinine clearance value based on Cockcroft-Gault method of:
If female, the subject is at least 2 years postmenopausal, surgically sterile or practicing effective birth control, and is not pregnant or lactating
Good venous access
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Cumberland Pharmaceuticals, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Pharmacology of Miami | Miami | Florida | 33014 | United States | ||
| Orlando Clinical Research Center |
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| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| C487637 | telavancin |
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| Orlando |
| Florida |
| 32809 |
| United States |
| DaVita Clinical Research | Minneapolis | Minnesota | 55404 | United States |
| New Orleans Center for Clinical Research | Knoxville | Tennessee | 37920 | United States |
| D052801 | Male Urogenital Diseases |
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |