A Study to Evaluate the Effect of Renal Function on the Biological Activity of Telavancin

Study Overview
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Brief Summary
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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.

Official Title
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A Phase 1 Open-Label Study to Evaluate the Effect of Renal Function on the Biological Activity of Telavancin

Conditions
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Kidney Diseases, End Stage Renal Disease

Intervention / Treatment
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* Drug: telavancin


Participation Criteria
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Eligibility Criteria
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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: >80 mL/min for subjects with normal renal function <30 mL/min for subjects with severe renal impairment receiving hemodialysis three times a week for subjects with end stage renal impairment 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: History of any clinically significant acute illness (other than renal disease and conditions related to the renal disease in renal impairment subjects, such as stable diabetes or hypertension) Has had a kidney transplant that is still functioning History of unexplained syncope, cardiac arrest, unexplained cardiac arrythmia or torsade de pointes, structural heart disease, prolonged QT interval, or family history of long QT syndrome Known hypersensitivity to telavancin or any of the excipients in the formulation, or a history of severe allergic or anaphylactic reactions History of consuming more than 7 units of alcoholic beverages per week, or history of alcoholism or substance abuse within past 2 years Known to be positive for human immunodeficiency virus antibody For subjects with normal renal function, has had treatment with prescription or non-prescription drugs, including complementary and alternative medicines or over-the counter medications, with the exception of oral contraceptives, hormone replacement therapy, daily aspirin, and occasional use of acetaminophen within the past 14 days For subjects with renal impairment, has not been on a stable dose of concomitant medications for at least 2 weeks prior to study start or is taking any medication that would interfere with the evaluation of televancin in this study Has received an experimental agent within 30 days or ten half-lives, whichever is longer, prior to study drug administration Has had any significant blood loss, donated one unit (450 mL) of blood or more, or received a transfusion of any blood or blood products within 60 days or donated plasma within 7 days prior to admission

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

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: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Normal renal function<br>Subjects with normal renal function | Drug: telavancin<br>* Intravenous<br>* Other names: ASP9809;|
| Experimental: Severe renal impairment<br>Subjects with severe renal impairment | Drug: telavancin<br>* Intravenous<br>* Other names: ASP9809;|
| Experimental: End stage renal disease<br>Subjects with end stage renal disease | Drug: telavancin<br>* Intravenous<br>* Other names: ASP9809;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic variables through analysis of blood samples |  | Days 1-4 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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telavancin, Pharmacokinetics, Severe renal disease, VIBATIV®, ASP9809