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



Status:Completed
Conditions:Renal Impairment / Chronic Kidney Disease
Therapuetic Areas:Nephrology / Urology
Healthy:No
Age Range:18 - 75
Updated:1/17/2019
Start Date:December 2010
End Date:February 2011

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

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.


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
We found this trial at
4
sites
825 South 8th Street
Minneapolis, Minnesota 55404
888-345-2567
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Minneapolis, MN
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5055 South Orange Ave Orlando FL 32909
Orlando, Florida 32806
407-240-7878
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Orlando, FL
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Knoxville, Tennessee 37920
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Knoxville, TN
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Miami, Florida 33014
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Miami, FL
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